The 3rd meeting of the Pharmacovigilance Risk Assessment Expert Committee (PRAEC) was held in the Committee Room of the Drug Regulatory Authority of Pakistan (DRAP) on the 17th of September, 2023. The minutes of meeting are attached hereunder:-
Pharmacovigilance is the science and practice of monitoring the safety and efficacy of drugs, both before and after they are marketed. It is a vital aspect of ensuring public health and patient safety, as well as complying with regulatory requirements and ethical standards.
Pharmacovigilance officers are professionals who are responsible for collecting, analyzing, and reporting data on adverse drug reactions, drug interactions, and other potential safety issues. They also conduct risk assessments, implement risk management plans, and communicate with health authorities, health professionals, and patients.
The National Pharmacovigilance Centre at Drug Regulatory Authority of Pakistan urges the pharma industry to nominate or appoint pharmacovigilance officers for their products, as this will ensure the highest standards of quality and safety for their customers and patients. Pharmacovigilance is not only a legal obligation but also a social responsibility. Focusing on pharmacovigilance can enhance reputation, credibility, and competitiveness of a product in the global market.
According to the Pharmacovigilance Rules, 2022, notified by the Drug Regulatory Authority of Pakistan (DRAP), it is the legal obligation of the pharma industry to nominate or appoint a pharmacovigilance officer for products registered under the DRAP Act, 2012. The pharmacovigilance officer is required to perform the following duties:
- To collect, record, and report adverse events and other safety data related to the product to the National Pharmacovigilance Centre (NPC) within the specified time frame.
- To conduct periodic safety update reports (PSURs) and risk-benefit assessments of the product and submit them to the NPC.
- To implement risk management plans (RMPs) and risk minimization measures (RMMs) for the product as per the NPC’s recommendations.
- To ensure compliance with the pharmacovigilance rules and guidelines issued by the NPC and DRAP.
- To maintain pharmacovigilance records and documentation for at least 10 years.
“The NPC was established by DRAP in July 2022 under the Pharmacovigilance Rules, 2022, with the aim to enhance the pharmacovigilance activities in the country . The NPC is responsible for collecting, analyzing, monitoring, and preventing adverse effects of therapeutic goods, as well as reviewing and assessing safety data, conducting risk evaluations, and communicating with health authorities, health professionals, and patients. The NPC also provides training, guidance, and support to the provincial or regional pharmacovigilance centres, public health programs, and product registration holders.”
Drug Safety Alert
Update from Pharmacovigilance Risk Assessment Expert Committee (PRAEC) of Pakistan
|Date:||11th of April, 2023|
|Target Audience:||• Manufacturers and importers of Finasteride;|
• Healthcare Professionals; and
• Patients, consumers or caregivers.
|Background:||The Health Sciences Authority (HSA) of Singapore in August 2022 reminded healthcare professionals of the potential risk of suicidal ideation with the use of finasteride following results of a recent pharmacovigilance study that suggests younger patients with alopecia may be more vulnerable to the risk of suicide ideation. In the study, disproportionality analysis was used to assess whether suicidality or psychological adverse events (AEs) were more frequently reported for finasteride than would be expected by chance alone by comparing them against similar reports for all other drugs in VigiBase (WHO global database of ICSRs). The study identified 356 reports of suicidality and 2,926 reports of psychological AEs in users of finasteride, reported from 1993 to 2019. Among the reports with data available, the majority (99%) occurred in males, and 71% occurred in individuals aged between 18 and 44 years. Significant disproportionality signals for suicidality (reporting odds ratio [ROR], 1.63; 95% CI, 1.47-1.81) and psychological AEs (ROR, 4.33; 95% CI, 4.17-4.49) were identified in finasteride users.|
On 19th of January, 2023, Health Canada through its summary safety review informed that it is
working with the manufacturers to update the product safety information in the Canadian product monographs (CPM) for finasteride-containing products to strengthen the warning statements on the risks of suicidal ideation and self-injury, and to include information about patient screening for psychiatric risk factors prior to starting treatment, as well as continuous patient monitoring during and after stopping treatment. The safety review was triggered by the publication of a media article that discussed the potential risk of suicide in patients using Propecia (finasteride) for male pattern hair loss. Health Canada’s review of the available information found a possible link between the use of finasteride and the risks of suicidal ideation and self-injury. At this time, there is not enough information to establish a link for the risk of suicide. However, strengthening of warning statements was warranted.
It was informed that Health Canada was monitoring the risk of suicidal ideation with the use of finasteride since 2012 and has completed 2 safety reviews in 2012 and 2015, and the information available at the time was considered too limited to determine whether there was a link between the use of finasteride and suicidal thoughts and behaviours (suicidality). In 2019, following reports of Canadian and international cases of suicide, suicidal ideation and self-injury with the use of finasteride, the agency completed a third safety review that found a possible link between finasteride and the risk of suicidal ideation. The CPMs of finasteride were accordingly updated to include the risk of suicidal ideation.
Most recently in 2022, due publication of a media article that discussed the potential risk of suicide in patients using Propecia (finasteride) for male pattern hair loss, Health Canada completed a review of the risk of suicidal ideation and potential risks of suicide and self-injury with the use of finasteride. The purpose of the current review was to consider recent information and determine if additional measures were warranted. A review of the available information found a possible link between the use of finasteride and the risks of suicidal ideation and self-injury. At this time, there is not enough information to establish a link between the use of
finasteride and the risk of suicide. Therefore, strengthening of warning statements on the risks of suicidal ideation and self-injury was warranted and Health Canada is working on it.
Furthermore, the most recent Vigilyze statistics related to the finasteride and Standard MedDRA Query(SMQ) selected Depression and suicide/self-injury study identified 2,995 reports and 471 reports specifically with suicidal ideation. The larger portion of the reactions in known gender occurred in males (31.9%, and 45.6% in individuals aged between 18 and 44 years respectively, with the broader SMQ and specifically suicidal ideation. Significant disproportionality signals for suicidal ideation (reporting odds ratio [ROR], 10.6) and SMQ (ROR, 4.5) were identified.
|Therapeutic Good(s) Affected:||Name: Finasteride. |
Finasteride is indicated for the treatment of benign prostatic hyperplasia and androgenic alopecia.
|Action in Pakistan||Accordingly, the case of the potential risk of suicidal ideation/thoughts & self-injury with finasteride was discussed in the 2nd meeting of the Pharmacovigilance Risk Assessment Expert Committee (PRAEC) of the National Pharmacovigilance Centre (NPC), Division of Pharmacy Services, Drug Regulatory Authority of Pakistan (DRAP), which decided as per Rule 10 (1) (h) (iv) of Pharmacovigilance Rules, 2022 that registration holders should update prescribing information/safety specification of finasteride containing drugs by strengthening the warning statements on the risks of suicidal ideation and self-injury, and to include information about patient screening for psychiatric risk factors before starting treatment.|
|Advice for healthcare professionals:||Healthcare professionals are informed that mood alterations including depression and, less frequently, suicidal ideation have been reported in patients treated with finasteride and are hereby advised to consider the potential risk of psychological adverse events when assessing the benefit-risk of finasteride for their patients. Healthcare professionals should also advise their patients to consult their doctors at the earliest when such thoughts are developed.|
|Advice for patients:||Patients are advised to immediately consult their doctors if they experience mood alterations including depression and less frequently, suicidal ideation or self-injury etc.|
|Guidelines for reporting Adverse Drug Reactions (ADRs):||Both healthcare professionals and patients are requested to report any suspected Adverse Drug Reaction (ADR) to National Pharmacovigilance Centre, Drug Regulatory Authority of Pakistan through Med Vigilance E-Reporting system available on DRAP website.|
Similarly, ADRs can also be reported through MedSafety App that is available for download from App store (for iOS devices) and Google Play (for Android devices).
|References:||Minutes of 2nd meeting of Pharmacovigilance Risk Assessment Expert Committee.|