Essential of Rational use

of Medicines

Mrs. Rihana Begum

Asst Professor
 DEFINITION

• In simplest words rational use means “prescribing right

drug, in adequate dose for the sufficient duration &
appropriate to the clinical needs of the patient at lowest
cost

• WHO: 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
 CRITERIA’ FOR USING MEDICINES
• Appropriate indication
• Appropriate drug
• Affordable
• Appropriate administration, dosage and duration
• Appropriate patient
• Appropriate patient information
PRACTICAL IMPLICATIONS OF THE
ACCESS FRAMEWORK

1. Rational 3. Sustainable
selection financing

ACCESS TO
ESSENTIAL MEDICINES

2. Affordable 4. Reliable
prices systems
 REASONS FOR
IRRATIONAL USE OF DRUGS
1. Lack of information
2. Role models – Teachers or seniors
3. Lack of diagnostic facilities/Uncertainty of diagnosis –
medicine for all possible causes
4. Demand from the patient
5. Patient load
6. Promotional activities of pharmaceutical industries
7. Drug promotion and exaggerated claim by companies
8. Defective drug supply system & ineffective drug regulation
 ABSOLUTELY IRRATIONAL USE
1. Injudicious use of Antibiotics in Viral fever and diarrhea
2. Unnecessary combinations
3. Use of drugs not related to diagnosis
4. Incorrect route
5. Incorrect dosing – under or overdose
6. Incorrect duration – prolong or short term use
7. 7. Unnecessary use of expensive medicines
8. Unsafe use of corticosteroids
9. Polypharmacy
 HAZARDS IRRATIONAL USE
1. Ineffective & unsafe treatment
• over-treatment of mild illness
• inadequate treatment of serious illness
2. Exacerbation or prolongation of illness
3. Distress & harm to patient
4. Increase the cost of treatment
5. Increased drug resistance - misuse of anti-infective drugs
6. Increased Adverse Drug Events
7. Increased morbidity and mortality
 IRRATIONAL USE OF MEDICINES
IS A WIDESPREAD HAZARD TO HEALTH

• Only half of 102 countries surveyed regulate drug promotion

• In some areas, by age 2 children have had more than 20 injections
• 15 billion injections aregiven per year - and half of them are
unsterile
PUBLISHED EXAMPLES OF IRRATIONAL
PRESCRIBING IN TEACHING HOSPITALS IN
DEVELOPING COUNTRIES
• Yemen 1990: 68% of hypertensive patients receive diazepam; 80% of
UTI receive furosemide, 80% of osteoarthritis receive vitamins
• Ilorin 1991: 33% of inpatients are on tranquillizers
• Kathmandu 1992: Only 70% of medicines prescribed are from the
national list of essential medicines
• Thailand 1991: 79% of surgical antibiotic prophylaxis is inappropriate
(choice, dose and/or duration)
• South Africa 1991: 54% of antibiotic treatment in gynaecology
inpatients is inappropriate
EXAMPLES OF IRRATIONAL PRESCRIBING FROM
4800 GENERAL PRACTICES IN THE UK (1995)
• Ulcer healing medication used “presumptively”
• In 0-90% of patients,SSRIs have replaced tricyclic
antidepressants
• In 0-56% of patients, buspirone has replaced diazepam (300x as
expensive)
• 0-97% of patients on beta-blockers receive long-acting
betablockers (16-25x as expensive)
• Other inhalors prescribed instead of salbutamol: (cost 8x)
• Combination medicines (cost up to 16x)
 HOW TO MEASURE IRRATIONAL
DRUG USE?
WHO/INRUD INDICATORS (1)
Prescribing indicators
• Average number of drugs per encounter (<2)
• Percentage of drugs prescribed by generic name (close to
100%)
• Percentage of encounters with an antibiotic prescribed (<30%)
• Percentage of encounters with an injection prescribed (<10%)
• Percentage of drugs prescribed from EDL or formulary (close to
100%)
HOW TO MEASURE IRRATIONAL
DRUG USE?
WHO/INRUD INDICATORS (2)
Patient care indicators
• Average consultation time
• Average dispensing time
• Percentage of drugs actually dispensed (100%)
• Percentage of drugs adequately labelled (100%)
• Patients’ knowledge of correct dosage (100%)

Facility indicators
• Availability of copy of EDL or formulary (100%)
• Availability of key drugs (100%)
STEPS OF RATIONAL DRUG USE
Step:- I
Identify the patient’s problem based on symptoms & recognize the need for
action
Step:- II
Diagnosis of the disease – define the diagnosis
Step:- III
List possible intervention or treatment (drug or no drug) – Identify the drug
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
STEPS OF RATIONAL DRUG USE
Step:-V
Give proper information, instruction & warning regarding the
treatment given e.g. side effects (ADR), dosage schedule &
dangers/risk of stopping the therapy suddenly
Step:-VI
Monitor the treatment to check, if the particular treatment has
solved the patient’s problem.
• 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
PROMOTING RATIONAL PRESCRIBING:
PROVEN EFFECTIVE INTERVENTIONS

• Standard treatment guidelines, when evidence-based,

developed with end-users, with active dissemination and
follow-up
• Essential Medicines lists, when linked to treatment
guidelines and used for training and supply
• Hospital Drugs and Therapeutic Committees
• Undergraduate training
• Comprehensive approach, with all components
THE ESSENTIAL MEDICINES TARGET
National list of
Registered medicines essential medicines
All the drugs
in the world
Levels of use

S CHW S
dispensary

Health center Supplementary

Hospital specialist
Referral hospital medicines

Private sector
CLINICAL GUIDELINES AND A LIST OF
ESSENTIAL MEDICINES LEAD TO
BETTER PREVENTION AND CARE
List of common diseases and complaints

Treatment choice

Essential medicines list /

Treatment guidelines
National formulary

Training and Financing and

Supervision Supply of drugs

Prevention
and care

Health Technology and Pharmaceuticals

 EXAMPLE OF CHALLENGE:
NEW ESSENTIAL DRUGS ARE EXPENSIVE

Antibiotics for gonorrhoea: 50-90x price of penicillins

Antimalarial drugs:
Antituberculosis:
Antiretrovirals:
<$2 pp/year
chloroquine $0.10 per treatment
artemether-lumefantrine $2.50/pp (25x)
atovaquone-proguanil $40/pp (400x)
$15 for DOTS vs $300 for MDR (20x)
$300-600/year; but 38 countries with a drug budget
 WHO MODEL LIST OF ESSENTIAL
DRUGS

• 1977 First Model list published, ± 200 active substances

• List is revised every two years by WHO Expert Committee
• Last revision (April 2002) contains 325 active substances
• 2002 Revised procedures approved by WHO

The first list was a major breakthrough in the history

of medicine, pharmacy and public health
Médecins sans Frontières, 2000
THE WHO MODEL LIST OF ESSENTIAL
MEDICINES IS A
MODEL PRODUCT, MODEL PROCESS AND
PUBLIC HEALTH TOOL
Model product: list of essential drugs with information

Core list: minimum drug needs for a basic health care system,
listing the most cost-effective drugs for priority conditions
(selected on the basis of public health relevance and
potential for safe and cost-effective treatment).
Complementary list: essential drugs for which specialised
diagnostic or treatment facilities may be needed
 WHO ESSENTIAL MEDICINES LIBRARY
COMBINING INFORMATION FROM
VARIOUS PARTNERS

WHO clusters WHO/ED

M
Clinical guideline Summary of clinical guideline
BNF
WHO/EC, Cochrane WHO Model
Reasons for inclusion Formulary
Systematic reviews WHO
Key references Model List
WHO/EDM
MSH Cost: Statistics: Quality information:
UNICEF - per unit
- per treatment - ATC - Basic quality tests
MSF - per month - DDD - Intern. Pharmacopoea
- per case prevented WCCs - Reference standards
Oslo/Uppsala
THE WHO MODEL LIST OF ESSENTIAL
MEDICINES IS A
MODEL PRODUCT, MODEL PROCESS AND
PUBLIC HEALTH TOOL
Model process: example for national committees

• Independent Membership of the Committee, careful

consideration of conflict of interest
• Transparent process, standard application, web review
• Link to evidence-based clinical guidelines
• Systematic review of comparative efficacy, safety, cost-
effectiveness and public health relevance
• Rapid dissemination, electronic access
• Regular review
 THE ESSENTIAL DRUGS CONCEPT IS
NEARLY UNIVERSAL
A FLOOR, NOT A CEILING - APPLIED DIFFERENTLY IN DIFFERENT SETTINGS

By Dec.1999:
National Essential Drugs List
156 countries with EDLS
< 5 years (127)
1/3 within 2 years > 5 years (29)
No NEDL (19)
3/4 within 5 years Unknown (16)

Countries with an official selective list for training, supply, reimbursement or related health objectives. Some
countries have selective state/provincial lists instead of or in addition to national lists.
 TREATMENT GUIDELINES AND
FORMULARY MANUALS PUT THE
ESSENTIAL DRUGS CONCEPT INTO
CLINICAL PRACTICE
135 countries have treatment guidelines, formularies
 DAP’s role
TRAINING IN RATIONAL PRESCRIBING
HAS EXPANDED IN UNIVERSITIES
THROUGHOUT THE WORLD

• Problem-based pharmacotherapy
• In 21 languages
• For medical students,
clinical officers
• Measurable improvement in prescribing
• Now also: Teacher’s Guide to Good
Prescribing
 Interventions

Impact of problem-based pharmacotherapy teaching

on examination scores (Argentina, 1999-2002)

1999(n=802) 52 36 9,5 2,4

2000(n=559) 41,5 37,6 15 5,9

2001(n=855) 40 36 16 6,9

2002(n=131) 25,2 42,7 24,4 8,4

0% 20% 40% 60% 80% 100%

3 4-5 6-7 >8

 PROMOTING RATIONAL PRESCRIBING:
INTERVENTIONS WHICH NEED MORE
TESTING
Probably effective:
• Drug sellers interventions
• Public education
• Changing fee structure

Probably ineffective:
• Drug information bulletins and other printed materials
• Banning ineffective/dangerous medicines
• Arbitrary prescription limitations, counter signatures
• Traditional stand-up lecturing
 PROMOTING RATIONAL PRESCRIBING:
POSSIBLE INTERVENTIONS IN THE
PRIVATE SECTOR
• Regulation: market approval, re-licensing, re-evaluation per therapeutic
category, regulation of promotion
• Training: basic training, national clinical guidelines, continuing medical
education by universities and professional bodies, re-licensing of
professionals on basis of education points, district DThCommittees,
medical audit, patient information leaflets, public education
• Financial incentives: separate prescribing from dispensing, dispensing fee
(flat or tiered), price controls on generic/brand drugs, contracting out
• Insurance: reimbursement limited to essential medicines, reference pricing
CONCLUSION

• Good experiences, policy advice, training tools and

national expertise are available

• Future of essential medicines lies with the public

sector and insurance systems

• There are many effective interventions possible for

the private sector
 Thank you

www.who.int / medicines