THANKS to the sustained efforts of global initiatives and government health initiatives, access to medicines has begun to improve in Pakistan. Drugs and other health products, however, need to be safe, effective, and of good quality to achieve their intended purpose. Here is a brief on the state of preparedness on aspects of medicine safety.
No medicine is without hazard, and not all hazards to human health and life can be known before a drug is marketed. Pharmacovigilance, an emerging safety system that encompasses processes involved in identifying, assessing and minimising the risks associated with medicines in clinical use, is now accepted as a vital public health function.
As a direct result of the thalidomide tragedy in the 1960s (which resulted in thousands of mothers who had used it for morning sickness giving birth to babies with shortened or absent limbs), the science, methodologies and tools of pharmacovigilance have evolved. Since thalidomide, the complexity of drug safety issues has increased manifold – including drug-related harm that may be similar to those of the background pathologies in the populations treated; harm that may be apparent only in very long-term use; and harm that may be difficult to distinguish from the condition being treated.
Following the promulgation of the Drug Regulatory Authority of Pakistan (Drap) Act, 2012, a pharmacovigilance section was developed in the Division of Pharmacy Services. The section has developed guidelines and online reporting forms for healthcare professionals, patients/consumers and manufacturers/importers of therapeutic goods; moreover, Drap is developing rules to provide legal cover. An online reporting system (called MED Vigilance) was launched on Drap’s official website last year, which gives patients, healthcare professionals and pharmaceutical companies the option to report adverse effects and events of drugs. However, there has been little real activity so far.
Slowly but surely, an efficient reporting system is taking hold in Pakistan.
Against the backdrop of the Punjab Institute of Cardiology tragedy in 2012, in which more than 200 people died after consuming contaminated medicine, Punjab’s government is first among the provinces to launch a pharmacovigilance centre. Reports accepted by the provincial pharmacovigilance centre in Lahore are sent to the National Pharmacovigilance Centre and the WHO’s Uppsala Monitoring Centre in Sweden.
Punjab has laid down a detailed procedure for implementation with its primary focus on collecting reports of adverse drug reactions at each district and tehsil headquarter hospital, where pharmacovigilance committees have been established in the respective hospitals. These committees work together to create awareness for reporting serious adverse drug reactions within the hospital, meet to discuss and scrutinise each such report and forward it to the provincial pharmacovigilance centre for necessary action.
Amongst the other three provinces, KP has been working quite actively towards establishing a pharmacovigilance centre, whereas Sindh and Balochistan have yet to make a start.
Drap has mandated that pharmacovigilance centres be established in each pharmaceutical firm along with appointing a qualified person who is bound to report any adverse event to the provincial pharmacovigilance centre. In case of any adverse drug reaction incident, the chief drug controller of the health department will be informed for legal action and samples of the suspected drug(s) sent immediately for testing and analysis. The centre issues an alert to immediately stop the use of suspect medicines and a notification is immediately issued to stop public procurement of the drugs. In case the drug is available in the market, instructions are immediately issued to the field force/ drug inspectors to take action accordingly.
Over years of witnessing repeated bad experiences with regard to medicine safety — which has lead to incalculable death and disease — public awareness and thus expectations have naturally grown, and delays in acting on drug safety issues are not going to be tolerated as much as they might have once been. All of these efforts by the federal and provincial governments have started, slowly but will surely bear fruit. Medicines regulators have shifted from a largely reactive response to drug safety issues, to a more proactive approach.
The future of drug safety in Pakistan lies on the performance of the pharmacovigilance system on the strict observance of ‘good pharmacovigilance practice’ — a concept widely accepted in the world. The challenge of pharmacovigilance today is as great, if not greater, than after the thalidomide tragedy. If the public, patients and healthcare professionals are to have confidence in the products they use, it is a challenge worthy of the commitment of all involved in the development, marketing and regulation of medicines.
The writer is a senior public health pharmacist.
Published in Dawn, February 24th, 2019