2.5.3 Reporting adverse events Flashcards
(11 cards)
We encourage, as a matter of best practice, the reporting of suspected adverse drug reactions under…
the Yellow Card scheme
Following a discussion with the patient regarding the adverse effect, it may also be appropriate to…
make a record in the patient’s notes and to notify the prescriber.
Where can adverse events can be reported?
online via the MHRA website: www.gov.uk; alternatively, a tear-out paper copy is available at the back of the BNF. A Yellow Card mobile app is also available through which side effects to medicines can be reported. The app also enables users to receive news updates from the MHRA.
The following examples highlight the value of the Yellow Card Scheme and the importance of reporting suspected adverse events in this way:
- Warnings were added to the product information for varenicline after the MHRA received reports of suicidal ideation via the scheme and the Yellow Card
- Reporting of adverse reactions to rimonabant (which was formerly used to treat obesity) contributed to the drug being withdrawn as new evidence meant the risks were considered to outweigh any benefits.
See Diagram 6
Patient safety professional standards
If a suspected adverse drug reaction (SADR) is related to a veterinary medicine which has affected a human and/or an animal…
refer to section 3.5.
A coronavirus yellow card reporting site coronavirus-yellowcard.mhra.gov.uk is dedicated to
Reporting any suspected side effects from medicines, vaccines and adverse incidents involving medical equipment (including ventilators or testing kits) relating to COVID-19 treatment. There is also a dedicated phone line to specifically report ventilators and respiratory support.
In regards to PATIENT SAFETY PROFESSIONAL STANDARDS,
The RPS has published
patient safety standards to support you when responding to patient safety incidents, this includes recording and reporting the incident in a timely and appropriate manner.
These PATIENT SAFETY PROFESSIONAL STANDARDS provide
a broad framework to support you to continually improve services, shape future services and roles and deliver high-quality care across all settings and sectors. Visit www.rpharms.com for the standards and supporting documents.
Diagram 6 outlines the standards and the outcomes outlined in the Patient Safety standards. For the supporting statements and further information on each standard view the standards in full at www.rpharms.com.
NATIONAL REPORTING AND LEARNING SYSTEM (NRLS)
From June 2012 the key functions for patient safety developed by the National Patient Safety Agency (NPSA) were transferred to the NHS Commissioning Board Special Health Authority - the National Reporting and Learning System (NRLS). The NPSA website continues to offer key information, guidance, tools and alerts. Healthcare organisations in England and Wales should report patient safety incidents to the NRLS (www.england.nhs.uk). The NRLS does not seek to collect identifiable information relating to staff and patients involved in an incident and so reporting is anonymous for the reporter, staff and patients.
In Scotland, each NHS board operates its own reporting system.
What tools have the RPS produced to provide guidance to help support clinical governance in pharmacy, and to promote an open culture of recording of near miss errors so that all pharmacy staff can reflect and learn from them.
The Near Miss Error Log and Near Miss Error Improvement Tool, along with supporting guidance are available from the RPS.
