TEMPLATE CASE REPORT FORM. Rapid Response Pharmacovigilance in Palliative Care
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1 TEMPLATE CASE REPORT FORM Rapid Response Pharmacovigilance in Palliative Care The case report form is to be completed in compliance with PaCCSC Standard Operating Procedures 1
2 Staff Participant Id: Date of Baseline: Demographics Gender Male Female Age years Weight (kg) estimated Height (cm) estimated Primary Life Limiting Illness Advanced cancer End stage renal failure Hepatic failure Neurodegenerative disease Other (please specify) AIDS Cardiac failure Respiratory failure Ischaemic heart disease Palliative Care Phase Stable Unstable Deteriorating Terminal 2
3 Laboratory tests (Only if available) Result Not Collected International normalised ratio (INR) Platelets Hb Urea Creatinine egfr Charlson Comorbidity Index Conditions: Myocardial infarct Congestive cardiac failure Peripheral vascular disease Cerebrovascular disease Dementia Chronic pulmonary disease Connective tissue disease Ulcer disease Mild liver disease Diabetes Hemiplegia Moderate or severe renal disease Diabetes with end organ damage Any tumour Leukaemia Lymphoma Moderate or severe liver disease Metastatic solid tumour AIDS 3
4 Australian Modified Karnofsky Performance Scale (AKPS) = Normal; no complaints; no evidence of disease. 90 = Able to carry on normal activity; minor signs or symptoms. 80 = Normal activity with effort; some signs of symptoms or disease. 70 = Cares for self; unable to carry on normal activity or to do active work. 60 = Requires occasional assistance but is able to care for most of his needs. 50 = Requires considerable assistance and frequent medical care. 40 = In bed more than 50% of the time. 30 = Almost completely bedfast. 20 = Totally bedfast and requiring extensive nursing care by professionals and/or family. 10 = Comatose or barely rouseable. 0 = Dead Not able to determine 4
5 T0 Baseline Medication Commencement Date: Time: Symptom of Interest Symptom Severity Score NCI Criteria Here Toxicity assessment SYMPTOM Ungradable No Symptom Other 1-please specify Other 2-please specify Other 1-please specify Other 2-please specify
6 T1- No of hours/days after commencement (to be decided by subcommittee) Current medication dose Drug Dose (mgs) Route Frequency (eg. Mane, nocte, bd, tds, over 24hrs) Symptom Severity Score NCI Criteria Here Toxicity assessment SYMPTOM Ungradable No Symptom Other 1-please specify Other 2-please specify Other 1-please specify Other 2-please specify Which toxicity is the most troublesome? Select: If there were toxicities, were any given a grade of 3 or more? t applicable 6
7 T1- Symptomatic Benefit Assessment - (Time from T0 T1) Assessed / Not assessed reason Assessed today (continue) t able to be contacted / located Too unwell Other Date of assessment Total dose given in last 24 hours (mgs) How long has the patient been on this dose (days) Select: (insert drop down box 1-14 days) Was there any benefit? Medication Changes Medication of interest dose maintained/continue current dose Medication of interest dose increased (please specify below) Medication of interest dose decreased Medication of interest dose ceased New medication added (please specify below) If "new medication added" above, please specify here If "medication of interest dose increased" above, please specify new dose mgs 7
8 T2- Assessment ( Date of Assessment --/--/-- Current medication dose Drug Dose (mgs) Route Frequency (eg. Mane, nocte, bd, tds, over 24hrs) Symptom Severity Score NCI Criteria Here Toxicity assessment SYMPTOM Ungradable No Symptom Other 1-please specify Other 2-please specify Other 1-please specify Other 2-please specify Which toxicity is the most troublesome? Select: If there were toxicities, were any given a grade of 3 or more? t applicable 8
9 T2- Symptomatic Benefit Assessment - Assessed / Not assessed reason Assessed today (continue) t able to be contacted / located Too unwell Other Date of assessment Total dose given in last 24 hours (mgs) How long has the patient been on this dose (days) Select: (insert drop down box 1-14 days) Was there any benefit? Medication Changes Medication of interest dose maintained/continue current dose Medication of interest dose increased (please specify below) Medication of interest dose decreased Medication of interest dose ceased New medication added (please specify below) If "new medication added" above, please specify here If "medication of interest dose increased" above, please specify new dose mgs 9
10 What is the intended treatment based on the assessment today? change to medication of interest/continue current dose Medication of interest ceased Medication of interest reduced Medication of interest dose increased (please specify new dose) Has a medication been added to treat a specific toxicity? Based on the assessment today has toxicity resolved? N/A Key questions derived from the Naranjo check list (only complete this section if any toxicity on the previous page is 3 or greater) 1. Did the adverse reaction appear after the suspected drug was given? Yes Don't know 2. Did the adverse reaction improve when the drug was discontinued or a specific antagonist was given? 3. Are there alternative causes (other than the drug) that could on their own have caused the reaction? Don't know 4. Did the patient have a similar reaction to the same or similar drug in any previous exposure? Don't know 5. Was the adverse event confirmed by any objective evidence? No Don't know 10
11 Medication Cessation (complete this page at any time the medication of interest is ceased) Date of assessment (medication cessation) Medication was ceased (related to indication of interest): Symptom resolved (provide date, question a) Symptom continued unchanged Symptom worsened (please specify, question b) Medication was ceased (related to other reasons): Toxicity - refer to unscheduled toxicity assessment Patient unable to take medication (go to question c) Other - please specify What treatment did you subsequently initiate following cessation of the medication of interest? a) Symptom resolved - date of resolution Date: b) Symptom worsened - Grade (NCI) c) Patient unable to take medication please specify 11
12 Unscheduled Adverse Event Assessment (a) Please list any symptomatic adverse events that occur at any time regardless of whether they are attributable to the medication of interest or not. Were there any symptomatic adverse events? Y Symptom Severity Score Toxicities Specify any adverse drug event and grade it according to NCI criteria Toxicity assessment SYMPTOM Ungradable No Symptom Other 1 Other 2 Other 1 please specify Other 2 please specify Which toxicity is the most troublesome? Select: If there were toxicities, were any given a grade of 3 or more? t applicable 12
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