Trapani Pharmacy, Sicily

Back in October of last year, I was in Sicily attending an international forum on improving patient safety. It seems a long time ago. Flying to Palermo. Sitting in a room with new people, talking. Shaking hands. Ordinary activities that seem risky propositions now.

However, the plan that arose at the meeting is more relevant than ever, as the debate on the safety of drugs for treating Covid-19 continues and the monitoring of the safety of potential vaccines will be under increased scrutiny.

The delegates came from varied backgrounds, with sometimes clashing perspectives. At times, it was hard to see how a consensus would be obtained, but an open debate did eventually lead to agreement on some core recommendations. As with most things, the clash of opposing viewpoints did strengthen those finally agreed on.1

  1. Raise public and professional awareness of the harms from medicines and devices.
  2. Shift the culture within regulatory and health care management systems from one of secrecy to one of transparency.
  3. Enforce existing effective regulations, revise ineffective ones, and implement effective regulations in those areas lacking appropriate regulatory infrastructure.
  4. Transfer from industry to healthcare systems the responsibility for providing information and support to healthcare providers on the use of medicines and devices.
  5. Encourage and enable prescription and use of medicines and devices that are appropriate and tailored to the needs of individual patients.
  6. Facilitate access to all relevant data.
  7. Recognize case reports, including those written by patients, as a valid and important form of evidence of harms.
  8. Improve baseline and continuing education of all stakeholders, including healthcare professionals, policymakers, and the public.
  9. Recognize the importance of patients and carers, as well as healthcare professionals, in studying all aspects of therapy.
  10. Establish and continuously develop effective communication with patients and other relevant stakeholders about the potential benefits and harms of interventions to improve the basis for shared decision making about treatments.

As we move closer to having a potentially useful vaccine, the issues of transparency and openness with the public become more important. Ensuring that known harms, and benefits, are communicated honestly with the public will be crucial to obtaining public trust. Clearly communicating how safety will be monitored to find any unknown harms, and the reporting lines for suspected adverse effects, will be equally important. The days of telling people something is “safe” is long gone. Such a strategy will merely give those seeking to spread misinformation an opportunity to exploit.

You can read more about this from Uppsala Reports and from the 4Es Website. There is also a podcast from the BMJ, which covers the meeting.

In other news, I will shortly be starting a new twice monthly newsletter on drug safety issues. Many of these will touch on the recommendations from the 4Es forum. You can sign up here.

Photograph: Pharmacy, Trapani, Sicily by Anthony Cox

  1. 4Es Forum: Improving the detection, analysis, and reporting of harms in medicines and devices - statement from the 2019 4Es Forum (Exploring, Enhancing, Empowering in Erice)LINK to PDF