Drug Information Principles and Classifying Requests, University of Toronto

Drug Information Principles and Classifying Requests Rana Khafagy PHM113H1 Pharmacy Informatics September 13th, 2024 Learning Objectives Discuss evidence-based medicine Distinguish between primary, secondary and tertiary sources Apply a...

Drug Information Principles and Classifying Requests Rana Khafagy PHM113H1 Pharmacy Informatics September 13th, 2024 Learning Objectives Discuss evidence-based medicine Distinguish between primary, secondary and tertiary sources Apply a systematic approach for accepting and answering drug information requests Accurately classify and categorize drug information questions Discuss the Ontario Drug Benefit program and how to utilize it Evidence Based Medicine (EBM) Using the best available science and combining it with one’s clinical experience and what the patient wants to arrive at the best medical decision for a patient Starts when pharmacist presented with a clinical question 3 How To Apply EBM 1. Define a clinically relevant question 2. Search for the best available evidence 3. Critically appraise the evidence 4. Apply the evidence 5. Evaluate the EBM How Do We “Rate” the Evidence? Level IA: evidence obtained from a meta-analysis of multiple, well-conducted, and well-designed randomized trials. Randomized trials provide some of the strongest clinical evidence, and if these are repeated and the results combined in a meta-analysis, then the overall results are assumed to be even stronger. Level IB: evidence obtained from a single well-conducted and well-designed randomized controlled trial. The randomized controlled study, when well-designed and well-conducted, is a gold standard for clinical medicine. Level IIA: evidence from at least one well-designed and executed non-randomized controlled study. When randomization does not occur, there may be more bias introduced into the study. Level IIB: evidence from at least one well-designed case-control or cohort study. Not all clinical questions can be effectively or ethically studied with a randomized controlled study. Level III: evidence from at least one non-experimental study. Typically, level III evidence would include case series as well as not well-designed case-control or cohort studies. Level IV: expert opinions from respected authorities on the subject based on their clinical experience. Should Low Quality Evidence Be Used? Drug Information Sources Easier to find quick, clear information Tertiary Secondary Primary More recent information Primary Sources Consists of clinical research studies and reports, both published and unpublished, that represents original research Not all literature published in a journal is classified as primary literature Review articles or editorials are not primary literature Examples of Primary Sources Secondary Sources References that index, analyze or provide commentary on original research, with the goal of directing the user to relevant primary literature Examples of Secondary Sources Tertiary Sources Summarizes and distills information on a topic Provides a quick easy summary but does not provide new information Examples of Tertiary Sources Is One Source Better? Think of the advantages and disadvantages of each Primary Secondary Tertiary Drug Information (DI) Questions Common in pharmacy practice Can come from: Patients Healthcare professionals Other pharmacists You! Important steps: 1. Clarify what the true question is 2. Decide if you need more information 3. Classify the question and answer it Systematic Approach to Responding to DI Questions 1. Identify the requestor 2. Define the true question and information needed 3. Obtain complete background information 4. Categorize the question 5. Perform a systematic search 6. Analyze the information 7. Disseminate the information 8. Document 9. Follow-up  Importance of Classifying DI Questions Helps identify where to Allows for triaging and Documentation and find information prioritization future retrieval Framework to think about what is being Anticipate future asked = efficiency, questions relevancy, patient- centered Classification of DI Questions Administration Adverse drug reactions Availability Calculations Complimentary/alternative medicine Contraindications Costs Dosage Drug interactions Identification Legislation Pregnancy/lactation Therapeutic use Toxicology What You Might Get In Practice Administration: Should I take amoxicillin with food? Adverse drug reactions: Do any of these medications cause pancreatitis? Availability: Is this drug available in Canada? Calculations: How many mL should the mom administer of fluconazole? Complimentary/alternative medicine: What are the ingredients in this natural health product? Contraindications: Can apixaban be given in renal failure? Costs: Will this drug be covered for me? Dosage: What is the dose of acetaminophen in a neonate? Drug interactions: Does ciprofloxacin interact with metformin? Identification: What is this pill? Legislation: Do I need a prescription to get codeine? Pregnancy/lactation: Is this medication safe in pregnancy? Therapeutic use: What is lorazepam used for? Toxicology: How do we treat warfarin toxicity? Possible Resources to Use Category Resources Administration Drug monographs (CPS, Lexicomp, Micromedex) Adverse drug reactions Drug monographs (CPS, Lexicomp, Micromedex), CPS: Therapeutic Choices Availability Canada – CPS, Drug Product Database, provincial formularies, NAPRA International – FDA, AHFS (via Lexicomp), Martindale (via Micromedex) Calculations CPS, Lexicomp, Micromedex Complimentary/alternative medicine Natural Medicine Database, Memorial Sloan-Kettering Cancer Center About Herbs Contraindications Drug monographs (CPS, Lexicomp, Micromedex) Costs Provincial formularies, whole distributers  Possible Resources to Use Category Resources Dosage Canada - Drug monographs (CPS, Lexicomp, Micromedex), Therapeutic Choices, Minor Ailments Off-label and International uses – Lexicomp, Micromedex, Martindale Drug Interactions Drug monographs (CPS, Lexicomp, Micromedex), Lexi-Interact, Micromedex Identification CPS (online, NOT in print), Lexicomp Drug ID, Micromedex Drug ID Legislation NAPRA, colleges of pharmacies (i.e., OCP) Pregnancy/lactation Briggs, Motherisk (decommissioned), Therapeutic Choices, drug monographs Therapeutic Use Similar to “Dosage” category Toxicology Micromedex, poison control websites Provincial Drug Formularies List of drugs funded by a province’s drug benefit program Ontario = Ontario Drug Benefit (ODB) Identify which drugs are covered, how much is covered and for who Developed in consultation with a health ministry’s external expert drug advisory committee The Committee to Evaluate Drugs (CED) in Ontario Most now online Hospital drug formularies are different! Who Can Be Covered By the Ministry of Health? 65 years and older Must be an Eligible for OHIP+ Ontario resident Ontario Disability Support Program with OHIP coverage Ontario Works Homes for special care or long-term care Home and community care services Trillium Drug Program OHIP Plus (OHIP+) Ontario residents < 24 years who are not covered by private drug plan Ontario Disability Support Program (ODSP) Income support payments qmonthly, on the last day of the month, and health benefits (i.e., ODB support) Eligibility: At least 18 years old living in Ontario Have assets no greater than limits set out in the program Financial need Person with disability or of a prescribed class Caseworker usually applies on patient’s behalf Assistance received depends on patient’s income, other sources of funds and assets Ontario Works Income support payments qmonthly, on the last day of the month, health benefits (i.e., ODB support), employment assistance (i.e., services to help prepare for and find a job) Eligibility: At least 16 years old living in Ontario Have assets no greater than limits set out in the program Financial need Participate in employment activities Caseworker usually applies on patient’s behalf Assistance received depends on patient’s income, other sources of funds and assets Homes For Special Care or Long-term Care Those living in long-term care home or home for special care have eligible medications covered via ODB Home and Community Care Services Support for Ontario residents of all ages that require care at home, school or the community Ontario Ministry of Health covers healthcare services provided in the community Healthcare professional visits Eligible drugs (ODB) Healthcare supplies (dressings, walking aids, braces, etc.) Homemaking visits to assist with routine household activities End-of-life care Set up via Community Care Support Services organization Trillium Drug Program Those who have high drug costs in relation to their income (i.e., if they’re spending >4% of their income on drugs) and do NOT already quality for another ODB program Application includes household income If approved, there is an annual deductible ~4% household income post-tax, then patient pays up to $2/prescription What’s Actually Covered by ODB’s General Program? On-formulary drugs: https://www.formulary.health.gov.on.ca/formulary/ Nutrition products Diabetic testing and monitoring agents (blood glucose test strips, some glucose monitors) Valved holding chambers Sections of the Electronic Formulary Product Interchangeability A product can be designated as interchangeable if it has the same active ingredient in the same amount and in the same dosage form Manufacturer provides evidence of interchangeability to the CED To be interchangeable is to be bioequivalent Are These Products Interchangeable? Bioequivalent vs Biosimilar Not the same thing! Biologics not considered bioequivalent Examples: Remicade®, Enbrel®, Humira®, Rituxan®, Copaxone® Are These Products Interchangeable? Remember: -mabs, insulin, low molecular weight heparins are examples of biologics What If A Drug Is Not On the ODB Formulary? (a) The patient will have to pay for it. Hopefully, it isn’t too expensive. (b) That’s too bad. Let’s try and find another drug that is covered. (c) There has to be another way! Maybe try the Exceptional Access Program (EAP)? Exceptional Access Program (EAP) Some drugs not funded through general ODB formulary may be funded for ODB-eligible patients List of drugs that may be considered if patient meets criteria: https://files.ontario.ca/moh-frequently-requested-drugs.pdf EAP request must be completed by prescriber or designate via SADIE (Special Authorization Digital Information Exchange) Who can be a designate? Drug covered once EAP approval letter issued *NOTE: EAP different than Special Drugs Program that covers full cost of certain outpatient drugs used in the treatment of specific conditions (i.e., transplant, HIV, schizophrenia, CF) Benefits of SADIE Faster approvals Tracking EAP applications between various healthcare team members Fewer requests for missing information Patient demographics auto-populate with their OHIP number Designates can work on requests and see application status Takeaways DI questions posed rarely reflect the whole issue More information usually needs to be obtained thus systematic approach will save you time Correct classification of a question leads to a more efficient and relevant response, as well as asking the right questions! There are multiple ways for Ontario residents to have their medications covered (think of the programs) and multiple medications that can be covered (think of the formularies and drug-specific criteria) When was APO-DAPAGLIFLOZIN-METFORMIN originally marketed in Canada? Use Health Canada’s Drug Product Database: https://health- products.canada.ca/dpd-bdpp/ Is echinacea effective in treating otitis media? Use Natural Medicines: https://naturalmedicines- therapeuticresearch-com.myaccess.library.utoronto.ca/ What is the drug schedule of acetaminophen IV? Use National Association of Pharmacy Regulatory Authorities (NAPRA): https://www.napra.ca/national-drug-schedules/ How long would oxcarbazepine be covered under the EAP? Use EAP: https://files.ontario.ca/moh-frequently-requested- drugs.pdf Is Humulin N 100U/mL Inj Susp-5x3mL Pk interchangeable (i.e., bioequivalent) with Humulin R 100U/mL Inj Sol-5x3mL Pk? Use the ODB e-formulary: https://www.formulary.health.gov.on.ca/formulary/ Homework Become familiar with the following references: Drug Product Database NAPRA National Drug Schedules Database Natural Medicines ODB and EAP CPS Lexicomp Micromedex Briggs References 1. Tenny S, Varacallo M. Evidence Based Medicine. [Updated 2022 Oct 24]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK470182/. 2. Sackett DL, Rosenberg WM, Gray JA, et al. Evidence based medicine: what it is and what it isn't. Clin Orthop Relat Res. 2007;455:3-5. 3. Gupta K, Hooton TM, Naber KG, et al; Infectious Diseases Society of America; European Society for Microbiology and Infectious Diseases. International clinical practice guidelines for the treatment of acute uncomplicated cystitis and pyelonephritis in women: A 2010 update by the Infectious Diseases Society of America and the European Society for Microbiology and Infectious Diseases. Clin Infect Dis. 2011;52(5):e103-20. 4. Watanabe AS, McCart G, Shimomura S, et al. Systematic approach to drug information requests. Am J Hosp Pharm. 1975;32(12):1282-5. 5. Calis KA, Sheehan AH. Chapter 2: Formulating effective responses and recommendations: A Structured Approach. In: Malone PM, Kier KL, Stanovich JE. Drug Information: A Guide for Pharmacists. 4th ed. New York, NY: McGraw-Hill Medical; 2012: 39-43.