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Month: November 2022

Stakeholder Comments are invited on the Draft Therapeutic Goods (Federal Inspectors, Laboratories and Federal Government Analysts) Rules, 2022

Asad Ullah Licensing and Inspections, News & Updates, Notifications, Regulatory Updates

Drug Regulatory Authority of Pakistan Act, 2012 provides the legal mandate to inspect and enforce GXPs through out the supply chain of therapeutic Goods. Inspection of establishments is an essential regulatory function, to monitor the regulatory compliance to ensure that operations at these establishments are carried out in accordance with approved standards, conditions, guidelines and legislations. The scope of the Inspections applies to different Good Practices (GXPs) including Good Manufacturing Practices (GMPs), Good Distribution Practices(GDPs) and Good Clinical Practices (GCPs), etc.

DRAP Act 2012, under its Schedule-V provides the legal provisions for appointment, powers and procedures for working of Inspectors. These draft rules are intended to replace the existing Drugs (Federal Inspectors, Federal Drug Laboratory and Federal Government Analyst) Rules, 1976 and are aimed at converting Inspection activities to be based on a risk management approach, capable of revealing weaknesses and deficiencies in the production, quality control, storage or distribution of therapeutic goods, as well as to devise a uniform procedures for taking regulatory actions and handling of products with suspected quality defects or identified as substandard and falsified.

These draft Therapeutic Goods (Federal Inspectors, Laboratories and Federal Government Analysts) Rules, 2022 were uploaded on the official website of DRAP dated 24th November, 2022, seeking comments and suggestions from stakeholders on the draft rules. Stakeholders can submit their comments and suggestions within 14 days of uploading this draft using prescribed format, (further information on comments submission is available on this link). Comments and suggestions can be forwarded via email to aamar.latif∂dra.gov.pk , copying at ajmal.shoail∂dra.gov.pk , or can be posted at mailing address, Additional Director, Division of Legal Affairs, Drug Regulatory Authority of Pakistan, 1st floor, TF Complex, 7th Mauve Area, G-9/4, Islamabad.

Draft-Therapeutic-Goods-Federal-Inspectors-Laboratories-and-Federal-Government-Analysts-Rules-2022Download

Drug Safety Update: Risk of Hypothyroidism in Babies and Young Children with Iodinated Contrast Media (ICM) Injections

Asad Ullah Safety Alerts, Safety Communication, Safety Info

Drug Safety Alert

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

Date:19th of November 2022
Target Audience:• Manufacturers and importers of Iodinated contrast media (ICM) injections such as iohexol, iopromide and iodixanol etc;
• Healthcare Professionals; and
• Patients, consumers or caregivers.
Background:On 30th March, 2022, the United States Food and Drug Administration (US-FDA) through a Drug Safety Communication informed that they have approved a new warning to the prescribing information for the entire class of iodinated contrast media (ICM) injections and monitoring recommendations for children 3 years or younger. The warning describes the risk of an underactive thyroid or a temporary decrease in thyroid hormone levels. These risks and recommendations pertain to ICM given as an injection through an artery or vein. Newborns, particularly those born premature, and children in their first 3 years with underlying conditions such as heart issues may be at higher risk for problems with the thyroid. It was informed that the agency first alerted the public about cases of underactive thyroid in infants receiving ICM back in 2015 and now six new research studies evaluating this risk have been published. The FDA has concluded based on their review of the published studies that there is compelling evidence of a significant risk for an underactive thyroid or a temporary decrease in thyroid hormone levels in newborns and children through 3 years after exposure to ICM. Back in December 2017, the Medicines and Medical Devices Safety Authority (Medsafe) of New Zealand also requested that data sheets for iodine-containing contrast agents (ICAs) to be updated with information on the risk of hypothyroidism, particularly in neonates and should include advice on thyroid monitoring.
Therapeutic Goods Affected:Iodinated contrast media (ICM) injections such as iohexol, iopromide and iodixanol etc.

ICM are drugs containing iodine that are given to patients to enhance the ability to see blood vessels, organs, and tissues on medical images such as X-rays or computed tomography (CT) scans, thus helping healthcare professionals to diagnose potential problems. Examples include iohexol (Omnipaque), iopromide (Ultravist 300, 370) and iodixanol (Visipaque 270, 320) etc. Common side effects associated with ICM include flushing in the face, nausea or vomiting, mild itchiness, and skin rash.
Action in PakistanAccordingly, the case of the risk of hypothyroidism in babies and young children with iodinated contrast media (ICM) injections 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 after detailed deliberation and discussion decided as per Rule 10 (1) (h) (iv) of Pharmacovigilance Rules, 2022 (reliance mechanism) to update the warning and precaution section of the prescribing information of the entire class of iodinated contrast media (ICM) that are used for radiological purposes to include risks of an underactive thyroid or a temporary decrease in thyroid hormone levels in children 3 years or younger i.e newborns, particularly those born premature, and children in their first 3 years with underlying conditions such as heart issues etc.
Advice for healthcare professionals:Healthcare professionals are advised to perform appropriate monitoring of patients from birth through 3 years for the possibility of hypothyroidism or a temporary decrease in thyroid hormone levels following exposure to iodinated contrast media (ICM) injections. Healthcare professionals are also advised to consider evaluating thyroid function within 3 weeks, especially in term and preterm neonates and children with some underlying conditions. If thyroid dysfunction is detected, it should be properly treated and monitored as clinically needed to avoid future cognitive and other developmental disabilities. Increased-risk pediatric patients include those who are newborns or have very low birth weight, prematurity, or the presence of cardiac or other conditions such as those requiring care in neonatal or pediatric intensive care units. Patients with cardiac conditions may be at the greatest risk since they often require high doses of contrast during invasive cardiac procedures. These increased-risk pediatric patients require close monitoring.
Advice for patients:Parents and caregivers of a child below 3 years and receiving ICM injections should talk with healthcare professionals for additional information. If the child is a newborn, has very low birth weight, was premature, has a heart condition, or was admitted to a neonatal or pediatric intensive care unit, they may be at higher risk of developing underactive thyroid or a temporary decrease in thyroid hormone levels. Babies & young children typically do not show any visible signs of thyroid problems & may need to be monitored by their healthcare professionals after receiving ICM.
Guidelines for reporting Adverse Drug Reactions (ADRs):Both healthcare professionals and patients are requested to report any suspected adverse drug reaction (ADRs) 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.
Drug Safety Communication of the United States Food and Drug Administration (US-FDA) regarding Iodinated contrast media (ICM).
    23_Safety_alert_of_risk_hypothyroidism_in_babies_and_young_children_with_Iodinated_contrast_New-1Download

    DRAP invited Comments from Stakeholders on the Draft Therapeutic Goods (Advertisement) Rules, 2022

    Ijaz Mustafa Advertisements, Drugs, Notifications, Publications

    Drug Regulatory Authority of Pakistan Act, 2012 under section 7 (c)(iii) and (x) mandated the DRAP for the regulation of Advertisements, enforcement and monitoring of advertisement rules and ban on false advertisement. Schedule II- B of the DRAP Act, 2012 prohibits the advertisements of any therapeutic goods except in accordance with the prescribed conditions.

    The current changing trend of advertisement and promotional activities by pharmaceutical companies and the requirement of extension of scope from drugs to therapeutic goods has led to the development of these draft rules. These draft rules contain provisions almost similar to the ones given in Rule 31 of the Drugs (Licensing, Registering & Advertising) Rules 1976, included but not limited to; amended Schedule with the list of drugs permissible for advertisement as earlier consulted with stakeholders, Schedule with diseases for which advertisement is prohibited, schedule with the details on advertisement or promotional material keeping in consideration the ethical criteria; Forms for submitting applications of advertisement approval, Formats for granting approval for advertisement and schedule with details on advertisement or promotional material keeping in consideration the ethical criteria.
    These draft Therapeutic Goods (Advertisement) Rules, 2022 were uploaded on the official website of DRAP dated 21st November, 2022, seeking comments and suggestions from stakeholders on the draft rules. Stakeholders can submit their comments and suggestions within 14 days of uploading this draft using prescribed format, (further information on comments submission can be accessed on this link). Comments and suggestions can be forwarded via email to aamar.latif∂dra.gov.pk , copying at aqsa.hashmi∂dra.gov.pk , or can be posted at mailing address, Additional Director, Division of Legal Affairs, Drug Regulatory Authority of Pakistan, 1st floor, TF Complex, 7th Mauve Area, G-9/4, Islamabad.

    Click here to View/Download the draft Therapeutic Goods (Advertisement) Rules, 2022

    Draft-Therapeutic-Goods-Advertisement-Rules-2022Download

    Drug Safety Update; PRAEC issued a Safety Alert on Risk of Sinus Bradycardia with Remdesivir

    Asad Ullah Safety Alerts, Safety Communication, Safety Info

    Drug Safety Alert

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

    Date:21st of November 2022
    Target Audience:• Manufacturers and importers of Remdesivir;
    • Healthcare Professionals; and
    • Patients, consumers or caregivers.
    BackgroundHealth Canada in August, 2021 announced that it will work with the manufacturer of Remdesivir to update the product information to include a warning on the potential risk of sinus bradycardia. Health Canada assessed case reports of sinus bradycardia in patients receiving Remdesivir in their database and in the literature and concluded that a link between the use of Remdesivir and the risk of sinus bradycardia is possible.

    Previously, in June 2021, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicine Agency (EMA) recommended a change to the product information for Remdesivir (Veklury®) to include sinus bradycardia as an adverse drug reaction. The PRAC reviewed available data on rare reported cases of bradycardia in patients treated with Remdesivir as well as data from clinical trials and the scientific literature. The PRAC concluded that a causal relationship between the use of Remdesivir and the event is reasonably possible and recommended the revision of the product information. The majority of the events of sinus bradycardia resolved a few days after the treatment with Remdesivir was discontinued.

    Sinus bradycardia occurs when the heart beats slower than normal. Sinus bradycardia can very rarely cause symptoms, such as dizziness, tiredness, shortness of breath, and chest discomfort.
    Action in PakistanAccordingly, the case of the risk of sinus bradycardia with Remdesivir 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 after discussion decided as per Rule 10 (1) (h) (iv) of Pharmacovigilance Rules, 2022 (reliance mechanism) to update the prescribing information (warning & adverse drug reactions sections) of Remdesivir to include the potential risk of sinus bradycardia.
    Therapeutic Goods Affected:Remdesivir injection

    Remdesivir is an antiviral medicine that is indicated to treat COVID-19 in adults and adolescents with pneumonia requiring supplemental oxygen. Remdesivir is a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleotide analog RNA polymerase inhibitor indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults and pediatric patients (28 days of age and older and weighing at least 3 kg) with positive results of direct SARS-CoV-2 viral testing, who are: hospitalized, or not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death..
    Advice / Directions for for Registration HolderRegistration holders of Remdesivir injection are hereby advised/directed to update the prescribing information/safety specification/ label of Remdesivir with the inclusion of information related to infusion-related hypersensitivity reactions and its monitoring in the warning and precaution sections. Furthermore, registration holders should also introduce educational training for healthcare professionals on proper preparation, administration and flow rate of Remdesivir, and monitoring of patients.
    Advice for healthcare professionals:Healthcare professionals are informed that the Pharmacovigilance Risk Assessment Expert Committee (PRAEC) of the NPC-DRAP has decided to update the prescribing information (warning & adverse drug reactions sections) of Remdesivir to include the potential risk of sinus bradycardia. Therefore, healthcare professionals should monitor patients receiving Remdesivir for sinus bradycardia and accordingly treat the patients as appropriate.
    Guidelines for reporting Adverse Drug Reactions (ADRs):Both healthcare professionals and patients are requested to report any suspected adverse drug reaction (ADRs) 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.
    Minutes of Meeting of PRAC of European Medicines Agency.
      24-Safety-Alert-of-Risk-of-Sinus-Bradycardia-with-RemdesivirDownload

      Drug Safety Update: Risk of Infusion-Related Hypersensitivity Reactions with Remdesivir

      Asad Ullah Safety Alerts, Safety Communication, Safety Info

      Drug Safety Alert

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

      Date:18th of November 2022
      Target Audience:• Manufacturers and importers of Remdesivir;
      • Healthcare Professionals; and
      • Patients, consumers or caregivers.
      Problem or Issue:The National Pharmacovigilance Centre (NPC), Division of Pharmacy Services, Drug Regulatory Authority of Pakistan (DRAP) received a cluster of three serious (life-threatening) adverse drug reaction reports from a hospital with Inj Remdesivir (100mg/20ml). The events of tachycardia, dyspnoea, chills and pyrexia were noted after the use of Remdesivir through an intravenous drip for COVID-19 Pneumonia, with a time to onset of 0 days. The causality assessment of all three cases was performed by the Causality Assessment Group of the NPC and classified that all three cases have a possible relationship with drug intake. However, at the same time, the NPC also carried out the quality testing of the suspected batch of Remdesivir, which was declared of standard quality with regard to the tests performed by the Central Drugs Laboratory, DRAP, Karachi. The NPC accordingly labelled it as a potential signal of infusion-related hypersensitivity reactions with the injection of Remdesivir.
      Further assessment was also carried out at NPC-DRAP, where the signal was confirmed from the approved label of the United States Food and Drugs Administration (US-FDA) and Summary of Product Characteristics (SmPC) of Medicine and Health Products Agency (MHRA) of the United Kingdom. There was also significant disproportionality and potential association of Remdesivir with infusion-related hypersensitivity reactions as per the statistical tools available in VigiLyze of the Uppsala Monitoring Centre.

      The case was discussed in the 1st meeting of the Pharmacovigilance Risk Assessment Expert Committee (PRAEC) of the NPC, DRAP and decides as to update the prescribing information/ safety specification/ label of Remdesivir injection with the inclusion of information related to infusion-related hypersensitivity reactions and its monitoring in the warning and precaution sections. Furthermore, it was also decided that all registration holders should introduce educational training for healthcare professionals on proper preparation, administration and flow rate of Remdesivir, and monitoring of patients.
      Therapeutic Goods Affected:Remdesivir injection
      Remdesivir is a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleotide analog RNA polymerase inhibitor indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults and pediatric patients (28 days of age and older and weighing at least 3 kg) with positive results of direct SARS-CoV-2 viral testing, who are: hospitalized, or not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including
      hospitalization or death.
      Advice / Directions for for Registration HolderRegistration holders of Remdesivir injection are hereby advised/directed to update the prescribing information/safety specification/ label of Remdesivir with the inclusion of information related to infusion-related hypersensitivity reactions and its monitoring in the warning and precaution sections. Furthermore, registration holders should also introduce educational training for healthcare professionals on proper preparation, administration and flow rate of Remdesivir, and monitoring of patients.
      Advice for healthcare professionals:Healthcare professionals are informed that the Pharmacovigilance Risk Assessment Expert Committee (PRAEC) of the DRAP has recommended updating the prescribing information/ safety specification/ label of Remdesivir injection with the inclusion of information related to infusion-related hypersensitivity reactions and its monitoring in the warning and precaution sections, and is working with registration holders in this regard.
      Healthcare professionals are also informed that the signs and symptoms of infusion-related hypersensitivity reactions may include hypotension, hypertension, tachycardia, bradycardia, hypoxia, fever, dyspnea, wheezing, angioedema, rash, nausea, diaphoresis, and shivering, which have been observed during and following administration of Remdesivir injection which mostly occurred within one hour. Therefore, slower infusion rates with a maximum infusion time of up to 120 minutes should be considered to potentially prevent these signs and symptoms. Furthermore, monitor patients during infusion and observe patients for at least one hour after the infusion is completed for signs and symptoms of hypersensitivity as clinically appropriate. If signs and symptoms of a clinically significant hypersensitivity reaction occur, immediately discontinue the administration of Remdesivir injection and initiate appropriate treatment.
      Advice for patients:Patients are informed that hypersensitivity reactions including infusion-related reactions have been observed during and following the administration of Remdesivir injection. Immediately call your doctor if you experience signs and symptoms such as hypotension, hypertension, tachycardia, bradycardia, hypoxia, fever, dyspnea, wheezing, angioedema, rash, nausea, diaphoresis, and shivering after administration of Remdesivir injection.
      Guidelines for reporting Adverse Drug Reactions (ADRs):Both healthcare professionals and patients are requested to report any suspected adverse drug reaction (ADRs) with Diclofenac Sodium 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.
      Approved label of Veklury (Remdesivir) of US-FDA.
        21-Safety-Alert-of-Infusion-related-hypersensitivity-reactions-with-RemdesivirDownload

        Drug Safety Alert: Risk of Serious Bowl complications with clozapine

        Asad Ullah Safety Alerts, Safety Communication, Safety Info

        Drug Safety Alert

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

        Date:18th of November 2022
        Target Audience:• Manufacturers and importers of Clozapine;
        • Healthcare Professionals; and
        • Patients, consumers or caregivers.
        BackgroundThe Therapeutic Goods Administration (TGA) of Australia on 22nd, April 2022 through a safety advisory informed that Product Information (PI) and Consumer Medicine Information (CMI) for Clozapine have been updated to strengthen warnings about potential severe gastrointestinal side effects, including constipation. It was informed that Clozapine may also affect the bowels by slowing them down and can cause severe constipation, the condition known as clozapine-induced gastrointestinal hypomotility. If untreated, it can lead to serious problems. Consumers who were using clozapine were informed to look out for changes in their bowel function and to contact their health professionals if they develop any of the symptoms.
        On 14th January 2022, the United States Food and Drug Administration (US-FDA) through Drug Safety Podcast referred to the already issued communication dated 18th of February 2020 where the FDA strengthens the existing warning that untreated constipation caused by schizophrenia medicine clozapine (Clozaril®) can lead to serious bowel problems. It was informed that serious bowel complications can lead to hospitalization or even death if constipation is not diagnosed and treated quickly.
        Action in PakistanAccordingly, the case of risk of serious bowel complications with Clozapine 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) which after detailed deliberation and discussion decided to update and strengthen the warning section of Clozapine with gastrointestinal side effects, including constipation and severe bowel problem in light of Rule 10 (1) (h) (iv) of Pharmacovigilance Rules, 2022 as a part of reliance mechanism on stringent regulatory authorities.
        Therapeutic Goods Affected:Clozapine Tablets
        Clozapine is a medicine that has been used for more than 40 years to treat schizophrenia in patients whose symptoms are not controlled with standard treatment
        Advice for healthcare professionals:Healthcare professionals are advised the following: to evaluate bowel function before starting a patient on clozapine and avoid co-prescribing clozapine with other anticholinergic medicines that can cause gastrointestinal hypomotility; advise patients frequently of the significant risk of constipation and life-threatening bowel issues and the need to stay hydrated to prevent constipation; advise patients to contact a healthcare professional right away if they have difficulty having a bowel movement or passing stools, do not have a bowel movement at least three times a week or less than their normal frequency.
        Advice for patients:Patients are advised to contact their healthcare professionals if they have symptoms that can be associated with serious bowel problems such as nausea, vomiting or stomach pain. To prevent constipation, they should eat more fruits, vegetables, and grains that are high in fibre; drink plenty of water and other liquids, and get enough exercise.
        Guidelines for reporting Adverse Drug Reactions (ADRs):Both healthcare professionals and patients are requested to report any suspected adverse drug reaction (ADRs) 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:1-Minutes of 1st meeting of Pharmacovigilance Risk Assessment Expert Committee.
        2-Safety Advisory- constipation: a potentially serious side effect issued by the Therapeutic Goods Administration of Australia.
        3-Drug safety podcast of the United States Food and Drug Administration (US-FDA) regarding constipation caused by schizophrenia medicine clozapine.
        22-Safety-Alert-of-Risk-of-Serious-Bowel-Complications-with-Clozapine.Download

        Drug Safety Alert: Risk of Anaphylactic Reaction / Anaphylactic Shock with Diclofenac Sodium Injection

        Asad Ullah Safety Alerts, Safety Communication, Safety Info

        Drug Safety Alert

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

        Date:10th of November 2022
        Target Audience:• Manufacturers and importers of Diclofenac Sodium.
        • Healthcare Professionals; and
        • Patients, consumers or caregiver
        Problem or Issue:The National Pharmacovigilance Centre (NPC), Division of Pharmacy Services, Drug Regulatory Authority of Pakistan (DRAP) through the Provincial Pharmacovigilance Centre (PPC), Directorate of Drugs Control Punjab received two serious cases of anaphylactic reactions upon STAT dose administration of injection Diclofenac Sodium 75mg/3ml intramuscular (IM). The cases were reported by Clinical Pharmacy and Pharmacovigilance Officers (CPPOs) of two public sector hospitals in the Punjab province. The diclofenac injection was used in these cases for the wound pain in the left leg and backache. One of the patients has a history of asthma. The symptoms noted were pruritus, erythema, sweating, apprehension and fainting due to a sudden drop in blood pressure, severe shortness of breath, wheezy chest, hypoxia and hypotension. The adverse drug reactions were assessed for causality using the WHO Causality Assessment Criteria and were categorized as “Possible” and “Probable” based on plausible time to onset (same day immediately after administration), positive dechallenge (recovered on withdrawing) and unable to explain from other drugs/ disease.

        The case were, therefore, discussed in the 1st meeting of the Pharmacovigilance Risk Assessment Expert Committee (PRAEC) of the NPC, DRAP which decided to update the warning, precaution & contraindication sections of the prescribing information / safety specification / label of Diclofenac Sodium injection about the occurrence of anaphylactic reaction/ anaphylactic shock and its contraindication in a patient with a history of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
        Therapeutic Goods Affected:Diclofenac Sodium injection
        Advice for healthcare professionals:Healthcare professionals are informed that Pharmacovigilance Risk Assessment Expert Committee of the DRAP has recommended to update the warning, precaution & contraindication sections of the prescribing information/ safety specification/ label of Diclofenac Sodium injection about the occurrence of anaphylactic reaction/ anaphylactic shock and its contraindication in a patient with a history of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Therefore, healthcare professionals should know that are rare chances that anaphylactic reactions may occur with diclofenac sodium injection in patients with the aspirin triad or in patients without prior exposure to diclofenac. Immediately discontinue the diclofenac injection if an anaphylactic reaction occurs. Likewise, Diclofenac is contraindicated in patients with a history of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
        Advice for patients:Patients are informed that there are rare chances of the development of anaphylactic reaction/ anaphylactic shock with an injection of diclofenac sodium. Talk to your doctor if you have a history of asthma or urticaria, or if you had previously experienced an anaphylactic reaction/ allergic-type reaction with diclofenac sodium or after taking aspirin or other NSAIDs.
        Guidelines for reporting Adverse Drug Reactions (ADRs):Both healthcare professionals and patients are requested to report any suspected adverse drug reaction (ADRs) with Diclofenac Sodium 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.
        20-Safety-Alert-of-Anaphylactic-reaction-with-Diclofenac-Sodium.Download

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

        Asad Ullah News & Updates, Pharmacovigilance, Press Releases

        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 Signed MoU with Pakistan Single Window to Foster Cooperation

        Asad Ullah News & Updates, Press Releases
        DRAP Signed MoU with Pakistan Single Window to Foster Cooperation

        The Islamabad 11th Nov, 2022; Drug Regulatory Authority of Pakistan signed a memorandum of understanding with the Pakistan Single Window (PSW) in a ceremony held on 11th Nov 2022 at Islamabad. This MoU is aimed at enhancing cooperation among two departments through digital integration of IT System of PSW with the regulatory processed of DRAP. This will enable therapeutic goods industry to utilize an integrated electronic platform for import and export of raw materials and finished products using single entry point.  PSW will support international trade of therapeutic goods by recognizing standardized information and documents on an online platform which will fulfill all import, export, and transit regulatory requirements.

        Speaking to the participant at the ceremony, Mr. Asim Rauf, CEO DRAP lauds the efforts and contribution of PSW team and stated that DRAP is continuously transforming its regulatory operations into IT based electronic solutions and various initiatives are underway to revamp drug regulatory system in the country. DRAP is one of the largest organizations in public sector that has fully replaced the manual filling system with an electronic office module for intradepartmental communication and decision making. This MoU will mutually benefit both Regulators and Industry by enabling one window working environment in electronic format which support compliance with all regulatory requirement and processes for cross border trade of therapeutic goods. DRAP and PSW will continue to support each other for provision of more facilitating regulatory environment to industry. In future, DRAP will also integrate licensing and registration systems for therapeutic goods with PSW.         

        Recall Alert: Drug Product; Moxtrex 400mg Tablets (Batch # 850) by M/s Gillman Pharmaceuticals, Hattar, Khyber Pakhtunkhwa

        Asad Ullah Product Recalls, Recall Alerts

        Recall Alert

        DRAP Alert NoNoII/S/10-22-32
        Action Date3rd November 2022
        Target Audience1. Pharmacists and Chemists at Distributions, Pharmacies and Medical Stores
        2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at Hospitals, Clinics and Healthcare Providing Institutions
        3. General Public
        Product(s) Affected Moxtrex 400mg Tablets,
        Active Ingredient(s): Moxifloxacin
        Company: M/s Gillman Pharmaceuticals, Hattar.
        Batch No. 850
        Manufacturing Date: 06-2022
        Expiry Date: 06-2024
        Problem / Issue Drug Testing Laboratory (DTL) Rawalpindi has analyzed the samples of Moxtrex 400mg Tablets manufactured by M/s Gillman Pharmaceuticals, Hattar, KPK and declared the batch No. 850 as “substandard” based on the analysis report.
        Action Initiated-The company is directed to immediately recall the defected batch of product from the market.

        -All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above-mentioned batch of product to the supplier / importer / company.

        -Distributors and pharmacies are advised to be vigilant and report any suspected batch of product(s) in the supply chain to the DRAP using online form, or through phone at +92 51 910 73 17, or 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 increase vigilance within the supply chains of healthcare institutions and hospital pharmacies to identify and return the defective batch(es) of this product to the importer / company.

        -Adverse reactions or quality problems experienced with the use of 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 batch number(s) and shall contact to their physician or healthcare provider(s) if they have had experienced any problem that may be related to taking or using this product.

        -All drug products must be obtained from the authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubt, please seek advice from your pharmacist.
          Moxtrex-400mg-TabDownload