Tools used in post-marketing pharmacovigilance

The various methods and resources used in post-marketing pharmacovigilance are data from healthcare professionals, marketing authorisation holders, regulatory authorities, world wide published literature and academic institutes. Several methods exist for studying adverse drug reactions in marketed medicines, including spontaneous reporting, prescription event monitoring, pharmacoepidemiological studies like cohort studies, case control studies, disease registries and various other automated databases.

Dealing with faulty medicines: Medicines & Medical Device Regulation

The MHRA’s Defective Medicines Report Centre (DMRC) issues alerts to healthcare professionals,

hospitals, GP surgeries, and wholesalers to tell them when a medicine is being recalled or when there are concerns about the quality that will affect its safety or effectiveness. These alerts are graded according to the seriousness of the threat to the public’s health: Class 1 requires immediate recall, because the product poses a serious or life threatening risk to health. Class 2 specifies a recall  within 48 hours, because the defect could harm the patient but is not life threatening. Class 3 requires action to be taken within 5 days because the defect is unlikely to harm patients and is being carried out for reasons other than patient safety. Class 4 alerts advise caution to be exercised when using the product, but indicate that the product poses no threat to patient safety. Most recalls fall into classes 2 or 3.

How are devices authorised- MHRA

In general, a medical device cannot be marketed in Europe without carrying a CE marking. A CE marking is applied by the manufacturer and means that the device meets the relevant regulatory requirements and, when used as intended, works properly and is acceptably safe.For all but the very lowest risk devices, such as unmedicated bandages, this must be verified by an independent certification body, called a Notified Body, before the CE marking can be affixed. The MHRA is responsible for appointing UK Notified Bodies and regularly audits them to ensure that they perform to high standards.
Manufacturers should be able to support their performance claims for the device. In many cases,
and in particular for higher risk devices, this information will come from a clinical trial. Where
a manufacturer plans to carry out a clinical trial in the UK, agreement must be obtained from the MHRA. On average, the Agency refuses one in five such requests on the grounds of patient safety or health policy restrictions.

Monitoring new medicines and vaccines- MHRA

New chemicals and vaccines are effectively put on probation for up to two years and labelled with a black triangle to ensure prescribers are aware of the need to monitor them carefully. The black triangle symbol accompanies new medicines and vaccines in prescribing manuals, product information, and advertising material. It prompts healthcare professionals to report any potential side effects to the MHRA. This information helps to build up a broader picture of how the treatment works in the general population and enables the MHRA to act promptly, should a previously unrecognised and serious side effect come to light. The black triangle may also be assigned to a medicine that has already been licensed if it contains a new combination of active chemicals or if it is being used in a new way or for a different condition. The black triangle is not removed until the MHRA is satisfied that the medicine works safely in large numbers of people. Additionally, the MHRA also asks manufacturers to keep a close watch on side effects that may be associated with newly marketed products.