Pharmacy Newsletter Q1 – Q2 2021
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PHARMACY NEWSLETTER Q1 – Q2 2021 CONTENT COVID-19 TREATMENT UPDATES COVID-19 TREATMENT Vaccine-Induced Thrombotic Thrombocytopenia UPDATES Shortly after widespread administration of cHaDOx1 nCoV-19 (Astra Zeneca), MEDICATION SAFETY an adenovirus vectored vaccine, case reports of severe thrombosis with thrombocytopenia emerged. In April 2021, the FDA briefly paused continued ANTIMICROBIAL distribution of AD26.COV2.S (Johnson & Johnson), similarly an adenovirus vectored vaccine, due to observation of several cases of thrombosis with STEWARDSHIP thrombocytopenia syndrome post-vaccination. FORMULARY Vaccine-Induced Thrombotic Thrombocytopenia (VITT) resembles the well known immune-mediated adverse effect, Heparin Induced Thrombocytopenia POLICY UPDATES (HIT). Like HIT, VITT is characterized by a positive PF4-heparin ELISA indicating platelet activating antibodies, mild to severe thrombocytopenia, and venous or arterial thrombosis. The syndrome can result in cerebral venous sinus DRUG SHORTAGES thrombosis (CVST), portal vein thrombosis (PVT), and has progressed to disseminated intravascular coagulation (DIC). Although extremely rare, health care professionals should be knowledgeable in the recognition and treatment of this life-threatening adverse effect. Prepared by Presentation and diagnosis of VITT are detailed elsewhere.1-4 Once VITT is suspected, treatment is similar to HIT. Several societal guidelines and expert Kaitlyn Moorehead, recommendations for management have been released and are summarized PharmD in the table below. Renu Bajwa, PharmD Ollie Liu, PharmD, Due to the ongoing research of the syndrome, treatment recommendations BCPS are subject to rapid change. Consultation with hematology is recommended. It should be emphasized that complications such as VITT following COVID-19 vaccination are exceptionally rare. Based on risk-benefit analysis, the Advisory Committee on Immunization Practices (ACIP) continue to recommend the use of all FDA authorized COVID-19 vaccines. Reports of VITT or any other serious adverse effects after COVID-19 vaccination should be submitted to the Vaccine Adverse Event Reporting System (VAERS) for continued surveillance of vaccine safety. Table 1. Summary of VITT Management Recommendations in patients with positive or pending ELISA1-4 Treatment Rationale IVIG 0.5-1g/kg q24h x 2 days Inhibits platelet activation. Resulted in rapid increases in platelet count and de-escalation of hypercoagulability in severe HIT treatment. Corticosteroids (e.g., prednisone 1-2 mg/) if May be helpful in suppression of immune reactivity. platelet count <50 x109/L Plasma Exchange q24h x 5 days if platelet Removes anti-PF4 antibodies. count remains <30 x109/L or fibrinogen<1 g/L Non-heparin therapeutic anticoagulation x Treatment of thrombosis avoids potential heparin- ≥3 months. dependent platelet activation. Analogous to HIT treatment although no direct evidence that heparin - Direct Thrombin Inhibitor products worsen VITT. (e.g. argatroban) - Direct Oral Anticoagulant Choice of agent depends on severity (e.g. rivaroxaban, apixaban) - Fondaparinux Avoid Rationale Platelet Transfusions Theoretical prothrombotic risk. Unknown whether platelet transfusion will exacerbate the condition. Higher mortality in HIT. Assess risk/benefit in setting of acute hemorrhage or emergent surgical procedure following IVIG. Heparin products Unknown whether heparin products (including heparin flushed) will exacerbate the condition. Could trigger further platelet activation. Warfarin Results in early protein C depletion which can lead to further thrombosis. Aspirin Does not block platelet activation in VITT. Monoclonal Antibody Recommendation Changes Regeneron’s investigational monoclonal anti-viral antibody cocktail, casirivimab and imdevimab (REGEN-COV) has emerged as the NIH’s recommended monoclonal antibody regimen for non-hospitalized patients with COVID-19 at high risk for progression. Previously authorized mABs, such as bamlanivimab and bamlanivimab plus etesevimab are no longer recommended due to decreased efficacy versus circulating SARS-CoV-2 variants of concern including Delta, Beta, and Gamma. Several changes to the REGEN-COV EUA in recent weeks should be noted.5 Based on results from a Phase 3 study of REGEN-COV2 in outpatients, the FDA updated the authorized dose of casirivimab and imdevimab from 1200 mg of each component to 600 mg each. Furthermore, casirivimab 600 mg and imdevimab 600 mg doses can be administered subcutaneously when IV administration is not feasible. Administration of the 10 mL total volume must be divided into four 2.5 mL doses given in four different quadrants of the abdomen, upper thighs, or back of upper arms. Patients still must be observed for at least 1 hour following subQ administration. The current REGEN-COV EUA continues to limit authorized use to nonhospitalized patients however recent news releases indicate Regeneron will seek expansion to include hospitalized patients. This is based on positive data from the Phase 3 RECOVERY trial which found hospitalized patients treated with REGEN-COV had a 20% reduced risk of death. We may see the EUA expansion as soon as this summer. MEDICATION SAFETY Verbal & Telephone Orders Prone To Error DOSE OF 15 OR 50? Medication Error Report: After consulting an endocrinologist, a medical resident ordered 50 units of insulin glargine for a pediatric patient. A pharmacist confirmed the high dose with the resident, who mentioned that the endocrinologist seemed tired when they spoke. Upon investigation, the endocrinologist stated he ordered 15, not 50, units during the phone consultation. Strategies for Safer Communication: When verbalizing medication orders, state the dose the way pilots state numbers (e.g., “15 units” stated as “one-five units”). Always follow through with read-back, where the listener documents what is heard and then reads it back to the speaker to ensure the order was heard and transcribed correctly. When possible, remove a mask and face shield when speaking by phone. Following a verbal read-back to the prescriber, recipients of verbal orders should request confirmation from the prescriber that the read-back matches the intended order. STAR Reporting Medication event reporting is critical to medication safety. CMHS utilizes STAR for event reports. Every medication event is investigated and presented to the Medication Error Reduction Program (MERP) committee. MERP analyzes the errors and develops improved medication processes to enhance patient safety. The more information collected from initial STAR report, promotes a more robust analysis and response. Providing contributing factors allows the MERP to identify patterns and direct improvements. The STAR event submission form includes an optional field for Contributing Factors. Pre-existing factors for selection include Administration, Drug Information, Labelling, Drug Storage or Delivery, Environment, Lack of Quality Control, Lack of Staff Education, Miscommunication of Drug Order, Monitoring, Organization, Patient Education, Patient Info Missing, Preparation, Prescribing, and Staff-specific factors. When entering events into STAR, please report contributing factors in the General information about the event. lPharmaceutical Waste Reminder Table 2. Excerpt from CMHS Pharmaceutical Waste Disposal Gudelines Recyclable waste Drain Disposal Pharmaceutical Waste -Empty, intact glass or plastic -Liquid dextrose, saline, sterile water, -Partially used or wasted prescription bottles/vials that are not and/or lactated ringers solutions or OTC medication associated with medications -Potassium salts -Syringes, needles, and/or carpujects with -Nonconfidential/Non PHI paper -Magnesium salts pourable medication -Newspapers, Magazines -Calcium salts -IV bags and tubing with pourable medication -Plastic bottles or containers -Other electrolytes to which no other drug -Epinephrine, Nitroglycerin, Insulins -Aluminum cans has been added -Empty medication containers, e.g.,syringes, -Small, empty cardboard boxes IV bags, tubing, bottle vials, insulin (e.g, glove boxes) containers, inhalers, epinephrine syringes Standardized Vaccine Abbreviations The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) provides a list (Table 1) of standardized abbreviations or acronyms for FDA-approved vaccines. The list includes most single and combination vaccines but not all. CDC believes this list will promote accuracy, consistency, and convenience, and will reduce errors and ambiguity in vaccine labelling, medical practice and scientific publications. ANTIMICROBIAL STEWARDSHIP Surgical Prophylaxis Guideline Update Surgical site infections (SSI) are a source of significant morbidity and mortality post-operatively. SSIs are estimated to occur in up to 4% of all patients undergoing inpatient surgical procedures5 and can cost over $25,000 per case.6 Surgical teams utilize several measures to prevent SSIs such as hand hygiene, PPE, patient skin prep, hair removal, and when indicated, preoperative antibiotics. Appropriate selection, dose, timing, and duration of antimicrobial prophylaxis can prevent SSIs without excess harm commonly associated antibiotics. As reportable health care associated infections (HAI), SSIs are closely monitored by institutional Infection Prevention teams. Recent audits and literature reviews performed by Main OR Nursing, Infection Prevention, and Antimicrobial Stewardship identified procedures in which routine preoperative prophylaxis may not be necessary.