Pharmaceutical Regulatory Framework in Ethiopia: A Critical Evaluation of Its Legal Basis and Implementation

Suleman, Sultan; Woliyi, Abdulkadir; Woldemichael, Kifle; Tushune, Kora; Duchateau, Luc; Degroote, Agnes; Vancauwenberghe, Roy; Bracke, Nathalie; Spiegeleer, Bart De

doi:10.4314/ejhs.v26i3.9

Cited by 43 publications

(46 citation statements)

References 8 publications

(8 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Although there are encouraging signs, the existing situation signals the urgent need to enforce the legislative framework at all levels to reduce and prevent illegal marketing and use of veterinary drugs. A similar failure to adequately regulate and control medicinal products for human use has already been reported in the country [ 31 ].…”

Section: Discussionsupporting

confidence: 58%

Aberrant use and poor quality of trypanocides: a risk for drug resistance in south western Ethiopia

Tekle¹,

Terefe

Cherenet³

et al. 2018

BMC Vet Res

View full text Add to dashboard Cite

BackgroundTrypanocidal drugs have been used to control African animal trypanosomosis for several decades. In Ethiopia, these drugs are available from both authorized (legal) and unauthorized (illegal) sources but documentation on utilization practices and quality of circulating products is scanty. This study looked at the practices of trypanocidal drug utilization by farmers and the integrity of active ingredient in trypanocides sold in Gurage zone, south western Ethiopia. The surveys were based on a structured questionnaire and drug quality determination of commonly used brands originating from European and Asian companies and sold at both authorized and unauthorized markets. One hundred farmers were interviewed and 50 drug samples were collected in 2013 (Diminazene aceturate = 33 and Isometamidium chloride = 17; 25 from authorized and 25 from unauthorized sources). Samples were tested at the OIE-certified Veterinary Drug Control Laboratory (LACOMEV) in Dakar, Senegal, by using galenic standards and high performance liquid chromatography.ResultsTrypanosomosis was found to be a major threat according to all interviewed livestock keepers in the study area. Diminazene aceturate and isometamidium chloride were preferred by 79% and 21% of the respondents respectively, and 85% of them indicated that an animal receives more than six treatments per year. About 60% of these treatments were reported to be administered by untrained farmers. Trypanocidal drug sources included both unauthorized outlets (56%) and authorized government and private sources (44%). A wide availability and usage of substandard quality drugs was revealed. Twenty eight percent of trypanocidal drugs tested failed to comply with quality requirements. There was no significant difference in the frequency of non-compliance between diminazene-based and isometamidium chloride products (P = 0.87) irrespective of the marketing channel (official and unofficial). However, higher rates of non-compliant trypanocides were detected for drugs originating from Asia than from Europe (P = 0.029).ConclusionThe findings revealed the presence of risk factors for the development of drug resistance, i.e. wide distribution of poor quality drugs as well as substandard administration practices. Therefore, it is strongly recommended to enforce regulatory measures for quality control of veterinary drugs, to expand and strengthen veterinary services and to undertake trypanocidal drug efficacy studies of wider coverage.Electronic supplementary materialThe online version of this article (10.1186/s12917-017-1327-6) contains supplementary material, which is available to authorized users.

show abstract

Section: Discussionsupporting

confidence: 58%

Aberrant use and poor quality of trypanocides: a risk for drug resistance in south western Ethiopia

Tekle¹,

Terefe

Cherenet³

et al. 2018

BMC Vet Res

View full text Add to dashboard Cite

show abstract

“…Ethiopia, Thailand, the United Republic of Tanzania and Zimbabwe, is on drug quality and licensing rather than availability and distribution channels. [10][11][12] In Thailand, the 1987 Drug Act did attempt to regulate the availability of some antibiotics, by dividing antibiotics into a large group of "dangerous drugs not requiring prescriptions" and a much smaller group of "special-control drugs requiring prescriptions". 30 This categorization meant that most antibiotics could be dispensed, by licensed pharmacists in retail pharmacies, without a prescription.…”

Section: Regulatory Environmentmentioning

confidence: 99%

“…Furthermore, in such countries, the enforcement of the drug regulations that do exist is often poor and the sale of substandard over-thecounter antibiotics and weak pharmaco-vigilance are often common. [10][11][12] One of the main aims of the Global Action Plan on Antimicrobial Resistance, which was adopted by the World Health Assembly in 2015, was to optimize the use of antibiotics in human and veterinary medicine. 13 A key goal of Thailand's subsequent National Action Plan on Antimicrobial Resistance, which was developed and endorsed by the Thai Cabinet in 2016, was to reduce antibiotic consumption, by 20% in human medicine and by 30% in veterinary medicine by 2021.…”

Section: Introductionmentioning

confidence: 99%

Antibiotic distribution channels in Thailand: results of key-informant interviews, reviews of drug regulations and database searches

Sommanustweechai

Chanvatik

Sermsinsiri

et al. 2018

Bull. World Health Organ.

View full text Add to dashboard Cite

Objective To analyse how antibiotics are imported, manufactured, distributed and regulated in Thailand. Methods We gathered information, on antibiotic distribution in Thailand, in in-depth interviews – with 43 key informants from farms, health facilities, pharmaceutical and animal feed industries, private pharmacies and regulators– and in database and literature searches. Findings In 2016–2017, licensed antibiotic distribution in Thailand involves over 700 importers and about 24 000 distributors – e.g. retail pharmacies and wholesalers. Thailand imports antibiotics and active pharmaceutical ingredients. There is no system for monitoring the distribution of active ingredients, some of which are used directly on farms, without being processed. Most antibiotics can be bought from pharmacies, for home or farm use, without a prescription. Although the 1987 Drug Act classified most antibiotics as “dangerous drugs”, it only classified a few of them as prescription-only medicines and placed no restrictions on the quantities of antibiotics that could be sold to any individual. Pharmacists working in pharmacies are covered by some of the Act’s regulations, but the quality of their dispensing and prescribing appears to be largely reliant on their competences. Conclusion In Thailand, most antibiotics are easily and widely available from retail pharmacies, without a prescription. If the inappropriate use of active pharmaceutical ingredients and antibiotics is to be reduced, we need to reclassify and restrict access to certain antibiotics and to develop systems to audit the dispensing of antibiotics in the retail sector and track the movements of active ingredients.

show abstract

“…11 According to reports, the weak implementation of pharmaceutical regulations in the country intensifies the problems. 12 Besides, pharmaceutical distribution chain evaluations showed a considerable effect on drug quality. Different forms of transportations seen to cause product instability; poor storage conditions lead drugs to degradation and then to toxicity.…”

Section: Introductionmentioning

confidence: 99%

<p>Physicochemical Quality Assessment of Antimalarial Medicines: Chloroquine Phosphate and Quinine Sulfate Tablets from Drug Retail Outlets of South-West Ethiopia</p>

Abuye¹,

Abraham²,

Kebede³

et al. 2020

IDR

Self Cite

View full text Add to dashboard Cite

Background: Malaria is a complex disease and main community health problem in Africa and the top leading cause of outpatient visits, admissions, and deaths in Ethiopia. Its effective management is possible through early diagnosis and immediate treatment employing antimalarials. The quality of these drugs has to be good enough to attain their intended purpose. However, there are treatment failures resulted from the consumption of falsified and substandard antimalarials. Therefore, the current study was undertaken to evaluate the quality of two commonly used antimalarial drugs [chloroquine phosphate and quinine sulfate tablets] and to determine whether the quality of these drugs was affected by the origin, brand and sample collection sites in SouthWest Ethiopia. Methods: Random sampling based on Ethiopian malaria eco-epidemiological strata map, with different levels of medicines outlets, was applied to select sampling sites. Results: Sixty samples were bought from 43 drug retails (pharmacy, drug store, and drug vendor) in twelve different geographical locations of SouthWest Ethiopia between June and July 2016. Visual inspection was done for all samples before the lab experiment. A 28.3%, 31.7%, and 6.8% of samples failed to comply with the Pharmacopoeial quality standards for visual inspection, hardness and weight variation tests, respectively. Statistical analysis revealed that origin and geography from which samples were collected significantly affects the active pharmaceutical content of both drugs at P < 0.05 level. Significant variation was observed for chloroquine samples within batches of the same manufacturing and between origins. Conclusion: This study indicated that all the chloroquine and quinine tablets met the quality specification concerning friability, dissolution and assay. Out-of-specification results for weight variation, hardness and visual inspection tests for the chloroquine tablets are signs of substandard/ spurious/falsely labeled/falsified/counterfeit actions that may compromise the quality of these drugs. Besides, within the acceptance limit, the origin of drugs and collection sites have found to determine the quality which raises good manufacturing practice and storage (drug supply chain system) issues to be evaluated.

show abstract

Pharmaceutical Regulatory Framework in Ethiopia: A Critical Evaluation of Its Legal Basis and Implementation

Cited by 43 publications

References 8 publications

Aberrant use and poor quality of trypanocides: a risk for drug resistance in south western Ethiopia

Aberrant use and poor quality of trypanocides: a risk for drug resistance in south western Ethiopia

Antibiotic distribution channels in Thailand: results of key-informant interviews, reviews of drug regulations and database searches

<p>Physicochemical Quality Assessment of Antimalarial Medicines: Chloroquine Phosphate and Quinine Sulfate Tablets from Drug Retail Outlets of South-West Ethiopia</p>

Contact Info

Product

Resources

About