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DRAP Pharmacovigilance Newsletter-August 2024

Asad Ullah Pharmacovigilance

The National Pharmacovigilance Centre (NPC), Division of Pharmacy Services, Drug Regulatory Authority of Pakistan (DRAP) is excited to announce the release of the new edition of its Pharmacovigilance Newsletter!

This edition is filled with essential updates and insights for healthcare professionals, regulators, and registration holders. Key highlights include:

  • Launching of VigiMobile App in Urdu 
  • Strengthening Pharmacovigilance Systems in Public Health Programmes 
  • Pharmacovigilance Training Sessions for Healthcare Professionals
  • Highlights from the 4th Meeting of the Pharmacovigilance Risk Assessment Expert Committee (PRAEC) 
  • Latest Safety Alerts 

Stay informed and enhance your knowledge of medication safety to help minimize medication harm and ensure better patient outcomes

NPC Newsletter_July24 Final (RS)Download

Webinar on Building Effective Medicine Pricing Policies for Low- and Middle-Income Countries

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Webinar on Building Effective Medicine Pricing Policies for Low- and Middle-Income Countries

The Drug Regulatory Authority of Pakistan held an insightful discussion on “Building Effective Medicine Pricing Policies for Low and Middle-Income Countries on Tuesday July 23, 2024 at 10:00 AM at DRAP HQ, Islamabad. The session was led by Prof. Zaheer-Ud-Din Babar, University of Huddersfield and Editor-in-Chief of the Journal of Pharmaceutical Policy and Practice. Senior management of the DRAP attended the session at DRAP HQ, Islamabad, while more than 100 colleagues from industry and academia participated in the session virtually.

The discussion among participants centered on evidence-based challenges and potential solutions for medicinal pricing policies, tailored to the specific needs of low and middle-income countries. It included an analysis of five distinct pharmaceutical pricing strategies and the primary enablers for developing effective policies.



In case you missed the live session, the webinar recording is available at the following link.

Bioequivalence and Bioavailability of Drug Products

Asad Ullah Drugs

The Drug Regulatory Authority of Pakistan (DRAP) is committed to ensure that all pharmaceutical drug products shall conform to acceptable standards of safety, efficacy and quality. The submission of bioequivalence studies is requirement of Form-5F (Common Technical Document) notified vide SRO 713(1)/2018 dated 08.06.2018.

The Registration Board, in its 338th meeting on July 4, 2024, resolved that the regulatory approval process for the registration of generic drugs in light of the guidelines of international regulatory agencies will include the implementation of Bio-equivalence studies in adherence to WHO guidelines. The decision of the Registration Board is hereby communicated for implementation.

Bioavailability-Bioequivalence-StudiesDownload

DRAP Finalized Guidelines on Standards for Establishment of Hospital Pharmacies 

Asad Ullah News & Updates, Regulatory Updates

Guidelines on standard for Establishment of Hospital Pharmacies are intended to serve as a basic guide for the provision of pharmacy services in the hospitals within the country. These guidelines outline a set of services that are expected from hospital pharmacy departments and are aimed at ensuring 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.

These guidelines were uploaded on DRAP website as well as shared with the stakeholder as draft document for their inputs and comments in January 2024. After careful consideration of comments and deliberation through multiple virtual meetings, these guidelines have been finalized and being circulated as a guidance document providing minimum standards for establishment and functioning of hospital pharmacies in the country.

PHSR-GL-HP-012 Guidelines on Standards for Establishment of Hospital Pharmacies in PakistanDownload

Recall Alert: Drug Products; Recall of 12 Substandard Batches from the Market

Asad Ullah Recall Alerts

Recall Alert

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DRAP Alert NoNo I/S/05-24-28
Action Date14th June 2024.
Target Audience– National Regulatory Field Force.
– Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
– Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics
– General Public
Problem / Issue The Directorate of Drugs Control (DDC) Punjab vide Alert No. 137/2024 and 135/2024 has informed that the following samples of drug products have been declared as Substandard by Drug Testing Laboratories (DTL). The Details of affected product batches is tabulated below.

Therapeutic Good(s) Affected: –

S#Product NameCompositionBatch No.Manufactured byTest Results  
01Metroin 100ml infusionMetronidazoleMT23-014M/s. Saturn Pharmaceuticals, Lahore.Substandard
02Tozen-D Ophthalmic SuspensionTobramycin and DexamethasoneTW019M/s. Epharm Laboratories, Karachi.Substandard
03Ann-Vil 50ml InjectionPheniramine MaleateV-44423M/s. Venus Pharma, Lahore.Substandard
04Arpes 500mg Powder for InjectionAcyclovirAR-099M/s. MTI Medical, Lahore.Substandard
05Torax 60ml SyrupAcefylline Piperazine and Diphenhydramine24-24M/s. Siza International, Lahore.Unacceptable Ethylene Glycol level identified
06Zonid 200mg/5ml syrup 120ml Metronidazole BenzoateZ396
Z244
Z243
Z413
Z398
Z414
Z397		M/s. Bloom Pharmaceuticals, Hattar.Unacceptable Ethylene Glycol level identified
Action Initiated–The manufacturers have been directed to immediately recall the defected batches of their products from the market. All pharmacists and chemist working at distributions and pharmacies should immediately check their stocks and stop supplying these batches of abovementioned product. The remaining stock should be quarantined and returned to the supplier/ company.

-Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or through phone at +92 51 910 73 17, or by Email at gsms∂dra.gov.pk.

–Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare ProfessionalsDRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product.  

-Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the Adverse Event Reporting Form or online through this link.

-Please click here for further information on problem reporting to DRAP.
Advice for Consumers-Consumers should stop using these product bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product.

-All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist.