Introduction to rational drug use Definition, Role of pharmacist in essential drug list preparation and immplementation

1. DOCTOR OF PHARMACY
II YEAR
Essential medicines concept
170101
CHAPTER-5
Introduction to Rational drug use
Dr. V. Chanukya (Pharm D)

2. History
• In 1975, the 28th World Health Assembly reviewed the main drug
problems facing in +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.
• The concept of essential drugs was born, & the first model list of
essential drugs was published in 1977

3. Introduction
• 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.
• They are selected with due regard to public health relevance, 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 adequate
information, and at a price the individual and the community can
afford.

4. • The selection of essential medicines is one of the core principles of a
national drug policy because it helps to set priorities for all aspects of
the pharmaceutical system.
• This is a global concept which can be applied in any country, in
private and public sectors and at different levels of the health care
system.
• The model list of essential drugs is used for :
– Development of treatment guidelines
– Development of national formularies
– Measures to improve drug use information for patients & general
public

5. Current versions
• The WHO Model Lists of Essential Medicines has been updated every
two years since 1977.
• 18 th 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
• The current versions are the 21st WHO Essential Medicines List
(EML)
• 7th WHO Essential Medicines List for Children (EMLc) updated in
June 2019.

6. Advantages
• Careful selection of a limited range of essential medicines results in a
higher quality of care, better management of medicines (including
improved quality of prescribed medicines), and more cost-effective
use of health resources.
• Numerous studies have documented the positive impact of clinical
guidelines and lists of essential medicines on the availability and
proper use of medicines within health care systems.
• All of this is even more important in resource-poor settings where the
availability of drugs in the public sector is often erratic.
• Under such circumstances measures to ensure a regular supply of
essential medicines will result in real health gains and in increased
public confidence in the health services.

7. Choice of essential drugs depends on
many factors like;
• Pattern of prevalent diseases in the country
• Treatment facilities available
• Level of training & experience of the personnel, who will actually
handle the drugs
• Financial resources available in the country
• Genetic, demographic & environmental factors

8. Essential medicines selection criteria
• Which treatment is recommended and which medicines are selected
depend on many factors, such as
• The pattern of prevalent diseases
• Treatment facilities
• The training and experience of available personnel
• Financial resources
• Genetic, demographic and environmental factors.

9. • The following criteria are used by the WHO Expert Committee on
the Selection and Use of Essential Medicines:
1. Only medicines for which sound and adequate evidence of efficacy
and safety in a variety of settings is available should be selected
2. Relative cost-effectiveness is a major consideration for choosing
medicines within the same therapeutic category.
– In comparisons between medicines, the total cost of the treatment
not only the unit cost of the medicine – must be considered, and
be compared with its efficacy.

10. 3. In some cases, the choice may also be influenced by other factors
such as pharmacokinetic properties or by local considerations
such as the availability of facilities for manufacture or storage
4. Each medicine selected must be available in a form in which
adequate quality, including bioavailability, can be ensured; its
stability under the anticipated conditions of storage and use must
be determined
5. Most essential medicines should be formulated as single
compounds.
– Fixed dose combination products are selected only when the
combination has a proven advantage in therapeutic effect, safety,
adherence or in decreasing the emergence of drug resistance in
malaria, tuberculosis and HIV/AIDS.

11. In short
Essential medicines are those the priority health care,
 Evidence on efficacy and safety,
 Comparative cost-effectiveness.
 Available all times
 Adequate amounts, in the
 Appropriate dosage forms, with
 Assured quality
 Adequate information
 Community can affordable price

12. Selection of essential medicines
• The selection of essential medicines is a two-step process.
• First, market approval of a pharmaceutical product is usually
granted on the basis of efficacy, safety and quality, and rarely on
the basis of a comparison with other products already on the
market, or cost.
• This regulatory decision defines the availability of a medicine in the
country.
• In addition, most public drug procurement and insurance schemes
have mechanisms to limit procurement or reimbursements of drug
costs.

13. • For these decisions an evaluation process is necessary, based on
comparison between various drug products, and on considerations of
value for money.
• This second step leads to a list of essential medicines.
• A list of essential medicines is best developed for different levels of
care, and on the basis of standard clinical guidelines for common
diseases and complaints that can and should be diagnosed and treated
at that level.

14. Role of pharmacist in selection of EML
• Government-employed pharmacists are responsible for drug
management, which includes the
• The selection of essential drugs
• The determination of drug requirements
• The procurement and distribution of drugs and their rational use
• As well as the design and use of information systems.
• Also, they collect and collate data required by their national
government agencies and by international bodies, such as the
international narcotics control board.

15. Role of pharmacist in selection of EML
• Drug Information expert It is the duty of pharmacist to maintain the
evidence on efficacy and safety patterns of every drug and report if
any adverse events occurs.
• The pharmacist should compare the costs of available different brands
of same drug and suggest the suggest the most comparative and cost-
effective drug for including in the essential drug list.
• Pharmacist as the head of pharmacy he has the responsibility to
maintain the essential drugs available all times in the pharmacy.

16. • The pharmacist should plan the budget of the pharmacy in order that
the drugs in the EDL are available in adequate amounts, and if any
stock out of these drugs should be ordered before the reordering time
so that stock outs would not affect the pharmacy functioning.
• The availability of appropriate dosage forms of drugs in EML is with
assured quality and adequate information in at which a community
can affordable price

17. Approach for Revising/Updating the WHO Model
EML
• Pre-1999, an experience-based approach was considered for addition or
deletion of molecules for preparing the WHO EML.
• In 1999, the Expert Committee recommended moving from experience
based approach to one that was evidence-based and modifications to the
methodology were developed.
• Post 2002, an evidence-based approach was adopted, including evidence
for public-health relevance, efficacy, and cost-effectiveness.
• The guidelines are now prepared with inputs from different stakeholders
present in the expert committee.

18. • Among the notable changes in the WHO EML since its inception are
the following:
• Use of the term “Essential Medicines” as an alternative to “Essential
Drugs,” reflecting the common use of the term “medicines” to
describe pharmaceutical preparations used in clinical practice
• Evolution from being experience-based to evidence-based
• Introduction of a more rationalized selection process where research
evidence was relied upon for evaluating comparative benefit and
safety of specific medicines

19. • Use of a comparative cost-effectiveness approach which is presented
as a range of cost per routine outcome (e.g., cost per case, cost per
cure, cost per month of treatment) compared to older methods where
cost of the total treatment was taken into account.

20. Steps for Updating WHO Model EML

21. Step 1 Scheduled Update of WHO Model EML
• The WHO has adopted an evidence-based approach for the selection
of medicines when updating the WHO EML.
• The selection of essential medicines depends on several factors,
including the disease burden, sound and adequate data on the efficacy,
safety, and comparative cost-‐effectiveness of available treatments.
• In case of unavailability of adequate scientific evidence on the current
treatment of priority disease, the Expert Committee either waits for
more evidence or chooses to make recommendations based on expert
opinion and experience.

22. Step 2 - Application Process
• Applications for inclusion, change or deletion of a medicine in the
WHO Model List of Essential Medicines are submitted by or through
relevant departments in the WHO to the secretary of the WHO Expert
Committee.
• There are 15 questions to be addressed completely in applications,
related to disease burden, efficacy, safety, comparative cost-
effectiveness, and product-specific considerations
Step 3- Internal Review
• The committee members are selected by the Director General from the
WHO Expert Advisory Panels.
• Around 8-12 members are selected based on equitable geographical
representation, gender balance and professional competencies

23. Step 4 - Publish on Web, External Review and Comment
• The application should be received at least four months before the
meeting of the Expert Committee.
• All the application reviews and comments are posted on the webpage
and checked by the Secretary of the Expert Committee for
completeness.
• Step 4 - WHO Expert Committee Review and Recommendation
• The final result is summarized in the Expert Committee report and
published as a WHO Technical Report Series
• Patient advocacy groups are invited to comment on applications and
draft recommendation but are not included in the decision-making
parts of meetings of the Expert Committee.

24. EML in Indian scenario
• The first National List of Essential Medicines (NLEM) was
introduced in 1996 with 2 subsequent revisions in 2003 and 2011.
• Process used for India EML:
• The Indian NLEM is reviewed in consultation with experts for
discussion on evidence-based criteria for addition and deletion of
medicines from the NLEM.
• This is followed by therapeutic area wise group discussion by
clinicians, pharmacologists, pharmacists, scientists, and regulators.
• The updated list is then presented for an open-house discussion, and
the draft is forwarded to NLEM for considerations with NLEM core
committee after modifications.