Essential medicines

McLean-Tooke APC, Bethime CA, Fay AC, Spickett GP Adrenahne in the treatment of anaphylaxis what is the evidence Br Med J 2003 327 1332-1335. WHO Model List of Essential Medicines, ed 15, March 2007, available from http //www.who.int/ medicines/publications/essentialmedicines/en (accessed December 17. 2008). 

Lindenberg M, Dressman J, Kopp S. Classification of orally administered drugs on the WHO Essential Medicines list according to the BCS. Eur J Pharm Biopharm 2004 58 265-278. 

Clinical pharmacology plays no less significant a role in primary health care. That includes emphasis on essential drugs, safe and rational use of essential medicines including their side effects and outcomes, drug data transmission and analysis, and training with emphasis on prevalent diseases. Interactions between orthodox and traditional (complementary) medicines are carefully considered. Cost-benefit analysis is made possible. 

Essential medicines are those medicines and vaccines that satisfy the most common and important health care needs of the population. An essential medicines list (EML) makes medicine management easier in every respect - procurement, storage, distribution, prescribing and dispensing. The national EML should be determined by national treatment guidelines. Selection of essential medicines for the list is based on clear criteria of efficacy, safety, quality, cost and cost-effectiveness, and the list should be regularly updated. 

Major causes of morbidity and mortality in many developing countries such as malaria, tuberculosis, pneumonia, acute diarrheas, maternal diseases can be treated with simple essential medicines (Box 1). But, essential medicines will save lives and improve health, only if they are available, affordable and of good quality, and properly utilized. 

In developed countries, the discovery of new medicines and their introduction in the existing health care system during the second part of the last century has dramatically improved health, reducing mortality and morbidity from many common diseases. The society in general have benefited from these advances through the regular access to the needed medicines in their health care system. However, in many developing countries the needed essential medicines are not always available, accessible and affordable to those in need. 

The discovery of new medicines and their introduction into the market will not optimally have positive impacts on health if the needed essential medicines are not available and affordable, if they are not of good quality and if they are not properly utilized by the health care providers and consumers. This chapter will highlight the issues related to commonly occurring problems in the area of medicines in developing countries, and relevant policies and programme to deal with them. In particular, the chapter will highlight the problems of access to... 

Essential medicines are those that satisfy the priority health care needs of the population. 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 quahty and adequate information, and at a price the individual and the community can afford. The implementation of the concept of essential medicines is intended to be flexible and adaptable to many different situations exactly which medicines are regarded as essential remain a national responsibility... 

Table 1. Key points for policy makers Access to medicines snpported by tbe principles of the essential medicines...

Individual health professionals normally use fewer than 50 different medicines, the WHO Model List of Essential Medicines contains about 300 active substances... 

Essential medicines are only one element in the continuum of health care provision but they are a vital element. The major access challenges which can be obstacles for health improvement are ... 

Inequitable access. About 30% of the world population lacks regular access to essential medicines. In the poorest parts of Africa and Asia the figure rises to over 50%. 

Treatment cost. High cost of treatments with new essential medicines for tuberculosis, HIV/AIDS, bacterial infections and malaria will be unaffordable for many low- and middle-income countries. 

Globalization. Global trade agreements can have a negative impact on access to newer essential medicines in low- and middle-income countries. Access to health care and therefore to essential... 

Improving access to essential medicines is perhaps the most complex challenges to all actors in the public, private and NGO (non-government organization) sectors involved in the field of medicines supply. They must all combine their efforts and expertise, and work jointly towards the solutions. Many factors define the level of access, such as financing, prices, distribution systems, appropriate dispensing and use of essential medicines. 

WHO has formulated a four part framework to guide and coordinate collective action on access to essential medicines, namely,... 

No health system in the world have unlimited access to all medicines. Rational selection of essential medicines is one of the core principles of national medicines policy. It focuses on therapeutic decisions, professional training, public information, financing, supply and quality assurance efforts on... 

Develop a national list of essential medicines based on national treatment guidelines... 

Use of national list of essential medicines for procurement, reimbursement, training, donations and supervision... 

Negotiate equitable pricing for newer essential medicines for priority diseases... 

Undertake price negotiation for newly registered essential medicines... 

Encourage local production of essential medicines of assured quality when appropriate and feasible Include WTO/TRIPS compatible safeguards into national legislation and apply Sustainable financing... 

National lists of essential medicines should be developed for different levels of care and on the basis of treatment guidelines for common diseases and conditions that should be treated at each level. Careful selection of essential medicines is the first step in ensuring access. 

Rational use of essential medicines is one of the core activities of health workers and patients. Trained and motivated health staff, and the necessary diagnostic equipment, are needed to ensure the safe and effective treatments, minimizing the risks and waste linked to irrational prescribing and use of medicines. 

With the potential cost saving of providing a full range of treatments for prevailing common diseases, medicines prices and financing are inescapable factors in access to essential medicines (Box 2). Affordable prices can be pursued through the following mechanism. 

AFRO Essential Drugs Price Indicator. Nearly 300 essential medicines and dosage forms are listed. Details are provided by Member States and low cost essential drugs suppliers. Published by the Regional Office for Africa and the WHO Collaborating Centre for the Quality Assurance of Medicines, University Potchefstroom, South Africa. 

Equitable pricing is especially important for newer essential medicines that are still protected by patents or other instmments that provide market exclusivity. Equitable pricing is explained as the adaptation of prices which are charged by the manufacturer or seller to countries with different purchasing... 

Sustainable financing for essential medicines must be viewed in the context of overall health care financing. Most low- and-middle income countries rely on a diverse set of health and medicines financing mechanisms which can contribute in the payment of medicines. Nevertheless there are still opportunities in many low and middle income countries for both better and more public funding on health and essential medicines. 

Reduction or elimination of duties and taxes for both generic and patented essential medicines contribute to price reduction. In developing countries, the final price of a medicines may be two five times the producer or importer price. This reflects the effects of multiple middlemen, taxes of over 20% in some countries, pharmaceutical import duties up to 65%, high distribution costs, and pharmacy and drug seller charges. 

Cost sharing with patients should be seen only as a transitional measure towards long term aims, such as universal health insurance. User charges or co-payment for medicines in public health services do not always lead to increased supply of medicines and may result in decreased utilization of public health services. In addition they can further impoverish already disadvantaged populations. User s charges should complement rather than replace government allocations for curative health services and essential medicines provision. 

Donor assistance and development loans such as bilateral aid and development loan/grants from development banks continue to provide for many countries sources of health sector financing, which can include funding for essential medicines, such... 

---