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Essential Drug Concept & Rational Use of Drugs

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What is Rational Drug Use?

•RDU: The use of appropriate, efficacious, safe and cost-effective drug given for the right indication, in the right dose and formulation, at right intervals and for the right duration of time.

Advantages of RDU

•Safe

•Effective

•Economical

•Used when required


Promotion of RDU:

•Adoption of Essential drug concept

•Training of health professionals in rational drug use

•Development of evidence-based clinical guidelines

•Unbiased and independent drug information

•Continuing education of health professionals

•Consumer education

•Regulatory strategies


Why RDU is very important

•Irrational drug use leads to unsafe and ineffective treatment

•Worsening of prolonged illness

•ADR’s

•Higher hospitalization costs

•Drug resistance

•May be fatal


Irrational Drug Use:

•Prescribing drugs of no proven value

•Prescribing empirically

•Unnecessary prescribing for self-limiting conditions

•Over/ Under dosing

•Prescribing costly drugs & formulations when cheaper drugs are available

•Using injectables when oral drugs would suffice

Using ‘available’/’favoured’ drugs when stocks of ideal drugs are not available


Essential Drugs

•WHO definition: Drugs that satisfy the health care needs of the majority of population. They must be available at all times in adequate amounts and in the appropriate dosage forms.

•1st WHO model list- 1975

•13th list-2003 having 325 drugs

•1st edn for children – 2007

•16th list -2009 adults and children 2nd edition

•National essential drug list (EDL)-1996

•WHO list is considered as the guide

•Each country can make their separate and own EDL

•WHO national essential drug list (INDIA) 15thedition March 2007

•Maharashtra state pharmacy council : 354 drugs as on July 2009


Principles of Preparing EDL

•Adoption of EDL should be a part of national drug policy

•Those drugs for which adequate scientific data available are only selected

•Keeping quality standards

•Accurate comprehensive drug information, drawn from unbiased sources should accompany the list

•Each country should appoint a selection committee

•Selection should be based on results of benefit and safety evaluation

•Regulations should be there about quality

•Generic names should be used wherever necessary

•Cost is a major selection criteria

•Influence of local diseases is considered for selection

•When several drugs are available for the same indication, consider the one with the highest benefit to risk ratio

•Fixed drug combination is useful only if

•Clinical documentation should justify concomitant use

•The therapeutic effect is greater than the sum of each

•Cost benefit

•Improved compliance

•Allowed for dosage adjustment

•List should be reviewed


Advantages of Essential drugs

•Integral part of primary health care practice

•Better material management: easy procurement, storage, supply

•More cost effective

•Improved drug use in terms of safety and efficacy

•Better and uniform patient information

•Matching to the epidemiological pattern

•Program evaluation is easy

•Easy identification of ADR possible with drug list

•Improvement in quality possible with limited number of drugs

•Restricted production depending on local requirement

•Less chance for the market forces to influence the drug utilization


Role of Pharmacist in RDU

•Drug procurement

•Inventory control

•Information and Education

•Pharmaceutical care


Drug procurement:

•Selection and range of drugs should be based on the EDC relevant to needs of the situation.

•Strict inventory control and cost-effective procurements should be practiced.

4 strategic objectives of pharmaceutical procurements:

•Procure the most cost-effective drugs in the right quantities

•Select reliable suppliers of high quality products

•Ensure timely delivery

•Achieve the lowest possible total cost


Inventory control:

•Monitoring drug stocks and minimizing ‘out-of-stock’ can be achieved by good inventory control.

•Use drug formulary or drug list to restrict the number and brands of drugs.

•Drugs with overdue expiry dates should not be dispensed or stored.

•All drugs required for the health facility should be kept in stock and patients should not be turned away due to unavailability.


Information and Education:

•Pharmacist should interact with other healthcare professionals and inform them of the introduction of new drugs, drug policy changes in the hospital, availability of drugs and drug-related problems.

•Verbally or written; drug bulletin, ADR reporting.

•Patient counseling on drug use and patience compliance, promote RDU by educational programs.


Pharmaceutical care:

•Aims to optimize the patients’ health-related quality of life and achieve positive and cost-effective clinical outcomes.

•Evidence-based therapy, risk-benefit ratio must be adopted.

•Assured all drug supplies, and be given information and assistance to carry out the drug therapy plan.

•Monitoring of treatment outcomes and suggestions to modify the treatment plan.



Investigating Drug Use in Health Facilities

•WHO in 1993: Identified a number of objective measures or indicators used to describe drug use patterns in country, region or individual health family

•Used to describe treatment practices, to compare prescribing behaviour in different areas or facilities, and to assess the impact of an intervention designed to improve drug use.


National Drug Policy of India

•Refers to the way in which a country regulates the availability, quality and use of drugs.

•Part of national health policy, aimed at improving the health of the people.

•India – one of first developing country to formulate a national drug policy.

  - Establishment of pharmaceutical industry, development of technological capabilities and price control of selected essential drugs.

•During the1950s, 1960s and 1970s: a number of developments occurred.

•Govt set up production units in the public sector to manufacture new drugs needed for the treatment of infectious diseases.

•Indian Patent Act 1970: disallowed pharmaceutical product patents and limited duration of process patents between 5-7yrs

•Provided for the registration of drugs through the office of the Drug Controller General (India) and created a basic system for testing the quality through state level Food and Drug Administrations (FDAs).

•1975: Committee on Drugs and Pharmaceuticals (Hathi Committee): dependence of the drug industry on imports and recommended a number of policies designed to give Indian companies preferential treatment.

•Govt’s new 1978 drug policy

•1979 Drug Price Control Order (DPCO): have major implications for the availability of essential medicines to the Indian public.

•1990s: New economic policy: deregulation, extensive liberalization, privatization of public sector and cutbacks in public healthcare.

•National Pharmaceutical Pricing Authority (NPPA)1996: price stability and availability of commonly used drugs.

•2001: To ensure international quality standards, schedule M of Drugs & Cosmetic Act 1945 was amended.

•GMP in 2004

•GATT: International Trade Agreement

•Govt leadership is needed in areas: funding for drug information centres, adverse drug reaction reporting, public education in medication use, drug utilization research, and continuing education for doctors and pharmacists, ethical promotion of drug advertisements.



Medication use in India

•Regulatory factors: process for marketing approval of new drugs, controls on ‘OTC’ drugs, more effective definition of a prescriber, quality assurance of products, assurance of good drug distribution systems, availability and price control of essential drugs, availability of unbiased drug information and control of drug promotion practices by industry.


Prescriber factors: heavy work load, poor diagnostic support, empirical treatment or ‘shot gun’ therapy, no evidence-based guidelines readily available, lack of continuing education for all healthcare professionals.

Patient factors: want quick response to treatment – use of multiple forms of therapy, lack of knowledge – non-compliance, availability of drugs as OTC, preference of injections to oral use, overuse of tonics and antibiotics.


Guidelines for Rational Prescribing

•Define patient’s problem, then specify the therapeutic goal.

•Use drugs only when indicated, and when the potential benefits of drug therapy outweigh the potential risks.

•Choose a drug of proven efficacy and safety. It must be suitable for individual patient and be affordable.

•Choose a dose which suitable for a individual patient.

•Avoid using more than one drug of same chemical class at the same time.

•Inform patient

•Monitor the effects of treatment

•If treatment has not been effective, try and identify why

•Continue treatment only if the original therapeutic objective is still relevant.


Rational use of Antibiotics

•Infectious diseases are a major cause of morbidity and mortality in developing countries.

•One-third of drug use is for antibiotics.

•Widely misused for conditions where they are not needed – common cold and URTIs of viral origin.

•Wrong Practice and antibiotic resistance: Starting antibiotic without diagnosis, frequently changing antibiotics, giving sub-optimal doses, not completing the course of treatment and relying on antibiotics without draining pus or removing foreign bodies as indicated.


Guidelines:

•Use antibiotics only when indicated.

•Where appropriate, specimens for Gram stain, culture and sensitivity testing should be obtained before commencing antibiotic therapy.

•The choice of agent should be based on factors such as spectrum of activity in relation to the known or suspected causative organism, safety, previous clinical response, cost, ease of use and potential for selection of resistant organism.




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By : 

Dr. Ateendra Jha