ACTIVITY 5

6. DRUG-DISPENSING SYSTEMS IN HOSPITALS

Drugs are one of the main tools of medical therapy and are a significant part of
hospital budgets. Implementing safe, organized, and efficient drug-dispensing
systems is essential for controlling costs and assuring that the medical prescription
is safely followed as requested within the appropriate deadline. An appropriate
dispensing system is an important ally for the prevention or reduction of medication
errors by helping to minimize dispensing error opportunities in a pharmacy. At
present there are various types of dispensing systems for medical prescriptions
within a hospital.
The first studies on the organization of such systems, specifically their relationship
with medication errors, were published in the mid-sixties. These studies mostly
performed in the United States of America were intensified during the 1970s and
1980s, aiming to provide safer dispensing systems. Investigation in this area in
Brazil was started during the1990s and is still not numerically significant.
Collective System
The collective system, also known as the traditional system, is the oldest and most
obsolete. In this system, drug-related actions are centered on nursing
professionals, and the pharmacy is merely a drug delivery agent. This system has
many facilitating conditions for errors. It is characterized by the distribution of
drugs per hospital unit/service based on a request by a nurse. It implies the
establishment of inventory in these units under the nurse's supervision. 16,17
It is estimated that nurses spend about 25% of their time transcribing
prescriptions, checking inventory, filling requests, and transporting and separating
drugs in the various units. Institutional costs are high due to losses by theft,
inadequate storage, and drug expiration.17,18
The advantages of this system are that drugs are readily available at the units,
there are fewer requests to the pharmacy, with a corresponding reduction in
pharmacy expenses related to human resources and materials. These advantages
become obstacles for improved pharmaceutical service to patients. 17 A negative
consequence is a high rate of medication errors, the most common being giving
twice the dosage, giving the wrong drug, inappropriate dose and administration
routes, and giving non-prescribed drugs. A further disadvantage is inefficient stock
control and increased expenses related to drugs. 16,18,19

According to the first pharmacy assessment in Brazil in 2002, 51.2% of hospital

pharmacies use the collective drug-dispensing system.20
Individualized System
In the individualized drug-dispensing system, the pharmacy and pharmacists
participate more actively on drug-use issues; however, nursing participation and
error rates are still high. In this system, drugs are dispensed per patient, usually for
a 24-hour treatment period. The pharmacy dispenses drugs separately per patient,
according to the medical prescription, to the hospital units. 16,17 In Brazil, 34.8% of
hospitals use this drug-dispensing system for in-hospital patients. 20
This system may be described as indirect, where drug dispensing is based on a
transcription of the medical prescription made by nurses, or direct, where
dispensing is based on a copy of the medical prescription (made daily). The indirect
system has a high rate of errors and theft, as failure and omission may take place
during transcription and items not present in the original prescription may be
added.
In the direct system, the prescription may be forwarded to the pharmacy as
follows17:
a) the prescription is written over carbon paper to produce a copy of the original.
Poor quality carbon paper or inadequate pens may result in prescription copies that
are difficult to read;
b) photocopy to reproduce the original prescription;
c) fax from the hospital unit to the pharmacy. This method may generate illegible
documents, opening the door for new sources of medication errors and allowing
loss of information with time;
d) the physician writes the prescription on computer terminals in the hospital unit
and sends it electronically to the pharmacy. The main advantage is the elimination
errors due to poor handwriting. However, other types of errors may appear, such as
printing the prescription made the previous day or not saving changes, resulting in
wrong prescriptions. Also the prescriptions of 2 or more patients may be
accidentally exchanged;
e) computerized prescription: using clinical management software interconnecting
the various hospital units. The prescription and the dispensing report are made in
the system that may be integrated with pharmacology and inventory control
software. Professionals access system data directly with no need to send files.

There are also safety systems that warn against toxic doses, allergic and crossreactions, drug interactions, duplication of therapeutic classes, contraindications,
and adverse effects. Automation using bar codes allows drugs to be checked when
dispensing and administering the drug;
f) radio system interconnecting computers and optic readers: the physician uses a
small electronic pen-operated or touch-sensitive terminal, allowing immediate
checking of patient data, rapid prescription (at the bedside), and fewer computers
in hospital units.
The individualized drug-dispensing system has advantages, such as the possibility
of reviewing medical prescriptions, increased control over drug use, less inventory
in hospital units, reduced theft and losses, and individual patient invoicing. The
disadvantages are the high rates of dispensing and delivery errors that still exist,
the time spent by nurses calculating and preparing drug doses, increased expense
regarding human resources and materials, and high losses due to theft and
inadequate drug delivery.16,17
Usually, the pharmacy is present in hospital units. Pharmacy assistants replenish
emergency stocks daily, collect prescriptions for the day, collect drugs returned
from the previous day, and send drugs for the following 24 hours of treatment. On
a monthly basis they also check drug validity in the inventory and unauthorized
inventory. Pharmacists visit hospital units daily to supervise work done by their
assistants. They also help nurses clarify doubts related to drug delivery and stability
as well as storage and use of heat-sensitive and photo-sensitive drugs. Pharmacists
also discuss prescription issues with physicians. In hospitals with adequate human
resources allied to professional and institutional interests, pharmacists develop
clinical activities with the professional health team to reduce medication errors.
Mixed System
The mixed dispensing system combines the collective and the individualized
systems and is also used in Brazilian hospitals. Hospital units are supported
partially or completely by the individualized systems, and specific units (radiology,
endoscopy, emergency, outpatient department, among others) are supported by the
collective system.17 The mixed system is used by 13.2% of Brazilian hospitals for
dispensing drugs.20
The main disadvantage of the mixed system is a trend towards the collective rather
than the individualized system, favoring drug dispensing by hospital unit rather
than per patient dispensing. It is easier to dispense drugs by hospital unit instead of
separating and packaging items for each patient. Pharmacy staff should be made

aware of the importance of their work and that collective dispensing is easier but
not as safe.
Unit dose system
Drug administration in hospitals may involve 20 to 30 steps from prescription to
delivery and monitoring. During the past 50 years, little has changed in this process
except for the development and implementation of the unit dose drug-dispensing
system.21
The high rate of medication errors in hospitals reported in many North-American
studies towards the end of the 1950s, demonstrated the need to review traditional
dispensing systems to improve safety in drug dispensing and delivery. In 1960,
North-American hospital pharmacists belonging to a multidisciplinary group
developed the unit dose system, aiming to reduce medication error rates, drug
costs, losses and theft, and to improve the productivity of health professionals and
the quality of health care. This system consists of ordered drug dispensing with
doses ready for delivery according to the patient's medical prescription. Every drug,
in all pharmaceutical forms, is dispensed ready-to-use with no need for prior
transference, calculation, and handling by nurses. Only drugs used in emergencies
are stored in hospital units, together with the necessary doses for the next 24
hours of treatment of patients.16,17
The system has the following advantages: drug identification right up to the
moment of delivery; lower medication error rates; less nursing time spent on drug
handling, increased nurse availability for patient care; less inventory in units, with
decreased losses; optimizing the return of unused drugs; better hospital infection
control through the practice of aseptic techniques in the preparation of drug doses;
increased adaptability for automation; increased precision in invoicing drug use per
patient; increased assurance for physicians that the prescription will be
administered; effective pharmacist participation in defining drug therapy; improved
control over the pattern and time of drug delivery; less space used to keep drugs in
hospital units; and improved patient assistance. The disadvantages are resistance
by nurses to the system, the need for extra staff and pharmacy infrastructure, the
need to acquire specific equipment, and a high initial financial
investment.16,17Furthermore, pharmacists need to be trained to prepare parenteral
drugs, knowledge not imparted by the majority of pharmacy colleges in Brazil.
Implementation of this system in Brazil is a huge challenge. Only 0.4% of hospitals
use it to dispense drugs.20The initial investment to acquire specific equipment for a
sterile product-preparation center is high and not within the reach of small and midsized institutions, which represent more than 80% of Brazilian hospitals. 17

ACTIVITY 6
3. How to report ADRs?
Local Case Report Forms (CRF) should be obtained from the National Drug
Regulatory Authority. Some countries have included CRF in their National
Formularies (British National Formulary, Formularies of South Africa, Zimbabwe
etc.).
There are different Case Report Forms in different countries. But all of them have at
least four sections which should be completed:
1. Patient information:
-

patient identifier
age at time of event or date of birth
gender
weight

2. Adverse event or product problem:

-

description of event or problem

date of event
date of this report
relevant tests/laboratory data (if available)
other relevant patient information/history
outcomes attributed to adverse event

3. Suspected medication (s):

-

name (INN and brand name)

dose, frequency & route used
therapy date
diagnosis for use
event abated after use stopped or dose reduced
batch number
expiration date
event reappeared after reintroduction of the treatment
concomitant medical products and therapy dates

4. Reporter:
- name, address and telephone number
- speciality and occupation
The completed Case Report Form should be sent to the national or regional ADR
centre or to the manufacturer of the suspected product.

Addresses of National Drug Regulatory Authorities and other useful information can
be found on the Website of the WHO Collaborating Centre for International Drug
Monitoring (www.who-umc.org) or requested from this Centre by e-mail: info@whoumc.org; by Fax: +46 18 65 60 80 or by Tel.: +46 18 65 60 60.
4. How Long Must a Health Care Provider Keep a Patient's Medical Records?
Generally, a provider must retain a patient's medical records for seven years after the
last treatment date, or three years from the patient's death. (Department of Public
Health (DPH) Regs. 19a-14-42).
ACTIVITY 7
1.
Roles and Responsibilities
Many of the responding P&TCs terms of reference indicated roles and responsibilities that are
much broader than those related to establishing and maintaining a drug formulary listing,
including but not limited to the following:
evaluating safe, effective, ethical, and fiscally responsible drug use
acting in an advisory capacity on all drug, as well as nutritional product use
developing clinical guidelines and decision support tools relating to appropriate

drug use
providing educational activities for all health care professionals involved in the

medication use process (i.e., prescribing, distribution, administration)

preparing drug budget impact analyses
developing criteria for use, treatment guidelines, and standardized orders
reviewing adverse drug reactions and formulating recurrence prevention strategies
establishing drug-use evaluation programs and conducting medication audits to

optimize drug use

having direct linkages to the provincial Ministry of Health for sharing information of

mutual interest, and coordinating drug-related planning and/or prioritizing

establishing subcommittees to address specialty practice areas (e.g., pediatrics,

oncology, anti-infectives)
working with other provincial organizations that may fund specific drugs in order to

expedite and coordinate formulary status

Functions and Scope of PTC

A. To serve in an evaluative, educational, and advisory capacity to the medical staff

and organiztional administration in all matters pertaining to the use of drugs.
B. To develop a formulary of drugs accepted for use in the organization and provide for its
constant revision.
C. To establish programs and procedures that help ensure safe and effective drug therapy.
D. To establish programs and procedures that help ensure cost effective drug therapy.
E. To establish or plan suitable educational programs for the organization's professional staff
on matters related to drug use.
F. To participate in quality assurance activities related to distribution, administration, and use
of medications.
G. To monitor and evaluate ADRs in the health care setting and to make appropriate
recommendations to prevent their occurrence
H. To initiate or direct (or both) drug use evaluation program and studies, review the results
of such activities, and make appropriate recommendations to optimize drug use.
I. To advise the pharmacy department in the implementation of effective drug distribution
and control procedures.
J. To disseminate information on its actions and approved recommendations to all
organizational health care staff.
2. How often does the Committee review medications?
The P&T Committee meets quarterly to review new drugs that have recently been approved by
the FDA as well as drugs that have been FDA approved for new medical conditions.
The committee should meet on a regular basis to discuss the rapidly changing drug
products and medical literature.

Frequency: Monthly meeting.

Length: 60-90 minutes.

Note: Minimum: 10 meetings/year.

3. Responsibilities:
1. Formulary system maintenance:

Develop list of medications for use.

Guidelines for optimal use of medications.
Review list & guidelines on regular basis.
2. Medication selection and review:
Medication selection criteria should be set and should include medication
efficacy, safety and cost.
3. Medication Use Evaluation:
E.g. overuse of antibiotics resistant infections and increased cost.
Approve drugs to be kept under restriction.
4. Medication Safety Evaluation:
Adverse drug reaction reports.
Medication error reports.
Review drug intervention reports.
5. Drug Therapy Guidelines:
Evaluates optimal use of drugs e.g. dosage, frequency, patient selection, length of
therapy and combination.
Guidelines should be updated routinely.
6. Policy & Procedure Development:
Medication procurement, selection and distribution.
Medication for specific settings e.g. ICU.
Develop policies e.g. automatic stop order, drug recall.
Responsibilities:
7. Education:
Newsletter is often employed to communicate the committee decisions.
Newsletter includes the following:
Clinical information on drugs added to formulary.
Drug therapy guidelines developed.

Medication safety information.

ACTIVITY 8
2. "Formulary" Designation
Only those drugs approved by the Pharmacy and Therapeutics Committee on the
basis of safety,
efficacy, and cost to be most advantageous in patient care shall be designated as
formulary drugs.
These drugs are listed in the formulary; only formulary drugs are routinely stocked
and available
from the pharmacy.
Only those drugs that have been approved by the Food and Drug Administration
(FDA) shall be
considered for formulary addition. Therefore, investigational drugs do not meet
criteria for
formulary addition.
Drugs are included in the formulary by their generic names, even though trade
names may be in
common use in the hospital. Physicians are strongly encouraged to prescribe drugs
by their
generic names.
The Department of Pharmacy is responsible for selecting, from available generic
equivalents,
those drugs to be dispensed pursuant to a physician's order for a particular drug
product.
Generally, this choice is consistent with competitive bids awarded by the University
Hospitals
group purchasing organization (Novation)
5. Selection of Guiding Principles for Admission or Deletion of Drugs
Criteria:
1.
Drugs must be of proven clinical value based upon experience.
2.

The drugs must be recognized by USP/NF or their supplement.

3.
The manufacturers of these drugs must be of proven integrity and dependability as well
as having the regulation of initiating and supporting research activities of merits.
4.

No preparation of secret composition will be considered or admitted to the formulary.

5.
No product of multiple composition shall be admitted if the same therapeutic value can
be obtained through the use of a single drug entity.
6. A formulary can contain both name-brand and generic drugs. Patients pay co-pays on
formulary drugs. If a drug is not on the list, the patient will pay much more, up to the full
cost of the drug. Every health care plan has a different list of acceptable drugs and copay prices.
Since it is impossible to stock every type of medicine for every disease, hospitals create
formularies listing the drugs they keep in house. It is possible for a hospital to obtain nonformulary drugs by ordering them from a neighboring hospital or pharmacy.
7. Formularies cover all the categories of medications that patients need. The list is
constantly being revised and updated to make sure patients receive the appropriate
medication. For example, before a medication is added to or deleted from the formulary,
teams of pharmacists, physicians, and other healthcare professionals in the hospital
evaluate the drug products to make sure that they are safe, work well, and are costeffective.
The Philippine National Drug Formulary (PNDF) is an integral component of
the Philippine Medicines Policy which aims to make quality essential drugs
available, accessible, efficacious, safe and affordable
The PNDF (Volume I) is the Essential Medicines List (EDL)for the Philippines
prepared by the National Formulary Committee (NFC) in consultation with
experts and specialists from organized professional medical societies, medical
academe and the pharmaceutical industry.
List of essential medicines that are registered with Food and Drug Administration
(FDA)
ACTIVITY 9
I. Setup and equipment
The center is equipped with computer terminals, printed materials (current, periodicals, bound
journal volumes, reference texts) and has access to Medline, the Internet and various other
online drug and medical references.
The center maintains subscriptions to nationally recognized journals and texts of Pharmacy and
Medicine.
Direct access to computerized on-line data searching, CD ROM databases and the World Wide
Web are also available.(Table 1)

2. Providing DI to patients, caregivers, and health care professionals

9 2. Creating a variety of educational resources for patients (e.g., tip sheets or
pamphlets)
10 and health care professionals (e.g., inservices) on topics such as optimal
medication use,
11 general health, or select clinical questions
12 3. Developing and educating health care professionals on safe and effective
medication-

13 use policies and/or processes

14 4. Leading or participating in continuing education services for health care
professional
15 staff
16 5. Precepting and educating pharmacy students and residents
17 6. Participating in quality improvement research projects

1. Providing information when there is not sufficient time for the health care
professional
to appropriately research the DI question, when there is a knowledge gap, or when
the
question requires more specialized DI resources
2. Establishing and maintaining a formulary based on scientific evidence of efficacy
and safety, pharmacoeconomics, and institution-specific factors
3. Coordinating programs to support population-based medication practices (e.g.,
development of pharmacotherapeutic guidelines and medication use evaluation
criteria)
4. Developing and participating in efforts to prevent medication misadventures,
including
6 adverse drug event, ensuring institutional compliance to Risk Evaluation and
Mitigation
Strategies (REMS), and medication error reporting and analysis programs
5. Collecting and applying health economic and outcome analyses
6. Coordinating investigational drug services
7. Managing drug shortages including identifying alternative treatments,
developing
protocols for restrictive use, and managing formulary concerns9a
8. Developing clinical decision support tools such as order sets, dosing protocols,
and
order-entry alerts

9. Maintaining DI and medication use policy related intranet resources

10. Precepting or providing advanced DI education and training to students and
residents
11. Coordinating purchase and selection of pharmacy and institution-wide DI
resources
12. Participating in various fee-for-service projects

ACTIVITY 10
3. To achieve these objectives, the Catalog is divided into the six Outcomes for
improvement
identified by the Institute of Medicine in the report Crossing the Quality Chasm: A
New Health
System for the 21st Century:
Safety avoiding injuries to patients from the care that is intended to help them
Effectiveness providing services based on scientific knowledge to all who could
benefit, and
refraining from providing services to those not likely to benefit
Patient-Centeredness providing care that is respectful of and responsive to
individual patient
preferences, needs, and values, and ensuring that patient values guide all clinical
decisions
Timeliness reducing waits and sometimes harmful delays for both those who
receive and those
who give care
Efficiency avoiding waste, including waste of equipment, supplies, ideas and
energy
Equitableness providing care that does not vary in quality because of personal
characteristics
such as gender, ethnicity, geographic location, and socioeconomic status