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National drug policy

3/30/2021

By: Nimona B. (B.Pharm, MSc)

E-mail: [email protected]
Outline
 Introduction
 Definition
 Rationale for national drug policy
 Characteristics & Objectives of NDP
 Components of NDP
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Introduction
3/30/2021

• The world pharmaceuticals market has witnessed an

increase in the number of pharmaceutical products
circulating worldwide
• However, only 70% of world population have access EM
•That means 2 billion people living without access to
EM(either unavailable or too expensive).
• To increase the accessibility of medicine, there
should be a framework to manage quality, safety
and effectiveness of medicine.
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Cont’d…
• Experience in many countries has shown that these
complicated and interdependent problems can be addressed
within a common framework
WHO recommends that all countries formulate and
implement a comprehensive national drug policy (NDP).
A policy is not static and will usually evolve over time.
It is recommended to revise medicine policy every
five years
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National drug policy (NDP)

A national drug policy is:-
• A promise and a guide for action that indicate how the
government will ensure that efficacious and safe medicines of
good quality are affordable, available, and rationally used.
• It provides a framework for coordinating the activities of
all the parties involved, Such as
The public and private sectors
NGOs, donors, and
other interested stakeholders.
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NDP….
• Formulation of NMP Strategies and activities that aim
achieve policy objectivesto are implemented by various
stakeholders the effect of these activities is monitored the
policy is adjusted as necessary.

• In this process the objectives must be defined, priorities must

be

set, strategies must be developed and commitment built.

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Why is a national drug policy needed?

• To present a formal record of values, aspirations, aims,
decisions and medium- to long-term government commitments
• To define the national goals and objectives for
the pharmaceutical sector, and set priorities
• To identify the strategies needed to meet those objectives, and
identify the various actors responsible for implementing the
main components of the policy
• To create a forum for national discussions on these issues.
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Characteristics of a National drug Policy
• Essential part of health policy, must fit
within the framework of a particular health care system.
• Goals should be consistent with broader health objectives
• Implementation of an effective drug promotes
policy
confidence in use of health services.
• Why do medicine policies differ by country?
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Objectives of national drug policy

• General
Access: equitable availability and affordability of
essential medicines
Quality: The quality, safety and efficacy of all medicines
Rational use: the promotion of therapeutically sound and cost-
effective use of medicines by health professionals and consumers.
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Specific objectives of national drug policy

• The more specific goals and objectives of a national
policy will depend upon
a. The country situation
b. The national health policy
c. Political priorities set by the government
d. Economic goals. For example, an additional objective may
be
to increase national pharmaceutical production capacity.
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Specific objectives of national drug

policy…
• It is critical that all the drug policy objectives are
clear, so that the roles of
The public and private sectors
The various ministries (health, finance, trade and industry)
Government bodies (such as the drug regulatory authority)
should be specified.
• A drug policy should be monitored, evaluated and have to
bring noticeable impact
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Cont’d…

Access
• The national drug policy and its implementation plan focused
on two strategies to improve access to essential medicines
(1) Appropriate selection and use of generic drugs, and
(2) Improved drug procurement and management (through
movement channel and in the h. facility)
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National drug policy…

 The four components of the “access framework” is essential
but not sufficient in itself to ensure access.
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National drug policy…

• Similarly, rational drug use depends on many factors, such
as rational selection, regulatory measures, financial factors,
prescribers and dispensers factors.
• Improving access to essential medicines is perhaps the most
complex challenge for all health sectors involved in the
field of medicines supply.
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T.able: the key components of a national drug

pol3i/3c0y/2021

X = direct link; (X) = indirect link

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1.Rational selection of essential

m e d icines
3/30 /20 21

• No health system in the world offers unlimited access to all

medicines
• Rational selection of essential medicines is one of the core
principles of a NDP.
• It focuses on therapeutic decisions, professional training,
public information, financing, supply and quality assurance
efforts on those medicines which will have the greatest impact
in a given health care setting.
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Rational selection of essential

medicines…
Rational selection can be approached through various

tools

1. National treatment guidelines

2. National lists of essential medicines

3. National drug formulary

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2. Affordability of essential m e d
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•icine
Affordable prices are an important precondition for ensuring
access to essential drugs in the health sectors
• Key policy issues are
Government commitment to ensuring access through increased
affordability;
I. For all drugs: reduction of drug taxes, tariffs and distribution
margins, pricing policy.
II. For multi-source products: promotion of competition through
generic policies, generic substitution and good procurement
practices
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Affordability of essential medicine…

III. For single-source products: price negotiations,
therapeutic substitution, and TRIPS (The
Agreement on Trade- Aspects
of
Related
Intellectual Property Rights)-compliant measures
such as compulsory licensing, “Early workings” of
patented drugs for generic manufacturers.
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3.Drug financing
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• Drug financing is essential component of drug

policies to improve access to essential drugs.
Key policy issues are:
a) Commitment to measures to improve efficiency and reduce
waste
b) Increased government funding for priority diseases, and
the poor and disadvantaged group
c) Promotion of drug compensation as part of public and
private health insurance schemes
d) Guidelines for drug donations.
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4.Realiable health and Supply System

To ensure that high-quality medicines are available to all,

• The governments not only need to select their
priority medicines, but also to define policies in
Production, procurement, distribution, as well as to
provide a
mechanism for financing, which can be a key
limitation.
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Supply system…
I. Public-private mix in drug supply and distribution systems
II. Commitment to good pharmaceutical procurement practices
in the public sector
III. Publication of price information on raw materials and
finished products
IV. Drug supply systems in acute emergencies
V. Inventory control, and prevention of theft and waste
VI. Disposal of unwanted or expired drugs.
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5. Regulation and quality assurance

• The drug regulatory authority is the agency that develops
and implements most of the legislation and regulations on
pharmaceuticals to ensure:
 The quality, safety and efficacy of medicines
 The accuracy of product information
• Drug regulation is a complex task, with many stakeholders
and vested interests involved.
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Regulation and quality assurance…

Key polices:-
• Government commitment to drug regulation
• Independence and transparency of the drug
regulatory authority
• Relations between the drug regulatory authority and
the ministry of health
• Stepwise approach to drug evaluation and registration;
definition of current and medium-term registration
procedures
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Regulation and quality assurance…

• commitment to good manufacturing practices, inspection
and law enforcement
• Commitment to regulation of drug promotion
• Potential for systems of adverse drug reaction monitoring
• International exchange of information.
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6.Rational use of
medicine 3/30/2021

• Irrational drug use by prescribers and consumers is a very

complex problem, which calls for the implementation of many
different interventions at the same time
• Efforts to promote rational drug use should also cover the use
of traditional and herbal medicines.
Key policy issues are:
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Rational use of medicine…

Development of evidence-based clinical guidelines, as the
basis for
• Training, prescribing, drug utilization review, drug supply and
drug compensation
 Establishment and support of drugs and therapeutics
committees
 Promotion of the concepts of essential drugs
Rational drug use and generic prescribing in basic and
in- service training of health professionals
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Rational use of medicine…

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The need and potential for training informal drug sellers

 Continuing education of health care providers
and independent, unbiased drug information
Consumer education
Educational, Economic, Regulatory and managerial
strategies to promote rational drug use.
Strategies to improve RMU
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7. Research 3/30/2021

• Research facilitates the implementation, monitoring and

evaluation of different aspects of drug policy
• Research is an essential tool in assessing the drug policy’s
impact on national health service systems and delivery

 Operational research?
 Drug development and clinical research?
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8. Human resources
developm e nt
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• Human resources development includes the policies

and strategies chosen to ensure that there are
Enough trained and motivated personnel available to
implement the components of the NDP
Lack of motivation and appropriate expertise has
been a decisive factor in the failure to achieve NDP
objectives
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Human resources development..

Key policy issues are
• Government responsibility for planning and overseeing the
development and training of the human resources needed
for the pharmaceutical sector
• Definition of minimum education and training
requirements for each category of staff
• Career planning and team building in government service
• The need for external assistance (national and
international).
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9. Monitoring and
evaluation 3/30/2021

• Monitoring and evaluation are essential components of a NDP,

and the necessary provisions need to be included in the
policy
Key policy issues are
Explicit government commitment to the principles of
monitoring and evaluation
monitoring of the pharmaceutical sector through
regular indicator-based surveys
Independent external evaluation of the impact of the national
drug policy on all sectors of the community and the economy.
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Drug management cycle

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Drug management cycle

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• The medicines management cycle illustrates the main steps of effective

management of medicines supply such as selection, quantification,
procurement, distribution, and storage
• Each major function in the cycle builds on the previous function and
leads logically to the next
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Drug supply management cycle

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Medicine selection
• Is defining what is most needed among available
alternatives
• Selection of medicines involves
🞄 Reviewing the prevalent health problems
🞄 Identifying treatments of choice, and
🞄 Deciding which drugs will be available at each level
of health care.
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Level of medicine selection

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Notes: S = specialist medicines available to special hospitals and departments in the

public sector
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Criteria of selection
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I. Relevance to the pattern of prevalent diseases

II. Proven efficacy and safety
III. Favorable cost-benefit ratio
IV. Personnel capable of using the drugs
V. Proven advantage of combination products over
single compounds being used separately
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Criteria of selection…
• Adequate quality, including bioavailability and stability
• Preference for drugs that are well known, with good
pharmacokinetic properties and possibilities for local
manufacture and etc…
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Why we select medicine? 3/30/2021

Because of
• Medicine represent a large part of the public health budget.
• Limited available funds are frequently spent on
ineffective, unnecessary, or even dangerous drugs
• 70 % of pharmaceuticals are duplicative.
• Some medicines have high toxicity relative to their
therapeutic
benefits
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Why we select medicine…

• Indications of some of the medicines are irrelevant to the

basic needs of the population

• New medicines are nearly always more

expensive than exciting medicine. brand vs

generic issue

• Variety of available drugs lead to irrational medicines

use
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Advantages of limited list

medicin e s storage, and distribution
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Easier procurement,
Better quality assurance
Easier dispensing
 Lower prices, more competition
Focused Education efforts
Reduced confusion and increased adherence to treatment
Improved drug availability
Focused and up-to-date information
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Medicine Selection….
• Formulary system
• Formulary list (Essential medicines
list)
• Formulary manual
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Formulary
• The formulary list is a periodically revised list of
medicines

that reflects the current judgment of the medical staff.

• Cornerstone for good pharmaceutical management and

rational drug use.

• Formulary process: Encompasses preparing, using and

updating a formulary list ( which is ideally based on

an essential medicines list )

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Formulary process…

• Formulary manual (providing information on drugs in

the formulary list)
• Standard treatment guidelines (STGs). are systematically
developed statements that assist prescribers in deciding
on appropriate treatments for specific clinical problems.
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Formulary process…
• Essential medicines: are those that satisfy the
priority health care needs of the population.
• Formulary manual: The formulary manual is the
publication that brings all the important summary
information on medicines in the formulary list/EML
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Formulary process…
Formulary manual: includes about drug:-
• Generic name/brand name,
• Indications/alternative treatment medicine dosage and
strengths,
• contraindications and precautions,
• Side-effects, dosage schedule, instructions and
warning,,
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Formulary process…

• Drug, food and laboratory interactions,

• Price, regulatory category, storage guidelines,
• Patient counselling information,
• Labeling information's, Poisoning (intoxication) guidelines
etc..
A good comprehensive formulary can provide excellent drug
information for health-care staff
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Formulary process…
It should be pocket-sized, distributed widely (ideally to
every prescriber).
 Regularly updated, developed in a transparent
and participatory way
Better if available in electronic format
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Standard treatment guidelines[STG]

• STG are treatment protocols / systematically developed
statements that assist prescribers in deciding on
appropriate treatments for specific clinical problems.
• The information is disease centered, emphasizing the common
diseases and complaints and the various treatment
alternatives.
• Information on medicines is usually limited to strength,
dosage, and duration
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STG… 3/30/2021

providing guidance to health professionals on the Dx

and treatment of specific clinical conditions
Orienting new staff about accepted norms in treatment
Providing prescribers with justification for prescribing
decisions made in accordance with STGs
Providing a reference point by which to judge the quality
of prescribing
Aiding efficient estimation of drug needs and setting priorities
for procuring and stocking drugs.
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STG…
• Recommending treatment choices that do not take into
account existing expertise or infrastructure.
• The key difference between a formulary manual and STG is
that the formulary manual is drug centered, concentrating
on drug information and usually not providing comparisons
of different medicines
• where as the STG are disease centered, listing
treatment alternatives and indicating treatments of
choice.
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Formulary system
• NEML, STG, Formulary Manual
• Which one need to be developed 1st? Why?