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Irrational use of medicines is a global problem and occurs in both developing and
developed countries. In developing countries this problem is enormous and not well
documented. It often leads to problems such as ineffective treatment, health risks,
medicine resistance, patient noncompliance, and overall decreases the quality care of
population and increases morbidity and mortality, also excessive spending on
pharmaceuticals and wastage of financial resources, by both patients and health care
system.
More than 50% of all medicines worldwide are prescribed, dispensed, or sold
inappropriately and 50% of patients fail to take them correctly. Con1versely, about
one-third of the worlds population lacks access to essential medicines 1. Treatment
with medicines is one of the most cost-effective medical interventions known, and the
proportion of national health budgets spent on medicines ranges between 10% and
20% in developed countries and between 20% and 40% in developing countries.
Thus, it is extremely serious that so much medicine is being used in an inappropriate
and irrational way.
Many interrelated factors influence medicine use. The health system, prescriber,
dispenser, patient, and community are all involved in the therapeutic process and all
can contribute to irrational use in a variety of ways. Published researches suggested
that medications wastages may be due to excessive and irrational prescribing and
dispensing, or the lack of control of the sales of prescription medications in the
community pharmacies and poor compliance of the patients.2-5 In previous household
surveys conducted in other countries, the type, quality, storage and use of medicines
in hands were studied. The studies founded therapeutic duplication, medication
wastages, and unnecessary hoarding of medications. About half of medicines in the
households were not in current use and around 40% of these medicines were
expired.6,7
Numerous studies, both from developed and developing countries describe a pattern
that includes polypharmacy 8-14, the use of drugs that are not related to the diagnosis 15-
19
or unnecessarily expensive
20-25
26- 33
and
An
indicator
is
measurable
characteristic
of
actual
system
facility
indicators
and
hospital
antimicrobial
indicators
pharmacy.
4. % drugs prescribed that were clearly unnecessary or
inappropriate by STP.
From pharmacy inventory we could get facility indicators:
1. % availability of drugs in the EDL for that facility .
2. Availability of Essential Medicine List, Formulary at the
health facility level .
The second important requirement in studying rational drug use is a standard. What is
rational? How much deviation from an agreed standard can be accepted? In practice
this implies that the prescription should be compared with an agreed treatment
protocol or with a list of therapeutic alternatives. This is also a core principle of
medical audit, which is becoming more and more important in developed countries
like the United Kingdom45. Audit needs a standard, and a standard needs consensus.
Treatment protocols and prescribing policies should be agreed by the prescribers
themselves in their own environment at the hospital or clinical department. In a
national perspective one would then distinguish between three levels: the total range
of drugs approved for sale and use in the country, usually defined by the regulatory
authorities; within this range, the national formulary or national list of essential drugs,
preferably sub-divided by level of care (health centre, general hospital, specialist
department) and developed by a national formulary committee; and within that, a
hospital formulary or departmental prescribing policy specific for one hospital, a
clinical department or a group of practitioners. This part, attempts to explain, the
various aspects related to essential medicines, their rational use and their irrational use
ESSENTIAL MEDICINES: 46
The Essential Medicines concept:
'Selecting a limited range of medicines to improve access to health care and quality of
health care'.
The implementation of the concept of essential medicines is intended to be flexible
and adaptable to many different situations. Essential medicines are those that satisfy
the priority health care needs of the population.
Careful selection of a limited range of essential medicines results in:
The aim of any medicine management system is to deliver the right medicine to the
patient who needs the medicine. The steps of selection, procurement, and distribution
are necessary precursors to the rational use of medicines.
The Conference of Experts on the Rational Use of Drugs, convened by the World
Health Organization (WHO) in Nairobi in 1985, defined rational use as follows:
The rational use of drugs requires that patients receive medications appropriate to
their clinical needs, in doses that meet their own individual requirements, for an
adequate period of time, and at the lowest cost to them and their community.
The requirements of the rational use of medicines can be fulfilled only if the process
of both prescribing and dispensing is appropriately followed. This includes steps
concerned with proper diagnosis, correct prescribing, dispensing, and giving proper
information to the patient.
Irrational use of medicines
The irrational use of medicines includes cases in which
a. A medicine is prescribed where none was needed.
b. Medicines are not prescribed according to Standard Treatment Guidelines
(STGs), or ineffective or unsafe medicines are prescribed.
c. Effective and available medicines are underused.
d.
The irrational use of medicines has an adverse impact on the outcome of therapy and
cost, and may cause adverse reactions or negative psychosocial impacts.
Table 2: Aspects of Irrational Drug Use
Diagnosis
Inadequate examination of patient
Incomplete communication between patient and doctor
Lack of documented medical history
Inadequate laboratory Resources
Prescribing
Extravagant prescribing
Over-prescribing
Incorrect prescribing
Under-prescribing
Multiple prescribing/ers
Dispensing:
Incorrect interpretation of the prescription
Retrieval of wrong ingredients
Inaccurate counting, compounding, or pouring
Inadequate labeling
Unsanitary procedures
Packaging:
Poor-quality packaging materials
Odd package size, which may require repackaging
Unappealing package
Patient adherence:
Poor labeling
Inadequate verbal instructions
Inadequate counseling to encourage adherence
Inadequate follow-up/support of patients
Treatments or instructions that do not consider the
patients beliefs, environment, or culture
Patients are not given proper instructions, and may swallow a chewable tablet.
b. When superior medicines with fewer side effects are available (metformin v/s
phenformin).
c. When side effects are more dangerous than the disease e.g. furazolidone and
nitrofurazone (can cause cancer).
d.
The following table lists drugs that have been discarded internationally, but are still
allowed to be marketed in India
Table 3: List of drugs discarded internationally, but are still in Indian Market
Drug
Analgin
Indication
Analgesic
Can
cause
bone
marrow
Cisapride
Acidity, GERD,
depression
Can cause
Furazolidone
Nimesulide
Phenylpropanola
constipation
Anti diarrhoeal
Pain killer, fever
Cough and cold
beats (arrhythmias)
Carcinogenic
Hepatotoxic
High doses can lead to stroke
mine
Nitrofurazone
Antibacterial
Carcinogenic
Piperazine
cream
Anthelmentic
irregular
heart
c. pancreatin, which are inadequate, and are generally not suitable in an acidic
medium.
Adverse impact of irrational use of medicines
The inappropriate use of medicines on a wide scale can have significant serious
effects on health care costs as well as on the quality of drug therapy and medical care.
Other negative effects are, increased likelihood of adverse reactions, and a patient's
inappropriate dependence on medicines.
Impact on quality of drug therapy and medical care
Inappropriate prescribing practices can, directly or indirectly, jeopardize the
quality of patient care and negatively influence the outcome of treatment.
The under use of ORS for acute diarrhoea, for example, can hinder the goal of
treatment: - to prevent or treat dehydration, and thus prevent death in children.
The likelihood of Adverse Drug Reactions increases when medicines are
prescribed irrationally. Misuse of injectable products , for example, has been
implicated in a high incidence of anaphylactic shock.
Over dosage or under dosage of antibiotics and chemotherapeutic agents also
leads to the rapid emergence of resistant strains of bacteria or the malaria
parasite.
Impact on cost
Overuse of medicines, even essential ones, leads to excessive expenditure on
pharmaceuticals, and waste of financial resources, by both patients and the
health care system.
In many countries, expenditures on nonessential pharmaceutical products,
such as multivitamins or cough mixtures, drain limited financial resources that
could otherwise be allocated for more essential and vital medicines and related
products, such as vaccines or antibiotics.
Inappropriate under use of medicines during the early stages of a disease may
also produce excess costs by increasing the probability of prolonged therapy
and eventual hospitalization.
Psychological Impact
Over prescribing communicates to patients that they need medication for all
conditions, even trivial ones.
The concept that there is a pill for every ill is harmful.
Patients begin relying on medicines, and this reliance increases demand.
Patients may demand unnecessary injections because during their years of
exposure to modern health services they may have become accustomed to
having practitioners administer injections.
Reasons for irrational use of drugs
Lack of information: Unlike many developed countries we dont have regular
facility which provides us up to date unbiased information on the currently
used drugs. Majority of our practitioners rely on medical representatives.
There are differences between pharmaceutical concern & the drug regulatory
authorities in the interpretation of the data related to indications & safety of
drugs.
Faulty & inadequate training & education of medical graduates: Lack of
proper clinical training regarding writing a prescription during training period,
dependency on diagnostic aid, rather then clinical diagnosis, is increasing day
by day in doctors.
Work place
- Heavy patient load.
- Pressure to prescribe.
- Insufficient staffing.
Drug supply system
- Unreliable suppliers.
- Medicine shortages.
- Supplying expired medicines.
- Supplying irrational medicines.
Drug regulation
- Availability of non-essential medicines.
- Presence of non-formal prescribers (Quacks).
- Lack of regulation enforcement.
- Sluggish judiciary.
Industry
- Promotional activities (through advertisements or medical representatives)
- Misleading claims.
Inappropriate use and over-use of medicines is a waste of resources often out ofpocket payments by patients. It also results in significant patient harm in terms of
poor patient outcomes and adverse drug reactions.
Irrational use is wasteful and can be harmful for both the individual and the
population. Adverse medicines events cause significant morbidity and mortality and
rank among the top 10 causes of death in the United States of America. They have
been estimated to cost 466 million annually in the United Kingdom of Great Britain
and Northern Ireland and up to US$ 5.6 million per hospital per year in the USA.
Antimicrobial resistance is dramatically increasing worldwide in response to
antibiotic use; much of it inappropriate overuses (and is causing significant morbidity
and mortality. It has been estimated that antimicrobial resistance costs annually US$
40005000 million in the USA and 9000 million in Europe. The use of unsterile
injections is associated with the spread of blood borne infections, such as hepatitis B
and C and HIV/AIDS. Although evidence-based medicine has gained importance the
use of both diagnostic and treatment guidelines is sub-optimal and could be greatly
improved.
Strategies to promote rational prescribing and their possible impact
The various interventions to promote rational prescribing are best classified as
educational, managerial and regulatory 47
Educational strategies include printed materials, seminars, bulletins and face-to-face
interventions.
Managerial methods refer to various restrictions on prescribing, e.g. restrictive lists, a
maximum number of drugs per prescription, budgetary or cost restrictions,
endorsement by higher qualified consultants, patient co-payment strategies, price
measures, structured prescription forms or a maximum duration for inpatient
prescriptions (automatic stop-orders).
Regulatory measures include procedures to critically evaluate drugs and product
information (e.g. data sheet, patient information leaflet) before market approval is
granted, scheduling drugs for different sales levels (over the counter, pharmacy only,
prescription only) and specifying for each drug a minimum level of prescriber or
health facility (for example, no injectable antibiotics at health centres).
Several studies have critically reviewed the available evidence to identify the most
48-50
effective interventions
52-53
. Most of
these interventions assume that the main reason for incorrect prescribing is a lack of
knowledge and that if prescribers had the correct information, their prescribing would
automatically improve. This is not always the case in view of the many other factors
influencing prescribing, like drug promotion
54
placebo drugs and prescriber preference based on personal experience rather than peer
reviewed standards 55. Technical information on cost and side effects of the drugs is of
much less influence, as shown in the Netherlands
56
lack of impact of a series of warnings in the FDA bulletin as recorded by Soumerai 57.
Another aspect of the problem is that prescribers with irrational prescribing behaviour
are the very ones that are less likely to read the educational material mailed to them.
Proven cost-effective interventions are face-to-face education focused on a particular
prescribing problem in selected individuals
57-63
focused educational campaigns together with widely discussed and frequently revised
treatment guidelines. An example of the latter is the success of the Australian
antibiotic guidelines
65
effect of clinical guidelines concluded that all but four of these studies detected
significant improvements in the process of care after the introduction of guidelines,
and all but two of the 11 studies that assessed the outcome of care, reported
significant improvements. However, the size of the improvements in performance
varied considerably 66. Essential drugs lists together with an educational programme
and follow-up are probably effective as well.
As mentioned above, most evidence suggests that printed materials alone are
ineffective. It is likely that this also applies to essential drugs lists and treatment
guidelines if these are just distributed to prescribers without an introduction campaign
and without intensive follow-up, and especially if the prescribers had not been
involved in the development process. A general problem is that many interventions
have only been tested in developed countries and that the results can therefore not
automatically be extrapolated to developing countries where conditions are so
different. In the absence of well conducted studies Laing has attempted to give
67
include specific training in rational prescribing; that essential drugs lists and
therapeutic guidelines should be developed through wide consultation and feed-back
and be disseminated by means of intensive educational programmes as recorded from
Yemen
68
, Uganda
69
and Zimbabwe
70
71
. However, in