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The Guideline Development Group then finalises the recommendations and the National Collaboration Centre produces the final guideline. This is submitted to NICE to formally approve the guideline and issue the guidance to the NHS. [citation needed] To date NICE has produced more than 200 different guidelines. [27]
Pursuant to article 54 of Council Directive 2001/83/EEC, the full registered name, dosage form, route of administration, posology and warnings of medicine should be incorporated in all drug labelling as regulated by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom. [7]
The guidance was provided by pharmacists and doctors whose expertise was in the care of adults. This was an anomaly, [ 4 ] as in relation to responses to medicines, the difference between a newborn and a sixteen-year-old is greater than the difference between a sixteen-year-old and a sixty-year-old.
The British National Formulary (BNF) is a United Kingdom (UK) pharmaceutical reference book that contains a wide spectrum of information and advice on prescribing and pharmacology, along with specific facts and details about many medicines available on the UK National Health Service (NHS).
Clinical Pharmacology - tells how the medicine works in the body, how it is absorbed and eliminated, and what its effects are likely to be at various concentrations. May also contain results of various clinical trials (studies) and/or explanations of the medication's effect on various populations (e.g. children, women, etc.).
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
Medicines reconciliation or medication reconciliation is the process of ensuring that a hospital patient's medication list is as up-to-date as possible. It is usually undertaken by a pharmacist and may include consulting several sources such as the patient, their relatives or caregivers, or their primary care physician .
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]