ARCS Pharmacovigilance update Richard Hill Medical Officer, Signal Investigation Unit, PMSB, TGA 12 March 2015
Contents • Patient support programs • Reports from (social) media • Information requests from TGA • MedDRA coding 1
Patient support programs (PSP) • Medicines Australia definition: – a program run by a company with or without involvement from a health consumer organisation, with the aim of increasing patient compliance and positive patient health outcomes. • Patient support programs include: – call/information centres – periodic contacts to ensure treatment compliance – nurse visits for medication administration – delivery of educational materials • Features of PSPs: – not designed to collect adverse event information – may be managed by a third party – may be long duration 2
PSP reports • ADR reports from PSP are solicited reports • ICH E2D: – Solicited reports are those derived from organized data collection systems, which include clinical trials, registries, post-approval named patient use programs, other patient support and disease management programs,… – solicited reports … should have an appropriate causality assessment by a healthcare professional or an MAH 3
PSP reports • Australian PV guideline: – 1.2.2: Sponsors should have permanently and continuously at their disposal a person in Australia responsible for pharmacovigilance... The person responsible for pharmacovigilance should be experienced in pharmacovigilance, and if not medically qualified, they should have ready access to a medically qualified person – 2.7.1 Minimum data elements: an identifiable patient one or more identifiable reporters one or more suspected reactions one or more suspected medicines 4
PSP reports • Causality assessment must be performed (2.7.2): 5
PSP reports – example • Was unable to be cannulated successfully. Received regular unspecified infusions for his Crohn’s Disease. 6
PSP reports – example • Patient received [] and thought she was having a stroke, her legs felt heavy with leg spasms, very bad back pain and general pains. 7
PSP reports • Reminder of general reporting requirements: – follow-up as needed – identify concomitant medications; suspect as appropriate – non-serious reports do not have to be sent to TGA on an expedited basis must be held on file by sponsor must include in PSURs 8
Reports from (social) media • These reports need to comply with mandatory requirements, especially identifiable patient • Media reports may be quite likely duplicates • Media reports may be quite likely unusual ADRs • PV guidelines 1.2.2: – Sponsors should regularly screen internet or digital media under their management or responsibility, for potential reports of suspected ARs. 9
Information from TGA • Reminder of the information we can provide: – line listings – “public case details” • Release of information must be approved by a senior medical officer • Manual system at present • Happy to work with sponsors to meet global reporting requirements 10
Common reporting/coding issues Reports of overdose with no clear ADR Case example: • Initial Information was received from a health care professional and concerns a 96 year old Male patient who was treated with EPO-analogue for an unknown indication. No concurrent conditions and medical history was reported. No concomitant medications and past drugs were reported. On an unspecified date, the patient had overdose of EPO-analogue. It was reported that a nurse was contacted, who advised to monitor haemoglobin levels at about 95 hours after administration. No adverse event reported in association with overdose, no need to report! 11
Common reporting/coding issues Reporting of neoplasm progression • Progressive disease in patients taking antineoplastic agents Case example: 1. “On an unspecified date the patient started antineoplastic drug (dose, route, form, frequency: not reported). On an unspecified date therapy with drug was discontinued. On an unspecified date, the patient once again developed disease relapsed in lungs and lymph glands.” 2. “On an unknown date he started treatment with antineoplastic drug. The patient died on 12 June 2012 from cancer” No need to report! 12
Common reporting/coding issues Reports where role of drug in ADR is unclear Case example: • “The patient was treated with drug-x, dose, dates and frequency unspecified, for ankylosing spondylitis. The patient stopped drug-x and decided to try drug-y for convenience while travelling. The patient reported that drug-y gave reasonable control, but he felt drug-x helped his ankylosing spondylitis more. The patient began treatment with drug-x, again, dose, dates and frequency unspecified. • On 06-AUG-2012, a right hip replacement was performed. The patient was recovering from right hip replacement. The reporter did not provide causality between right hip replacement and drug-x.” • Coded by sponsor as [hip arthroplasty], however no clear relationship between hip replacement and suspect drug 13
Common reporting/coding issues Reports where role of drug in ADR is unclear Case example: • “The patient was admitted to hospital 21-Dec-2008, where she had fluid drained from her abdomen due to a chronic liver condition. The patient had been on the liver transplant list since August 2008. She was also suffering from pneumonia and was given increasing levels of pain- relieving drug and other pain medication. Dose, date and route of administration of drug were not reported.” • “On 26-Dec-2008, just hours before she was discharged, the patient had vomited and was oozing a “moderate amount” of fluid from a drain site on her side. The patient had passed “dark, concentrated urine” and had a bloated abdomen. The patient was released on 26-Dec- 2008, blood test results showed a clear deterioration in her renal function. Her condition worsened and she returned to hospital on 27-Dec-2008 before dying there on 29-Dec-2008. The primary cause of death was listed as multi-organ failure.” • Sponsor coded terms: [multiorgan failure; renal impairment; urine colour abnormal; abdominal distension; vomiting; post-procedural drainage], however no clear relationship with suspect drug. 14
Common reporting/coding issues Reporting of death of unknown cause or unrelated to drug • Information too limited to assess causality • Sponsors should attempt to obtain more information if possible Case example: 1. “The patient received drug for an unspecified indication. On an unspecified date, the patient was deceased . Cause of death was not provided.” 2. “On 20 Aug 2012, while on drug, the patient passed away. The patient wasn’t admitted to hospital, passed away at nursing home. No other details known. The patient had a past medical history of previous silent myocardial infarction and chronic obstructive pulmonary disease.” 15
Common reporting/coding issues Reports with reaction terms not related to drug Case example: • “Initial consumer report received on 17 Jul 2012. An elderly female consumer used topical drug to help with shoulder pain caused by a pre-existing injury. She has been applying the product to the shoulder approximately 3 times a day when needed, on and off, for a number of years. She stated they do not use topical drug for longer than 2 weeks at a time. She finds the topical drug very effective at relieving the pain. The patient’s doctor advised her to use the product while awaiting shoulder surgery. On the patient’s recent visit to her surgeon they identified the bone in the shoulder was brittle and calcification had occurred making her ineligible for surgery. No treatment was necessary. Final outcome was reported as reaction continues. No other information provided.” • Coded by sponsor as [articular calcification] – related to underlying disease and [osteogenesis imperfecta] – genetic disorder, unrelated to drug 16
Common reporting/coding issues Reports with reaction terms not related to drug Case example: • Initial information was received from a physician in Australia concerning a female patient who was on an anticoagulant (formulation, dosage, frequency, indication, dates of therapy not reported). On an unreported date, the patient had a car accident and the hospital was unable to stop the bleeding. The patient is in a critical condition. Several specialists involved are trying to stop the bleeding. Information on the treatment provided, if any, was not reported. The outcome of the event was not reported. • Sponsor coded terms: [road traffic accident] [wound haemorrhage] • TGA coded term: [haemorrhage] 17
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