UNDERSTANDING RATIONAL USE OF MEDICINES

Irrational use of medicines is a global problem and occurs in both developing and

developed countries. In developing countries this problem is enormous and not well

documented. It often leads to problems such as ineffective treatment, health risks,

medicine resistance, patient noncompliance, and overall decreases the quality care of

population and increases morbidity and mortality, also excessive spending on

pharmaceuticals and wastage of financial resources, by both patients and health care

system.

More than 50% of all medicines worldwide are prescribed, dispensed, or sold

inappropriately and 50% of patients fail to take them correctly. Con1versely, about

one-third of the world’s population lacks access to essential medicines1. Treatment

with medicines is one of the most cost-effective medical interventions known, and the

proportion of national health budgets spent on medicines ranges between 10% and

20% in developed countries and between 20% and 40% in developing countries.

Thus, it is extremely serious that so much medicine is being used in an inappropriate

and irrational way.

Many interrelated factors influence medicine use. The health system, prescriber,

dispenser, patient, and community are all involved in the therapeutic process and all

can contribute to irrational use in a variety of ways. Published researches suggested

that medications wastages may be due to excessive and irrational prescribing and

dispensing, or the lack of control of the sales of prescription medications in the

community pharmacies and poor compliance of the patients.2-5 In previous household

surveys conducted in other countries, the type, quality, storage and use of medicines

in hands were studied. The studies founded therapeutic duplication, medication

wastages, and unnecessary hoarding of medications. About half of medicines in the

households were not in current use and around 40% of these medicines were

expired.6,7

Numerous studies, both from developed and developing countries describe a pattern

that includes polypharmacy 8-14, the use of drugs that are not related to the diagnosis 15-

19 or unnecessarily expensive 20-25, the inappropriate use of antibiotics 26- 33 and

irrational self-medication 34- 38 with drugs frequently taken in underdose.39-40

The problem is worsened by a global shift from public to private sector spending,

which, in many developing countries without adequate regulation and inspection,

usually results in a large proportion of drugs being purchased without any prescription

at all.

Rational use of medicines is essential in today's situation, especially in a country like

India, where there is a wide disparity in the availability of medicines amongst cities

and villages. The concept of the rational use of medicines has not yet penetrated the

minds of health care providers and the public, and as a result there is rampant

irrationality in both the medicines available, as well as the medicines prescribed.

Rational drug use cannot be defined without a method of measurement and a

reference standard. These same tools are even more necessary to measure the impact

of an intervention 41, to make comparisons between facilities, districts or regions, and

for supervisory purposes. Knowledge of the prescriber has sometimes been used as an

output measure of interventions. However, adequate knowledge on rational drug use

does not always result in rational prescribing behaviour. Actual behaviour is therefore

preferred as a measurement.

Over the past few years the International Network for Rational Use of Drugs

(INRUD) and the WHO Action Programme on Essential Drugs have closely

collaborated in developing and testing a set of 12 quantitative indicators to measure

some key aspects of prescribing and the quality of care 42 . These indicators, which are

now also recommended by UNICEF, are listed in Table 1. A detailed manual on their

use is available from WHO 43.

Table 1 : Indicators used for monitoring drug use

Indicators used for monitoring drug

use An indicator is a measurable characteristic of actual system

performance that determines the extent to which desired

outcomes are achieved, or the degree to which guidelines and

standard operating procedures are adhered to. Indicators are

used to monitor the quality or appropriateness of important

clinical and management activities.

Health facility indicators and hospital antimicrobial indicators

developed by WHO indicate general trends in prescribing. These

are validated, widely tested, easy to use, can be used to compare

performance of health facilities from time to time and across

different levels and States.44

From records of procurement, pharmacy stock, and from

patient records we could get

1. Pattern of Consumption of drugs: One could do an ABC

or VED, analysis .

2. Medication error ADR reports.

3. Antimicrobial resistance surveillance reports

From prescription audits we could get an idea of prescriber

specific indicators

1. Average number of drugs prescribed per prescription

2. % prescription for antibiotics

3. % prescription for injections

4. % prescription for steroids, vitamins

5. % drugs prescribed by generic name

6. % drugs prescribed from Essential Medicine List

From prescription audit and from pharmacy we could get

patient care indicators

1. Dispensing time.

2. % prescribed drugs dispensed.

3. % drugs prescribed that were unavailable in facility

pharmacy.

4. % drugs prescribed that were clearly unnecessary or

inappropriate by STP.

From pharmacy inventory we could get facility indicators:

1. % availability of drugs in the EDL for that facility .

2. Availability of Essential Medicine List, Formulary at the

health facility level .

The second important requirement in studying rational drug use is a standard. What is

rational? How much deviation from an agreed standard can be accepted? In practice

this implies that the prescription should be compared with an agreed treatment

protocol or with a list of therapeutic alternatives. This is also a core principle of

medical audit, which is becoming more and more important in developed countries

like the United Kingdom45. Audit needs a standard, and a standard needs consensus.

Treatment protocols and prescribing policies should be agreed by the prescribers

themselves in their own environment at the hospital or clinical department. In a

national perspective one would then distinguish between three levels: the total range

of drugs approved for sale and use in the country, usually defined by the regulatory

authorities; within this range, the national formulary or national list of essential drugs,

preferably sub-divided by level of care (health centre, general hospital, specialist

department) and developed by a national formulary committee; and within that, a

hospital formulary or departmental prescribing policy specific for one hospital, a

clinical department or a group of practitioners. This part, attempts to explain, the

various aspects related to essential medicines, their rational use and their irrational use

ESSENTIAL MEDICINES: 46

The Essential Medicines concept:

'Selecting a limited range of medicines to improve access to health care and quality of

health care'.

The implementation of the concept of essential medicines is intended to be flexible

and adaptable to many different situations. Essential medicines are those that satisfy

the priority health care needs of the population.

Careful selection of a limited range of essential medicines results in:

A higher quality of care,

Better management of medicines (including improved quality of prescribed

medicines)

More cost effective use of available health resources.

Better inventory management.

The WHO Model List of Essential Medicines:

The WHO Model List of Essential Medicines is a useful reference, derived from the

consensus of recognized international experts and updated every two to four years.

The medicines that appear on this list are recognized as safe, efficacious and cost

effective.

This list contains medicines that have been studied carefully to gauge their

effectiveness in treating specific conditions, and comparing the value (effect or cure)

they provide, in relation to their cost. The essential medicines concept (then known as

the Essential Drugs Concept) was defined in 1975, and followed up in 1977, with the

first WHO Model List of Essential Medicines. The Model List has formed a key

component of the information required by countries, in relation to their medicine

procurement and supply programmes.

The National List of Essential Medicines - (INDIA):

The Ministry of Health and Family Welfare, Government of India came up with a

National List of Essential Medicines in 2003. The list includes 392 medicines in 27

different categories. Unfortunately in India this list has so far not been strictly

followed, as a result of which thousands of drugs and FDCs continue to be

manufactured and marketed. The rationality of many of these continues to be

doubtful, and the consequence is that the people continue to consume irrational drugs

and drugs of doubtful efficacy. On the other hand, some medicines listed on the

Essential Medicines List are not easily available in our country.

The importance and advantages of the essential medicines concept

A list of essential medicines is an immensely useful tool for: -

1) Policy making.

2) Selection, procurement, distribution and quality assurance.

3) For financing.

4) For promoting rational use:

a. When a limited list of essential medicines represents the physician's consensus on the treatment of first choice, the quality of care improves.

b. Irrational treatments are avoided.c. Physicians become familiar with a smaller number of medicines- thus

promoting rational drug use.5) For training health professionals: A selected list of essential medicines can form

the basis for training health professionals in the proper use of medicines.

6) For providing information and imparting education relating to medicines: Patient

education and efforts to promote proper use of medicines by patients are enhanced

when centered on specific medicines.

Advantages of having an Essential Medicines Concept to a pharmacy:

a. Fewer number of medicines, leading to a fewer number of brands that need to

be stocked.

b. Better inventory control.

c. Easier to remember names because of a fewer number of medicines.

d. Less confusion in brands because of a fixed number of medicines.

e. Fewer drug interactions and adverse drug reactions.

f. If there are fewer medicines, pharmacists can remember more information

about each medicine, rather than remembering bits of information for all the

medicines in the market.

The concept of the rational use of medicines

The concept of rational drug use is age old, as evident by the statement made by the

Alexandrian physician Herophilus 300 B.C that is “Medicines are nothing in

themselves but are the very hands of god if employed with reason & prudence”

The aim of any medicine management system is to deliver the right medicine to the

patient who needs the medicine. The steps of selection, procurement, and distribution

are necessary precursors to the rational use of medicines.

The Conference of Experts on the Rational Use of Drugs, convened by the World

Health Organization (WHO) in Nairobi in 1985, defined rational use as follows:

The requirements of the rational use of medicines can be fulfilled only if the process

of both prescribing and dispensing is appropriately followed. This includes steps

concerned with proper diagnosis, correct prescribing, dispensing, and giving proper

information to the patient.

Irrational use of medicinesThe irrational use of medicines includes cases in which

a. A medicine is prescribed where none was needed.

b. Medicines are not prescribed according to Standard Treatment Guidelines (STGs), or ineffective or unsafe medicines are prescribed.

c. Effective and available medicines are underused.

d. Medicines are used incorrectly.

The irrational use of medicines has an adverse impact on the outcome of therapy and cost, and may cause adverse reactions or negative psychosocial impacts.

Table 2: Aspects of Irrational Drug Use

Diagnosis Inadequate examination of patient Incomplete communication between patient and doctor Lack of documented medical history Inadequate laboratory Resources

Prescribing

Extravagant prescribing Over-prescribing Incorrect prescribing Under-prescribing Multiple prescribing/ers

Dispensing:

“The rational use of drugs requires that patients receive medications appropriate to

their clinical needs, in doses that meet their own individual requirements, for an

adequate period of time, and at the lowest cost to them and their community.”

Incorrect interpretation of the prescription Retrieval of wrong ingredients Inaccurate counting, compounding, or pouring Inadequate labeling Unsanitary procedures Packaging:

Poor-quality packaging materials Odd package size, which may require repackaging Unappealing package

Patient adherence:

Poor labeling Inadequate verbal instructions Inadequate counseling to encourage adherence Inadequate follow-up/support of patients Treatments or instructions that do not consider the

patient’s beliefs, environment, or culture

Examples of the irrational use of medicines

Prescribing patterns, unfortunately, do not always conform to fixed criteria, and hence

can be classified as inappropriate or irrational. Common patterns of irrational

prescribing, may, therefore be manifested in the following ways.

A. The medicine is a rational one, but:

1. It was used even though it was not needed

Example:

a. Unnecessary prescribing of antibiotics for viral colds and coughs, and viral

diarrheas. (Such viral infections cannot be cured by antibiotics since

antibiotics are antibacterial, and do not work against viruses).

b. Use of injections to give placebo effect to patient, or where oral medicines

would have been sufficient.

2. Medicines not prescribed according to Standard Treatment Guidelines (STGs)

Physicians often do not prescribe in accordance to STGs.

Example:

a. Use of a higher generation of antibiotics, e.g. cefotaxime, cefuroxime, where

narrow spectrum antibiotics would have done the job.

3. Under use of available effective medicines

Failure to provide available, safe, and effective medicines

Example -

a. Failure to prescribe, or insufficient information about ORS for acute

diarrhea.

b. Prescribing antibiotics for less than the required duration.

4. Incorrect use of medicines

The use of correct medicines with incorrect administration, dosages, and duration

Example:

a. Patients are given the wrong dose (either under dose or overdose)

b. Patients are not given proper instructions, and may swallow a chewable tablet.

B. Use of Irrational Medicines

1. Ineffective medicines and medicines with doubtful efficacy.

Excessive and unnecessary use of multivitamin preparations or tonics is an example

of this prescribing pattern.

2. Unsafe Medicines.

The likelihood of adverse reactions outweighs the therapeutic effects when unsafe

medicines are prescribed.

Common examples include

a. The use of anabolic steroids for growth and appetite stimulation in children or

athletes.

b. In many countries, dipyrone (metamizol), analgin, a drug banned in most

developed countries, is used indiscriminately in both health facilities and the

community for several minor ailments.

When are medicines banned?

a. When side effects are unacceptable, and safer alternatives are available [for

example Analgin (blood disorders) and Rofecoxib (Cardiovascular disease)].

b. When superior medicines with fewer side effects are available (metformin v/s

phenformin).

c. When side effects are more dangerous than the disease e.g. furazolidone and

nitrofurazone (can cause cancer).

d. The use of these medicines should be discouraged.

The following table lists drugs that have been discarded internationally, but are still

allowed to be marketed in India

Table 3: List of drugs discarded internationally, but are still in Indian Market

Drug Indication Reason for Ban

Analgin Analgesic Can cause bone marrow

depression

Cisapride Acidity, GERD,

constipation

Can cause irregular heart

beats (arrhythmias)

Furazolidone Anti diarrhoeal Carcinogenic

Nimesulide Pain killer, fever Hepatotoxic

Phenylpropanola

mine

Cough and cold High doses can lead to stroke

Nitrofurazone Antibacterial

cream

Carcinogenic

Piperazine Anthelmentic Can cause nerve damage

Medicines of doubtful efficacy

These are medicines with little or no therapeutic value and no clinically proven

evidence is available about their use.

Examples

a. Appetite stimulants (Cyproheptadine and Buclizine HCl) should not be used in

children. Over dosage may produce hallucinations, CNS depression,

convulsions and even death.

b. Digestants (given to boost digestion) contain concentrations of amylase,

papain, pepsin or

c. pancreatin, which are inadequate, and are generally not suitable in an acidic

medium.

Adverse impact of irrational use of medicines

The inappropriate use of medicines on a wide scale can have significant serious

effects on health care costs as well as on the quality of drug therapy and medical care.

Other negative effects are, increased likelihood of adverse reactions, and a patient's

inappropriate dependence on medicines.

Impact on quality of drug therapy and medical care

► Inappropriate prescribing practices can, directly or indirectly, jeopardize the

quality of patient care and negatively influence the outcome of treatment.

► The under use of ORS for acute diarrhoea, for example, can hinder the goal of

treatment: - to prevent or treat dehydration, and thus prevent death in children.

► The likelihood of Adverse Drug Reactions increases when medicines are

prescribed irrationally. Misuse of injectable products , for example, has been

implicated in a high incidence of anaphylactic shock.

► Over dosage or under dosage of antibiotics and chemotherapeutic agents also

leads to the rapid emergence of resistant strains of bacteria or the malaria

parasite.

Impact on cost

► Overuse of medicines, even essential ones, leads to excessive expenditure on

pharmaceuticals, and waste of financial resources, by both patients and the

health care system.

► In many countries, expenditures on nonessential pharmaceutical products,

such as multivitamins or cough mixtures, drain limited financial resources that

could otherwise be allocated for more essential and vital medicines and related

products, such as vaccines or antibiotics.

► Inappropriate under use of medicines during the early stages of a disease may

also produce excess costs by increasing the probability of prolonged therapy

and eventual hospitalization.

Psychological Impact

► Over prescribing communicates to patients that they need medication for all

conditions, even trivial ones.

► The concept that there is a pill for every ill is harmful.

► Patients begin relying on medicines, and this reliance increases demand.

► Patients may demand unnecessary injections because during their years of

exposure to modern health services they may have become accustomed to

having practitioners administer injections.

Reasons for irrational use of drugs

► Lack of information : Unlike many developed countries we don’t have regular

facility which provides us up to date unbiased information on the currently

used drugs. Majority of our practitioners rely on medical representatives.

There are differences between pharmaceutical concern & the drug regulatory

authorities in the interpretation of the data related to indications & safety of

drugs.

► Faulty & inadequate training & education of medical graduates : Lack of

proper clinical training regarding writing a prescription during training period,

dependency on diagnostic aid, rather then clinical diagnosis, is increasing day

by day in doctors.

► Poor communication between health professional & patient : Medical

practitioners & other health professional giving less time to the patient & not

explaining some basic information about the use of drugs.

► Lack of diagnostic facilities/Uncertainty of diagnosis : Correct diagnosis is an

important step toward rational drug therapy. Doctors posted in remote areas

have to face a lot of difficulty in reaching to a precise diagnosis due to non

availability of diagnostic facilities. This promotes poly-pharmacy.

► Demand from the patient : To satisfy the patient expectations and demand of

quick relief, clinician prescribe drug for every single complaint. Also, there is

a belief that “every ill has a pill” All these increase the tendency of

polypharmacy.

► Defective drug supply system & ineffective drug regulation : Absence of well

organized drug regulatory authority & presence of large number of drugs in

the market leads to irrational use of drugs.

► Promotional activities of pharmaceutical industries : The lucrative promotional

programmes of the various pharmaceutical industries influence the drug

prescribing.

Forces promoting irrational use of medicines

► 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 drug efficacy.

- Marketing pressures and lucrative offers.

► Work place

- Heavy patient load.

- Pressure to prescribe.

- Insufficient staffing.

► Drug supply system

- Unreliable suppliers.

- Medicine shortages.

- Supplying expired medicines.

- Supplying irrational medicines.

► Drug regulation

- Availability of non-essential medicines.

- Presence of non-formal prescribers (Quacks).

- Lack of regulation enforcement.

- Sluggish judiciary.

► Industry

- Promotional activities (through advertisements or medical representatives)

- Misleading claims.

OBSTACLES EXIST IN RATIONAL DRUG USE

Various obstacles in rational drug use are:-

► Lack of objective information & of continuing education & training in

pharmacology.

► Lack of well organized drug regulatory authority & supply of drugs.

► Presence of large number of drugs in the market & the lucrative methods of

promotion of drugs employed by pharmaceutical industries.

► The prevalent belief that “every ill has a pill.”

Consequences of irrational use

Lack of access to medicines and inappropriate doses result in increasing morbidity

and mortality, particularly for childhood infections and chronic diseases such as

hypertension, diabetes, epilepsy and mental disorders

Inappropriate use and over-use of medicines is a waste of resources – often out of-

pocket payments by patients. It also results in significant patient harm in terms of

poor patient outcomes and adverse drug reactions.

Irrational use is wasteful and can be harmful for both the individual and the

population. Adverse medicines events cause significant morbidity and mortality and

rank among the top 10 causes of death in the United States of America. They have

been estimated to cost £466 million annually in the United Kingdom of Great Britain

and Northern Ireland and up to US$ 5.6 million per hospital per year in the USA.

Antimicrobial resistance is dramatically increasing worldwide in response to

antibiotic use; much of it inappropriate overuses (and is causing significant morbidity

and mortality. It has been estimated that antimicrobial resistance costs annually US$

4000–5000 million in the USA and €9000 million in Europe. The use of unsterile

injections is associated with the spread of blood borne infections, such as hepatitis B

and C and HIV/AIDS. Although evidence-based medicine has gained importance the

use of both diagnostic and treatment guidelines is sub-optimal and could be greatly

improved.

Strategies to promote rational prescribing and their possible impact

The various interventions to promote rational prescribing are best classified as

educational, managerial and regulatory 47

Educational strategies include printed materials, seminars, bulletins and face-to-face

interventions.

Managerial methods refer to various restrictions on prescribing, e.g. restrictive lists, a

maximum number of drugs per prescription, budgetary or cost restrictions,

endorsement by higher qualified consultants, patient co-payment strategies, price

measures, structured prescription forms or a maximum duration for inpatient

prescriptions (automatic stop-orders).

Regulatory measures include procedures to critically evaluate drugs and product

information (e.g. data sheet, patient information leaflet) before market approval is

granted, scheduling drugs for different sales levels (over the counter, pharmacy only,

prescription only) and specifying for each drug a minimum level of prescriber or

health facility (for example, no injectable antibiotics at health centres).

Several studies have critically reviewed the available evidence to identify the most

effective interventions 48-50, and the following provisional conclusions may be drawn.

An important observation is that printed materials alone hardly influence prescriber

behaviour 51, and that any such influence is usually of short duration 52-53. Most of

these interventions assume that the main reason for incorrect prescribing is a lack of

knowledge and that if prescribers had the correct information, their prescribing would

automatically improve. This is not always the case in view of the many other factors

influencing prescribing, like drug promotion 54, patient demand, intentional use of

placebo drugs and prescriber preference based on personal experience rather than peer

reviewed standards 55. Technical information on cost and side effects of the drugs is of

much less influence, as shown in the Netherlands 56 and further illustrated by the total

lack of impact of a series of warnings in the FDA bulletin as recorded by Soumerai 57.

Another aspect of the problem is that prescribers with irrational prescribing behaviour

are the very ones that are less likely to read the educational material mailed to them.

Proven cost-effective interventions are face-to-face education focused on a particular

prescribing problem in selected individuals 57-63, structured prescription forms 64, and

focused educational campaigns together with widely discussed and frequently revised

treatment guidelines. An example of the latter is the success of the Australian

antibiotic guidelines 65. Most recently, a review of 59 published evaluations of the

effect of clinical guidelines concluded that all but four of these studies detected

significant improvements in the process of care after the introduction of guidelines,

and all but two of the 11 studies that assessed the outcome of care, reported

significant improvements. However, the size of the improvements in performance

varied considerably 66. Essential drugs lists together with an educational programme

and follow-up are probably effective as well.

As mentioned above, most evidence suggests that printed materials alone are

ineffective. It is likely that this also applies to essential drugs lists and treatment

guidelines if these are just distributed to prescribers without an introduction campaign

and without intensive follow-up, and especially if the prescribers had not been

involved in the development process. A general problem is that many interventions

have only been tested in developed countries and that the results can therefore not

automatically be extrapolated to developing countries where conditions are so

different. In the absence of well conducted studies Laing has attempted to give

provisional advice to developing countries with regard to possible effective

interventions 67. He suggests that basic and post-basic medical education should

include specific training in rational prescribing; that essential drugs lists and

therapeutic guidelines should be developed through wide consultation and feed-back

and be disseminated by means of intensive educational programmes as recorded from

Yemen 68, Uganda 69 and Zimbabwe 70; that general limitations on prescribers

(maximum number of drugs per prescriptions, maximum quantities, maximum costs

etc) may have unexpected effects which should be avoided through careful studies

before such measures are taken; that face-to-face education may be effective but

expensive; and that printed materials, including treatment guidelines, are ineffective

without educational programmes and follow-up activities. The overall impact of drug

bulletins is not clear. Experience from developed countries is not encouraging, but

this may be due to the fact that prescribers receive so many promotional and other

materials that some of them did not even recognize a carefully designed set of

academic detailing material as different from commercial material 71. However, in

most developing countries the lack of information, promotional or other, is so serious

that any unbiased material sent out to prescribers might be studied with more care.

Bulletins, especially when geared to actual day-to-day prescribing problems, may

therefore have more impact in developing countries than elsewhere. This hypothesis is

worth examining.

Table : Strategies to promote rational use of medicines

A mandated multi-disciplinary national body to

coordinate medicine use policies

Clinical guidelines

Essential medicines list based on treatments of

choice

Drugs and therapeutics committees in districts and

hospitals

Problem-based pharmacotherapy training in

undergraduate curricula

Continuing in-service medical education as a

licensure requirement

Supervision, audit and feedback

Independent information on medicines

Public education about medicines

Avoidance of perverse financial incentives

Appropriate and enforced regulation