Drug Regulation and Control in Nigeria: the Challenge of Counterfeit Drugs

Erhun, Wilson O.; Babalola, Oladipo O; M.O., M.O.

doi:10.12927/whp..17597

Cited by 73 publications

(87 citation statements)

References 9 publications

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“…Previous studies showed that university undergraduate students are involved in misuse and abuse of various drugs 7,12,13,14 . However, in Nigeria, implementation of regulations governing the distribution, sales and use of antibiotics and other prescription medicines are weak, and sometimes non-existent 15 . As a result, the populace are at more risk of irrational use of drugs including antibiotics 2,7,12,14 .…”

Section: Introductionmentioning

confidence: 99%

Use of antibiotics among non-medical students in a Nigerian university

Sanya¹,

Titilayo²,

Adisa³

et al. 2014

Afr H. Sci.

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Background: Antibiotic misuse is a major contributory factor to treatment failure, antibiotic resistance and high healthcare costs. Objectives: To evaluate level of self-reported antibiotic misuse among non-medical undergraduate students of a Nigerian university. Methods: Respondents' knowledge of antibiotics and disposal system for left-over antibiotics were explored using a structured questionnaire. Data were summarized with descriptive statistics. Chi square was used to evaluate relationship between specific categorical variables and respondents' opinions with p<0.05. Results: More than half the respondents obtained their antibiotics through doctor's prescriptions (273; 68.3%). The study revealed gross antibiotic misuse with majority, (298;74.5%) either by keeping left-over antibiotics for future use or throwing it away with refuse. Respondents (289; 72.3%) sometimes forgot to take the antibiotics. Financial constraints (73; 18.3%), long duration of treatment (70; 17.5%), side effects experienced (60;15.0%), polypharmacy (56;14.0%), tablet size (45;11.3%), and perceived low level of confidence in the prescriber (11; 2.8%) were major reasons for non-adherence. Course of study of respondents had no significant effect on respondents' knowledge or adherence (p>0.05). Conclusion: Misuse of antibiotics among non-medical undergraduate students in a Nigerian university setting is pervasive suggesting an urgent need for enlightenment on rational use and disposal of antibiotics.

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Section: Introductionmentioning

confidence: 99%

Use of antibiotics among non-medical students in a Nigerian university

Sanya¹,

Titilayo²,

Adisa³

et al. 2014

Afr H. Sci.

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“…As explained above during the procedures carried out as part of parallel trade, changes in packaging, relabelling and reconditioning provide opportunities for falsifying and counterfeiting even legitimate products [45,[62][63][64][65][80][81][82].…”

Section: International Trade -On the Brink Of Changementioning

confidence: 99%

Risks Associated with International Trading of Medicines by Non-Licensed Entities and Non-Professionals

Malangu¹

2017

International Trade - On the Brink of Change

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The making, distribution and trading of medicines can be traced back as far as antiquity. When talking about trading, sale or dispensing of medicines, it is almost impossible to separate this topic with the profession of pharmacy or pharmacists. Although most countries introduced legislations that put the trading of medicines largely in the hand of licensed businesses and professionals mainly pharmacists, informal and international trading of medicines and related substances has continued to be practiced in almost all countries due to loopholes in legislations among other reasons. This chapter highlights the risks associated with the trading of medicines by unlicensed organisations and non-professionals. These risks include the production and sale of counterfeit medicines, encouraging abuse and misuse of medicines, anti-competitive behaviour and so on. The major indings are that concessions made to allow non-licensed businesses and nonprofessionals to trade in medicines have resulted in several consequences that are threatening the whole world. It is this realisation that has prompted the recommendation that courage from decision makers is required for them to take a stand and hand over back the trading of medicines irmly in the hands of licensed professionals while outlawing loopholes that sustained the trade of medicines by unlicensed entities and non-professionals.Keywords: informal, illegal, trade, medicines, non-licensed, non-professional IntroductionThe making, distribution and trading of medicines can be traced back as far as antiquity. The making, production or manufacturing of medicines, mixtures, admixtures and other dosages forms have been performed over the years by a wide categories of people including lay peo- ple, priests, herbalists, traditional healers, midwives, medical doctors, nurses and pharmacists. As elaborated below, the practice of the art of healing was based on Arab, Egyptian, Greek and Roman texts, particularly those of Hippocrates, Aristotle, Dioscorides, Galen and others. The making of medicines was the domain of monasteries and local healers as medical training was not formalised then. The formal training and development of preparation techniques of medicinal mixtures based on standardised processes of harvesting, drying and distillation led to the abandonment of the old-fashioned herbal preparations practices by lay people who fell out of favour with the professionalization of the healing/medical community. But the distribution, sale as well as the local and international trade of medicines have been performed, in addition, by licensed and non-licensed people and businesses. This paper aims to describe and report on the risks associated with the trading of medicines by non-licensed business entities and non-professionals. In doing so, the paper elaborates on the reasons why international trade is prone to being conducted by unlicensed businesses and non-professionals, as well as on the sources of medicines traded.In order to accomplish the above, the literature search, wit...

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“…Companies are required to submit applications for the registration of medicines for the evaluation and approval; (3) Undertake appropriate investigations into the production premises and raw materials for drugs and establish relevant quality assurance systems including certification of the production sites and regulated products; (4) Undertake inspection of drugs' whole and retail sellers owned by both public or private sectors; (5) Compile standard specifications and regulations and guidelines for the production, importation, exportation, sale and distribution of drugs, cosmetics, etc. (6) Control of quality of medicines: This will be done by regular inspection and post-marketing surveillance; (7) Licensing of pharmacy premises (i.e., pharmaceutical plants, wholesalers and retail pharmacies); (8) Maintain national drug analysis laboratories for the pre-and post-marketing analysis of medicines; (9) Coordination with states departments of pharmacy to ensure the enforcement of the Act and its rules and directives.…”

Section: Aim and Objectivementioning

confidence: 99%

Faking and Counterfeiting of Drugs: Evaluation of Pharmacy Regulatory, Privatisation, Social Welfare Services and its Alternatives of Sudan

Omer¹

2017

Int. J. Curr. Res. Med. Sci.

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The strategy of price liberalisation and privatisation had been implemented in Sudan over the last decade, and has had a positive result on government deficit. The investment law approved recently has good statements and rules on the above strategy in particular to pharmacy regulations. Under the pressure of the new privatisation policy, the government introduced radical changes in the pharmacy regulations. To improve the effectiveness of the public pharmacy, resources should be switched towards areas of need, reducing inequalities and promoting better health conditions. Medicines are financed either through cost sharing or full private. The role of the private services is significant. A review of reform of financing medicines in Sudan is given in this study. Also, it highlights the current drug supply system in the public sector, which is currently responsibility of the Central Medical Supplies Public Corporation (CMS). In Sudan, the researchers did not identify any rigorous evaluations or quantitative studies about the impact of drug regulations on the quality of medicines and how to protect public health against counterfeit or low quality medicines, although it is practically possible. However, the regulations must be continually evaluated to ensure the public health is protected against by marketing high quality medicines rather than commercial interests, and the drug companies are held accountable for their conduct.

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Drug Regulation and Control in Nigeria: the Challenge of Counterfeit Drugs

Cited by 73 publications

References 9 publications

Use of antibiotics among non-medical students in a Nigerian university

Use of antibiotics among non-medical students in a Nigerian university

Risks Associated with International Trading of Medicines by Non-Licensed Entities and Non-Professionals

Faking and Counterfeiting of Drugs: Evaluation of Pharmacy Regulatory, Privatisation, Social Welfare Services and its Alternatives of Sudan

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