Hunter Pharmacy Services Clinical Update

Transcription

1 Hunter Pharmacy Services Clinical Update Hunter Pharmacy Services, Inc Executive Center Drive Suite 100 Austin, TX Inside This Issue 1 - Top Stories & Pharmacist Good Catches 2 & 3 - In The News 4 & 5 - From The Pharmacist Letter FDA approves novel preventive treatment for migraine FDA News Release (05/17/18) FDA approved on Thursday erenumab-aooe (Aimovig Amgen) for the preventive treatment of migraine in adults. The drug, administered once-monthly via self-injection, is the first FDAapprove preventive migraine treatment in a new class of drugs that work by blocking the activity of calcitonin gene-related peptide. That molecule is involved in migraine attacks. "Aimovig provides patients with a novel option for reducing the number of days with migraine," said Eric Bastings, MD, deputy director of the Division of Neurology Products in FDA's Center for Drug Evaluation and Research. "We need new treatments for this painful and often debilitating condition." Three clinical trials were used to evaluate the effectiveness of erenumab-aooe for the preventive treatment of migraine. The most frequent adverse effects reported by patients in the clinical trials were injection site reactions and constipation. Amgen announced that it will charge $6,900 a year for its newly approved migraine treatment for adults. Hunter Pharmacy RePas Good Catches - 35 yo M admitted with recurrent pancreatitis. Upon chart review, pharmacist noted pt had active orders for divalproex which is noted to have a black box warning for pancreatitis and should be discontinued. MD was alerted of warning and he immediately discontinued. (Kathleen Baker, PharmD) - Providence The RN entered Trandate q6h prn pain. I called to question the order as it is a blood pressure medication. She had selected the wrong medication and meant Toradol. (Kathy DeMello, PharmD) Page 1

2 In the News FDA Approves Lofexidine Hydrochloride for Mitigating Symptoms of Opioid Withdrawal in Adults The US Food and Drug Administration (FDA) has approved lofexidine hydrochloride (Lucemyra, US WorldMeds), a nonopioid, for the mitigation of symptoms in the setting of abrupt opioid withdrawal in adults. The approval follows a recommendation for approval back in March by the FDA Psychopharmacologic Drugs Advisory Committee. The committee found the drug to be both safe and effective in reducing symptoms such as diarrhea, nausea, vomiting, anxiety, and an overall feeling of sickness that often keeps patients from successfully withdrawing from opioids. Lofexidine may lessen the severity of withdrawal symptoms but may not completely prevent them, and is approved for treatment for only up to 14 days. Lofexidine is not a treatment for opioid use disorder (OUD) but can be used as part of a broader, long-term treatment plan for managing OUD. Lofexidine is an oral, selective alpha 2- adrenergic receptor agonist that reduces the release of norepinephrine, which is believed to play a role in many of the symptoms of opioid withdrawal. The most common side effects seen with lofexidine include hypotension, bradycardia, somnolence, sedation, and dizziness. Lofexidine was also associated with a few cases of syncope. Lofexidine may also raise the risk for abnormal heart rhythms. When lofexidine is stopped, patients may experience a marked increase in blood pressure. FDA Approves First Epoetin Alfa Biosimilar for the Treatment of Anemia FDA News Release (05/15/18) - FDA has approved epoetin alfa-epbx (Retacrit Hospira) as a biosimilar to epoetin alfa (Epogen/Procrit Amgen) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine for individuals with HIV. Epoetin alfa-epbx is also cleared for use before and after surgery to reduce the chance that red blood cell transfusions will be needed because of blood loss during surgery. FDA's approval of epoetin alfa-epbx is based on a review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates epoetin alfa-epbx is biosimilar to epoetin alfa. The most frequent adverse effects of epoetin alfa-treated patients in clinical studies of the reference product included high blood pressure, joint pain, muscle spasm, fever, dizziness, medical device malfunction, blood vessel blockage, respiratory infection, cough, rash, difficulty swallowing, low blood potassium, blood clots, itching, headache, injection site pain, and chills. As with epoetin alfa, epoetin alfa-epbx must be dispensed with a patient Medication Guide that details the drug's uses and risks, and it carries a boxed warning to alert health care professionals and patients about increased risks of death, heart problems, stroke, and tumor growth and recurrence. Tolvaptan, First FDA approved drug treatment to slow decline in kidney function in adults at risk for rapidly progressing ADPKD. The US Food and Drug Administration (FDA) has approved tolvaptan (Jynarque, Otsuka) to slow decline in kidney function in adults at risk for rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). Tolvaptan, a vasopressin-2 receptor antagonist, is the first FDA-approved drug treatment to slow decline in kidney function in adults at risk for rapidly progressing ADPKD. Page 2

3 ADPKD is a rare, chronic, progressive, inherited disease that causes the proliferation and growth of cysts in the kidneys, leading to an increase in kidney size. Complications include chronic and acute pain, hypertension, and kidney failure leading to dialysis or kidney transplant. Owing to the risks of serious liver injury, tolvaptan is available only through a restricted distribution program supported by a risk evaluation and mitigation strategy program approved by the FDA. Otsuka said tolvaptan will be sold in a 28-day treatment pack at a wholesale acquisition cost of $13, FDA confirms EpiPen shortage in United States - Agency calling it an intermittent supply chain shortage FDA added EpiPen, EpiPen Jr, and the generic versions of those products from the maker Mylan to its list of drugs currently in shortage. FDA called it an intermittent supply chain shortage due to delays from Pfizer, Mylan s manufacturing partner. The American Society of Health-System Pharmacists added EpiPen to its list of drugs in short supply in the United States a week before FDA s announcement. Shingrix demand outpaces supply - CDC: Expect ordering limits and shipping delays through June Having trouble stocking Shingrix? It s not you, it s the supply. CDC recently updated its current list of current vaccine shortage and delays to include a note about the vaccine, stating providers should expect ordering limits and intermittent shipping delays through the end of June, regardless of whether they order the vaccine directly from the manufacturer, GlaxoSmithKline (GSK) or through wholesalers and distributors. The page notes that GSK is working to make more doses available. FDA Warns about the Risk of HLH when taking Lamotrigine The anticonvulsant medication lamotrigine can cause the rare but serious immune system reaction hemophagocytic lymphohistiocytosis (HLH),according to the US and Food and Drug Administration. The FDA said a warning about the risk for HLH will be added to the prescribing information on lamotrigine drug labels. Lamotrigine is used alone or with other medicines to treat seizures in patients age 2 years and older. It is also indicated for maintenance treatment in patients with bipolar disorder to help stave off mood episodes (depression, mania or hypomania, and mixed episodes). HLH is a hyperinflammatory syndrome that can lead to hospitalization and death, especially if not diagnosed and treated quickly. Diagnosis is often complicated because early signs and symptoms, such as fever and rash, are not specific, the FDA notes. HLH may also be confused with other serious immune-related adverse reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS). Healthcare professionals are encouraged to report adverse events related to use of lamotrigine to the FDA's MedWatch Safety Information and Adverse Event Reporting Program. Patients receiving lamotrigine should be advised to seek immediate medical attention if they experience symptoms of HLH. HLH can be diagnosed if a patient has at least five of the following eight signs or symptoms: 1) Fever and rash; 2) Enlarged spleen; 3) Cytopenias; 4) Elevated levels of triglycerides or low blood levels of fibrinogen; 5) High levels of blood ferritin; 6) Hemophagocytosis identified through bone marrow, spleen, or lymph node biopsy; 7) Decreased or absent natural killer cell activity; and, 8)Elevated blood levels of CD25 showing prolonged immune cell activation. Page 3

4 From The Pharmacist Letter Hypertension in Diabetes The recent Am College of Cardiology and Am Heart Assn guidelines recommend a BP goal of less than 130/80 mmhg in patients across the board. Years ago, many of us were also taught this goal for patients with diabetes. But the Am Diabetes Assn has backed off over the past few years. They now recommend a goal of less than 140/90 for most diabetes patients...or less than 130/80 for diabetes PLUS other CV risk factors. These BP goals have been a moving target because the benefits of stricter BP control are less clear-cut in patients with diabetes. For example, a systolic BP goal of less than 120 in diabetes might reduce stroke risk...but not other CV events or death. Plus reaching a lower goal usually means adding one more BP med... and increases the risk of hypotension, electrolyte problems, etc. Individualize BP goals for diabetes patients with hypertension. First, continue to aim for a goal of less than 140/90. There s good evidence this goal improves CV and renal outcomes in diabetes patients. Then discuss the pros and cons of a lower goal with your patient. Weigh CV risks, especially a prior CV event, kidney disease, etc... with med side effects, fall risk, life expectancy, etc. Consider a goal of less than 130/80 for those at highest CV risk. For example, suggest a goal of less than 130/80, if tolerated, in a 70-year-old with a prior heart attack who s motivated and adherent. Continue to recommend an ACEI or ARB first for diabetes patients with hypertension AND albuminuria...to slow kidney damage. But for patients without albuminuria, feel comfortable with an ACEI, ARB, thiazide diuretic, or dihydropyridine calcium channel blocker first. For example, black patients may get better BP lowering with a thiazide or calcium channel blocker first, compared to an ACEI or ARB. Emphasize proper home BP monitoring...resting before checking BP, using proper cuff size, etc. Remind patients to track and share results. Appropriate Med Use You ll get more questions about Shingrix, the new zoster vaccine...especially now that CDC prefers it over Zostavax. Give Shingrix starting at age 50...instead of 60. It seems to prevent shingles better than Zostavax...and immunity may last longer. Shingrix requires two intramuscular doses, 2 to 6 months apart. Does a patient who s had Zostavax need 2 Shingrix doses? Yes...to boost immunity. Wait at least 2 months after Zostavax to give Shingrix. Give Shingrix even if the patient has had shingles...but wait until acute symptoms, such as the rash, go away. Can immunocompromised patients get Shingrix? In some cases, yes... it s a NON-live recombinant vaccine with an adjuvant. For example, feel comfortable giving Shingrix to patients on less than 20 mg/day of prednisone. This is low-level immunosuppression. It may be safe and effective in high-level immunosuppression, such as posttransplant...but wait for CDC guidance, possibly later this year. Are injection site reactions common with Shingrix? Yes...as well as possible aches, fatigue, shivering, etc. Inform patients these may last a couple of days...but don t seem to worsen with the second Shingrix dose. Can Shingrix be given at the same time as other vaccines? Generally yes...including flu, pneumococcal, and Tdap. There isn t much evidence about co-administration, but CDC guidelines don t suggest a concern. Will Zostavax be discontinued? Probably not soon...so work with your staff to prevent mix-ups between Shingrix and Zostavax. If Shingrix is given subcutaneously instead of IM, don t repeat the dose. But follow your pharmacy s policy for reporting vaccine errors. Store both Shingrix vials in the FRIDGE. Discard if accidentally frozen...below 32 F for the adjuvant or -13 F for the vaccine. And reconstitute Shingrix with its adjuvant...not the Zostavax diluent. Page 4

5 Antithrombotics New evidence will raise questions about the role of aspirin for venous thromboembolism (VTE) prophylaxis after hip or knee replacement. Anticoagulants are usually the go-to meds to prevent VTE in these patients...with aspirin saved as a potentially less effective option. But VTE risk with these surgeries is going down...due to newer techniques and post-op protocols that get patients up and moving early. Now evidence suggests that switching to aspirin 81 mg/day after 5 days of the direct oral anticoagulant (DOAC) Xarelto (rivaroxaban) seems as effective as continuing Xarelto...with a similar bleeding risk. This blended approach could be a game changer. That s because DOACs and low-molecular-weight heparins (LMWH) such as enoxaparin are pricey...and warfarin is tough to stabilize short-term. Expect a DOAC or LMWH to still be preferred for most patients at higher VTE risk...such as those with a prior VTE, CV disease, extremely limited mobility, or with active cancer. But don t be surprised if lower-risk patients take 5 days total of an anticoagulant...then switch to aspirin 81 mg/day. Explain that higher aspirin doses don t improve efficacy...but might increase bleeding risk. Most patients will need VTE prophylaxis for a total of 10 to 14 days...or preferably up to 35 days, especially after hip replacement. If patients switch to aspirin, educate them to start it when their next anticoagulant dose would be due...and emphasize adherence. Hear our team discuss all this with a thrombosis expert on PL Page 5