Post on 19-Feb-2017
transcript
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!