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Question - Consider the ways in which post marketing surveillance can be carried out, some are listed

below, discuss the limitations associated with each of them

a) Case reports

b)Case control study

c)Cohort study

d)Yellow card scheme

e)Patient information


info


How are adverse drug reactions monitored?


Adverse drug reactions (ADRs) are monitored as part of the process of pharmacovigilance.



The MHRA classify Pharmacovigilance in the following way:


• Monitoring the use of medicines in everyday practice to identify previously unrecognized adverse effects or changes in the patterns of adverse effects


• Assessing the risks and benefits of medicines to determine what action, if any, is necessary or needed to improve their safe use


• Providing information to health care professionals and patients to optimize safe and effective use of medicines


• Monitoring the effect of any action taken


The MHRA is responsible for the monitoring the safety of all medicines marketed in the UK and data from the UK spontaneous reporting scheme, the Yellow Card Scheme, underpins the process of pharmacovigilance in the UK. 


However, the UK pharmacovigilance system does not rely solely on ADR reporting. The other data sources regularly used in the monitoring of drug safety in the UK include formal safety studies, the published medical literature, information from pharmaceutical companies and other Regulatory Authorities throughout the world together with information on the level of drug prescribing.


The MHRA issues safety warnings and guidance to healthcare professionals and these can be found on the MHRA website:


https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency 



A multi-disciplinary team at the MHRA is responsible for the operation of the General Practice Research Database (GPRD), which is the world's largest database of anonymized longitudinal medical records from primary care.



Spontaneous ADR reporting 


The MHRA and the Commission on Human Medicines (CHM) run the UK's spontaneous ADR reporting scheme, called the Yellow Card Scheme, it receives voluntary reports of suspected ADRs from health professionals and members of the public.


The Yellow Card Scheme alerts the MHRA and CHM to potential safety concerns such as previously unrecognised ADR or ADR related to a specific drug. It also helps to confirm a signal of an ADR with limited information from an alternative data source. 

https://yellowcard.mhra.gov.uk/the-yellow-card-scheme/ 


Pharmacovigilance and reporting of ADRs are important because the information collected during the pre-marketing phase of drug development is inevitably incomplete with regard to possible ADRs:

 

• Tests in animals are insufficient to predict human safety.

• Participants in clinical trials are selected and limited in number, the conditions of actual use differ from those in clinical trials and trials have limited duration.

• Exposure of fewer than 5000 human subjects to a drug allows only the more common ADRs to be detected before the drug is licensed.

• At least 30,000 people need to be treated with a drug to be sure that at least 1 person with an ADR that has an incidence of 1 in 10,000 exposed persons is not missed.

• Information about rare but serious adverse reactions, long-term effects, and use in special groups (such as children, elderly people, or pregnant women) or drug interactions is often incomplete or not available.

• Therefore, it is vital that the safety of all medicines is monitored throughout their marketed life. Consequently, pharmacovigilance and reporting of ADRs are important to permit detection of less common but sometimes very serious ADRs.



The National Reporting and Learning System (NRLS) is a central database of patient safety incident reports and aims to identify hazards, risks and opportunities to improve patient safety. 


https://report.nrls.nhs.uk/nrlsreporting/

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