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Pulse Newsletter

Your source for the latest industry trends and drug information news.

Volume 4 | Issue 22
November 15, 2022

Chief Authors: Rebecca Waite, PharmD, Bonnie Broczkowski, PharmD & Colleen Peehler, PharmD
Contributing Authors: Yi (Eve) Zheng, PharmD/MBA Candidate, Gabrielle Graca, PharmD/MBA Candidate

Clinical Pharmacy Update

CDC Updates Clinical Guidelines for Prescribing Opioids for Pain

On November 3, 2022, the Centers for Disease Control and Prevention (CDC) released updated guidelines and recommendations for physicians prescribing opioid medications for adults with short-term or long-term pain. These recommendations are intended to advise prescribers on how to optimize safety, efficacy and compassion when approaching treatment planning for their patients experiencing pain. Over the past six years, the CDC has prioritized evidence-based practice to better understand patients and the challenges faced in pain management. Since releasing their previous opioid prescribing guidelines in 2016, the CDC has continued consulting with patients, caregivers, and experts in pain management, and they have used the input they received along with the latest research to develop their new recommendations. Within the new guidelines, the CDC restructured their approach into four main components. These include: determining whether it is appropriate to initiate opioids for the patient’s pain, selecting the optimal opioid medication for the patient and dosing it appropriately, deciding how long to initially treat the pain with an opioid medication and when to reevaluate the need for it, and assessing the risk and potential harm of opioid use for the patient. These updated guidelines support the U.S. Department of Health & Human Services (HHS) Overdose Prevention Strategy, which works to reduce substance-related harm, prevent substance use disorders and provide support for patients who are in recovery. For patients looking to better understand their pain and treatment options, the CDC provides an informational website with information about types of pain, potential risks of opioid use, non-opioid therapy options and frequently asked questions

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Drug Safety

Impurity Leads to Recall of Quinapril and Hydrochlorothiazide Combination Tablets

On October 24, 2022, the U.S. Food & Drug Administration (FDA) announced Aurobindo Pharma’s voluntary recall of 2 lots of quinapril and hydrochlorothiazide 20mg/12.5mg tablets, used for the treatment of high blood pressure. These are round, pink film-coated tablets with a “D” on the scored side and “19” on the other side. They were recalled due to the presence of Nitrosamine Drug Substance Related Impurity (NDSRI). Although small amounts are common in some food and water, long-term exposure to nitrosamines can increase the risk of cancer. The recalled lots began shipping to customers nationwide during May 2021. To date, Aurobindo Pharma USA has not received any complaints or reports of adverse events related to this recall. The company is in the process of notifying distributors and affected customers about the recall. Patients should contact their health care provider if they have received one of the recalled lots to gain guidance about whether to continue taking the medication or if they should change to an alternative therapy. Patients experiencing any adverse events related to the recall are advised to contact their physician or health care provider and report to the FDA’s MedWatch Adverse Event Reporting Program.

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From the Pharmaceutical Industry

FDA Provides Warning of Amoxicillin Shortage

On October 28, 2022, the FDA alerted the country regarding the current shortage of amoxicillin oral powder, which is used in making amoxicillin oral suspension for patients. Amoxicillin is an antibiotic in the penicillin drug class, and it is used to treat a large variety of bacterial infections. It is used frequently in respiratory illnesses experienced by pediatric patients, which have been on the rise in recent months. Respiratory Syncytial Virus (RSV) is a virus that can cause mild cold-like symptoms but can also lead to more serious illness. It is the most common cause of bronchiolitis and pneumonia in young children in the United States. Recently there has been a surge in RSV cases, and while amoxicillin cannot treat viral illness like RSV, it can be used to treat bacterial infections that often develop in patients recovering from RSV. The increasing trend of these infections, along with a move into cold and flu season, has been a large contributor to the shortage. One pharmaceutical company, Sandoz, has a limited supply of amoxicillin while the medication distribution is on allocation by Aurobindo and Teva Pharmaceuticals. Fortunately, Rising Pharma Holding and Hikma Pharmaceuticals have amoxicillin available for current customers. Many pharmacies will have a limited stock of certain strengths of this medication and as a result, pharmacists and providers will have to efficiently work together to prescribe an appropriate dose of amoxicillin based on which products the pharmacy can acquire. As pharmaceutical manufacturers work to increase production, health care providers will continue to optimize the use of available amoxicillin and other treatment options. The amoxicillin shortage is estimated to continue into 2023.

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FDA Approvals

New FDA Approvals

New Indication: Rinvoq® (upadacitinib)

Oral tablet approved for the treatment of a type of active inflammatory arthritis of the spine known as non-radiographic axial spondyloarthritis (nr-axSpA). It has been approved in adult patients with signs of inflammation that have had an inadequate response or intolerance to tumor necrosis factor (TNF) blocker therapy. [10/21/2022 – ABBVIE]

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New Generics

New Generics Entering the Marketplace

Daliresp® (roflumilast)
Indication: To decrease the number of serious flare-ups in adults with severe chronic obstructive pulmonary disease (COPD)
Dosage Form/Strength: 250mcg, 500mcg oral tablets
Average Wholesale Price (AWP): Generic = $452 | Brand = $502