ESSENTIAL DRUGS

Presented by;Aiswarya.A.TFirst year M.PharmDept. of Pharmacy PracticeGrace College of Pharmacy

Essential drugsHISTORYIn 1975, the 28th World Health Assembly reviewed the

main drug problems facing the developing countries & outlined possible new drug policies

The Director General of WHO, referred to the experience gained by some countries, where schemes of basic or essential drugs had been implemented with tremendous success

Such schemes were intended to extend the accessibility & rational use of most necessary drugs to their respective populations, whose basic health needs could not be met by the existing supply systems

The concept of essential drugs was born, & the first model list of essential drugs was published in 1977

Current versions 18th WHO Essential Medicines List

in April 2013

4th WHO Essential Medicines List for Children updated in April 2013

19th WHO Model List of Essential Medicines in April 2015

WHO Definition

Essential drugs are those that satisfy the health care needs of the majority of the population which is available at all times in adequate amounts & in appropriate dosage forms.

The model list of essential drugs is important in developing countries because of the reasons:

Development of treatment guidelinesDevelopment of national formulariesMeasures to improve drug use information for

patients & general public

Guidelines For Establishing A National Programme For Essential Drugs

A national drug authority should be established

A National Drugs & Therapeutics Committee (NDTC) should be established

Generic names should be used for all drugs

A concise, accurate & comprehensive drug information booklet should be prepared

The quality of all products, including stability & bioavailability should be assured throughout product registration process

Competent health authorities should decide on the level of expertise needed to prescribe drugs

Efficient administration of supply, storage & distribution of drugs in the essential drug list, is indeed required for the success of ED programme

There should be a well-documented procurement policy, based on records of turnover of drugs

Research, both clinical & pharmaceutical, is sometimes needed to settle a choice of a particular drug under local conditions

Guidelines … contd…

Criteria For The Selection Of Essential Drugs

Choice of essential drugs depends on many factors like;Pattern of prevalent diseases in the countryTreatment facilities availableLevel of training & experience of the

personnel, who will actually handle the drugsFinancial resources available in the countryGenetic, demographic & environmental

factors

Selection of essential drugs must always be;

Evidence-based; not situation based

Selected drugs should have sound & adequate data on their efficacy & safety, based on clinical studies

Performance of a drug in general use has been proved in variety of medical settings

Each selected drug must be available in adequate quantities & in the dosage form that is recommended by NDTC

It must have assured quality, including bioavailability & stability, under various conditions prevailing in the country

When 2 or more drugs appear to be similar in quality, bioavailability, stability, choice should be made on the basis of careful evaluation of their relative efficacy, safety, quality, price & availability

When cost becomes an issue in the selection of drugs, only the unit cost of the drug alone should not be considered

Comparative pharmacokinetic properties of drugs in the same therapeutic category, proves helpful for the choice

Local facilities to manufacture drugs or their storage should also be considered

ED’s should contain only one single basic drug or active ingredient

Contd…

Tasks After The Formation Of Essential Drug List

1. Updating the ED listGuiding principles have been laid down by WHO:

The extend to which the countries implement schemes, or establish EDL is a national policy decision of each country

EDL must accommodate a variety of social situations to meet the real health needs of the majority of the population

The model EDL is a tentative identification of ‘common core’ or ‘common thread’ which runs across health care needs of many a developing country

Exclusion from model EDL doesn’t mean rejectionThe formation of EDL & its updating is a continuing

process

2. EDL for primary health care centres

Existing system of medicines

National Health Infrastructure

The pattern of endemic diseases

Supplies

3. Specialist control of drug use

Egs of situations where specialist control of drug use is necessary are;

The use of reserve antimicrobials (antibiotics) for multiresistant bacteria

Establishing adequate regimens for treatment of TB & leprosy

The use of antineoplastic & immunosuppressive drugs

The use of antiretroviral (AIDS) drugsThe use of antimicrobial, antifungal, antiviral agents

for TB treatment, respiratory infections of HIV positive & AIDS patients, who are highly susceptible to such infections.

4. Research & Developmenta) Pharmaceutical aspects

Development of local or regional capacities in quality assurance, inorder to ensure that quality is maintained.

Development of procurement procedures, especially for large quantities, to get best price.

Development of processing & packaging of dosage forms, to ensure quality of products.

Development of efficient distribution systems with suitably trained personnel

b) Clinical & Epidemiological aspects

To assess efficacy & safety of new candidate drugsTo assess benefits & safety of traditional medicines &

medicinal plants in the regionTo assess effects of genetic & ethnic differences among local

population on the pharmacokinetics & other therapeutic parameters

c) Educational aspectsDevelopment of training programmes in policy

formation, quality control, information system, drug procurement, storage & distribution aspects.

Development of educational & training programmes for prescribers & other healthcare workers.

Development of appropriate public education programmes, information programmes on diagnosis, early recognition of symptoms & use of correct self medication.

Development of information booklets & leaflets for consumer education.

5. Drug information & educational activities

For safe, effective & prudent use of ED, relevant & reliable drug information is a must.

Make effective use of several WHO publications on “model prescribing information”. Already five titles on drugs in anaesthesia, parasitic diseases, mycobacterial diseases, STD’s& in skin diseases, exist.

Develop model formulary to complement model list of ED’s.

Develop drug information sheets on all drugs in EDL, to guide the prescribers to safe & effective use of drugs.

6. Making a list of reserve AntimicrobialsAntimicrobial agent Specific indications in which to be usedAmoxicillin plusClavulanic acid

Beta lactamase inhibitor- producing bacteria.To be used in polymicrobial infection related to surgical conditions of intestinal or female genital tract

Ceftriaxone Treatment of meningitis due to Streptococcus pneumonia Should not be used as chemoprophylaxis

Ceftazidine Use only when prevalence of resistance to gentamycin is high & confirmed

Imipenme plusCilastatin

Use only for the treatment of Acinetobacter spp. Infection & Pseudomonas spp resistance. These organisms are usually found in ICU’s where use of prophylactic antibiotics is high

Ciprofloxacin & Other Fluoroquinolones

Use for typhoid fever, severe shigellosis, gonorrhea, hospital acquired infections of E.coli, P.aeroginosa

Vancomycin For use against methicillin-resistant Staph. aureus strains which are resistant to all beta lactum antimicrobials & other antibiotics like erythromycin, clindamycin, & chloramphenicol

Artemisin & its derivatives For patients with falciparum malaria, resistant to chloroquine derivatives, sulphadoxine, plus pyrimethamine, mefloquine or quinine are used

7. Post- Registration drug studies

Although the EDL is made out all due considerations & extensive data including clinical trial data, on the drugs included, there will be occasions, when drugs used in practice will fail to produce benefit that was expected out of it.

The reasons are;Clinical trials do not include groups like children,

pregnant women, old peopleGenetic & environmental factors differ from

population to populationData on overdose or longer term medication of the

drug are usually not availableUnexpected use of the drug, other than for what it

was meant to be usedPoor manufacturing practices in some countries

which may lead to poor dissolution & ultimately poor bioavailability

Thank you!