Welcome to the New Year

The West Virginia Pharmacists Association extends New Year’s appreciation to pharmacists for their contribution and support of pharmacy during 2019.

The Drug Enforcement Administration(DEA) has announced proposed regulations to improve the agency’s ability to oversee the production of opioids and other potentially dangerous drugs. The proposed regulations would further limit the quantities of medications that might be vulnerable to division and misuse.

The proposal would also amend the manner in which DEA grants quotas to certain registered manufacturers to levels aligned with current manufacturing standards aimed at promoting quality and efficiency while also ensuring that the country has sufficient quantities of Scheduled II controlled substances (CS) necessary for medical, scientific, research and industrial needs.

The proposal also introduces several new types of quotas that DEA would grant to certain DEA-registered manufacturers. These use-specific quotas include quantities of CS for use in commercial sales, product development, packaging/repacking and labeling/relabeling , or replacement for quantities destroyed. These quotas are intended to improve DEA’s ability to respond quickly to drug shortages.

The DEA has proposed to reduce the amount of five prescription opioids that can be manufactured in the US this year. If adopted, the proposal would affect the following CS as compared to production in 2019: fentanyl production to be reduced by 31%; hydrocodone to be reduced by 19%; hydromorphone to be reduced by 25%; oxycodone to be reduced by 9%; and oxymorphone to be reduced by 55%.

The proposal would result in a 53% reduction in the allowable production of CS opioids since 2016 and would also increase the amount of marijuana that can be produced for research by almost a third compared to 2019.

DEA is warning health care providers and other members of the public of another increase in fraudulent phone calls attempting to extort money. Though the tactics change regularly, the callers typically claim to represent DEA and provide either fake names and badge numbers, or the names of well-known senior officials with DEA. The scammers then threaten legal action, including arrest, against the victim unless large fines are paid by wire transfer.

According to the Center for Disease Control and Prevention (CDC), together, oxycodone, hydrocodone, heroin and fentanyl have killed more than 400,000 Americans since the turn of the century, a quarter of whom have died from fentanyl in just the past six years.

Insulin’s high price was in the spotlight in 2019. It surged in list price more than 250 percent over the past 10 years — despite being a century-old invention. The three largest manufacturers, one American and two European, were accused of excessively pricing their drugs.

The 2020 edition of the Survey of Pharmacy Law is a valuable resource for anyone looking for an overview of the laws and regulations that govern pharmacy practice in all 50 states. The Survey, which is published in a downloadable pdf format, consists of four chapters: a state-by-state overview or organization law; licensing law; drug law; and census data. It is available for purchase online for $195 at www.nabp.pharmacy

While most chain pharmacies relied heavily on wholesalers to supply prescription opioids, Walgreens obtained 97% of its pain pills directly from drug manufacturers, a Washington Post analysis found. At the height of the opioid epidemic, Walgreens handled nearly one out of every five oxycodone and hydrocodone pills shipped to pharmacies across America.

Walgreens dominated the nation’s retail opioid market from 2006 through 2012, buying about 13 billion pills — 3 billion more than CVS, its closest competitor, according to a DEA database of opioid shipments.

Introduced in Congress, the “Ensuring Seniors Access to Local Pharmacies Act” would allow seniors to medically underserved areas to access lower copays at any pharmacy willing to accept the Medicare Part D drug plan’s “preferred pharmacy” terms and conditions. The bill would require claims level reimbursement transparency so pharmacies have a clearer understanding of their reimbursement.

It also includes language to prevent PBMs from reimbursing their affiliated pharmacies more than they do other pharmacies and to ensure reimbursement covers acquisition and dispensing costs.