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SPECIAL SUPPLEMENT
PPN 2020
Corporate Profiles Section begins on page 17.
CLINICAL
Building a just culture of safety ............................... ID pharmacist: fast isn’t always foolproof in COVID-19 .....................
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POLICY
Doing the ‘Gemba Walk’ toward cleanroom compliance ..................... 33 SPECIALTY PHARMACY
Pandemic offers lessons for payors, health plans ....................
COVID-19 Spurs Renewed Crisis in OUD Patients
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he controversy over the use of hydroxychloroquine (HCQ) and chloroquine (CQ) for COVID-19 has left pharmacists in the middle of the debate, struggling to offer advice. Early anecdotal reports appeared promising, but more recent, betterdesigned studies have shown little or no benefit, and some have demonstrated a risk for cardiovascular and other adverse events. The National Institutes of Health stopped its ORCHID study of HCQ in hospitalized adults with COVID-19 early because the data and safety monitoring board determined that while there was no harm, HCQ provided no additional benefit compared with placebo. An interim analysis of the HCQ arm of RECOVERY (Randomized Trial of COVID-19 Therapy), sponsored by
pioid use disorder (OUD) has become an epidemic within the COVID-19 pandemic, a panel of public health experts said during a webinar organized by the Association of Schools and Programs of Public Health. Without adequate access to treatment, relapse rates among patients with OUD are surging. And when these patients do get access to opioids, their lowered tolerance places them at risk for overdoses, the he experts noted during the webinar. “This is a perilous time for peo-ple with [OUD],” said Brandon n Marshall, PhD, an associate proo-fessor of epidemiology at Brown wn n University School of Public Health, h h, in Providence, R.I. “Counterintuiu uitively, disruptions in the drug supply pply and lack of income to purchase il illicit llicit opioids might have led to a drop in n drug use during the COVID pandemic. However, this could lead to Continued on page 14
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Feed the Patient, Fuel the Savings 46
REVIEW ARTICLE
Role of Specialty Pharmacists in Treating Patients With HIV See page 40.
HCQ for COVID-19: Yes? No? I Don’t Know!
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TECHNOLOGY
Can patients help solve ongoing drug shortages? ......................
Volume 47 • Number 8 • August 2020
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new analysis conducted by the American Society for Parenteral and Enteral Nutrition (ASPEN) shows that appropriate nutrition support can save an estimated $580 million in annual Medicare spending. “With evidence from this study, [providers], payors and policymakers must recognize that nutrition support is a linchpin to [providing] high-quality, cost-effective care,” said critical care and nutrition support pharmacist Angela Bingham, PharmD, an associate professor of clinical pharmacy at the University of the Sciences, Philadelphia College of Pharmacy, who was not involved in the research. Continued on page 3
Generics ‘Wall’ Costs Nearly $1B in Lost Savings
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recent study in Health Affairs found that when the market entry of generic drugs is delayed due to patent fights and other factors, the price tag for lost savings opportunities approaches $1 billion (2020;39[6]:1011-1017). Among 69 brand-name drugs studied that were expected to lose patent exclusivity in 2010 to 2016, generic entry occurred before or within three months of the expected date for just 38 products (55%), the investigators found. Market entry for generics was delayed by more than three months for 20 products (29%) and did not occur for 11 products (16%). For the 31 products that had delayed or no generic entry, Medicaid spent an estimated
Special Focus:
COVID-19 Pandemic More on pages 4, 12, 16 and 44
$761 million more over seven years, or $109 million annually. Patent litigation was cited as the most common reason for the delays. “Delaying generic entry is one of the key strategies that pharmaceutical manufacturers use to maintain their high revenue streams,” said Aaron S. Kesselheim, MD, JD, MPH, a professor of medicine at Harvard Medical School, in Boston. “That’s a big problem because it raises costs for patients, which reduces patient adherence to important medications. For Medicaid, which provides drug coverage with limited out-ofpocket spending for patients, it raises costs for the health care system.” Continued on page 45