Master of Science in Pharmaceutical Management Dissertation
Medicines and Allied Substances [No. 3 of 2013 47 | An Act to continue the existence of the Pharmaceutical Regulatory Authority and re-name it as the Zambia Medicines Regulatory Authority; provide for the functions and powers of the Authority; provide for the registration and regulation of pharmacie...s, health shops and agro-veterinary shops; provide for the registration and regulation of medicines and allied substances; provide for the regulation of the manufacture, importation, exportation, possession, storage, distribution, supply, promotion, advertising, sale and use of medicines and allied substances; provide for the regulation and control of clinical trials; repeal and replace the Pharmaceutical Act, 2004; and provide for matters connected with, or incidental to, the foregoing.
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CHAPTER 15:03 | Acts 14/1969, 62/1971, 35/1974, 20/1978, 41/1978 (s. 35) 39/1979, 7/1987, 11/1988, 18/1989 (s. 27), 1/1996, 6/2000, 22/2001; R.G.N. 899/1978.
This guidance should be followed if an unlicensed medicine is prepared in
a registered pharmacy. The preparation of an unlicensed medicine (for
example unlicensed methadone, or menthol in aqueous cream) in a pharmacy is called ‘extemporaneous preparation’.
The guidance should be read alon...gside the standards for registered pharmacies. These aim to create and maintain the right
environment, both organizational and physical, for the safe and effective practice of pharmacy.
By following this guidance, the pharmacy will:
• demonstrate that it meets our standards, and
• provide assurances that the health, safetyand wellbeing of patients and the public are safeguarded
Responsibility for making sure this guidance is followed lies with the pharmacy owner. If the registered pharmacy is owned by a ‘body
corporate’, the directors have responsibility.
Those responsible for the overall safe running of the pharmacy need to take into account the nature of the pharmacy and the range of services
already provided and, most importantly, the needs of patients and members of the public.
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In order to streamline and effectively control compounding of medicinal products in hospitals and pharmacies, these Guidelines for Production of Extemporaneous and Hospital Based Sterile Preparations has been crafted. The purpose of these guidelines therefore is to assist pharmacists in ...discharging their legal and professional obligations to patients in the area of extemporaneous dispensing. This guidance will help to assure the safe and appropriate preparation and supply of extemporaneously prepared medicinal products to patients, where
the supply of such products is necessary.
Extemporaneous and hospital based sterile preparations are critical for patients whose clinical needs cannot be met by registered medicinal products. The guidelines outline the principles and application of the concepts of Good Manufacturing Practice (GMP) requirements for premises, equipment, personnel, storage, quality management system, quality control, compounding processes as well as documentation.
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The Kenyan Health Sector has been playing a critical role in
providing health care services in response to the population
needs in line with the Kenya Health Policy, 2014-2030’s goal
of attaining the highest possible health standards in a manner
responsive to the population needs.
WHO recently conducted a survey to assess the availability and cost of a national tracer list of essential medicines in the outpatient sector in Ukraine using a new collection tool – the WHO Essential Medicines and Health Products Price and Availability Monitoring Mobile Application. This tool fac...ilitates rapid and inexpensive data collection at the facility level.
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The strategic framework gives guidance to public and private health facilities and health workers on compliance with standards relating to IPC practices. To further assist health facilities to implement the IPC strategic framework, this practical implementation manual has been developed in parallel ...to accompany the document.
These implementation strategies should be read in conjunction with the National Infection Prevention and Control (IPC) Strategic Framework (2020) to support an IPC programme at health facility level towards reducing healthcare-associated infections (HAI) and antimicrobial resistance (AMR). This manual is aligned with the World Health Organization (WHO) Core Component IPC programme recommendations and highlights the essentials for developing and improving IPC at health facility level in a systematic, stepwise manner for South Africa. It supports the Framework for the Prevention and Containment of AMR in South African Hospitals (2018).
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Antibiotics 2022, 11(3), 329; https://doi.org/10.3390/antibiotics11030329.
The authors found that the most-represented antibiotics on the Rwandan market were amoxicillin, co-trimoxazole and cloxacillin. No counterfeit antibiotics were found in this study. However, substandard batches with moderate ...deviations were found, suggesting that regular quality control of antibiotics is needed in Rwanda.
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2014-2020, Draft March 2014