In yet another strategic move aimed at encouraging better involvement of the healthcare professionals in strengthening the Pharmacovigilance Programme of India (PvPI), the Indian Pharmacopoeia Commission (IPC) has recently released the suspected adverse drug reaction (ADR) reporting form for voluntary reporting of adverse drug reactions by healthcare professionals. It is understood that all healthcare professionals including clinicians, dentists, pharmacists and nurses can report ADRs to IPC through the help of this form to ensure patient safety by efficiently monitoring drug safety.
This form empowers healthcare professionals to notify IPC which acts as the national coordination centre (NCC) for the PvPI programme on any suspected cases of ADRs to further tightening its scrutiny. All that a healthcare professional needs to do is duly fill suspected ADR reporting form and send it to the nearest adverse drug reaction monitoring centre (AMC) or directly to the NCC. They can even call on the helpline number to report ADRs or directly email the completed form to any of the AMCs listed nationwide.
Dr V Kalaiselvan, principal scientific officer from IPC, informed that this form primarily consists of patient initials, age at onset of reaction, reaction terms, date of onset of reaction, suspected medications and reporter information. He stressed that through this forum the healthcare professionals can share their expertise for ensuring better healthcare by effectively reporting suspected serious adverse drug reactions in a patient resulting in death, life-threatening, hospitalisation which includes the initial or prolonged period, disability which is significant, persistent or permanent, congenital anomaly, etc. They can also highlight non-serious, known or unknown, frequent or rare adverse drug reactions due to medicines, vaccines and herbal products.
“We have developed this keeping in synch with our motto to ensure patient safety through constant vigilance. Most importantly, the information generated through such initiatives are used to make continuous assessment of the benefit-risk ratio of medicines running in the country. Since confidentiality is the key for its success, any information provided in this form will be handled in strict confidence,” stressed Dr Kalaiselvan.
It is understood that the causality assessment as always will be carried out at AMCs by using WHO-UMC scale. He added that the analysed forms will later be forwarded to the NCC through ADR database, which will be further scrutinised and forwarded to the global pharmacovigilance database managed by WHO Uppsala Monitoring Centre (UMC) in Sweden. It is imperative to note that these reports generated in this manner are periodically reviewed by the NCC-PvPI, information of which is submitted to the steering committee of PvPI constituted by the ministry of health.
The committee is entrusted with the responsibility to review the data and suggest any interventions that may be required.