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• the health professionals who administer the vaccines, whether they are provided through funded programs or purchased privately. Consumers also play an important role in reporting adverse events of concern to them. Effective post-marketing surveillance, therefore, relies on cooperation between the TGA, the vaccine companies, state and territory health authorities, health professionals and consumers. International post-marketing surveillance experience is also important for understanding vaccine and drug safety and the TGA maintains close liaison with its overseas counterparts to share safety information. The core of the post-market monitoring system for vaccines is the identification, reporting, and evaluation of adverse events following immunisation (AEFIs). The system is managed through the Office of Product Review of the TGA as part of the monitoring of all adverse drug reactions. The primary function of the AEFI monitoring system is to detect early warning signals and generate hypotheses about possible new vaccine adverse events or changes in frequency of known ones. The monitoring of AEFI is largely through passive surveillance, which relies on voluntary reporting of AEFIs by state and territory health authorities, immunisation providers, other health professionals and consumers. AEFI reporting is mandatory for vaccine sponsors and the Act requires sponsors to submit reports of serious AEFIs within 15 days of becoming aware of the event. In all jurisdictions, other than Tasmania and Victoria, health professionals notify serious or unexpected AEFIs to the relevant health authority. In Victoria, AEFIs are notified to SAEFVIC, a service funded by the Department of Health. Reporting to the health authority is mandated by jurisdictional legislation except in Tasmania, South Australia and Victoria. Health authorities and SAEFVIC forward some or all of the reports to TGA after processing. Each jurisdiction has its own report form and data collection differs across the jurisdictions. In Tasmania, health professionals report directly to the TGA, with TGA providing a line listing of each month’s reports and a separate report for each case to the Tasmanian Department of Health and Human Services about 2 weeks into the following month. The TGA provides all jurisdictions monthly with case details of all AEFIs reported to the TGA that occurred in the relevant jurisdiction in the previous month. An important aspect of the monitoring of AEFIs at jurisdictional level is the capacity to provide advice to the reporting health professional or consumer on the clinical investigation and management of the event itself and for provision of advice on future vaccination. Some jurisdictions have specialised services to support the clinical management of persons who have experienced an AEFI. Health professionals reporting directly to TGA may do so by telephone, on-line or through completing a Report of suspected adverse reaction to medicines or vaccines (“Blue Card”) form and submitting it by mail, fax or email. Consumers may report adverse events to the relevant health authority in some jurisdictions (eg South Australia). They can also report through their doctor, directly to the TGA, or by phoning the Adverse Medicine Events Line a service funded through the National Prescribing Service and based at the Mater Hospital in Brisbane, which forwards reports to the TGA. Information about how consumers can make a report is available on the TGA website. AEFI reports received by the TGA are triaged as serious or non-serious based on internationallyaccepted criteria. They are then coded using standard terminology in accordance with the Medical Dictionary for Regulatory Activities (MedDRA), a document endorsed by the The Australian Regulatory System for Drugs and Vaccines 7
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Reports are entered into the Adverse Drug Reactions System (ADRS) database within 48 hours of receipt—in most cases within 24 hours. Causality is assigned using the WHO Uppsala Monitoring Centre (UMC) causality assessment criteria (WHO UMC 2011). All individual reports of serious AEFIs are reviewed and entered into the database by a medical officer. TGA medical officers also undertake a weekly review of all reports for quality control and for identifying clusters of reports or unusual reports. AEFIs are reviewed separately from other reports. Two-monthly reviews are also undertaken of proportional reporting ratios (PRRs), a statistical aid to finding signals within the ADRS database. An acknowledgement is sent to each person reporting an AEFI. Further information may be sought from the reporter to assist in the assessment of the event. Further information is routinely requested for adverse events of special interest (AESIs) involving vaccines, using clinical follow-up templates. TGA staff may request advice about AEFIs from the TGA’s Advisory Committee on the Safety of Medicines (ACSOM). If potential safety signals are identified, the TGA may also convene an ad-hoc expert advisory committee to augment its in-house and statutory committee expertise and enable TGA to rapidly undertake focused assessment of emerging safety signals. The TGA can also obtain expert advice from the Australian Technical Advisory Group on Immunisation (ATAGI) and utilise the expertise of the National Centre for Immunisation Research and Surveillance (NCIRS) to assist in undertaking further investigation of safety signals. TGA may place additional post-marketing safety monitoring requirements on vaccine sponsors through the risk management plans (RMPs), required since 2009 as part of the registration process for new vaccines or vaccines with changed indications. These plans may include requirements for undertaking active surveillance or other specific post-marketing research studies. An example is the requirement for CSL to undertake active surveillance for Guillain Barré Syndrome (GBS) following Panvax vaccination. A hospital-based sentinel surveillance program (the Paediatric Active Enhanced Disease Surveillance, or PAEDS, program) is also in place in Australia. The program is modelled on the Canadian IMPACT (see 3.4 International post-market surveillance and monitoring of vaccines) and is coordinated through the NCIRS in collaboration with the Australian Paediatric Surveillance Unit (APSU). The program currently collects data from tertiary paediatric hospitals in four jurisdictions (New South Wales, South Australia, Victoria, and Western Australia). AEFIs currently under active surveillance through this program include intussusception, varicella (vaccine failures) and acute flaccid paralysis. De-identified AEFI data are routinely released to the NCIRS which undertakes a range of analyses. NCIRS collaborates with the TGA to prepare annual national surveillance reports, which have been published in Communicable Diseases Intelligence (CDI) since 2003. The TGA publishes specific safety information on the Alerts and Advisories section of the TGA website. Such information can be reports on the post-marketing surveillance experience with new vaccines—recent examples include human papillomavirus (HPV) vaccine and the pandemic H1N1 vaccine—or advice about a specific issue such as the identification of porcine circovirus (PCV) in rotavirus vaccines. Regulatory action that TGA may take if a safety problem is identified can include requiring amendments to the product information or inclusion of black box warnings, restricting the use of vaccine to specific group, suspending the supply of the vaccine or withdrawing the product from the market. 8 Review of the management of adverse events associated with Panvax and Fluvax
Page 1 and 2: Review of the management of adverse
Page 3 and 4: Review of the management of adverse
Page 5 and 6: 5.9 Seasonal influenza vaccination
Page 7 and 8: MedDRA Medsafe NCIRS NIBSC NIC NIS
Page 9 and 10: The Review has found that the Austr
Page 11 and 12: Recommendation 4 Raising Community
Page 13 and 14: WA Minister for Health, the Hon Dr
Page 16 and 17: 3 THE AUSTRALIAN REGULATORY SYSTEM
Page 20 and 21: 3.4 International post-market surve
Page 22: and others by providing information
Page 25 and 26: is an agency of the Department and
Page 28 and 29: 5 INFLUENZA AND THE ROLE OF IMMUNIS
Page 30 and 31: there was some evidence of cross pr
Page 32 and 33: TGA published summary reports on th
Page 34 and 35: 6 THE FINDINGS OF THE REVIEW 6.1 Ra
Page 36 and 37: Table 1. Timeline of the investigat
Page 38 and 39: the TGA requested case report infor
Page 40 and 41: 6.2.2 Were the actions of the Commo
Page 42 and 43: iii. restructuring immunisation gov
Page 44 and 45: There was a perception among some s
Page 46 and 47: 7 RECOMMENDATIONS OF THE REVIEW Rec
Page 48 and 49: 8 REFERENCES Australian Government
Page 50 and 51: APPENDICES Appendix I: Documents an
Page 52 and 53: Appendix II: People interviewed •
Page 54 and 55: Country Canada Regulatory Agency an
Page 56 and 57: Regulatory Agency and Country Relev
Page 59: www.health.gov.au All information i

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