Rational use of Medicines

Dr A.Jerad Suresh, M.Pharm., Ph.D., M.B.A.,

Principal, College of Pharmacy,
Madras Medical College,
Chennai-3.
 Rational use of medicines is simply defined as
“Prescribing right drug, in adequate dose for the sufficient
duration & appropriate to the clinical needs of the patient at
lowest cost”.

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.”
A estimated one third of the world’s population lack regular access to

essential medicines with this figure rising to over 50% of the

population in the poorest parts of Africa and Asia. When available, the

medicines are often used incorrectly.

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

or sold inappropriately and 50% of patients fail to take them correctly.

 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.

Rational drug use attained more significance nowadays in terms

of Medical, Socio-Economical and Legal Aspect.

Source: http://www.who.int/en
 Factors that have led Sudden Realization for
rational drug use are.
Drug Explosion:- Increase in the number of drugs available has incredibly
complicated the choice of appropriate drug for particular indication.

Efforts to Prevent the Development of Resistance :- Irrational use of

drugs may lead to the premature demise of highly efficacious & life saving new
antimicrobial drug due to development of resistance.

Growing Awareness:- Today, the information about drug development, it’s

uses & adverse effects travel from one end of the planet to the other end with
amazing speed through various media.
Increased Cost of the Treatment:- Increase in cost of the drug
increases economic burden on the public as well as on the government. This

can be reduced by rational drug use.

Consumer Protection Act. (CPA):- Extension of CPA in medical

profession may restrict the irrational use of drugs.
 REASONS FOR IRRATIONAL USE OF DRUGS

1.Lack of Information:-
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.

2.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.
3. 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.

4. 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.
5.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.

6. 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.

7.Promotional Activities of Pharmaceutical Industries:

The lucrative promotional programmes of the various
pharmaceutical industries influence the drug prescribing.
Indian private practice: Every 4th 'Patient' is a
drug company representative
 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.
The over-use of antibiotics is leading to increased antibiotic
resistance while the use of non-sterile injections is leading to
the transmission of hepatitis, HIV/AIDS and other blood-borne
diseases.

Irrational 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.
 5-55% of PHC patients receive injections - 90% may be
medically unnecessary.

 15 billion injections per year globally.

 half are with unsterilized needle/syringe.
 2.3-4.7 million infections of hepatitis B/C and up to 160,000 infections of
HIV per year associated with injections.

30 to 60 % of PHC patients receive antibiotics - perhaps

twice what is clinically needed.

Source: Quick et al, 1997, Managing Drug Supply

 RATIONAL USE OF MEDICINES ESSENTIAL FOR
COMBATING ANTIMICROBIAL RESISTANCE?

Irrational use (misuse) of antimicrobial medicines is a major driver of

antimicrobial resistance (AMR). Antimicrobials are misused when taken for too
short or too long a period, at too low a dosage, at substandard potency, or for the
wrong disease. Both under-use and over-use favour the development of AMR.
 Only 50% of people with malaria receive the recommended first-line
antimalarial medicine.
 Only 50–70% of people with pneumonia are treated with appropriate
antibiotics.
 Up to 60% of people with viral upper respiratory tract infection receive
antibiotics inappropriately.

Source: http://www.who.int
 Facts on antimicrobial resistance
About 4,40,000 new cases of multidrug-resistant tuberculosis (MDR-TB)
emerge annually, causing at least 1,50,000 deaths. Extensively drug-resistant
tuberculosis (XDR-TB) has been reported in 64 countries to date.
Resistance to earlier generation antimalarial medicines such as
chloroquine and sulfadoxine-pyrimethamine is widespread in most malaria-
endemic countries. Falciparum malaria parasites resistant to artemisinins are
emerging in South-East Asia; infections show delayed clearance after the start of
treatment (indicating resistance).
A high percentage of hospital-acquired infections are caused by highly
resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA)
and vancomycin-resistant enterococci.

Source: http://www.who.int/mediacentre/factsheets/fs194/en/
 Types 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 : B. Use of Irrational Medicines:
 It was used even though it was Ineffective medicines and
not needed. medicines with doubtful
 Medicines not prescribed efficacy.
according to Standard Treatment Unsafe Medicines.
Guidelines (STGs).
Under use of available effective
medicines.
Incorrect use of medicines.
 HOW “RATIONAL” IS OUR USE OF MEDICINES?

Misreading the symptoms

Between 25 to 30% of patients who attend primary health
care facilities do so because of minor, but common psychiatric
disorders. Many of these conditions are presented to the medical
providers as complaints of headache, backache, abdominal and
other body pains.
Typhoid is another condition which is often irrationally
treated at primary care level. In the absence of clinical evidence
many patients are treated with strong antibiotics for typhoid when
in reality they are suffering from depression or anxiety.
 Bad use of good medicine
Self medication is another common example of the irrational
use of drugs. A less common but increasing problem of irrational use
of medicines is the misuse of cough mixtures containing codeine.
Symptoms of addiction to cough mixtures are similar to those of
heroin addiction.
Another problem on the increase is the abuse of laxatives and
diuretics to induce diarrhoea and fluid lose respectively. This is done
to lose weight. Stimulant abuse, which leads addiction and are
dangerous in some cases.

Source: Dr.Frank G.Njenga, Contact, no183, Oct-Dec-2006, 12-13.

 LURES TO IRRATIONAL USE OF MEDICINES
LURING OF PRESCRIBERS
Medical and pharmaceutical journals/Reference books
Most medical and pharmaceutical journals depend on advertisements for
income from the companies. Such journals cannot provide totally objective
information as the articles cannot be too critical of the activities or products of
these companies.
Software
Many pharmaceutical companies offer software to physicians to facilitate
the prescribing procedure. It generates a prescription for each diagnosis. The
snag is that in most cases the drugs displayed for each diagnosis are those
manufactured by the company providing the software. The suggested drugs are
not necessarily the most effective in treating the illness.
 LURING OF CONSUMERS

Commercial promotion of brands

Most medical and pharmaceutical journals carry advertisements of
medicines sponsored by pharmaceutical manufacturing companies. Most of the
medicines advertised do not require a doctor’s prescription making them
appealing for consumers to purchase over-the-counter to make profits from the
sales.

Direct to consumer advertising

Direct to consumer advertisement for medicines that have to be
prescribed by a doctor is forbidden in most countries.

Source: Albert Petersen, Contact, no183, Oct-Dec-2006, 14-16.

Forces promoting irrational use of medicines
Patients -Drug misinformation.
- Misleading beliefs.
- Patient demands/expectations.
-Lack of education and training.
Prescribers
- 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.
 - Unreliable suppliers.
Drug supply
- Medicine shortages.
system - Supplying expired medicines.
- Supplying irrational medicines.

- Availability of non-essential medicines.

Drug
- Presence of non-formal prescribers
regulation (Quacks).
- Lack of regulation enforcement.
- Sluggish judiciary.
- Promotional activities (through
Industry
advertisements or medical
representatives)
- Misleading claims.
 Monitoring the use of medicines
From 1990 to date, the World Health Organization (WHO)
has created a database of more than 700 published and
unpublished surveys of medicine use carried out in developing
countries and countries with economies in transition.

The first step to correct irrational use of medicines is to

measure it. Indeed, prescribing, dispensing and patient use should
be regularly monitored in terms of:

The types of irrational use of medicines, so that strategies

can be targeted towards changing specific problems.
 The amount of irrational use, so that the size of the problem
is known and the impact of the strategies can be monitored.
The 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. Causes of irrational use include lack of
knowledge, skills or independent information, unrestricted
availability of medicines, overwork of health personnel,
inappropriate promotion of medicines and profit motives from
selling medicines.
 STEPS TO IMPROVE RATIONAL DRUG PRESCRIBING

Step:- I
Identify the patient’s problem based on symptoms & recognize the need
for action.
Step:-II
Diagnosis of the disease. Identify underlying cause & motivating factors.
This may be specific as in infectious disease or non specific.
Step:-III
List possible intervention or treatment. This may be non drug treatment
or drug treatment. Drug must be chosen from different alternatives based on
efficacy, convenience & safety of drugs including, drug inter-actions & high risk
group of patients.
Step:-IV
Start the treatment by writing an accurate & complete prescription e.g.
name of drugs with dosage forms, dosage schedule & total duration of the
treatment.

Step:-V
Given proper information instruction & warning regarding the treatment
given e.g. side effects(ADR), dosage schedule & dangers/risk of stopping the
therapy suddenly.

Step:-VI
Monitoring:
Passive monitoring - done by the patient himself. Explain him what to do if the
treatment is not effective or if too many side effect occurs
Active monitoring - done by physician and he make an appointment to check the
response of the treatment.
 Relation between treatment guidelines and a list of essential medicines

Source: WHO / Essential Drugs Monitor No. 032 (2003)

 WHO policies to promote rational use of
medicines
1. A mandated multi-disciplinary national body to coordinate medicine use
policies.
2. Clinical guidelines.
3. Essential medicines list based on treatments of choice.
4. Drugs and therapeutics committees in districts and hospitals.
5. Problem-based pharmacotherapy training in undergraduate curricula.
6. Continuing in-service medical education as a licensure requirement.
7. Supervision, audit and feedback.
8. Independent information on medicines.
9. Public education about medicines.
10. Avoidance of perverse financial incentives.
11. Appropriate and enforced regulation.
12. Sufficient government expenditure to ensure availability of medicines and staff.
 Essential Medicines

Essential medicines are those that satisfy the priority health care
needs of the population.
Essential medicines are selected with due regard to disease
prevalence, evidence on efficacy and safety, and comparative
cost-effectiveness.
Essential medicines are intended to be available within the
context of functioning health systems at all times in adequate
amounts, in the appropriate dosage forms, with assured quality,
and at a price the individual and the community can afford.
 Essential Drug List
 It should contain the list of
all drugs under different
therapeutic categories
along the WHO guidelines.
 The list should contain the
correct technical name or
synonym (no brand names).
 It should contain the correct
information regarding the
pharmacopoeia under
which it is official.
 It should contain the
strength and volume /weight
of the formulation.
 It should contain information
regarding the method of
administration like
IM/IV/SC.
 It should include additional
information like nature of
coating (in the case of
tablets) or whether the
formulation is a lyophillized
powder , sustained release
product etc.,
 Challenges in making the EDL

 Too many items of the same therapeutic use

without much advantage.
 Same formulation in too many strengths.
 Same formulation in too many dosage forms.
 Same formulation with different names.
 Too many formulations under same
therapeutic category
 Doxycline Cap. IP 100mg.
 Tetracycline Cap IP 250 & 500mg.
 Doxycycline is more potent than Tetracycline. The dose is 200mg
initially and thereafter 100mg OD, whereas Tetracycline is to be
administered four times a day in a dose of 500mg.
 With Doxycycline there will be better patient compliance.
 Doxycycline has comparatively lower renal toxicity and less liable
to cause diarrhoea.
 Amoxycillin Cap.IP 250 & 500 mg
Ampicillin Cap.IP 250 & 500mg

 Amoxycillin is better absorbed than ampicillin and the

incidence of diarhhoea is less.
 Moreover food does not interfere with its absorption and
sustained high blood levels are produced.
 Tobramycin Inj &Gentamycin Inj.

 The antibacterial and pharmacokinetic properties as well as

dosages of Tobramycin are identical to Gentamicin.
 It is only a reserve alternative to Gentamicin.
 Omeprazole Cap & Pantoprazole Cap

 Pantoprazole is a new PPI and is similar in potency and

clinical efficacy to Omeprazole.

 It is the only PPI available for IV administration, particularly

employed for prophylaxis of acute stress ulcers.

 It has lower affinity for cytochrome P450 than Omeprazole.

 Atracurium ,Pancuronium Vecuronium

 Atracurium is four times less potent than Pancuronium.

 Vecuronium is more expensive than pancuronium.
 Pancuronium because of its longer duration of action needs
reversal of action.
Formulations included in too many strengths

 Ceftazidime Inj.2gm ,1gm ,500mg &250mg.

 Cefuroxime Tab. 125mg ,250mg & 500mg.
 Ceftriaxone Inj. 2gm,1gm,500mg ,250mg &125mg.
 Amoxycillin + Clavulinic Acid Capsules (250mg+125mg),
(500mg+125mg)
 Other Changes……
 Liquid oral preparations for paediatric purposes.
 Whereas possible these preparations should be replaced by
dispersible kid tablets because.
 They are less heavy and occupy less space than the bottle
preparations.
 The bottle preparations are more expensive.
 Moreover the liquid preparations tend to deteriorate much
faster than the reconstituted tablets.
 Vitamin C 500 mg

 Vitamin C in such high doses may not be commonly required.

 Very high concentrations of Vit C can cause the formation of
urinary stones.
 Normally a 100 mg Tab should be enough.
 Even if a high dose is required more than tab can be used.
 Drugs and Therapeutic committes in
hospitals
 Functions:
 Ensure safe and effective use of medicines in the facility.
 They promote rational and cost effective use of medicines in
hospital.

 Comprises of:
 Representatives of the administration and all major
specialities.
 A senior doctor would be the chair person and chief
pharmacist, the secretary.
 Drugs and Therapeutic committes in hospitals.
Cont..
 All members should be independent and declare
conflict of interest.

 Activity should be broad and include developing or

adapting clinical guidelines, medicines selection,
monitoring medicines use and taking corrective
action and staff education.
 Drug Information Centres

 The major source of drug information is the

medical representative. It could be biased
information.

 Drug information centre and drug bulletins are too

useful to disseminate unbiased drug information.
 Pharmacovigilance

 This is a world wide programme to collate

information on ADRs and suspected ADRs.

 Uppsala in Sweden is the head quarters for the

ultimate collation of information.
 Public education
 Ensuring that OTC medicines are sold in a correct
manner.

 Monitoring and regulating advertising, which

adversely influence both prescribers and
consumers.

 Running targeted public education campaigns.

 Enforced Regulation

 Authority should ensure availability of quality

medicines.
 For which they should be adequate in strength and
their presence felt.
 They should be backed by the judiciary.
 Conclusion

Indiscriminate use of drugs not only waste scarce

resources that could otherwise be spent on other
essential services, but also leads to drug induced
disease. The drug control authority, the teaching
institutes, drug industries, N.G.O & the patient himself
may be helpful for rational drug use.
 Drug authority must circulate the list of essential drugs which
could be updated from time to time. It must monitor the safe & proper
use of these drugs & enforce a uniform regulation for promotional
literature.

Teaching institute must conduct regular research work &

proper training of undergraduates & post graduates. Motivation of NGO
to organize various programmes for public awareness lastly, the patient
himself should observe strict compliance to the physician’ prescription
& never indulge in self medication.
To conclude, the demands of rational drug use are:-

Availability of essential & life saving drugs and unbiased drug

information with generic name.

Adequate quality control & drug control.

Withdrawal of hazardous & irrational drugs.

Drug legislation reform.

Thank You For
Your Kind
Attention