Role of Essential Medicines in framing National Medicine Policy – An Approach from Concept to Clinic

About Authors: Ashish Chauhan.
Department of Pharmaceutical Sciences,
Lovely Professional University,
Jalandhar, Punjab.

Abstract:
The essence of essential medicines underlies in satisfying the priority health care needs of the population. The selection of essential medicines is one of the core principles of a national medicine policy as it helps to set primacies for all the aspects of the pharmaceutical system and helps in the maintenance of a proficient healthcare system globally. Devising of essential medicines and national medicine policy is fast emerging as global concept of high relevance to the public irrespective of their nationalities. The prevalence of dreaded diseases like HIV, cancer, and a worldwide upsurge in case of malaria, tuberculosis and other infectious diseases with an addendum problem of multidrug resistance has further augmented the relevance of essential medicines and formulation of a rigid comprehensive national drug policy under the endorsement of WHO medicine strategy andimplementing the same under a complete implementation plan or master plan. This review emphasis the development and selection of essential medicines along with Indian scenario. This review also emphasis the mission, objectives, components, devising and implementation of essential medicine policy along with WHO tenets and regulations.

1. INTRODUCTION

1.1  Definition
In accordance to World Health Organisation, essential drugs are the "drugs that satisfy the primary health care needs of the population."¹They are selected with due respect to public health relevance, confirmation on efficacy and safety and comparative cost effectiveness.²

1.2  Development
The concept of Essential drugs was launched in 1977, and regarded among one of the eight pillars of WHO's "Primary Health Care" strategy. The WHO List of Essential drugs is updated every two years by an expert committee. The current list is the 16^th model list released in 2009. This list is regarded as “WHO Model List of Essential Medicines” which is designed in accordance to set a model list for countries to adapt to their needs. SATELLIFE and a group of volunteer moderators in 1995 started E-Drug, the English language discussion group of essentialdrugs.org. E-Drug promotes an idea to support the concept of essential drugs by improving and speeding up communications among all health professionals of the world. This concept was applied in all the countries at national, provincial, district and hospital level. This concept of essential drugs proves valuable in poor-resource settings by allowing one to get the best medicines. The essentialdrugs.org website was launched in 2002 on the eve of 25th anniversary of the essential drug concept and in the same year WHO amended the name of "essential drugs" into "essential medicines." ¹

1.3  Selection of Essential Medicine List
The selection process of medicines is precarious. The process should be consultative, transparent, unambiguous, and concomitant to evidence-based standard clinical guidelines. The list is divided into levels of care, and are regularly reviewed and updated. The review of clinical guidelines and the list should be revised out at least every second year, and their use and the impact should be supervised.³

1.4  Indian Scenario
The overall budget of medicines contrasts widely in different states in India. The expenditure outline on medicines of the State Government demonstrates that there are widespread differences across states, from as little as less than 2% in Punjab to as much as 17% in Kerala during 2001-02. Assam, Bihar, U.P., and Orissa spent about 5% or less of their health budget on medicines. The Central Government's stake of medicines in its total health budget is around 12%., roughly 10% of the health budget goes into procurement of   medicines in India. Even then, availability of medicines often is a big concern. The non-availability of essential medicines endangers the trustworthiness of the public health system.

The availability of medicines is destabilised by several factors:

*  Deprived medicine supply

*  Dispersal systems

*  Inadequate health facilities and staff

*  Low outlay in health

*  High cost of medicines

The Essential Medicine can help countries rationalize the purchasing and distribution of medicines, thereby reducing costs to the health system.³

2.      ESSENTIAL DRUGS AND MEDICINES POLICY (EDM)

2.1 Mission
The mission of the country Essential Drugs and Medicines Policy (EDM) program is entrenched in the WHO mission in medicines which is “to aid and save lives and improve health by making it available to the underprivileged society of the world.” The country EDM program follows the WHO medicine strategy. It works in alliance with the Ministry of Health and other partners to recognise the needs and priorities; plan, implement and monitor action in the pharmaceutical zone including traditional medicines.²

2.2  National Medicine Policy (NMP)
A national medicine policy (NMP) is an obligation to goals and to monitor action. Irrespective of a nation’s specific settings, a complete national medicine policy consider all the components of the pharmaceutical segment and all relevant shareholders. The NMP of   any country varies. WHO endorses all the countries to frame and implement a comprehensive national medicine policy. A national medicines policy provides a mutual framework to resolve problems in pharmaceuticals. The process of developing an NMP is as important as the final product. A national medicine policy, presented and printed as an official government proclamation, is imperative because it acts as a formal record of ambitions, aims, decisions and promises.⁴

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The components of a national medicines policy can be summarized as:
i.  Selection of essential medicines
ii. Affordability
iii.  Financing options
iv. Supply systems
v. Regulation and quality assurance
vi.  Rational use
vii. Research
viii. Human resources
ix. Monitoring and evaluation

2.3  Objectives of NMP
The broad objectives of a national drug policy are to ensure following 3 to medicines:⁵

i.            Access
ii.            Quality
iii.            Rational use

2.4  Regulation and quality assurance
The drug regulatory develops and implements the legislation and regulations on pharmaceuticals, to ensure the quality, safety and efficacy of drugs. Key policy issues are:⁵

*  Government obligation to drug regulation.

*  Independence and transparency of the drug regulatory agency.

*  Stepwise approach to drug evaluation and registration.

*  Obligation to good manufacturing practices (GMP).

*  Access to drug control facilities.

*  Obligation to regulation of drug promotion.

*  Regulation of traditional and herbal medicine.

*  Prerequisite and potential for systems of adverse drug reaction monitoring.

*  International altercation of information.

Core elements of drug regulations are:
* Quality
* Safety
* Efficacy
* Information

2.5  NMP process- An overview

                    i.            Planning: A drug policy without an implementation plan remains a numb document. Vigilant planning of the implementation phases and actions necessary to reach at the expected outcome is important throughout the process.

                  ii.            Involvement of all the parties: There must be consultation, dialogue and negotiations with all interested groups and stakeholders throughout the policy process. These comprises of ministries (higher education, trade, industry), doctors, pharmacists and nurses, local and international pharmaceutical industries, drug sellers, academia, nongovernmental organizations (NGOs), professional associations and consumer groups.

                iii.            Political dynamics: Framing and implementing a national drug policy is extremely political processes it is important to identify political associates, and to maintain their support and help throughout the process.⁵

2.6  Components of  National Drug Policy which needs political and legislative support.⁵

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2.7  Formulation of National Medicine Policy
Steps in formulation a NMP are summarised as: ⁵
i.  Organize the process of policy making.
ii.  Identification of the main problems.
iii. Making of detailed situation analysis.
iv. Establishing goals and objectives of NMP.
v. Drafting the text of policy.
vi. Circulation and revision of draft policy.
vii. Securing formal endorsement of the policy
viii. Launching the national drug policy.

2.8  Implementation of National Medicine Policy
A policy, however carefully formulated, is insignificant if it is not well implemented. Every drug policy desires a complete implementation plan or “master plan.” Each component of the policy requires a exhaustive strategy and definite action plans.⁵
Implementation of essential medicines policy will have a direct and practical effect on the following areas: ⁶
*  Public sector procurement and distribution.
*  Medicine benefits.
*  Basic training of health care providers.
*  Drug donations and international aids.
*  Monitoring systems on availability and pricing.
*  Public education.

2.9  WHO Principles for essential drugs
i. Necessary medicines should be available to all the people at reasonable prices.
ii. All prescribers should be appropriately trained.
iii.Drugs must be assured safe, efficacious and having good quality.
iv. Access of medicines to each part of our society, i.e. population residing in rural areas must be benefitted.
v. Important drugs must be given priority.
vi. Consumers must be empowered via education and information.
vii. Patient counselling must be good.
viii. Manufacturers and exporters both should understand their responsibilities and reliabilities.
ix. Ethical promotion and marketing must be exercised.
x. There must be effective stop to donations of hazardous or ineffective products.
xi. Significant community involvement and participation should be there.⁶

2.10 WHO Model List of Essential Medicines (16th List, March 2009)
This list is divided in to core list and complementary list. Medicines are specified by international non-proprietary name (INN) or generic name without reference to brand names or specific manufacturers. Medicines and dosage forms are listed in alphabetical order within each section and there is no implication of first choice for one form over another.⁷

3.      CONCLUSION
Essential and medicine policy is fast evolving as global concept of high relevance to the public regardless of their nationalities. The selection of essential medicines is one of the central principles of a national drug policy as it helps to set primacies for all aspects of the pharmaceutical system and helps in the maintenance of an efficient healthcare system globally.

4.      REFERENCES
1.      essentialdrugs.org
2.      who.int/countries/eth/areas/medicines/en/
3.      Sitanshu Sekhar Kar, Himanshu Sekhar Pradhan, Guru Prasad Mohanta. (2010) Concept of essential medicines and rational use in public health. Indian Journal of Community Medicine, (35), 10-13.
4.      emro.who.int/emp/medicines.htm
5.      whqlibdoc.who.int/publications/924154547X.pdf        
6.      Asgar Ali, Farhan Jalees Ahmad, Mohd. Aqil, Zeenat Iqbal, Sushma Talegaonkar. (2005). In text book of "General Pharmaceuticals laws and guidelines,” Jamia Hamdard, Excel Books Private Ltd. 94-99.
7.      who.int/medicines/publications/essentialmedicines/en/

Reference ID: PHARMATUTOR-ART-1010

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