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A Study On Clinical Practice

Decent Essays

7. When Noxafil® was launched in 2005 the BNF the monograph would have included the symbol ▼. What is this symbol? Why would this symbol have been included in the early monographs for Noxafil®? Include in your answer (a) a description of what the system represents and (b) what are its implications for clinical practice in the scenario? (20 marks) This symbol is known as the black triangle. It is used in the BNF monograph of any medicine that is new. The definition of new as set by the MHRA is as follows. ‘’Any medicine or vaccine which: A) contains a new active ingredient or biosimilar medicine, B) new combination of medicine or active ingredients, C) new route of administration, D) new drug …show more content…

Finally the length of time which the company tests the drug on patients/volunteers is very limited. Pharmaceutical companies have a limited time to test the long-term safety. Therefore the medicine comes into the market with sufficient evidence of safety, and the black triangle along with the yellow card scheme accumulate information on the use of the medicine in the real world. In use of patients of differing ethnicities, different chronic and acute conditions, differing patients with multiple medications and also patients of a variety of occupations. Many factors affect the action of drugs that may not have been found out during the clinical testing phases. The information that is generated from the yellow card scheme is valuable for the safety of the medicine and it can be used by the MHRA to alter the indications and cautions amongst many other changes to the drug monograph. A new medicine as defined above, may have the black triangle in its monograph for a varied length of time. Once sufficient amount of information about its safety is generated and the level of pharmacovigilence can be reduced and the black triangle can be removed. This period of time is usually five years from the date of release into the market. (EMA) Having said

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