Spotlight on prescription medicine post-market reforms Enhanced monitoring and compliance Dr Claire Behm Director, Signal Investigation Unit Pharmacovigilance and Special Access Branch Medicines Regulation Division, TGA 2017 ARCS Annual Conference
Background • MMDR recommendation 27 The Panel recommends that the Australian Government develop a more comprehensive post-market monitoring scheme for medicines and medical devices. Such a scheme to include: 1. Better integration and timely analysis of available datasets, including analysis of matched de-identified data from the Pharmaceutical Benefits Scheme, Medical Benefits Scheme, eHealth records, hospital records, private health insurance records and device and other relevant registries and datasets; 2. Establishment and maintenance of registries for all high-risk implantable devices; 3. Implementation of a scheme to alert practitioners and consumers that a drug is newly registered and to encourage reporting of any adverse events; 4. Provision for electronic reporting of adverse events; and 5. Enhanced collaboration with overseas NRAs to share information relating to safety or efficacy. Spotlight on prescription medicine post market MMDR reforms 1
Background • Government response to MMDR recommendation 27 The Commonwealth accepts Recommendation Twenty-Seven, with the exception of part 2. Consideration of registries for high-risk implantable devices is being deferred until other work is undertaken (Recommendation Twenty-Two). The development of a more comprehensive post-market monitoring scheme will enhance consumer protection and complement existing post-market monitoring processes. Spotlight on prescription medicine post market MMDR reforms 2
Polling question • Have you read our consultation paper on strengthening monitoring of medicines in Australia? (yes/no) Spotlight on Prescription Medicines MMDR reforms 3
Summary of enhancements 1. Enhanced adverse event reporting • Black triangle scheme • PI reformat • Adverse events management system 2. Enhanced compliance with post-market requirements • Pharmacovigilance inspection program • RMP compliance monitoring 3. Enhanced collection and use of data • Adverse events management system • Use of linked data sets to support signal investigation 4. Enhanced international collaboration 5. Changes to pathways for accessing unapproved medicines 4
▼ Black triangle scheme • Provides means to identify new medicines • Encourages the reporting of adverse events associated with their use • The symbol and text will appear on the PI and CMI, and TGA-related materials PI: ▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events. CMI: ▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. Spotlight on prescription medicine post market MMDR reforms 5
▼ Black triangle scheme Implementation Inclusion criteria • Scheme starts in January 2018 • All new medicines, except: • 5 year duration for standard registration – Biosimilars – Seasonal influenza vaccines • 5+ years for provisional registration • Medicines with a provisional extension of Provisional registration period ± additional period indications • Inclusion automatically lapses at the end of the agreed period • Extensions of indication into significantly different conditions or patient groups may be • Intensive communication planned for health included professionals and consumers from late 2017 – – E.g. for an oncology to rheumatology indication 2019 Spotlight on prescription medicine post market MMDR reforms 6
▼ Comparison to EU black triangle scheme • Australian Black Triangle Scheme similar to EU: – Wording that accompanies the symbol: the same (excluding reference to information about reporting adverse events in SmPC) – Inclusion of symbol on medicine information is similar to EU: Will appear on Australian PI and CMI – Inclusion criteria: Biosimilar medicines excluded in Australia, but not in EU In EU, medicines can be included based on PRAC advice – Duration of inclusion is the same in EU 5 years in EU for new medicines Duration for ‘conditional approval’ linked to post-market commitments Spotlight on prescription medicine post market MMDR reforms 7
PI reformat • The PI is being reformatted to: – Improve its usability for health professionals, by bringing critical clinical information to the front of the PI indications, dosage and administration, contraindications, precautions, adverse events – Align format with European Summary of Product Characteristics (SmPC), and NZ Data Sheet • Transition to the new format will be over 3 years – New medicines and any medicines with new PI information will be in the new format E.g. extended indications, safety updates • All PIs in the market will be in the new format by the end of 2020 Spotlight on prescription medicine post market MMDR reforms 8
PI reformat – high level changes Current format Proposed format – Name of the medicine 1. Product Name – Description 2. Qualitative and Quantitative Composition – Pharmacology 3. Pharmaceutical Form – Clinical trials 4. Clinical Particulars – Indications 5. Pharmacology – Contraindications 6. Pharmaceutical particulars – Precautions 7. Medicine Schedule (Poisons standard) – Adverse effects 8. Name and address of the Sponsor – Dosage and administration – Overdosage 9. Date of first approval (ARTG entry) – Presentation and storage conditions 10.Date of most recent amendment – Name and address of the sponsor – Poison schedule of the medicine – Date of approval Spotlight on prescription medicine post market MMDR reforms 9
PI reformat – detailed changes of interest Current format Proposed format – Name of the medicine 4. Clinical Particulars – Description 4.1. Indications – Pharmacology 4.2. Dosage and administration – Clinical trials 4.3. Contraindications – Indications – Contraindications 4.4. Precautions – Precautions Use in hepatic impairment, Use in renal impairment, Use in the elderly, Paediatric use, Effects on laboratory tests – Adverse effects – Dosage and administration 4.5. Interactions with other medicines and other forms of interactions – Overdosage 4.6. Fertility, pregnancy and lactation – Presentation and storage conditions Effects on fertility, Use in pregnancy, Use in lactation – Name and address of the sponsor 4.7. Effects on ability to drive and use machines – Poison schedule of the medicine 4.8. Adverse effects – Date of approval 4.9. Overdose Spotlight on prescription medicine post market MMDR reforms 10
PI reformat – detailed changes of interest Current format – Name of the medicine Proposed format – Description – Pharmacology 5. Pharmacology – Clinical trials 5.1 Pharmacodynamic properties – Indications Mechanism of Action, Clinical Trials – Contraindications 5.2. Pharmacokinetic properties – Precautions Absorption, Distribution, Metabolism, Excretion – Adverse effects 5.3. Preclinical safety data – Dosage and administration Genotoxicity, Carcinogenicity – Overdosage – Presentation and storage conditions – Name and address of the sponsor – Poison schedule of the medicine – Date of approval Spotlight on prescription medicine post market MMDR reforms 11
Pharmacovigilance inspection program (PVIP) • PVIP being implemented from 1 September 2017: – Sponsor information sessions in Sept/Oct – Inspections to commence in 2018 • PV inspections will enable us to: – verify sponsor compliance with their pharmacovigilance requirements (reporting AEs, significant safety issues) and other related legislative requirements; – educate sponsors to assist them to meet their requirements; and – promote continuous improvement in pharmacovigilance – safeguard patient safety by ensuring the ongoing positive risk benefit balance of a medicine in the Australian context collect and collate current information on the safety and efficacy of your medicines(s) assess the risk/benefit balance of your medicine(s) Spot light on prescription medicine post market MMDR reforms 12
Pharmacovigilance inspection program (PVIP) • Routine inspections of sponsors will be prioritised based on risk, assessed according to: – Biannual PV risk assessment survey to be completed by sponsors – Internal intelligence: including whistleblower information, information from regulatory compliance, previous PV inspection history, overseas agency data – Non-compliance to other TGA requirements: PSUR submission, RMP commitments, GMP findings, PV reporting requirements, updating PIs – Product risk profile • Further guidance and information for sponsors will be published in a new PVIP section of the TGA webpage from 1 September 2017 Spotlight on prescription medicine post market MMDR reforms 13
Polling question • Do you think your company is ready for a pharmacovigilance inspection (yes/no)? Spotlight on Prescription Medicines MMDR 14 reforms
Recommend
More recommend
