The 3rd meeting of the Pharmacovigilance Risk Assessment Expert Committee (PRAEC) was held in the Committee Room of the Drug Regulatory Authority of Pakistan (DRAP) on the 17th of September, 2023. The minutes of meeting are attached hereunder:-
Month: October 2023
National Hazardous Waste Management Policy 2022
The National Hazardous Waste Management Policy, 2022 of Pakistan is a set of guidelines for the environmentally sound management of solid and hazardous waste in the country. The Ministry of Climate Change has formulated this comprehensive national level policy through consultative process with relevant stakeholders. This Policy is aimed at acting as an umbrella document to address the issue of hazardous waste.
Pharmaceutical Industry being a potential source of generating hazardous material as byproduct of its manufacturing, research and development processes. These involve handling of various chemical compounds which may be toxic, reactive, flammable or otherwise hazardous to human health and environment Therefore, proper management of hazardous waste in pharmaceutical industry is crucial to protect human health and environment.
The Drug Regulatory Authority of Pakistan (DRAP) in 167th meeting directed to upload the National Hazardous Waste Management Policy 2022 on its website for the information and awareness of pharmaceutical industry and other stakeholders.
Recall Alert: Medical Devices; Trifecta Family of Valves by M/s ST. Jude Medical, USA
Recall Alert
| DRAP Alert No | No II/S/09-23-37 |
| Action Date | 10th October, 2023 |
| Target Audience | • Healthcare Professionals particularly working in the critical care areas of hospitals including Physicians, Cardiologists, Pharmacists, and Nurses. • People implanted with affected Trifecta Family Valves. • Procurement Officers at Hospitals and Healthcare Institutions. • Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores. |
| Problem / Issue | Abbot Structural Heart (St.Jude Medical, USA) has initiated a market withdrawal for the Trifecta family of valves (TrifectaTM Valve and TrifectaTM Valve with Glide Technology see table below) and will be removing the limited remaining inventory from the field due to potential for early Structural Valve Deterioration (SVD). Accordingly, the manufacturing company is recalling all the defective products from the international market including Pakistan. The Medical Device Board has already suspended the product registration in its 61st Meeting and further course of action for deregistration is in process under the Medical Device Rules 2017. |
Therapeutic Goods Affected:-
| Brand Names and Description | Model No | GTN/UDI | Manufacturer and Distributor |
|---|---|---|---|
| TrifectaTM Valve 19mm TrifectaTM Valve 21mm TrifectaTM Valve 23mm TrifectaTM Valve 25mm TrifectaTM Valve 27mm TrifectaTM Valve 29mm TrifectaTM Valve with Glide Technology 19mm TrifectaTM Valve with Glide Technology 21mm TrifectaTM Valve with Glide Technology 23mm TrifectaTM Valve with Glide Technology 25mm TrifectaTM Valve with Glide Technology 27mm TrifectaTM Valve with Glide Technology 29mm | TF-19A TF-21A TF-23A TF-25A TF-27A TF-29A TFGT-19A TFGT-21A TFGT-23A TFGT-25A TFGT-27A TFGT-29A | 05414734052016 05414734052023 05414734052030 05414734052047 05414734052054 05414734052061 05415067018205 05415067018212 05415067018229 05415067018236 05415067018243 05415067018250 | M/s St. Jude Medical 11 county road b e saint paul, mn USA 55117 Distributor in Pakistan: M/s Verizon, 60-D, F.C.C Zahoor Elahi Road, Gulberg-IV, Lahore. Products registration no. MDIR -0003639. MDIR -0000233. |
| Risk Statement: | The valves are intended to maximize valve opening and improve hemodynamic performance. Therefore, defective trifecta family heart valves pose a risk of patient harm which will compromise the hemodynamic performance of the valve and can lead to cardiac arrest, other serious injuries. |
| Action Initiated | -The manufacturing company has initiated a recall of the affected lots of defective products from the market where it was distributed. -All healthcare professionals working in critical care units of hospitals as well as pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying these lots of the 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 Professionals | DRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by these defective lots of the Medical Device. Patient using the affected device should immediately contact their doctors for further guidance. Furthermore, Abbott, USA provided patient management considerations for those patients implanted with the Trifecta and Trifecta GT valves. https://www.structuralheart.abbott/fileadmin/pdf/FINAL_Abbott_Letter_US_Trifecta_Abbott_Website_sig ned.pdf) Understanding that clinical decisions are shared between healthcare providers and patients, please consider the following post-implant: · Patients should be reminded to seek medical attention with new onset of symptoms such as shortness of breath or fatigue. · An initial post-procedural transthoracic echocardiogram (TTE) study is recommended for all patients within 1 to 3 months after the implant procedure to evaluate valve hemodynamics and ventricular function. · Schedule annual follow-up visits beginning 1-year post-implant for clinical evaluation, including TTE to assess transvalvular gradients and valvular regurgitation grade. · Patients presenting with changes in symptoms (e.g., shortness of breath or fatigue on exertion) or signs (e.g., murmur) indicative of potential SVD should undergo a TTE. · Patients with evidence of hemodynamically significant SVD should be considered, in consultation with a heart team, for a possible valve intervention with either surgical aortic valve replacement (SAVR) or a trans catheter valve-in-valve intervention depending on individual patient risks and benefits. · Patients being considered for a valve-in-valve intervention should undergo pre-procedure planning with imaging studies to ensure all potential procedure-related risks such as coronary obstruction are minimized. Additional information regarding future valve-in-valve considerations can be found in the Trifecta GT valve IFU. Please note that the titanium frame of the Trifecta GT valve cannot be fractured using a balloon. Actions Abbott is Asking You to Take: · Please consider this information in your practice and share with relevant health care professionals (e.g., cardiac surgeons, cardiologists, primary care physicians) involved in the care of patients implanted with the Trifecta family of valves in your institution. · Complete and return the provided Acknowledgement Form. · Report any product incidents, regardless of procedure or patient outcome, to Abbott. -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using 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 this product bearing the affected Model no and shall contact to their physician or healthcare provider if they have experienced any problems that may be related to using this Medical Device and report the incident to National Pharmacovigilance Centre of Drug Regulatory Authority of Pakistan, through MedSafety Mobile Application, or online at Med Vigilance E Reporting System. -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. |
Recall Alert: Drug Product; Albex 200mg Tablets (Batch#112) by M/s Swat Pharmaceuticals, Swat
Recall Alert
| DRAP Alert No | No II/S/09-23-34 |
| Action Date | 22th Sep, 2023 |
| Target Audience | · Healthcare Professionals particularly working in hospitals; Physicians, Pharmacists, and Nurses. · Procurement Officers at Hospitals and Healthcare Institutions. · Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores. |
| Problem / Issue |
Therapeutic Good(s) Affected: –
| Product Names | Composition | Batch No | Manufacturer |
|---|---|---|---|
| Albex 200mg Table Reg No. 020291 | Albendazole 200mg | Batch No 112 Mfg date 04.2023 Exp date 03.2025 | Ms. Swat Pharmaceutical, Swat. |
| Risk Statement: | Albendazole is an anthelminthic drug used to treat various parasitic worm infections. Substandard preparations of albendazole tablets may lead to treatment failure or suboptimal therapeutic effects, adverse effects, and increased antimicrobial resistance by exposing the parasitic worms to suboptimal concentrations of the drug. |
| Action Initiated | -The manufacturer has been directed to immediately recall the defective batch of product from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying this batch of product. The remaining stock should be quarantined and returned to the supplier/ company. The regulatory field force of all federating units (DRAP and Provincial Health Departments) has increase surveillance in the market to ensure the effective recall of defective products(s). -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 Professionals | DRAP 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 this 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. |
Rapid Alert; Drug Product: Unregistered and Falsified Lipiodol Ultra Fluide 480mg/mL Injection
Rapid Alert
| DRAP Alert No | No I/S/09-24-37 |
| Action Date | October 05, 2023 |
| Target Audience | 1. Regulatory Field Force. 2. Healthcare Professionals – Physicians, Pharmacists, and Nurses. 3 Procurement officer at hospitals and institutions 4. General Public. |
| Problem Statement | The regulatory field force of DRAP and the Chief Drug Inspector Office, Karachi have identified a suspected falsified lot of Lipiodol Ultra Fluide 480mg/ml Injection which was intended to supply to tertiary care hospitals. The said product is not registered in Pakistan and is not imported using special permission pathways. |
| Threats to Public Health | The use of falsified or counterfeit Lipiodol injection can pose serious health risks as it may contain unknown ingredients or no active ingredient at all. This can lead to ineffective treatment, worsening of the condition, or unexpected side effects. In some cases, falsified products have been found to contain toxic materials which expose patients to harmful substances. The safety, sterility, and quality of the falsified products referenced in this alert are also unknown. |
The product identification details are as under: –
Therapeutic Goods Affected:-
| Product Name | Composition | Batch / Lot | Manufacture Name (as stated on label) | Remarks |
|---|---|---|---|---|
| Lipiodol Ultra Fluide 480mg/ml Solution for Injection (10ml) Registration No. Nil | Ethiodized-oil (radio-opaque contrast injection) | Batch No.: 15LU606A Exp. Date: 07-2024 | Guerbet, 15 rue des Vanesses, Zone Paris Nord II France | The outer packaging, solution colour and consistency were different from the comparison to the original product. |
| Action Initiated | The Regulatory Field Force has been directed to increase surveillance throughout the supply chain system including healthcare facilities to confiscate/seize this product from the market without any delay. Since this product is not registered with DRAP, it is not permitted to be stocked or sold in pharmacies or other retail outlets. However, it is crucial for all healthcare professionals, including pharmacists and chemists, to check their stock immediately and stop the distribution or supply of this product if it is found. Information related to the supplier of this product should be provided to the Regulatory field force (DRAP, Provincial Health Departments, and States) to ensure the removal of this product. |
| Advice for Healthcare Professionals | -DRAP requests increased vigilance at hospitals and within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this product. -Adverse reactions or quality problems experienced with the use of these products shall be reported to the National Pharmacovigilance Centre (NPC), DRAP using 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 not use this product and should contact their physician or healthcare provider if they have experienced any problem related to taking or using this drug product, and should report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre. All therapeutic goods must be obtained from licensed pharmacies and other authorized/licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt. |