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USP 800 (Hazardous Drugs—Handling in Healthcare Settings) is a guideline created by the United States Pharmacopeia Convention (USP), as one of their General Chapters through which the USP "sets quality standards for medicines, dietary supplements and food ingredients".
The Institute for Safe Medication Practices (ISMP) is an American 501(c)(3) organization focusing on the prevention of medication errors and promoting safe medication practices. [1] It is affiliated with ECRI .
Schedule 3 (S3) drugs and poisons, otherwise known as Pharmacist Only Medicines, are substances and preparations for therapeutic use that – are substantially safe in use but require professional advice or counselling by a pharmacist; require pharmacist advice, management, or monitoring; are for ailments or symptoms that –
using safe systems of work and handling procedures (written procedures, etc.). It is for the employer to decide on the method of controlling exposure. The regulations, however, limit the use of personal protective equipment (e.g. respirators, dust marks, protective clothing), as the means of protection to only those situations where other ...
Promote safe use of medicines and devices. Manage the Clinical Practice Research Datalink and the British Pharmacopoeia. The MHRA hosts and supports a number of expert advisory bodies, including the British Pharmacopoeia Commission, and the Commission on Human Medicine which replaced the Committee on the Safety of Medicines in 2005. [citation ...
In the 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.
The REMS program developed out of previous systems dating back to the 1980s for monitoring the use of a small number of high-risk drugs such as the Accutane, which causes serious birth defects, Clozaril, which can cause agranulocytosis, and Thalidomide, which is used to treat leprosy but causes serious birth defects. [4]
Errors related to medication use, lack of documentation on how medicines are prescribed, used and dispensed, as well as insufficient communication have a considerable impact on national mortality and morbidity rates. Therefore, the safe and appropriate use of medicines, which depends on the right information being available to those that need ...