Literature Review 3.1 Introduction To Prescription

CHARUSAT/Faculty of Pharmacy/RPCP/Ph.
D Literature Review
3. LITERATURE REVIEW
3.1 Introduction to Prescription
Prescription order is an important transaction between the physician and the patient. It
is an order for a scientific medication for a person at a particular time (37) It brings
into focus the diagnostic acumen and therapeutic proficiency of the physician with
instructions for palliation or restoration of the patient’s health (38) Prescription is a
written document that engages the medical and legal responsibility not only of the
physician but of all those subsequently involved in its execution (39).
Prescription writing used to be an art as well as a science. Unfortunately, times have

changed. More often than not, we find incomplete and illegal prescriptions being
handed over to patients, and, more unfortunately, honored at pharmacies. This has
resulted in a disturbing trend of putting the patients safety at risk; and there is an
urgent need to put things right (40). Nowadays the prescribing pattern is changing and
it has become just an indication of medicine with some instructions of doses without
considering its rationality. (37)
3.1.1 History
Early medicines were made up of multiple ingredients requiring complex preparation,

and Latin was adopted as the standard language of the prescription to ensure
understanding between physician and pharmacist and consistency in pharmaceutical
composition. Latin no longer is the international language of medicine, but a number
of commonly used abbreviations derive from old Latin usage. The symbol "Rx" is
said to be an abbreviation for the Latin word recipere, meaning "take" or "take thus,"
as a direction to a pharmacist, preceding the physician's "recipe" for preparing a
medication. The abbreviation "Sig" for the Latin Signatura, is used on the prescription
to mark the directions for administration of the medication (41 ibid page no 1879)
Jalpa Suthar/ID No. 10DRPHC001

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CHARUSAT/Faculty of Pharmacy/RPCP/Ph.D Literature Review
3.1.2 Parts of the Prescription (42, 43).
The elementary requirements of a prescription are that it should state what is to be

given to whom and by whom prescribed, and give instructions on how much should
be taken how often, by what route and for how long or total quantity to be supplied.
1) Date
2) Address of doctor
3) Superscription {Symbol (Rx)}
4) Inscription or the name and dose of medication prescribed
5) Subscription or Dispensing direction to Pharmacist
6) Signature or Instructions for Patient
7) Signature of doctor
1) Date: Prescriptions are dated at the time they are written and also when they are
received and filled in the pharmacy. The date is important in creating the
medication record of the patient. The Date is also important to pharmacist in
filling prescription of controlled substances. No Prescription order of controlled
drugs may be dispensed or renewed more than 6 months after the date
prescribed.
2) Address of doctor: It is important to write physician’s name, address, telephone
number and Drug Enforcement Agency (DEA) number or Medical council
registration number in India on prescription pads.
3) Superscription {Symbol (Rx)}: This is the symbol R generally is understood to
be a contraction of the Latin verb recipe, meaning take thou or you take. The
stroke after “R” is considered as an invocation to Jupiter. Jupiter is a god of
healing. Sign of Jupiter employed as request for healing. Today, the symbol is
representative of both the prescription and the pharmacy itself.
4) Inscription or the name and dose of medication prescribed: This is the body
or principal part of the prescription order. It contains the name and quantities of
the prescribed ingredients (41).
Today, majority of the prescriptions are written for medication already prepared
or prefabricated into dosage forms by industrial manufacturers. The medications

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may be prescribed under their trademarked or manufactures proprietary name or
by their nonproprietary or generic names. Pharmacists are required to dispense
the trademarked products when prescribed, unless substitution of an equivalent
product is permitted by the prescribing physician or by the state law. Prescription
orders requiring the pharmacist to mix ingredients are termed compounding
prescriptions. Prescriptions requiring compounding contain the names and
quantities of each ingredients required. The names of the ingredients generally
are written using the nonproprietary names of the materials, although
occasionally proprietary names may be employed. Quantities of ingredients to be
used may be indicated in the metric or apothecary system of weights and
measures; however, the use of the apothecary system is diminishing. In the
metric system the decimal point is often replaced by vertical line that may be
imprinted on the prescription blank or drawn by the prescriber(41).
5) Subscription or Dispensing directions to Pharmacist: This part of the
prescription consists of directions to the pharmacists for preparing the
prescription. In majority of prescriptions, the subscription serves merely to
designate the dosage form (as tablets, capsules, etc) and the number of dosage
units to be supplied. Examples of prescription directions to the pharmacist are
"make a solution," "mix and place into 30 capsules," or "dispense 30 tablets (41).
6) Signature or Instructions for Patient: The prescriber indicates the directions
for the patient’s use of the medication in the portion of the prescription called
signature. The word, usually abbreviated signa or sig means mark thou. The
directions in the signa commonly are written using abbreviated forms of English
or Latin terms or a combination of each (41). Examples are
Tabs ii q4h (Take two tablets every four hours)

Caps I 4xd pc & hs (Take one capsule four times a day after meals and at
bedtime)
Instill gtts ii od (Instill two drops into the right eye)
The directions for use must be both drug-specific and patient-specific. The simpler the
directions, the better; and the fewer the number of doses (and drugs) per day, the
better. Many physicians continue to use Latin abbreviations; for example, "1 cap tid
pc," will be interpreted by the pharmacist as "take one capsule three times daily after
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meals." However, the use of Latin abbreviations for these directions only mystifies
the prescription and is discouraged. This can be a hindrance to proper patient-
physician communication and is an otherwise unnecessary source of potential
dispensing errors. Because the pharmacist always writes the label in English (or, as
appropriate, in the language of the patient), the use of such abbreviations or symbols
is unnecessary. Many serious dispensing errors can be traced to the use of
abbreviations (44). Instructions to patients should be clear and preferably in English
or vernacular language. 7) Signature of the doctor: It is the end of prescription.
Date:__________ ABC Hospital

Dr. A. B. Shah
12, Modern Centre
Anand, Gujarat
Name: ______________________ M/F Age:_______
Address:_____________________ Wt:________
Losartan 50 milligram Tab, Dispense 30 tablets
Take one by Mouth daily in the morning

For blood pressure control
Refill____________ times Signature____________________

Generic Substitution________ Registration No.: ______________
Figure 1: Sample Format of ideal Prescription

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The prescription must be carefully prepared to identify the patient and the medication
to be dispensed, as well as the manner in which the drug is to be administered.
Accuracy and legibility are essential. Use of abbreviations, particularly Latin, is
discouraged, because it leads to dispensing errors. Inclusion of the therapeutic
purpose in the subscription (e.g., "for control of blood pressure") can prevent errors in
dispensing. For example, the use of losartan for the treatment of hypertension may
require 100 mg/day (1.4 mg/kg/day), whereas treatment of congestive heart failure
with this angiotensin II receptor antagonist generally should not exceed 50 mg/day.
Including the therapeutic purpose of the prescription also can assist patients in
organizing and understanding their medications. In addition, including the patient's
weight on the prescription can be useful in avoiding dosing errors, particularly when
drugs are administered to children. (41 ibid page no. 1880)
3.1.3 Introduction to Good Prescribing: What constitutes good prescribing? (45)
Barber stated that ‘Drugs are the stronghold of medical treatment, yet there are few
reports on what constitutes “good prescribing” and the existing direction tends to
imply that right answers exist, rather than recognizing the complex trade-offs that
have to be made between conflicting aims’(45). There are four aims that a prescriber
should try to achieve, both on first prescribing a drug and on subsequently monitoring
it. They are: to maximize effectiveness, minimize risks, minimize costs, and respect
the patient’s choices (45). This model of good prescribing brings together the
traditional balancing of risks and benefits with the need to reduce costs and the right
of the patient to make choices in treatment (45).
‘The four aims are shown as a diagram plotting their commonest conflicts, which may
be used as an aid to discussion and decision making:’ (45)
Maximize effectiveness
Minimize cost Respect patient sources
Minimize risk
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3.1.3.1 Assessing good prescribing

Barber said that “Whereas consensus may be gained within medicine on how to
balance effectiveness, risk, and cost of drug treatment for a condition, including the
patient makes judgments on the quality of prescribing difficult to conduct at a
distance. In contrast, drug and therapeutics committees, pharmacists, medical
advisers, and commissioning agencies are increasingly making judgments on the
acceptability of prescribing. These approaches need not be mutually exclusive. The
model of good prescribing proposed … can be integrated with the proscriptive,
protocol driven approach currently gaining favors – for example, by setting a standard
that 80 per cent of prescribing meets the protocol. The level at which the standard is
set must come from debate among prescribers, patients, and commissioning agencies”
(45).
3.2 Types of Prescribing (10)

There are two types of prescribing based on approach of prescriber, one is Rational
(Appropriate) and another approach is irrational (Inappropriate) prescribing.
3.2.1 Rational (Appropriate) prescribing: (9, 10)
Rational prescribing Appropriate prescribing
 The process whereby prescribing Rational prescribing + tailored to patients
decisions are made needs and characteristic
 follows guidelines
need not be appropriate !
The terms "appropriate" and "rational" use of drugs will be used interchangeable (46).
Laing R stated “What is rational use of drugs? What does rational mean? People may
have different perceptions and meanings regarding rational use of drugs or more
specifically regarding rational prescribing” (46). However, the Conference of Experts
on the Rational Use of Drugs, convened by the World Health Organization in Nairobi
in 1985, defined rational use as follows:

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Rational use, and thus rational prescribing of drugs, requires that patients receive
medicines 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 (46).
Rational use of medicines refers to the correct, proper and appropriate use of
medicines. Rational use requires that patients receive the appropriate medicine, in the
proper dose, for an adequate period of time, and at the lowest cost to them and their
community (46).
The requirements for rational use will be fulfilled if the process of prescribing is
appropriately followed. This process includes steps in defining a patient’s problems
(or diagnosis); in defining effective and safe treatments (drugs and nondrug); in
selecting appropriate drugs, dosage, and duration; in writing a prescription; in giving
patients adequate information; and in planning to evaluate treatment responses (46).
The definition implies that rational use of drugs, especially rational prescribing,
should meet certain criteria as follows: (46)
 Appropriate indication. The decision to prescribe drug(s) is entirely based on

medical rationale plus safety and effectiveness of drug therapy.
 Appropriate drug. It depends on efficacy, safety, suitability, and cost of drug.
 Appropriate patient. No contraindications exist, with minimum adverse reactions

and acceptable to the patient.
 Appropriate patient information. Patients are provided with relevant, accurate,

important and clear information regarding their conditions and for the prescribed
medication(s).
 Appropriate evaluation. Appropriately monitored and interpret unexpected effects

of medications.
3.2.2 Irrational (Inappropriate) Prescribing: (47)

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Vance MA reported that “Medically inappropriate, ineffective and economically
inefficient use of pharmaceuticals is commonly observed in health care systems
throughout the world, including developing countries” (47). However, various forms
of inappropriate prescribing often remain unnoticed by those who are involved in
health sector decision making or delivery of health services (47). This problem will
usually come to the attention of health decision makers or managers when there is an
acute shortage of pharmaceutical budget that requires action for cost-efficiency (47).
Promoting appropriate use of drugs in the health care system is needed not only
because of the financial reasons with which policy makers and managers are usually
most concerned. Appropriate use of drugs is also one essential element in achieving
quality of health and medical care for patients and the community. Obviously, quality
of care is of concern to practitioners. Actions or intervention programs to promote the
appropriate use of drugs should, therefore, be continuously implemented and
systematically incorporated as an integral part of the health care system (48).
Unfortunately, in the real world, prescribing patterns do not always conform to these
criteria and can be classified as inappropriate or irrational prescribing. Irrational
prescribing may be regarded as "pathological" prescribing when the above-mentioned
criteria are not fulfilled. Common patterns of irrational prescribing may, therefore, be
manifested in the following forms: (49-51)
 Use of drugs when no drug therapy is indicated, e.g., antibiotics for viral upper
respiratory infections
 Use of the wrong drug for a specific condition requiring drug therapy, e.g.,
tetracycline in childhood diarrhea requiring ORS
 Use of drugs with doubtful or unproven efficacy, e.g., the use of antimotility
agents in acute diarrhea
 Use of drugs of uncertain safety status, e.g., use of dipyrone (Baralgan, etc.)
 Failure to provide available, safe, and effective drugs, e.g., failure to vaccinate
against measles or tetanus, or failure to prescribe ORS for acute diarrhea

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 Use of correct drugs with incorrect administration, dosages, and duration, e.g., the
use of IV metronidazole when suppositories or oral formulations would be
appropriate
 Use of unnecessarily expensive drugs, e.g. the use of a third generation, broad-
spectrum antimicrobial when a first-line, narrow spectrum agent is indicated
Some examples of commonly encountered inappropriate prescribing practices in

many health care settings include— overuse of antibiotics and antidiarrheals for
nonspecific childhood diarrhea, indiscriminate use of injections, e.g., in malaria
treatment, multiple or over-prescription, excessive use of antibiotics for treating minor
acute respiratory infection, multivitamins and tonics for malnutrition and unnecessary
use of expensive anti-hypertensive.
The drug use system is complex and varies from country to country. Drugs may be
imported or manufactured locally. The drugs may be used in hospitals or health
centers, by private practitioners and often in a pharmacy or drug shop where over the
counter preparations are sold. In some countries all drugs are available over the
counter as in India. Finally, the public includes a very wide range of people with
differing knowledge, beliefs, and attitudes about medicines. Consumers may have a
very different perspective of what is rational (49-51).
3.2.3 Factors contributing to inappropriate use of medicines (52)
Various different factors have an effect on the irrational use of drugs. In addition,
different cultures view drugs in different ways, and this can affect the way drugs are
used.
 Lack of skills and knowledge. Diagnostic uncertainty, lack of prescriber
knowledge of optimal diagnostic approaches, lack of independent information such as

clinical guidelines, lack of opportunity for patient follow-up, or fear of possible
litigation, lead to inappropriate prescription and dispensing of medicines.
 Inappropriate unethical promotion of medicines by pharmaceutical companies.
Most prescribers get medicine information from pharmaceutical companies rather

than independent sources such as clinical guidelines. This can often lead to overuse.

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Some countries allow direct-to-consumer advertising of prescription medicines, which
may lead to patients pressuring doctors for unnecessary medicines.
 Profits from selling medicines. In many countries, drug retailers prescribe and sell
medicines over-the-counter. Extra income can be generated by more sale and generate
more income leading to overuse of medicines, particularly the more expensive
medicines.
 Unrestricted availability of medicines. In many countries including India,
prescription medicines such as antibiotics, are freely available over-the-counter. This

leads to overuse, inappropriate self-medication and non-adherence to dosing regimes.
This creates drug resistance.
 Overworked health personnel. Many prescribers have too little time with each
patient, which can result in poor diagnosis and treatment. In such conditions
prescribers rely on prescribing pattern as they do not have the time to update their
knowledge of medicines.
 Unaffordable medicines. Where medicines are too costly, people may not purchase
a full course of treatment or may not purchase the medicine at all. Instead they may
seek alternatives, such as medicines of non-assured quality from the Internet or other
sources, or medicines prescribed to family or friends.
 Lack of coordinated national pharmaceutical policy. Less than half of all
countries implement the basic policies recommended by World Health Organization

(WHO) to ensure the appropriate use of medicine. These include appropriate
measures and infrastructure for monitoring and regulation of medicine use, and
training and supervision of prescribing health workers.
The major forces can be categorized as those deriving from patients, prescribers, the
workplace, the supply system including industry influences, regulation, drug
information and misinformation, and combinations of these factors (52).

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Table 1: Factors contributing to inappropriate use of drugs
Patients - drug misinformation

- misleading beliefs
- patient demands/expectations
Prescribers - lack of education and training
- inappropriate role models
- lack of objective drug information
- generalization of limited experience
- misleading beliefs about drugs efficacy
Workplace - heavy patient load
- pressure to prescribe
- lack of adequate lab facility
- insufficient staffing
Drug Supply System - unreliable suppliers
- drug shortages
- expired drugs supplied
Drug Regulation - nonessential drugs available
- informal prescribers
- lack of regulation enforcement
Industry - promotional activities
- misleading claims
All of these factors are affected by changes in national and global practices (46, 47,
48).
3.2.4 Impact of Inappropriate Use of Drugs
The impact of irrational use of drugs can be seen in many ways:
 Reduction in the quality of drug therapy leading to increased morbidity and

mortality
 Waste of resources leading to reduced availability of other vital drugs and

increased costs

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 Increased risk of unwanted effects such as adverse drug reactions and the
emergence of drug resistance, e.g., malaria or multiple drug resistant tuberculosis
 Psychosocial impacts, e.g. when patients come to believe that there is “a pill for
every ill.” This may cause an apparent increased demand for drugs (51).

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3.3 Current Scenario of Prescribing
Indian markets are flooded with over 70,000 formulations, compared to roughly 350
preparations listed on the WHO Essential Drugs List (53). There are thousands of
drug companies, and several companies manufacture generic preparations using
different brand names. In addition, thousands of formulations of vitamins, tonics, and
multi-drug combinations that are unique to the Indian market are manufactured and
marketed regularly.
A visit to the physician has come to necessarily mean a prescription comprising of a

broad-spectrum combination of antibiotics — one or more, an anti pyretic or
frequently an unnecessary combination of the two drugs, a multivitamin tonic, and a
cough syrup. Intravenous, rehydration, and parenteral medication are also used
frequently (54).
Worldwide, more than half of all medicines are prescribed, dispensed, or sold
unacceptably, and 50% of patients take them wrongly. Moreover, about one third of
the world’s population lacks access to essential medicines (55). A survey conducted
in 8 hospitals in southern Ethiopia that investigated their prescription patterns
concluded that irrational prescribing, as evidenced by high average number of drugs
prescribed per encounter, high percentage of injections, and high percentage of
antibiotic use, was prevalent in the studied region (56). It is obvious that irrational
prescribing is a global problem. Bad prescribing habits lead to ineffective and unsafe
treatment, exacerbation or prolongation of illness, distress and harm to the patient,
and higher costs. Irrational prescribing patterns are perpetuated through patient
pressure, bad example of colleagues, and high-powered salesmanship by drug
company representatives. In teaching hospitals, new graduates will copy from seniors,
completing the vicious circle. Changing existing practice of prescribing habits
becomes very difficult (57). Assessment of drug use patterns with the WHO drug use
indicators is becoming increasingly necessary to promote rational drug use in
developing countries (48, 58). Physician prescribing is the most frequent medical
intervention with a highest impact on healthcare costs and outcomes. Therefore
improving and promoting rational prescribing is of great interest. In a study a four-
arm randomized trial with economic evaluation was conducted in Tehran. Three
interventions (routine feedback, revised feedback, and printed educational material)
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and a no intervention control arm were compared. Physicians working in outpatient
practices were randomly allocated to one of the four arms using stratified randomized
sampling. The interventions were developed based on a review of literature, physician
interviews, and current experiences in Iran and with theoretical insights from the
Theory of Planned Behavior. Effects of the interventions on improving antibiotic and
corticosteroid prescribing were assessed using regression analyses. Cost data was
assessed from a health care provider’s perspective and an incremental cost-
effectiveness ratio was calculated (58). The another study by Soleymani et al
determined the effectiveness and cost-effectiveness of three interventions and
determined the most effective interventions in improving prescribing pattern. Study
concluded that if the interventions are cost effective, they would likely to be applied
nationwide (59).
Before activities to promote rational drug use are started, an effort should be made to
describe and quantify the situation. Several well-established survey methods are
available for this purpose. One assessment method is a prescribing and patient care
survey using the WHO health facility drug use indicators. These quantitative
indicators are now widely accepted as a global standard for problem identification and
have been used in over 30 developing countries (60). Prescribing patterns need to be
evaluated periodically to increase the therapeutic efficacy, decrease adverse effects
and provide feedback to prescribers (61).
3.3.1 The problem of irrational use
Irrational use is the use of medicines in a way that is not compliant with rational use
as defined earlier. Worldwide more than 50% of all drugs are prescribed, dispensed,
or sold inappropriately, while 50% of patients take them incorrectly. Moreover, about
one-third of the world’s population does not have access to essential medicines. This
incorrect use of medicine may take the form of overuse, underuse and misuse of
prescription or non-prescription drugs. In developing countries, the proportion of
patients managed as per clinical guidelines for common diseases in primary care is
less than 40% in the public sector as well as 30% in the private sector. Common
types of irrational medicine use are: the use of more than two medicines per patient
(polypharmacy), inappropriate use of antimicrobials, often in inadequate dosage, for
non-bacterial infections, over-use of injections when oral formulations would be more

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appropriate, failure to prescribe in accordance with clinical guidelines and
inappropriate use of self-medications (61). Finally, irrational over-use of medicines
can stimulate inappropriate patient demand, and lead to reduced access and attendance
rates due to medicine stock-outs and loss of patient confidence in the health system
(62).
3.3.1.1 Consequences of incorrect use of medicines
Incorrect use of medicines occurs in all countries, causing harm to people and wasting
resources. Consequences include:
a) Antimicrobial resistance. Overuse of antibiotics increases antimicrobial

resistance and the number of medicines that are no longer effective against
infectious disease. Many surgical procedures and cancer therapies are not
possible without antibiotics to fight infection. Resistance prolongs illnesses
and hospital stays, and can even cause death, leading to costs of US$ 4–5
billion per year in the United States of America (63) and €9 billion per year in
Europe (64).
b) Adverse drug reactions and medication errors. Harmful reactions to medicines
caused by wrong use, or allergic reactions to medicines can lead to increased

illness, suffering and death. Adverse drug reactions have been estimated to
cost millions of dollars each year (65, 66).
c) Lost resources. Between 10–40% of national health budgets are spent on

medicines. Out-of-pocket purchases of medicines can cause severe financial
hardship to individuals and their families. If medicines are not prescribed and
used properly, billions of dollars of public and personal funds are wasted.
d) Eroded patient confidence. Exacerbated by the overuse of limited medicines,
drugs may often go out of stock or be available at unaffordable prices and as a

result, erode patient confidence. Poor or negative health outcomes due to
inappropriate use of medicines may also reduce confidence (66).

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3.4 Measures to Improve Rational Use of Medicines
Rational use of drugs is multifaceted. Its medical, social, and economic aspects are
well reflected in the World Health Organization (WHO) definition: “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, at
the lowest cost to them and their community” (47, 53).
A major step towards rational use of medicines was taken in 1977, when WHO
established the 1 st Model List of Essential Medicines to assist countries in formulating
their own national lists. The present definition of rational use was agreed at an
international conference in Kenya in 1985. In 1989, the International Network for the
Rational Use of Drugs (INRUD) was formed to conduct multi-disciplinary
intervention research projects to promote more rational use of medicines. Following
this, the WHO/INRUD indicators to investigate drug use in primary health care
facilities were developed and many intervention studies conducted. A review of all
the published intervention studies with adequate study design was presented at the 1st
International Conference for Improving the Use of Medicines (ICIUM) in Thailand in
1997 (47).
The effect varied with intervention type, printed materials alone having little impact
compared to the greater effects associated with supervision, audit, and group process
and community case management. Furthermore, the effects of training were variable
and often unsustained, possibly due to differences in training quality and the presence
or absence of follow-up and supervision (47).
3.4.1 Training courses related to the rational use of medicines (66)

 Promoting the rational use of drugs (medicines), in collaboration with the
International Network for the Rational Use of Drugs (INRUD) coordinated by
Management Sciences for Health, USA. This course teaches the investigation
of medicine use in primary health care and how to promote rational use of
medicines by providers.

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 Promoting rational drug (medicine) use in the community, in collaboration
with the University of Amsterdam, The Netherlands. This course teaches the
investigation of medicine use in the community, and how to promote rational
use of medicines by consumers. The National Health Policy 2002 of India also
emphasizes on the rational use of drugs within the modern medicine system,
along with increased access to systems of traditional medicine (67).
 Drugs and therapeutics committees, in collaboration with the Rational
Pharmaceutical Programme coordinated by Management Sciences for Health,
USA. This course teaches methods for evaluating medicine utilization and
how to promote rational use of medicines in hospitals and districts.
 Problem-based pharmacotherapy teaching, in collaboration with Groningen
University, The Netherlands, the University of Cape Town, South Africa, the
University of La Plata, Argentina (in Spanish) and the National Centre for
Pharmacovigilance, Ministry of Health, Algiers, Algeria (in French). This
course teaches a problem-based approach to rational prescribing based on
WHO’s Guide to Good Prescribing (68).
 Pharmacoeconomics, This course teaches how to do economic evaluation in
medicine selection.
 Drug (medicine) policy issues for developing countries, in collaboration
with Boston University, USA. This course teaches about general medicines
policy including aspects relating to promoting more rational use of medicines.
 ATC/DDD methodology for medicine consumption, in collaboration with
the WHO Collaborating Centre for Drug Statistics Methodology. This course
provides an introduction to the application of ATC/DDD methodology in
measuring medicine consumption (69) International Network for the Rational
Use of Drugs (51).
 Electronic Prescribing- The era of e-prescribing has begun. Its
implementation is still expensive, but the subsequent benefits to patients and
savings in personnel costs, along with its integration with electronic medical
records, drug inventory control, and billing, point to the wide use of e-
prescribing in the future. Computerized prescription ordering eliminates some
of the subjective features of prescribing. Thus, if the proper information is
entered correctly in the electronic system, medication errors due to illegible
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handwriting, incorrect dose, incorrect medication for medical condition, and
drug interactions can be reduced, because each prescription can be linked to
high-quality drug databases that check that the information on the prescription
is appropriate for the patient (e.g., age, weight, gender, condition, lab values,
disease being treated, concurrent medications) and that known warnings and
potential problems are brought to the attention of the physician, pharmacist,
and patient. Such systems must not be used as a substitute for personal
attention to the individual patient by healthcare workers but, rather, as an
adjunct measure that ensures safe, high-quality, efficient care (70).
Saeed et al have highlighted that there was high incidence of irrational
prescribing practices that increased with the total number of drugs per
prescription. Irrational therapy needs to be identified and weeded out. The
results of study call for interventional strategies to promote rational drug
therapy (70).
3.4.2 WHO activities to improve rational use of medicine (71)
To improve rational medicine use, WHO:
 monitors global medicine use and pharmaceutical policy;
 provides policy guidance and support to countries in monitoring medicine use

and to develop, implement and evaluate national strategies to promote rational
use of medicines;
 develops and delivers training programmers’ to national health professionals

on how to monitor and improve medicines use at all levels of the health
system (55).
3.4.3 Core policies to promote more rational use of medicines

Although many gaps remain in our knowledge, a summary of what is known
concerning core policies, strategies and interventions to promote more rational use of
medicines are as below:
Twelve core interventions to promote more rational use of medicines (55)

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1. A mandated multi-disciplinary national body to coordinate medicine use
policies
Many societal and health system factors, as well as professionals and many others,
contribute to how medicines are used. Therefore, a multi-disciplinary approach is
needed to develop, implement and evaluate interventions to promote more rational use
of medicines. A national regulatory authority (RA) is the agency that develops and
implements most of the legislation and regulation on pharmaceuticals. Ensuring
rational use will require many additional activities which will need coordination with
many stakeholders. Thus a national body is needed to coordinate policy and strategies
at national level, in both the public and private sectors. The form this body takes may
vary with the country, but in all cases it should involve government (ministry of
health), the health professions, academia, the RA, pharmaceutical industry, consumer
groups and non-governmental organizations involved in health care. The impact on
medicine use is better if many interventions are implemented together in a
coordinated way, single interventions often having little impact.
2. Clinical guidelines
Clinical guidelines (standard treatment guidelines, prescribing policies) consist of
systematically developed statements to help prescribers make decisions about
appropriate treatments for specific clinical conditions. Evidence-based clinical
guidelines are critical to promoting rational use of medicines. Firstly, they provide a
benchmark of satisfactory diagnosis and treatment against which comparison of actual
treatments can be made. Secondly, they are a proven way to promote more rational
use of medicines provided they are: (1) developed in a participatory way involving
end-users; (2) easy to read; (3) introduced with an official launch, training and wide
dissemination; and (4) reinforced by prescription audit and feedback. Guidelines
should be developed for each level of care (ranging from paramedical staff in primary
health care clinics to specialist doctors in tertiary referral hospitals), based on
prevalent clinical conditions and the skills of available prescribers. Evidence-based
treatment recommendations and regular updating help to ensure credibility and
acceptance of the guidelines by practitioners.
3. Essential Medicines List based on treatments of choice
Essential medicines are those that satisfy the priority health care needs of the
population. Using an essential medicines list (EML) makes medicine management

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easier in all respects; procurement, storage and distribution are easier with fewer
items, and prescribing and dispensing are easier for professionals if they have to know
about fewer items. A national EML should be based upon national clinical guidelines.
Medicine selection should be done by a central committee with an agreed membership
and using explicit, previously agreed criteria, based on efficacy, safety, quality, cost
(which will vary locally) and cost-effectiveness. EMLs should be regularly updated
and their introduction accompanied by an official launch, training and dissemination.
Public sector procurement and distribution of medicines should be limited primarily
to those medicines on the EML, and it must be ensured that only those health workers
approved to use certain medicines are actually supplied with them. Government
activities in the pharmaceutical sector (e.g. quality assurance, insurance
reimbursement policies and training), should focus on the EML. The WHO Model
List of Essential Medicines can provide a starting point for countries to develop their
own national EML. The latest edition of WHO EDL is October, 2013 (72) and
Current National Essential drug list available in India is 2011(73).
4. Drugs and therapeutics committees in districts and hospitals

A drugs and therapeutics committee (DTC), also called a pharmacy and therapeutics
committee, is a committee designated to ensure the safe and effective use of
medicines in the facility or area under its jurisdiction. Such committees are well-
established in industrial countries as a successful way of promoting more rational,
cost effective use of medicines in hospitals. Governments may encourage hospitals to
have DTCs by making it an accreditation requirement to various professional
societies. DTC members should represent all the major specialties and the
administration; they should also be independent and declare any conflict of interest. A
senior doctor would usually be the chairperson and the chief pharmacist, the secretary.
Factors critical to success include: clear objectives; a firm mandate; support by the
senior hospital management; transparency; wide representation; technical
competence; a multidisciplinary approach; and sufficient resources to implement the
DTC’s decisions.
The operation of Drug and therapeutics committee (DTC) in health establishments has
become a norm to ensure good management and rational use of drugs. The availability

Page 26
of functional DTC in hospitals is a prerequisite for accreditation in the USA, and
almost all hospitals in Australia and United Kingdom have DTCs.
5. Problem-based training in pharmacotherapy in undergraduate curricula

The quality of basic training in pharmacotherapy for undergraduate medical and
paramedical students can significantly influence future prescribing. Rational
pharmacotherapy training, linked to clinical guidelines and essential medicines lists,
can help to establish good prescribing habits. Training is more successful if it is
problem-based, concentrates on common clinical conditions, takes into account
students’ knowledge, attitudes and skills, and is targeted to the students’ future
prescribing requirements. The Guide to Good Prescribing is a publication that
describes the problem-based approach, which has been adopted in a number of
medical schools.
Clinical pharmacology and therapeutics (CPT) envisages undergraduate (UG) medical
students being able to plan, select, communicate, and guide patients throughout their
illness to use medicines and other devices. The main objective of CPT is to impart
knowledge, skills, and attitudes so that a student is able to check risk benefit ratio of
treatment along with cost-effectiveness, understand the sources of variability in
responses to medicine, best prescribing decisions on sound evidence, and monitor
medicine effects appropriately (74).
It develops the premise that a thorough understanding of basic principles translates
into good prescribing, and lists essential attributes for prescribers under three
headings concerning the use of drugs: knowledge, understanding, skills, and attitudes.
This curriculum should form the basis of teaching better prescribing at all UK medical
schools, and elsewhere could be adapted to local needs (75).
It includes the establishment of local student formularies as a teaching tool, a concept
that could be extended to the training of junior hospital doctors and other prescribers.
The uses of problem-based, computer-aided, and web-based teaching -learning in
other countries have been discussed (76). No single intervention can be relied upon to
improve prescribing, and a combination of multiple interventions may be required
(77). However, education must be the kingpin. An educational intervention program
led by the practicing pharmacist will be considered and applied (78). The impact
evaluation of such program will be done by detecting level of errors before and after

Page 27
each intervention (79).Clinical pharmacology and therapeutics education has been
integrated progressively into the UG curricula of many countries, such as the US, UK,
India, Nepal, and the Netherlands (80-84).
The process of rational therapy- A good scientific experiment follows a rather rigid
methodology with a definition of the problem, a hypothesis, an experiment, an
outcome and a process of verification. This process, and especially the verification
step, ensures that the outcome is reliable. The same principles apply when you treat a
patient. First we need to define carefully the patient's problem (the diagnosis). After
that, specify the therapeutic objective, and to choose a treatment of proven efficacy
and safety, from different alternatives. Then start the treatment, for example by
writing an accurate prescription and providing the patient with clear information and
instructions. After some time monitors the results of the treatment; only then we
will know if it has been successful. If the problem has been solved, the treatment can
be stopped. If not, then need to re-examine all the steps. Choose P-treatment on the
basis of efficacy, safety, suitability and cost (68)
The process of rational treatment
Step 1: Define the patient's problem

The Diagnosis/ based on symptoms
Step 2: Specify the therapeutic objective

What do you want to achieve with the treatment?
Step 3: Verify the suitability of your P-treatment

Check effectiveness and safety
Step 4: Start the treatment
Step 5: Give information, instructions and warnings
Step 6: Monitor (and stop) treatment (68)

6. Continuing in-service medical education as a licensure requirement

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Continuing in-service medical education (CME) is a requirement for licensure of
health professionals in many industrialized countries. In many developing countries
opportunities for CME are limited and there is also no incentives since it is not
required for continued licensure. CME is likely to be more effective if it is problem-
based, targeted, involves professional societies, universities and the ministry of health,
and is face-to-face. Printed materials that are unaccompanied by face-to-face
interventions, have been found to be ineffective in changing prescribing behavior.
CME need not be limited only to professional medical or paramedical personnel, but
may also include people in the informal sector such as medicine retailers. Often CME
activities are heavily dependent on the support of pharmaceutical companies, as
public funds are insufficient. This type of CME may not be unbiased. Governments
should therefore support efforts by university departments and national professional
associations to give independent CME.
It has been observed that some of the Medical Institutes in Gujarat have developed
and implemented changes in practical training in Pharmacology emphasizing
prescription writing skill (84).
7. Supervision, audit and feedback

Supervision is essential to ensure good quality of care. Supervision that is supportive,
educational and face to- face, will be more effective and better accepted by
prescribers than simple inspection and punishment. Effective forms of supervision
include prescription audit and feedback, peer review and group processes.
Prescription audit and feedback consists of analyzing prescription appropriateness and
then giving feedback. Prescribers may be told how their prescribing compares with
accepted guidelines or with that of their peers. Involving peers in audit and feedback
(peer review) is particularly effective. In hospitals, such audit and feedback is known
as drug use evaluation.
Assessing the problem of irrational use

To address irrational use of medicines, prescribing, dispensing and patient use should
be regularly monitored in terms of:
• Types of irrational use, so that strategies can be targeted towards changing specific
problems;

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• Amount of irrational use, so that the size of the problem is known and the impact of
the strategies can be monitored;
• Reasons why medicines are used irrationally, so that appropriate, effective and
feasible strategies can be chosen. People often have very rational reasons for using
medicines irrationally. There are several well-established methods to measure the type
and degree of irrational use. Aggregate medicine (drug) consumption data can be used
to identify expensive medicines of lower efficacy or to compare actual consumption
versus expected consumption (from morbidity data). Anatomical Therapeutic
Classification (ATC)/Defined Daily Dose (DDD) methodology can be used to
compare drug consumption among institutions, regions and countries. WHO drug use
indicators (69) can be used to identify general prescribing and quality of care
problems at primary health care facilities. Focused drug use evaluation (drug
utilization review) can be done to identify problems concerning the use of specific
medicines or the treatment of specific diseases, particularly in hospitals. The
qualitative methods employed in social science, (e.g. focus group discussion, in-depth
interviews, structured observation and structured questionnaires), can be used to
investigate the motives underlying irrational use. The data collected can then be used
to design appropriate interventions and to measure the impact of those interventions
on medicine use.
Group process approaches amongst prescribers consist of health professionals
themselves identifying a medicine use problem and developing, implementing and
evaluating a strategy to correct the problem. This process needs facilitation by a
moderator or supervisor.
According to a Cochrane Review, audit and feedback is defined as a summary of
health care performance over a specified period of time with or without
recommendations for a clinical action. Evidence from 118 randomized controlled
trials indicated that audit and feedback resulted in a modest improvement in care.
Grimshaw and colleagues undertook a comprehensive review of the effects of using
different strategies for implementing guidelines. They found that audit and feedback
alone or combined with educational meetings and materials result in a modest
improvement in the implementation of guidelines in comparison to no intervention
group (85, 86). Other study concluded that constant review of the teaching and
evaluation methods through feedback from students and modification of the

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methodologies is very important for planning the undergraduate medical curriculum
(87).
8. Independent medicine information
Often, the only information about medicines that practitioners receive is provided by
the pharmaceutical industry and may be biased. Provision of independent (unbiased)
information is therefore essential. Drug information centers (DICs) and drug bulletins
are two useful ways to disseminate such information. Both may be run by government
or a university teaching hospital or a nongovernmental organization, under the
supervision of a trained health professional. Whoever runs the DIC or bulletins must
(1) be independent of outside influences and disclose any financial or other conflict of
interest, and (2) use evidence-based medicine and transparent deduction for all
recommendations made. The WHO Model Formulary provides independent
information on all medicines in the WHO Model List of Essential Medicines. Drug
information is the provision of written and/or verbal information about drugs and drug
therapy in response to a request from other healthcare providing organizations,
committees, patients, and public community. Drug information services refer to the
activities undertaken by pharmacists in providing information to drug use (88).
Poor drug regulations and lack of independent, unbiased drug information are the
main contributing reasons for irrational drug use in India. About 40% of the health
care service's budget is consumed by medicines and with a limited resource available,
it becomes essential to promote rational drug use (47).
9. Public education about medicines
It is obvious that without adequate knowledge about the risks and benefits of using
medicines and when and how to use them, people will often not get the expected
clinical outcomes and may suffer adverse effects. This is true for prescribed
medicines, as well as over-the-counter medicines. Governments have a responsibility
to ensure both the quality of medicines and the quality of the information about
medicines available to consumers. This will require:
• Ensuring that over-the-counter medicines are sold with adequate labeling and
instructions that are accurate and legible, understood by laypersons. The information
should include the medicine name, indications, contra-indications, dosages, drug
interactions, and storage.

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• Monitoring and regulating advertising, which may adversely influence consumers as
well as prescribers, and which may occur through television, radio, newspapers and
the internet (71).
• Education about the use of medicines may be introduced into the health education
component of school curricula or into adult education programmers such as literacy
courses. In India government and regulatory health care amenities developed certain
health care awareness programmes like TB awareness programmes, ORS promotions
for diarrhea treatment. They are in place and in touch with community through audio
visual means (Television advertisements), through banner and display at government
hospitals.
10. Avoidance of perverse financial incentives
Financial incentives may strongly promote rational or irrational use. Examples
include:
• Prescribers who earn money from the sale of medicines (e.g. dispensing doctors),
prescribe more medicines, and more expensive medicines, than prescribers who do
not; therefore the health system should be organized so that prescribers do not
dispense or sell medicines.
• Flat prescription fees, covering all medicines in whatever quantities within one
prescription, lead to over prescription; therefore user charges should be made per
medicine, not per prescription.
• Dispensing fees, calculated as a percentage of the cost of the medicines, encourage
the sale of more expensive medicines; therefore a flat dispensing fee irrespective of
the price of the medicine is preferable. Although it may increases cost of cheaper
medicines and it lowers the price of higher cost medicines.
Patients prefer medicines that are free or reimbursed. If only essential medicines are
provided free by government or reimbursed through insurance so patients will
pressure prescribers to prescribe only essential medicines. If medicines are only
reimbursed when the prescription conforms to clinical guidelines, there may be an
even stronger pressure on prescribers to prescribe rationally (67).
11. Appropriate and enforced regulation
Regulation of the activities of all actors involved in the use of medicines is critical to
ensuring rational use. If regulations are to have any effect, they must be enforced, and

Page 32
the regulatory authority must be sufficiently funded and backed up by the judiciary
(67).
12. Sufficient government expenditure to ensure availability of medicines and
staff
Lack of essential medicines would lead to the use of nonessential medicines, and lack
of appropriately trained personnel leads to irrational prescribing. Furthermore,
without sufficient competent personnel and finances, it is impossible to carry out any
of the core components of a national programme to promote rational use of medicines.
Poor clinical outcome, needless suffering and economic waste are sufficient reasons
for large government investment.
Governments are responsible for investing the necessary funds to ensure that all
public health facilities have sufficient, appropriately trained health professionals and
enough essential medicines at affordable prices for all the population. Achieving these
will require limiting government procurement and supply to essential medicines only,
and investing in adequate training, supervision and health staff salaries (67).
Regulatory measures to support rational use
• Registration of medicines to ensure that only safe efficacious medicines of good
quality are available in the market and that unsafe non-efficacious medicine are
banned;
• Limiting prescription of medicines by level of prescriber; this includes limiting
certain medicines to being available only with a prescription and not available over-
the-counter;
• Setting educational standards for health professionals and developing and enforcing
codes of conduct; this requires the cooperation of the professional societies and
universities;
• Licensing of health professionals – doctors, nurses, paramedics – to ensure that all
practitioners have the necessary competence with regard to diagnosis, prescribing and
dispensing;
• Licensing of medicine outlets – retail shops, wholesalers – to ensure that all supply
outlets maintain the necessary stocking and dispensing standards;
• Monitoring and regulating medicine promotion to ensure that it is ethical and
unbiased. All promotional claims should be reliable, accurate, truthful, informative,

Page 33
balanced, up-to-date, capable of substantiation and in good taste. WHO’s ethical
guideline (1988) may be used as a basis for developing control measures (67, 71).

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3.5 Why Do We Need Prescribing Quality Evaluation?
In spite of all measures developed at various stages like local, state, national &
international level, the situation still needs improvement and as reviewed previously
inappropriate or irrational prescribing is widespread all over the world. To improve
the situation further stringent continuous efforts will be required. The first step in this
direction would be to assess the quality of prescribing at local, state, national &
International level. Several tools have been developed and introduced from time to
time for this purpose. They ranged from simple tools (WHO core prescribing
indicators) to complex tools (Beer’s criteria, explicit criteria, Medication
Appropriateness Index).
3.5.1 Introduction to tools to assess quality of prescribing

During the last few decades there has been an increased focus on quality development
in medical care, and the area of pharmacotherapy and prescribing is no exception
from this general tendency. Using a slight modification of an existing well-established
definition, Lawrence, M. has define prescribing quality indicator as “a measurable
element of prescribing for which there is evidence or consensus that it can be used to
assess quality, and hence change in the quality, of treatment provided” (89). Quality
of drug treatment in this context can be considered equivalent to rational
pharmacotherapy, covering the aspects of effectiveness (maximizing benefit), safety
(minimizing harm), economy (minimizing costs or maximizing cost-effectiveness)
and patient acceptance of treatment (45). Quality indicators can be valuable tools both
in the hospital and primary care setting. This review will focus on prescribing quality
indicators in general practice.
A large number of candidate indicators of prescribing quality based on register
data have been constructed and validated by consensus methods. Few studies have
systematically analyzed other validity aspects of these indicators. (90). Indicators are
used for a number of different purposes, covering quality management in a broad
sense. At the professional level, physicians use indicators for quality development and
educational activities, assisting learning processes (91). The indicators or tools are
used by researchers to evaluate interventions, for example in experimental
randomized studies testing new methods for changing prescribing behavior (92).
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Finally, indicators are increasingly used by administrators of the health system for
monitoring quality, screening for quality problems, benchmarking and providing
feedback to physicians (90).
Different types of drug use studies evaluating the quality of prescribing are reported
from all over the world (8). However, one of the great limitations in measuring the
quality of prescription is lack of a method that is sufficiently valid and reliable to
allow systematic use in clinical setting (8). Various measures have been developed to
evaluate prescribing quality, e.g. explicit indicators (26, 27) like The Medication
Appropriateness Index (MAI) developed by Hanlon et al. (28) at Duke University
Medical Centre (Durham, NC, USA) to evaluate the appropriateness of medication
use in individual patients has been found to be reliable and valid in a number of
clinical settings, WHO prescribing indicators, it has been formulated as a set of "Core
drug use indicators" namely prescribing indicators, patient care indicators and facility
indicators (29) and multidimensional indicators, it includes multidisciplinary
medication review (28, 30).
The Swedish National Board of Health and Welfare has established explicit indicators
for evaluation of drug therapy among elderly patients (31). For geriatric prescribing,
several criteria or tools are used. Beers' criteria include explicit (criterion-based) or
implicit (judgement-based) prescribing indicators (29) for evaluating prescribing
practice for elderly patients. More recently, the STOPP (Screening Tool of Older
Persons' potentially inappropriate Prescriptions) criteria were validated in a European
setting (30) and the START (Screening Tool to Alert doctors to the Right Treatment)
criteria, which highlight under prescription or omission of clinically indicated,
evidence based medications (31), for evaluating quality of prescribing to elderly were
introduced but they are not specifically designed to address the multiple problems
associated with prescription quality(8).
However, there is no universal definition of medication appropriateness, because

quality may be assessed in different ways, depending on data available (prescription
database vs. individual assessments), setting, and comprehensiveness. Most of
measures are based on expert judgment of practitioners or consensus (93, 97, 34-36),
without information on the psychometric properties of the instruments. Thus there is
Page 36
a lack of a single tool that will capture all facets of prescription quality and which is
applicable for measurement of prescription quality in chronic diseases, especially
those with multiple co morbidities (8).
Elderly patients are at high risk of drug-related problems, for several reasons: age-
related changes in the pharmacokinetics and pharmacodynamics of medicines; higher
incidence of polymedication; lack of knowledge of the prescriber specific to the use
of medicines in the elderly; frequent cognitive and physical impairment; multiple
prescribers. There is strong evidence from the literature that use of medicines in that
population is often far from ideal. More than 50% of adverse drug events are
potentially preventable. Opportunities for improvement can occur at several steps of
medication use process (prescription, administration, follow-up, education, and
compliance) (94, 95).
3.5.2 Brief Introduction to Various Indicators and tools
Prescribing indicators are commonly used in the public sector to gain an impression
of a quality of services. If they are developed and used appropriately they can help to
identify potential problems and encourage quality improvement and/ or improved
safety. In the UK, there is a long history of indicators being used to show how
prescribing performance of NHS general practices might compare with other
practices, local and national averages or with themselves over time. The National
Prescribing Centre and the Prescribing Indicators National Group recommend that
prescribing indicators should:
 be based on scientific evidence and supplemented in a systematic way by
expert opinion
 cover a range of process and outcome measures
 represent areas where change is largely within the control of the clinician
 represent areas of practice that are regarded as important by clinicians and
consistent with national health policy initiatives
 represent areas of practice where the most important case mix and risk
adjustment factors are known and data about them can be collected
 be based on clinical data that:
-should be recorded by clinicians as part of the process of clinical care
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- should be electronically recorded in clinical records using current clinical
terminologies and codes
- can be extracted in a timely manner
- are sensitive to changes in quality of care
- can be easily checked for validity and reliability (96).
Indicators based on the use of GP prescribing data continue to be employed regularly

in the UK, and continue to form part of local prescribing incentive schemes.
Nevertheless, while potentially extremely useful for analyzing prescribing patterns,
these data are rarely linked to diagnoses and patient characteristics and so they have
limitations when assessing quality and safety. Other indicators have required very
detailed analysis and assessment of clinical records e.g. the medication
appropriateness index (97). These are potentially very useful for research purposes,
but are not feasible for the large-scale assessment GP prescribing.
A major advance in recent years in terms of developing and using more sophisticated
indicators of quality and safety of prescribing has involved the interrogation of
electronic medical records. This has come about because of considerable
improvements in the quality and completeness of electronic records in general
practices, and also due to developments in the ability to run electronic searches and
analyze the results across large numbers of practices. Table 2 summarizes some of the
indicators.

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Table 2: Tools for prescribing quality assessment
Indicator /Tool Content Type / Method Strength Limitation
WHO core 5 Indicators Explicit data expressed as Cover limited
Prescribing (criterion-based) percentage, mean and parameters of
Indicator s(29) total numbers appropriate therapy
reliability is lower
when assessed by
researchers different
from the authors
Medication 10 Criteria Implicit Addresses all Requires expertise in
Appropriateness (judgment-based) medications geriatric medicine
Index (28) Variable inter-rater
Measures the Addresses multiple reliability
appropriateness of aspects of prescribing
prescribing for Time consuming (10
elderly patients Does not require min per medication)
regular updating
38 Indicators Delphi Validation A Canadian initiative, limited applicability to

McLeod (1997)
Explicit were developed geriatric clinical
(98)
(criterion-based) following the Beers practice
criteria 1991, based
on risk-benefit ratios,
drug-drug interactions
and
drug-disease
interactions, and
describing 38
prescribing practices
IPET 2000 14 different Based on does not address the
Improving drug/disease McLeod Criteria occurrence of potential
Prescribing in the interactions prescribing omissions
Elderly Tool -

Page 39
Canadian guideline not been widely or
which was derived extensively used
from the criteria
developed by
McLeod et al.,
Beers criteria 42 Indicators Delphi Validation Relatively quick to use Need regular updating
(27) (updated in Explicit Some criteria do not Address a limited range
2003) for (criterion-based) require clinical data of medications
potentially and can be applied to Do not address all
inappropriate large prescribing aspects of prescribing,
medication use in databases e.g.duration of therapy
older adults Do not take into
Recently updated in Can be used as account patient’s
2012 indicators of quality of clinical
care situation, e.g. life
expectancy
Can be integrated into
decision support May not be easily
software transferable between
Countries
STOPP/START STOPP – 65 Explicit

(33) criteria Delphi validation
Developed to assess START- 22
the appropriateness Criteria
of prescribing for
older people Widely used in
different settings to
study the prevalence
of inapprpriate
prescribing in the
older population
ACOVE (Assessing 102 aimed to develop a set
Care of Vulnerable indicators of evidence-based,
Elders) quality of care
(99) UK and the indicators relevant to
Netherlands vulnerable older
people

Page 40

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 Indicators that focus primarily on elderly potential prescribing safety:
ACOVE (Assessing Care of Vulnerable Elders) – this RAND project aimed to

develop a set of evidence-based, quality of care indicators relevant to vulnerable older
people using systematic literature reviews, expert opinion and guidance from expert
groups and stakeholders. The indicators have been considered for use in the UK and
the Netherlands. A multidisciplinary panel of 10 health professionals in the UK
accepted 102 (86 per cent) of the 119 quality indicators as being valid for use in
England (99).
PINCER trial indicators – a cluster randomized trial took place in the UK between
2005 and 2009 to assess a pharmacist-led intervention versus simple feedback in
correcting clinically important problems in medicines management in general
practices in England (100). This was a parallel-group, pragmatic, cluster trial in which
72 general practices in England were randomized to either: (1) computer-generated
feedback (‘simple feedback’) in which practices were asked to make changes to
patients’ medication within a 12-week period, or (2) the pharmacist-led intervention
comprising computer-generated feedback, educational outreach and dedicated
support. The pharmacist-led complex intervention was successfully delivered in all 36
general practices. Preliminary results indicate that compared with simple feedback,
the pharmacist-led intervention resulted in reductions in the proportion of patients at
risk of prescribing and monitoring errors (100).
STOPP and START tools (Gallagher et al 2008) – these sets of indicators have been
developed to assess the appropriateness of prescribing for older people (the STOPP
tool relates to potentially inappropriate drugs and the START tool relates to
potentially indicated appropriate drugs). The tools have been developed and validated
by a team from Cork, Republic of Ireland (33).
The Medication Appropriateness Index: (MAI) measures the appropriateness of

prescribing for elderly patients, using 10 criteria for each medication prescribed. For

Page 42
each criterion, the evaluator rates whether the medication is appropriate, marginally
appropriate, or inappropriate. Support is provided through explicit definitions and
instructions. The MAI has been used in observational and interventional studies. Its
feasibility, content validity, predictive validity, and reliability have been demonstrated
in ambulatory settings. Its limitations are that reliability was lower when assessed by
researchers different from the authors and that the original instrument does not
address some areas (drug allergy, adverse drug reactions, compliance) (28).
Table 3: Medication Appropriateness Index
Explicit criteria
Several studies have been conducted to determine and formulate lists of explicit
criteria.

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 McLeod criteria
McLeod et al. developed a Canadian consensus-based, explicit list of criteria to
identify PIP in older patients in 1997. The criteria were validated by a panel of 32
experts in geriatric pharmacotherapy from diverse locations in Canada and consisted
of clinical pharmacologists, geriatricians, GPs and pharmacists. The final list of
criteria contains 38 scenarios of PIP (18 medications contraindicated in older adults,
16 drug-disease interactions and 4 drug-drug interactions that should be avoided in the
older person) (McLeod et al. 1997). The criteria are divided into four main headings:
medicines for the Cardiovascular System (CVS) (n=8), psychotropics (n=12), non-
steroidal anti-inflammatory drugs (NSAIDs) (n=11) and miscellaneous (n=7). Each
criterion was qualified with a statement of a risk to patients and an alternative therapy
was suggested. This screening tool did not address under-prescribing of indicated
medicines (PPOs) and did not state medication dosages that should be avoided in
older patients (98).
 Improving Prescribing in the Elderly Tool (IPET)
Naugler et al. formulated the Improving Prescribing in the Elderly Tool (IPET) (99).
It is a Canadian guideline which was derived from the criteria developed by McLeod
et al., based on the most prevalent instances of PIP found in a geriatric unit using the
McLeod criteria. IPET lists 14 different drug/disease interactions which should be
avoided in the older person but does not address the occurrence of potential
prescribing omissions (PPOs). This tool has not been widely or extensively used in
determining PIP, possibly owing to its brevity and that one of the listed instances of
PIP has been superseded with newer evidence i.e. it states that β blockers should not
be used in patients with CCF (98).
 Beers’ Criteria
Beers’ criteria, a United State (US) based guideline, was originally formulated in
1991 (Beers et al. 1991). This screening tool contains a list of 30 medicines that
should not be used in older patients. It was compiled for nursing home residents who
are considered frailer, older and sicker than the general elderly population. The
authors therefore cautioned that modifications may be necessary if the criteria were to
be applied to older patients in a non-nursing home setting. The 1991 criteria were

Page 44
updated and expanded in 1997 to make the criteria more applicable to the general
older population (26).
The guidelines consist of two different lists or situations in which medicines should
be avoided; one considering diagnosis (CD) and one independent of diagnosis (ID).
Doses or frequencies of administrations that should not be exceeded were also listed.
The 1997 criteria were revised and updated in 2003 (27). A 12- member expert panel
consisting of psycho-pharmacologists, pharmacoepidemiologists, clinical geriatric
pharmacologists and clinical geriatricians from diverse geographical locations in the
US completed the study which used a modified Delphi technique to reach consensus
for each criterion. Eleven criteria that were listed in the 1997 tool were excluded from
the 2003 list, one from the ID lists (phenylbutazone) and ten from the CD lists.
Twenty five medicines were added to the ID list and 19 were added to the CD list.
Four criteria were modified. The new criteria list 48 medicines ID and 20 medicines
CD that should be avoided. It also rates the severity of the PIM into instances of “high
severity” or “low severity” and provides a qualifying statement as to why the scenario
is considered potentially inappropriate. Beers’ criteria do not address errors of
prescribing omission and list several medicines as inappropriate that are not available
or prescribed in Northern Ireland and the Republic of Ireland.
Beers criteria (Fick et al 2003) are a set of criteria from the US for assessing
potentially inappropriate medication use in people aged 65 years and older. The
original list of criteria was published in the 1990s and updated in 2003. Beers criteria
have been recently revised by American Geriatrics Society 2012 (101).
Screening Tool of Older People’s potentially inappropriate Prescriptions

(STOPP) and Screening Tool to Alert doctors to Right i.e. appropriate, indicated
but often omitted Treatments (START)
Screening Tool of Older People’s Prescriptions (STOPP) and Screening Tool to Alert
doctors to Right i.e. appropriate, indicated but often omitted Treatments (START)
were formulated collaboratively by the Department of Geriatric Medicine, Cork
University Hospital (CUH) and the School of Pharmacy, University College Cork
(UCC) (33). The new screening tool addresses common instances of PIP (STOPP)
and potential prescribing omissions (PPOs) (START). The STOPP tool lists 65
instances of PIP and is divided into ten sections according to the physiological

Page 45
systems to which the instances of PIP relate. The START tool lists 22 common
instances of PPOs divided into six physiological systems to which the PPOs pertain.
The initial list of criteria was formulated based on a combination of evidence and
common instances of PIP and PPOs observed throughout clinical working practice.
The STOPP and START tools were validated by the Delphi validation method.
Eighteen experts in geriatric pharmacotherapy from diverse geographical locations
throughout Ireland and the UK rated their level of agreement with each criterion on a
five-point Likert scale. Agreement was achieved by the first Delphi validation round
for all of the 22 criteria in the START tool and therefore all of these were included in
the final published version of the START tool. Two postal rounds of the STOPP tool
were required as the panel did not reach full consensus on the first round, the initial
STOPP tool contained 68 criteria and the final STOPP tool contained 65 criteria. A
number of studies have reported on the prevalence of IP in the older population from
different health care settings (33).
 Indicators that focus general prescribing quality:
National Patient Safety Agency (NPSA) documents – the NPSA has produced a
number of documents that are relevant to the safety of prescribing in primary care
(102). For example, the fourth report from the Patient Safety Observatory (103)
highlighted medication incidents in the community and at the interface between
community and hospital care and also suggested ways in which risks of harm could be
reduced. In addition, the NPSA has highlighted a number of specific safety issues
relevant to primary care including anticoagulant prescribing, dosing errors with opioid
medicines and the prescribing of methotrexate (NPSA 2009). A number of these
issues could be incorporated into indicators (102).
WHO prescribing indicators: the World Health Organization (WHO) in 1993 has
formulated a set of "Core drug use indicators" namely prescribing indicators, patient
care indicators and facility indicators. Among them, for this study only "prescribing
indicators" were taken which measure the performance of prescribers. The core
prescribing indicators are average number of drugs per prescription, percentage of
drugs prescribed by generic name, percentage of encounters with an antibiotic

Page 46
prescribed, percentage of encounters with an injection prescribed and percentage of
drugs prescribed from essential drug list or formulary.
Some additional indices are percentage of encounters with a NSAID prescribed,
percentage of encounters with an antiulcerant prescribed, percentage of encounters
with a calcium preparation prescribed and the data was expressed as percentage, mean
and total numbers (29).
Selected WHO/INRUD drug use indicators for primary health care facilities (WHO,
1993) (29)
Prescribing Indicators:
Average number of medicines prescribed per patient encounter
% medicines prescribed by generic name
% encounters with an antibiotic prescribed
% encounters with an injection prescribed
% medicines prescribed from essential medicines list or formulary
Patient Care Indicators:
Average consultation time
Average dispensing time
% medicines actually dispensed
% medicines adequately labeled
% patients with knowledge of correct doses
Facility Indicators:
Availability of essential medicines list or formulary to practitioners
Availability of clinical guidelines
% key medicines available
Complementary Drug Use Indicators:
Average medicine cost per encounter
% prescriptions in accordance with clinical guidelines

Page 47
3.6 Review of Relevant Studies
Table 4: Review of relevant studies
Sr. Studies Reported /findings Inference Authors

No related to (Reference
No)
1 Prescribing A total of 1,115 clinically significant prescribing errors Hospitalized patients are at risk for Timothy S
errors involving medication dosage forms were detected adverse outcomes due to prescribing Lesar .- 2002,
errors related to inappropriate use of (104)
medication dosage forms. This
information should be considered in
the development of strategies to
prevent adverse patient outcomes
resulting from such errors
2 Prescribing A total of 196 (89.9 %) MAEs were identified from the There is a need to modify the way Yemisirach
error 218 observations made. From these, 178 (90.8 %) information is handled and shared by Feleke et al.-
occurred with intravenous (IV) bolus medications while professionals as wrong time error was 2010, (105)
16 (8.2 %) of them pertained to oral medications. the most implicated error.
3 Prescribing Of all prescriptions collected, 21% (n = 373) contained at The physician's effort in determining Allen F et al.-
error least one error. Prescriptions with omissions accounted for the correct diagnosis and then 1989, (106)
39% of those with errors and 5% of all prescriptions. choosing the best medication for the
Jalpa Suthar/ID No. 10DRPHC001 Page 48

Errors in dosage or directions or incomplete directions patient and illness can be undermined
were found in 117 (6%) of the study prescriptions. by a written prescription with
erroneous intention of the prescriber
4 Prescribing Of the 226 medication errors, 99.12% were prescribing Pharmacists needed to prevent and to Dyah Aryani
error errors, 3.02% were pharmaceutical errors and 3.66% were overcome the medication errors et al. -2010,
dispensing errors. The most type of prescribing error was (107).
incomplete prescription orders.
5 Prescribing The medication errors were analyzed by means of Strong Intervention could be made by Sayali Pote et
error Micromedex Drug-Reax database. Of the 304 cases, 103 clinical pharmacist, and to begin al.-2007,
(34%) cases had at least one error. The total number of with, could confine to identification of (108)
errors found was 157. the medication errors
6 Prescribing Out of total 397 prescriptions screened, 96.7% had one or This indicates a need for pharmacy Kuan Mun Ni
error more of the legal or procedural requirements missing. and medical educators to further et al. -2002,
Additionally, 8.4% of the prescribed drugs had errors of emphasize the importance of writing (109)
commission. A total of 39 drug –drug interactions were clear and complete prescriptions. It
identified. also calls for the implementation of
educational and monitoring
programmes and hence minimize the
occurrence of prescribing errors.
7 Prescribing From a total of 6340 prescriptions, 43 prescriptions There should be the importance of Chua Siew

error (0.68%) required interventions by the pharmacy staff. prescription screening and Siang et al.-
These included 54% errors of omission and 46% that interventions by pharmacists in 2003, (110)
contained the wrong drug, dose regimen, strength and minimizing preventable adverse
dosage form (errors of commission). events attributed to medication errors.
8 Prescribing Out of 756 inpatients included, overall 23.9% of Values need to be improved by Laura
error prescriptions were illegible and 29.9% of prescriptions enhancing the safety culture. Bad Calligaris et
were incomplete. Legibility and completeness are higher prescription writing can be prevented al.-2009,
in unusual drugs prescriptions. The overall illegibility and through the awareness of the (111)
incompleteness (above 20%) were unacceptably high. professionals on the consequences
that happen with bad prescription
writing.
9 Prescribing The prescription error related to prescriber’s name, There is a need to critically address Ansari M et
error qualification, NMC registration number and signature the legibility of prescription, correct al.-2009,
were 85.4%, 99.6%, 99.6% and 15.7% respectively. spelling of drugs, authorized (112)
Similarly, the symbol Rx was missing in 66.8%. Dosage abbreviations and all other
form, quantity, dose, frequency and route of information of a prescription
administration were not mentioned in 12%, 60%, 19%, concerned with patient, prescriber and
10% and 63% of the prescriptions respectively. Likewise, drugs to minimize the occurrence of
strength of the prescribed medicines was not stated in 40% medication errors.
of the cases.

10 Patient error Authors synthesized the ideas that emerged from the The taxonomy is an early attempt to Stephen
nominal groups into taxonomy of patient errors. The understand and recognize how Buetow et
taxonomy is a 3-level system encompassing 70 potential patients may err and what clinicians al.-2009,
types of patient error. The first level classifies 8 categories should aim to influence so they can (113)
of error into 2 main groups: action errors and mental help patients act safely.
errors. The action errors, which result in part or whole
from patient behavior, are attendance errors, assertion
errors, and adherence errors. The mental errors, which are
errors in patient thought processes, comprise memory
errors, mindfulness errors, misjudgments, and—more
distally— knowledge deficits and attitudes not conducive
to health.
11 Prescribing Of 4238 prescriptions evaluated, one or more error was The electronic prescribing systems Seden K et
error observed in 1857 (43.8%) prescriptions, with a total of could potentially have prevented up to al.-2012,
3011 errors observed. Of these, 1264 (41.9%) were minor, a quarter of (but not all) errors. (114)
1629 (54.1%) were significant, 109 (3.6%) were serious
and 9 (0.30%) were potentially life threatening.
12 Prescribing Approximately 113 (7.1%) prescribing errors were Lack of knowledge of prescribing A.A. Al-
error detected during the study period out of 1580 medication skill was the main cause of such Dhawailie -

orders. Wrong strength (35%) and wrong administration errors. 2011 (115)
frequency (23%) of the prescribed drug were the most
errors encountered.
13 Rationality of A total of 4231 prescriptions were encountered with the A trend towards irrational prescribing Saurav
prescriptions total of 10591 drugs prescribed. The average number of and dispensing. Authors felt a need to Ghimire et
according to drug per prescription was 2.5. Only 13% (n= 10591) of be minimized by effective al.-2009,
WHO drugs were prescribed by generic name. Percentage of intervention programme. Also need to (116)
indicators drug prescribed from WHO model list of Essential drugs, encourage the physicians and
Essential drug list of Nepal and Nepalese National dispensing pharmacists in promoting
Formulary was 21.7%, 32.8% and 42.3% respectively. more rational drug use
Antibiotics and injections encountered were 28.3% and
3.1% respectively.
14 E- Study was conducted before and after involving Implementation of these commercial Westbrook JI
Prescribing medication chart audit of 3,291 admissions (1,923 at e-prescribing systems resulted in et al.-2012,
& its impact baseline and 1,368 post e-prescribing system) at two statistically significant reductions in (117)
on Australian teaching hospitals. In Hospital A, the Cerner prescribing error rates
prescribing Millennium e-prescribing system was implemented on one
errors ward, and three wards, which did not receive the e-
prescribing system, acted as controls. In Hospital B, the
iSoft MedChart system was implemented on two wards

and authors compared before and after error rates.

15 Rational use At baseline, more prescriptions from private hospitals had Prescriptions lacked details and most Obehi A and
of drugs- hospitals’ addresses (p=0.005) and patients’ ages were not clearly legible. Intervention Isah AO.-
interventional (p=0.015); more from public hospitals were signed resulted in modest changes, which in 2007, (118)
study (p=0.001) and 20% of prescriptions were clearly legible. public hospitals were more significant
Post-intervention, more prescriptions from public among doctors who had group
hospitals were signed (p=0.017); more from private seminars.
hospitals had the doses (p=0.04) and routes (p=0.05) of
administration, and the intervention group in private
hospitals wrote patients’ ages more frequently than
controls (p=0.05).
16 Rational use Total 200 prescriptions comprising of 92 prescriptions of Large number of prescriptions does K.U. Ansari
of drugs Private Sector and 108 prescriptions of Service Sector not conform to ideal pattern and lack et al.-1998,
according to were audited. In pediatric prescriptions (30% of the in their rationality. (11)
WHO paediatric prescriptions)85 % of prescriptions were
indicators without the age of the patient. Superscription was not
mentioned in 71% of the prescriptions. Inscription,
subscription and signature were inadequate in 50%, 18%
and 35% of the prescriptions, respectively. In more than
52 % prescriptions, drugs were inappropriately

administered. It was more common among the consultants

in P.S. (65%) than in S.S. (41%). Forty percent of the
prescriptions showed overprescribing. Polypharmacy was
more in P.S. (5.05 medications per prescription) than S.S.
(3.52).
17 Prescription Author had developed, validated and checked reliability of Nine indicators of prescribing Judith A
quality & indicators of the appropriateness of long term prescribing appropriateness were produced Cantrill et al-
prescribing in general practice medical records in the United suitable for application to the medical 1998, (119).
indicators
Kingdom. Consensus was reached on 30, from which 13 record of any patient on long term
indicators suitable for application were produced. medication in United Kingdom
general practice. Although the use of
the medical record has limitations.
18 Prescription The meeting was organized by the European Drug The state of the art of the development JL Hoven et
quality & Utilization Research Group (EuroDURG), the Belgian and application of prescribing quality al. -2005,
prescribing National Health Insurance Institute (RIZIV-INAMI), and indicators in all represented countries (120)
indicators
the World Health Organization Regional Office for was made, together with a first draft
Europe (WHO-Euro). The field of prescribing quality was of a database of prescribing quality
defined and delineated from the medical error field. A indicators, already subjected to

conceptual grid for classifying quality indicators was validation procedures.

discussed, combining two axes (a drug/disease/patient axis
and a structure/process/outcome axis).
19 Prescription Total 247 prescriptions were randomly selected for There is a need for educational Alam K et
quality & analysis, wherein 720 drugs were prescribed. Only 15% of intervention for prescribers and both al.-2006,
prescribing drugs were prescribed by generic name, 21.67% of the managerial and educational (121)
indicators
total drugs consisted of fixed-dose combinations, only intervention for the hospital
40% of drugs were from the Essential drug list of Nepal pharmacists to improve prescribing
and 29.44% (n=212) were from the WHO Essential drug and dispensing.
list. It was found that more than half (54.17%) of the
drugs were from Nepalese National Formulary and
35.69% were from WHO model formulary.
20 Prescription A review of a large number of prescribing quality Furthermore, the statistical and Morten
quality & indicators has been proposed and many are used routinely epidemiological properties of Andersen et
prescribing in quality management. Often the content and face validity prescribing quality indicators need al.-2003, (92)
indicators
of indicators have been assessed by consensus methods. more attention .
Prescription data are frequently used for indicators, but
they do not provide any direct information about disease
and patient factors important for judging the quality of
prescribing. The concurrent validity of indicators should

be assessed by comparing to a ‘‘gold standard’’ quality

assessment at the patient level using all available clinical
information. In the future, detailed clinical information
from practice databases and computerized hospital records
will be an important data source for indicators and for
validation studies.
21 Prescription One hundred ninety-six outpatients aged 65 and older who Inappropriate medication use is most Michael A et
quality & were taking five or more medications. Inappropriate frequent in patients taking many al.-2006
prescribing prescribing was assessed using a combination of the Beers medications, but underuse is also (122)
indicators
drugs-to-avoid criteria (2003 update) and subscales of the common and merits attention
Medication Appropriateness Index that assess whether a regardless of the total number of
drug is ineffective, not indicated, or unnecessary medications taken.
duplication of therapy. Underuse was assessed using the
Assessment of Underutilization of Medications
instrument. Use of one or more inappropriate medications
was documented in 128 patients (65%), including 73
(37%) taking a medication in violation of the Beers drugs-
to-avoid criteria and 112 (57%) taking a medication that
was ineffective, not indicated, or duplicative.
22 Prescription The prescribing knowledge of first-year postgraduate Efforts are needed to develop a Prerna
quality &

prescribing doctors in a medical college in India, were evaluated using curriculum that encompasses Upadhyaya et
indicators structured questionnaire. Eighty-eight percent of residents important aspects of clinical al.- 2012 (87)
said that they were taught prescription writing in pharmacology and therapeutics along
undergraduate pharmacology teaching; 48% of residents with incorporation of the useful
rated their prescribing knowledge at graduation as suggestions given by the residents.
average, 28% good, 4% excellent, 14% poor, and 4% very
poor; 58% felt that their undergraduate training did not
prepare them to prescribe safely, and 62% felt that their
training did not prepare them to prescribe rationally. Total
92% thought that undergraduate teaching should be
improved.
23 Prescription Prescribing audit and feedback interventions such as This is the most effective Soleymani et
quality & routine feedback, revised feedback, and printed interventions in improving prescribing al-2012 (59)
prescribing educational material and a no intervention control arm was pattern. If the interventions are cost
indicators
compared to assess effectiveness and cost effectiveness. effective, they will likely be applied
nationwide.
24 Prescription This retrospective survey was conducted on a total of Because of the wide variability in the Gholam-
quality & 7999530 prescriptions from all general and specialist pattern of drug prescribing depending Hossein
prescribing physicians. Assessment of prescribing indicators revealed on the medical specialties, specific Sadeghiane
indicators

poor-quality prescribing performance by general performance indicators should be et al.-2013

practitioners including high number of medicines developed for each specific medical (123)
prescribed per client, wide range of prescribed medicines specialty for better assessing of
in each prescription, over-prescribing of antibiotics, prescribing quality in specialist
corticosteroids and injectable drugs. There were also wide physicians
differences in the pattern of drug prescribing depending on
the medical specialties.
25 Prescription Main outcome measures Face validity (median rating of The 12 indicators rated as valid by Stephen M
quality & 79 on a nine point scale without disagreement) and leading prescribing advisers had a Campbell et
prescribing reliability (rating 8 or 9) of indicators for assessing quality narrow focus and would allow only a al.-2000
indicators
and cost minimization. The median rating was 7 for cost limited examination of prescribing at (124).
minimization and 6 for quality, and in all except four a general practice, primary care group,
cases individual respondents rated indicators significantly or health authority level
higher for cost than for quality.
26 Prescription Review study identified Australian studies involving the Present evidence of studies carried out Hoti K et al.-
quality & area of expanded pharmacist prescribing. The available in Australia provides valuable insight 2011 (125)
prescribing Australian literature indicated support from pharmacists of pharmacist prescribing in order to
indicators
and pharmacy clients for an expanded pharmacist move the agenda of pharmacist
prescribing role, with preference for doctors retaining a prescribing forwards and to relevant
primary role in diagnosis. Australian pharmacists and policymakers on the issue.

pharmacy client’s views were also in agreement in terms

of other key issues surrounding expanded pharmacist
prescribing.
27 Prescription A set of potential prescribing-safety indicators for the The RAND Appropriateness Method Anthony J
quality & purposes of revalidation of individual GPs in the UK was was used to select the most Avery et al.-
prescribing identified. A final set of 34 indicators was obtained appropriate indicators. This method 2011 (126).
indicators
seeks to combine scientific evidence
with the collective judgment of
experts: a consensus opinion is
derived from a group, with individual
opinions aggregated into refined
aggregated opinion.
28 Prescription Out of total of 485 morbid episodes, 302 were treated at The prescribing practices and use of Alipta Dutta
quality with some healthcare facility. Injection use was seen in 9.49% drugs have been found to be truly et al. -
WHO of the prescriptions. In all, 29.20% prescriptions contained unsatisfactory 2010(54)
indicators
at least one antibiotic. Overall 63.51% prescriptions were
found to be irrational.
29 Prescription WHO guidelines was used to evaluate the practice of There was a high incidence of Shaheen
quality with rational prescription in patients. The most commonly irrational prescribing practice that Saeed et al.-
WHO prescribed drugs were vitamins and tonics (57.5%) increased with the total number of 2012 (70)
indicators

followed by anti-microbial agents (12.7%), non-steroidal drugs per prescription

anti-inflammatory drugs (10.5%), anti-hypertensive
(5.2%), anti cough remedies and acid peptic disease drugs.
Generic drug prescription was very low as most of drugs
prescribed were proprietary.
30 Prescription A total of 1944 prescriptions were analyzed after To improve rational use of medicine K A
quality with excluding those that were illegible. 7146 drugs were continuous medical education with a Oshikoya et
WHO prescribed and the numbers of drugs prescribed per patient focus on evidence based medicine is al.- 2006
indicators
per visit were between 1 and 8 with a mean value of 3.7. required. (127)
Injections were prescribed for 349 (18.0%) patients and
artemether 144 (41.3%) was the most frequently
prescribed injection. Only 141 (7.3%) of the drugs were
prescribed with pure generic names.
31 Prescription WHO prescribing indicators were used. The average The pattern of drug prescribing in the Afsan M et
quality with number of drugs per encounter was 3.78 and no single OPD of orthopaedics was al.-2012
WHO drug was prescribed by generic name. Use of an antibiotic inappropriate. (128)
indicators
and an injection was in 6.67% and 3.33% of encounters
respectively. Only 4.32% drugs were prescribed from
national essential drug list (EDL). Percentage of
encounters with a NSAID, an antiulcerant and a calcium

preparation prescribed were 97%, 97.33% and 67.33%

respectively.
32 Prescription Average number of drugs/prescription is 8.8. Drugs were To promote rational drug usage Balbir kaur et
quality with prescribed by generic names in 4.16% of cases, drugs on standard policies on use of drugs must al.- 2013 (61)
WHO EDL are only 36.92% and fixed dose combinations are be set, and practice of prescribers
indicators
35.87% of total drugs. Dosage forms used were mostly would be audited frequently.
oral 84.40%. Injectable were only 12.07% and topical
forms were least 0.58%. Basic information of patient was
written in 100% prescriptions. Complete diagnoses were
written in 73.26% prescriptions. Total 86.80%
prescriptions were legible.
33 Prescription The average number of drugs prescribed per encounter or Promoting use of EDL will promote Anteneh
quality with mean was 1.9 (SD 0.91) with a range between 1 and 4 as rational use of medicine. EDL were Assefa
WHO evaluated using WHO core prescribing indicators. The not found to be a problem in this Desalegn-
indicators
percentage of encounters in which an antibiotic or study. 2013 (129)
injection was prescribed was 58.1% (n = 749) and 38.1%
(n = 491), respectively. The Percentage of drugs
prescribed by generic name and from an essential drug list
was 98.7% (n=2419) and 96.6% (n=2367), respectively.

34 Prescription Prescription analysis was done using WHO basic drug There is a considerable scope for Nihar R et al.
quality with indicators and it showed that 75 to 95% drugs were improving prescribing habits -2000 (130)
WHO prescribed from essential drug list. The average number of according to rational drug use and to
indicators
drugs per prescription was 1.42 to 4.07. Percentage of provide a feed back to hospital
antibiotics prescribed varied from 14.39% to 22.28%. The authority for making maximum
use of injections was from nil to 4.4%. Non-availability of number of drugs available to the
drug was major problem. patients

3.7 Introduction to PQI tool (8)

The Prescription Quality Index (PQI) is a newly developed tool intended for health
care providers such as clinicians and pharmacists to evaluate the quality of drug
prescriptions in chronic diseases. Donabedian conceptualization of structure, process,
and outcome quality model was used as an approach for the index construction. The
PQI was developed based on published literatures (9, 28, 29, 131), peer reviews and
expert consensus. The criteria in the PQI were specifically chosen to measure the
common problems related to prescription quality in general and clinical practice. The
PQI is expected to serve as a way of measuring and monitoring prescription quality in
practice and to extend knowledge on other information related to prescription quality.
Prescriptions may contain a single drug or multiple drug therapy. For prescriptions
which consist of more than one drug, each drug is rated individually. Similarly, if
patients suffer from more than one disease state or condition or problem, each disease
state is rated separately. Then, minimum scores for each criterion are selected for
summation. Compliance criterion is measured using physician notes written in
patient’s medical record. To use the PQI, drug prescription and basic patient
information are required at a minimum. However, to obtain a more valid and reliable
assessments, patients’ social, clinical and laboratory information are necessary. When
it is not possible to obtain certain data such as cholesterol level or compliance status,
indicators are rated as having no information and score of 9 is given.
The rate-based PQI consists of 22-criteria in question forms and the total score ranges
from 0 to the maximum of 43. The range of scales in the PQI varies from 0 to 4 for
very important criteria, 0 to 2 for criteria considered as important and 0 to 1 for the
less important criteria. If criterion 1 for drug indication was scored as 0 (not
indicated), then criterion 2 (dosage), criterion 11 (duration) and criterion 12 (cost) are
all scored as 0 (poor prescription quality). The PQI total score is obtained by
summing up all the minimum scores for the 22 criteria with the maximum possible
score of 43. Prescription with the PQI total score of ≤ 31 is interpreted as poor quality,
32 - 33 as medium quality and 34 – 43 as high quality (8). The criteria for PQI are
shown in table 4.

Table 5: List of PQI Criteria
1. Is there an indication 2
0 9
for the drug? Weakly 4
Not No
Indicated Indicated
Indicated Information
2. Is the dosage correct? 2
9
0 Marginally 4
No
Incorrect Correct Correct
Information
3. Is the medication 1
9
effective for the 0 Slightly 2
No
condition? Ineffective Effective Effective
Information
4. Is the usage of the drug 0
1
for the indication No 2 9
Weak
supported by Evidence/ Strong No
Evidence
evidence? Not supported Evidence Information
5. Are the directions for 1 9

0 2
administration correct? Marginally No
Incorrect Correct
Correct Information
6. Are the directions for 9
1
administration No
0 Marginally 2
practical? Information
Impractical Practical Practical
7. Are there clinically 2

significant drug-drug Insignificant
0 1 9
interactions? /No
Major Minor No
Interaction
Significance Significance Information
8. Are there clinically

significant drug- 2 9
0
disease/condition Insignificant No
Significant
interactions? /No Interaction Information
9. Does the patient

9
experience any adverse 0 1 2
No
drug reaction (s)? Definite Possible No ADR
Information
10. Is there unnecessary 1
duplication with other Necessary
0 9
drug(s)? Duplication/
Unnecessary No
No Duplication
Duplication Information
11. Is the duration of

therapy acceptable? 1 9
0 2
Marginally No
Unacceptable Acceptable
Acceptable Information
12. Is this drug the

cheapest compared to 9
0 1
other alternatives for No
No Yes
the same indication? Information
13. Is the medication being 0 1 9

prescribed by generic No Yes No

name? Information
14. Is the medication
0 9
available in the 1
No No
formulary or essential Yes
Information
drug list?
15. Does the patient 9
0
comply with the drug 2 No
Non-
treatment? Compliant Information
Compliant
16. Is the medication’s
name on the 0 1
2
prescription clearly Not Marginally
Clear
written? Clear Clear
17. Is the prescriber’s

0 1 2
writing on the
Illegible Barely Legible Legible
prescription legible?
18. Is the prescriber’s
0
information on the 2
Inadequate
prescription adequate? Adequate
19. Is the patient’s 1

0 2
information on the Marginally
Inadequate Adequate
prescription adequate? Adequate
20. Is the diagnosis on the 1
0
prescription clearly Marginally 2
Not
written? Clear Clear
Clear/written
21. Does the prescription
fulfil the patient’s 0 9
1
requirement for drug No No
Yes
therapy? Information
22. Has the patient’s 9

condition (s) improved 0 1 No
2
with treatment? Not Slightly Information
Improved
Improved Improved
The PQI is claimed to be a promising new instrument for measuring quality of

prescription. The PQI captured the multidimensional criteria of prescription quality.
The PQI incorporates the concept of rational drug therapy, evidence-based approach
and other criteria required for prescription quality. The PQI was shown by the
developers to be a valid, reliable and responsive tool to measure the quality of
prescription in chronic diseases.

STEPS for using THE PQI
Step 1: Select the prescription to be rated
To evaluate the quality of the prescription, past or current prescription should be

available for assessment
Step 2: Obtain patient information
Review patient’s demographic information, including age, weight, height, gender,

race, etc.
Step 3: Obtain patient’s medical history
Review past and current medical problems, physical assessments and relevant
laboratory results
Step 4: Obtain patient’s medication profile
Review past and current medication regimens
Step 5: Read the questions in the PQI carefully
If you don’t understand the question, refer to the specific instructions below
Step 6: Circle the most applicable answer from your assessment
• For judgemental questions rated as 0 (poor quality), please give your reasons
for your rating.
• If you don’t know the answer to the question, consult at least two standard
references available in your facility. Standard references could be either
pharmaceutical/pharmacological texts or softwares or credible clinical journals or
established online websites. Examples are Martindale, British National Formulary,
Drug Facts and Comparison, USPDI, AHFS Drug Information, Micromedex,
Evidence Based Medical Reviews (EBMR), Medline, Pub Med, etc.
• If the specific instructions for the particular questions mention specific

references, follow the instructions.

• At times, you may require additional information from the patient's chart to
answer a question. If the information is not available, circle ‘No Information’ (scale
9) and may state the necessary requirements in the comments section.
Step 7 If prescriptions consist of more than one drug, rate each drug separately.
Similarly, if patients suffer from more than one disease state or condition or problem,
rate each disease state separately. Then choose the MINIMUM score for summation
of overall score.
Step 8 If criteria 1 is scored as 0 (not indicated), then criteria 2(dosage), criteria 11

(duration) and criteria 12 (cost) are all scored as 0 (poor quality).
Step 9 Sum up the total scores of your assessment
Step 10 Evaluate the quality of prescription
Specific Instructions for Raters & Definition of each Criterion
Criterion 1
Is there an indication for the drug?
Definition: Indication is defined as the sign, symptom, disease, or condition for

which the medication is prescribed. The question assesses whether there is sufficient
reason for the use of the drug. Sufficient reason includes not only curative and
palliative therapy but also preventive therapy for a disease, condition or drug effect,
assistance in diagnostic process and correction of abnormal laboratory values (132).
Instructions: Answer the question taking into consideration the conditions found in
the current medical problems. If score = 0 (not indicated), then indicator
2(dosage), indicator 11 (duration) and 12 (cost) are also scored as 0. For repeat
prescription, check whether the drug is still appropriate for the patient if considerable
time has elapsed between repeats.
Criterion 2
Is the dosage correct?

Definition: Dosage is defined as the total amount of medication taken per 24-hour
period for regularly scheduled medications.
Instructions: Correct dose is the amount specified within the dosage range for initial
and maintenance therapy in the standard pharmacological or medical references.
Other sources may specify newer or more appropriate therapeutic dosage ranges (e.g.
Micromedex) or specific geriatric dosage ranges (e.g., BNF, USPDI, APhA Geriatric
Drug Dosage Handbook). These ranges should supersede the standard texts as long as
references are given.
The dosing regimen is determined primarily by the pharmacokinetics of the drug in

the patient. Dosage should take into account known age-related changes in drug
pharmacokinetics and pharmacodynamics. Objective data such as vital signs,
calculated creatinine clearance and laboratory values (e.g., blood chemistries,
cholesterol, PT/INR) should also be considered. For patients who have drug
laboratory values/levels.
Criterion 3
Is the medication effective for the condition?
Definition: Effective is defined as producing a beneficial result. The question

assesses whether the drug prescribed is effective for the indication.
Instructions: Indication and effectiveness are tightly but not perfectly linked items.
Physicians may prescribe a drug for a given condition because of theoretical and
standard practice reasons (indication) but clinicians may find in clinical practice that
the drug is ineffective.
Criterion 4
Is the usage of the drug for the indication supported by evidence?
Definition: Evidence-based clinical practice is an approach to decision making in
which the clinician uses the best evidence available, in consultation with the patient,
to decide upon the best option which suits that patient
Criterion 5

Are the directions for administration correct?
Definition: Directions are defined as the instructions in the use of a medication for
the patient. The question assesses the route of administration, relationship to food and
liquid, the schedule and time of the day.
Criterion 6
Are the directions for administration practical?
Definition: Practical is defined as capable of being used or being put into practice
without sacrificing efficacy. This question assesses whether the directions for use are
practical for the patient to take, or for the pharmacy to dispense or for the nurse to
administer and take into consideration the potential for patient compliance without
sacrificing efficacy.
In this study, practical direction is rated from the patient’s perspective only.
Criterion 7
Are there clinically significant drug-drug interactions?
Definition: A drug-drug interaction is defined as the effect that the administration of

one medication has on another drug. Clinical significance connotes a harmful
interaction. This question assesses whether the drug in question interacts with another
drug in the patient's regimen by affecting its pharmacokinetics (i.e., absorption,
distribution, metabolism and excretion) or pharmacodynamics (i.e., the effect that it
has on the body).
Instructions: A drug interactions text, such as Hansten's Drug Interactions and
Updates, and Micromedex will serve as the reference for significant interactions. The
decision should be based on the severity of potential interaction, the availability and
quality of clinical documentation
Criterion 8
Are there clinically significant drug-disease/condition interactions?
Definition: Significant drug-disease interaction is defined as the harmful effect that

the drug has on a pre-existing disease or condition. This question assesses whether

the drug in question may be worsening the patient's disease or condition. A previous
history of an idiosyncratic allergic reaction to a drug (e.g., penicillin, sulfonamides) is
considered a pre-existing condition.
Criterion 9
Does the patient experience any adverse drug reaction (s)?
Definition:
Adverse drug reaction (ADR) means an unwanted or harmful side effect experienced
following the administration of a drug or combination of drugs and is suspected to be
related to the drug. The reaction may be a known side effect of the drug or it may be a
new previously unrecognized adverse drug reaction.
WHO definition: any noxious, unintended, and undesired effect of a drug, which
occurs at doses used in humans for prophylaxis, diagnosis, or therapy. This excludes
therapeutic failures, intentional or accidental poisoning or drug abuse, and adverse
effects due to errors in administration or compliance.
Criterion 10
Is there unnecessary duplication with other drug(s)?
Definition: Duplication is defined as simultaneous prescribing or usage of drug(s)

from the same chemical or pharmacological class.
Unnecessary duplication is defined as non-beneficial or risky copying of drug(s)

when two drugs from the same chemical or pharmacological class are prescribed
simultaneously. In general, 2 drugs from the same subclass of major therapeutic
classifications will be considered unnecessary duplication
Instructions:
The evaluator will look up the generic names of all regularly scheduled medications
in the index to determine the class of each individual drug. The latest version of
USPDI or BNF may be used as reference. The evaluator will look up the generic
names of all regularly scheduled medications to determine the class of each individual
drug.

Criterion 11
Is the duration of therapy acceptable?
Definition: Duration is defined as the length of therapy. This question assesses

whether the length of time that the patient has received the drug is acceptable
Instructions:
Duration of therapy should be written clearly so that patients will not stop taking
drugs prematurely and will understand why prescription probably need not be
renewed. For chronic condition, a prolonged duration of therapy will be acceptable.
However, duration for the prescription should take into consideration the need for
continued contact with the clinic or physician, the cost, drug accumulation, storage &
stability problems, potential for drug toxicity, drug overdose or drug abuse. Some
institutions may have their own policy regarding the acceptable length of therapy in
prescription. In this study, 3 months is considered as maximum duration for a drug to
be prescribed.
Criterion 12
Is this drug the cheapest compared to other alternatives for the same indication?
Definition: This question assesses how the cost of the drug compares to other drugs
for the same indication with similar efficacy and safety.
Instructions: Alternatives should be considered as medications within the same
therapeutic class. For the rating, evaluator can use the local institutional setting prices
(e.g., cost per month or per day supply or cost per dose) as their standard. Whenever
possible, administrative costs should be included. If the drug is not indicated in item
1, then the score should be 0
Criterion 13
Is the medication being prescribed by generic name?
Definition:
Generic name refers to the actual scientific name of the drug. Generic name or
nonproprietary name is preferred than brand name or proprietary name.

* Exception:
Trade name or brand name may be used and scored as 1 in these circumstances:
1) Certain drugs such as lithium, phenytoin and theophylline from different
manufacturers have significant differences in bioavailability.
2) Combination products such as Lomotil, Bactrim, Hyzaar.
Criterion 14
Is the medication available in the formulary or essential drug list?
Definition:
Many institutions have their own drug formulary or drug list. Others may follow
national drug list or WHO essential drug list.
Instructions: Check each drug in the prescription carefully and refer to the
formulary/drug list available in your facility. If the drug is not listed, then the score
should be 0.
Criterion 15
Does the patient comply with the drug treatment?
Definition:
Compliance describes the extent to which a person’s behaviour coincided with
medical advice (132,133). Garfield & Caro (1999) defined compliant patients as those
who accepted their physician’s advice to start drug therapy and who take their
medication at least 80% of the time (134). Non-compliance means constant neglect
rather than just temporary forgetfulness or neglect of treatment (135). In selecting and
prescribing medications for patients, prescribers should consider drugs which enhance
compliance.
Instructions:
The evaluation of compliance continues to be a key methodological problem,
particularly in terms of the most valid measurement scale that measure compliance
comprehensively (135). The direct methods are those by which the drug can be
identified in the patient. The indirect methods include those where there is an

assessment, either by the patient himself or some other individual, as to whether the
patient is likely to have taken the medication. Direct methods generally give higher
figures of non-compliance than indirect methods. Assessment of compliance can be
evaluated by self report, physician’s judgement, pill count, and checking repeat
prescriptions. Examples of direct methods are measuring blood levels or urinary
excretion of medication.
Criterion 16
Is the medication’s name on the prescription clearly written?
Definition:
Medication name refers to the generic name or trade name of the drug. Drug names
should be written out fully and acronyms should not be used
Criterion 17
Is the prescriber’s writing on the prescription legible?
Definition:
Legible means easy or capable of being read or deciphered or understood or distinct to
the eye. The quality of handwriting can have a profound impact upon medication
treatment since illegible handwriting may lead to serious medication error. The widely
used four keys to assess legibility are shape, slant, spacing, and size of the letters.
Illegible means difficult to read or understand the handwriting.
Criterion 18
Is the prescriber’s information on the prescription adequate?
Definition:
Prescriber’s information refers to prescriber’s name, address and signature.
Criterion 19
Is the patient’s information on the prescription adequate?

Definition:
Patient’s information refers to the patient’s full name, registration number, age,
bodyweight, gender, date and address/name of the clinic where patient is treated.
Criterion 20
Is the diagnosis on the prescription clearly written?
Definition:
Diagnosis – the process of determining the nature of a disorder by considering
patient’s signs and symptoms, medical background, and when necessary, results of
laboratory tests and X-ray examinations. The diagnosis is best written according to
the latest International Classification of Diseases
Criterion 21
Does the prescription fulfil the patient’s requirement for drug therapy?
Definition:
This question refers to circumstances when a patient is suffering from an illness or
develops a new or worsening condition and is in need of pharmacotherapy. The major
causes for requiring new or additional drug therapy are as follows:
 To treat an untreated condition
 To add a synergistic or potentiating drug therapy
 To fill the need for prophylactic or preventive drug therapy
This problem may occur when patients are transferred from another hospital, from
one physician care to another, or from one pharmacy to another and their therapies are
not continued.
Instruction:
A comprehensive assessment of each patient’s drug-related need is required. Simply
reviewing an existing prescription or patient medication profile may result in missing
this problem.
Criterion 22
Has the patient’s condition improved with treatment?

Definition:
Improve refers to positive progress in achieving the desired outcomes, stabilizing
patient’s condition or resolving problems. Not improve refers to lack of progress,
worsening in patient condition, treatment failure, or death while receiving drug
therapy
Instructions:
Improvement in patient’s condition can be measured by clinical outcome such as
absence, presence, degree of magnitude or severity of a particular condition such as
pain, discomfort, or distress, change in functional status of the patient, overall patient
satisfaction or quality of life.
For acute disorders, follow-up evaluations can serve to evaluate the actual (final)
outcomes. For chronic conditions, evaluations can only establish the present status of
the patient and the progress or lack of progress in achieving desired therapeutic goals.
Physical or laboratory results may be used to assess the improvement of the outcome
treatments such as level of blood pressure, blood sugar, patency of a coronary artery
on an angiogram, the size of a mass on a radiology examination, or the titer of an
antibody. Subjective assessment include bodily comfort, physical activity, social
activity, personal and professional role function, sexual function, cognitive function,
sleep, vitality and overall perception of health.
Optimal timing for evaluation should be based on the most likely period for the
desired benefits to manifest, balanced with the most likely time for harm or side
effects to appear. Researcher may choose only one outcome or several outcomes for
evaluation. For multiple outcomes, rate each outcome separately. Then take the
minimum value for overall score.

Literature Review 3.1 Introduction To Prescription

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Literature Review 3.1 Introduction To Prescription

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CHARUSAT/Faculty of Pharmacy/RPCP/Ph.

Prescription writing used to be an art as well as a science. Unfortunately, times have

Early medicines were made up of multiple ingredients requiring complex preparation,

Jalpa Suthar/ID No. 10DRPHC001

The elementary requirements of a prescription are that it should state what is to be

Jalpa Suthar/ID No. 10DRPHC001

Tabs ii q4h (Take two tablets every four hours)

Date:__________ ABC Hospital

Losartan 50 milligram Tab, Dispense 30 tablets

Take one by Mouth daily in the morning

Refill____________ times Signature____________________

Figure 1: Sample Format of ideal Prescription

Jalpa Suthar/ID No. 10DRPHC001

3.1.3 Introduction to Good Prescribing: What constitutes good prescribing? (45)

Minimize cost Respect patient sources

3.1.3.1 Assessing good prescribing

3.2 Types of Prescribing (10)

need not be appropriate !

Jalpa Suthar/ID No. 10DRPHC001

 Appropriate indication. The decision to prescribe drug(s) is entirely based on

 Appropriate drug. It depends on efficacy, safety, suitability, and cost of drug.

 Appropriate patient. No contraindications exist, with minimum adverse reactions

 Appropriate patient information. Patients are provided with relevant, accurate,

 Appropriate evaluation. Appropriately monitored and interpret unexpected effects

3.2.2 Irrational (Inappropriate) Prescribing: (47)

Jalpa Suthar/ID No. 10DRPHC001

Jalpa Suthar/ID No. 10DRPHC001

Some examples of commonly encountered inappropriate prescribing practices in

3.2.3 Factors contributing to inappropriate use of medicines (52)

 Lack of skills and knowledge. Diagnostic uncertainty, lack of prescriber

knowledge of optimal diagnostic approaches, lack of independent information such as

 Inappropriate unethical promotion of medicines by pharmaceutical companies.

Most prescribers get medicine information from pharmaceutical companies rather

Jalpa Suthar/ID No. 10DRPHC001

 Unrestricted availability of medicines. In many countries including India,

prescription medicines such as antibiotics, are freely available over-the-counter. This

 Lack of coordinated national pharmaceutical policy. Less than half of all

countries implement the basic policies recommended by World Health Organization

Jalpa Suthar/ID No. 10DRPHC001

Patients - drug misinformation

3.2.4 Impact of Inappropriate Use of Drugs

The impact of irrational use of drugs can be seen in many ways:

 Reduction in the quality of drug therapy leading to increased morbidity and

 Waste of resources leading to reduced availability of other vital drugs and

Jalpa Suthar/ID No. 10DRPHC001

Jalpa Suthar/ID No. 10DRPHC001

A visit to the physician has come to necessarily mean a prescription comprising of a

Jalpa Suthar/ID No. 10DRPHC001

3.3.1.1 Consequences of incorrect use of medicines

a) Antimicrobial resistance. Overuse of antibiotics increases antimicrobial

caused by wrong use, or allergic reactions to medicines can lead to increased

c) Lost resources. Between 10–40% of national health budgets are spent on

d) Eroded patient confidence. Exacerbated by the overuse of limited medicines,

drugs may often go out of stock or be available at unaffordable prices and as a

Jalpa Suthar/ID No. 10DRPHC001

3.4 Measures to Improve Rational Use of Medicines

3.4.1 Training courses related to the rational use of medicines (66)

Jalpa Suthar/ID No. 10DRPHC001

Refill times Signature________