How DRAP Monitor Safety

Last Updated on July 22, 2022

Although drugs and vaccines reaches to market after passing through a rigorous process of drug discovery and development, followed by the clinical studies and review of scientific data by the regulatory bodies, with the key focus on the safety of drugs. Nevertheless, clinical trials provides insight information of drug safety and efficacy, but certain limitation exists as the safety and efficacy data is limited to its use in clinical trials. Some exceptional risks associated with a drug may be identified when it is consumed by a large number of population after the placement of drug in the market, similarly certain effects may be experienced over a time in the post-marketing phase.

National Pharmacovigilance Centre

DRAP has established National Pharmacovigilance Centre (NPC) to monitor therapeutic goods’ safety across the country. The NPC collect reports of adverse events for assessment of the risks and benefits of drugs in order to determine what action, if any, is necessary to improve their safe use, and provide updated information to healthcare professionals to protect the patients from any potential harm.

The National Pharmacovigilance Center (NPC) works in collaboration with regional pharmacovigilance centers established by the respective provincial governments for collection and assessment of adverse events received from the healthcare professionals and hospitals of their territory. The National Pharmacovigilance Centre closely works with the World Health Organization Program for International Drug Monitoring (WHO-PIDM) and Uppsala Monitoring Centre, Sweden (UMC) to fulfil the purpose of drug safety monitoring in the country. Mailing address and contact details of the National Pharmacovigilance Centre are:-

In-charge National Pharmacovigilance Centre (NPC),
Division of Pharmacy Services, Drug Regulatory Authority of Pakistan
Email Address: npc@dra.gov.pk

Benefit-Risk Analysis

New drugs and vaccines are registered in Pakistan based on their benefit-risk assessment and review of data based on the reliance principle. A drug product would be consider safe if its expected benefits are greater than any associated risks of harmful reactions. Registration holders companies (manufactures, importers of therapeutic goods) are required to collect the adverse events (both serious and non-serious) related to their product and submit periodic benefit-risk evaluation reports and reports of special circumstances to National Pharmacovigilance Centre. DRAP also collect reports of adverse events from provincial pharmacovigilance centres, public health programmes, healthcare professionals and patients. These reports are then assessed for any new risks that impact the patient and presented in the meeting of the pharmacovigilance risk assessment expert committee of the DRAP for its evaluation and decision. Based on its benefit-risk assessment, the committee may recommend any risk minimization measures in Pakistan for the protection of patients.

National Essential Medicines List

National Essential Medicine List NEML is a critical document which provides and supports quality of health services across the country. The list is based on disease prevalence, evidence on efficacy and safety, and comparative cost-effectiveness and parameters adapted by W.H.O in its latest edition of Model List of Essential Medicines.

Availability of essential medicines is one of the essential building blocks of healthcare system. Essential medicines are those which satisfy the primary healthcare need of the population. These are intended to be available within the context of functioning of health system at all times, in adequate amounts, in the appropriate dosage form with assured quality, and at a price that the individual and community can afford. . Careful selection of a limited range of essential medicines of high quality can provide better management towards judicious use of health resources.

Click here for more information about National Essential Medicines List of Pakistan

High Alerts Medications / Drugs List

High Alert Medications (HAMs) are medicine that bears a heightened risk of causing significant patient harm when these medications/ drugs are used in error or inappropriately. The consequences of errors or inappropriate use of drugs on this list can be more devastating and of serious concern. National Pharmacovigilance Centre (NPC), Drug Regulatory Authority of Pakistan has developed a High Alert Medications/Drugs List for Pakistan.  NPC, DRAP intends to encourage healthcare professionals to actively monitor the safety of high alert medications/ drugs mentioned in the list ensuring their careful and rational use. If any Adverse Event or adverse drug reaction (ADR)  occur associated with their use, it should be managed appropriately and must be reported to NPC, DRAP through the our reporting channels.