Guidelines on Standards for Establishment of Hospital Pharmacies is now open for comments.

Drug Regulatory Authority of Pakistan is seeking feedback on proposed guidelines for hospital pharmacies. These standards aim to ensure consistent, high-quality pharmacy services across all hospitals, ultimately benefiting patients and the healthcare system as a whole.

The guidelines cover four key areas:

  1. Hospital Pharmacy Operations which include aspects like organizational structure, staffing, resources, policies, and procedures for managing medications from procurement and storage to dispensing and monitoring.
  2. Medicine Use Management where the focus is on optimizing medication use within the hospital. This involves procedures for medication reconciliation, identifying potential issues, and implementing strategies to improve medication effectiveness and avoid medication-related harm.
  3. Quality Improvement with the believe in continuous improvement! These guidelines outline practices for assessing the effectiveness of hospital pharmacy services, identifying areas for improvement, and implementing corrective actions.
  4. Human Resources Development for ensuring a competent and skilled pharmacy workforce is crucial. The guidelines address training and development programs for all pharmacy personnel, from pharmacists to technicians.

DRAP invites you to review the proposed guidelines and share your thoughts and suggestions. Your input will be invaluable in shaping the final document and ensuring it reflects the needs and expectations of patients, healthcare professionals, and the community.

These guidelines were uploaded on the official website of DRAP on 12th of January, 2024 for seeking comments and suggestions from stakeholders on the draft document. Stakeholders can submit their comments and suggestions within 15 days of uploading this document using prescribed format. For further guidelines on how to submit comments visit DRAP website or click here. Comments and suggestions can be forwarded via email to dir.psdra.gov.pk, copying aqsa.hashmidra.gov.pk, or can be posted at mailing address, Director, Division of Pharmacy Services, Drug Regulatory Authority of Pakistan, 3rd floor TF Complex, 7th Mauve Area, G-9/4, Islamabad.

DRAP’s Pharmacovigilance Newsletter (December, 2023 ; Issue-II)

The Pharmacovigilance Newsletter is a quarterly publication that aims to inform and educate the healthcare professionals and the public about the importance of pharmacovigilance and adverse drug reaction reporting. It also showcases the activities of the National Pharmacovigilance Centre (NPC) and initiatives taken by the NPC for monitoring and evaluating the safety of medicines in Pakistan.

We are pleased to announce that the second issue of the Pharmacovigilance Newsletter (Dec-2023) is now available for download from our website. This issue covers the latest updates on the safety of medicinal products and regulatory actions taken by the Drug Regulatory Authority of Pakistan (DRAP) and other international authorities.

We hope that you will find the newsletter informative and useful. We welcome your feedback and suggestions for improvement. You can contact us at npcdrap.gov.pk or call us at +92-51-9255980. Thank you for your interest and support in pharmacovigilance.

Together, we can ensure the safe and effective use of medicines in Pakistan.

DRAP Participating in International Med Safety Week 2023 Social Media Campaign

From 6 to 12 November, Drug Regulatory Authority of Pakistan (DRAP) will take part in the global #MedSafetyWeek campaign, a collaboration involving more than 80 medicines regulatory agencies and several non-governmental organizations, to raise awareness about the importance of reporting side effects of medicines. With the theme ‘Who can report?’, this year’s campaign will focus on the key role of every patient, doctor, nurse, and pharmacist who reports a side effect and contributes to using medicines safely.

DRAP seek your support to enhance reporting of adverse drug reactions (ADRs) to ensure medicines on the market are acceptably safe.

Reports about side effects can be submitted easily through Med Safety App, DRAP med Vigilance e-reporting system or yellow reporting form.

For detail on how to report visit the link.

#MedSafetyWeek2023

Play your part in medicines safety. Whether you’re a patient, doctor, nurse, or pharmacist, you can help make medicines safer by reporting side effects to National Pharmacovigilance Centre, DRAP.

Through the #MedSafetyWeek campaign more than 80 countries will work together to improve the safety of medicines globally

All medicines agencies operate systems to detect and analyse side effects of medicines. The purpose of safety monitoring is to gain more information about known side effects and find out about new ones. Constantly collecting and monitoring information from the reports received helps identify risks associated with medicines and take action to minimise harm.

#MedSafetyWeek is an international campaign of Uppsala Monitoring Centre (UMC).

The campaign is supported by WHO and by members of the International Coalition of Medicines Regulatory Authorities (ICMRA)

DRAP emphasizes the importance of reporting side effects through Med Safety App, DRAP med Vigilance e-reporting system or yellow reporting form. All reports made to National Pharmacovigilance Centre (NPC) DRAP will be thoroughly assessed and examined to determine the right steps to be taken to protect the population from harm. Since 2018, NPC DRAP has received and processed over 30,000 reports in which patients, carers, and healthcare professionals have played a key role

“Every report is important in building more knowledge and understanding of the benefits and risks of medicines in clinical use and allows action to be taken to minimise risks.

“Reporting suspected side effects to the NPC DRAP helps to make medicines safer for patients all around the world. In some cases, it can result in better prescribing advice, which can improve patient outcomes.

“If you, or a patient you are supporting, experience a side effect with a medicine, make sure to report it to us promptly.”

Dr.Obaidullah,

National Pharmacovigilance Centre, DRAP, Pakistan

The National Pharmacovigilance Center, DRAP urge the manufacturers and importers to nominate Pharmacovigilance Officer to ensure safe use of drugs.

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.”

Med Safety App Updates; Mobile Application for Reporting of Adverse Drug Reaction is Updated and Improved

Dear Med Safety App User!

DRAP would like to request all Med Safety Application Users to update the “Med Safety App” from the respective application store to install the latest features, improvements and bug fixes.

The developer of the app Medicines and Health Regulatory Agency (MHRA) UK has announced a significant update to the Med Safety App which is available from both Android and Apple app stores from Thursday 2nd March 2023. This update supports new features in the reporting form and allows us (National Pharmacovigilance Centre DRAP) to ask specific questions relating to a patient’s report based on the information provided. The update will also enable requests for further information to be displayed within the app and for user responses to be sent back to us. 

Improvements to general performance and bug fixes released as part of this major update in new version of Med Safety Mobile Application.

Drug Safety Alert: Risk of Kidney Injury and Death due to Hydroxyethyl-Starch Solutions for Infusion.

Drug Safety Alert

Update from Pharmacovigilance Risk Assessment Expert Committee (PRAEC) of Pakistan

Date:29th of November, 2022
Target Audience:• Manufacturers and importers of hydroxyethyl-starch solutions for infusion.
• Healthcare Professionals; and
• Patients, consumers or caregivers.
Background:The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicine Agency (EMA) on 11th February, 2022 recommended that the market authorization of hydroxyethyl-starch (HES) solutions for infusion should be suspended across the European Union. These solutions for infusion products are indicated as an addition to other treatments for plasma volume replacement following acute (sudden) blood loss.
The safety of these solutions for infusion was reviewed in 2013, and a number of restrictions and measures to minimise the risk of kidney injury and death in certain patients (those critically ill, with burn injuries or with sepsis, a bacterial infection in the blood) were put in place at that time.

Likewise, as a result of a third review conducted in 2018, the use of HES solutions for infusion was further restricted to only accredited hospitals, and healthcare professionals prescribing or administering the medicines had to be trained in their appropriate use. In addition, further warnings were introduced to remind healthcare professionals that these medicines must not be used in patients with sepsis or kidney impairment or in other vulnerable patients such as the critically ill in order to ensure these solutions for infusion were not used in patients who were at increased risk of harm. Market authorization holders of HES solutions for infusion were also requested to conduct a drug utilization study to check that the restrictions were adhered to in clinical practice.

The PRAC of the EMA accordingly reviewed the results of the study, which show that HES solutions for infusion are still being used outside the recommendations included in the product information and concluded that the further restrictions introduced in 2018 have not sufficiently ensured that the medicines are used safely and that HES solutions were continually used in certain groups of patients in whom serious harm has been demonstrated. In view of the serious risks that certain patient populations were still exposed to, the PRAC recommended the suspension of the marketing authorizations for HES solutions for infusion in the European Union. Accordingly, the European Commission on 24th May, 2022 issued a legal decision confirming the suspension of the market authorization of HES solution for infusion.
Therapeutic Good(s) Affected:Name: Hydroxyethyl-Starch solutions for infusion.

These solutions for infusion products are indicated as an addition to other treatments for plasma volume replacement following acute (sudden) blood loss.
Action in PakistanAccordingly, the case of the risk of kidney injury and death due to hydroxyethyl-starch solutions for infusion was discussed in the 1st 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). The PRAEC-DRAP after detailed deliberation and discussion and as per Rule 10 (1) (h) (v) of Pharmacovigilance Rules, 2022 (reliance mechanism) decided to recommend to the Registration Board of the DRAP to suspend the registration of Hydroxyethyl-Starch (HES) solutions in Pakistan subject to the availability of alternative treatment options.
Advice for healthcare professionals:Healthcare professionals are informed that the National Pharmacovigilance Centre, DRAP is working with the Registration Board and manufacturers/importers of hydroxyethyl-starch solutions for infusion to suspend the registration of these solutions in Pakistan. Therefore, healthcare professionals are reminded that there are alternative solutions for infusion available in the Pakistani market for the treatment of plasma volume replacement following acute (sudden) blood loss and the same must be considered as the treatment in these conditions.
Advice for patients:Patients are informed that the National Pharmacovigilance Centre, DRAP is working with the Registration Board and manufacturers/importers of hydroxyethyl-starch solutions for infusion to suspend the registration of these solutions in Pakistan. Therefore, talk with your doctor before initiation of treatment with those solutions as alternative treatment options are available in the market.
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 1st meeting of Pharmacovigilance Risk Assessment Expert Committee.
European Medicine Agency update regarding hydroxyethyl-starch solutions for infusion recommended for suspension from the market.

Medicine Safety Week 2022; DRAP’s Call to Healthcare Professionals and Patients to Report Suspected Adverse Reactions of drugs and vaccines.

The seventh annual Social Media Campaign #MedSafetyWeek was launched on the 7th of November, 2022 by the National Pharmacovigilance Centre, DRAP, which was observed until 13th November 2022, to encourage everyone to report suspected side effects of medicines. The International campaign was led by the Uppsala Monitoring Centre (UMC), the World Health Organisation (WHO) Collaborating Centre for International Drug Monitoring.

This year’s global campaign involved medicines regulators from 81 countries and focused on the key role of every healthcare professional, patient, and caregivers who reports a suspected side effect and contributes to using medicines safely. This campaign was supported by the members of the International Coalition of Medicines Regulatory Authorities (ICMRA)

#MedSafetyWeek 2022

Every report to the National Pharmacovigilance Centre, DRAP helps to improve the safety of medicines for all patients.

People are encouraged to report suspected side effects of medicines as part of the global #MedSafetyWeek social media campaign

Why Reporting is required?

All medicines may cause side effects in some patients, so there are steps in place to continuously monitor their safety after they are placed on the market. The purpose of safety monitoring is to gain more information about known side effects and find out about new ones. Regulatory bodies operate systems to detect and analyse those side effects and prevent harm to future patients.

The National Pharmacovigilance Centre, DRAP, collects, organises, and investigates reports of suspected side effects / Adverse effects.

By reporting suspected side effects, you are actively participating in identifying emerging safety issues, so that DRAP can take action when necessary and protect you and others from harm.

Every Report is important for us

Every report made by a patient, a healthcare professional, or a caregiver plays a key role in gaining more knowledge about the benefits and risks of medicines in clinical use and allows action to be taken to minimize risks and can result in better tailored prescribing advice, which can improve patient outcomes.

Patients / care givers and all healthcare professionals can report suspected side effects to the National Pharmacovigilance Centre, DRAP. You can submit a report in many ways:

Are you a Pharmacist?

You are the first person patients go to when they have questions about their medicines.  Please report any new side effects of a medicine via the [Med Safety App & E reporting https://primaryreporting.who-umc.org/PK 


DRAP issued Guidelines on Management of High Alert Medication

DRAP envisions advancement in the healthcare system of Pakistan by working at par with international standards, and best regulatory practices through effective management and regulation of therapeutic goods. The National Pharmacovigilance Centre (NPC) at DRAP issues guidelines from time to time for different activities relating to Pharmacovigilance and promotion of pharmacy services to cater to the needs of different stakeholders.

High Alert medicines are those that have a high risk of causing injury or harm if they are misused or used in error. NPC, DRAP has issued a a Guidelines on Management of High Alert Medication to illustrate recommended practices for safe handling of those drug products that are classified as High Alert Medication (HAM)

The main objective for issuing this guidance document is to support healthcare professionals working at hospitals and healthcare services providing institutes for ensure safe practices for prescribing, dispensing, administration and monitoring of high alert medication (HAM) and applies to all healthcare settings and healthcare professionals involved in the handling and usage of HAM. The outlined and recommended strategies are intended to educate HCPs, prevent risks associated with HAM, implement safety checks and encourage reporting of Adverse Events /Adverse Drug Reactions. 

This draft guideline was uploaded on the official website of DRAP dated 16th June, 2022 with request of comments submissions by the stakeholders. The National Pharmacovigilance centre, Division of Pharmacy Services has finalized the documents after careful evaluation of the comments and input received from internal and external stakeholder consultation.

Suggestions can be forwarded via email to npcdra.gov.pk, copying at aqsa.hashmidra.gov.pk , or can be posted at mailing address, Director, Division of Pharmacy Services, Drug Regulatory Authority of Pakistan, 3rd floor, TF Complex, 7th Mauve Area, G-9/4, Islamabad.

click to view the Guidelines on Management of High Alert Medication (Edition 01). For more information related the regulatory guidelines and guidance documents issued by the DRAP please navigate to the Publications > Guidelines tab of our website.

National Pharmacovigilance Cell (NPC), DRAP released draft Guidelines on National Pharmacovigilance System (Edition 02) seeking comments from stakeholders

DRAP has established the National Pharmacovigilance Centre (NPC), under the Division of Pharmacy Services, DRAP, Islamabad, to monitor the safety of therapeutic goods across the country. NPC is working with National and International coordination for the development of a functional Pharmacovigilance system in the country. Since 2018, Pakistan is the Full member of the World Health Organization Programme for International Drug Monitoring (WHO-PIDM), Uppsala Monitoring Centre (UMC), Sweden.

The NPC has developed multi channel reporting system, including electronic and manual reporting forms supported with the guidelines that are available through the official website for stakeholders. With the promulgation of Pharmacovigilance Rules, 2022, it is now the legal obligation of all pharmacovigilance stakeholders to establish their system and report the pharmacovigilance data to NPC.

The 1st Edition of National Pharmacovigilance Guidelines were published in October, 2019. This is the draft for 2nd Edition of National Pharmacovigilance Guidelines, being revised in the light of recently enacted Pharmacovigilance Rules, 2022. This Guidance document is intended to assist all pharmacovigilance stakeholders i.e. Healthcare professionals, Marketing Authorization Holders, Healthcare providing institutes, Patients and caregivers, etc., in playing their roles and responsibilities in the national pharmacovigilance system. The WHO Pharmacovigilance indicators have been incorporated in the chapter 11 of the draft 2nd edition to harmonize the procedure performance evaluation with international standards.

These guidelines are uploaded on the official website of DRAP on 24th of August, 2022 for seeking comments and suggestions from stakeholders on the draft document. Stakeholders can submit their comments and suggestions within 15 days of uploading this document using prescribed format. For further guidelines on how to submit comments visit DRAP website or click here. Comments and suggestions can be forwarded via email to npcdra.gov.pk, or can be posted at mailing address, Director, Division of Pharmacy Services, Drug Regulatory Authority of Pakistan, 3rd floor TF Complex, 7th Mauve Area, G-9/4, Islamabad.

Please click here to view the draft document National Pharmacovigilance Guidelines 2022

National Essential Medicine Lists

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.

National standard treatment guidelines navigate selection of essential medicine with the expectation to ensure their availability with reference to proper use of medicine within the healthcare system while reducing its cost.

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.

Health sector in general and Pharmaceutical sector in particular is expected to seriously consider adopting this list as a way forward to guide Provincial Governments in Medicine & Pharmaceutical sector policies, the determinants of medicines access and availability. The Provincial Governments can play a pivotal role to encourage procurement and supply chain management policies based on essential medicine concepts to promote rational use of scarce public resources. Drug Regulatory Authority is committed to make all efforts to improve patient care through availability of cost efficacious, safe & quality medicines availability in the country.

Current List

The current version, updated in October 2023 is based on the 23rd WHO Model List of Essential Medicines List (MLEM).

National Essential Medicine List-2023
English ( 47.8 MB – PDF)

Previous Lists

National Essential Medicine List-2021
English ( 10.8 MB – PDF)

National Essential Medicine List-2020
English ( 55 MB – PDF)

National Essential Medicine List-2018
English ( 15 MB – PDF)

National Essential Medicine List-2016
English ( 39 MB – PDF)