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Schedule 4 (S4) drugs and poisons, otherwise known as prescription only medicines, are substances and preparations for therapeutic use that – require professional medical, dental, or veterinary management or monitoring; are for ailments or symptoms that require professional medical, dental, or veterinary diagnosis or management;
Medication therapy management, generally called medicine use review in the United Kingdom, is a service provided typically by pharmacists, medical affairs, and RWE scientists that aims to improve outcomes by helping people to better understand their health conditions and the medications used to manage them. [1]
The WHO/HAI project selects 50 medicines to survey, including 14 global core medicines, 16 regional core medicines and 20 supplementary medicines. When comparing prices, one dosage form and strength is specified for each medicine. To calculate affordability, a typical treatment schedule for a named indication is specified. For example, [6]: 95
Volume 7 - Guidelines. Volume 8 - Maximum residue limits. Concerning Medicinal Products for Human and Veterinary use: Volume 4 - Good Manufacturing Practices. Volume 9 - Pharmacovigilance. Miscellaneous: Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03)
A medical guideline (also called a clinical guideline, standard treatment guideline, or clinical practice guideline) is a document with the aim of guiding decisions and criteria regarding diagnosis, management, and treatment in specific areas of healthcare. Such documents have been in use for thousands of years during the entire history of medicine
European Union: In the EU, Good Clinical Practice is backed and regulated by formal legislation contained in the Clinical Trial Regulation (Officially Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC). [3]