The primary purpose of pharmacovigilance is risk mitigation, prevention and management of adverse drug reactions. A major impediment to achieving this purpose is lack of effective communication about signals, adverse drug reactions (ADRs), and drug interactions to health care professionals and patients. Even when the communication occurs, it is important that the information is sufficiently absorbed and used by clinicians, and reaches patients.
For example, from 1998 to 2000, terfenadine, mibefradil, astemizole, and cisapride were removed from the US market or restricted in their use since their co-prescription with interacting drugs had resulted in deaths. Each one had value in the pharmaceutical marketplace and for patients. However, they continued to be prescribed in an unsafe manner, even after warnings from the manufacturer and the FDA. Consequently, the risk associated with their continued widespread availability could not be justified.
Similarly, valproate, a drug prescribed for epilepsy and bipolar disorder is contraindicated in pregnancy and in patients with child-bearing potential. Despite warnings and communications to health care professionals and patients, one in five women taking valproate in the EU are unaware of the risks of taking it when pregnant. In 2018, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency recommended new measures to prevent valproate exposure in pregnancy.
Many physicians fail to recognise the connection between medications and illness, and patients are needlessly prescribed medications to treat symptoms without dealing with the root cause. Understanding adverse drug reactions and drug interactions should be an essential diagnostic tool in clinical practice, especially in patients with chronic conditions or on multiple medications. Pharmacovigilance needs to transform from a reactive to a proactive process.
So is misdiagnosis of an adverse drug reaction as a new ailment by a clinician a human error or rather a lapse in the system? With the amount of data on adverse drug reactions and drug interactions, is it possible for clinicians to keep track of all adverse events and interactions and be conversant with latest research? Can this be resolved through a systems approach, by bringing in technology and expertise from pharmacology and pharmacovigilance for clinical decisions?
From the technology perspective, drug interaction trackers such as Epocrates and The Medical Letter can be powerful aids. Searches in databases such as VigiAccess can also inform health professionals of emerging signals, and serve as a starting point in identifying similar events in patients. Medication and adverse event review by pharmacologists during hospital rounds can help make the right diagnosis and spot ADRs. Hands-on experience with pharmacovigilance data in ADR monitoring centres during internships and medical training could also assist future clinicians to appreciate the significance of pharmacovigilance in clinical assessment.
Another important area is patient engagement and empowerment. Patients have access to online tools, symptom checkers, drug interaction trackers, and drug information websites, with information on ADRs and drug dosages. However, there is still resistance in the medical fraternity to patients armed with knowledge. When patients come with limited knowledge and with information from inauthentic sources, it becomes a challenge for the consulting clinician. A paternalistic approach towards patient engagement in healthcare decisions erodes patients’ trust and confidence in their clinicians, and compromises patient safety. Listening to patients’ concerns and providing them with the right information can be helpful in reaching the right diagnosis.
Patient awareness campaigns by national authorities and patient safety organisations help build patient engagement. However, true patient centricity can only be achieved when their opinions are respected and considered as an aid in diagnosis. Authentic and reliable sources of information for patients are vital, and physicians can help interested patients find the right information sources to lead them to appropriate decisions regarding their treatment.
During the Pharmacovigilance Programme of India’s (PvPI) national pharmacovigilance week, the CDSIMER* Adverse Drug Reaction monitoring centre released an e-book where university clinicians shared their experiences and reflections on ADRs they’d encountered. The reflections explored how these personal experiences sensitised the professionals on the importance of pharmacovigilance and ADR review in clinical practice and influenced their approach when diagnosing conditions. This is a welcome step as discussions on adverse drug reactions and patient stories can really help in raising awareness among health care professionals. The publication also emphasised the need for a more active role of pharmacologists in clinical practice.
Pharmacovigilance reflective writing e-book
“The whole set of events of this incident was an eye opener for me not to overlook any adverse reaction.”
– Senior resident
“The person involved took the courage and the time to do everything possible to bring into light the rare adverse event which could have easily been missed. At the same time, it could have been misinterpreted as a flare up of the pre-existing disease which in this case was allergic conjunctivitis.”
– Postgraduate student
“Interns must be posted in wards specifically to collect details about ADRs and reporting of ADR must be made compulsory for completion of Internship.”
– 2nd year post-graduate
“Some of the possible actions that can be taken for avoiding such incidents are properly reading the medication charts or medication orders and to have specific information about the adverse events and its prevention.”
– Resident doctor
Dr. Shiva Murthy Nanjundappa, PV coordinator, and Associate Professor at CDSIMER medical college, who took the lead in this initiative, commented that “reflective writing plays a very important role in learning from each other’s experiences. Every case may be different, but if we learn one point from each case and improve the systems to address these issues, patient care will improve and patient safety will be ensured”.
Adverse events are known to be the fourth leading cause of death and it is estimated that possibility of adverse drug reactions increases exponentially with four or more medications.5 Integration of pharmacovigilance expertise in clinical practice could be the way forward and might help bring these numbers down. Should we start by looking at diagnoses and prescriptions through the pharmacovigilance lens before any other?
*Dr. Chandramma Dayananda Sagar Institution for Medical Education and Research (CDSIMER), Bengaluru, Karnataka, India
US FDA, Preventable Adverse Drug Reactions: A Focus on Drug Interactions
EMA, PRAC recommends new measures to avoid valproate exposure in pregnancy
P Roy, P Nadig, CA Jayashankar, “Adverse drug reaction monitoring through active surveillance in the inpatients of general medicine ward of a tertiary care hospital”, Journal of Internal Medicine, 2022.
CDSIMER, Pharmacovigilance reflective writing e-book, 2021
T Jacubeit, D Drisch, E Weber, “Risk factors as reflected by an intensive drug monitoring system”, Agents and Actions Supplements, 1990.