Presentation: The role of the patient in pharmacovigilance
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TGA insights into the importance of involving patients in pharmacovigilance and initiatives to improve reporting and the resulting data.
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Presentation: The role of the patient in pharmacovigilance
- 1. The role of the patient in pharmacovigilance TGA perspective Dr Claire Behm Director, Signal Investigation Unit Pharmacovigilance and Special Access Branch Medicines Regulation Division, TGA 2017 ARCS Annual Conference August 2017
- 2. Overview • Importance of involving patients in pharmacovigilance • TGA’s current approach • Challenges for involving patients in pharmacovigilance • Opportunities for involving patients in pharmacovigilance • Future TGA initiatives The role of the patient in pharmacovigilance 1
- 3. Importance of involving patients in pharmacovigilance • TGA’s role is to safeguard and enhance the health of the Australian community through effective and timely regulation of therapeutic goods: direct line of sight to consumers and their experiences is vital in enabling us to do this • Patient empowerment • Consumers often much better able to articulate non-clinical aspects of their adverse events • Consumers may report different ADRs than healthcare professionals (HCPs) • Involving consumers can overcome some barriers that may prevent HCPs from reporting • Builds trust in the Australian regulatory system and health system • Identification of product quality issues and tampering The role of the patient in pharmacovigilance 2
- 4. Source of TGA ADR reports 2016 54% 17% 11% 5% 6% 4% 2% 1% 0% 0% 0% Sponsor State/Territory Health Department Hospital pharmacist Community pharmacist Consumer General practitioner Medical specialist Nurse Coroner's court Complementary healthcare practitioner Dentist 3The role of the patient in pharmacovigilance
- 5. Source of TGA reports 2012-2016 0 1000 2000 3000 4000 5000 6000 7000 8000 9000 10000 2012 2013 2014 2015 2016 NumberofReports Year Sponsors State and Territory Health Departments Hospitals and hospital pharmacists Community pharmacists General Practitioners Consumers Other The role of the patient in pharmacovigilance 4
- 6. The Consumer knowLEdge adVerse Event Reporting (CLEVER) project • TGA identified a decrease in reports from consumers from 2011 – 2014 • CLEVER project initiated in collaboration with ARCS, Consumer Health Forum of Australia, NPS MedicineWise, University of Sydney • Qualitative study using focus groups to explore consumers’ opinions about adverse events associated with medicines, vaccines and medical devices, and experiences with managing and reporting adverse events • Major findings: - The term ‘side effect’ was most commonly known amongst consumers with relatively few recognising the terms ‘adverse event’ or ‘adverse reaction’ - Most people did not expect to experience a side-effect - Participants were generally unaware of AE reporting avenues and of the TGA and its regulatory activities The role of the patient in pharmacovigilance 5
- 7. 6
- 8. The Consumer knowLEdge adVerse Event Reporting (CLEVER) project • Major findings continued: - Participants saw value in reporting for themselves and the greater medicine-taking population to improve safety, monitoring and quality of medicines - Predominant opinion from consumer participants was that side effects should be reported to the doctor, or as some suggested the pharmacist, who would then report the information - Reporting had to be easy, accessible and time-efficient - Consumers would like feedback on their reports - There was no consumer insight that a sponsor could access AE information or even if they would want the information The role of the patient in pharmacovigilance 7
- 9. The Consumer knowLEdge adVerse Event Reporting (CLEVER) project • “I would like to report it but I’m so busy running around and I’m so forgetful that I would either a) forget it if it wasn’t easy and quick for me to do it or b) just not have time to go somewhere to actually report it. If it was easy to report I would definitely do it.” • “I think if you’ve got to go jump through hoops and everything, answer a whole, 30 page document, and you just go, “Nup. Couldn’t be bothered.” • “I prefer to report to the government because I feel like it would be taken more seriously rather than a call centre, a representative working for a company.” The role of the patient in pharmacovigilance 8
- 10. TGA’s current approach • Website content developed specifically for consumers – link for reporting problems is prominent • Multiple ways consumers can report, including online form designed for consumers to “report a side-effect” • Consumers receive an acknowledgement letter with their ADR number • FAQs about adverse event reporting for consumers • Transparent safety information: PI and CMI on website, DAEN, safety alerts • Consumer representatives on committees • TGA Twitter feed @TGAgovau The role of the patient in pharmacovigilance 9
- 11. Involvement of patients in RMP activities • Consumer activities may be included as part of the Risk Management Plan for new medicines, especially for the post-marketing period, e.g.: – Post-authorisation safety studies or registries where patients play a role in collecting ‘real world’ data – Patient alert cards – Patient education apps, websites and printed materials • It is anticipated that such activities may increase with the introduction of provisional approvals. The role of the patient in pharmacovigilance 10
- 12. Challenges • Variation in health literacy • Meeting consumer expectations • Translating assessment of benefit-risk at the population level to an individual consumer’s experience • Regulatory issues vs clinical practice issues • Vexatious complaints • Incomplete information in AE reports • Media interest and stimulated reporting • New technologies and social media • Mistrust of Government and Industry The role of the patient in pharmacovigilance 11
- 13. Opportunities • Better engagement with health literate consumers and better education of consumers with lower levels of health literacy • Better engagement with patient and consumer groups • Better engagement of consumers via new technologies and social media • Better collaboration with Industry to encourage patient involvement in pharmacovigilance • Better engagement with mainstream media to create positive news stories • International collaboration and adoption of successful strategies implemented internationally The role of the patient in pharmacovigilance 12
- 14. New/future TGA initiatives • Medsearch app (and future upgrades) • Black triangle launching in 2018 • PI reformat • Revamp of consumer content on website • Looking at whether can link CMI and ADR reporting to My Health records • Participation in international project with other regulators, aimed at increasing consumer adverse event reporting The role of the patient in pharmacovigilance 13
Editor's Notes
- Non-clinical aspects include quality of life, ability to attend work, financial burden, impacts on carers, impacts on interpersonal relationships. Barriers to HCP reporting include time-pressures, fear of disclosing a prescribing error they may have made, failure to make a link between an adverse event and a medicine at the time of seeing a patient. These barriers lead to under-reporting – involving consumers therefore helps to address under-reporting.
- Was the fall in numbers from: Not understanding what an adverse event is? Lack of knowledge of the reporting process? Or do consumers not care about the safety of medication? 6 focus groups with 48 total participants – 1.5 hours in length with audio recording. Participants had to be at least 18 years of age, Able to participate without a translator, Were or had taken in the past 12 months at least one prescription medicine or were a parent/carer of a child who had received a vaccination in the past 5 years.
- Was the fall in numbers from: Not understanding what an adverse event is? Lack of knowledge of the reporting process? Or do consumers not care about the safety of medication? 6 focus groups with 48 total participants – 1.5 hours in length with audio recording. Participants had to be at least 18 years of age, Able to participate without a translator, Were or had taken in the past 12 months at least one prescription medicine or were a parent/carer of a child who had received a vaccination in the past 5 years.
- Unlike some other international jurisdictions, the TGA has a long history of accepting ADR reports from consumers.
- These activities feed into our overall pharmacovigilance program, and emphasise the importance of ADR reporting pre-implementation testing of risk min activities with patients is a valuable step in developing effective risk min materials to check that messages are clear and materials usable. This sort of testing can often substitute for post-implementation surveys of patient knowledge, which can be more challenging to conduct and susceptible to bias. A couple of the key themes for risk min for patients for us at the moment are: injectable products for home use, for which our discussions with sponsors thru the RMP evaluation often cover things like labels on injectors, consumer-directed instructions for use and sometimes additional risk min measures like patient guides to support correct administration and avoid medication errors. There is EMA guidance on risk min and prevention of medication errors, which provides useful guidance on analysing the possible sources of medication error and planning risk min for medication error. Spontaneous reporting system is often used to monitor occurrence of medication error – under-reporting is obviously a problem and in some cases we may require a drug utilisation study to better characterise risk/whether risk min is sufficient. ‘Real world experience’ from consumers can contribute to better risk min to avoid errors. Use of patient alert or reminder cards to remind patients about actions to take to manage/avoid significant safety concerns (eg use of effective contraception for teratogenic medicines, reporting of signs of infection to allow prompt management) and assist patients to tell health professionals other than prescriber if they may be experiencing an adverse drug reaction