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WHO/DAP/94.
11
Distr: General
Original: English
WHO/DAP/94.11
Distr: General
Original: English
Guide to Good Prescribing
A practical manual
World Health Organization
Action Programme on Essential Drugs
Geneva
uthors
T. P. G. M. de ries
!
". H. Henning
!
H. . Hogerzeil
#
D. A. $resle
#
With contributions from F.M. Haaijer-Ruskamp and R.M. van Gilst
!
Department o% &linical Pharmacolog'( $acult' o% Medicine( )niversit' o%
Groningen( The *etherlands +WHO &ollaborating &entre %or Pharmacotherap'
Teaching and Training,
#
WHO Action Programme on Essential Drugs( Geneva( -.itzerland
Ac/no.ledgments
The support o% the %ollo.ing persons in revie.ing earlier dra%ts o% this boo/ is
grate%ull' ac/no.ledged0 -.". Ahmad +Pa/istan,( A. Al.an +WHO,( $.-. Antezana
+WHO,( 1.-. 2apna +3ndia,( W. 2ender +*etherlands,( 4. 2ero +)-A,( -. 2erthoud
+$rance,( 5. 2esseghir +3ran,( &. 2oelen +WHO,( P. 2rudon61a/obo.icz +WHO,(
P. 2ush +)-A,( M.". &ouper +WHO,( M. Das +Mala'sia,( &.T. Doller' +)nited
5ingdom,( M.*.G. Du/es +*etherlands,( 1.$. Dunne +WHO,( H. $raser +2arbados,(
M. Gabir +-udan,( 2.2. Gaitonde +3ndia,( W. Gard7ito +3ndonesia,( M. Helling6
2orda +WHO,( A. Her8heimer +)nited 5ingdom,( 1. 3d9np99n6Hei//il9 +WHO,( 5.5.
5a%le +*epal,( :.4. 5intanar +Philippines,( M.M. 5ochen +German',( A..
5ondrachine +WHO,( &. 5unin +)-A,( ". 4aing +;imbab.e,( &.D.1. de 4angen
+*etherlands,( . 4epa/hin +)--",( A. Mabade7e +*igeria,( .-. Mathur +2ahrain,(
E. *anga.e +Tanzania,( 1. Orle' +WHO,( M. Orme +)nited 5ingdom,( A. Pio +WHO,(
1. :uic/ +)-A,( A. -aleh +WHO,( 2. -antoso +3ndonesia,( E. -anz +-pain,(
$. -avage +WHO,( A.1.1.A. -cherpbier +*etherlands,( $. -iem T7am +WHO,(
$. -7<=vist +-.eden,( A. -itsen +*etherlands,( A.1. -mith +Australia,( 1.4. Tulloch
+WHO,( 5. Weerasuri'a +-ri 4an/a,( 3. ;ebro.s/a64upina +Poland,( ;. 2en ;vi
+3srael,.
The %ollo.ing persons gave invaluable assistance in %ield testing the dra%t( and their
support is grate%ull' ac/no.ledged0 1.-. 2apna +3ndia,( 4. 2ero +)-A,( 5.5. 5a%le
+*epal,( A. Mabade7e +*igeria,( 2. -antoso +3ndonesia,( A.1. -mith +Australia,.
3llustrations on p. >?( @#0 2. &ornelius +.ith permission %rom ademecum,A p. @0
P. ten HaveA anne8es and cartoon on p. ##0 T.P.G.M. de ries.
A
iii
Contents
able o% contents
W
h' 'ou need this boo/.....................................................................................................
Part 1: Overview ...................................................................................................................
&hapter !0 The process o% rational treatment...............................................................
Part 2: Selecting your P(ersonal) drugs...............................................................................
&hapter #0 3ntroduction to P6drugs...............................................................................
&hapter B0 E8ample o% selecting a P6drug0 angina pectoris..........................................
&hapter C0 Guidelines %or selecting P6drugs.................................................................
&hapter >0 P6drug and P6treatment..............................................................................
Part 3: Treating your patients............................................................................................ 33
&hapter ?0 -TEP !0 De%ine the patientDs problem.........................................................
&hapter @0 -TEP #0 -peci%' the therapeutic ob7ective..................................................
&hapter E0 -TEP B0 eri%' the suitabilit' o% 'our P6drug...............................................
&hapter F0 -TEP C0 Write a prescription.......................................................................
&hapter !G0 -TEP >0 Give in%ormation( instructions and .arnings.................................
&hapter !!0 -TEP ?0 Monitor +and stopH, the treatment.................................................
Part 4: Keeping uptodate.....................................................................................................
&hapter !#0 Ho. to /eep up6to6date about drugs...........................................................
!nne"es..................................................................................................................................
Anne8 !0 Essentials o% pharmacolog' in dail' practice...............................................
Anne8 #0 Essential re%erences...................................................................................
Anne8 B0 Ho. to e8plain the use o% some dosage %orms...........................................
Anne8 C0 The use o% in7ections...................................................................................
T
i
ist o% patient e8amples
!. Ta8i6driver .ith dr' cough................................................................................................ ?
#. Angina pectoris.............................................................................................................. !?
B. -ore throat.................................................................................................................... BC
C. -ore throat( H3............................................................................................................. BC
>. -ore throat( pregnanc'.................................................................................................. BC
?. -ore throat( chronic diarrhoea.......................................................................................BC
@. -ore throat.................................................................................................................... BC
E. Pol'pharmac'................................................................................................................ B>
F. Girl .ith .ater' diarrhoea.............................................................................................. BE
!G. -ore throat( pregnanc'.................................................................................................. BE
!!. 3nsomnia........................................................................................................................ BE
!#. Tiredness....................................................................................................................... BE
!B. Asthma and h'pertension..............................................................................................C!
!C. Girl .ith acute asthma attac/........................................................................................C!
!>. Pregnant .oman .ith abscess...................................................................................... C#
!?. 2o' .ith pneumonia...................................................................................................... C#
!@. Diabetes and h'pertension............................................................................................CB
!E. Terminal lung cancer..................................................................................................... CB
!F. &hronic rheumatic disease............................................................................................CB
#G. Depression.................................................................................................................... CB
#!. Depression.................................................................................................................... C@
##. &hild .ith giardiasis....................................................................................................... C@
#B. Dr' cough...................................................................................................................... CE
#C. Angina pectoris.............................................................................................................. CE
#>. -leeplessness............................................................................................................... CE
#?. Malaria proph'la8is....................................................................................................... CE
#@. 2o' .ith acute con7unctivitis..........................................................................................CE
#E. Wea/ness( anaemia...................................................................................................... CE
#F. 2o' .ith mild pneumonia............................................................................................... >B
BG. &ongestive heart %ailure and h'pertension....................................................................>B
B!. Migraine........................................................................................................................ >C
B#. Terminal pancreatic cancer............................................................................................>C
BB. &ongestive heart %ailure and h'pertension....................................................................>?
BC. Depression.................................................................................................................... >F
B>. aginal trichomonas...................................................................................................... >F
B?. Essential h'pertension.................................................................................................. >F
B@. 2o' .ith pneumonia...................................................................................................... >F
BE. Migraine........................................................................................................................ >F
BF. Pneumonia.................................................................................................................... ?B
CG. M'algia and arthritis...................................................................................................... ?B
C!. Mild h'pertension.......................................................................................................... ?B
C#. -leeplessness............................................................................................................... ?C
ii
4
Why you need this book
h' 'ou need this boo/
At the start o% clinical training most medical students %ind that the' donDt have a ver'
clear idea o% ho. to prescribe a drug %or their patients or .hat in%ormation the' need
to provide. This is usuall' because their earlier pharmacolog' training has
concentrated more on theor' than on practice. The material .as probabl' Ddrug6
centredD( and %ocused on indications and side e%%ects o% di%%erent drugs. 2ut in
clinical practice the reverse approach has to be ta/en( %rom the diagnosis to the
drug. Moreover( patients var' in age( gender( size and sociocultural characteristics(
all o% .hich ma' a%%ect treatment choices. Patients also have their o.n perception o%
appropriate treatment( and should be %ull' in%ormed partners in therap'. All this is
not al.a's taught in medical schools( and the number o% hours spent on
therapeutics ma' be lo. compared to traditional pharmacolog' teaching.
&linical training %or undergraduate students o%ten %ocuses on diagnostic rather than
therapeutic s/ills. -ometimes students are onl' e8pected to cop' the prescribing
behaviour o% their clinical teachers( or e8isting standard treatment guidelines(
.ithout e8planation as to why certain treatments are chosen. 2oo/s ma' not be
much help either. Pharmacolog' re%erence .or/s and %ormularies are drug6centred(
and although clinical te8tboo/s and treatment guidelines are disease6centred and
provide treatment recommendations( the' rarel' discuss .h' these therapies are
chosen. Di%%erent sources ma' give contradictor' advice.
The result o% this approach to pharmacolog' teaching is that although
pharmacological /no.ledge is ac=uired( practical prescribing s/ills remain .ea/. 3n
one stud'( medical graduates chose an inappropriate or doubt%ul drug in about hal%
o% the cases( .rote one6third o% prescriptions incorrectl'( and in t.o6thirds o% cases
%ailed to give the patient important in%ormation. -ome students ma' thin/ that the'
.ill improve their prescribing s/ills after %inishing medical school( but research
sho.s that despite gains in general e8perience( prescribing s/ills do not improve
much a%ter graduation.
2ad prescribing habits lead to ine%%ective and unsa%e treatment( e8acerbation or
prolongation o% illness( distress and harm to the patient( and higher costs. The'
also ma/e the prescriber vulnerable to in%luences .hich can cause irrational
prescribing( such as patient pressure( bad e8ample o% colleagues and high6
po.ered salesmanship. 4ater on( ne. graduates .ill cop' them( completing the
circle. &hanging e8isting prescribing habits is ver' di%%icult. -o good training is
needed before poor habits get a chance to develop.
This boo/ is primaril' intended %or undergraduate medical students .ho are about
to enter the clinical phase o% their studies. 3t provides step b' step guidance to the
process o% rational prescribing( together .ith man' illustrative e8amples. 3t teaches
s/ills that are necessar' throughout a clinical career. Postgraduate students and
practising doctors ma' also %ind it a source o% ne. ideas and perhaps an incentive
%or change.
3ts contents are based on ten 'ears o% e8perience .ith pharmacotherap' courses
%or medical students in the Medical $acult' o% the )niversit' o% Groningen
W
1
+*etherlands,. The dra%t has been revie.ed b' a large bod' o% international e8perts
in pharmacotherap' teaching and has been %urther tested in medical schools in
Australia( 3ndia( 3ndonesia( *epal( *etherlands( *igeria and the )-A +see 2o8 !,.
This manual %ocuses on the process o% prescribing. 3t gives 'ou the tools to thin/ %or
'oursel% and not blindl' %ollo. .hat other people thin/ and do. 3t also enables 'ou
to understand .h' certain national or departmental standard treatment guidelines
have been chosen( and teaches 'ou ho. to ma/e the best use o% such guidelines.
The manual can be used %or sel%6stud'( %ollo.ing the s'stematic approach outlined
belo.( or as part o% a %ormal training course.
Part 1: T#e process o$ rational treat%ent
This overvie. ta/es 'ou step b' step %rom problem to solution. "ational treatment
re=uires a logical approach and common sense. A%ter reading this chapter 'ou .ill
/no. that prescribing a drug is part o% a process that includes man' other
components( such as speci%'ing 'our therapeutic ob7ective( and in%orming the
patient.
Part 2: Selecting your Pdrugs
This section e8plains the principles o% drug selection and ho. to use them in
practice. 3t teaches 'ou ho. to choose the drugs that 'ou are going to prescribe
regularl' and .ith .hich 'ou .ill become %amiliar( called P+ersonal,6drugs. 3n this
selection process 'ou .ill have to consult 'our pharmacolog' te8tboo/( national
%ormular'( and available national and international treatment guidelines. A%ter 'ou
have .or/ed 'our .a' through this section 'ou .ill /no. ho. to select a drug %or a
particular disease or complaint.
Part 3: Treating your patients
This part o% the boo/ sho.s 'ou ho. to treat a patient. Each step o% the process is
described in separate chapters. Practical e8amples illustrate ho. to select(
prescribe and monitor the treatment( and ho. to communicate e%%ectivel' .ith 'our
patients. When 'ou have gone through this material 'ou are read' to put into
practice .hat 'ou have learned.
2
2o8 !0 $ield test o% the Guide to Good Prescribing in seven universities
The impact o% a short interactive training course in pharmacotherap'( using the Guide to Good
Prescribing( .as measured in a controlled stud' .ith #!F undergraduate medical students in
Groningen( 5athmandu( 4agos( *e.castle +Australia,( *e. Delhi( -an $rancisco and
Iog'a/arta. The impact o% the training course .as measured b' three tests( each containing
open and structured =uestions on the drug treatment o% pain( using patient e8amples. Tests
.ere ta/en be%ore the training( immediatel' a%ter( and si8 months later.
A%ter the course( students %rom the stud' group per%ormed signi%icantl' better than controls in all
patient problems presented +pJG.G>,. This applied to all old and ne. patient problems in the
tests( and to all si8 steps o% the problem solving routine. The students not onl' remembered ho.
to solve a previousl' discussed patient problem +retention e%%ect,( but the' could also appl' this
/no.ledge to other patient problems +trans%er e%%ect,. At all seven universities both retention and
trans%er e%%ects .ere maintained %or at least si8 months a%ter the training session.
Why you need this book
Part 4: Keeping uptodate
To become a good doctor( and remain one( 'ou also need to /no. ho. to ac=uire
and deal .ith ne. in%ormation about drugs. This section describes the advantages
and disadvantages o% di%%erent sources o% in%ormation.
!nne"es
The anne8es contain a brie% re%resher course on the basic principles o%
pharmacolog' in dail' practice( a list o% essential re%erences( a set o% patient
in%ormation sheets and a chec/list %or giving in7ections.
word of warnin!
Even i% 'ou do not al.a's agree .ith the treatment choices in some o% the
e8amples it is important to remember that prescribing should be part o% a
logical deductive process( based on comprehensive and ob7ective in%ormation.
3t should not be a /nee67er/ re%le8( a recipe %rom a Dcoo/6boo/D( or a response
to commercial pressure.
&rug na%es
3n vie. o% the importance that medical students be taught to use generic names(
the 3nternational *onproprietar' *ames +3**s, o% drugs are used throughout the
manual.
'o%%ents
The WHO Action Programme on Essential Drugs .ould be ver' glad to receive
comments on the te8t and e8amples in this manual( as .ell as reports on its use.
Please .rite to0 The Director( Action Programme on Essential Drugs( World Health
Organization( !#!! Geneva #@( -.itzerland. $a8 C!6##6@F!C!?@.
3
4
Part 1 Overview
art !0 Overvie.
As a %irst introduction to the rest o% the boo/( this
section presents an overvie. o% the logical
prescribing process. A simple e8ample o% a ta8i
driver .ith a cough is %ollo.ed b' an anal'sis o% ho.
the patientDs problem .as solved. The process o%
choosing a %irst6choice treatment is discussed %irst(
%ollo.ed b' a step b' step overvie. o% the process
o% rational treatment. Details o% the various steps are
given in subse=uent chapters.
&hapter ! page
The process o% rational treatment.........................................................................?
What is 'our %irst6choice treatment %or dr' coughH.......................................@
The process o% rational prescribing..............................................................F
&onclusion and summar'..........................................................................!G
P
5
hapter !
The process o% rational treatment
This chapter presents a %irst overvie. o% the process o% choosing a drug treatment.
The process is illustrated using an e8ample o% a patient .ith a dr' cough. The
chapter %ocuses on the principles o% a step.ise approach to choosing a drug( and is
not intended as a guideline %or the treatment o% dr' cough. 3n %act( some prescribers
.ould dispute the need %or an' drug at all. Each o% the steps in the process is
discussed in detail in subse=uent chapters.
A good scienti%ic e8periment %ollo.s a rather rigid methodolog' .ith a de%inition o%
the problem( a h'pothesis( an e8periment( an outcome and a process o%
veri%ication. This process( and especiall' the veri%ication step( ensures that the
outcome is reliable. The same principles appl' .hen 'ou treat a patient. $irst 'ou
need to de%ine care%ull' the patientDs pro(le% +the diagnosis,. A%ter that( 'ou have
to speci%' the t#erapeutic o()ective( and to c#oose a treat%ent o% proven
e%%icac' and sa%et'( %rom di%%erent alternatives. Iou then start t#e treat%ent( %or
e8ample b' .riting an accurate prescription and providing the patient .ith clear
in$or%ation and instructions. A%ter some time 'ou %onitor t#e results o% the
treatmentA onl' then .ill 'ou /no. i% it has been success%ul. 3% the problem has
been solved( the treatment can be stopped. 3% not( 'ou .ill need to re6e8amine all
the steps.
*"a%ple: patient 1
"ou sit in with a !eneral practitioner and observe the followin!
case. #$-year old ta%i-driver complains of a sore throat and
cou!h which started two weeks earlier with a cold. He has
stopped snee&in! but still has a cou!h' especially at ni!ht. (he
patient is a heavy smoker who has often been advised to stop.
Further history and e%amination reveal nothin! special' apart from
a throat inflammation. (he doctor a!ain advises the patient to stop
smokin!' and writes a prescription for codeine tablets )# m!' )
tablet * times daily for * days.
4etKs ta/e a closer loo/ at this e8ample. When 'ou observe e8perienced
ph'sicians( the process o% choosing a treatment and .riting a prescription seems
eas'. The' re%lect %or a short time and usuall' decide =uic/l' .hat to do. 2ut donDt
tr' to imitate such behaviour at this point in 'our trainingL &hoosing a treatment is
more di%%icult than it seems( and to gain e8perience 'ou need to .or/ ver'
s'stematicall'.
3n %act( there are t.o important stages in choosing a treatment. Iou start b'
considering 'our M%irst6choiceK treatment( .hich is the result o% a selection process
6
&
Chapter 1 The process of rational treatment
done earlier. The second stage is to veri%' that 'our %irst6choice treatment is
suitable %or this particular patient. -o( in order to continue( .e should de%ine our
%irst6choice treatment %or dr' cough.
What is 'our %irst6choice treatment %or dr' coughH
"ather than revie.ing all possible drugs %or the treatment o% dr' cough ever' time
'ou need one( 'ou should decide( in advance( 'our %irst6choice treatment. The
general approach in doing that is to speci%' 'our therapeutic ob7ective( to ma/e an
inventor' o% possible treatments( and to choose 'our MP+ersonal, treatmentK( on the
basis o% a comparison o% their e%%icac'( sa%et'( suitabilit' and cost. This process o%
choosing 'our P6treatment is summarized in this chapter and discussed in more
detail in Part # o% this manual.
Speci$y your t#erapeutic o()ective
3n this e8ample .e are choosing our P6treatment %or the suppression o% dr' cough.
+a,e an inventory o$ possi(le treat%ents
3n general( there are %our possible approaches to treatment0 in%ormation or adviceA
treatment .ithout drugsA treatment .ith a drugA and re%erral. &ombinations are also
possible.
7
$or dr' cough( in$or%ation and advice can be given(
e8plaining that the mucous membrane .ill not heal
because o% the cough and advising a patient to avoid
%urther irritation( such as smo/ing or tra%%ic e8haust
%umes. -peci%ic nondrug treat%ent %or this condition
doesnKt e8ist( but there are a %e. drugs to treat a dr'
cough. Iou should ma/e 'our personal selection
.hile still in medical school( and then get to /no.
these MP+ersonal, drugsK thoroughl'. 3n the case o% dr'
cough an opioid cough suppressant or a sedative
antihistamine could be considered as potential P6
drugs. The last therapeutic possibilit' is to re$er the
patient %or %urther anal'sis and treatment. $or an initial
treatment o% dr' cough this is not necessar'.
3n summar'( treatment o% dr' cough ma' consist o% advice to avoid irritation o% the
lungs( andNor suppression o% the cough b' a drug.
'#oose your Ptreat%ent on t#e (asis o$ e$$icacy- sa$ety- suita(ility and cost
The ne8t stage is to compare the various treatment alternatives. To do this in a
scienti%ic and ob7ective manner 'ou need to consider %our criteria0 e%%icac'( sa%et'(
suitabilit' and cost.
8
&artoon !
3% the patient is .illing and able to %ollo. advice to avoid lung irritation %rom smo/ing
or other causes( this .ill be therapeuticall' e%%ective( since the in%lammation o% the
mucous membrane .ill subside .ithin a %e. da's. 3t is also sa%e and cheap.
Ho.ever( the discom%ort o% nicotine .ithdra.al ma' cause habituated smo/ers to
ignore such advice.
Opioid cough depressants( such as codeine( noscapine( pholcodine(
de8tromethor%an and the stronger opiates such as morphine( diamorphine and
methadone( e%%ectivel' suppress the cough re%le8. This allo.s the mucous
membrane to regenerate( although the e%%ect .ill be less i% the lungs continue to be
irritated. The most %re=uent side e%%ects are constipation( dizziness and sedation. 3n
high doses the' ma' even depress the respirator' centre. When ta/en %or a long
time tolerance ma' develop. -edative antihistamines( such as diphenh'dramine(
are used as the cough depressant component o% man' compound cough
preparationsA all tend to cause dro.siness and their e%%icac' is disputed.
Weighing these %acts is the most di%%icult step( and one .here 'ou must ma/e 'our
o.n decisions. Although the implications o% most data are %airl' clear( prescribers
.or/ in var'ing sociocultural conte8ts and .ith di%%erent treatment alternatives
available. -o the aim o% this manual is to teach 'ou #ow( and not w#at( to choose(
.ithin the possibilities o% 'our health care s'stems.
3n loo/ing at these t.o drug groups one has to conclude that there are not man'
alternatives available %or treating dr' cough. 3n %act( man' prescribers .ould argue
that there is hardl' an' need %or such drugs. This is especiall' true %or the man'
cough and cold preparations that are on the mar/et. Ho.ever( %or the sa/e o% this
e8ample( .e ma' conclude that an unproductive( dr' cough can be ver'
inconvenient( and that suppressing such a cough %or a %e. da's ma' have a
bene%icial e%%ect. On the grounds o% better e%%icac' .e .ould then pre%er a drug
%rom the group o% opioids.
Within this group( codeine is probabl' the best choice. 3t is available as tablets and
s'rup. *oscapine ma' have teratogenic side e%%ectsA it is not included in the 2ritish
*ational $ormular' but is available in other countries. Pholcodine is not available
as tablets. *either o% the t.o drugs are on the WHO Model 4ist o% Essential Drugs.
The stronger opiates are mainl' indicated in terminal care.
On the basis o% these data .e .ould propose the %ollo.ing %irst6choice treatment
+'our P6treatment,. $or most patients .ith a dr' cough a%ter a cold( advice .ill be
e%%ective i% it is practical and acceptable %or the patientDs circumstances. Advice is
certainl' sa%er and cheaper than drugs( but i% the patient is not better .ithin a .ee/(
codeine can be prescribed. 3% the drug treatment is not e%%ective a%ter one .ee/( the
diagnosis should be reconsidered and patient adherence to treatment veri%ied.
&odeine is our P6drug %or dr' cough. The standard dose %or adults .ould be BG6
?G mg B6C times dail' +2ritish *ational $ormular',. *oscapine and pholcodine
could be an alternative.
9
The process o% rational prescribing
*o. that .e have de%ined our P6treatment %or dr' cough( .e can revie. the
process o% rational prescribing as a .hole. This process consists o% si8 steps( each
o% .hich is discussed brie%l'( using the e8ample o% our patient .ith a dr' cough.
Each step is e8plained in detail in Part B.
Step 1: &e$ine t#e patient.s pro(le%
The patientDs problem can be described as a persistent dr' cough and a sore
throat. These are the s'mptoms that matter to the patientA but %rom the doctorDs
vie.point there might be other dangers and concerns. The patientDs problem could
be translated into a .or/ing diagnosis o% persistent dr' cough %or t.o .ee/s a%ter a
cold. There are at least three possible causes. The most li/el' is that the mucous
membrane o% the bronchial tubes is a%%ected b' the cold and there%ore easil'
irritated. A secondar' bacterial in%ection is possible but unli/el' +no %ever( no green
or 'ello.ish sputum,. 3t is even less probable that the cough is caused b' a lung
tumour( although that should be considered i% the cough persists.
Step 2: Speci$y t#e t#erapeutic o()ective
&ontinuous irritation o% the mucous membranes is the most li/el' cause o% the
cough. The %irst therapeutic ob7ective is there%ore to stop this irritation b'
suppressing the cough( to enable the membranes to recover.
Step 3: /eri$y w#et#er your Ptreat%ent is suita(le $or t#is patient
Iou have alread' determined 'our P+ersonal, treatment( the most e%%ective( sa%e(
suitable and cheap treatment %or dr' cough in general. 2ut no. 'ou have to veri%'
.hether 'our P6treatment is also suitable %or this particular patient0 is the treatment
also e$$ective and sa$e in this caseH

3n this e8ample there ma' be reasons .h' this advice is unli/el' to be %ollo.ed.
The patient .ill probabl' not stop smo/ing. Even more important( he is a ta8i6driver
and cannot avoid tra%%ic %umes in the course o% his .or/. -o although advice should
still be given( 'our P6drug should also be considered( and chec/ed %or suitabilit'. 3s
it e%%ective( and is it sa%eH
&odeine is e%%ective( and it is not inconvenient to ta/e a %e. tablets ever' da'.
Ho.ever( there is a problem .ith sa%et' because the patient is a ta8i6driver and
codeine has a sedative e%%ect. $or this reason it .ould be pre%erable to loo/ %or a
cough depressant .hich is not sedative.
Our t.o alternatives .ithin the group o% opiates +noscapine( pholcodine, share the
same side e%%ectA this is o%ten the case. The antihistamines are even more sedative
and probabl' not e%%ective. We must there%ore conclude that it is probabl' better not
to prescribe an' drug at all. 3% .e still consider that a drug is needed( codeine
remains the best choice but in as lo. a dosage as possible( and %or a %e. da's
onl'.
10
Step 4: Start t#e treat%ent
The advice should be given %irst( .ith an e8planation o% .h' it is important. 2e brie%
and use .ords the patient can understand. Then codeine can be prescribed0
"Ncodeine !> mgA !G tabletsA ! tablet B times dail'A dateA signatureA name( address
and age o% the patient( and the insurance number +i% applicable,. Write clearl'L
Step 0: 1ive in$or%ation- instructions and warnings
The patient should be in%ormed that codeine .ill suppress the cough( that it .or/s
.ithin #6B hours( that it ma' cause constipation( and that it .ill ma/e him sleep' i%
he ta/es too much o% it or drin/s an' alcohol. He should be advised to come bac/ i%
the cough does not go .ithin one .ee/( or i% unacceptable side e%%ects occur.
$inall' he should be advised to %ollo. the dosage schedule and .arned not to ta/e
alcohol. 3tDs a good idea to as/ him to summarize in his o.n .ords the /e'
in%ormation( to be sure that it is clearl' understood.
Step 2: +onitor (stop) t#e treat%ent
3% the patient does not return( he is probabl' better. 3% there is no improvement and
he does come bac/ there are three possible reasons0 +!, the treatment .as not
e%%ectiveA +#, the treatment .as not sa%e( e.g. because o% unacceptable side e%%ectsA
or +B, the treatment .as not convenient( e.g. the dosage schedule .as hard to
%ollo. or the taste o% the tablets .as unpleasant. &ombinations are also possible.
3% the patientDs s'mptoms continue( 'ou .ill need to consider .hether the diagnosis(
treatment( adherence to treatment and the monitoring procedure .ere all correct.
3n %act the .hole process starts again. -ometimes there ma' be no end solution to
the problem. $or e8ample( in chronic diseases such as h'pertension( care%ul
monitoring and improving patient adherence to the treatment ma' be all that 'ou
can do. 3n some cases 'ou .ill change a treatment because the therapeutic %ocus
s.itches %rom curative to palliative care( as in terminal cancer or A3D-.
&onclusion
-o( .hat at %irst seems 7ust a simple consultation o% onl' a %e. minutes( in %act
re=uires a =uite comple8 process o% pro%essional anal'sis. What 'ou should not do
is cop' the doctor and memorize that dr' cough should be treated .ith !> mg
codeine B times dail' %or three da's 6 .hich is not al.a's true. 3nstead( build 'our
clinical practice on the core principles o% choosing and giving a treatment( .hich
have been outlined. The process is summarized belo. and each step is %ull'
described in the %ollo.ing chapters.
11
-ummar'
The process o% rational treatment
Step 1: &e$ine t#e patient.s pro(le%
Step 2: Speci$y t#e t#erapeutic o()ective
What do 'ou .ant to achieve .ith the treatmentH
Step 3: /eri$y t#e suita(ility o$ your Ptreat%ent
&hec/ e%%ectiveness and sa%et'
Step 4: Start t#e treat%ent
Step 0: 1ive in$or%ation- instructions and warnings
Step 2: +onitor (and stop3) treat%ent
12
Part 2 Selecting your P(ersonal) drugs
13
art #0 -electing 'our P+ersonal,
drugs
This section teaches 'ou ho. to choose 'our
personal selection o% drugs +called P6drugs,. 3t
e8plains the principles o% drug selection and ho. to
use them in practice. &hapter # e8plains .h' 'ou
should develop 'our o.n list o% P6drugs. 3t also tells
'ou ho. not to do it. &hapter B gives a detailed
e8ample o% selecting P6drugs in a rational .a'.
&hapter C provides the theoretical model .ith some
critical considerations( and summarizes the process.
&hapter > describes the di%%erence bet.een P6drug
and P6treatment0 not all health problems need
treatment .ith drugs.
When selecting 'our P6drugs 'ou ma' need to
revise some o% the basic principles o% pharmacolog'(
.hich are summarized in Anne8 !.
&hapter # page
3ntroduction to P6drugs........................................................................................ !C
&hapter B
E8ample0 angina pectoris....................................................................................!?
&hapter C
Guidelines %or selecting P6drugs.........................................................................##
-tep i0 De%ine the diagnosis..............................................................................................##
-tep ii0 -peci%' the therapeutic ob7ective...................................................................##
-tep iii0 Ma/e an inventor' o% e%%ective groups o% drugs....................................#B
-tep iv0 &hoose an e%%ective group according to criteria....................................#B
-tep v0 &hoose a P6drug.....................................................................................................#?
&hapter >
P6drug and P6treatment...................................................................................... #F
14
P
Chapter 2 Introduction to P-drugs
hapter #
3ntroduction to P6drugs
As a doctor 'ou ma' see CG patients per da' or more( man' o% .hom need
treatment .ith a drug. Ho. do 'ou manage to choose the right drug %or each patient
in a relativel' short timeH 2' using +-dru!sL P6drugs are the drugs 'ou have chosen
to prescribe regularl'( and .ith .hich 'ou have become %amiliar. The' are 'our
priorit' choice %or given indications.
The P6drug concept is more than 7ust the name o% a pharmacological substance( it
also includes the dosage %orm( dosage schedule and duration o% treatment. P6
drugs .ill di%%er %rom countr' to countr'( and bet.een doctors( because o% var'ing
availabilit' and cost o% drugs( di%%erent national %ormularies and essential drugs
lists( medical culture( and individual interpretation o% in%ormation. Ho.ever( the
principle is universall' valid. P6drugs enable 'ou to avoid repeated searches %or a
good drug in dail' practice. And( as 'ou use 'our P6drugs regularl'( 'ou .ill get to
/no. their e%%ects and side e%%ects thoroughl'( .ith obvious bene%its to the patient.
Pdrugs- essential drugs and standard treat%ent guidelines
Iou ma' .onder .hat the relation is bet.een 'our set o% P6drugs and the WHO
Model 4ist o% Essential Drugs or the national list o% essential drugs( and e8isting
standard treament guidelines.
3n general( the list o% drugs registered %or use in the countr' and the national list o%
essential drugs contain man' more drugs than 'ou are li/el' to use regularl'. Most
doctors use onl' CG6?G drugs routinel'. 3t is there%ore use%ul to ma/e 'our o.n
selection %rom these lists( and to ma/e this selection in a rational .a'. 3n %act( in
doing so 'ou are preparing 'our o.n essential drugs list. &hapter C contains
detailed in%ormation on the process o% selection.
3nstitutional( national and international +including WHO, standard treatment
guidelines have been developed to deal .ith the most common conditions( such as
acute respirator' tract in%ections( diarrhoeal diseases and se8uall' transmitted
diseases. The' are based on good scienti%ic evidence and consensus bet.een
e8perts. $or these reasons the' are a valuable tool %or rational prescribing and 'ou
should consider them ver' care%ull' .hen choosing 'our P6drugs. 3n most cases
'ou .ill .ant to incorporate them in 'our practice.
Pdrugs and Ptreat%ent
There is a di%%erence bet.een P6drugs and P6treatment. The /e' point is that not all
diseases need to be treated .ith a drug. *ot ever' P6treatment includes a P6drugL
&
15
The concept o% choosing a P6treatment .as alread' introduced in the previous
chapter. The process o% choosing a P6drug is ver' similar and .ill be discussed in
the %ollo.ing chapters.
4ow not to co%pile your list o$ Pdrugs
3nstead o% compiling 'our o.n list( one o% the most popular .a's to ma/e a list o%
P6drugs is 7ust to cop' it %rom clinical teachers( or %rom e8isting national or local
treatment guidelines or %ormularies. There are %our good reasons not to do this.
H Iou have %inal responsibilit' %or 'our patientDs .ell6being and 'ou cannot pass
this on to others. While 'ou can and should dra. on e8pert opinion and
consensus guidelines( 'ou should al.a's thin/ %or 'oursel%. $or e8ample( i% a
recommended drug is contraindicated %or a particular patient( 'ou have to
prescribe another drug. 3% the standard dosage is inappropriate( 'ou must adapt
it. 3% 'ou do not agree .ith a particular drug choice or treatment guideline in
general( prepare 'our case and de%end 'our choice .ith the committee that
prepared it. Most guidelines and %ormularies are updated regularl'.
H Through developing 'our o.n set o% P6drugs 'ou .ill learn ho. to handle
pharmacological concepts and data. This .ill enable 'ou to discriminate
bet.een ma7or and minor pharmacological %eatures o% a drug( ma/ing it much
easier %or 'ou to determine its therapeutic value. 3t .ill also enable 'ou to
evaluate con%licting in%ormation %rom various sources.
H Through compiling 'our o.n set o% P6drugs 'ou .ill /no. the alternatives .hen
'our P6drug choice cannot be used( %or e8ample because o% serious side
e%%ects or contraindications( or .hen 'our P6drug is not available. The same
applies .hen a recommended standard treatment cannot be used. With the
e8perience gained in choosing 'our P6drugs 'ou .ill more easil' be able to
select an alternative drug.
H Iou .ill regularl' receive in%ormation on ne. drugs( ne. side e%%ects( ne.
indications( etc. Ho.ever( remember that the latest and the most e8pensive
drug is not necessaril' the best( the sa%est or the most cost6e%%ective. 3% 'ou
cannot e%%ectivel' evaluate such in%ormation 'ou .ill not be able to update 'our
list( and 'ou .ill end up prescribing drugs that are dictated to 'ou b' 'our
colleagues or b' sales representatives.
16
Chapter 3 Example of selecting a P-drug: angina pectoris
hapter B
E8ample o% selecting a P6drug0 angina pectoris
*"a%ple: patient 2
"ou are a youn! doctor' and one of your first patients is a ,--year
old man' with no previous medical history. .urin! the last month
he has had several attacks of suffocatin! chest pain' which be!an
durin! physical labour and disappeared /uickly after he stopped.
He has not smoked for four years. His father and brother died of a
heart attack. part from occasionally takin! some aspirin he has
not used any medication in the past year. uscultation reveals a
murmur over the ri!ht carotid artery and the ri!ht femoral artery.
+hysical e%amination reveals no other abnormalities. 0lood
pressure is )*-12#' pulse 32 re!ular' and body wei!ht is normal.
"ou are fairly sure of the dia!nosis' an!ina pectoris' and e%plain
the nature of this disease to him. (he patient listens carefully and
asks4 50ut' what can be done about it67. "ou e%plain that the
attacks are usually self-limitin!' but that they can also be stopped
by dru!s. He responds 5Well' that8s e%actly what 9 need.7 "ou tend
to a!ree that he mi!ht need a dru!' but which6 tenolol' !lyceryl
trinitrate' furosemide' metoprolol' verapamil' haloperidol :no' no
that8s somethin! else; all cross your mind. What to do now6 "ou
consider prescribin! <ordacor
=
)
' because you have read
somethin! about it in an advertisement. 0ut which dose6 "ou
have to admit that you are not very sure.
>ater at home you think about the case' and about your problem
in findin! the ri!ht dru! for the patient. n!ina pectoris is a
common condition' and you decide to choose a +-dru! to help
you in the treatment of future cases.
&hoosing a P6drug is a process that can be divided into %ive steps +Table !,. Man'
o% these are rather similar to the steps 'ou .ent through in treating the patient .ith
cough in &hapter !. Ho.ever( there is an important di%%erence. 3n &hapter ! 'ou
have chosen a drug %or an individual patientA in this chapter 'ou .ill choose a drug
o% %irst choice %or a common condition( .ithout a speci%ic patient in mind.
1
A fctitious brandname
&
17
Each o% the steps is discussed in detail belo.( %ollo.ing an e8ample o% choosing a
P6drug %or angina pectoris.
18
Table !0 -teps in choosing a P6drug
i De%ine the diagnosis
ii -peci%' the therapeutic ob7ective
iii Ma/e an inventor' o% e%%ective groups o% drugs
iv &hoose an e%%ective group according to criteria
v &hoose a P6drug
Step i: &e$ine t#e diagnosis
Angina pectoris is a s'mptom rather than a diagnosis. 3t can be subdivided into
classic angina pectoris or variant angina pectorisA it ma' also be divided into stable
and unstable. 2oth aspects have implications %or the treatment. Iou could speci%'
the diagnosis o% patient # as stable angina pectoris( caused b' a partial
+arteriosclerotic, occlusion o% the coronar' arteries.
Step ii: Speci$y t#e t#erapeutic o()ective
Angina pectoris can be prevented and treated( and preventive measures can be
ver' e%%ective. Ho.ever( in this e8ample .e limit ourselves to treatment onl'. 3n that
case the therapeutic ob7ective is to stop an attac/ as soon as it starts. As angina
pectoris is caused b' an imbalance in o8'gen need and suppl' in the cardiac
muscle( either o8'gen suppl' should be increased or o8'gen demand reduced. 3t is
di%%icult to increase the o8'gen suppl' in the case o% a sclerotic obstruction in the
coronar' arter'( as a stenosis cannot be dilated .ith drugs. This leaves onl' one
other approach0 to reduce the o8'gen need o% the cardiac muscle. -ince it is a li%e6
threatening situation this should be achieved as soon as possible.
This therapeutic ob7ective can be achieved in %our .a's0 b' decreasing the preload(
the contractilit'( the heart rate or the a%terload o% the cardiac muscle. These are the
%our pharmacological sites o% action.
#
Step iii: +a,e an inventory o$ e$$ective groups o$ drugs
The %irst selection criterion %or an' group o% drugs is e$$icacy. 3n this case the drugs
must decrease preload( contractilit'( %re=uenc' andNor a%terload. There are three
groups .ith such an e%%ect0 nitrates( beta6bloc/ers and calcium channel bloc/ers.
The sites o% action are summarized in Table #.
2

If you do not know enough about pathophysiology of the disease or of the pharmacological sites of action, you
need to update your knowledge. You could start by reviewing your pharmacology notes or textbook; for this
example you should probably also read a few paragraphs on angina pectoris in a medical textbook.
19
Table #0 -ites o% action %or drug groups used in angina pectoris
Preload 'ontractility 5re6uency !$terload
7itrates OO 6 6 OO
8eta(loc,ers O OO OO OO
'alciu% c#annel (loc,ers O OO OO OO
Step iv: '#oose an e$$ective group according to criteria
The pharmacological action o% these three groups needs %urther comparison.
During this process( three other criteria should be used0 sa$ety( suita(ility and
cost o$ treat%ent. The easiest approach is to list these criteria in a table as in
Table B. O% course( e%%icac' remains o% %irst importance. &ost o% treatment is
discussed later.
E%%icac' is not based on pharmacod'namics alone. The therapeutic ob7ective is that
the drug should .or/ as soon as possible. Pharmacokinetics are there%ore
important as .ell. All groups contain drugs or dosage %orms .ith a rapid e%%ect.
Sa$ety
All drug groups have side e%%ects( most o% .hich are a direct conse=uence o% the
.or/ing mechanism o% the drug. 3n the three groups( the side e%%ects are more or
less e=uall' serious( although at normal dosages %e. severe side e%%ects are to be
e8pected.
Suita(ility
This is usuall' lin/ed to an individual patient and so not considered .hen 'ou ma/e
'our list o% P6drugs. Ho.ever( 'ou need to /eep some practical aspects in mind.
When a patient su%%ers an attac/ o% angina pectoris there is usuall' nobod' around
to administer a drug b' in7ection( so the patient should be able to administer the
drug alone. Thus( the dosage %orm should be one that can be handled b' the
patient and should guarantee a rapid e%%ect. Table B also lists the available dosage
%orms .ith a rapid e%%ect in the three drug groups. All groups contain drugs that are
available as in7ectables( but nitrates are also available in sublingual %orms
+sublingual tablets and oromucosal spra's,. These are e=uall' e%%ective and eas'
to handle( and there%ore have an advantage in terms o% practical administration b'
the patient.
'ost o$ treat%ent
Prices di%%er bet.een countries( and are more lin/ed to individual drug products
than to drug groups. 3n Table C( indicative prices %or drugs .ithin the group o%
nitrates( as given in the 2ritish *ational $ormular' o% March !FFC( have been
included %or the sa/e o% the e8ample. As 'ou can see %rom the table( there are
considerable price di%%erences .ithin the group. 3n general( nitrates are ine8pensive
drugs( available as generic products. Iou should chec/ .hether in 'our countr'
nitrates are more e8pensive than beta6bloc/ers or calcium channel bloc/ers( in
.hich case the' ma' lose their advantage.
20
Table B0 &omparison bet.een the three drug groups used in angina pectoris
E%%icac' -a%et' -uitabilit'
7itrates
?ide effects
<ontraindications
+harmacodynamics ?ide effects <ontraindictions
Peripheral vasodilatation
$lushing( headaches(
&ardiac %ailure( h'po6
$lushing( headaches(
temporar' tach'cardia
&ardiac %ailure( h'potension(
raised intracranial pressure
21
Tolerance +especiall' .ith
constant blood levels,
*itrate poisoning due to
*itrate poisoning due to long6
lasting oral dosage
long6lasting oral dosage
Anaemia
Anaemia
+harmacokinetics
High %irst pass metabolism
ar'ing absorption in the
alimentar' tract +less in
mononitrates,
Fast effect dosa!e forms4
Gl'cer'l trinitrate is volatile0
tablets cannot be /ept long
3n7ection( sublingual tablet(
oromucosal spra'
3n7ection( sublingual tablet(
oromucosal spra'
8eta(loc,ers
?ide effects
<ontraindications
H'potension( congestive
+harmacodynamics ?ide effects
-inus brad'cardia( A bloc/
2rad'cardia( A bloc/(
<ontraindications
sic/ sinus s'ndrome
"educed heart contractilit' H'potension( congestive heart
%ailure
heart %ailure
"educed heart %re=uenc'
Provocation o% asthma
Asthma
&old hand and %eet
"a'naudKs disease
2rad'cardia( A bloc/( sic/
sinus s'ndrome
H'pogl'caemia
Diabetes
2ronchoconstriction( muscle
vasoconstriction( inhibited
gl'cogenol'sis
4ess vasodilatation in penis
3mpotence
Provocation o% asthma
&old hands and %eet
H'pogl'caemia
3mpotence
Asthma
"a'naudKs disease
Diabetes
+harmacokinetics
4ipophilicit' increases passage
through blood6brain barrier
Dro.siness( decreased
4iver d's%unction
Dro.siness( decreased
reactions( nightmares
4iver d's%unction
reactions( nightmares
3n7ection
3n7ection
'alciu% c#annel (loc,ers
+harmacodynamics ?ide effects
?ide effects
<ontraindications
<ontraindictions
22
&oronar' vasodilatation
Peripheral vasodilatation
+a%terload,
"educed heart contractilit'
"educed heart %re=uenc'
Tach'cardia( dizziness(
H'potension
Tach'cardia( dizziness(
%lushing( h'potension
&ongestive heart %ailure
%lushing( h'potension
H'potension
A bloc/( sic/ sinus
s'ndrome
3n7ection
Table C0 &omparison bet.een drugs .ithin the group o% nitrates
E%%icac' -a%et' -uitabilit' &ostN!GG +P,Q
1lyceryl trinitrate *20 volatile
-ublingual tab G.C6!mg G.>6BG min *o di%%erence *o di%%erence G.#F 6 G.>F
Oral tab #.?mg( cap !6
#.>mg
G.>6@ hours bet.een bet.een B.#> 6 C #E
Transdermal patch !?6
>Gmg
!6#C hours individual individual C#.GG 6
@@.GG
*20 tolerance nitrates nitrates
9sosor(ide dinitrate
-ublingual tab >mg #6BG min !.C> 6 !.>!
Oral tab !G6#G mg G.>6C hours !.!G 6 #.!>
Oral tab +retard, #G6CGmg G.>6!G hours F.># 6 !E.F>
*20 tolerance
Pentaeritritol tetranitrate
Oral tab BG mg !6> hours C.C>
9sosor(ide %ononitrate
Oral tab !G6CGmg G.>6C hours >.@G 6 !B.BG
Oral tabNcaps +retard, !6!G hours #>.GG 6
CG.E#
*20 tolerance
@ 9ndicative prices only' based on prices !iven in the 0ritish Aational Formulary of March )BBC
A%ter comparing the three groups 'ou ma' conclude that nitrates are the group o%
%irst choice because( .ith acceptable e%%icac' and e=ual sa%et'( the' o%%er the
advantages o% an immediate e%%ect and eas' handling b' the patient( at no e8tra
cost.
Step v: '#oose a Pdrug
'#oose an active su(stance and a dosage $or%
*ot all nitrates can be used in acute attac/s( as some are meant %or proph'lactic
treatment. 3n general( three active substances are available %or the treatment o% an
23
acute attac/0 gl'cer'l trinitrate +nitrogl'cerin,( isosorbide mononitrate and
isosorbide dinitrate +Table C,. All three are available in sublingual tablets .ith a
rapid e%%ect. 3n some countries an oromucosal spra' o% gl'cer'l trinitrate is available
as .ell. The advantage o% such spra's is that the' can be /ept longerA but the' are
more e8pensive than tablets.
There is no evidence o% a di%%erence in e%%icac' and sa%et' bet.een the three active
substances in this group. With regard to suitabilit'( the three substances hardl'
di%%er in contraindications and possible interactions. This means that the ultimate
choice depends on cost. &ost ma' be e8pressed as cost per unit( cost per da'( or
cost per total treatment. As can be seen %rom Table C( costs ma' var' considerabl'.
-ince tablets are cheapest in most countries( these might .ell be 'our %irst choice.
3n this case the active substance %or 'our P6drug o% choice %or an attac/ o% angina
pectoris .ould be0 sublingual tablets o% gl'cer'l trinitrate ! mg.
'#oose a standard dosage sc#edule
As the drug is to be ta/en during an acute attac/( there is no strict dosage
schedule. The drug should be removed %rom the mouth as soon as the pain is
gone. 3% the pain persists( a second tablet can be ta/en a%ter >6!G minutes. 3% it
continues even a%ter a second tablet( the patient should be told to contact a doctor
immediatel'.
'#oose a standard duration o$ t#e treat%ent
There is no .a' to predict ho. long the patient .ill su%%er %rom the attac/s( so the
duration o% the treatment should be determined b' the need %or %ollo.6up. 3n
general onl' a small suppl' o% gl'cer'l trinitrate tablets should be prescribed as the
active substance is rather volatile and the tablet ma' become ine%%ective a%ter some
time.

3% 'ou agree .ith this choice( gl'cer'l trinitrate sublingual tablets .ould be the %irst
P6drug o% 'our personal %ormular'. 3% not( 'ou should have enough in%ormation to
choose another drug instead.
-ummar'
E8ample o% selecting a P6drug0 angina pectoris
i. &e$ine t#e diagnosis -table angina pectoris( caused b' a partial
occlusion o% coronar' arter'
ii. Speci$y t#erapeutic o()ective -top an attac/ as soon as possible
"educe m'ocardial o8'gen need b' decreasing
preload( contractilit'( heart rate or a%terload
iii. +a,e inventory o$ e$$ective groups
*itrates
R6bloc/ers
&alcium channel bloc/ers
iv. '#oose a group according
to criteria e%%icac' sa%et' suitabilit' cost
24
*itrates +tablet, O S OO O
2eta6bloc/ers +in7ection, O S 6 6
&alcium channel bloc/ers +in7ection, O S 6 6
v. '#oose a Pdrug e%%icac' sa%et' suitabilit' cost
Gl'cer'l trinitrate +tablet, O S O O
+spra', O S +O, 6
3sosorbide dinitrate +tablet, O S O S
3sosorbide mononitrate +tablet, O S O S
'onclusion
Active substance( dosage %orm0 gl'cer'l trinitrate( sublingual tablet ! mg
Dosage schedule0 ! tablet as neededA second tablet i% pain
persists
Duration0 length o% monitoring interval
25
hapter C
Guidelines %or selecting P6drugs
The previous chapter gave an e8ample o% choosing a P6drug %or the treatment o%
acute angina pectoris( on the basis o% e%%icac'( sa%et'( suitabilit' and cost. This
chapter presents more general in%ormation on each o% the %ive steps.
-tep i0 De%ine the diagnosis
When selecting a P6drug( it is important to remember that 'ou are choosing a drug
o% %irst choice %or a common condition. Iou are not choosing a drug %or an individual
patient +.hen actuall' treating a patient 'ou .ill veri%' .hether 'our P6drug is
suitable %or that particular case 6 see &hapter E,.
26
&
&artoon #
Chapter 4 Guidelines for selecting P-drugs
To be able to select the best drug %or a given condition( 'ou should stud' the
pathoph'siolog' o% the disease. The more 'ou /no. about this( the easier it is to
choose a P6drug. -ometimes the ph'siolog' o% the disease is un/no.n( .hile
treatment is possible and necessar'. Treating s'mptoms .ithout reall' treating the
underl'ing disease is called s'mptomatic treatment.
When treating an individual patient 'ou should start b' care%ull' de%ining the
patientKs problem +see &hapter ?,. When selecting a P6drug 'ou onl' have to
choose a common problem to start the process.
-tep ii0 -peci%' the therapeutic ob7ective
3t is ver' use%ul to de%ine e8actl' .hat 'ou .ant to achieve .ith a drug( %or e8ample(
to decrease the diastolic blood pressure to a certain level( to cure an in%ectious
disease( or to suppress %eelings o% an8iet'. Al.a's remember that the
+patho,ph'siolog' determines the possible site o% action o% 'our drug and the
ma8imum therapeutic e%%ect that 'ou can achieve. The better 'ou de%ine 'our
therapeutic ob7ective( the easier it is to select 'our P6drug.
-tep iii0 Ma/e an inventor' o% e%%ective groups o% drugs
3n this step 'ou lin/ the therapeutic ob7ective to various drugs. Drugs that are not
e%%ective are not .orth e8amining an' %urther( so e$$icacy is the %irst criterion %or
selection. 3nitiall'( 'ou should loo/ at groups o% drugs rather than individual drugs.
There are tens o% thousands o% di%%erent drugs( but onl' about @G pharmacological
groupsL All drugs .ith the same .or/ing mechanism +d'namics, and a similar
molecular structure belong to one group. As the active substances in a drug group
have the same .or/ing mechanism( their e%%ects( side e%%ects( contraindications
and interactions are also similar. The benzodiazepines( beta6bloc/ers and
penicillins are e8amples o% drug groups. Most active substances in a group share a
common stem in their generic name( such as dia&epam( lora&epam and
tema&epam %or benzodiazepines( and propranolol and atenolol %or beta6bloc/ers.
There are t.o .a's to identi%' e%%ective groups o% drugs. The %irst is to loo/ at
%ormularies or guidelines that e8ist in 'our hospital or health s'stem( or at
international guidelines( such as the WHO treatment guidelines %or certain common
disease groups( or the WHO Model 4ist o% Essential Drugs. Another .a' is to chec/
the inde8 o% a good pharmacolog' re%erence boo/ and determine .hich groups are
listed %or 'our diagnosis or therapeutic ob7ective. 3n most cases 'ou .ill %ind onl' #6
C groups o% drugs .hich are e%%ective. 3n Anne8 # various sources o% in%ormation on
drugs and therapeutics are listed.
*"ercise
:oo, at a nu%(er o$ advertise%ents $or new drugs. ;ou will (e
surprised at #ow very $ew o$ t#ese .new. drugs are real innovations
and (elong to a drug group t#at is not already ,nown.
-tep iv0 &hoose an e%%ective group according to criteria
To compare groups o% e%%ective drugs( 'ou need in%ormation on e$$icacy( sa$ety(
suita(ility and cost +Tables B and C,. -uch tables can also be used .hen 'ou
stud' other diagnoses( or .hen loo/ing %or alternative P6drugs. $or e8ample( beta6
bloc/ers are used in h'pertension( angina pectoris( migraine( glaucoma and
27
arrh'thmia. 2enzodiazepines are used as h'pnotic( an8iol'tic and antiepileptic
drugs.
Although there are man' di%%erent settings in .hich drugs are selected( the criteria
%or selection are more or less universal. The WHO criteria %or the selection o%
essential drugs are summarized in 2o8 #.
*$$icacy
This column in Table B +&hapter B, sho.s data on pharmacod'namics and
pharmaco/inetics. 3n order to be e%%ective( the drug has to reach a minimum
plasma concentration and the /inetic pro%ile o% the drug must allo. %or this .ith an
eas' dosage schedule. 5inetic data on the drug group as a .hole ma' not be
available as the' are related to dosage %orm and product %ormulation( but in most
cases general %eatures can be listed. 5inetics should be compared on the grounds
o% !bsorption( &istribution( +etabolism and *8cretion +ADME %actors( see
Anne8 !,.

2o8 #0 &riteria %or the selection o% essential drugs +WHO,
Priorit' should be given to drugs o% proven e%%icac' and sa%et'( in order to meet the needs o% the
ma7orit' o% the people. )nnecessar' duplication o% drugs and dosage %orms should be avoided.
Onl' those drugs %or .hich ade=uate scienti%ic data are available %rom controlled clinical trials
andNor epidemiological studies and %or .hich evidence o% per%ormance in general use in a
variet' o% settings has been obtained( should be selected. *e.l' released products should onl'
be included i% the' have distinct advantages over products currentl' in use.
Each drug must meet ade=uate standards o% =ualit'( including .hen necessar' bioavailabilit'(
and stabilit' under the anticipated conditions o% storage and use.
The international nonproprietar' name +3**( generic name, o% the drug should be used. This is
the shortened scienti%ic name based on the active ingredient. WHO has the responsibilit' %or
assigning and publishing 3**s in English( $rench( 4atin( "ussian and -panish.
The cost o% treatment( and especiall' the costNbene%it ratio o% a drug or a dosage %orm( is a
ma7or selection criterion.
Where t.o or more drugs appear to be similar( pre%erence should be given to +!, drugs .hich
have been most thoroughl' investigatedA +#, drugs .ith the most %avourable pharmaco/inetic
propertiesA and +B, drugs %or .hich reliable local manu%acturing %acilities e8ist.
Most essential drugs should be %ormulated as single compounds. $i8ed6ratio combination
products are onl' acceptable .hen the dosage o% each ingredient meets the re=uirements o% a
de%ined population group and .hen the combination has a proven advantage over single
compounds administered separatel' in therapeutic e%%ect( sa%et'( compliance or cost.
Sa$ety
This column summarizes possible side e%%ects and to8ic e%%ects. 3% possible( the
incidence o% %re=uent side e%%ects and the sa%et' margins should be listed. Almost all
28
side e%%ects are directl' lin/ed to the .or/ing mechanism o% the drug( .ith the
e8ception o% allergic reactions.
Suita(ility
Although the %inal chec/ .ill onl' be made .ith the individual patient( some general
aspects o% suitabilit' can be considered .hen selecting 'our P6drugs.
&ontraindications are related to patient conditions( such as other illnesses .hich
ma/e it impossible to use a P6drug that is other.ise e%%ective and sa%e. A change in
the ph'siolog' o% 'our patient ma' in%luence the d'namics or /inetics o% 'our
P6drug0 the re=uired plasma levels ma' not be reached( or to8ic side e%%ects ma'
occur at normal plasma concentrations. 3n pregnanc' or lactation( the .ell6being o%
the child has to be considered. 3nteractions .ith %ood or other drugs can also
strengthen or diminish the e%%ect o% a drug. A convenient dosage %orm or dosage
schedule can have a strong impact on patient adherence to the treatment.
All these aspects should be ta/en into account .hen choosing a P6drug. $or
e8ample( in the elderl' and children drugs should be in convenient dosage %orms(
such as tablets or li=uid %ormulations that are eas' to handle. $or urinar' tract
in%ections( some o% 'our patients .ill be pregnant .omen in .hom sul%onamides 6 a
possible P6drug 6 are contraindicated in the third trimester. Anticipate this b'
choosing a second P6drug %or urinar' tract in%ections in this group o% patients.
'ost o$ treat%ent
The cost o% the treatment is al.a's an important criterion( in both developed and
developing countries( and .hether it is covered b' the state( an insurance compan'
or directl' b' the patient. &ost is sometimes di%%icult to determine %or a group o%
drugs( but 'ou should al.a's /eep it in mind. &ertain groups are de%initel' more
e8pensive than others. Al.a's loo/ at the total cost o% treatment rather than the
cost per unit. The cost arguments reall' start counting .hen 'ou choose bet.een
individual drugs.
The %inal choice bet.een drug groups is 'our o.n. 3t needs practice( but ma/ing
this choice on the basis o% e%%icac'( sa%et'( suitabilit' and cost o% treatment ma/es it
easier. -ometimes 'ou .ill not be able to select onl' one group( and .ill have to
ta/e t.o or three groups on to the ne8t step.
2o8 B0 E%%icac'( sa%et' and cost
E%%icac'0 Most prescribers choose drugs on the grounds o% e%%icac'( .hile side e%%ects are onl'
ta/en into consideration a%ter the' have been encountered. This means that too man' patients
are treated .ith a drug that is stronger or more sophisticated than necessar' +e.g. the use o%
.ide spectrum antibiotics %or simple in%ections,. Another problem is that 'our P6drug ma'
score %avourabl' on an aspect that is o% little clinical relevance. -ometimes /inetic
characteristics .hich are clinicall' o% little importance are stressed to promote an e8pensive
drug .hile man' cheaper alternatives are available.
-a%et'0 Each drug has side e%%ects( even 'our P6drugs. -ide e%%ects are a ma7or hazard in the
industrialized .orld. 3t is estimated that up to !GT o% hospital admissions are due to adverse
drug reactions. *ot all drug induced in7ur' can be prevented( but much o% it is caused b'
29
inappropriate selection or dosage o% drugs( and 'ou can prevent that. $or man' side e%%ects(
high ris/ groups can be distinguished. O%ten these are e8actl' the groups o% patients 'ou
should al.a's be ver' care%ul .ith0 the elderl'( children( pregnant .omen and those .ith
/idne' or liver disease.
&ost0 Iour ideal choice in terms o% e%%icac' and sa%et' ma' also be the most e8pensive drug(
and in case o% limited resources this ma' not be possible. -ometimes 'ou .ill have to choose
bet.een treating a small number o% patients .ith a ver' e8pensive drug( and treating a much
larger number o% patients .ith a drug .hich is less ideal but still acceptable. This is not an
eas' choice to ma/e( but it is one .hich most prescribers .ill %ace. The conditions o% health
insurance and reimbursement schemes ma' also have to be considered. The best drug in
terms o% e%%icac' and sa%et' ma' not +or onl' partiall', be reimbursedA patients ma' re=uest
'ou to prescribe the reimbursed drug( rather than the best one. Where %ree distribution or
reimbursement schemes do not e8ist( the patient .ill have to purchase the drug in a private
pharmac'. When too man' drugs are prescribed the patient ma' onl' bu' some o% them( or
insu%%icient =uantities. 3n these circumstances 'ou should ma/e sure that 'ou onl' prescribe
drugs that are reall' necessar'( available and a%%ordable. Iou( the prescriber( should decide
.hich drugs are the most important( not the patient or the pharmacist.
-tep v0 &hoose a P6drug
There are several steps to the process o% choosing a P6drug. -ometimes short6cuts
are possible. DonDt hesitate to loo/ %or them( but do not %orget to collect and
consider all essential in%ormation( including e8isting treatment guidelines.
'#oose an active su(stance and a dosage $or%
&hoosing an active substance is li/e choosing a drug group( and the in%ormation
can be listed in a similar .a'. 3n practice it is almost impossible to choose an active
substance .ithout considering the dosage %orm as .ellA so consider them together.
$irst( the active substance and its dosage %orm have to be e%%ective. This is mostl'
a matter o% /inetics.
Although active substances .ithin one drug group share the same .or/ing
mechanism( di%%erences ma' e8ist in sa%et' and suitabilit' because o% di%%erences in
/inetics. 4arge di%%erences ma' e8ist in convenience to the patient and these .ill
have a strong in%luence on adherence to treatment. Di%%erent dosage %orms .ill
usuall' lead to di%%erent dosage schedules( and this should be ta/en into account
.hen choosing 'our P6drug. 4ast( but not least( cost o% treatment should al.a's be
considered. Price lists ma' be available %rom the hospital pharmac' or %rom a
national %ormular' +see Table C( &hapter B %or an e8ample,.
5eep in mind that drugs sold under generic +nonproprietar', name are usuall'
cheaper than patented brand6name products. 3% t.o drugs %rom the same group
appear e=ual 'ou could consider .hich drug has been longest on the mar/et
+indicating .ide e8perience and probabl' sa%et',( or .hich drug is manu%actured in
'our countr'. When t.o drugs %rom t.o di%%erent groups appear e=ual 'ou can
choose both. This .ill give 'ou an alternative i% one is not suitable %or a particular
patient. As a %inal chec/ 'ou should al.a's compare 'our selection .ith e8isting
30
treatment guidelines( the national list o% essential drugs( and .ith the WHO Model
4ist o% Essential Drugs( .hich is revie.ed ever' t.o 'ears.
'#oose a standard dosage sc#edule
A recommended dosage schedule is based on clinical investigations in a group o%
patients. Ho.ever( this statistical average is not necessaril' the optimal schedule
%or 'our individual patient. 3% age( metabolism( absorption and e8cretion in 'our
patient are all average( and i% no other diseases or other drugs are involved( the
average dosage is probabl' ade=uate. The more 'our patient varies %rom this
average( the more li/el' the need %or an individualized dosage schedule.
"ecommended dosage schedules %or all P6drugs can be %ound in %ormularies( des/
re%erences or pharmacolog' te8tboo/s. 3n most o% these re%erences 'ou .ill %ind
rather vague statements such as M#6C times BG6FG mg per da'K. What .ill 'ou
choose in practiceH
The best solution is to cop' the di%%erent dosage schedules into 'our o.n %ormular'.
This .ill indicate the minimum and ma8imum limits o% the dosage. When dealing
.ith an individual patient 'ou can ma/e 'our de%initive choice. -ome drugs need an
initial loading dose to =uic/l' reach stead' state plasma concentration. Others
re=uire a slo.l' rising dosage schedule( usuall' to let the patient adapt to the side
e%%ects. Practical aspects o% dosage schedules are %urther discussed in &hapter E.
31
'#oose a standard duration o$ treat%ent
When 'ou prescribe 'our P6drug to a patient 'ou need to decide the duration o% the
treatment. 2' /no.ing the pathoph'siolog' and the prognosis o% the disease 'ou
.ill usuall' have a good idea o% ho. long the treatment should be continued. -ome
diseases re=uire li%e6long treatment +e.g. diabetes mellitus( congestive cardiac
%ailure( Par/insonDs disease,.
The total amount o% a drug to be prescribed depends on the dosage schedule and
the duration o% the treatment. 3t can easil' be calculated. $or e8ample( in a patient
.ith bronchitis 'ou ma' prescribe penicillin %or seven da's. Iou .ill onl' need to
see the patient again i% there is no improvement and so 'ou can prescribe the total
amount at once.
32
2o8 C0 General characteristics o% dosage %orms
Syste%ic dosage $or%s
oral +mi8ture( s'rup( tablet +coated( slo.6release,( po.der( capsule,
sublingual +tablet( aerosol,
rectal +suppositor'( rectiol,
inhalation +gasses( vapour,
in7ections +subcutaneous( intramuscular( intravenous( in%usion,
:ocal dosage $or%s
s/in +ointment( cream( lotion( paste,
sense organ +e'e dropsNointment( ear drops( nose drops,
oralNlocal +tablets( mi8ture,
rectalNlocal +suppositor'( enema,
vaginal +tablet( ovule( cream,
inhalationNlocal +aerosol( po.der,
Oral $or%s
e%%icac'0 +6, uncertain absorption and %irst6pass metabolism( +O, gradual e%%ect
sa%et'0 +6, lo. pea/ values( uncertain absorption( gastric irritation
convenience0 +6,H handling +children( elderl',
Su(lingual ta(lets and aerosols
e%%icac'0 +O, act rapidl'( no %irst6pass metabolism
sa%et'0 +6, eas' overdose
convenience0 +6, aerosol di%%icult to handle( +O, tablets eas' to use
<ectal preparations
e%%icac'0 +6, uncertain absorption( +O, no %irst6pass metabolism( rectiol %ast e%%ect
sa%et'0 +6, local irritation
convenience0 +O, in case o% nausea( vomiting and problems .ith s.allo.ing
9n#alation gasses and vapours
e%%icac'0 +O, %ast e%%ect
sa%et'0 +6, local irritation
convenience0 +6, need handling b' trained sta%%
9n)ections
e%%icac'0 +O, %ast e%%ect( no %irst6pass metabolism( accurate dosage possible
sa%et'0 +6, overdose possible( sterilit' o%ten a problem
convenience0 +6, pain%ul( need trained sta%%( more costl' than oral %orms
Topical preparations
e%%icac'0 +O, high concentrations possible( limited s'stemic penetration
sa%et'0 +6, sensitization in case o% antibiotics( +O, %e. side e%%ects
convenience0 +6, some vaginal %orms di%%icult to handle
3% the duration o% treatment is not /no.n( the monitoring interval becomes
important. $or e8ample( 'ou ma' re=uest a patient .ith ne.l' diagnosed
h'pertension to come bac/ in t.o .ee/s so that 'ou can monitor blood pressure
and an' side e%%ects o% the treatment. 3n this case 'ou .ould onl' prescribe %or the
t.o .ee/ period. As 'ou get to /no. the patient better 'ou could e8tend the
monitoring interval( sa'( to one month. Three months should be about the
ma8imum monitoring interval %or drug treatment o% a chronic disease.
-ummar'
Ho. to select a P6drug
i &e$ine t#e diagnosis (pat#op#ysiology)
ii Speci$y t#e t#erapeutic o()ective
iii +a,e an inventory o$ e$$ective groups
iv '#oose a group according to criteria
e%%icac' sa%et' suitabilit' cost
Group !
Group #
Group B
v '#oose a Pdrug
e%%icac' sa%et' suitabilit' cost
Drug !
Drug #
Drug B
&onclusion0 Active substance( dosage %orm0
-tandard dosage schedule0
-tandard duration0
33
hapter >
P6drug and P6treatment
*ot all health problems need treatment .ith drugs. As e8plained in &hapter l( the
treatment can consist o% advice and in%ormation( non6drug therap'( drug treatments(
re%erral %or treatment( or combinations o% these. Ma/ing an inventor' o% e%%ective
treatment alternatives is especiall' important in order not to %orget that non6drug
treatment is o%ten possible and desirable. *ever 7ump to the conclusion that 'our P6
drug should be prescribedL As .ith selecting 'our P6drugs( the criteria o% e%%icac'(
sa%et'( suitabilit' and cost should be used .hen comparing treatment alternatives.
The e8amples illustrate ho. this .or/s in practice.
*"ercise
+a,e a list o$ possi(le e$$ective and sa$e treat%ents $or t#e
$ollowing co%%on patient pro(le%s: constipation- acute diarr#oea
wit# %ild de#ydration in a c#ild- and a super$icial open wound.
T#en c#oose your Ptreat%ent $or eac#. T#e answers are
discussed (elow.
'onstipation
&onstipation is usuall' de%ined as a %ailure to pass stools %or at least a .ee/. The
list o% possible e%%ective treatments is as %ollo.s.
Advice and in%ormation0 Drin/ a lot o% %luids( eat %ruit and high %ibre %ood. Onl'
go to the toilet .hen the need is %elt. Do not tr' to pass
stools b' %orce. "eassure patient that nothing points to
serious disease.
*on6drug treatment0 Ph'sical e8ercise.
Drug treatment0 4a8ative +'our P6drug,.
"e%erral %or treatment0 *ot indicated.
3n man' cases advice and non6drug treatment .ill solve the problem. 2ecause o%
tolerance( la8atives are onl' e%%ective %or a short period and ma' then lead to abuse
and eventuall' even to electrol'te disturbances. The %irst treatment plan( 'our
P6treatment( should there%ore be adviceA not drugsL 3% the constipation is severe
+and temporar', 'our P6drug could be prescribed( e.g. senna tablets %or a %e. da's.
3% it persists( %urther e8amination is needed to e8clude other diseases( e.g. a colon
carcinoma.
!cute watery diarr#oea wit# %ild de#ydration in a c#ild
34
&
Chapter 5 P-drug versus P-treatment
3n acute diarrhoea .ith mild deh'dration in a child( the main ob7ective o% the
treatment is to prevent %urther deh'dration and to reh'drateA the goal is not to cure
the in%ectionL The inventor' o% possible e%%ective treatments is there%ore0
Advice and in%ormation0 &ontinue breast %eeding and other regular %eedingA
care%ul observation.
*on6drug treatment0 Additional %luids +rice .ater( %ruit 7uice( homemade
sugarNsalt solution,.
Drug treatment0 Oral reh'dration solution +O"-,( oral or b' nasogastric
tube.
"e%erral %or treatment0 *ot necessar'.
Iour advice .ill prevent %urther deh'dration( but .ill not cure it( and e8tra %luids and
O"- .ill be needed to correct the loss o% .ater and electrol'tes. Metronidazole and
antibiotics( such as cotrimo8azole or ampicillin( are not listed in the inventor'
because these are not e%%ective in treating .ater' diarrhoea. Antibiotics are onl'
indicated %or persistent blood' andNor slim' diarrhoea( .hich is much less common
than .ater' diarrhoeaA metronidazole is mainl' used %or proven amoebiasis.
Antidiarrhoeal drugs( such as loperamide and dipheno8'late( are not indicated(
especiall' %or children( as the' mas/ the continuing loss o% bod' %luids into the
intestines and ma' give the %alse impression that Msomething is being doneK.
Iour P6treatment is there%ore0 advice to continue %eeding and to give e8tra %luids
+including home made solutions or O"-( depending on the national treatment
guidelines,( and to observe the child care%ull'.
Super$icial open wound
The therapeutic ob7ective in the treatment o% an open .ound is to promote healing
and to prevent in%ection. The inventor' o% possible treatments is0
Advice and in%ormation0 "egularl' inspect the .oundA return in case o% .ound
in%ection or %ever.
*on6drug treatment0 &lean and dress the .ound.
Drug treatment0 Antitetanus proph'la8is.
Antibiotics +local( s'stemic,.
"e%erral %or treatment0 *ot necessar'.
The .ound should be cleaned and dressed( and tetanus proph'la8is should
probabl' be given. All patients .ith an open .ound should be .arned about
possible signs o% in%ection( and to return immediatel' i% these occur. 4ocal
antibiotics are never indicated in .ound in%ections because o% their lo. penetration
and the ris/ o% sensibilization. -'stemic antibiotics are rarel' indicated %or
proph'lactic purposes( e8cept in some de%ined cases such as intestinal surger'.
The' .ill not prevent in%ection( as permeabilit' into the .ound tissue is lo.( but
the' can have serious side e%%ects +allerg'( diarrhoea, and ma' cause resistance.
Iour P6treatment %or a super%icial open .ound is there%ore to clean and dress the
.ound( give antitetanus proph'la8is( and advice on regular .ound inspection. *o
drugsL
35
&onclusion
These three e8amples sho. that %or common complaints the treatment o% %irst
choice o%ten does not include an' drugs. Advice and in%ormation are o%ten
su%%icient( as in the case o% constipation. Advice( %luids and reh'dration are
essential in the treatment o% acute .ater' diarrhoea( rather than antidiarrhoeals or
antibiotics. Dressing and advice are essential in the case o% open .ounds( not
antibiotics.
3n more serious cases( e.g. persistent constipation( serious deh'dration in a small
child or a deep open .ound( re%erral ma' be the treatment o% choice( and not
MstrongerK drugs. "e%erral can there%ore also be 'our P6treatment( e.g. .hen no
%acilities e8ist %or %urther e8amination or treatment.
36
Part 3 Treating your patients
37
art B0 Treating 'our patients
This part o% the boo/ sho.s 'ou ho. to treat a
patient .ith 'our P6drugs. Each step o% the process
is described in separate chapters. Practical
e8amples illustrate ho. to select( prescribe and
monitor the treatment( and ho. to communicate
e%%ectivel' .ith 'our patients. When 'ou have gone
through this material 'ou are read' to put into
practice .hat 'ou have learned.
&hapter ? page
-tep !0 De%ine the patientKs problem...............................................................BC
&hapter @
-tep #0 -peci%' the therapeutic ob7ective.........................................................BE
&hapter E
-tep B0 eri%' the suitabilit' o% 'our P6drug......................................................CG
BA0 Are the active substance and dosage %orm suitable
%or this patientH...............................................................................C!
B20 3s the standard dosage schedule suitable %or this patientH.............CB
B&0 3s the standard duration o% treatment suitable %or this patientH.......C@
&hapter F
-tep C0 Write a prescription.............................................................................>!
&hapter !G
-tep >0 Give in%ormation( instructions and .arnings .......................................>?
&hapter !!
-tep ?0 Monitor +and stopH, the treatment.......................................................?#
38
P
Chapter 7 Step 2: Specify the therapeutic objective
hapter ?
-TEP !0 De%ine the patientDs problem
A patient usuall' presents .ith a complaint or a problem. 3t is obvious that ma/ing
the right diagnosis is a crucial step in starting the correct treatment.
Ma/ing the right diagnosis is based on integrating man' pieces o% in%ormation0 the
complaint as described b' the patientA a detailed histor'A ph'sical e8aminationA
laborator' testsA U6ra's and other investigations. A discussion on each o% these
components is outside the scope o% this manual. 3n the ne8t sections on +drug,
treatment .e shall there%ore assume that the diagnosis has been made correctl'.
PatientsK complaints are mostl' lin/ed to s'mptoms. A s'mptom is not a diagnosis(
although it .ill usuall' lead to it. The %ollo.ing %ive patients all have the same
complaint( a sore throat. 2ut do the' all have the same diagnosisH 4etDs loo/ at
them in more detail.
*"ercise: patients 3=
&e$ine t#e pro(le% $or eac# o$ t#e $ollowing patients. T#e cases are
discussed (elow.
Patient 3:
Man' #C years. <omplains of a severe sore throat. Ao !eneral
symptoms' no fever' sli!ht redness in the throatD no other findin!s.
Patient 4:
Woman' $* years. <omplains of a sore throat but is also very tired
and has enlar!ed lymph nodes in her neck. ?li!ht fever. ?he has
come for the results of last week8s laboratory tests.
Patient 0:
Woman student' )B years. <omplains of a sore throat. ?li!ht
redness of the throatD but no fever and no other findin!s. ?he is a
little shy and has never consulted you before for such a minor
complaint.
Patient 2:
Man C* years. <omplains of a sore throat. ?li!ht redness of the
throatD no fever and no other findin!s. Medical record mentions
that he suffers from chronic diarrhoea.
&
39
Patient =:
Woman' *$ years. Eery sore throat' caused by a severe bacterial
infection' despite penicillin prescribed last week.
Patient 3 (sore t#roat)
The sore throat o% patient B probabl' results %rom a minor viral in%ection. Perhaps
he is a%raid o% a more serious disease +throat cancerH,. He needs reassurance and
advice( not drugs. He does not need antibiotics( because the' .ill not cure a viral
in%ection.
Her blood test con%irms 'our clinical diagnosis o% A3D-. Her problem is completel'
di%%erent %rom the previous case( as the sore throat is a s'mptom o% underl'ing
disease.
Iou noticed that she .as rather sh' and remembered that she had never consulted
'ou be%ore %or such a minor complaint. Iou as/ her gentl' .hat the real trouble is(
and a%ter some hesitation she tells 'ou that she is B months overdue. Her real
concern had nothing to do .ith her throat.
3n this case( in%ormation %rom the patientKs medical record is essential %or a correct
understanding o% the problem. His sore throat is probabl' caused b' the loperamide
he ta/es %or his chronic diarrhoea. This drug ma' produce reduced salivation and
dr' mouth as a side e%%ect. "outine treatment o% a sore throat .ould not have
solved his problem. Iou ma' have to investigate the reason %or his chronic
diarrhoea( and consider A3D-.
Patient = (sore t#roat)
A care%ul histor' o% patient @( .hose bacterial in%ection persists despite the
penicillin( reveals that she stopped ta/ing the drugs a%ter three da's because she
%elt much better. -he should( o% course( have completed the course. Her problem
has come bac/ because o% inade=uate treatment.
These e8amples illustrate that one complaint ma' be related to man' di%%erent
problems0 a need %or reassuranceA a sign o% underl'ing diseaseA a hidden re=uest
%or assistance in solving another problemA a side e%%ect o% drug treatmentA and non6
adherence to treatment. -o the lesson is0 donDt 7ump to therapeutic conclusionsL
*"a%ple: patient >
Man' ,3 years. He comes for his medication for the ne%t two
months. He says that he is doin! very well and has no complaints.
He only wants a prescription for di!o%in -.$# m! :,- tablets;'
isosorbide dinitrate # m! :)2- tablets;' furosemide C- m! :,-
tablets;' salbutamol C m! :)2- tablets;' cimetidine $-- m! :)$-
tablets;' prednisolone # m! :)$- tablets;' and amo%icillin #-- m!
:)2- tablets;.
40
This patient states that he has no complaints. 2ut is there reall' no problemH He
ma' su%%er %rom a heart condition( %rom asthma and %rom his stomach( but he
de%initel' has one other problem0 polyp#ar%acyL 3t is unli/el' that he needs all
these drugs. -ome ma' even have been prescribed to cure the side e%%ects o%
another. 3n %act it is a miracle that he %eels .ell. Thin/ o% all the possible side e%%ects
and interactions bet.een so man' di%%erent drugs0 h'po/alemia b' %urosemide
leading to digo8in into8ication is onl' one e8ample.
&are%ul anal'sis and monitoring .ill reveal .hether the patient reall' needs all
these drugs. The digo8in is probabl' needed %or his heart condition. 3sosorbide
dinitrate should be changed to sublingual gl'cer'l trinitrate tablets( onl' to be used
.hen needed. Iou can probabl' stop the %urosemide +.hich is rarel' indicated %or
maintenance treatment,( or change it to a milder diuretic such as h'drochloro6
thiazide. -albutamol tablets could be changed to an inhaler( to reduce the side
e%%ects associated .ith continuous use. &imetidine ma' have been prescribed %or
suspected stomach ulcer( .hereas the stomach ache .as probabl' caused b' the
prednisolone( %or .hich the dose can probabl' be reduced an'.a'. 3t can also be
changed to an aerosol. -o 'ou %irst have to diagnose .hether he has an ulcer or
not( and i% not( stop the cimetidine. And %inall'( the large =uantit' o% amo8icillin has
probabl' been prescribed as a prevention against respirator' tract in%ections.
Ho.ever( most micro6organisms in his bod' .ill no. be resistant to it and it should
be stopped. 3% his respirator' problems become acute( a short course o% antibiotics
should be su%%icient.
2o8 >0 Patient demand
A patient ma' demand a treatment( or even a speci%ic drug( and this can give 'ou a hard time.
-ome patients are di%%icult to convince that a disease is sel%6limiting or ma' not be .illing to put
up .ith even minor ph'sical discom%ort. There ma' be a DhiddenD ps'cho6social problem( e.g.
long6term use and dependence on benzodiazepine. 3n some cases it ma' be di%%icult to stop the
treatment because ps'chological or ph'sical dependence on the drugs has been created.
Patient demand %or speci%ic drugs occurs most %re=uentl' .ith pain /illers( sleeping pills and
other ps'chotropic drugs( antibiotics( nasal decongestants( cough and cold preparations( and
e'eNear medicines.
The personal characteristics and attitudes o% 'our patients pla' a ver' important role. PatientsD
e8pectations are o%ten in%luenced b' the past +the previous doctor al.a's gave a drug,( b' the
%amil' +the drug that helped Aunt -all' so much,( b' advertisements to the public( and man'
other %actors. Although patients do sometimes demand a drug( ph'sicians o%ten assume such a
demand even .hen it doesnDt e8ist. -o a prescription is .ritten because the ph'sician thin/s
that the patient thin/s... This also applies to the use o% in7ections( or Mstrong drugsK in general.
Patient demand %or a drug ma' have several s'mbolic %unctions. A prescription legitimizes a
patientDs complaint as an illness. 3t ma' also %ul%ill the need that something be done( and
s'mbolize the care o% the ph'sician. 3t is important to realize that the demand %or a drug is much
more than a demand %or a chemical substance.
There are no absolute rules about ho. to deal .ith patient demand( .ith the e8ception o% one0
ensure that there is a real dialogue .ith the patient and give a care%ul e8planation. Iou need
good communication s/ills to be a good ph'sician. $ind out .h' the patient thin/s as +s,he
41
does. Ma/e sure 'ou have understood the patientDs arguments( and that the patient has
understood 'ou. *ever %orget that patients are partners in therap'A al.a's ta/e their point o%
vie. seriousl' and discuss the rationale o% 'our treatment choice. alid arguments are usuall'
convincing( provided the' are described in understandable terms.
Iour enem' .hen dealing .ith patient demand is time( i.e. the lac/ o% it. Dialogue and
e8planation ta/e time and 'ou o%ten .ill %eel pressed %or it. Ho.ever( in the long run the
investment is .orth.hile.
&onclusion
Patients ma' come to 'ou .ith a re=uest( a complaint or a =uestion. All ma' be
related to di%%erent problems0 a need %or reassuranceA a sign o% underl'ing diseaseA
a hidden re=uest %or assistance in solving another problemA a side e%%ect o% drug
treatmentA non6adherence to treatmentA or +ps'chological, dependence on drugs.
Through care%ul observation( structured histor' ta/ing( ph'sical e8amination and
other e8aminations( 'ou should tr' to de%ine the patientDs real problem. Iour
de%inition +'our .or/ing diagnosis, ma' di%%er %rom ho. the patient perceives the
problem. &hoosing the appropriate treatment .ill depend upon this critical step. 3n
man' cases 'ou .ill not need to prescribe a drug at all.
-ummar'
-TEP !0 De%ine the patientDs problem
6 Disease or disorder
6 -ign o% underl'ing disease
6 Ps'chological or social problems( an8iet'
6 -ide e%%ect o% drugs
6 "e%ill re=uest +pol'pharmac',
6 *on6adherence to treatment
6 "e=uest %or preventive treatment
6 &ombinations o% the above
42
hapter @
-TEP #0 -peci%' the therapeutic ob7ective
2e%ore choosing a treatment it is essential to speci%' 'our therapeutic ob7ective.
What do 'ou .ant to achieve .ith the treatmentH The %ollo.ing e8ercises enable
'ou to practice this crucial step.
*"ercise: patients ?12
5or eac# o$ t#ese patients try to de$ine t#e t#erapeutic o()ective.
T#e cases are discussed (elow.
Patient ?:
Girl' C years' sli!htly undernourished. Watery diarrhoea without
vomitin! for three days. ?he has not urinated for $C hours. Fn
e%amination she has no fever :*,.2
o
<;' but a rapid pulse and low
elasticity of the skin.
Patient 1@:
Woman student' )B years. <omplains of a sore throat. ?li!ht
redness of the throat' no other findin!s. fter some hesitation she
tells you that she is three months overdue. Fn e%amination' she is
three months pre!nant.
Patient 11:
Man' CC years. ?leeplessness durin! si% months' and comes for a
refill of dia&epam tablets' # m!' ) tablet before sleepin!. He wants
,- tablets.
Patient 12:
Woman' $C years. <onsulted you * weeks a!o' complainin! of
constant tiredness after delivery of her second child. ?li!htly pale
sclerae' but normal Hb. "ou had already advised her to avoid
strenuous e%ercise. ?he has now returned because the tiredness
persists and a friend told her that a vitamin injection would do her
!ood. (his is what she wants.
Patient ? (diarr#oea)
3n this patient the diarrhoea is probabl' caused b' a viral in%ection( as it is .ater'
+not slim' or blood', and there is no %ever. -he has signs o% deh'dration
+listlessness( little urine and decreased s/in turgor,. This deh'dration is the most
.orr'ing problem( as she is alread' slightl' undernourished. The therapeutic
&
43
ob7ective in this case is there%ore +!, to prevent %urther deh'dration and +#, to
reh'drate. *ot0 to cure the in%ectionL Antibiotics .ould be ine%%ective an'.a'.
Patient 1@ (pregnancy)
3n Patient !G 'ou .ill have recognized Patient > .ho complained o% a sore throat
.hile her real problem .as the suspected pregnanc'. Iou .ill not solve her
problem b' prescribing something %or her throat. The therapeutic ob7ective depends
on her attitude to.ards the pregnanc' and she .ill probabl' need counselling more
than an'thing else. The therapeutic ob7ective is then to assist her to plan %or the
%uture. This .ill probabl' not involve drug treatment %or her sore throat. Moreover(
the %act that she is in earl' pregnanc' should stop 'ou %rom prescribing an' drug at
all( unless it is absolutel' essential.
Patient 11 (sleeplessness)
3n Patient !! the problem is not .hich drugs to prescribe( but ho. to stop
prescribing them. Diazepam is not indicated %or long term treatment o%
sleeplessness as tolerance =uic/l' develops. 3t should onl' be used %or short
periods( .hen strictl' necessar'. The therapeutic ob7ective in this case is not to
treat the patientDs sleeplessness but to avoid a possible dependence on diazepam.
This could be achieved through a gradual and care%ull' monitored lo.ering o% the
dose to diminish .ithdra.al s'mptoms( coupled .ith more appropriate behavioural
techni=ues %or insomnia( .hich should lead to eventual cessation o% the drug.
Patient 12 (tiredness)
3n Patient !# there is no clear cause %or the tiredness and it is there%ore di%%icult to
ma/e a rational treatment plan. Having e8cluded anaemia 'ou ma' guess that as a
'oung mother .ith small children and perhaps a 7ob outside the home( she is
chronicall' over.or/ed. The therapeutic ob7ective is there%ore to help her reduce
ph'sical and emotional overload. To achieve this it ma' be necessar' to involve
other members o% the %amil'. This is a good e8ample o% the need %or non6drug
therap'. itamins .ill not help( and .ould onl' act as a placebo. 3n %act( the' .ould
probabl' act as a placebo %or 'oursel% as .ell( creating the %alse impression that
something is being done.
&onclusion
As 'ou can see( in some cases the therapeutic ob7ective .ill be straight%or.ard0 the
treatment o% an in%ection or a condition. -ometimes the picture .ill be less clear( as
in the patient .ith une8plained tiredness. 3t ma' even be misleading( as in the
student .ith the sore throat. Iou .ill have noticed that speci%'ing the therapeutic
ob7ective is a good .a' to structure 'our thin/ing. 3t %orces 'ou to concentrate on
the real problem( .hich limits the number o% treatment possibilities and so ma/es
'our %inal choice much easier.
-peci%'ing 'our therapeutic ob7ective .ill prevent a lot o% unnecessar' drug use. 3t
should stop 'ou %rom treating t.o diseases at the same time i% 'ou cannot choose
bet.een them( li/e prescribing antimalarial drugs and antibiotics in case o% %ever( or
anti%ungal and corticosteroid s/in ointment .hen 'ou can not choose bet.een a
%ungus and eczema.
-peci%'ing 'our therapeutic ob7ective .ill also help 'ou avoid unnecessar'
proph'lactic prescribing( %or e8ample( the use o% antibiotics to prevent .ound
in%ection( .hich is a ver' common cause o% irrational drug use.
44
3t is a good idea to discuss 'our therapeutic ob7ective .ith the patient be%ore 'ou
start the treatment. This ma' reveal that +s,he has =uite di%%erent vie.s about
illness causation( diagnosis and treatment. 3t also ma/es the patient an in%ormed
partner in the therap' and improves adherence to treatment.
45
hapter E
-TEP B0 eri%' the suitabilit' o% 'our P6drug
A%ter de%ining 'our therapeutic ob7ective 'ou should no. veri%' .hether 'our P6drug
is suitable %or the individual patient. Iou .ill remember that 'ou have chosen 'our
P6drugs %or an imaginar'( standard patient .ith a certain condition( using the
criteria o% e%%icac'( sa%et'( convenience and cost. Ho.ever( 'ou cannot assume that
this M%irst6choiceK treatment .ill al.a's be suitable %or ever'one. M&oo/boo/K
medicine does not ma/e %or good clinical practiceL Iou should there%ore al.a's
veri%' .hether 'our P6drug is suitable %or this individual patient. The same applies
.hen 'ou practice .ithin the limits o% national treatment guidelines( a hospital
%ormular' or departmental prescribing policies.
&hapter > e8plained the relationship bet.een P6drug and P6treatment. 3n %act( 'ou
should de%ine P6treatments %or the most common problems 'ou .ill encounter in
practiceA such P6treatments .ill %re=uentl' include non6drug treatment. Ho.ever( as
this manual is primaril' concerned .ith the development o% prescribing s/ills( %rom
no. on the %ocus .ill be on drug treatment( based on the use o% P6dru!s. Al.a's
/eep in mind that man' patients do not need drugs at allL
The starting point %or this step is to loo/ up 'our P6drugs +described in Part #,( or
the treatment guideline that is available to 'ou. 3n all cases 'ou .ill need to chec/
three aspects0 +!, are the active substance and the dosage %orm suitable %or this
patientH +#, is the standard dosage schedule suitableH and +B, is the standard
duration o% treatment suitableH $or each aspect( 'ou have to chec/ .hether the
proposed treatment is e$$ective and sa$e. A chec/ on e%%ectiveness includes a
revie. o% the drug indication and the convenience o% the dosage %orm. -a%et'
relates to contraindications and possible interactions. 2e care%ul .ith certain high
ris/ groups.
Eerify the suitability of your +-dru!
! !ctive su(stance and dosage $or%
8 Standard dosage sc#edule
' Standard duration o$ treat%ent
46
&
Chapter 8 Step 3: Verify the suitability of your P-drug
$or each o% these( chec/0
*$$ectiveness +indication( convenience,
Sa$ety +contraindications( interactions( high ris/ groups,
47
-tep BA0 Are the active substance and dosage %orm suitable %or this patientH
*$$ectiveness
We assume that all 'our P6drugs have alread' been selected on the basis o%
e%%icac'. Ho.ever( 'ou should no. veri%' that the drug .ill also be e$$ective in this
individual patient. $or this purpose 'ou have to revie. .hether the active
substance is li/el' to achieve the therapeutic ob7ective( and .hether the dosage
%orm is convenient %or the patient. 'onvenience contributes to patient adherence
to the treatment( and there%ore to e%%ectiveness. &omplicated dosage %orms or
pac/ages and special storage re=uirements can be ma7or obstacles %or some
patients.
Sa$ety
The sa%et' o% a drug %or the individual patient depends on
contraindications and interactionsA these ma' occur more
%re=uentl' in certain high ris/ groups. 'ontraindications are
determined b' the mechanism o% action o% the drug and the
characteristics o% the individual patient. Drugs in the same
group usuall' have the same contraindications. -ome
patients .ill %all into certain high ris/ groups +see Table >, and
an' other illnesses should also be considered. -ome side
e%%ects are serious %or categories o% patients onl'( such as
dro.siness %or drivers. 9nteractions can occur bet.een the
drug and nearl' ever' other substance ta/en b' the patient.
2est /no.n are interactions .ith other prescribed drugs( but
'ou must also thin/ o% over6the6counter drugs the patient
might be ta/ing. 3nteractions ma' also occur .ith %ood or
drin/s +especiall' alcohol,. -ome drugs interact chemicall'
.ith other substances and become ine%%ective +e.g.
tetrac'cline and mil/,. $ortunatel'( in practice onl' a %e.
interactions are clinicall' relevant.
*"ercise: patients 1312
/eri$y in eac# o$ t#ese cases w#et#er t#e active su(stance and
dosage $or% o$ your Pdrug is suita(le (e$$ective- sa$e) $or t#is
patient. *"a%ples are discussed (elow.
Patient 13:
Man' C# years. ?uffers from asthma. Gses salbutamol inhaler.
few weeks a!o you dia!nosed essential hypertension :)C#1)-- on
various occasions;. "ou advised a low-salt diet' but blood
pressure remains hi!h. "ou decide to add a dru! to your
treatment. "our +-dru! for hypertension in patients under #- is
atenolol tablets' #- m! a day.
Patient 14:
Girl' * years. 0rou!ht in with a severe acute asthmatic attack'
probably precipitated by a viral infection. ?he has !reat difficulty in
breathin! :e%piratory whee&e' no viscid sputum;' little cou!hin!
48
Table >0
High ris/ %actorsN
groups
Pregnanc'
4actation
&hildren
Elderl'
"enal %ailure
Hepatic %ailure
Histor' o% drug
allerg'
Other diseases
Other medication
and a sli!ht temperature :*2.$
o
<;. Further history and physical
e%amination reveal nothin!. part from minor childhood infections
she has never been ill before and she takes no dru!s. "our +-
dru! for such a case is a salbutamol inhaler.
Patient 10:
Woman' $$ years' $ months pre!nant. >ar!e abscess on her ri!ht
forearm. "ou conclude that she will need sur!ery fast' but in the
meantime you want to relieve the pain. "our +-dru! for common
pain is acetylsalicylic acid :aspirin; tablets.
Patient 12:
0oy' C years. <ou!h and fever of *B.#
o
<. .ia!nosis4 pneumonia.
Fne of your +-dru!s for pneumonia is tetracycline tablets.
Patient 13 (#ypertension)
Atenolol is a good P6drug %or the treatment o% essential h'pertension in patients
belo. >G 'ears o% age( and it is ver' convenient. Ho.ever( li/e all beta6bloc/ers( it
is relativel' contraindicated in asthma. Despite the %act that it is a selective beta6
bloc/er( it can induce asthmatic problems( especiall' in higher doses because
selectivit' then diminishes. 3% the asthma is not ver' severe( atenolol can be
prescribed in a lo. dose. 3n severe asthma 'ou should probabl' s.itch to diureticsA
almost an' thiazide is a good choice.
Patient 14 (c#ild wit# acute ast#%a)
3n this child a %ast e%%ect is needed( and tablets .or/ too slo.l' %or that. 3nhalers
onl' .or/ .hen the patient /no.s ho. to use them and can still breathe enough to
inhale. 3n the case o% a severe asthma attac/ this is usuall' not possibleA moreover(
some children belo. the age o% %ive ma' e8perience di%%iculties .ith an inhaler.
3ntravenous in7ection in 'oung children can be ver' di%%icult. 3% an inhaler cannot be
used( the best alternative is to give salbutamol b' subcutaneous or intramuscular
in7ection( .hich is eas' and onl' brie%l' pain%ul.
Patient 10 (a(scess)
This patient is pregnant and .ill soon be operated on. 3n this case acet'lsalic'lic
acid is contraindicated as it a%%ects the blood clotting mechanism and also passes
the placenta. Iou should s.itch to another drug that does not inter%ere .ith clotting.
Paracetamol is a good choice and there is no evidence that it has an' e%%ect on the
%etus .hen it is given %or a short time.
Patient 12 (pneu%onia)
Tetrac'cline is not a good drug %or children belo. !# 'ears o% age( because it can
cause discolouration o% the teeth. The drug ma' interact .ith mil/ and the child ma'
have problems s.allo.ing the large tablets. The drug and( i% possible( the dosage
%orm( .ill there%ore have to be changed. Good alternatives are cotrimo8azole and
amo8icillin. Tablets or parts o% tablets could be crushed and dissolved in .ater(
.hich is cost6e%%ective i% 'ou can clearl' e8plain the procedure to the parents.
B
Iou
could also prescribe a more convenient dosage %orm( such as a s'rup( although
this is more e8pensive.
3n all these patients 'our P6drug .as not suitable( and in each case 'ou had to
change either the active substance or the dosage %orm( or both. Atenolol .as
contraindicated because o% another disease +asthma,A an inhaler .as not suitable
3
This is a cheap and convenient way of giving a drug to a small child. However, it should not be done with
capsules nor with special tablets such as sugarcoated or slow-release preparations.
49
because the child .as too 'oung to handle itA acet'lsalic'lic acid .as
contraindicated because it a%%ects the blood clotting mechanism and because the
patient is pregnantA and tetrac'cline tablets .ere contraindicated because o%
serious side e%%ects in 'oung children( possible interactions .ith mil/( and
inconvenience as a dosage %orm.
-tep B20 3s the standard dosage schedule suitable %or this patientH
The aim o% a dosage schedule is to maintain the plasma level o% the drug .ithin the
therapeutic .indo.. As in the previous step( the dosage schedule should be
e$$ective and sa$e %or the individual patient. There are t.o main reasons .h' a
standard dosage schedule ma' have to be adapted. The .indo. andNor plasma
curve ma' have changed( or the dosage schedule is inconvenient to the patient. 3%
'ou are not %amiliar .ith the concept o% the therapeutic .indo. and the plasma
concentration6time curve( read Anne8 !.
*"ercise: patients 1=2@
<eview $or eac# o$ t#e $ollowing cases w#et#er t#e dosage
sc#edule is suita(le (e$$ective- sa$e) $or t#e patient. !dapt t#e
sc#edule w#ere necessary. T#e cases are discussed (elow.
Patient 1=:
Woman' C* years. History of insulin dependent diabetes for $,
years. ?table on treatment with two daily doses of neutral insulin'
$- 9G and *- 9G. Recently mild hypertension was dia!nosed' and
diet and !eneral advice have not been sufficiently effective. "ou
would like to treat this condition with a beta-blocker. "our +-dru!
is atenolol #- m! once daily.
Patient 1>:
Man' C# years. (erminal lun! cancer. He has lost * k! durin! the
last week. "ou have been treatin! his pain successfully with your
+-dru!' oral morphine solution' )- m! twice daily. Aow he
complains that the pain is !ettin! worse.
Patient 1?:
Woman' #- years. <hronic rheumatic disease' treated with your
+-dru!' indometacin' * times #- m! daily plus a #- m!
suppository at ni!ht. ?he complains of pain early in the mornin!.
Patient 1> again- a$ter one wee,:
He has lost another , k!' and looks very ill. He was on oral
morphine solution' )# m! twice daily' to which he had responded
well. However' he has become very drowsy and has to be woken
up to hear what you say. He has no pain.
Patient 2@:
Man' 3* years. Has suffered from depression for two years' after
the death of his wife. "ou want to prescribe an antidepressant
dru!. "our +-dru! is amitriptyline' $# m! daily initially' followed by
a slowly risin! dose till the dru! is effective :with a ma%imum of
)#- m! per day;.
50
'#anges in t#erapeutic window
$or a variet' o% reasons +e.g. age(
pregnanc'( disturbed organ %unctions,
individual patients ma' di%%er %rom the
standard. These di%%erences ma' in%luence
the pharmaco6d'namics or
pharmaco/inetics o% 'our P6drug. A change
in pharmacod'namics ma' a%%ect the level
+position, or .idth o% the therapeutic
.indo. +$igure !A see also Anne8 !,. The
therapeutic .indo. re%lects the sensitivit'
o% the patient to the action o% the drug.
&hanges in the therapeutic .indo. are
sometimes e8pressed as the patient being
MresistantK or Mh'per6sensitiveK. The onl'
.a' to determine the therapeutic .indo. in the individual patient is b' trial( care%ul
monitoring and logical thin/ing.
3n Patient 1= (dia(etes) it is important to note that 6bloc/ers counteract the e%%ect
o% insulin. This means that higher concentrations o% insulin are needed %or the same
e%%ect0 the therapeutic .indo. %or insulin shi%ts up.ards. The plasma curve no
longer matches the .indo.( and the dail' dose o% insulin must be raised. 6
bloc/ers ma' also mas/ an' signs o% h'pogl'cemia. $or these t.o reasons 'ou
ma' decide to change to another drug group that does not a%%ect glucose tolerance(
e.g. calcium channel bloc/ers.
Patient 1> (lung cancer) has probabl' become tolerant to morphine( as he
responded .ell to the drug be%ore. Tolerance to e%%ect and also to side e%%ects( is
common in opiates. The therapeutic .indo. is shi%ted up.ards and the dose has to
be raised( %or e8ample to !> mg t.ice dail'. 3n terminal patients drug absorption
and metabolism ma' be so disturbed that even larger dosages +e.g. !G times the
normal dose, ma' be necessar'.
'#anges in plas%a concentrationti%e curve
The plasma concentration6time curve ma' be lo.ered or raised( or the
concentration ma' %luctuate outside the therapeutic .indo.. This e%%ect depends
on the pharmaco/inetics o% the drug in that patient.
51
3n Patient 1? (pain at nig#t) the plasma concentration o% indometacin probabl' %alls belo.
the therapeutic .indo. earl' in the morning +see $igure #,. An' change in medication
should there%ore aim at increasing the plasma level in that period. Iou could advise her to
ta/e the evening dose later( or to set the alarm in the night to ta/e an e8tra tablet. Iou could
also increase the strength o% the evening suppositor' to !GG mg( .hile decreasing her %irst
morning tablet to #> mg.
The second visit o% Patient 1> (lung cancer)
presents a complicated problem. He has
probabl' been overdosed( because his
metabolism is impaired b' the terminal cancer(
decreasing the elimination o% the drug and
there%ore lengthening its hal%6li%e. 3n addition( the
distribution volume o% his bod' is reduced
because o% emaciation. The curve there%ore
probabl' lies above the .indo.( impl'ing that the
dail' dose should be reduced. "emember that it
ta/es about %our hal%6lives to lo.er the plasma
concentration to a ne. stead' state. 3% 'ou .ant
to speed up this process 'ou can stop the
morphine %or one da'( a%ter .hich 'ou can start
.ith the ne. dose. This is the reverse process o%
a loading dose.
$our %actors determine the course o% the concentration curve( usuall' called ADME6%actors0
Absorption( Distribution( Metabolism and E8cretion. Iou al.a's have to chec/ .hether ADME6
%actors in 'our patient are di%%erent compared to average patients. 3% so( 'ou have to
determine .hat this .ill do to the plasma curve. An' change in ADME6%actors in%luences
plasma concentration +see Table ?,.
Ho. can 'ou de%ine the position o% the plasma curve in an individual patientH The plasma
concentration can be measured b' laborator' investigations( but in man' settings this is not
possible and it ma' be e8pensive. More important( each measurement represents onl' one
point o% the curve and is di%%icult to interpret .ithout special training and e8perience. More
measurements are e8pensive and ma' be stress%ul to the patient( especiall' in an outpatient
setting. 3t is simpler to loo/ %or clinical signs o% to8ic e%%ects. These are o%ten eas' to detect
b' histor' ta/ing and clinical investigation.
'#anges in window and curve
52
Table ?0
"elation bet.een ADME
%actors and plasma
concentration
Plas%a concentration
curve will drop i$:
Absorption is lo.
Distribution is high
Metabolism is high
E8cretion is high
Plas%a concentration
curve will rise i$:
Absorption is high
Distribution is lo.
Metabolism is lo.
E8cretion is lo.
&hanges in both .indo. and curve are also possible( as
illustrated in Patient 2@ (depression) +see $igure C,.
Elderl' people are one o% several categories o% high6ris/
patients. Dosage schedules %or antidepressant drugs in
the elderl' usuall' recommend that the dose be reduced
to hal% the adult dose( %or t.o reasons. $irst( in the
elderl' the therapeutic .indo. o% antidepressant drugs
shi%ts do.n.ards +a lo.er plasma concentration .ill
su%%ice,. At a %ull adult dose the plasma curve ma' rise
above the therapeutic .indo.( leading to side e%%ects(
especiall' anticholinergic and cardiac e%%ects. -econdl'(
metabolism and renal clearance o% the drug and its
active metabolites ma' be reduced in the elderl'( also
increasing the plasma curve. Thus( in prescribing the normal adult dosage 'our patient .ill
be e8posed to unnecessar' and possibl' harm%ul side e%%ects.
'onvenience
A dosage schedule should be convenient. The more comple8 the schedule( the
less convenient it is. $or e8ample( t.o tablets once dail' are much more
convenient than hal% a tablet %our times dail'. &omple8 dosage schedules decrease
patient adherence to treatment( especiall' .hen more than one drug is used( and
thus decrease e%%ectiveness. Tr' to ad7ust a dosage schedule to other schedules o%
the patient.
3n patients !@6#G the standard dosage schedule o% 'our P6drug .as not suitable. 3%
'ou had not adapted the schedule( the P6drug treatment .ould have been less
e%%ective( or unsa%e. Iou can prevent this b' care%ull' chec/ing the suitabilit' o% the
standard dosage schedule be%ore .riting the prescription. Iou ma' have to modi%'
the schedule( or change to a completel' di%%erent P6drug.
4ow to adapt a dosage sc#edule
There are three .a's to restore the mismatch
bet.een curve and .indo.0 change the dose(
change the %re=uenc' o% administration( or both.
&hanging dose or %re=uenc' have di%%erent e%%ects.
The dail' dose determines the mean plasma
concentration( .hile the %re=uenc' o% administration
de%ines the %luctuations in the plasma curve. $or
e8ample( t.ice dail' #GG mg .ill give the same
mean plasma concentration as %our times dail' !GG
mg( but .ith more %luctuations in plasma level. The
minimum %luctuation .ould be obtained b' delivering
CGG mg in #C hours b' means o% a continuous
in%usion +$igure >,.
Decreasing the dail' dose is usuall' eas'. Iou can reduce the number o% tablets( or
divide them into halves. 2e.are o% antibiotics( because some ma' need high pea/s
in plasma concentration to be e%%ective. 3n that case 'ou should reduce the
%re=uenc'( not the dose.
53
3ncreasing the dail' dose is a little more complicated. Doubling the dose .hile
maintaining the same %re=uenc' not onl' doubles the mean plasma level( but also
increases the %luctuations on both sides o% the curve. 3n drugs .ith a narro. sa%et'
margin the curve ma' no. %luctuate outside the therapeutic .indo.. The sa%est
.a' to prevent this is to raise the %re=uenc' o% dosage. Ho.ever( %e. patients li/e
ta/ing drugs !# times a da' and a compromise has to be %ound to maintain
adherence to treatment. A%ter changing the dail' dose it ta/es %our times the hal%6
li%e o% the drug to reach the ne. stead' state. Table @ lists those drugs %or .hich it
is advisable to start treatment .ith a slo.l' rising dosage schedule.
54
Table @0 Drugs in .hich slo.l' raising the dose is advisable
Tric'clic antidepressants +anticholinergic e%%ects,
-ome anti6epileptics +carbamazepine( valproic acid,
Dopa6based anti6Par/inson drugs
A&E6inhibitors in patients using diuretics
Alpha6receptor bloc/ing agents in h'pertension +orthostasis,
-ome hormonal drug therapies +corticosteroids( levoth'ro8in,
Gold salts in rheumatism
Mi8tures %or desensitization
Opiates in cancer
-tep B&0 3s the standard duration o% treatment suitable %or this patientH
Man' doctors not onl' prescribe too much o% a drug %or too long( but also %re=uentl'
too little o% a drug %or too short a period. 3n one stud' about !GT o% patients on
benzodiazepines received them %or a 'ear or longer. Another stud' sho.ed that
!?T o% outpatients .ith cancer still su%%ered %rom pain because doctors .ere a%raid
to prescribe morphine %or a long period. The' mistoo/ tolerance %or addiction. The
duration o% the treatment and the =uantit' o% drugs prescribed should also be
e%%ective and sa%e %or the individual patient.
Overprescribing leads to man' undesired e%%ects. The patient receives
unnecessar' treatment( or drugs ma' lose some o% their potenc'. )nnecessar'
side e%%ects ma' occur. The =uantit' available ma' enable the patient to overdose.
Drug dependence and addiction ma' occur. -ome reconstituted drugs( such as e'e
drops and antibiotic s'rups( ma' become contaminated. 3t ma' be ver'
inconvenient %or the patient to ta/e so man' drugs. 4ast( but not least( valuable and
o%ten scarce resources are .asted.
)nderprescribing is also serious. The treatment is not e%%ective( and more
aggressive or e8pensive treatment ma' be needed later. Proph'la8is ma' be
ine%%ective( resulting in serious disease( e.g. malaria. Most patients .ill %ind it
inconvenient to return %or %urther treatment. Mone' spent on ine%%ective treatment is
mone' .asted.
*"ercise: patients 212>
5or eac# o$ t#e $ollowing cases veri$y w#et#er t#e duration o$
treat%ent and total 6uantity o$ t#e drugs are suita(le (e$$ective-
sa$e). 9n all cases you %ay assu%e t#at t#e drugs are your
Pdrugs.
Patient 21:
Woman' #, years. Aewly dia!nosed depression. R1amitriptyline
$# m!' one tablet daily at ni!ht' !ive *- tablets.
Patient 22:
<hild' , years. Giardiasis with persistent diarrhoea. R1metronida&ole
$-- m!1# ml oral suspension' # ml three times daily' !ive )-# ml.
55
Patient 23:
Man' )2 years. .ry cou!h after a cold. R1codeine *- m!' ) tablet
three times daily' !ive ,- tablets.
Patient 24:
Woman' ,$ years. n!ina pectoris' waitin! for referral to a
specialist. R1!lyceryl trinitrate # m!' as necessary ) tablet
sublin!ual' !ive ,- tablets.
Patient 20:
Man' CC years. ?leeplessness. <omes for a refill' R1dia&epam #
m!' ) tablet before sleepin!' !ive ,- tablets.
Patient 22:
Girl' )# years. Aeeds malaria prophyla%is for a two week trip to
Ghana. R1meflo/uine $#- m!' ) tablet weekly' !ive 3 tabletsD start
one week before departure and continue four weeks after return.
Patient 2=:
0oy' )C years. cute conjunctivitis. R1tetracycline -.#H eye drops'
first * days every hour ) drop' then $ drops every si% hours' !ive
)- ml.
Patient 2>:
Woman' $C years. Feels weak and looks a bit anaemic. Ao Hb
result available. R1ferrous sulfate ,- m! tablets' ) tablet three
times daily' !ive *- tablets.
Patient 21 (depression)
A dose o% #> mg per da' is probabl' insu%%icient to treat her depression. Although
she can start .ith such a lo. dose %or a %e. da's or a .ee/( mainl' to get used to
side e%%ects o% the drug( she ma' %inall' need !GG6!>G mg per da'. With BG tablets
the =uantit' is su%%icient %or one month( i% the dosage is not changed be%ore that
time. 2ut is it sa%eH At the beginning o% the treatment the e%%ect and side e%%ects
cannot be %oreseen. And i% the treatment has to be stopped( the remaining drugs
are .asted. The ris/ o% suicide also has to be considered0 depressive patients are
more liable to commit suicide in the initial stages o% treatment .hen the' become
more active because o% the drug( but still %eel depressed. $or these reasons BG
tablets are not suitable. 3t .ould be better to start .ith !G tablets( %or the %irst .ee/
or so. 3% she reacts .ell 'ou should increase the dose.
Patient 22 (giardiasis)
With most in%ections time is needed to /ill the microbes( and short treatments ma'
not be e%%ective. Ho.ever( a%ter prolonged treatment the micro6organisms ma'
develop resistance and more side e%%ects .ill occur. 3n this patient the treatment is
both e%%ective and sa%e. Giardiasis .ith persistent diarrhoea needs to be treated %or
one .ee/( and !G> ml is e8actl' enough %or that period. Ma'be it is even too e8act.
Most pharmacists do not .ant to dispense =uantities such as !G> ml or CF tablets.
The' pre%er rounded %igures( such as !GG ml or >G tablets( because calculating is
easier and drugs are usuall' stoc/ed or pac/ed in such =uantities.
56
Patient 23 (dry coug#)
The =uantit' o% tablets is much too high %or this patient. The persistent dr' cough
prevents healing o% the irritated bronchial tissue. -ince tissue can regenerate .ithin
three da's the cough needs to be suppressed %or %ive da's at most( so !G6!>
tablets .ill be su%%icient. Although a larger =uantit' .ill not harm the patient( it is
unnecessar'( inconvenient and needlessl' e8pensive. Man' prescribers .ould
argue that no drug is needed at all +see p.E,.
Patient 24 (angina)
$or this patient the =uantit' is e8cessive. -he .ill not use ?G tablets be%ore her
appointment .ith the specialist. And did 'ou remember that the drug is volatileH
A%ter some time the remaining tablets .ill no longer be e%%ective.
Patient 20 (sleeplessness)
The diazepam re%ill %or patient #> is .orr'ing. Iou suddenl' remember that he
came %or a similar re%ill recentl' and chec/ the medical record. 3t .as t.o .ee/s
agoL 4oo/ing more closel' 'ou %ind that he has used diazepam %our times dail' %or
the last three 'ears. This treatment has been e8pensive( probabl' ine%%ective and
has resulted in a severe dependenc'. Iou should tal/ to the patient at the ne8t visit
and discuss .ith him ho. he can graduall' come o%% the drug.
2o8 ?0 "epeat prescriptions in practice
3n long6term treatment( patient adherence to treatment can be a problem. O%ten the patient
stops ta/ing the drug .hen the s'mptoms have disappeared or i% side e%%ects occur. $or patients
.ith chronic conditions repeat prescriptions are o%ten prepared b' the receptionist or assistant
and 7ust signed b' the ph'sician. This ma' be convenient %or doctor and patient but it has
certain ris/s( as the process o% rene.al becomes a routine( rather than a conscious act.
Automatic re%ills are one o% the main reasons %or overprescribing in industrialized countries(
especiall' in chronic conditions. When patients live %ar a.a'( convenience ma' lead to
prescriptions %or longer periods. This ma' also result in over prescribing. Iou should see 'our
patients on long6term treatment at least %our times per 'ear.
Patient 22 (%alaria prop#yla"is)
There is nothing .rong .ith this prescription .hich %ollo.s the WHO guidelines on
malaria proph'la8is %or travellers to Ghana. The dosage schedule is correct( and
she received enough tablets %or the trip plus %our .ee/s a%ter.ards. Apart %rom a
small ris/ o% drug resistance this drug treatment is e%%ective and sa%e.
Patient 2= (acute con)unctivitis)
The prescription o% !G ml e'edrops seems ade=uate( at %irst sight. 3n %act( e'edrops
are usuall' prescribed in bottles o% !G ml. 2ut did 'ou ever chec/ ho. man' drops
there are in a bottle o% !G mlH One ml is about #G drops( so !G ml is about #GG
drops. One drop ever' hour %or the %irst three da's means B 8 #C V @# drops. That
leaves about !#E drops in the bottle. T.o drops %our times per da' %or the
remaining period is E drops a da'. That is %or another !BGNE V !? da's. The total
treatment there%ore covers B O !? V !F da'sL Iet( seven da's treatment at most
should be enough %or bacterial con7unctivitis. A%ter some arithmetic +@# O +C 8 E, V
!GC drops V !GC 8 G.G> V >.# ml, 'ou conclude that > ml .ill be enough in %uture.
This .ill also prevent an' le%tovers %rom being used again .ithout a proper
57
diagnosis. Even more important( e'edrops become contaminated a%ter a %e.
.ee/s( especiall' i% the' are not /ept cool( and can cause severe e'e in%ections.
Patient 2> (wea,ness)
Did 'ou notice that this is a t'pical e8ample o% a prescription .ithout a clear
therapeutic ob7ectiveH 3% the diagnosis is uncertain( the Hb should be measured. 3%
the patient is reall' anaemic she .ill need much more iron than the ten da's given
here. -he .ill probabl' need treatment %or several .ee/s or months( .ith regular
Hb measurements in bet.een.
&onclusion
eri%'ing .hether 'our P6drug is also suitable %or the individual patient in %ront o%
'ou is probabl' the most important step in the process o% rational prescribing. 3t
also applies i% 'ou are .or/ing in an environment in .hich essential drugs lists(
%ormularies and treatment guidelines e8ist. 3n dail' practice( adapting the dosage
schedule to the individual patient is probabl' the most common change that 'ou .ill
ma/e.
-ummar'
-TEP B0 eri%' that 'our P6drug is suitable %or this patient
3! !re t#e active su(stance and dosage $or% suita(le3
*$$ective: 3ndication +drug reall' needed,H
&onvenience +eas' to handle( cost,H
Sa$e: &ontraindications +high ris/ groups( other diseases,H
3nteractions +drugs( %ood( alcohol,H
38 9s t#e dosage sc#edule suita(le3
*$$ective: Ade=uate dosage +curve .ithin .indo.,H
&onvenience +eas' to memorize( eas' to do,H
Sa$e0 &ontraindications +high ris/ groups( other diseases,H
3nteractions +drugs( %ood( alcohol,H
3' 9s t#e duration suita(le3
*$$ective: Ade=uate duration +in%ections( proph'la8is( lead time,H
&onvenience +eas' to store( cost,H
Sa$e: &ontraindications +side e%%ects( dependence( suicide,H
:uantit' too large +loss o% =ualit'( use o% le%tovers,H
3% necessar'( change the dosage %orm( the dosage schedule or the duration o%
treatment.
3n some cases it is better to change to another P6drug.
58
Chapter 9 Step 4: Write a prescription
hapter F
-TEP C0 Write a prescription
A prescription is an instruction %rom a prescriber to a dispenser. The prescriber is
not al.a's a doctor but can also be a paramedical .or/er( such as a medical
assistant( a mid.i%e or a nurse. The dispenser is not al.a's a pharmacist( but can
be a pharmac' technician( an assistant or a nurse. Ever' countr' has its o.n
standards %or the minimum in%ormation re=uired %or a prescription( and its o.n la.s
and regulations to de%ine .hich drugs re=uire a prescription and .ho is entitled to
.rite it. Man' countries have separate regulations %or opiate prescriptions.
3n%ormation on a prescription
There is no global standard %or prescriptions and ever' countr' has its o.n
regulations. Do 'ou /no. the legal re=uirements in 'our o.n countr'H The most
important re=uirement is that the prescription be clear. 3t should be legible and
indicate precisel' .hat should be given. $e. prescriptions are still .ritten in 4atinA
the local language is pre%erred. 3% 'ou include the %ollo.ing in%ormation( not much
can go .rong.
7a%e and address o$ t#e prescri(er- wit# telep#one nu%(er (i$ possi(le)
&
&artoon B
59
This is usuall' pre6printed on the %orm. 3% the pharmacist has an' =uestions about
the prescription +s,he can easil' contact the prescriber.
&ate o$ t#e prescription
3n man' countries the validit' o% a prescription has no time limit( but in some
countries pharmacists do not give out drugs on prescriptions older than three to si8
months. Iou should chec/ the rules in 'our o.n countr'.
7a%e and strengt# o$ t#e drug
"N +not "8, is derived %rom Recipe +4atin %or Mta/eK,. A%ter "N 'ou should .rite the
name o% the drug and the strength. 3t is strongl' recommended to use the generic
+nonproprietar', name. This %acilitates education and in%ormation. 3t means that 'ou
do not e8press an opinion about a particular brand o% the drug( .hich ma' be
unnecessaril' e8pensive %or the patient. 3t also enables the pharmacist to maintain
a more limited stoc/ o% drugs( or dispense the cheapest drug. Ho.ever( i% there is a
particular reason to prescribe a special brand( the trade name can be added. -ome
countries allo. generic substitution b' the pharmacist and re=uire the addition M.o
not substituteK or M.ispense as writtenK i% that brand( and no other( is to be
dispensed.

The strength o% the drug indicates ho. man' milligrams each tablet( suppositor'( or
milliliter o% %luid should contain. 3nternationall' accepted abbreviations should be
used0 g %or gram( ml %or milliliter. Tr' to avoid decimals and( .here necessar'( .rite
.ords in %ull to avoid misunderstanding. $or e8ample( .rite levoth'ro8in >G
micrograms( not G.G>G milligrams or >G ug. 2adl' hand.ritten prescriptions can
lead to mista/es( and it is the legal dut' o% the doctor to .rite legibl' +2o8 @,. 3n
prescriptions %or controlled drugs or those .ith a potential %or abuse it is sa%er to
.rite the strength and total amount in .ords( to prevent tampering. 3nstructions %or
use must be clear and the ma8imum dail' dose mentioned. )se indelible in/.
2o8 @0 4egal obligation to .rite clearl'
Doctors are legall' obliged to .rite clearl'( as emphasized in the )5 &ourt o% Appeal ruling in
the %ollo.ing case. A doctor had .ritten a prescription %or Amo8il tablets +amo8icillin,. The
pharmacist misread this and dispensed Daonil +glibenclamide, instead. The patient .as not a
diabetic and su%%ered permanent brain damage as a result o% ta/ing the drug.
The court indicated that a doctor o.ed a dut' o% care to a patient to .rite a prescription clearl'
and .ith su%%icient legibilit' to allo. %or possible mista/es b' a bus' pharmacist. The court
concluded that the .ord Amo8il on the prescription could have been read as Daonil. 3t %ound
that the doctor had been in breach o% his dut' to .rite clearl' and had been negligent. The
court concluded that the doctorDs negligence had contributed to the negligence o% the
pharmacist( although the greater proportion o% the responsibilit' +@>T, la' .ith the pharmacist.
On appeal the doctor argued that the .ord on the prescription standing on its o.n could
reasonabl' have been read incorrectl' but that various other aspects o% the prescription should
have alerted the pharmacist. The strength prescribed .as appropriate %or Amo8il but not %or
DaonilA the prescription .as %or Amo8il to be ta/en three times a da' .hile Daonil .as usuall'
ta/en once a da'A the prescription .as %or onl' seven da'sD treatment( .hich .as unli/el' %or
DaonilA and %inall'( all prescriptions o% drugs %or diabetes .ere %ree under the *ational Health
60
-ervice but the patient did not claim %ree treatment %or the drug. All o% these %actors should
have raised doubts in the mind o% the pharmacist and as a result he should have contacted the
doctor. There%ore( the chain o% causation %rom the doctorDs bad hand.riting to the eventual
in7ur' .as bro/en.
This argument .as re7ected in the &ourt o% Appeal. The implications o% this ruling are that
doctors are under a legal dut' o% care to .rite clearl'( that is .ith su%%icient legibilit' to allo. %or
mista/es b' others. When illegible hand.riting results in a breach o% that dut'( causing
personal in7ur'( then the courts .ill be prepared to punish the careless b' a.arding su%%icient
damages. 4iabilit' does not end .hen the prescription leaves the doctorDs consulting room. 3t
ma' also be a cause o% the negligence o% others.
?ource4 I R <oll Gen +ract' )B2B4 *C3-2
&osage $or% and total a%ount
Onl' use standard abbreviations that .ill be /no.n to the pharmacist.
9n$or%ation $or t#e pac,age la(el
- stands %or ?i!na +4atin %or M.riteK,. All in%ormation %ollo.ing the - or the .ord
M4abelK should be copied b' the pharmacist onto the label o% the pac/age. This
includes ho. much o% the drug is to be ta/en( ho. o%ten( and an' speci%ic
instructions and .arnings. These should be given in la' language. Do not use
abbreviations or statements li/e Mas be%oreK or Mas directedK. When stating Mas
re=uiredK( the ma8imum dose and minimum dose interval should be indicated.
&ertain instructions %or the pharmacist( such as MAdd > ml measuring spoonK are
.ritten here( but o% course are not copied onto the label.
Prescri(er.s initials or signature
7a%e and address o$ t#e patientA age ($or c#ildren and elderly)
2o8 E0 3ncomplete labels
The label on the drug pac/age is ver' important %or the patient as a reminder o% the
instructions %or use. 3n man' cases( ho.ever( labels are incomplete. An anal'sis o% !>BB
+V!GGT, labels sho.ed0
*o label or illegible !.T
:uantit' not recorded >G.T
*o directions( or onl' Mas be%oreKNKas directedK #?.T
*o date !C.T
The data listed above are the core o% ever' prescription. Additional in%ormation ma'
be added( such as the t'pe o% health insurance the patient has. The la'out o% the
prescription %orm and the period o% validit' ma' var' bet.een countries. The
61
number o% drugs per prescription ma' be restricted. -ome countries re=uire
prescriptions %or opiates on a separate sheet. Hospitals o%ten have their o.n
standard prescription %orms. As 'ou can chec/ %or 'oursel%( all prescriptions in this
chapter include the basic in%ormation given above.
*"ercise: Patients 2?32
Brite a prescription $or eac# o$ t#e $ollowing patients.
Prescriptions are discussed (elow.
Patient 2?:
0oy' # years. +neumonia with !reenish sputum. "our +-dru! is
amo%icillin syrup.
Patient 3@:
Woman' 3- years. Moderate con!estive cardiac failure. For
several years on di!o%in -.$# m! ) tablet daily. ?he phones to
ask for a repeat prescription. s you have not seen her for some
time you ask her to call. .urin! the visit she complains of sli!ht
nausea and loss of appetite. Ao vomitin! or diarrhoea. "ou
suspect side effects of di!o%in' and call her cardiolo!ist. s she
has an appointment with him ne%t week' and he is very busy' he
advises you to halve the dose until then.
Patient 31:
Woman' $$ years. Aew patient. Mi!raine with increasin!ly
fre/uent vomitin!. +aracetamol no lon!er effective durin! attacks.
"ou e%plain to her that the paracetamol does not work because
she vomits the dru! before it is absorbed. "ou prescribe
paracetamol plus an anti-emetic suppository' metoclopramide'
which she should take first' and wait $--*- minutes before takin!
the paracetamol.
Patient 32:
Man' #* years. (erminal sta!e of pancreatic cancer' confined to
bed at home. "ou visit him once a week. (oday his wife calls and
asks you to come earlier because he is in considerable pain. "ou
!o immediately. He has slept badly over the weekend and re!ular
painkillers are not workin!. (o!ether you decide to try morphine
for a week. Makin! sure not to underdose him' you start with )-
m! every si% hours' with $- m! at ni!ht. He also has non-insulin
dependent diabetes' so you add a refill for his tolbutamide.
There is nothing .rong .ith an' o% the %our prescriptions +$igures ?( @( E and F,.
Ho.ever( a %e. remar/s can be made. "epeat prescriptions( such as the one %or
patient BG( are permitted. Man' prescriptions are li/e that. 2ut the' also need 'our
%ull attention. Do not .rite a repeat prescription automaticall'L &hec/ ho. man'
times it has been repeated. 3s it still e%%ectiveH 3t is still sa%eH Does it still meet the
original needsH
$or the opiate %or patient B#( the strength and the total amount have been .ritten in
.ords so the' cannot easil' be altered. The instructions are detailed and the
ma8imum dail' dose is mentioned. 3n some countries it is mandator' to .rite an
opiate prescription on a separate prescription sheet.
-ummar'
62
A prescription should include0
Q *ame( address( telephone o% prescriber
Q Date
Q Generic name o% the drug( strength
Q Dosage %orm( total amount
Q 4abel0 instructions( .arnings
Q *ame( address( age o% patient
Q -ignature or initials o% prescriber
Fi!ure ,4 +rescription for patient $B Fi!ure 34 +rescription for patient *-
Fi!ure 24 +rescription for patient *) Fi!ure B4 +rescription for patient *$
Dr 2. Who
$armstreet !#
5ir/ville
tel. BE@?
"N date
MsNMr
address0
age0
Dr 2. Who
$armstreet !#
5ir/ville
tel. BE@?
"N date
MsNMr
address0
age0
63
hapter !G
-TEP >0Give in%ormation( instructions and
.arnings
*"a%ple: patient 33
Woman' #B years. ?he is takin! dru!s for con!estive heart failure and hypertension. ?he
also has a newly dia!nosed !astric ulcer' for which she has been prescribed another dru!.
s the doctor is e%plainin! why she needs the new dru! and how she should take it' her
thou!hts are driftin! away. (he doctor8s voice sinks into the back!round as she starts
worryin! about the new illness' afraid of the conse/uences and how she will remember to
take all these dru!s. (he doctor doesn8t notice the loss of attention' doesn8t encoura!e a
dialo!ue but just keeps on talkin! and talkin!. 9n the pharmacy her thou!hts are still
64
&
Chapter 10 Step 5: Give information, instructions and warnings
wanderin! off even when the pharmacist is e%plainin! how to take the dru!. When she !ets
home she finds her dau!hter waitin! to hear the results of her visit to the doctor. Without
tellin! her the dia!nosis she talks about her worry4 how to cope with all these different
dru!s. Finally her dau!hter reassures her and says that she will help her to take the dru!s
correctly.
On average( >GT o% patients do not ta/e prescribed drugs correctl'( ta/e them
irregularl'( or not at all. The most common reasons are that s'mptoms have
ceased( side e%%ects have occurred( the drug is not perceived as e%%ective( or the
dosage schedule is complicated %or patients( particularl' the elderl'. *on adherence
to treatment ma' have no serious conse=uences. $or e8ample( irregular doses o% a
thiazide still give the same result( as the drug has a long hal%6li%e and a %lat dose6
response curve. 2ut drugs .ith a short hal%6li%e +e.g. %en'toin, or a narro.
therapeutic margin +e.g. theoph'lline, ma' become ine%%ective or to8ic i% ta/en
irregularl'.
Patient adherence to treatment can be improved in three .a's0 prescribe a .ell
chosen drug treatmentA create a good doctor6patient relationshipA ta/e time to give
the necessar' in%ormation( instructions and .arnings. A number o% patient aids are
discussed in 2o8 F. A .ell chosen drug treatment consists o% as %e. drugs as
possible +pre%erabl' onl' one,( .ith rapid action( .ith as %e. side e%%ects as
possible( in an appropriate dosage %orm( .ith a simple dosage schedule +one or
t.o times dail',( and %or the shortest possible duration.
Ho. to improve patient adherence to treatment
Q Prescribe a .ell6chosen treatment
Q &reate a good doctor6patient relationship
Q Ta/e the time to give in%ormation( instructions and .arnings
A good doctor6patient relationship is established through respect %or the patientDs
%eelings and vie.point( understanding( and .illingness to enter into a dialogue
.hich empo.ers the patient as a partner in therap'. Patients need in%ormation(
instructions and .arnings to provide them .ith the /no.ledge to accept and %ollo.
the treatment and to ac=uire the necessar' s/ills to ta/e the drugs appropriatel'. 3n
some studies less than ?GT o% patients had understood ho. to ta/e the drugs the'
had received. 3n%ormation should be given in clear( common language and it is
help%ul to as/ patients to repeat in their o.n .ords some o% the core in%ormation( to
be sure that it has been understood. A %unctional name( such as a Mheart pillK is
o%ten easier to remember and clearer in terms o% indication.
2o8 F0 Aids to improving patient adherence to treatment
Patient lea$lets
Patient lea%lets rein%orce the in%ormation given b' the prescriber and pharmacist. The te8t
should be in clear( common language and in easil' legible print.
65
Pictorials and s#ort descriptions
3% the patient cannot read( tr' pictorials. 3% the' are not available( ma/e pictorials or short
descriptions %or 'our o.n P6drugs( and photocop' them.
&ay calendar
A da' calendar indicates .hich drug should be ta/en at di%%erent times o% the da'. 3t can use
.ords or pictorials0 a lo. sun on the le%t %or morning( a high sun %or midda'( a sin/ing sun %or
the end o% the da' and a moon %or the night.
&rug passport
A small boo/ or lea%let .ith an overvie. o% the di%%erent drugs that the patient is using(
including recommended dosages.
&osage (o"
The dosage bo8 is becoming popular in industrialized countries. 3t is especiall' help%ul .hen
man' di%%erent drugs are used at di%%erent times during the da'. The bo8 has compartments %or
the di%%erent times per da' +usuall' %our,( spread over seven da's. 3t can then be re%illed each
.ee/. 3% cost is a problem( the bo8 can be made locall' %rom cardboard. 3n tropical countries a
cool and clean place to store the bo8 .ill be necessar'.
Even i% the patient aids described here donDt e8ist in 'our countr'( .ith creativit' 'ou can o%ten
%ind 'our o.n solutions. The important thing is to give 'our patients the in%ormation and tools
the' need to use drugs appropriatel'.
The si8 points listed belo. summarize the %ini%u% in%ormation that should be
given to the patient.
1. *$$ects o$ t#e drug
Wh' the drug is needed
Which s'mptoms .ill disappear( and .hich .ill not
When the e%%ect is e8pected to start
What .ill happen i% the drug is ta/en incorrectl' or not at all
2. Side e$$ects
Which side e%%ects ma' occur
Ho. to recognize them
Ho. long the' .ill continue
Ho. serious the' are
What action to ta/e
3. 9nstructions
Ho. the drug should be ta/en
When it should be ta/en
Ho. long the treatment should continue
Ho. the drug should be stored
What to do .ith le%t6over drugs
4. Barnings
When the drug should not be ta/en
66
What is the ma8imum dose
Wh' the %ull treatment course should be ta/en
0. 5uture consultations
When to come bac/ +or not,
3n .hat circumstances to come earlier
What in%ormation the doctor .ill need at the ne8t appointment
2. *veryt#ing clear3
As/ the patient .hether ever'thing is understood
As/ the patient to repeat the most important in%ormation
As/ .hether the patient has an' more =uestions
This ma' seem a long list to go through .ith each patient. Iou ma' thin/ that there
is not enough timeA that the patient can read the pac/age insert .ith the medicineA
that the pharmacist or dispenser should give this in%ormationA or that too much
in%ormation on side e%%ects could even decrease adherence to treatment. Iet it is
the prime responsibilit' o% the doctor to ensure that the treatment is understood b'
the patient( and this responsibilit' cannot be shi%ted to the pharmacist or a pac/age
insert. Ma'be not all side e%%ects have to be mentioned( but 'ou should at least
.arn 'our patients o% the most dangerous or inconvenient side e%%ects. Having too
man' patients is never accepted b' a court o% la. as a valid e8cuse %or not
in%orming and instructing a patient correctl'.
*"ercise: Patients 343>
<eview t#e $ollowing prescriptions and list t#e %ost i%portant
instructions and warnings t#at s#ould (e given to t#e patient. ;ou
%ay consult your p#ar%acology (oo,s. 'ases are discussed
(elow.
Patient 34:
Man' #, years. Aewly dia!nosed depression. R1amitriptyline $#
m!' ) tablet daily at ni!ht for one week.
Patient 30:
Woman' $2 years. Ea!inal trichomonas infection. R1metronida&ole
#-- m!' ) va!inal tablet daily for )- days.
Patient 32:
Man' C# years. Aewly dia!nosed essential hypertension.
R1atenolol #- m!' ) tablet daily.
Patient 3=:
0oy' # years. +neumonia. R1amo%icillin syrup' # ml :J $#- m!;
three times daily.
Patient 3>:
Woman' $$ years. Mi!raine. R1paracetamol #-- m!' $ tablets $-
min. after R1metoclopramide )- m! ) suppository' at the onset of
an attack.
Patient 34 (depression)
3t .ill ta/e appro8imatel' t.o to three .ee/s be%ore the patient starts to %eel better(
but side e%%ects( such as dr' mouth( blurred vision( di%%icult' in urinating and
67
sedation( ma' occur =uic/l'. 2ecause o% this man' patients thin/ that the treatment
is .orse than the disease and stop ta/ing the drug. 3% the' are not told that this ma'
happen and that these e%%ects disappear a%ter some time( adherence to treatment
.ill be poor. $or this reason a slo.l' rising dosage schedule is usuall' chosen( .ith
the tablets ta/en be%ore bedtime. This should be e8plained care%ull' to the patient.
Older people( especiall'( ma' not remember di%%icult dosage schedules. Write them
do.n( or give a medication bo8. Iou can also as/ the pharmacist to e8plain it again
+.rite this on the prescription,. 3nstructions are to %ollo. the dosage schedule( to
ta/e the drug at bedtime and not to stop the treatment. Warnings are that the drug
ma' slo. reactions( especiall' in combination .ith alcohol.
Patient 30 (vaginal tric#o%onas)
As in an' in%ection the patient should be told .h' the course has to be %inished
completel'( even .hen the s'mptoms disappear a%ter t.o da's. The patient should
also be in%ormed that treatment is useless i% the partner is not treated as .ell.
&are%ul and clear instructions are needed %or vaginal tablets. 3% possible( pictures or
lea%lets should be used to sho. the procedure +see Anne8 B,. -ide e%%ects o%
metronidazole are a metal taste( diarrhoea or vomiting( especiall' .ith alcohol( and
dar/ urine. Give a clear .arning against the use o% alcohol.
Patient 32 (essential #ypertension)
The problem .ith the treatment o% h'pertension is that patients rarel' e8perience
an' positive e%%ect o% the drugs( 'et the' have to ta/e them %or a long time.
Adherence to treatment ma' be ver' poor i% the' are not told .h' the' should ta/e
the drug( and i% treatment is not monitored regularl'. The patient should be told that
the drug prevents complications o% high blood pressure +angina( heart attac/(
cerebral problems,. Iou can also sa' that 'ou .ill tr' to decrease the dosage a%ter
three months( or even stop the drug entirel'. "emember to chec/ .hether the
patient has a histor' o% asthma.
Patient 3= ((oy wit# pneu%onia)
The patientKs mother should be told that the penicillin .ill need some time to /ill the
bacteria. 3% the course o% treatment is stopped too soon( the stronger ones .ill
survive( and cause a second( possibl' more serious in%ection. 3n this .a' she .ill
understand .h' it is necessar' to %inish the course. 5no.ing that an' side e%%ects
.ill disappear soon .ill increase the li/elihood o% adherence to treatment. -he
should also be told to contact 'ou immediatel' i% a rash( itching or rising %ever
occur.
Patient 3> (%igraine)
3n addition to other in%ormation the important instruction here is that the drug
+pre%erabl' a suppositor', should be ta/en #G minutes be%ore the analgesic( to
prevent vomiting. 2ecause o% possible sedation and loss o% coordination she should
be .arned not to drive a car or handle dangerous machiner'.
-ample page o% a personal %ormular'
Ta(let 0@- 1@@ %g 8eta (loc,er !T*7O:O:
C &OS!1*
68
Hypertension0 start .ith >G mg in the morning. Average0 >G6!GG mg per da'.
n!ina pectoris0 !GG mg per da' in !6# doses
Ad7ust to each patient individuall'( start as lo. as possible. "aise the dose a%ter #
.ee/s( i% needed.
C B4!T TO T*:: T4* P!T9*7T
9n$or%ation
Hypertension0 drug decreases blood pressure( patient .ill usuall' not notice an'
e%%ect. Drug .ill prevent complications o% high blood pressure +angina( heart attac/(
cerebrovascular accident,.
n!ina pectoris0 decreases blood pressure( prevents the heart %rom .or/ing too
hard( preventing chest pain.
-ide e%%ects0 hardl' an'( sometimes slight sedation.
9nstructions
Ta/e the drug .. times per da'( %or .. da's
Barnings
n!ina pectoris0 do not suddenl' stop ta/ing the drug.
7e"t appoint%ent
Hypertension0 one .ee/.
n!ina pectoris0 .ithin one month( earlier i% attac/s occur more %re=uentl'( or
become more severe.
C 5O::OBDP
Hypertension0 during %irst %e. months pulse and blood pressure should be chec/ed
.ee/l'. Tr' to decrease dosage a%ter three months. Higher dosages do not increase
therapeutic e%%ect( but ma' increase side e%%ects. Tr' to stop treatment %rom time to
time.
n!ina pectoris0 in case %re=uenc' or severit' o% the attac/s increase( more
diagnostic tests or other treatment are needed. Tr' to stop drug treatment %rom time
to time.
Iour personal %ormular'
During 'our medical studies 'ou should continue to e8pand 'our list o% common
complaints and diseases( .ith 'our P6drugs and P6treatments. Ho.ever( ver' soon
'ou .ill notice that man' drugs are used %or more than one indication. E8amples
are analgesics( certain antibiotics( and even more speci%ic drugs li/e beta6bloc/ers
+used %or h'pertension and angina pectoris,. Iou can( o% course( repeat the
necessar' drug in%ormation .ith each disease or complaint( but it ma' be easier to
ma/e a separate section in 'our personal %ormular' .here 'ou collect the
necessar' in%ormation %or each o% 'our P6drugs. This .a' 'ou .rite do.n or update
the drug in%ormation onl' once. Iou can also %ind the in%ormation more easil' .hen
'ou need it.
3t is good advice to note the essential instructions and .arnings .ith each P6drug in
'our personal %ormular'. 3% 'ou do this %or ever' ne. drug 'ou learn to use( the
%ormular' .ill be reasonabl' complete and read' %or use b' the time 'ou %inish 'our
medical studies. An e8ample o% the contents o% such a personal %ormular' is given
on the previous page. Please note that this is not a published te8t( but should be
'our personal +hand.rittenH, summar' o% important in%ormation.
-ummar'
-TEP >0 Give in%ormation( instruction and .arnings
69
1. *$$ects o$ t#e drug
Which s'mptoms .ill disappearA and .henA ho. important is it to ta/e
the drugA .hat happens i% it is not ta/enA
2. Side e$$ects
Which side e%%ects ma' occurA ho. to recognize themA ho. long .ill the'
remainA ho. serious the' areA .hat to do i% the' occurA
3. 9nstructions
When to ta/eA ho. to ta/eA ho. to storeA ho. long to continue the
treatmentA .hat to do in case o% problemsA
4. Barnings
What not to do +driving( machiner',A ma8imum dose +to8ic drugs,A need
to continue treatment +antibiotics,A
0. 7e"t appoint%ent
When to come bac/ +or not,A .hen to come earlierA .hat to do .ith le%t6
over drugsA .hat in%ormation .ill be neededA
2. *veryt#ing clear3
Ever'thing understoodA repeat the in%ormationA an' more =uestions.
70
Chapter 11 Step 6: Monitor (and stop?) the treatment
hapter !!
-TEP ?0 Monitor +and stopH, the treatment
Iou have no. learned ho. to choose a rational drug treatment( ho. to .rite the
prescription and .hat to tell 'our patient. Iet even a .ell chosen treatment ma' not
al.a's help the patient. Monitoring the treatment enables 'ou to determine .hether
it has been success%ul or .hether additional action is needed. To do this 'ou need
to /eep in touch .ith 'our patient( and this can be done in t.o .a's.
Passive %onitoring means that 'ou e8plain to the patient .hat to do i% the
treatment is not e%%ective( is inconvenient or i% too man' side e%%ects occur. 3n this
case monitoring is done b' the patient.
!ctive %onitoring means that 'ou ma/e an appointment to determine 'oursel%
.hether the treatment has been e%%ective. Iou .ill need to determine a monitoring
interval( .hich depends on the t'pe o% illness( the duration o% treatment( and the
ma8imum =uantit' o% drugs to prescribe. At the start o% treatment the interval is
usuall' shortA it ma' graduall' become longer( i% needed. Three months should be
the ma8imum %or an' patient on long6term drug therap'. Even .ith active
monitoring the patient .ill still need the in%ormation discussed in &hapter !G.
The purpose o% monitoring is to chec/ .hether the treatment has solved the
patientDs problem. Iou chose the treatment on the basis o% e%%icac'( sa%et'(
suitabilit' and cost. Iou should use the same criteria %or monitoring the e%%ect( but
in practice the' can be condensed into t.o =uestions0 is the treatment e%%ectiveH
Are there an' side e%%ectsH
Histor' ta/ing( ph'sical e8amination and laborator' tests .ill usuall' provide the
in%ormation 'ou need to determine the e%%ectiveness o% treatment. 3n some cases
more investigations ma' be needed.
Treat%ent is e$$ective
3% the disease is cured( the treatment can be stopped.
C
3% the disease is not 'et
cured or chronic( and the treatment is e%%ective and .ithout side e%%ects( it can be
4
Except in cases in which a standard duration of treatment is crucial, such as with most antibiotics.
71
&
continued. 3% serious side e%%ects have occurred 'ou should reconsider 'our
selected drug and dosage schedule( and chec/ .hether the patient .as correctl'
instructed. Man' side e%%ects are dose dependent( so 'ou ma' tr' to lo.er the dose
be%ore changing to another drug.
Treat%ent is not e$$ective
3% the treatment is not e%%ective( .ith or .ithout side e%%ects( 'ou should reconsider
the diagnosis( the treatment .hich .as prescribed( .hether the dose .as too lo.(
.hether the patient .as correctl' instructed( .hether the patient actuall' too/ the
drug( and .hether 'our monitoring is correct. When 'ou have determined the
reason %or the treatment %ailure 'ou should loo/ %or solutions. -o the best advice is
to go again through the process o% diagnosis( de%inition o% therapeutic ob7ective(
veri%ication o% the suitabilit' o% the P6drug %or this patient( instructions and .arnings(
and monitor6ing. -ometimes 'ou .ill %ind that there is no real alternative to a
treatment that has not been e%%ective or has serious side e%%ects. Iou should
discuss this .ith the patient. When 'ou cannot determine .h' the treatment .as
not e%%ective 'ou should seriousl' consider stopping it.
3% 'ou decide to stop drug treatment 'ou should remember that not all drugs can be
stopped at once. -ome drugs +Table E, have to be tailed o%%( .ith a decreasing
dosage schedule.
*"ercise: patients 3?42
9n t#e $ollowing cases- try to decide w#et#er t#e treat%ent can (e
stopped or not. 'ases are discussed (elow.
Patient 3?:
72
Table E0
-ome e8amples o% drugs in
.hich a slo. reduction in dose
should be considered
Amphetamines
Antiepileptics
Antidepressants
Antips'chotics
&ardiovascular drugs
clonidine
meth'ldopa
beta6bloc/ers
vasodilators
&orticosteroids
H'pnoticsNsedatives
benzodiazepines
barbiturates
Opiates
Man' C- years. Review visit after pneumonia' treated with oral
ampicillin :$ !rams daily; for one week. Ao symptoms remain'
only sli!ht unproductive cou!h. K%amination normal.
Patient 4@:
Man' ## years. ?evere myal!ia and undefined arthritis for many
years. Has been on prednisolone :#- m! daily; and indometacin
:)- m! daily; for a lon! time. Kpi!astric pain and pyrosis over
several months' for which he takes aluminum hydro%ide tablets
from time to time. .urin! the consultation he complains that the
epi!astric pain and pyrosis have not disappearedD in fact they
have become worse.
Patient 41:
Woman' #$ years. Mild hypertension for the past two years.
Responded well to a thia&ide diuretic :$# m! daily;. (he
maintenance dose has already been decreased twice because
her blood pressure had dropped to around normal. ?he re!ularly
for!ets to take the dru!.
Patient 42:
Man' 3# years. Had been prescribed tema&epam for one week'
:)- m! daily; because of sleeplessness after his wife died si%
months a!o. He asks for more' because he is afraid he will still
not be able to sleep.
Patient 3? (pneu%onia)
The course o% treatment .as de%ined in advance. 3t .as e%%ective and .ithout side
e%%ects. The ampicillin can be stopped.
Patient 4@ (epigastric pain)
3n this case the treatment has not been e%%ective because the epigastric pain is a
side e%%ect o% the drugs used %or m'algia. The treatment that reall' needs
monitoring is the anti6in%lammator' drugs( not the aluminium h'dro8ide. The
problem can be solved b' %inding out .hether the pain occurs at certain times(
rather than being continuous. 3n this case the dosage schedule could be ad7usted
to reach pea/ plasma concentrations at those times( and the total dail' dose could
be lo.ered. The lesson to be learned %rom this patient is that it is better to
reconsider the original therap' rather than to MtreatK its side e%%ects .ith another
drug.
Patient 41 (%ild #ypertension)
This treatment seems e%%ective and .ithout side e%%ects. The patient is no longer
h'pertensive and ma' not need continued therap'( especiall' since she regularl'
%orgets to ta/e the drug. Iou can stop the treatment %or assessment but 'ou must
continue to monitor the patient.
Patient 42 (inso%nia)
As the patient .ants to continue the treatment it .as obviousl' e%%ective. Ho.ever(
benzodiazepines can produce ps'chological and ph'sical dependence .hen ta/en
regularl' %or more than a %e. .ee/s. 3n addition( tolerance develops =uic/l' and
this can lead patients to ta/e more than the recommended dose. Iou should
e8plain this to the patient and also tell him that the nature o% the sleep induced b'
such drugs is not the same as normal sleep( but the result o% suppressed brain
activit'. Encourage him to tr' to return to natural sleep patternsA possibl' a .arm
bath or a hot mil/ drin/ .ill help to promote rela8ation be%ore bedtime. 3t ma' also
73
help to encourage him to e8press his %eelings about his lossA acting as a
s'mpathetic listener is probabl' 'our ma7or therapeutic role in this case( rather than
prescribing more drugs. 3n this case the drug can be stopped at once because it
.as onl' used %or one .ee/. This cannot be done .hen patients have ta/en
benzodiazepines %or longer periods o% time.
74
-ummar'
-TEP ?0 Monitor +and stopH, the treatment
Bas t#e treat%ent e$$ective3
a. Ies( and disease cured0 -top the treatment
(. Ies( but not 'et completed0 An' serious side e%%ectsH
W*o0 treatment can be continued
WIes0 reconsider dosage or drug choice
c. *o( disease not cured0 eri%' all steps0
WDiagnosis correctH
WTherapeutic ob7ective correctH
WP6drug suitable %or this patientH
WDrug prescribed correctl'H
WPatient instructed correctl'H
WE%%ect monitored correctl'H
75
76
Part 4 Keeping up-to-date
art C0 5eeping up6to6date
3n this section various sources o% drug and
therapeutic in%ormation are discussed( together .ith
their relative advantages and disadvantages. 3t also
includes practical advice on ho. to read scienti%ic
papers in general( and clinical trials in particular.
&hapter !# page
Ho. to /eep up6to6date about drugs..................................................................?E
Ma/e an inventor' o% available in%ormation...............................................?E
&hoose bet.een sources o% in%ormation...................................................@C
E%%icient reading........................................................................................ @C
&onclusion................................................................................................ @>
77
P
hapter !#
Ho. to /eep up6to6date about drugs
5no.ledge and ideas about drugs are constantl' changing. *e. drugs come on
the mar/et and e8perience .ith e8isting drugs e8pands. -ide e%%ects become better
/no.n and ne. indications or .a's o% using e8isting drugs are developed. 3n
general a ph'sician is e8pected to /no. about developments in drug therap'. $or
e8ample( i% a drug6induced illness occurs .hich the ph'sician could have /no.n
and prevented( courts in man' countries .ould hold the doctor liable. 4ac/ o%
/no.ledge is not an e8cuse.
Ho. can 'ou /eep up6to6dateH This problem can be solved in the usual .a'0 ma/e
an inventor' o% available t'pes o% in%ormationA compare their advantages and
disadvantagesA and choose 'our o.n source+s, o% in%ormation.
Ma/e an inventor' o% available sources o% in%ormation
There are numerous sources o% drug in%ormation( ranging %rom international data
bases( 7ournals and re%erence boo/s( to national or regional drug in%ormation
centres( and locall' produced %ormularies and bulletins. Anne8 # provides a list o%
essential re%erences. -ome sources are commercial and independent( others are
non6commercial. 3n%ormation is available verball' or in .ritten %orm( on tape or
video( Mon6lineK +interactive connection .ith a central computer data base, or on &D6
"OM +&ompact Dis/ "ead6Onl' Memor'( a compact dis/ .ith in%ormation( read b'
personal computer,.
<e$erence (oo,s
"e%erence boo/s can cover general or clinical pharmacolog'( or specialize in a
particular aspect. E8amples o% general pharmacological re%erence boo/s in English
are Goodman and GilmanKs (he +harmacolo!ical 0asis of (herpautics and
4aurence and 2ennettKs <linical +harmacolo!y +see Anne8 #,. Good e=uivalents
e8ist in other languages. An important criterion in choosing re%erence boo/s is the
%re=uenc' o% ne. editions. Onl' publications that are revised ever' t.o to %ive 'ears
can provide up6to6date /no.ledge.
MartindaleKs (he K%tra +harmacopoeia is an e8cellent re%erence boo/ .ith detailed
drug in%ormation on most active substances and chemicals. Ho.ever( it does not
78
&
Chapter 12 How to keep up-to-date about drugs
distinghuish bet.een essential and non6essential drugs and does not contain
comparative therapeutic in%ormation. Aver'Ks .ru! (reatment is a more specialized
boo/( appropriate %or prescribers .ith a special interest in clinical pharmacolog'.
Another e8ample o% a specialized te8tboo/ is Me'lerDs ?ide Kffects of .ru!s( .hich
provides an annuall' updated assessment o% side e%%ects o% drugs reported
.orld.ide. 3t is( ho.ever( e8pensive. Other specialized boo/s address such areas
as ps'chotropic drugs( or speci%ic ris/ groups such as drugs in lactation( drugs %or
children( or drugs %or the elderl'.
&rug co%pendia
3n man' countries there are publications that list the drugs available on the mar/et.
These compendia var' in t'pe and scope but usuall' include generic and brand
namesA chemical compositionA clinical indications and contraindicationsA .arnings(
precautions and interactionsA side e%%ectsA administration and dosage
recommendations. -ome are based on the o%%icial labelling in%ormation %or the
product as approved b' the national regulator' authorit'. An e8ample is the annual
+hysician8s .esk Reference' .hich is available %ree o% charge to ph'sicians in the
)nited -tates.
&ommerciall' sponsored drug compendia ma' have additional limitations. $or
e8ample( the drug listing ma' be incomplete( and comparative assessments are
usuall' lac/ing. An e8ample is the Monthly 9nde% of Medical ?pecialities :M9M?;
.hich is published in di%%erent parts o% the .orld.
Ho.ever( comprehensive and ob7ective compendia are available .hich do include
comparative assessments andNor provide criteria %or choice .ithin .ell6de%ined
therapeutic drug categories. E8amples are the Gnited ?tates +harmacopeia
.ispensin! 9nformation :G?+ .9;( .hich is not available %ree o% charge( and the
0ritish Aational Formulary :0AF;( .hich is %ree to all )5 prescribers. The latter
includes in%ormation on cost( .hich is not o%ten included in other compendia. The
%re=uent revisions o% both publications contribute to their value. 3n %act( the' are
issued so %re=uentl' that old copies( .hich ma' be available at ver' lo. cost or %ree
o% charge( remain use%ul %or =uite some time.
7ational lists o$ essential drugs and treat%ent guidelines
3n man' developing countries a national list o% essential drugs e8ists. 3t usuall'
indicates the essential drugs chosen %or each level o% care +dispensar'( health
centre( district hospital( re%erral hospital,. 3t is based on a consensus on the
treatment o% choice %or the most common diseases and complaints( and de%ines the
range o% drugs that is available to prescribers. 3% no national list o% essential drugs
e8ists( 'ou ma' consult the WHO model list +see Anne8 #,. er' o%ten national
treatment guidelines( .hich include the most important clinical in%ormation %or the
prescriber +treatment o% choice( recommended dosage schedule( side e%%ects(
contraindications( alternative drugs( etc., are available. Iou should veri%' .hether
such guidelines e8ist in 'our countr'. Tr' to obtain the most recent edition.
&rug $or%ularies
$ormularies contain a list o% pharmaceutical products( together .ith in%ormation on
each drug. The' can be national( regional or institutional. The' are usuall'
developed b' therapeutic committees and the' list the drugs that are approved %or
use in that countr'( region( district or hospital. 3n man' countries drug %ormularies
are also developed %or health insurance programmes( listing the products that are
79
reimbursed. Drug %ormularies are usuall' drug6centred. Their value is enhanced i%
the' contain comparisons bet.een drugs( evaluations and cost in%ormation( but
that is o%ten not the case. The e8cellent 0AF has alread' been mentioned. Tr' to
get 'our o.n cop'( even i% it is not the most recent one. 3t %its .ell in 'our poc/et.
&rug (ulletins
These periodicals promote rational drug therap' and appear at %re=uent intervals(
ranging %rom .ee/l' to =uarterl'. 3ndependent drug bulletins( i.e. non6industr'
sponsored( provide impartial assessments o% drugs and practical recommend6
ations( based on a comparison bet.een treatment alternatives.
Drug bulletins can be a critical source o% in%ormation in helping prescribers to
determine the relative merits o% ne. drugs and in /eeping up6to6date. Drug bulletins
can have a variet' o% sponsors( such as government agencies( pro%essional bodies(
universit' departments( philanthropic %oundations and consumer organizations.
The' are published in man' countries( are o%ten %ree o% charge( and are highl'
respected because o% their unbiased in%ormation. E8amples in English are0 .ru!
and (herapeutics 0ulletin +)5,( Medical >etter +)-A, and ustralian +rescriber
+Australia,. A good independent drug bulletin in $rench is +rescrireA it is not %ree o%
charge.
*ational drug bulletins are appearing in an increasing number o% developing
countries( .hich include 2olivia( &ameroon( Mala.i( the Philippines and ;imbab.e.
The main advantages o% national drug bulletins are that the' can select topics o%
national relevance and use the national language.
+edical )ournals
-ome medical 7ournals are general( such as (he >ancet( the Aew Kn!land Iournal
of Medicine or the 0ritish Medical IournalA others are more specialized. Most
countries have their o.n national e=uivalents. 2oth t'pes contain much in%ormation
o% relevance to prescribers. The general 7ournals regularl' publish revie. articles
on treatment. The specialized 7ournals include more detailed in%ormation on drug
therap' %or speci%ic diseases.
Good medical 7ournals are Dpeer revie.edD( that is( all articles are sent %or
independent e8pert revie. prior to publication. Iou can usuall' chec/ .hether
7ournals meet this important criterion b' reading the published instructions %or
submission o% articles.
-ome 7ournals are not independent. The' are usuall' gloss' and o%ten present
in%ormation in an easil' digestible %ormat. The' can be characterized as0 %ree o%
charge( carr'ing more advertisements than te8t( not published b' pro%essional
bodies( not publishing original .or/( variabl' sub7ect to peer revie.( and de%icient in
critical editorials and correspondence. 3n the industrialized .orld the' are promoted
to the ph'sician as a D.a' to save timeD. 3n %act reading them is a loss o% time( .hich
is .h' the' are commonl' re%erred to as Dthro.a.a'sD. Also be care%ul .ith 7ournal
supplements. The' sometimes report on commerciall' sponsored con%erencesA in
%act( the .hole supplement ma' be sponsored.
-o donDt assume that because a revie. article or research stud' appears in print
that it is necessaril' good science. Thousands o% DmedicalD 7ournals are published
and the' var' enormousl' in =ualit'. Onl' a relativel' small proportion publish
scienti%icall' validated( peer revie.ed articles. 3% in doubt about the scienti%ic value
80
o% a 7ournal( veri%' its sponsors( consult senior colleagues( and chec/ .hether it is
included in the 9nde% Medicus( .hich covers all ma7or reputable 7ournals.
/er(al in$or%ation
Another .a' to /eep up6to6date is b' dra.ing on the /no.ledge o% specialists(
colleagues( pharmacists or pharmacologists( in%ormall' or in a more structured .a'
through postgraduate training courses or participation in therapeutic committees.
&ommunit' based committees t'picall' consist o% general practitioners and one or
more pharmacists. 3n a hospital setting the' ma' include several specialists( a
clinical pharmacologist andNor a clinical pharmacist. -uch committees meet
regularl' to discuss aspects o% drug treatment. 3n some cases the' establish local
%ormularies and %ollo. up on their use. )sing a clinical specialist as the %irst source
o% in%ormation ma' not be ideal .hen 'ou are a primar' health care ph'sician. 3n
man' instances the /no.ledge o% specialists ma' not reall' be applicable to 'our
patients. -ome o% the diagnostic tools or more sophisticated drugs ma' not be
available( or needed( at that level o% care.
&rug in$or%ation centres
-ome countries have drug in%ormation centres( o%ten lin/ed to poison in%ormation
centres. Health .or/ers( and sometimes the general public( can call and get help
.ith =uestions concerning drug use( into8ications( etc. Modern in%ormatics( such as
on6line computers and &D6"OM( have dramaticall' improved access to large
volumes o% data. Man' ma7or re%erence data bases( such as Martindale and
Meylers ?ide Kffects of .ru!s( are no. directl' accessible through international
electronic net.or/s. When drug in%ormation centres are run b' the pharmaceutical
department o% the ministr' o% health( the in%ormation is usuall' drug %ocused.
&entres located in teaching hospitals or universities ma' be more drug problem or
clinicall' oriented.
'o%puteriEed in$or%ation
&omputerized drug in%ormation s'stems that maintain medication pro%iles %or ever'
patient have been developed. -ome o% these s'stems are =uite sophisticated and
include modules to identi%' drug interactions or contraindications. -ome s'stems
include a %ormular' %or ever' diagnosis( presenting the prescriber .ith a number o%
indicated drugs %rom .hich to choose( including dosage schedule and =uantit'.
Prescribers can also store their o.n %ormular' in the computer. 3% this is done(
regular updating is needed using the sources o% in%ormation described here. 3n
man' parts o% the .orld access to the hard.are and so%t.are needed %or this
technolog' .ill remain be'ond the reach o% individual prescribers. 3n countries
.here such technolog' is easil' accessible it can ma/e a use%ul contribution to
prescribing practice. Ho.ever( such s'stems cannot replace in%ormed prescriber
choice( tailored to meet the needs o% individual patients.
P#ar%aceutical industry sources o$ in$or%ation
3n%ormation %rom the pharmaceutical industr' is usuall' readil' available through all
channels o% communication0 verbal( .ritten and computerized. 3ndustr' promotion
budgets are large and the in%ormation produced is invariabl' attractive and eas' to
digest. Ho.ever( commercial sources o% in%ormation o%ten emphasize onl' the
positive aspects o% products and overloo/ or give little coverage to the negative
aspects. This should be no surprise( as the primar' goal o% the in%ormation is to
promote a particular product. &ommercial in%ormation is o%ten tailored to the
81
prescriberDs speci%ic situation0 in%ormation on an anti6nauseant given to a
g'naecologist in a universit' hospital ma' di%%er %rom that given to a general
practitioner in rural practice.
)suall' the pharmaceutical industr' uses a Dmulti6trac/D approach. This means that
the in%ormation is provided through a number o% media0 medical representatives
+detail menN.omen,( stands at pro%essional meetings( advertising in 7ournals and
direct mailing.
$rom industr'Ds point o% vie.( medical representatives are usuall' ver' e%%ective in
promoting drug products( and much more e%%ective than mailings alone. O%ten over
>GT o% the promotional budget o% pharmaceutical companies in industrialized
countries is spent on representatives. -tudies %rom a number o% countries have
sho.n that over FGT o% ph'sicians see representatives( and a substantial
percentage rel' heavil' on them as sources o% in%ormation about therapeutics.
Ho.ever( the literature also sho.s that the more reliant doctors are on commercial
sources o% in%ormation onl'( the less ade=uate the' are as prescribers.
3n deciding .hether or not to use the services o% drug representatives to update
'our /no.ledge on drugs( 'ou should compare the potential bene%its .ith those o%
spending the same time reading ob7ective comparative in%ormation.
3% 'ou do decide to see representatives( there are .a's to optimize the time 'ou
spend .ith them. Ta/e control o% the discussion at the outset so that 'ou get the
in%ormation 'ou need about the drug( including its cost. 3% 'our countr' has a health
insurance scheme( chec/ .hether the drug is included in the list o% reimbursable
products. Earl' on in the discussion as/ the representative to give 'ou a cop' o%
the o%%iciall' registered drug in%ormation +data sheet, on the product under
discussion( and during the presentation compare the verbal statements .ith those
in the o%%icial te8t. 3n particular loo/ at side e%%ects and contraindications. This
approach .ill also help 'ou to memorize /e' in%ormation about the drug.
Al.a's as/ %or copies o% the published re%erences on e%%icac' and sa%et'. Even
be%ore reading these( the =ualit' o% the 7ournals in .hich the' appear .ill be a
strong indication o% the li/el' =ualit' o% the stud'. Iou should /no. that the ma7orit'
82
o% ne.l' mar/eted drugs do not represent true therapeutic advances but are .hat
is /no.n as Mme tooK products. 3n other .ords( the' are ver' similar in chemical
composition and action to other products on the mar/et. The di%%erence is usuall' in
priceA the most recentl' mar/eted drug is usuall' the most e8pensiveL -eeing
medical representatives can be use%ul to learn .hat is ne.( but the in%ormation
should al.a's be veri%ied and compared .ith impartial( comparative sources.
Drug in%ormation %rom commercial sources is also issued as ne.s reports( and as
scienti%ic articles in pro%essional 7ournals. 3ndustr' is also a ma7or sponsor o%
scienti%ic con%erences and s'mposia. The line bet.een ob7ective and promotional
in%ormation is not al.a's clear. A number o% countries and pro%essional
associations are tightening regulations controlling drug promotion to tac/le this
problem. -ome 7ournals no. re=uire that an' sponsorship %rom the pharmaceutical
industr' should be mentioned in the article.
As mentioned above and as studies sho.( it is not good practice to use onl'
commercial in%ormation to /eep up6to6date. Although it ma' seem an eas' .a' to
gather in%ormation( this source is o%ten biased to.ards certain products and is li/el'
to result in irrational prescribing. This is particularl' true %or countries .ithout an
e%%ective regulator' agenc'( because more drugs o% sometimes doubt%ul e%%icac'
ma' be available and there ma' be little control on the contents o% data6sheets and
advertisements.
WHO has issued Kthical <riteria for Medicinal .ru! +romotion .hich contain global
guidelines %or promotional activities. The 3nternational $ederation o%
Pharmaceutical Manu%acturersK Associations also has a code o% pharmaceutical
mar/eting practices. 3n several countries national guidelines e8ist as .ell. Most
guidelines speci%' that the promotional in%ormation should be accurate( complete
and in good taste. 3t is a ver' good e8ercise to compare a number o% drug
advertisements .ith the national or global criteria. Most guidelines also cover the
use o% samples and gi%ts( participation in promotional con%erences and clinical trials(
etc.
3% 'ou do use commercial in%ormation %ollo. these ground rules. $irst( loo/ %or more
in%ormation than advertisements contain. -econd( loo/ or as/ %or re%erences( and
chec/ their =ualit'. Onl' re%erences in .ell established peer revie.ed 7ournals
should be ta/en seriousl'. Then chec/ the =ualit' o% the research methodolog' on
.hich the conclusions are based. Third( chec/ .hat 'our colleagues( and
pre%erabl' a specialist in the %ield( /no. about the drug. $inall'( al.a's collect data
%rom unbiased sources be%ore actuall' using the drug. Do not start b' using %ree
samples on a %e. patients or %amil' members( and do not base 'our conclusions
on the treatment o% a %e. patientsL
Iet commercial in%ormation is sometimes help%ul in a general sense( especiall' to
/no. o% ne. developments. Ho.ever( comparative in%ormation %rom drug bulletins
or therapeutic revie.s is absolutel' essential to help 'ou evaluate the ne. drug in
relation to e8isting treatments( and to decide .hether 'ou .ish to include it in 'our
personal %ormular'.
&hoose bet.een sources o% in%ormation
The advantages and disadvantages o% various drug in%ormation sources have been
outlined. Possible in%ormation sources .ill var' according to countr' and 'our o.n
personal situation. Iour 7ob is no. to decide ho. best to /eep up6to6date( b'
ma/ing a list o% all the possible resources to .hich 'ou have access. Tr' to %ind at
83
least one each o% the %ollo.ing0 +!, medical 7ournalsA +#, drug bulletinsA +B,
pharmacolog' or clinical re%erence boo/sA +C, therapeutic committees or
consultants or a postgraduate training course.
Although 'our primar' source o% prescribing in%ormation in 'our dail' clinical .or/
should be 'our personal %ormular'( 'ou .ill sometimes %ace a di%%icult problem(
.hich calls %or an additional source o% in%ormation. This could be a pharmacolog' or
clinical re%erence boo/( a drug bulletin( consultants +pharmacist( specialist(
colleagues,( a drug compendium or a %ormular'.
The limitations o% commercial in%ormation have been clearl' described. 3% 'ou
decide( nevertheless( that it has a role to pla'( %ollo. the ground rules alread'
outlined. 2ut do not use commercial in%ormation in isolation %rom other more
ob7ective sources.
E%%icient reading
!rticles
Man' prescribers have a problem in reading ever'thing the' .ould li/e. The
reasons are lac/ o% time and 6 in industrialized countries 6 the sheer volume o%
materials mailed to them. 3tDs .ise to adopt a strateg' to use 'our time as e%%icientl'
as possible.

Iou can save time .hen reading clinical 7ournals b' identi%'ing at an earl' stage
articles .hich are .orth reading( through the steps listed belo..
!. 4oo/ at the title to determine i% it appears interesting or use%ul to 'ou. 3% not(
move on to the ne8t article.
#. "evie. the aut#ors. The e8perienced reader .ill /no. o% man' authors
.hether the' generall' provide valuable in%ormation or not. 3% not( re7ect the
article. 3% the authors are un/no.n( give them the bene%it o% the doubt.
B. "ead the a(stract. The main point here is to decide .hether the conclusion is
important to 'ou. 3% not( re7ect the article.
C. &onsider the site to see i% it is su%%icientl' similar to 'our o.n situation( and
decide .hether the conclusion ma' be applica(le to 'our .or/. $or e8ample( a
conclusion %rom research in a hospital ma' not be relevant %or primar' care. 3%
the site di%%ers too much %rom 'our o.n situation( re7ect the article.
>. &hec/ the F%aterials and %et#odsG section. Onl' b' /no.ing and accepting
the research method can 'ou decide .hether the conclusion is valid.
?. &hec/ the re$erences. 3% 'ou /no. the sub7ect 'ou .ill probabl' be able to
7udge .hether the authors have included the /e' re%erences in that %ield. 3% these
are missing( be care%ul.
'linical trials
3t is be'ond the scope o% this boo/ to go into the details o% ho. reports on clinical
trials should be assessed( but a %e. general principles are given here. Generall'(
onl' randomized( double6blind clinical trials give valid in%ormation about the
e%%ectiveness o% a treatment. &onclusions dra.n %rom studies o% other design ma'
be biased.
84
-econd( a complete description o% a clinical trial should include +!, the patients in
the trial( .ith number( age( se8( criteria %or inclusion and e8clusionA +#,
administration o% the drug+s,0 dose( route( %re=uenc'( chec/s on non6adherence to
treatment( durationA +B, methods o% data collection and assessment o% therapeutic
e%%ectsA and +C, a description o% statistical tests and measures to control %or bias.
$inall' 'ou should loo/ at the clinical relevance o% the conclusion( not onl' its
statistical signi%icance. Man' statistical di%%erences are too small to be clinicall'
relevant.
-ometimes con%licting evidence is presented b' di%%erent sources. 3% in doubt( %irst
chec/ on the methodolog'( because di%%erent methods ma' give di%%erent results.
Then loo/ at the population studied to see .hich one is more relevant to 'our
situation. 3% doubts remain( it is better to .ait and to postpone a decision on 'our P6
drug choice until more evidence has emerged.
&onclusion
5eeping up6to6date should not be too di%%icult %or prescribers in developed
countriesA it can be %ar %rom eas' in some parts o% the .orld .here access to
independent sources o% drug in%ormation is ver' limited. 2ut .herever 'ou live and
.or/ it is important to develop a strateg' to ma8imize 'our access to the /e'
in%ormation 'ou need %or optimal bene%it o% the drugs 'ou prescribe. 2e a.are o%
the limitations o% some t'pes o% in%ormation( and spend 'our time on in%ormation
that is .orth it.
85
86
Annex 1
nne8es
Anne8 !0 page
Essentials o% pharmacolog' in dail' practice.............................................@F
Anne8 #0
Essential re%erences..................................................................................E>
Anne8 B0
Ho. to e8plain the use o% some dosage %orms..........................................E@
Anne8 C0
The use o% in7ections...............................................................................!G!
87
A
88
Annex 1
nne8 !
Essentials o% pharmacolog' in dail' practice
&ontents
9ntroduction..................................................................................................... @F
P#ar%acodyna%ics........................................................................................EG
The &pNresponse curve.........................................................................EG
P#ar%aco,inetics........................................................................................... EG
The &pNtime curve .ith a therapeutic .indo.........................................E!
&rug treat%ent................................................................................................ E#
-tarting drug treatment..........................................................................E#
-tead' state drug treatment ..................................................................E#
-topping drug treatment........................................................................EB
Special $eatures o$ t#e curve.........................................................................EB
4oading dose.........................................................................................EB
-lo.l' raising initial dose.......................................................................EC
Tapering the dose..................................................................................EC
9ntroduction
Pharmacolog' describes the interaction bet.een drugs and organisms. 3n this
interaction t.o %eatures are especiall' important. P#ar%acodyna%ics deals .ith
the e%%ects o% a drug on the bod'A ho. a drug acts and its side e%%ects( in .hich
tissues( at .hich receptor sites( at .hich concentration( etc. The e%%ects o% drugs
ma' be altered b' other drugs or disease states. Antagonism( s'nergism( addition
and other phenomena are also described b' pharmacod'namics.
P#ar%aco,inetics deals .ith the e%%ects o% the bod' on the drug( through
Absorption( Distribution( Metabolism and E8cretion +ADME,.

89
A
The d'namics and /inetics o% a drug determine its therapeutic use%ulness. The
p#ar%acodyna%ics o% a drug determine its e%%ectiveness and .hich side e%%ects
ma' occur( and at .hat concentration. The prescriber has ver' little in%luence on
this. The p#ar%aco,inetics o% a drug determine ho. o%ten( in .hat =uantit' and
dosage %orm and %or ho. long the drug should be given to reach and maintain the
re=uired plasma concentration. As the prescriber can activel' in%luence the
process( the %ollo.ing section concentrates on this aspect.
Pharmacod'namics
The e%%ects o% a drug are usuall' presented in a doseresponse curve. The e%%ect
o% the drug is plotted on the I6a8is and the dose on the U6a8is +$igure !G,. The
dose is usuall' plotted on a logarithmic scale. The higher the dose the stronger the
e%%ect( until the e%%ect levels o%% to a ma8imum. The e%%ect is usuall' e8pressed as a
percentage o% the ma8imum. The ma8imum e%%ect o% one drug ma' be more than
that o% another. Desired and side e%%ects can both be plotted in dose6response
curves.
The dose is usuall' e8pressed per /ilogram bod' .eight or per m
#
bod' sur%ace
area. Ho.ever( the most accurate .a' is to use the plasma concentration( because
it e8cludes di%%erences in absorption and elimination o% the drug. 3n the %ollo.ing
te8t the plasma concentration6response curve +&pNresponse curve, is used.
T#e 'pHresponse curve
The shape o% the &pNresponse curve is determined b' pharmacod'namic %actors.
&pNresponse curves re%lect the result in a number o% individuals( re%erred to as a
MpopulationK. 3% the plasma concentration is lo.er than .here the curve begins( GT
o% the population .ill e8perience an e%%ect. An e%%ect o% >GT means that the
average e%%ect in the total population is >GT o% the ma8imum +and not a >GT e%%ect
in one individual, +$igure !G,.
)n%ortunatel'( most drugs have a &pNresponse curve %or side e%%ects as .ell. This
curve should be interpreted in the same .a' as &pNresponse curves. The t.o
curves together de%ine the minimum and ma8imum plasma concentrations. The
concentration that gives the minimum use%ul e%%ect is the t#erapeutic t#res#old(
.hile the plasma concentration at .hich the ma8imum tolerated side e%%ects occur
is called the t#erapeutic ceiling. "emember that &pNresponse curves represent
90
Fi!ure )-4 .ose-response curve
Annex 1
the d'namics in a group o% patients( and can onl' o%%er a guideline .hen thin/ing in
terms o% an individual patient.
Pharmaco/inetics
A dose is usuall' repeated over a certain period. The plasma concentration in one
or more patients during a certain period is depicted in a so called plas%a
concentrationHti%e curve +&pNtime curve,. $igure !! sho.s the &pNtime curve o%
the %irst @ da's a%ter starting treatment.
91
Fi!ure ))4 <p1time curve
The shape o% the &pNtime curves is de%ined b' pharmaco/inetic %actors. The
relationship bet.een dose and plasma concentration is linear. This implies that i%
the dose is doubled( the stead' state plasma concentration is also doubled +$igure
!#,.
T#e 'pHti%e curve wit# a t#erapeutic window
T.o horizontal lines can be placed over the &pNtime curve( indicating therapeutic
threshold and ceiling. The space bet.een these t.o lines is called the t#erapeutic
window +$igure !B,. Drug treatment aims at plasma concentrations .ithin this
therapeutic .indo.. The possible variables to be considered are there%ore +!, the
position and the .idth o% the .indo.( and +#, the
pro%ile o% the curve.
T#erapeutic window
92
Fi!ure )$4 <p1time curve' dose
doubled
Fi!ure )*4 <p1time curve and
therapeutic window
Annex 1
The position and the .idth o% the .indo. are determined b' pharmacod'namic
%actors +$igure !C,. The position o% the .indo. ma' shi%t up.ards in case o%
resistance b' the patient or competitive antagonism b' another drug0 a higher
plasma concentration is needed to e8ert the same e%%ect. The .indo. can shi%t
do.n.ards in case o% h'persensitization or s'nergism b' another drug0 a lo.er
plasma concentration is needed.
The .idth o% the .indo. ma' also var'. 3t ma' become narro.er in case o% a
decreased sa%et'6margin. $or e8ample( the therapeutic .indo. o% theoph'lline is
narro.er in small children than in adults. A broader .indo. usuall' has no
conse=uences.
'urve
The pro%ile o% the curve is determined b' %our %actors0 bsorption( .istribution(
Metabolism and K8cretion. These are usuall' re%erred to as ADME %actors.
Although most treatments consist o% more than one dose o% a drug( some
pharmaco/inetic parameters can best be
e8plained b' loo/ing at the e%%ect o% one dose
onl'.
One o% the most important parameters is the #al$li$e o% a drug +$igure !>,. Most
drugs are eliminated b' means o% a $irstorder process. This means that per unit
o% time the same percenta!e o% drug is eliminated( %or e8ample ?T per hour. The
hal%6li%e o% a drug is the time it ta/es to decrease the plasma concentration to hal% o%
its initial value. With ?T per hour the hal%6li%e is about !! hours +i% no more o% the
drug is given in the meantime,. A%ter # hal%6lives +## hours, it .ill be #>TA a%ter B
hal%6lives !#.>TA and a%ter C hal%6lives ?.#>T. 3% the original plasma concentration
%alls .ithin the therapeutic .indo.( a decline to ?.#>T .ill usuall' be %ar belo. the
therapeutic threshold. $or this reason it is usuall' said that drugs no longer have a
pharmacological e%%ect C hal%6lives a%ter the last dose.
93
Drug treatment
The total &pNtime curve is in%luenced b' three actions b' the prescriber0 starting the
drug6treatmentA stead' state treatmentA stopping the treatment. All have a distinct
e%%ect on the curve.
Starting drug treat%ent
The most important issue in starting treatment is
the speed at .hich the curve reaches stead' state(
.ithin the therapeutic .indo.. 3% 'ou give a %i8ed
dose per unit o% time( this speed is onl' determined
b' the hal%6li%e o% the drug. On a %i8ed dosage
schedule( stead' state is reached a%ter about C
hal%6lives +$igure !?,. 3n case o% a long hal%6li%e it
ma' there%ore ta/e some time %or the drug to reach
a therapeutic concentration. 3% 'ou .ant to reach
the .indo. =uic/er( 'ou can use a loading dose
+see belo.,.
Steady state drug treat%ent
3n stead' state drug treatment t.o aspects are important. $irst( the mean plasma
concentration is determined b' the dose per da'. The relation bet.een dose and
plasma concentration is linear0 at double dose the
mean plasma concentration also doubles.
-econd( %luctuations in the curve are determined b' the %re=uenc' o%
administration. With the same total dose per da'( a higher %re=uenc' o%
administration gives %e.er %luctuations in the curve +$igure !@,. With a continuous
in%usion there are no %luctuations at all.
94
Fi!ure ),4 ?teady state is reached
after C half-lives
Fi!ure )34 .ose dependent
fluctuations in the
<p1time curve
Annex 1
3% 'ou decide to raise the dose it .ill again ta/e about C hal%6lives be%ore 'ou reach
the ne. stead' state. The same applies .hen 'ou decrease it b' giving a lo.er
dose.
Stopping drug treat%ent
$or drugs .ith $irstorder eli%ination /inetics the plasma concentration decreases
b' >GT each hal%6li%e period( i% no more o% the drug is ta/en +$igure !E,. The e%%ect
o% the drug stops .hen the concentration %alls belo. the therapeutic threshold. $or
e8ample( i% the initial plasma concentration is BGG ugNml( the therapeutic threshold
@> ugNml and the hal%6li%e E hours( this .ill ta/e !? hours +# hal%6lives,. This principle
applies e=uall' to drugs ta/en in overdose.
-ome drugs are eliminated b' Eeroorder eli%ination process. This means that
the same amount o% drug is eliminated per period o% time. $or e8ample( !GG mg is
eliminated per da'( regardless o% .hether the total amount in the bod' is ?GG mg or
#G grams. -uch drugs do not have a hal%6li%e. This also means that the &pNtime
curve never levels o%% to a certain ma8imum0 the plasma concentration can rise
%orever i% more o% the drug is administered than the bod' can eliminate. To maintain
a stead' state 'ou .ill have to administer e8actl' the amount that the bod'
eliminates. The dosage o% drugs in this categor' re=uires great care because o% the
increased ris/ o% accumulation. $ortunatel' onl' a %e. such drugs e8ist. E8amples
are phen'toin( dicoumarol and probenicid. Acet'lsalic'lic acid in high dosage
+grams per da', also behaves li/e this. And so does alcoholL
-pecial %eatures o% the curve
3n commonl' used dosage schedules .ith identical doses ta/en at regular intervals(
the re=uired stead' state is reached a%ter C hal%6lives( and plasma concentration
drops to zero .hen the treatment is stopped.
:oading dose
95
There ma' be reasons to use another schedule. 3n
stead' state the total amount o% drug in the bod'
remains constant. 3% 'ou .ant to reach this state
=uic/l' 'ou can administer at once the total amount
o% drug .hich is present in the bod' in stead' state
+$igure !F,. What =uantit' is then neededH
Theoreticall' 'ou .ill need the mean plasma
concentration( multiplied b' the distribution volume.
3n the ma7orit' o% cases these %igures can be %ound
in pharmacolog' boo/s( or ma' be obtained %rom
the pharmacist or the manu%acturer. $or several
drugs %i8ed schedules e8ist( e.g. %or digo8in.

Slowly raising initial dose
-ome drugs cannot be used in %ull dosage at once. There are three possible
reasons %or this. The %irst reason is .hen a drug has a narro. therapeutic .indo.
or a large variation in location o% the therapeutic .indo. in individuals. The aim is
to get slo.l' .ithin the .indo.( .ithout an overshoot. This is called dose$inding.
A second reason is variation in /inetics among di%%erent patients. A third is to induce
tolerance o% side e%%ects. The rule is Mgo lo.( go slo.K.
As mentioned earlier( it ta/es about C hal%6lives to reach a stead' state. This means
that 'ou should not raise the dose be%ore this time has elapsed and 'ou have
veri%ied that no un.anted e%%ects have occurred. Table @ in &hapter E lists drugs in
.hich slo.l' raising the dose is usuall' recommended.
Tapering t#e dose
-ometimes the human bod' gets used to the presence o% a certain drug and
ph'siological s'stems are ad7usted to its presence. To prevent rebound s'mptoms
the treatment cannot be abruptl' stopped but must be tailed o%% to enable the bod'
to read7ust. To do this the dose should be lo.ered in small steps each time a ne.
stead' state is reached. Table E in &hapter !! lists the most important drugs %or
.hich the dosage should be decreased slo.l'.
96
Annex 2
nne8 #
Essential re%erences
Practical lo.6cost boo/s on drugs and prescribing
7ational essential drugs list- national $or%ulary- #ospital $or%ulary-
institutional and national treat%ent guidelines. These are essential tools in 'our
prescribing( as the' indicate .hich drugs are recommended and available in the
health s'stem. 3% these re%erences do not e8ist0
B4O +odel :ist o$ *ssential &rugs. -ee0 T#e use o$ essential drugs
+containing the latest model list, under WHO publications on p.E?. 3n the absence
o% a national list( the WHO model list o%%ers a good indication o% e%%ective( sa%e and
relativel' cheap essential drugs .ithin each therapeutic categor'.
B4O treat%ent guidelines $or co%%on diseases( such as acute respirator'
tract in%ections( diarrhoeal diseases( malaria and other parasitic diseases( se8uall'
transmitted diseases( tuberculosis( lepros' and others. These are ver' use%ul
re%erences( based on international e8pert consensus. 3n man' cases the' are used
b' countries .hen developing their national treatment guidelines.
8ritis# 7ational 5or%ulary. 4ondon0 2ritish Medical Association X The
Pharmaceutical -ociet' o% Great 2ritain. This is a highl' respected re%erence .or/
containing essential in%ormation on a selection o% drugs available on the )5
mar/et( .ith price indication. There are short evaluative statements %or each
therapeutic group. Although revised ever' si8 months( old issues remain a valuable
source o% in%ormation and ma' be available to 'ou at no or ver' lo. cost.
'linical 1uidelines &iagnostic and Treat%ent +anual. Paris0 MYdecins sans
$rontiZres. Editions Hatier( !FFG. This is a ver' practical boo/( .hich is largel'
based on WHO treatment guidelines %or common diseases.
Ma7or re%erence .or/s
Aver' G-. &rug Treat%ent. #nd ed. -'dne'0 AD3- Press( !FE@.
4aurence D"( 2ennett P*. 'linical P#ar%acology. @th ed. Edinburgh0 &hurchill
4ivingstone( !FF#.
Goodman X Gilman. T#e P#ar%acological 8asis o$ T#erapeutics. Eth ed. *e.
Ior/0 McMillan Publications &o( !FF#.
Martindale. T#e *"tra P#ar%acopoeia. BGth Ed. 4ondon0 Pharmaceutical Press(
!FFB
97
A
)-P D3( ol. !.0 &rug 9n$or%ation $or t#e 4ealt# 'are Provider( ol. #.0
9n$or%ation $or t#e Patient. )nder authorit' o% the )nited -tates Pharmacopeial
&onvention 3nc.( !#?G! T.inbroo/ Par/.a'( "oc/ville( Mar'land #GEB#( )-A.
Drug bulletins
&rug and T#erapeutics 8ulletin( &onsumersK Association( !C 2uc/ingham -treet(
4ondon W&#* ?D-( )5. Published %ortnightl'A o%%ers comparative assessments o%
therapeutic value o% di%%erent drugs and treatments.
Prescrire 9nternational( Association Mieu8 Prescrire( 2P C>F( @>>#@ Paris &ede8
ll( $rance. Published =uarterl'A provides English translations o% selected articles on
clinical pharmacolog'( ethical and legal aspects o% drugs( .hich have appeared in
4a "evue Prescrire.
T#e +edical :etter( The Medical 4etter 3nc. >? Harrison -treet( *e. "ochelle( *I
!GEG!( )-A. Published %ortnightl'A provides comparative drug pro%iles and advice
on the choice o% drugs %or speci%ic problems.
3% 'ou .ant to chec/ .hether an independent drug bulletin is published in 'our
countr' contact0 T#e 9nternational Society o$ &rug 8ulletins( lGB Hert%ord "oad(
4ondon *# F2U( )5( or the WHO Action Programme on Essential Drugs.
WHO publications
T#e Dse o$ *ssential &rugs (including t#e >t# +odel :ist o$ *ssential &rugs).
Geneva0 World Health Organization( !FF>. Technical "eport -eries E>G. This
boo/let also contains the criteria %or the selection o% essential drugs and in%ormation
on applications o% the model list. The boo/ is updated ever' t.o 'ears.
B4O +odel Prescri(ing 9n$or%ation. Geneva0 World Health Organization. A
series o% authoritative boo/lets .ith unbiased drug in%ormation %or the prescriber(
including most drugs on the WHO Model 4ist o% Essential Drugs. Each module
deals .ith one therapeutic group. The series is not 'et complete.
B4O *t#ical 'riteria $or +edicinal &rug Pro%otion. Geneva0 World Health
Organization( !FEE. This is the te8t o% a WHO statement adopted b' the World
Health Assembl' o% !FEE( setting out general principles .hich could be adapted b'
governments to national circumstances. "eprinted in Essential Drugs Monitor !@.
B4O &rug 9n$or%ation. Geneva0 World Health Organization. A =uarterl' 7ournal
that provides an overvie. o% topics relating to drug development and regulation. 3t
see/s to relate regulator' activit' to therapeutic practice.
9nternational 7onproprietary 7a%es (977) $or P#ar%aceutical Su(stances.
Geneva0 World Health Organization( !FF#. This boo/ contains an updated
cumulative list o% o%%iciall' approved generic names in 4atin( English( $rench(
"ussian and -panish.
*ssential &rugs +onitor( Geneva0 World Health Organization( Action Programme
on Essential Drugs. $ree o% charge and published three times per 'earA contains
regular %eatures on issues related to the rational use o% drugs( including drug polic'(
research( education and training( and a revie. o% ne. publications.
98
Annex 3
nne8 B
Ho. to e8plain the use o% some dosage %orms
3n%ormation( in simple language( on ho. to administer e'e drops to a child or ho. to
use an aerosol inhaler is not al.a's easil' available. This anne8 contains step b'
step guidance on ho. to administer di%%erent dosage %orms. This in%ormation is
included because( as a doctor( 'ou are ultimatel' responsible %or 'our patientKs
treatment( even i% that treatment is actuall' administered b' a colleague( such as a
nurse( or b' patients themselves. Iou .ill o%ten need to e8plain to patients ho. to
administer a treatment correctl'. Iou ma' also need to teach other health .or/ers.
The instructions have been presented in such a .a' that the' can be used as a
sel%6standing in%ormation sheet %or patients. 3% 'ou have access to a photocop'
machine 'ou might consider ma/ing copies o% them as the' are. Iou might also
.ish to adapt them to 'our o.n situation or translate them into a national language.
Table o% contents page
!. E'e drops......................................................................................................... EE
#. E'e ointment.................................................................................................... EF
B. Ear drops......................................................................................................... FG
C. *asal drops...................................................................................................... F!
>. *asal spra'...................................................................................................... F#
?. Transdermal patch........................................................................................... FB
@. Aerosol............................................................................................................. FC
E. 3nhaler .ith capsules....................................................................................... F>
F. -uppositories................................................................................................... F?
!G. aginal tablet .ith applicator............................................................................F@
!!. aginal tablet .ithout applicator.......................................................................FE
!#. aginal cream( ointment and gel......................................................................FF
99
A
&HE&543-T !
E'e drops
!. Wash 'our hands.
#. Do not touch the dropper opening.
B. 4oo/ up.ard.
C. Pull the lo.er e'elid do.n to ma/e a MgutterK.
>. 2ring the dropper as close to the [gutterD as possible .ithout touching it or the
e'e.
?. Appl' the prescribed amount o% drops in the MgutterK.
@. &lose the e'e %or about t.o minutes. Do not shut the e'e too tight.
E. E8cess %luid can be removed .ith a tissue.
F. 3% more than one /ind o% e'e6drop is used .ait at least %ive minutes be%ore
appl'ing the ne8t drops.
!G. E'e6drops ma' cause a burning %eeling but this should not last %or more than
a %e. minutes. 3% it does last longer consult a doctor or pharmacist.
Steps 4 and 0
When giving e'e6drops to children0
!. 4et the child lie bac/ .ith head straight.
#. The childDs e'es should be closed.
B. Drip the amount o% drops prescribed into the corner o% the e'e.
C. 5eep the head straight.
>. "emove e8cess %luid.
100
Annex 3
&HE&543-T #
E'e ointment
!. Wash 'our hands.
#. Do not touch an'thing .ith the tip o% the tube.
B. Tilt the head bac/.ards a little.
C. Ta/e the tube in one hand( and pull do.n the lo.er e'elid .ith the other hand(
to ma/e a MgutterK.
>. 2ring the tip o% the tube as close to the MgutterK as possible.
?. Appl' the amount o% ointment prescribed.
@. &lose the e'e %or t.o minutes.
E. "emove e8cess ointment .ith a tissue.
F. &lean the tip o% the tube .ith another tissue.
Steps 4 and 0
101

&HE&543-T B
Ear drops
!. Warm the ear6drops b' /eeping them in the hand or the armpit %or several
minutes. Do not use hot .ater tap( no temperature controlL
#. Tilt head side.a's or lie on one side .ith the ear up.ard.
B. Gentl' pull the lobe to e8pose the ear canal.
C. Appl' the amount o% drops prescribed.
>. Wait %ive minutes be%ore turning to the other ear.
?. )se cotton .ool to close the ear canal a%ter appl'ing the drops O*4I i% the
manu%acturer e8plicitl' recommends this.
@. Ear6drops should not burn or sting longer than a %e. minutes.
Step 1 Steps 2 and 3 Step 2

102
Annex 3
&HE&543-T C
*asal drops
!. 2lo. the nose.
#. -it do.n and tilt head bac/.ard strongl' or lie do.n .ith a pillo. under the
shouldersA /eep head straight.
B. 3nsert the dropper one centimeter into the nostril.
C. Appl' the amount o% drops prescribed.
>. 3mmediatel' a%ter.ard tilt head %or.ard strongl' +head bet.een /nees,.
?. -it up a%ter a %e. seconds( the drops .ill then drip into the phar'n8.
@. "epeat the procedure %or the other nostril( i% necessar'.
E. "inse the dropper .ith boiled .ater.
Steps 2 and 3 Step 0
103
&HE&543-T >
*asal spra'
!. 2lo. the nose.
#. -it .ith the head slightl' tilted %or.ard.
B. -ha/e the spra'.
C. 3nsert the tip in one nostril.
>. &lose the other nostril and mouth.
?. -pra' b' s=ueezing the vial +%las/( container, and sni%% slo.l'.
@. "emove the tip %rom the nose and bend the head %or.ard strongl' +head
bet.een the /nees,.
E. -it up a%ter a %e. secondsA the spra' .ill drip do.n the phar'n8.
F. 2reathe through the mouth.
!G. "epeat the procedure %or the other nostril( i% necessar'.
!!. "inse the tip .ith boiled .ater.
Steps 4 and 0 Step =
104
Annex 3
&HE&543-T ?
Transdermal patch
!. $or patch site see instructions included .ith the drug or chec/ .ith 'our
pharmacist.
#. Do not appl' over bruised or damaged s/in.
B. Do not .ear over s/in %olds or under tight clothing and change spots regularl'.
C. Appl' .ith clean( dr' hands.
?. &lean and dr' the area o% application completel'.
@. "emove patch %rom pac/age( do not touch MdrugK side.
E. Place on s/in and press %irml'. "ub the edges to seal.
F. "emove and replace according to instructions.
Step = Step >
105
&HE&543-T @
Aerosol
!. &ough up as much sputum as possible.
#. -ha/e the aerosol be%ore use.
B. Hold the aerosol as indicated in the manu%acturerDs instructions +this is usuall'
upside do.n,.
C. Place the lips tightl' around the mouthpiece.
>. Tilt the head bac/.ard slightl'.
?. 2reathe out slo.l'( empt'ing the lungs o% as much air as possible.
E. 2reathe in deepl' and activate the aerosol( /eeping the tongue do.n.
F. Hold the breath %or ten to %i%teen seconds.
!G. 2reathe out through the nose.
!!. "inse the mouth .ith .arm .ater.
Steps 4 and 0 Step >
106
Annex 3
&HE&543-T E
3nhaler .ith capsules
!. &ough up as much sputum as possible.
#. Place the capsule+s, in the inhaler according to manu%acturerDs instructions.
B. 2reathe out slo.l' and empt' lungs o% as much air as possible.
C. Place lips tightl' around the mouthpiece.
>. Tilt head bac/.ard slightl'.
?. Ta/e a deep breath through the inhaler.
@. Hold the breath %or ten to %i%teen seconds.
E. 2reathe out through the nose.
F. "inse the mouth .ith .arm .ater.
Step 4 Step 0
107
&HE&543-T F
-uppositor'
!. Wash 'our hands.
#. "emove the covering +unless too so%t,.
B. 3% the suppositor' is too so%t let it harden %irst b' cooling it +%ridge or hold under
cold running .ater( still pac/edL, then remove covering.
C. "emove possible sharp rims b' .arming in the hand.
>. Moisten the suppositor' .ith cold .ater.
?. 4ie on 'our side and pull up 'our /nees.
@. Gentl' insert the suppositor'( rounded end %irst( into the bac/ passage.
E. "emain l'ing do.n %or several minutes.
F. Wash 'our hands.
!G. Tr' not to have a bo.el movement during the %irst hour.
Step 2
108
Annex 3
&HE&543-T !G
aginal tablet .ith applicator
!. Wash 'our hands.
# "emove the .rapper %rom the tablet.
B. Place the tablet into the open end o% the applicator.
C. 4ie on 'our bac/( dra. 'our /nees up a little and spread them apart.
>. Gentl' insert the applicator .ith the tablet in %ront into the vagina as %ar as
possible( do *OT use %orceL
?. Depress the plunger so that the tablet is released.
@. Withdra. the applicator.
E. Discard the applicator +i% disposable,.
F. &lean both parts o% the applicator thoroughl' .ith soap and boiled( lu/e.arm
.ater +i% not disposable,.
!G. Wash 'our hands.
Steps 4 and 0 Step 2
109
&HE&543-T !!
aginal tablet .ithout applicator
!. Wash 'our hands.
#. "emove the .rapper %rom the tablet.
B. Dip the tablet in lu/e.arm .ater 7ust to moisten it.
C. 4ie on 'our bac/( dra. 'our /nees up and spread them apart.
>. Gentl' insert the tablet into the vagina as high as possible( do *OT use %orceL
?. Wash 'our hands.
Steps 4 and 0
110
Annex 3
&HE&543-T !#
Appl'ing vaginal creams( ointments and gels
+most o% these drugs come .ith an applicator,
!. Wash 'our hands.
#. "emove the cap %rom the tube containing the drug.
B. -cre. the applicator to the tube.
C. -=ueeze the tube until the re=uired amount is in the applicator.
>. "emove the applicator %rom the tube +hold the c'linder,.
?. Appl' a small amount o% cream to the outside o% the applicator.
@. 4ie on 'our bac/( dra. 'our /nees up and spread them apart.
E. Gentl' insert the applicator into the vagina as %ar as possible( do *OT use
%orce.
F. Hold the c'linder and .ith the other hand push the plunger do.n thus
inserting the drug into the vagina.
!G. Withdra. the applicator %rom the vagina.
!!. Discard the applicator i% disposable or clean thoroughl' +boiled .ater, i% not.
!#. Wash 'our hands.
Steps 4 and 0 Steps = and >
111
112
Annex 4
nne8 C
The use o% in7ections
There are t.o main reasons to prescribe an in7ection. The %irst is because a %ast
e%%ect is needed( and the second is because the in7ection is the onl' dosage %orm
available that has the re=uired e%%ect. A prescriber should /no. ho. to give
in7ections( not onl' %or emergenc' and other situations .here it might be necessar'(
but also because it .ill sometimes be necessar' to instruct other health .or/ers
+e.g. a nurse, or the patients themselves.
Man' in7ections are prescribed .hich are unnecessaril' dangerous and
inconvenient. *earl' al.a's the' are much more e8pensive than tablets( capsules
and other dosage %orms. $or ever' in7ection the prescriber should stri/e a balance
bet.een the medical need on the one hand and the ris/ o% side e%%ects(
inconvenience and cost on the other.
When a drug is in7ected certain e%%ects are e8pected( and also some side e%%ects.
The person giving the in7ection must /no. .hat these e%%ects are( and must also
/no. ho. to react i% something goes .rong. This means that i% 'ou do not give the
in7ection 'oursel% 'ou must ma/e sure that it is done b' someone .ho is =uali%ied.
A prescriber is also responsible %or ho. .aste is disposed o% a%ter the in7ection. The
needle and sometimes the s'ringe are contaminated .aste and special measures
are needed %or their disposal. A patient .ho in7ects at home must also be a.are o%
this problem.
Table o% contents page
General practical aspects o% in7ecting...................................................................!G#
!. Aspirating %rom ampoules +glass( plastic,.......................................................!GB
#. Aspirating %rom a vial..................................................................................... !GC
B. Dissolving dr' medicine.................................................................................!G>
C. -ubcutaneous in7ection..................................................................................!G?
>. 3ntramuscular in7ection...................................................................................!G@
113
A
?. 3ntravenous in7ection...................................................................................... !GE
114
Annex 4
General practical aspects o% in7ecting
Apart %rom the speci%ic techni=ue o% in7ecting( there are a %e. general rules that 'ou
should /eep in mind.
l. *"piry dates
&hec/ the e8pir' dates o% each item including the drug.
3% 'ou ma/e housecalls( chec/ the drugs in 'our medical bag regularl' to
ma/e sure that the' have not passed the e8pir' date.
2. &rug
Ma/e sure that the vial or ampoule contains the right drug in the right
strength.
3. Sterility
During the .hole preparation procedure( material should be /ept sterile.
Wash 'our hands be%ore starting to prepare the in7ection.
Disin%ect the s/in over the in7ection site.
4. 7o (u((les
Ma/e sure that there are no air bubbles le%t in the s'ringe.
This is more important in intravenous in7ections.
0. Prudence
Once the protective cover o% the needle is removed e8tra care is needed.
Do not touch an'thing .ith the unprotected needle.
Once the in7ection has been given ta/e care not to pric/ 'oursel% or somebod'
else.
2. Baste
Ma/e sure that contaminated .aste is disposed o% sa%el'.
115
&HE&543-T !
Aspirating %rom ampoules
+glass( plastic,
+aterials needed
-'ringe o% appropriate size( needle o% re=uired size( ampoule .ith re=uired drug or
solution( gauze.
Tec#ni6ue
!. Wash 'our hands.
#. Put the needle on the s'ringe.
B. "emove the li=uid %rom the nec/ o% the ampoule b' %lic/ing it or s.inging it
%ast in a do.n.ard spiralling movement.
C. $ile around the nec/ o% the ampoule.
>. Protect 'our %ingers .ith gauze i% ampoule is made o% glass.
?. &are%ull' brea/ o%% the top o% the ampoule +%or a plastic ampoule t.ist the top,.
@. Aspirate the %luid %rom the ampoule.
E. "emove an' air %rom the s'ringe.
F. &lean upA dispose o% .or/ing needle sa%el'A .ash 'our hands.
Step 4 Step 0 Step 2
116
Annex 4
&HE&543-T #
Aspirating %rom a vial
+aterials needed
ial .ith re=uired drug or solution( s'ringe o% the appropriate size( needle o% right
size +im( sc( or iv, on s'ringe( disin%ectant( gauze.
Tec#ni6ue
!. Wash 'our hands.
#. Disin%ect the top o% the vial.
B. )se a s'ringe .ith a volume o% t.ice the re=uired amount o% drug or solution
and add the needle.
C. -uc/ up as much air as the amount o% solution needed to aspirate.
>. 3nsert needle into +top o%, vial and turn upside6do.n.
?. Pump air into vial +creating pressure,.
@. Aspirate the re=uired amount o% solution and G.! ml e8tra. Ma/e sure the tip o%
the needle is belo. the %luid sur%ace.
E. Pull the needle out o% the vial.
F. "emove possible air %rom the s'ringe.
!G. &lean upA dispose o% .aste sa%el'A .ash 'our hands.
Step 4 Step 2 Step =
117
&HE&543-T B
Dissolving dr' medicine
+aterials needed
ial .ith dr' medicine to be dissolved( s'ringe .ith the right amount o% solvent(
needle o% right size +iv( sc or iv, on s'ringe( disin%ectant( in7ection needle( gauze.
Tec#ni6ue
!. Wash hands.
#. Disin%ect the rubber cap +top, o% the vial containing the dr' medicine.
B. 3nsert the needle into the vial( hold the .hole upright.
C. -uc/ up as much air as the amount o% solvent alread' in the s'ringe.
>. 3n7ect onl' the %luid into the vial( not the airL
?. -ha/e.
@. Turn the vial upside6do.n.
E. 3n7ect the air into the vial +creating pressure,.
F. Aspirate the total amount o% solution +no air,.
!G. "emove an' air %rom the s'ringe.
!!. &lean upA dispose o% .aste sa%el'A .ash hands.
Step 4 Step 0 Step >
118
Annex 4
&HE&543-T C
-ubcutaneous in7ection
+aterials needed
-'ringe .ith the drug to be administered +.ithout air,( needle +Gauss #>( short and
thinA on s'ringe,( li=uid disin%ectant( cotton .ool( adhesive tape.
Tec#ni6ue
!. Wash hands.
#. "eassure the patient and e8plain the procedure.
B. )ncover the area to be in7ected +upper arm( upper leg( abdomen,.
C. Disin%ect s/in.
>. MPinchK %old o% the s/in.
?. 3nsert needle in the base o% the s/in6%old at an angle o% #G to BG degrees.
@. "elease s/in.
E. Aspirate brie%l'A i% blood appears0 .ithdra. needle( replace it .ith a ne. one(
i% possible( and start again %rom point C.
F. 3n7ect slo.l' +G.> 6 # minutesL,.
!G. Withdra. needle =uic/l'.
!!. Press sterile cotton .ool onto the opening. $i8 .ith adhesive tape.
!#. &hec/ the patientDs reaction and give additional reassurance( i% necessar'.
!B. &lean upA dispose o% .aste sa%el'A .ash hands.
119
&HE&543-T >
3ntramuscular in7ection
+aterials needed
-'ringe .ith the drug to be administered +.ithout air,( needle +Gauss ##( long and
medium thic/nessA on s'ringe,( li=uid disin%ectant( cotton .ool( adhesive tape.
Tec#ni6ue
!. Wash hands.
B. )ncover the area to be in7ected +lateral upper =uadrant ma7or gluteal muscle(
lateral side o% upper leg( deltoid muscle,.
C. Disin%ect the s/in.
>. Tell the patient to rela8 the muscle.
?. 3nsert the needle s.i%tl' at an angle o% FG degrees +.atch depthL,.
@. Aspirate brie%l'A i% blood appears( .ithdra. needle. "eplace it .ith a ne. one(
i% possible( and start again %rom point C.
E. 3n7ect slo.l' +less pain%ul,.
F. Withdra. needle s.i%tl'.
!G. Press sterile cotton .ool onto the opening. $i8 .ith adhesive tape.
!!. &hec/ the patientDs reaction and give additional reassurance( i% necessar'.
!#. &lean upA dispose o% .aste sa%el'A .ash 'our hands.
120
Annex 4
&HE&543-T ?
3ntravenous in7ection
+aterials needed
-'ringe .ith the drug to be administered +.ithout air,( needle +Gauss #G( long and
medium thic/nessA on s'ringe,( li=uid disin%ectant( cotton .ool( adhesive tape(
tourni=uet.
Tec#ni6ue
!. Wash 'our hands.
B. )ncover arm completel'.
C. Have the patient rela8 and support his arm belo. the vein to be used.
>. Appl' tourni=uet and loo/ %or a suitable vein.
?. Wait %or the vein to s.ell.
@. Disin%ect s/in.
E. -tabilize the vein b' pulling the s/in taut in the longitudinal direction o% the
vein. Do this .ith the hand 'ou are not going to use %or inserting the needle.
F. 3nsert the needle at an angle o% around B> degrees.
!G. Puncture the s/in and move the needle slightl' into the vein +B6> mm,.
!!. Hold the s'ringe and needle stead'.
!#. Aspirate. 3% blood appears hold the s'ringe stead'( 'ou are in the vein. 3% it
does not come( tr' again.
!B. 4oosen tourni=uet.
!C. 3n7ect +ver', slo.l'. &hec/ %or pain( s.elling( hematomaA i% in doubt .hether
'ou are still in the vein aspirate againL
!>. Withdra. needle s.i%tl'. Press sterile cotton .ool onto the opening. -ecure
.ith adhesive tape.
!?. &hec/ the patientDs reactions and give additional reassurance( i% necessar'.
!@. &lean upA dispose o% .aste sa%el'A .ash 'our hands.
Step > Step ? Steps 11 to 14
121
122
Annex 4
123

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