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:-
SafetyAlert
Rapid Alert: Drug Product Recall: Incidents of loss and damage of vision with the off-label use of Avastin 100mg/4ml injection
Information Update on 3rd Nov, 2023: The recall of Avastin 100mg/4ml has been terminated based on the report of Central Drugs Laboratory, Karachi which declared the samples as of standard quality.
Rapid Alert
| DRAP Alert No | No I/S/09-24-36 |
| Action Date | September 24, 2023 |
| Target Audience | 1. Ophthalmologists and Endocrinologists 2. Healthcare Professionals – Physicians, Pharmacists, and Nurses. 3. Regulatory Field Force. 4. General Public |
| Problem Statement | Incidents of loss of vision in diabetic patients have been reported following treatment with Altered/Dispensed/Diluted Avastin injection. This product is approved by the Drug Regulatory Authority of Pakistan (DRAP) to treat Colorectal and other metastatic carcinomas. The use of this drug product in diabetic retinopathy or other ophthalmic conditions is one of the off-label uses and is not approved by DRAP. The incident is linked with the alteration/dispensing/dilution and sale of Avastin 100mg/4mL Injection under unhygienic/non-sterile conditions illegally and without any Drug Sale/Dispensing License (DSL) from Provincial Health Authority by M/s Genius Advanced Pharmaceutical Services Lahore. |
| Threats to Public Health | Avastin is a registered drug of M/s. Roche Pharma in Pakistan and is available in strength of 100mg/4ml and 400mg/16ml preparations. This drug is indicated for the treatment of colorectal and other metastatic carcinomas as a VGRF (vascular endothelial growth factor) inhibitor. However, the use in diabetic retinopathy is an off-label use to block the growth of abnormal blood vessels in the eye. Since this drug was being dispensed/diluted/repacked in 1.25mg/0.05ml dose under unhygienic conditions and in an unapproved manner, therefore, its safety cannot be ascertained which may lead to damage and loss of vision in the patients. |
The product identification details are as under: –
Therapeutic Goods Affected:-
Following is the detail of the alleged product:
| Product Involved | Manufacturer |
|---|---|
| Inj. Avastin 1.25 mg/0.05ml Composition: Bevacizumab Registration No. Nil | Genius Advanced Pharmaceutical Services. |
Following is the detail of DRAP approved product:
| Product Name | Suspected Batch | Manufacturer/Importer |
|---|---|---|
| Avastin 100mg/4ml Injection Composition: Bevacizumab Registration No. 043004 | H0352B11 B7266B20 B7266B07 | M/s Roche Diagnostics, Germany Importer: M/s Roche Pharma, Karachi. |
| Action Initiated | The Regulatory field force raided the premises of M/s Genius Advanced Pharmaceutical Services, Lahore, involved in the repacking and dispensing of Avastin injection under unhygienic/non-sterile conditions. The premises have been sealed and legal proceedings have been initiated against the personnel involved. The Importer of the registered product has been directed to recall the suspected batches of Avastin 100mg injection from the marked immediately. The sale/distribution of registered Avastin Injection has been put on halt till verification of its quality through sampling and laboratory testing to safeguard public health. Healthcare Professionals, Pharmacists and Chemists have been directed to stop the distribution, dispensing and administration of this product immediately, and check their stocks and stop supplying this product. The remaining stocks should be quarantined and returned to the supplier/company. |
| Advice for Healthcare Professionals | -DRAP requests increased vigilance at hospitals and within the supply chains of institutions/pharmacies/healthcare facilities regarding the off-label use of 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 | Patients should not use this product for any ophthalmic disease 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. |
Rapid Alert: Drug Product; Suspected increase in the availability of falsified versions of Glucagon-like Peptide-1 Receptor Agonist (GLP-1-RA) in the markets.
Rapid Alert
Suspected Falsified GLP-1 Receptor Agonists
| DRAP Alert No | No I/S/07-23-24 |
| Action Date | 12th July 2023 |
| Target Audience | 1. Regulatory Field Force 2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics, etc. 3. Pharmacists and Chemists at Distribution, Pharmacies, and Medical Stores 4. Patients, Caregivers, and General Public. |
| Problem Statement | Glucagon-like Peptide 1 Receptor Agonists (GLP-1-RA) are a class of Pharmaceuticals indicated to manage Diabetes type II. In Pakistan, only a single brand i.e. Ozempic injection manufactured by Novo Nordisk is registered by DRAP currently and is available as a “prescription only” product. It is reported that there has been a surge of online information promoting the use of GLP-1 RA products for weight loss which is its unapproved use and this situation is encouraging risky procurement behaviors. Numerous online sources offer GLP-1 RA products for sale without requiring a prescription. The quality and safety of these medical products manufactured and distributed in poorly controlled environments (such as the internet) cannot be assured. Due to the stated reasons, an increased demand resulting in a global shortage of these products has risen which may create environments favorable for the availability of falsified medical products. Reports have been received by WHO regarding an increase in the availability of falsified GLP-1-RA products in the past six months. It is possible that several versions of falsified GLP-1 RA – regardless of the brand name – are in circulation and available online. |
| Therapeutic Goods Affected:- | GLP-1 receptor agonists Products containing the following active ingredients:- -semaglutide -exenatide -liraglutide -dulaglutide -lixisenatide |
| Threat to Public Health | Falsified medical products have been known to lack efficacy and/or cause toxic reactions. They are neither approved nor controlled by DRAP and may have been produced in unhygienic conditions by unqualified personnel, contain unknown impurities, and are sometimes contaminated with bacteria. It is also possible that people living with diabetes type II who miss treatment due to the unavailability of GLP-1-RA products may also suffer clinical consequences. |
| Advice for Healthcare Professionals | -DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by these batches of the above-mentioned products. -Endocrinologists and Pharmacists present at healthcare facilities are requested to remain vigilant and inform patients of procuring medical products only from authorized channels. -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 | To ensure authenticity, consumers should always obtain medical products from authorized licensed pharmacies /outlets. The authenticity of these products should be carefully checked and If the consumer has any doubt, advice must be sought from your pharmacist. In case a consumer has experienced any problem related to taking or using these drug product(s), they should cease the use of the product in question immediately and contact their Physician or Pharmacist and should also report the incident to the Drug Regulatory Authority of Pakistan. |