WHO Programme Expert, UMC
I believe direct patient reporting holds the key to the future of pharmacovigilance. While we keep struggling to convince healthcare professionals to report, often with a poor response, patients are usually happy to share their experiences if we provide a respectful environment for sharing information.
The reporting domain has undergone significant changes since the early days of pharmacovigilance. When I started working in the field, reporting was completely owned by physicians. The common perception was that since doctors are trained to make differential diagnoses - in other words to distinguish between the effects of the disease and the effects of the medicine - they should be the only ones to report. There was a great fear that random observations from lay people would distract and delay the uncovering of patterns of reactions to medicines, the first step to identify new signals. Today, when artificial intelligence is used to recognize patterns in big databases, random observations are much less distracting. In the early days however, there was limited data storing capacity and it made sense to store only validated reports from trained physicians.
The physicians’ reporting monopoly was challenged in the 1990s, when studies showed that nurses’ or pharmacists’ reports are just as valid, and that there is little overlap between them. Perhaps not surprisingly, those studies indicated that members of different professional categories are more likely to report issues connected to their role. Whereas physicians mostly describe serious problems that require their intervention, nurses highlight issues that arise during patient care, and pharmacists tend to report problems related to the drug’s dosage or its interaction with other medicines.
Patients, on the other hand, contribute an additional level of information. They are often well educated and can make valid observations about their health status. We know from scientific studies that patients can teach us a lot about the impact of drug intake on quality of life. Patients are also more likely to report events that seem questionable to physicians, nurses and pharmacists. Healthcare professionals tend to refrain from reporting altogether if they cannot determine the cause, or possible cause, of the problem. Patients however are not inhibited by such concerns and their candour makes them valuable players in the identification of new signals.
Not only do patients contribute to identifying novel adverse reactions, but they play an important role in confirming previously described ones. An old medicine taken by a new patient is in some ways a new medicine. A drug may have been on the market for several years and its adverse reactions well described, but that will not stop patients from reporting – the adverse reaction they experience will be new to them and if they are bothered by it, they will keep on reporting. Healthcare professionals limit themselves to reporting the most serious cases after medicines have been on the market for a couple of years. Patients’ reports instead will better reflect the actual burden of medicine-related problems for society.
Involving patients in drug safety reporting has additional advantages. In many communities and in many countries, healthcare services and professionals are not easily accessible, or the costs of consulting them are prohibitive. Self-treatment with pharmaceuticals or traditional remedies is common in such settings and adverse consequences will rarely be reported to healthcare professionals. Electronic reporting via free messaging services or smartphone apps allows medicine users to report directly to the pharmacovigilance centres, bypassing the need to consult expensive or difficult-to-access health facilities. Direct patient reporting systems have already been introduced in many low-and middle-income countries. They are more likely to reveal whether adverse reactions to self-treatment have manifested and whether the patient adhered to the treatment or not. Information on patient adherence is crucial to understanding treatment outcomes, but is often not shared with healthcare professionals. Reasons for lack of adherence may well be revealed in a direct patient reporting system, if the patient feels reassured that confidentiality will be maintained.
If we succeed in mobilising patients worldwide into active reporting, we can create even bigger and more diversified databases of suspected problems associated with drug exposure.
If we succeed in mobilising patients worldwide into active reporting, we can create even bigger and more diversified databases of suspected problems associated with drug exposure. Combined with rapidly developing technology for data storage and analysis, such collections should lead to the earlier detection and a deeper understanding of the range of effects that medicines exert in different populations. A recent article referred to direct patient reporting as the ‘renaissance of pharmacovigilance’ and I couldn’t agree more. We are only at the beginning of this exciting development in medicine safety, and I am looking forward to seeing what the renaissance will bring.
A word of caution though. Focusing only on patient reporting might make health professionals feel redundant, which would be disastrous. If there is one thing we have learnt from decades of pharmacovigilance activities, it’s that there is no single truth. We will always need the observational and analytical intelligence of trained physicians, nurses and pharmacists to understand why medicines occasionally cause harm and how to minimize that damage. Nurses, pharmacists, doctors and patients each hold a piece of the puzzle and only by placing the pieces together will we be able to see the big picture at last. Everyone - patients included – needs to be invited to the big round table of medicine safety.