Clinical Insights: September 22, 2020

    Welcome to RxStrategies’ Clinical Insights, designed to help pharmacy professionals stay up to date on the ever-changing pharmaceutical and pharmacy market place. Contact us to learn more.

    New Drug Approval

    No new update.

    New Formulation Approval

    No new update.

    New Indication/Dosage Approval

    No new update.

    New Drug Shortage

    September 21, 2020 

    September 18, 2020

     September 16, 2020

    New Drug Recall and Safety Alerts

    NP Thyroid® (thyroid) Tablets by Acella Pharmaceuticals, LLC – New Drug Recall – September 17, 2020 – Acella Pharmaceuticals, LLC is voluntarily recalling one lot of 15-mg and one lot of 120-mg NP Thyroid®, Thyroid Tablets, USP [levothyroxine (T4) and liothyronine (T3)] to the consumer level. The products are being recalled because testing has found these lots to be sub potent. The product may have as low as 87% of the labeled amount of levothyroxine (T4). More information can be found at www.npthyroid.com/product-updates. <Read More>

    New Generic/Biosimilar Approval and Launch

    No new update.

    Clinical and Pharmacy News

    Women in Pharmacy Face Intolerable Levels of Harassment and Intimidation – September 21, 2020 – We want to make this clear right off the bat: APhA is steadfastly opposed to sexism, racism, discrimination, harassment, and intimidation – implicit or explicit – and we are committed to combatting behaviors that undermine any member of our profession. A recent change.org petition called on national pharmacy organizations to address the ways women are silenced: Women risk leadership roles, awards, and opportunities to present their research if they speak out about sexism and sexual misconduct. The petition inspired a wave of women to share their own stories of abuse and harassment based on their gender. The petition also led to discussions about the unfairness of guilty parties receiving tenure-track promotions, positions of power, and professional awards and accolades with no consideration of their unprofessional and destructive treatment of their women peers. <Read More> 

    Integrating New Technology into Pharmacy Operations – September 21, 2020 – As technology increasingly changes pharmacy operations, pharmacists must take into account several important considerations when determining how to incorporate technological advances, according to a presentation at the 2020 National Association of Specialty Pharmacy Annual Meeting and Expo Virtual Experience. Panelists Shivani Patel, PharmD, senior vice president of clinical operations and technology at Asembia and Allene Naples, PharmD, MBA, CSP, specialty, home delivery, and accountable care organization pharmacy manager at University Hospital, discussed how technology can help revolutionize how a pharmacy manages patients, collects payments, and communicates, as well as how it can improve overall efficiency. <Read More>

    American Psychiatric Association Publishes Updated Practice Guidelines for the Treatment of Schizophrenia – September 21, 2020 – In December 2019, the American Psychiatric Association (APA) Board of Trustees approved updated practice guidelines for the treatment of schizophrenia. The last full APA practice guideline was published in 2004, with an update in 2009. The 2019 guidelines aim to improve care quality and treatment outcomes for patients with schizophrenia. <Read More> 

    NCPA Surveys Community Pharmacies About Patient Prescription Transfers to Competitors – September 21, 2020 – Results from a recent NCPA survey indicated that patients’ prescriptions are being transferred from independent pharmacies to chain stores without patients’ permission. Almost 80% of community pharmacists who responded to the survey said they’ve lost patients because of unfair “patient steering” in the past 6 months — and CVS Health is most often the culprit, NCPA said in the news release. For the survey, NCPA collected responses from 412 pharmacy owners and managers between September 8-11, 2020. “Many members have been telling us that their patients are being transferred to larger competitors, and in many cases the patients don’t know when, why, or how. This survey sheds some light on the problem, and the results are very disturbing,” said B. Douglas Hoey, RPh, CEO of NCPA. According to the survey, 79% of community pharmacists reported that their patients’ prescriptions were transferred to another pharmacy in the last 6 months without their patients’ knowledge or consent. The median average of patients lost was 12. <Read More>

    What to Expect From a Specialty Pharmacy Partner – September 21, 2020 – Clinical education, strong data analytics, and valuing collaboration are the best ways to provide patient support and access to specialty pharmaceutical manufacturers, according to a panel session at the virtual National Association of Specialty Pharmacy 2020 Annual Meeting and Expo. When asked to elaborate on partnering with specialty pharmaceutical manufacturers, Patti Weber, vice president of Client Services at ReCept Pharmacy, explained how clinical education is an area that specialty pharmacies excel at. <Read More> 

    Exercise Amount Impacts A1C Reduction in T2D Population, Study Finds – September 18, 2020 – Individuals with type 2 diabetes (T2D) who complete a higher volume of exercise training exhibit more improved glycemic control compared with individuals who exercise less frequently, according to a study published in Medicine & Science in Sports & Exercise. In addition to improving glycemic control, exercise can induce modest weight loss, improve insulin sensitivity, and modify cardiovascular risk factors, including blood pressure and triglycerides in the T2D population. The American Diabetes Association recommends individuals with T2D complete a minimum of 150 minutes of aerobic physical activity per week, at least 2 weekly sessions of resistance exercise training, and minimize sedentary time. <Read More>

    Specialty Pharmacy Outpaces Traditional Pharmacy Growth – September 18, 2020 – Specialty pharmacy growth is outpacing traditional product growth and currently accounts for 49% of total non-discounted spending in the pharmacy space, according to a presentation by Doug Long, vice president of Industry Relations at IQVIA, during the National Association of Specialty Pharmacy (NASP) Annual Meeting and Expo 2020. Specialty pharmacy spending grew by 10% in June 2020, while traditional pharmacy spending decreased by 0.4%. This trend was seen in both retail and mail-order pharmacies. Specialty spending grew 10.7% in June 2020 while traditional retail spending grew 1%. For mail-order, specialty growth accounted for 80% of the total non-discounted spend. Specialty spend grew 11.4% in June 2020 while traditional products decreased 2%. <Read More> 

    How New Graduates Can Break into Specialty Pharmacy – September 17, 2020 – Specialty pharmacy professionals and students discussed changes in the specialty pharmacy field and how new and recently graduated pharmacy students can break into the field, during a session at the 2020 National Association of Specialty Pharmacy (NASP) Annual Meeting and Expo Virtual Experience…Specialty pharmacy is a growing field with diverse job offerings at every level. Postgraduate opportunities can be an effective way for students to familiarize themselves with the field, according to the panel. In addition, residencies can provide a bridge for recent graduates into the specialty pharmacy world and can provide a competitive advantage over other applicants vying for the same position. <Read More> 

    Prescriptions Slowly Recovering From Pandemic Hit – September 17, 2020 – Acute, new and retail prescriptions are increasing gradually from the dramatic impact on volume during the early months of the COVID-19 pandemic, said Doug Long, the vice president of industry relations for the pharmaceutical information leader IQVIA, during a presentation at the National Association of Specialty Pharmacy 2020 Annual Meeting & Expo Virtual Experience. <Read More> 

    Co-pay Accumulators, Maximizers, and the Impact for Specialty Pharmacy – September 17, 2020 – The impact of co-pay accumulators and maximizers on specialty pharmacy is significant and represents a challenge that will not go away, which affects the type of care patients are able to receive, according to a session at the virtual NASP 2020 Annual Meeting and Expo on September 17, 2020. When examining key health care financials, many families and individuals have not been able to pay their out-of-pocket costs or do not have enough money saved to pay their deductibles, according to Charles Collins, Jr, MS, MBA, president of Healthcare Stakeholder Solutions. Unemployment from the effects of the coronavirus disease 2019 (COVID-19) pandemic have caused even more significant financial issues for families, including layoffs, foreclosures, and loss of benefits as a whole. <Read More> 

    Help Patients Obtain HIV Medications – September 17, 2020 – Specialty medications can allow patients to go beyond managing symptoms to treat the root causes of diseases like never before. Look no further than antiretroviral therapeutics (ARTs) to see the real-world impact of such medical innovation. These specialty medications have turned the tide in the war against HIV/AIDS. For ARTs to make the most difference, distribution models, retail and specialty pharmacies, must meet patients with HIV where they are to ensure widespread medication access and adherence. <Read More>

    Experts: Working from Home is Largest Challenge for Specialty Pharmacy During COVID-19, But Has Unexpected Benefits – September 17, 2020 – Although most companies had planned for localized or regional natural disasters, the global scale of the coronavirus disease 2019 (COVID-19) pandemic brought sudden, unexpected challenges for all stakeholders in specialty pharmacy. An expert panel discussed the changes to their businesses and what they think the future holds during a session titled “Lessons Learned from COVID-19” at the 2020 National Association of Specialty Pharmacy (NASP) Annual Meeting and Expo.  <Read More> 

    Taking Aim at Antibiotic-Resistant Bacteria During COVID – September 16, 2020 – Patients afflicted with COVID-19 have an increased susceptibility to antibiotic resistant infections both from prolonged hospitalizations and the use of immunocompromising agents such as dexamethasone. Even in the midst of the coronavirus disease 2019 (COVID-19) pandemic, we should not forget that about 500 people in the United States die each day from antibiotic-resistant organisms. That was one of the points stressed by Admiral Brett Giroir, the nation’s Assistant Secretary of Health at the US Department of Health and Human Services (HHS) during the 2020 Fall Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria. <Read More> 

    Antidepressant Discontinuation: What the Tertiary Databases and Package Insert Tells You – September 16, 2020 – Discontinuation of antidepressants should take place gradually, as abrupt stoppage or marked reduction in the dosage of an antidepressant is frequently associated with adverse effects (AEs), such as withdrawal symptoms. Withdrawal symptoms, manifested by flu-like symptoms, insomnia, nausea, imbalance, “brain zaps,” sensory disturbances, and hyperarousal, usually occur within a few days after discontinuing the medication and may last months without intervention. The exact incidence of withdrawal symptoms is unknown but may develop in approximately 20%-63% of patients following rapid discontinuation of antidepressants, infectious diseases, and AEs of other medications a patient takes. <Read More> 

    Expanding the Role for Technicians in Specialty Pharmacy – September 16, 2020 – There are a lot of areas for technicians to get involved in the specialty pharmacy space, and it is imperative for forward thinking pharmacies and pharmacy owners to engage technicians in the different roles at the pharmacy, according to a session at the National Association of Specialty Pharmacy (NASP) 2020 Annual Meeting & Expo Virtual Experience on September 15, 2020. It makes the most sense to get more technicians involved when pharmacies are continuing to grow, since the number of roles that are needed to operate are well suited for technicians, said Jonathan Ogurchak, PharmD, CSP and education consultant at NASP. <Read More>

    Pharmacists Play a Critical Role in Managing Changes to HIV Care During COVID-19 – September 16, 2020 – Since the beginning of the HIV epidemic, approximately 33 million people have died from HIV/AIDS and 76 million people have been infected with the virus, according to a virtual session at the National Association of Specialty Pharmacy (NASP) Annual Meeting & Expo 2020. During the session on the state of HIV care in 2020, Brandon Patchett, PharmD AAHIVP, senior director of pharmacy—clinical services at the AIDS Healthcare Foundation, said that in the late 1980s and the 1990s, the virus was thought to affect only men who have sex with men. However, by the 2000s, the prevalence of the virus among minority communities was evident, according to Patchett. <Read More> 

    The Pharmacist Will See You Now – September 15, 2020 – In 1995, Geisinger tried an experiment. At the main hospital in Danville, Pa., it started its first pharmacist-run anticoagulation clinic. While the clinic was initially met with resistance from a small group of physicians, others expressed their support and created a solid patient referral base. The experiment was a success, and over the next 25 years, Geisinger began adding pharmacists to other services, including primary care offices. Today, it has 58 primary care clinical pharmacists embedded in 51 sites across the system, as well as 20 pharmacists practicing in specialty medicine sites. <Read More>

    Pharmacy Times® Re-Launches #ThankAPharmacist Social Media Campaign During American Pharmacists Month – September 15, 2020 – Pharmacy Times®, the leading multimedia resource for pharmacy professionals, will celebrate American Pharmacists Month in October with its annual #ThankAPharmacist campaign, which recognizes pharmacists and pharmacy technicians through Twitter, Facebook and Instagram for their dedication and commitment to improving patients’ lives. Now in its sixth year, the Pharmacy Times® #ThankAPharmacist campaign honors pharmacy professionals who, this year, are serving their communities by being on the front line during the coronavirus disease 2019 (COVID-19) pandemic. Colleagues, patients, friends and family members of outstanding pharmacists, pharmacy technicians or others in the field are encouraged to post their messages to pharmacy professionals on social media using #ThankAPharmacist or #APharmacistIs. <Read More> 

    APhA Names Antonio Ciaccia Senior Advisor for Disruptive Innovation and Practice Transformation – September 14, 2020 – The American Pharmacists Association (APhA) announced that it has named Antonio Ciaccia, Chief Strategy Officer of 3 Axis Advisors, as APhA’s Senior Advisor for Disruptive Innovation and Practice Transformation. This addition will supercharge the association’s efforts to disrupt our broken payment models and drive the profession of pharmacy forward. Antonio begins his duties immediately. 3 Axis Advisors (3AA) is a consultancy that partners with private and government sector organizations to solve complex, systemic problems, and propel industry reform through data-driven advocacy. Ciaccia and 3AA President Eric Pachman were instrumental in exposing the drug pricing distortions and supply chain inefficiencies embedded in Ohio’s Medicaid managed care program, which led to the discovery of $244 million in hidden PBM spread pricing in just one year. This set off a tidal wave of national scrutiny and reform, and their more recent data analyses have exposed new ways in which middlemen abuse a lack of transparency, poor incentives, conflicts of interest, and unchecked power to undermine patient care and siphon value out of the healthcare system. <Read More>

     

    340B in the News

    Moran Calls for 340B Drug Pricing Program Enforcement – September 21, 2020 – U.S. Sen. Jerry Moran (R-KS) last week joined several of his U.S. Senate colleagues in expressing concerns about recent actions by pharmaceutical manufacturers that they say threaten to undermine the role of contract pharmacies in the 340B Drug Pricing Program during the coronavirus pandemic. Manufacturers participating in Medicaid agree to provide outpatient drugs to covered entities at significantly reduced prices under the 340B Drug Pricing Program, according to the Health Resources and Services Administration (HRSA). <Read More> 

    Regulatory and Legislative Actions Currently Impacting the 340B Program – September 21, 2020 – Protections for covered entities under the 340B program will most likely be affected by decisions in the Senate, according to a virtual panel at the National Association of Specialty Pharmacy (NASP) Annual Meeting and Expo 2020. The panelists explained that these congressional decisions will have implications on the future of the program over the next 2 years. During the session on 340B Drug Pricing, Peggy Tighe, JD, legislative counsel for Ryan White Clinics for 340B Access &​ Principal at the Powers Law Firm; Neil Minkoff, MD​, founder of FountainHead HealthCare​; and Mark Ogunsusi, JD, PharmD​, associate at the Powers Law Firm discussed the regulatory and legislative actions that are currently affecting the 340B program, as well as how the upcoming presidential election may affect the program further. <Read More>

    Hospitals ask Appeals Court for a Rehearing on 340B Decision – September 17, 2020 – The American Hospital Association and other organizations which lost an appeal over 340B drug payments, have asked the court for a rehearing. The AHA and others filed the request on September 14 in the U.S. Court of Appeals in the District of Columbia. The plaintiffs want a rehearing before the full court, rather than a panel of judges. In August, a panel of judges ruled 2-1 against the AHA and in favor of the Department of Health and Human Services’ decision to reduce payment for Medicare Part B drugs to 340B hospitals. <Read More> 

    Manufacturers Push Back on the Use of Contract Pharmacies by 340B Covered Entities – September 17, 2020 – Manufacturers and providers participating in the 340B Drug Pricing Program have entered into a new phase of tensions this summer, as manufacturers push back on the use of contract pharmacies by providers. At least one major manufacturer published a letter stating that providers will be able to purchase the manufacturer’s drugs only when shipped to an in-house pharmacy, prompting HRSA to consider regulatory action against the manufacturer. Additionally, beginning in June, some manufacturers sent letters to providers, directing them to upload contract pharmacy claims data for 340B-eligible prescriptions to the vendor 340B ESP to minimize duplicate discounts for claims that are submitted to Medicaid, Medicare Part D, and commercial payors. 340B administrator entities responded by sending communications to the same providers, reminding them of the confidentiality and data privacy obligations governing the claims data, and refusing to provide authorization to disclose data for payors other than Medicaid. <Read More> 

    243 House Members Urge HHS to Stop Drugmakers From Blocking 340B Discounts – September 15, 2020 – A bipartisan group of 243 members of the House of Representatives sent a letter to HHS Secretary Alex Azar Sept. 14 urging him to use his authority to stop drugmakers from blocking safety-net hospitals’ access to 340B discounts. Reps. David McKinley, R-W.Va., Diana DeGette, D-Colo., Greg Gianforte, R-Mont., Dusty Johnson, R-S.D., Doris Matsui, D-Calif., and Peter Welch, D-Vt., led the House members in sending the letter. The letter calls on Mr. Azar to stop drugmakers from refusing to offer 340B discounts on drugs dispensed through community pharmacies. <Read More> 

    AHF Applauds Congressional Demand that Drug Companies Follow Laws on 340B Drug Program – September 15, 2020 – AIDS Healthcare Foundation (AHF) expressed its appreciation to the 243 members of the U.S. House of Representatives who sent a letter to U.S. Health and Humans Services Secretary Alex Azar demanding that the agency stop drug companies from violating their legal obligations under the 340B Drug Discount Program statute. “Drug companies are not above the law,” said Tom Myers, general counsel and chief of public affairs for AHF. AstraZeneca, Eli Lilly, Merck, Novartis and Sanofi recently announced that they would limit their statutory responsibility to provide drug discounts to non-profit safety net providers,” Myers added, “The 340B statute certainly doesn’t allow drug companies to set conditions for safety net providers to access 340B discounts. Their idea that manufacturers can unilaterally regulate the program themselves is ridiculous and has been rejected by 243 members of Congress.” <Read More>