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Access to Essential Drugs in Poor Countries a Lost Battle?

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SPECIAL COMMUNICATION Access to Essential Drugs in Poor Countries A Lost Battle? Bernard Pe´coul, MD, MPH Drugs offer a simple, cost-effective solution to many health problems, pro- Pierre Chirac, PharmD vided they are available, affordable, and properly used. However, effective treatment is lacking in poor countries for many diseases, including African Patrice Trouiller, PharmD trypanosomiasis, Shigella dysentery, leishmaniasis, tuberculosis, and bac- Jacques Pinel, PharmD terial meningitis. Treatment may be precluded because no effective drug ex- ists, it is too expensive, or it has been withdrawn from the market. More- HE EFFECTIVENESS OF DRUGS DE- over, research and development in tropical diseases have come to a near pends on a long chain of fac- standstill. This article focuses on the problems of access to quality drugs for tors: research and develop- the treatment of diseases that predominantly affect the developing world: ment (R&D) of an appropriate (1) poor-quality and counterfeit drugs; (2) lack of availability of essential Tpharmaceutical agent, production, qual- drugs due to fluctuating production or prohibitive cost; (3) need to develop ity control, distribution, inventory con- field-based drug research to determine optimum utilization and remotivate trol, reliable information for health care research and development for new drugs for the developing world; and (4) professionals and the general public, di- potential consequences of recent World Trade Organization agreements on agnosis, prescription, financial accessi- the availability of old and new drugs. These problems are not independent bility, drug dispensing, observance, and and unrelated but are a result of the fundamental nature of the pharmaceu- pharmacovigilance. At each level, those tical market and the way it is regulated. involved may have conflicting interests, JAMA. 1999;281:361-367 www.jama.com and poor populations are the first to suf- fer the effects of frail links in this long due to fluctuating production or prohibi- THE PROBLEMS chain. Today, entire populations lack ac- tive cost; (3) need to develop field-based Examples of problems related to devel- cess to essential quality drugs, and the drug research to determine optimum opment and access to drugs and the mag- situation appears to be deteriorating, fur- utilization and remotivate R&D pro- nitude of the public health problems con- ther marginalizing much of the world’s grams for new drugs for the developing cerned are given in TABLE 1. population. world; and (4) potential consequences of Essential drugs are the foundation for the recent World Trade Organization Counterfeit and nearly every public health program aimed (WTO) agreements on the availability of Substandard Products at reducing morbidity and mortality in old and new drugs. For all these issues, Drug products must be produced ac- the developing world, and pharmaceu- practical recommendations to improve cording to good manufacturing prac- tical expenditure can account for a high the situation are proposed. tices.1 Unfortunately, many developing proportion of the total health expendi- The lack of access to essential drugs countries do not have the technical, fi- ture of a country. Important health pro- or vaccines because of economic rea- nancial, or human resources required for grams that rely on essential drugs in- sons raises new human rights issues in the application of such standards, and clude child survival programs, antenatal a world that remains divided among some developed countries may be less care, treatment of enteric and respira- wealthy countries, developing coun- strict when the product being manufac- tory pathogens, and control of tubercu- tries, and the rest of the world. Yet, tured is destined for exportation. To- losis and malaria. Other major public financial access to drugs does not nec- day, the quality of drugs and, therefore, health issues exist for which there is no essarily mean correct use. Continuous their effectiveness and safety are less and effective pharmaceutical treatment. training for health care professionals, This article focuses on 4 main issues dissemination of reliable pharmacologi- Author Affiliations: Fondation Me´ decins Sans Fron- associated with the inaccessibility of cal data, and improvement of the man- tie` res, Paris, France. drugs for populations in greatest need: agement of drugs are fundamental steps Corresponding Author and Reprints: Bernard Pe´ coul, MD, MPH, Me´ decins Sans Frontie` res, (1) poor-quality and counterfeit drugs; in improving the quality of care in the 8 rue St Sabin, 75011 Paris, France (e-mail: (2) lack of availability of essential drugs developing world. [email protected]). JAMA, January 27, 1999—Vol 281, No. 4 361 ACCESS TO ESSENTIAL DRUGS IN POOR COUNTRIES Table 1. 1996 Worldwide Accessibility to Drugs or Vaccines for 10 Diseases* Incidence (I) or Diseases† Deaths† Prevalence (P)† Drugs or Vaccines Type of Problem Acute lower respiratory tract 3.9 394 (I) Ceftriaxone sodium (for severe cases Available but limited use, prohibitive infections in hospital) price Anti-Haemophilus vaccine (Hib Available but limited use, prohibitive conjugates Haemophilus) price Antipneumococcal vaccine (group A Clinical development (phase 1 trial) streptococci) Tuberculosis 3.0 7.4 (I) Isoniazid, rifampicin, pyrazinamide, Poor compliance with therapy and ethambutol hydrochloride, outbreaks of drug-resistant strains streptomycin, thiacetazone (isoniazid, rifampicin) Sodium aminosalicylate, ethionamide, Production not secured, toxic effects of capreomycin sulfate drugs Rifapentine Available but limited use BCG vaccine Effectiveness disputed Diarrhea 2.5 4000 (I) Ciprofloxacin (shigellosis) Available but limited use, prohibitive price Antirotavirus vaccine Available but limited use, prohibitive price Anticholera vaccine (whole cell B) Available but limited use Anticholera vaccine (103Hgr) Available but limited use Antishigellosis vaccine Clinical development (phase 2, 3 trials) Malaria 2.0‡ 300-500 (I) Pyronaridine Clinical development (phase 3 trial) Artemisinin derivatives Available but production not secured for substandard products Coartemether Clinical development (phase 2, 3 trials) Atovaquone-proguanil Available but limited use Antimalaria vaccine (preerythrocytic) Clinical development (phase 2, 3 trials) Antimalaria vaccine (asexual erythrocytic Clinical development (phase 2 trial) stage) Preventable diseases (pertussis, 1.7 82 (I) Pertussis whole cell, measles, diphtheria, Substitution of classic formulations by measles, diphtheria, polio, oral polio, and tetanus vaccines new formulations, prohibitive price tetanus) (eg, acellular pertussis) Human immunodeficiency virus 1.5 3.1 (I), 22.6 (P) Antiretroviral drugs Available but limited use, prohibitive price Anti-HIV vaccines Clinical development (phase 1, 2 trials) Hepatitis B 1.2 200 (P) Hepatitis B recombinant vaccine Available but limited use Human African trypanosomiasis 0.15 0.2 (I), 0.3 (P) Suramin sodium Production not secured (no commercial interest) Pentamidine isethionate Production not secured (no commercial interest) Melarsoprol Production not secured (no commercial interest) Eflornithine hydrochloride No longer produced (no commercial interest) Leishmaniasis 0.08 2 (I) Meglumine antimoniate Production not secured (no commercial interest) Amphotericin B lipid complex Limited use Aminosidine Old drug (production stopped) Meningitis 0.04 0.4 (I) Ceftriaxone sodium Available but limited use, prohibitive price Oily chloramphenicol Available but production not secured for substandard products Antipneumococcal vaccine Clinical development (phase 2, 3 trials) Anti-Haemophilus vaccine (Hib) Available but limited use, prohibitive price Meningococcal A-C conjugates vaccine Clinical development (phase 2 trial) *For these diseases, there were a total of 16.07 million deaths of 52 million worldwide. One third (17.3 million) were due to infectious diseases (.90% in developing countries). †Data, in millions, are from the World Health Organization, World Health Statistics Annual, 1996.17 ‡Data indicated in World Health Statistics Annual as 1.8/2.2.17 362 JAMA, January 27, 1999—Vol 281, No. 4 ACCESS TO ESSENTIAL DRUGS IN POOR COUNTRIES less certain, especially for the poorest Poor quality may be accidental, with somiasis shows resistance to melarso- populations, who are attracted by lower- no intention to deceive, but oversights prol, and such resistance is becoming priced drugs sold outside pharmacies. in manufacturing or neglected controls more frequent (20% in Omungo, Recent years have seen an increase in can have tragic consequences. Such was Uganda).9 This drug was sold at an ex- the prevalence of counterfeit and sub- the case in recent decades with acetami- tremely high price and is now no longer standard drugs on the market. Counter- nophen syrups that contained, by mis- manufactured. Only through a joint ef- feit drugs are those that mimic authen- take, a lethal ingredient.4,5 fort of the World Health Organization tic drugs; substandard drugs are those (WHO), nongovernmental organiza- produced with little or no attention to Fluctuating Production tions involved in fieldwork, coopera- good manufacturing practices. of Essential Drugs tive bodies, and pharmaceutical compa- For example, during the meningitis epi- Drugs necessary for the treatment of cer- nies could this drug become available and demic in Niger in 1995 (41 000 cases re- tain tropical diseases have begun to dis- affordable again. ported), Niger authorities
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