Coronavirus (COVID-19): latest guidance for medicines safety

Key MHRA advice and guidance issued so far on medicines safety and pharmacovigilance, including on reporting to the Yellow Card Scheme.

From:
Medicines and Healthcare products Regulatory Agency
Published
27 April 2020

How the MHRA is supporting the response to COVID-19

The MHRA is working closely with DHSC and other healthcare partners on coronavirus (COVID-19; see guidance page).

We are prioritising work including:

  • Supporting and authorising the development of vaccines

  • Clinical trials of medicines

  • Managing the supply of medicines and healthcare products

Reporting side effects and safety concerns

The Yellow Card Scheme is vital in helping the MHRA monitor the safety of all healthcare products in the UK to ensure they are acceptably safe for patients and users.

During the pandemic, healthcare professionals, patients, and caregivers are asked to submit all suspected side effect reports electronically to enable us to process reports while working remotely. If you sent a Yellow Card by post after 17 March 2020, and you have not received an acknowledgement of your report, you may wish to resubmit your suspected side effect electronically.

You can report suspected side effects electronically via:

For anyone that does not have online access to report a suspected side effect to the Yellow Card Scheme, call 0800 731 6789 for free, Monday to Friday between 9:00am and 5:00pm. You can leave a message outside of these hours and someone from the Yellow Card team will get back to you.

Please continue to use the Yellow Card website to report information on suspected problems or incidents involving a defective medicine, a falsified product, and safety concerns associated with e-cigarettes or their refill containers (e-liquids). See website guidance for guidance on reporting medical devices adverse incidents.

Recent advice on medicines safety concerns

The Commission on Human Medicines (CHM) continues to advise government ministers and MHRA on the safety, efficacy, and quality of medicinal products, including medicines and vaccines. During the pandemic, an Expert Working Group of CHM is considering the latest safety data relating to COVID-19.

We will continue to monitor the safety of medicinal products, and provide updates through our information channels and alert systems. See information on the Central Alerting System page on COVID-19 alerts and registration.

Ibuprofen and NSAIDs

The Expert Working Group has advised there is currently insufficient evidence to establish a link between use of ibuprofen, or other non-steroidal anti-inflammatory drugs (NSAIDs), and susceptibility to contracting COVID-19 or the worsening of its symptoms (see MHRA statement, 14 April 2020). See also joint alert to healthcare professionals from the MHRA, NHS England and NHS Improvement, and NICE.

Antihypertensives

We have advised that is no evidence from clinical or epidemiological studies to support the concern that treatment with angiotensin-converting-enzyme inhibitors (ACE inhibitors or ACE-i) or angiotensin-receptor blockers (ARBs) might worsen COVID-19 infection (see MHRA statement, 27 March 2020).

Chloroquine and hydroxychloroquine

We have also issued guidance on chloroquine and hydroxychloroquine (see MHRA statement, 25 March 2020). Clinical trials are ongoing to test chloroquine and hydroxychloroquine in the treatment of COVID-19 or to prevent COVID-19 infection. Until we have clear, definitive evidence that these treatments are safe and effective for the treatment of COVID-19, these agents should only be used for this purpose within a clinical trial.

Information on Direct Healthcare Professional Communications

We are also working with industry on flexible approaches to regulation during the COVID-19 outbreak. These include allowing dissemination of Direct Healthcare Professional Communications (DHPCs) and educational materials to healthcare professionals via email rather than sending hard copies. DHPC letters will continue to be highlighted in Drug Safety Update – see Letters sent in March 2020.

A call to continue reporting and discussing side effects with patients

We thank all those that participated in raising awareness about the importance of reporting Yellow Cards during the February 2020 adverse drug reaction (ADR) awareness week, which saw an increase in reporting.

With the national health system focussed on the pandemic response, Yellow Card reporting has decreased, especially from healthcare professionals. We would like to reassure healthcare professionals that the Yellow Card Scheme continues to operate as usual and that concerns about side effects should still be reported to us. We support healthcare professionals in continuing to discuss side effects in patient consultations, albeit remotely, and in encouraging self-reporting of side effects by patients and caregivers using our website or App.

We realise patients may have concerns about their medicines and we have received a small number of Yellow Card reports associated with treatment non-compliance. Please continue to encourage patients to speak to a healthcare professional if they are worried about their health or the medicines they are taking.

Drug Safety Update volume 13, issue 9: April 2020: 1.

The information in this article reflects understanding at the time of publication on 27 April 2020 and will not be updated. See guidance on COVID-19 for all our latest information, including after publication of this article.

Published 27 April 2020
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