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BMC Pregnancy and Childbirth. 2017 Jun 5; 17(1):170.BACKGROUND: Judicious utilization of drugs rescues the fetus from the harmful effects while treating the health problems of the pregnant women. This study aimed at evaluating drug utilization pattern and its associated factors among pregnant women in Southern Tigray, Ethiopia. METHOD: Institution based cross-sectional study was conducted among 647 pregnant women who had been attending obstetrics-gynecology and antenatal care units in different health facilities of Southern Tigray region. The study participants were selected using multistage sampling technique. Data collection was done using pre-tested semi-structured questionnaires and by reviewing antenatal follow-up cards. Descriptive and inferential statistics were analyzed, to assess drug utilization pattern and its associated factors among pregnant women, using SPSS version 20 software. RESULTS: Of 647 pregnant women, 87.5% were prescribed with at least one medication. As per the United States Food and Drug Administration (US-FDA) risk classification system, 87.7, 7.9, 3.9, and 0.5% of the prescribed drug were from category A, B, C and D, respectively. Prescription drug use was more likely among gynecology ward visitors [AOR = 8.97, 95% Cl (2.69-29.88)] and among those who visited health facilities for the first time during their first [AOR =2.65, 95% Cl (1.44-4.84)] and second [AOR = 2.50, 95% Cl (1.36-4.61)] trimesters. CONCLUSION: Majority of the study population used safe and appropriate medications according to US-FDA risk classification system, with the exception of low proportion (0.5%) of medication with potential risk for the fetus. The average number of drug prescribed per pregnant women was in the recommended range of WHO drug use indicators guideline.
Management of childhood diarrhea by healthcare professionals in low income countries: An integrative review.
International Journal of Nursing Studies. 2017 Jan; 66:82-92.Background The significant drop in child mortality due to diarrhea has been primarily attributed to the use of oral rehydration solutions, continuous feeding and zinc supplementation. Nevertheless uptake of these interventions have been slow in developing countries and many children suffering from diarrhea are not receiving adequate care according to the World Health Organization recommended guidelines for the clinical management of childhood diarrhea. Objectives The aim of this integrative review is to appraise healthcare professionals’ management of childhood diarrhea in low-income countries. Design Whittemore and Knafl integrative review method was used, in conjunction with the Reporting of Observational Studies in Epidemiology (STROBE) checklist for reporting observational cohort, case control and cross sectional studies. Method A comprehensive search performed from December 2014 to April 2015 used five databases and focused on observational studies of healthcare professional's management of childhood diarrhea in low-income countries. Results A total of 21 studies were included in the review. Eight studies used a survey design while three used some type of simulated client survey referring to a fictitious case of a child with diarrhea. Retrospective chart reviews were used in one study. Only one study used direct observation of the healthcare professionals during practice and the remaining eight used a combination of research designs. Studies were completed in South East Asia (n = 13), Sub-Saharan Africa (n = 6) and South America (n = 2). Conclusion Studies report that healthcare providers have adequate knowledge of the etiology of diarrhea and the severe signs of dehydration associated with diarrhea. More importantly, regardless of geographical settings and year of study publication, inconsistencies were noted in healthcare professionals’ physical examination, prescription of oral rehydration solutions, antibiotics and other medications as well as education provided to the primary caregivers. Factors other than knowledge about diarrhea were shown to significantly influence prescriptive behaviors of healthcare professionals. This review demonstrates that “knowledge is not enough” to ensure the appropriate use of oral rehydration solutions, zinc and antibiotics by healthcare professionals in the management of childhood diarrhea.
Pakistan Journal of Medical Sciences. 2007 Oct-Dec; 23(6):932-935.The objectives were to compare the prevailing prescribing practices of paediatricians with minor and major diploma for common paediatric problems. It was a Cross sectional study in which 10 % of children visiting the outpatient department of paediatrics, Hamdard university hospital with gastroenteritis and Acute respiratory infections, diagnosed according to UNICEF/ WHO protocol were enrolled, their prescriptions checked and results were entered in specially designed Performa. Five hundred prescriptions were reviewed of which 308 were due to Gastro enteritis, 192 were due to respiratory tract infections1). Average numbers of drugs/ prescription were 3.33 +or- 1.2. Paediatricians with minor diploma prescribed 3.5 +or- 1.2 drugs/ prescription. Paediatricians with major diploma prescribed 2.8 +or-1.2 drugs/ prescription (p-valve 0.32) Antibiotic in diarrhoea and respiratory tract infections (upper and lower respiratory tract infections were written in 81.7% cases by paediatricians with lower diploma and 77.7 % cases by paediatricians with major diploma (p-valve 0.27). In respiratory tract infections antihistamines were prescribed in 79.7% of cases by paediatricians with minor diploma and 69.5 % cases by paediatricians with major diploma (p-valve0.11). Anti emetic in Gastroenteritis were written in 69.1% cases by paediatricians with minor diploma and 56.2% cases by Paediatricians with major diploma (p-valve 0.021). More drugs and more antibiotic were given by doctors, with major diploma. Antibiotics were totally different than recommended by the National ARI programme, which the Paediatricians teach in Medical Colleges. The antibiotics prescribed for common Paediatric Problems were totally different than recommended by the National ARI programme which the Paediatricians teach in Medical College. Active intervention is needed to improve the quality of medical education of physicians who treat children, while in depth measures are required for the training of paediatricians. (author's)
Geneva, Switzerland, WHO, Action Programme on Essential Drugs, 1993. ii, 87 p. (WHO/DAP/93.1; DAP Research Series No. 7)The WHO Action Program on Essential Drugs has developed and field tested a core set of drug use indicators capable of describing drug use patterns and prescribing behaviors in a country, region, or individual health facility. These indicators can be used to measure the impact of interventions designed to change prescribing practices, detect performance problems, and compare the performance of providers and institutions. Three categories have been developed: 1) prescribing indicators--average number of drugs per encounter, percentage of drugs prescribed by generic name, percentage of encounters with antibiotic prescribed, percentage of encounters with injection prescribed, and percentage of drugs prescribed from essential drugs list or formulary; 2) patient care indicators--average consultation time, average dispensing time, percentage of drugs actually dispensed, percentage of drugs adequately labelled, and patients' knowledge of correct dosage; and 3) facility indicators--availability of copy of essential drugs list or formulary and availability of key drugs. All data required to measure the core indicators can be derived from medical records or direct observation. Field testing in developing countries such as Nigeria and Tanzania found these measures both feasible to obtain and informative as first-level indicators. Also presented are descriptions of key issues related to study design and sampling, field methods, analysis, and follow up.
Social Science and Medicine. 1996 Apr; 42(7):1011-9.Inappropriate drug use is a major problem in the control of diarrheal diseases. Addressing the problem, the World Health Organization's (WHO) Program for the Control of Diarrheal Diseases reviewed the literature on the most commonly used antidiarrheal agents, and distributed the resulting document widely in 1990. Individual and group campaigns against the registration and use of antidiarrheal drugs also brought considerable attention to the issue in the popular media. This article evaluates the actions taken against antidiarrheal drugs by national drug regulators during and after these events, January 1989 through December 1993. Information on regulatory actions was requested from countries and extracted from published and unpublished sources. 16 countries reported regulatory actions on 21 occasions during the period of study, with the majority of actions taken against antimotility drugs. Few were against adsorbents, antidiarrheal drugs containing antimicrobials, or adult formulae. Six countries took action against large and heterogenous groups of antidiarrheal drugs, with most actions occurring within two years of the distribution of the WHO review and the attention in the media. Many more antidiarrheal drugs may lose their register in the future through a passive deregistration process. The deregistration of inappropriate drugs, however, will probably take quite a while, with widespread deregistrations unlikely. Moreover, regulatory actions alone are probably not enough to achieve a more appropriate use of drugs. Greater effect can be expected from simultaneous regulatory, managerial, and educational interventions directed at providers, combined with communication to the general public.
SANTE-SALUD. 1993 Summer; (2):5-6.The World Health Organization (WHO) has coordinated and supported the eradication of malaria in various countries of the world since 1957. Unlike some countries in the temperate zone which have been successful in eradicating the disease, malaria remains endemic in tropical and subtropical countries. In 1969 WHO recommended that, although eradication should remain an ultimate goal, malaria control operations may form a transitional phase in countries where eradication does not appear feasible. Malaria control, however, remains an impossible goal in many countries where the disease is endemic. Plasmodium falciparum is the predominant malaria pathogen responsible for severe disease and death. It is estimated that 90% of all malaria cases worldwide occur in Africa, where the majority of people live in highly endemic or endemic prone areas. Only about 12% of the population lives in risk-free or low-risk areas. Between one-third and two-thirds of all cases of fever among children are associated with malaria, and in some parts of Africa the case-fatality rate is as high 31.9% for infants and 20.4% for children. The malaria situation in the African continent is rapidly changing due to variants of P. falciparum that are resistant to chloroquine; mosquitoes that are resistant to insecticides; movement of nonimmune individuals to endemic areas; increasing short-term travel patterns; and ecological reasons. Malaria is also appearing in previously free areas because of technological (agricultural) advances. Adult and pediatric dosages of antimalarial drugs are suggested for the treatment and prevention of P. falciparum malaria.
Social Science and Medicine. 1992 May; 34(9):959-64.Insufficient information contributes to failure in markets. Government officials also use it to justify intervention in the health sector in the developing countries. Further, in these countries,health care workers have misused pharmaceuticals considerable as well as make improper diagnoses. Moreover both health practitioners and the general public do not always follow instructions on drug use. A shortage of information on appropriate use may indeed cause these problems. A staff member of the World Bank proposes a methodology to use to balance 2 competing risks. Either public health officials allow drugs to be available to consumers over the counter or they require a prescription from a licensed health professional. The risks include obvious diagnostic errors made my consumers untrained in medicine and patients not receiving needed, potentially life saving, drugs. Since there is a shortage of medical personnel in most developing countries, people face considerable obstacles (e.g., travel time and expense) when it comes time to go to a licensed medical facility. The proposed methodology to evaluate the tradeoff between the 2 risks involves looking at the problems as one of determining the value of a more accurate diagnosis through the intervention of a skilled professional as a specific and costly mechanism for acquiring an accurate diagnosis. The article applies the model to illustrative examples to identify the information to answer the regulatory issue question. Further the model also allows public health policy makers to determine the appropriate level of training needed for medical professionals and to evaluate projects which improve public access to information on the use of drugs.
ESSENTIAL DRUGS MONITOR. 1991; (11):12-4.In the late 1980s, the WHO Action Programme on Essential Drugs conducted an evaluation of the drug ration kit system in developing countries. The most successful effect on the kit system was the much improved availability of essential drugs in rural health facilities. External donors tended to pay for and supply the essential kits, however, which contributed to better availability. In those cases, where external funding did not exist, lack of funds were a major problem. Indeed the evaluation determined that the sustainability of the kit system is dependent on funding. The kit system diminished the practice of drugs being diverted to other levels of health care and wastage by expiry. Most kit programs included training for health workers in diagnosing and treating a limited list of common diseases which led to rational prescribing. An ample supply of essential drugs lent itself to quality health care and revealed ruthlessly any weaknesses in the health system, such as lack of training. It took about 2 years to iron out the problems of estimating requirements and achieving a stable kit content. Accumulation of surpluses sometimes occurred early in the kit program. The drugs that accumulated are usually stable and inexpensive drugs (oral rehydration salts and iron tablets), however. The biggest problems of matching need and supply arose from suppliers, e.g., long delivery times. The evaluation showed that a kit system can operate if health workers can adequately identify essential drugs, funding can be secured, and management if well trained and dedicated. In conclusion, the kit system addresses the logistic problem and lends itself to rational prescribing.
In: Advances in international maternal and child health. Volume 7. 1987, edited by D.B. Jelliffe and E.F.P. Jelliffe. Oxford, England, Clarendon Press, 1987. 170-9.General principles of the WHO Essential Drug List (EDL) and the International Non-Proprietary Names (INN) list and their application to maternal and child health are summarized. 8 principles of good prescribing habits are introduced, such as careful dosing for infants, children, pregnant or lactating women, elderly, or those with liver or kidney disease. Most INN drug names are identical to the generic names used in the country of origin, but some are coined from common chemical or pharmacological stems. Drugs for pregnant women should be limited in number, and used with care since almost all cross the placenta and may not be tolerated by the fetus with its immature liver and kidneys. The most serious reason for restricting certain drug intake by pregnant women is the risk of teratogenicity, particularly in the 1st trimester. Potential teratogens include antiepileptics, barbiturates, cytotoxics, anticoagulants, and female sex hormones. Salicylates should not be taken near term. Opioid analgesics should not be used during labor. Drugs dangerous for the infant during breastfeeding include high dose oral contraceptives, the antithyroid drugs thiouracil and iodine, diazepam and lithium. Education and training in pharmacokinetics for personnel in maternal-child health should be included. Fixed combinations of drugs are not advisable: out of 220 drugs in the EDL, there are only 11 drug combinations.
London, England, London School of Hygiene and Tropical Medicine, Evaluation and Planning Centre for Health Care, 1985 Winter. 97 p. (EPC Publication No. 8)Many developing countries spend sizeable sums on the purchase of drugs yet an estimated 60-80% of their populations, particulary in rural areas, do not have constant access to even the most essential drugs. The provision of adequate amounts of effective drugs to treat the most important and common disease conditions is crucial if health services are to be effective and credible. Many problems are associated with the provision and utilization of therapeutic drugs in developing countries: inequitable access to cost-effective safe drugs; inequitable production and consumption with market concentration in the hands of a few multinationals encouraging competition based on product differntion and not price; escalating drug costs; inefficient procurement, distribution, management; and irrational prescription and consumption. To combat these problems, the essential drug concept was introduced by the WHO in 1977. In 1981, WHO established a special Action Program on Essential Drugs. This is a worldwide collaborative program that aims at urging member states to adopt national drug policies, as well as helping developing countries procure and use essential drugs. Several countries have implemented some of the suggestions of the Drug Action Program. Though some progress has been made towards achieving an increase in the use and availability of cost-effective drugs, very few countries have succeeded in decreasing the use of unsafe drugs and those of low cost-effectiveness. Effective legislation is a prerequisite to the effective use of drugs. Recommended action for governments of developing countries to involve the private sector include: creating incentive for increased domestice production; controlling promotional practices; and exerting price controls.
Tropical Doctor. 1984 Jan; 14(1):8.Enormous problems in developing countries concerning drug supply, such as inadequate control of money spent on drugs, insufficient government supervision of the importation and distribution of drugs, dumping, and so on, prompted the World Health Organization to set up an expert committee to compile a list of drugs which would provide adequate health care. This Essential Drug list is intended to extend the accessibility of the most necessary drugs to those populations whose basic health needs could not be met by the existing supply system. In cooperation with Medicus Mundi Nederland the use of this basic list is investigated in a population of medical doctors in Africa, sent out by Medicus Mundi. Investigated were: actual use of the essential drug; use of other drugs in the same pharmacotherapeutical group; priority; availability; and suppliers. In addition, insight into a number of other factors, such as the number of patients, beds, stocklists, local production, and supply of information, was obtained. The total number of patients in the combined areas was about 3,500,000. It was found that 3% of WHO's suggested drugs were not used at all, 22 essential drugs were used by only 5% of the doctors, and 41 essential drugs were used by more than 95% of the doctors. In the 1979 Revised List 25 drugs had been added and 10 deleted, compared with the 1st list, although it should be remembered that the differences were not always great. Several essential drugs mentioned for the 1st time in the Revised List are little used. Some complementary drugs scored better than the essential drugs from the same group. A number of drugs not mentioned in the List of Essential Drugs have a high priority. The results of the inquiry will be useful to evaluate the list further.
Tropical Doctor. 1984 Jan; 14(1):3-7.On April 27, 1982 the Ministry of Health of the government of Bangladesh, set up an 8-man expert committee to evaluate all the registered pharmaceutical products presently available, and to formulate a draft National Drug Policy. Objectives are: 1) to provide support for ensuring quality and availability of drugs; 2) to reduce drug prices; 3) to eliminate useless, nonessential, and harmful drugs from the market; 4) to promote local production of finished drugs; 5) to ensure coordination among government branches; 6) to develop a drug monitoring and information system; 7) to promote the scientific development and application of unani, ayurvedic, and homeopathic medicines; 8) to improve the standard of hospital and retail pharmacies; and 9) to insure good manufacturing practices. 16 criteria were agreed on as guidelines for evaluating the drugs on the country's market. Drugs in Bangladesh have been classified into 3 categories. The 1st is drugs that are positively harmful. They should be banned immediately and withdrawn from the market. There are 265 locally manufactured drugs and 40 imported drugs in this category. The 2nd, drugs to be slightly reformulated by eliminating some of their requirements. There are 134 drugs in this category. The 3rd is drugs that do not conform to 1 or more of the 16 criteria/guidelines. There are over 500 drugs in this category. The new drug policy will produce a saving of 800 million taka (US $32.4 million). Drug supply in Bangladesh is a problem. The public sector distributes 20% of the total. In the private sector, drugs are supplied through import and local production. Investment for research by the pharmaceutical companies is essential. The principles laid down by the International Federation of Pharmaceutical Manufacturers Associations for the supply of good medicine needs to be put into practice.
In: National Council for International Health [NCIH]. Pharmaceuticals and developing countries: a dialogue for constructive action. Washington, D.C., NCIH, 1982 Aug. 14-20.The US Food and Drug Administration (FDA) carries out its activities relating to drugs in developing countries through dealing with drug registration authorities in each country as well as through the World Health Organization (WHO), the Office of International Health in the Public Health Service, and the Pharmaceutical Manufacturers Association. In addition about 300 foreign government officials visit the FDA annually to learn about its practices and to inquire about drug legislation practices. The FDA is often asked for copies of documents regarding drug approval and has a regular mailing list for its publications. FDA officials participate in pharmaceutical-related WHO expert committees and its International Affairs Staff provides personnel for on-site technical assistance in developing countries which are trying to improve their drug quality. There are bilateral agreements with a number of developing countries such as Egypt and Nigeria. Work is now being performed with WHO to develop new drug application standards.
World Health. 1981 May; 18-9.Conflict of interest between the public health sector and the commercial sector has given rise to the controversial question of regulating prophylactic, diagnostic, and therapeutic substances. The public health sector contends that effective drug regulation and control is necessary in any public health administration while the pharmaceutical industry claims that strict criteria for drug approval interferes with innovative research and drug development. In many countries, political pressures result in priority being given to commercial development rather than to health development. In view of this controversy, the WHO Regional Office for Europe sponsored a series of 9 symposia on "Clinical pharmacological evaluation in drug control" starting in 1972. The first symposium held in Heidelberg, Germany involved the assessment of preclinical data, selection of investigators and subjects for early human studies, design of clinical trials, assessment of risk/benefit in drug evaluation, and drug monitoring. The need to establish more facilities and to provide teaching in clinical pharmacology at both under- and post-graduate levels was emphasized. Also proposed during the meeting was the holding of pharmacological seminars at country and intercountry levels, international exchanges of clinical pharamacologists, and seminars on methodological and clinical pharmacologic aspects of drug consumption. The rest of the symposia discussed the following: 1) comparative studies on drug evaluation practice in various countries; 2) assessment of evaluation of specific groups of drugs; 3) evaluation of drugs in man at a European level; and 5) evaluation of conclusions and recommendation of previous symposia and provision of guidance for planning possible future meetings (e.g., focus on drugs for elderly, and for infants and children). The interest generated by the findings of the symposia has not been limited to the European region.
Some factors influencing the regulation of pharmaceuticals in developing countries, with particular reference to Africa.
International Digest of Health Legislation. 1980; 31(3):453-83.This long review discusses a few of the factors liable to influence attempts at drug regulation in developing countries, i.e., the existing situation with regard to pharmaceuticals and some of the manifold factors (psychosocial, geopolitical, etc.) that are likely to affect legislation, particularly in countries recently achieving independence, as well as all developing countries. Sections in the monograph include, an analysis of the present situation of pharmaceutical distribution and regulation in developing countries; problems in the regulation of pharmaceuticals in Africa; analysis of legislation already in force (including those countries which have communicated their legislation to WHO and those who have not and why); adequacy of pharmaceutical supplies and approriateness of legislation; priorities (e.g., pricing, regulation, importation, distribution, quality control, and substance control); and problems connected with enforcement of legal measures (e.g., unguarded frontiers, inadequacy of administration, regional uniformity of legislation, and shortage of qualified pharmacy and medical personnel). The monograph ends with published pharmaceutical legislation in developing countries, from Algeria to Zambia.
Weekly Epidemiological Record / Releve Epidemiologique Hebdomadaire. 1982 Dec 10; 57(49):381-4.In view of reports of resistance of the Malaria parasite Plasmodium falciparum in localities in East Africa to the prophylactic drug chloroquine, the WHO has made medium-term recommendations for drug suppression, pending a thorough review. There are 3 types of drugs available for malaria suppression: the dihydrofolate reductase inhibitors (DHFR), the 4-amino-quinolines (chloroquine and amodiaquine), and the dihydropteroate synthetase inhibitors (DHPS). The DHPS drugs, proguanil, pyrimethamine or others, are no longer considered adequate used alone. The DHPS drugs Fansidar and Maloprim are already being used in part of South America and East Asia where the M. falciparum has become chloroquine resistant. Recommendations for prophylaxis in Africa depend on the type of risk. Non-immune travellers should take chloroquine or amodiaquine 300 mg weekly and carry a treatment course of sulfadoxine-pyrimethamine in case of fever. The triple drug regimen is not advised because of chance of selection of resistant malaria parasites. Non-immune residents may take chloroquine as recommended for a total of 6.5 years. Those residing longer should take preventive measures against mosquito bites and use treatment if affected. Among semi-immune residents, only pregnant women past the 4th month should take chloroquine, and if infected use quinine or antibiotics (not tetracycline). Special at-risk groups such as army units should rely on preventive measures to reduce selection of resistant parasites.