Medication Formulary Medication Order Writing Vanessas Law Mandatory ADR and MDI Reporting Opioid Prescribing in Hospital July 2021 Lisa Nodwell BScPharm ACPR Clinical Pharmacy Manager ID: 1048485
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1. Medication Safety – Practical TipsMedication FormularyMedication Order WritingVanessa’s Law (Mandatory ADR and MDI Reporting)Opioid Prescribing in HospitalJuly 2021Lisa Nodwell, BScPharm, ACPRClinical Pharmacy Manager
2. Medication SafetyMedication Safety - Freedom from preventable harm with medication use. Medication Incident - Any preventable event that may cause or lead to inappropriate medication use or patient harm. Medication incidents may be related to professional practice, drug products, procedures, and systems, and include prescribing, order communication, product labelling/ packaging/ nomenclature, compounding, dispensing, distribution, administration, education, monitoring, and use. Institute for Safe Medication Practices (ISMP) Canada 2007 https://www.ismp.orgDischarge Abstract Database, 2014–2015 Canadian Institute for Health Information (CIHI) 5.6% of acute care hospitalizations in Canada or 1 in 18 — involved at least 1 occurrence of harm. This rate has remained constant over the past 3 years. https://www.cihi.ca Canadian Patient Safety Institute (CPSI) 2017-18 Preventable medication hospitalizations cost over $140 million CAD in direct and indirect healthcare expenditures, with lost productivity, including time off work, adding $12 million in costs. https://www.patientsafetyinstitute.ca
3. Medication Safety
4. Medication FormularyA medication formulary is a continually updated listing of medications which represent the best current clinical evidence and health care expert recommendations for the diagnosis and treatment of disease and preservation of health. Ensures effective therapy consistent with best practice, current evidence and cost effectiveness dataOptimizes the number of medications availableEstablishes policies on the use of medications, related products and therapies, i.e. patients own medication/use of home medicationEnsures periodic review
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6. Formulary EvaluationsSubmit a request to the Drugs and Therapeutics Committee (D&T) via the Formulary SubcommitteeA standardized evaluation is completed by the most appropriate subcommittee of D&T in collaboration with the requestor to create a recommendationEvidence based risk benefit assessmentAn economic impact analysisPolicy considerationsFormulary RequestD&T Decisions Newsletterhttp://chdintra.cdha.nshealth.ca/departmentservices/pharmacy/forms/DrugFormularyRequest.doc
7. Medication Formulary ManagementTherapeutic Interchange: Pharmacist dispenses a therapeutically similar drug if included on list of approved therapeutic equivalents.For example: second generation antihistamines (desloratadine, loratadine, fexofenadine) are interchanged to cetirizine (Reactine®)Non-Formulary Requests: Each request is critically reviewed by the pharmacistIf the request is a continuation of home therapy, the pharmacist requests that the patient uses their own medication (POM).If the patient does not have their own supply, a formulary alternative is suggested or less commonly a non-formulary medication is authorized.Obtaining a non-formulary medication may require 24-48 hours.Non-formulary medications ≥ $200/day or ≥$500/dose require Administrative Authorization
8. Special Access MedicationsThe Special Access Program (SAP) a division of Health Canada provides access to non-marketed medications for practitioners treating patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable.The SAP authorizes a manufacturer to sell a drug that cannot otherwise be sold or distributed in Canada. Drugs considered for release by the SAP include pharmaceutical, biologic, and radio-pharmaceutical products not approved for sale in Canada.https://www.canada.ca/en/health-canada/services/drugs.../special-access/drugs.htmlhttps://www.canada.ca/en/health-canada/services/drugs-health-products/special-access/drugs/special-access-request-form.html
9. Medication Order WritingAgency For Healthcare Research and Quality (2010) It is estimated that 21% of handwritten prescriptions contain at least one prescription-writing error.The Institute of Medicine strongly supports greater use of information technology to improve medication safety.Computerized Prescriber Order Entry (CPOE) systems, when correctly implemented, are associated with a reduction in errors—in some studies by more than 50%.In a recent study that investigated the impact of a CPOE system on errors in the ambulatory clinic setting, the greatest reduction was seen in the odds of an error of illegibility (97% reduction), followed by use of inappropriate abbreviations (94%), and missing information (85%).
10. Medication Order WritingComponents of a Medication Order:Date and time (of order composition)Drug name (using ONLY generic names - a brand name may only for be used for clarification, i.e. acetaminophen CR 650mg po TID as Tylenol Arthritis)Dose (specify ONLY metric units using approved abbreviations)Orders for pediatric patients or actual body weight 50 kg or less may require weight based dosing (i.e. mg/kg) or Body Surface Area based dosing (mg/sq meter)Route of administration (using ONLY approved abbreviations)Site of administration (when appropriate, i.e. IM deltoid)Dilution and/or Rate (when appropriate, i.e. vancomycin 1g in 250mL NaCl over 60 minutes)Frequency or times of administration (using ONLY approved abbreviations)Authorized Prescriber signature and License number (include printed name and contact information such as pager #)
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13. Medication Order Writing TIPSDouble check patient’s nameDocument medication allergies (including severity and reaction)Inform Nursing that a new order was writtenFlag the chart (i.e. green = new, red = STAT AND verbally communicate all STAT and Emergency medication orders)Write legiblyWrite only one medication order per lineUse Discontinue orders for changes to medication ordersUse a HOLD order only if the order includes parameters defining when to hold (i.e. for systolic blood pressure greater than …) as well as a timeline (i.e. x 48 hours)Pre-printed orders must not be alteredWrite an order to cancel original order and then re-write Use decimals at a minimum “Lead But DO NOT follow” (i.e. write 0.5 mg NOT .5 mg and 5 mg NOT 5.0 mg)
14. Medication Order Writing TIPSFor antibiotics (especially IV antibiotics) specify the time of the first dose (if known) and the total number of doses or days of therapyPRN orders should include timeline and maximum number of doses in time period (i.e. q4h prn to maximum 4 doses in 24 hours)Specify the indication for prn orders (i.e. dimenhydrinate 25 mg q6h prn for nausea)For inhalers, specify the strength and number of puffsNote: there are may different types of inhalers (dry powder, MDI, Diskus, turbuhalers and capsule inhalers, i.e. Spiriva®)For patches, specify on and off times (i.e. Nitro patch)Patches may not be cut to achieve intermediate dosesFor medications administered weekly, monthly (i.e. risedronate), indicate the day (and time) of administration and the date of the last dose if knownAlways specify the dose in units for insulin not the equivalent mL
15. Medication Order Writing TIPS cont.Orders must be discontinued and rewritten when the patient goes to OR and when a patient transfers to different level of care (i.e. ICU)Not acceptable to write as resume pre-op orders or restart home medicationsSpecify which eye, ear or nare for Eye/Ear/Nose drops or inhalers (i.e. left, right or both)Specify the area(s) to be applied for topical medicationsFor medications with multiple dosage forms available (i.e. diltiazem ER, CR, SR or hydromorphone CR, IR) specify controlled release for long acting versionsFor combination medications (i.e. calcium/vitamin D) specify the mg strength required for each medication (i.e. Calcium 500 mg/ Vitamin D 200 units po tid) instead of the number of tablets
16. Medication Order WritingHow would you read these directions? Four times daily or once daily?
17. Potassium chloride QD was intended but was interpreted as QID. Write daily not OD or QD.
18. How do you interpret the above order?
19. Regular Insulin 6 units was intended but was interpreted as 60 units & Humalog 4 units was intended but was interpreted as 44 units. Write unit not “U”.
20. What is the dose of Vincristine?
21. The intended dose of vincristine was written as .4 mg but was interpreted as 4 mg. The dose should have been written as 0.4 mg.Zeros LEAD but do NOT FOLLOW.
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23. Medication Incident ReportingSafety Improvement and Management System (SIMS)SIMS promotes reporting of incidents, timely and efficient management, and continuous learning and improvement while enhancing our capability to respond to issues and trends with effective solutions (both locally and provincially). http://intra.nshealth.ca/SIMS/SitePages/Home.aspx
24. Vanessa’s Law: Mandatory reporting of ADRs and MDIs to Health Canada (December 16, 2019)Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) introducesmandatory reporting of serious adverse drug reactions (ADRs) and medical device incidents (MDIs) by hospitals.Requires that: Hospitals report serious ADRs and MDIs to Health Canada within 30 days of the event being documented within the hospital.Includes: Pharmaceuticals (prescription and non-prescription drugs), Biologic drugs, Radiopharmaceutical drugs, Disinfectants, Drugs for an urgent public health needs, Medical devices.Exempt: clinical trial drugs, investigational testing medical devices, Special Access Program drugs, Vaccines (administered under a routine immunization program), adverse reactions to cells, tissues and organs, blood and blood components, and semen/ova.What is a serious adverse drug reaction (ADR)?Noxious and unintended response to a drug, regardless of the dose.Causes: hospital admission or prolongs stay, congenital malformations, persistent or significant disability or incapacity, life-threatening OR death OR requires intervention to prevent one of these.
25. Vanessa’s Law: Mandatory reporting of ADRs and MDIs to Health Canada (December 16, 2019)Who reports?The health care professional who recognizes the serious ADR or MDI must ensure a report is completed as soon as possible, and before the end of their shift. (provided all minimal required data elements are within the Control of the Hospital)How to report?SIMS has all required data elements programmedin for serious ADRs reportingdrug's brand name & identification number (DIN), description of the serious ADR, date, any medical condition that directly relates to the serious ADR and, the effect of the serious ADR on the patient’s health.Resources:Vanessa’s Law Mandatory LMS moduleshttp://intra.nshealth.ca/patientsafety/SitePages/vanessaslaw.aspxNSHA/IWK Policy AD-QR-030 Mandatory reporting of Serious Adverse Drug Reactions and Medical Device Incidents (Vanessa’s Law)
26. Opioid Prescribing – Useful ResourcesCanada continues to experience a serious opioid crisis. Across the country, it is having devastating effects on families and communities. The Public Health Agency of Canada works closely with the provinces and territories to collect and share data on apparent opioid-related deaths. June 2019
27. Opioid Prescribing PrinciplesReducing our contribution to the opioid crisisAssess patient risk Use risk tools Check DIS/PMPOther medications increase risk e.g., benzodiazepines, gabapentin, alcohol etc.Acute Pain Prescribe lowest effective dose, for the shortest period of time for usual pain durationThresholds- i.e. 3 days supply often and no more than 7 days Immediate release, short–acting opioids recommendedEducate patient Goal – pain reduction, not complete pain reliefSide effects (e.g., sedation, nausea, constipation, dizziness, increased risk for falls etc.) Proper use, storage (out of reach/locked) and disposal (bring back to pharmacy)Availability of Take Home Naloxone Program in NSChronic Pain – follow Cdn. guidelines i.e., Patients beginning opioid therapy, restricting to less than 90 mg morphine equivalents daily (MED) and suggest restricting the maximum prescribed dose to less than 50 mg MED.http://www.cmaj.ca/content/cmaj/189/18/E659.full.pdf Remember: “Several non-opioid therapies (including both drug and non-drug alternatives) may achieve a similar magnitude of improvement in pain and function more safely without the potentially serious side effects of opioid therapy (e.g. harms related to dependence, addiction and overdose).” Internal Medicine Recommendation #6 (Choosing Wisely)
28. Opioid Prescribing ResourcesReducing our contribution to the opioid crisisThe 2017 Canadian Guideline for Opioids for Chronic Non-Cancer Pain – endorsed by NS College of Physicians and Surgeons http://nationalpaincentre.mcmaster.ca/guidelines.htmlhttp://www.cmaj.ca/content/189/18/E659Nova Scotia's Opioid Use and Overdose Frameworkhttps://novascotia.ca/opioid/nova-scotia-opioid-use-and-overdose-framework.pdfPrescribing practices and provider support: Health professionals are at the forefront of the response to opioid misuse and overdose. Supporting providers to follow best practice guidelines on opioid use will help reduce inappropriate prescribing of opioids and support efforts to taper and care for patients on high-dose opioids. Establishing prescribing thresholds will help to control initial prescriptions and prevent overprescribing of opioids for acute pain, reduce the pool of unused medications available for diversion, and reduce the rates of dependence or addiction.CADTH OPIOID EVIDENCE BUNDLE:https://www.cadth.ca/evidence-bundles/opioid-evidence-bundle
29. Choosing Wisely Canadahttps://choosingwiselycanada.org/campaign/opioid-wisely/Example:
30. QUESTIONS???