Author: Peter

With a major Indian production hub now locked down in a COVID-19 containment zone, the spotlight on pharma's emerging markets suppliers will likely shine even hotter...Drug manufacturing facilities in Baddi, Himachal Pradesh, India—a key source of drug supplies—have shut down or reduced capacity since the region locked down in mid-April...Fifty facilities reportedly have shuttered, including at least one operated by top generics player Sun Pharmaceuticals...A slew of others are hobbled by the lockdown...The U.S. supply of generic and branded medicines, heavily reliant on emerging markets in India and China, has come under close scrutiny as COVID-19 sends shockwaves through the industry...the FDA said it would temporarily allow hospitals to source hard-to-find drugs from compounding pharmacies to treat certain patients hospitalized with severe COVID-19...READ MORE

All pharmacy staff—along with everyone entering the pharmacy—should wear face masks, according to new guidance from the CDC...The CDC’s “Guidance for Pharmacists” also says that pharmacies should postpone and reschedule some routine preventive services, such as adult immunizations, since they require face-to-face interaction...This guidance applies to all pharmacy staff to minimize their risk of exposure to the virus and reduce the risk for customers during the COVID-19 pandemic...According to the guidance, pharmacies should:

Implement universal use of face coverings.
Advise staff who are sick to stay home.
Encourage all prescribers to submit prescription orders via telephone or electronically.
Limit direct contact with customers.
Reduce risk during COVID-19 testing.
Maintain social distancing
Ensure that the waiting area is cleaned regularly.
Close self-serve blood pressure units.

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Dogged by whistleblower kickback claims over its multiple sclerosis med Gilenya for years, Novartis has run off a recent string of court wins to escape the allegations...But in one New Jersey suit, Novartis will now be forced to confront a former employee's claims that he was fired without cause for bringing a kickback scheme to light...Novartis must face claims it retaliated against one of its employees for raising concerns the drugmaker engaged in a pharmacy benefit manager kickback scheme...former Novartis employee Joseph Perri alleged he was terminated after notifying management about "disparities" between the drugmaker's commercial and Medicare Part D rebates paid to a PBM for Gilenya...READ MORE

The Food and Drug Administration in the past month has stepped up seizures of prescription drugs being sent to American customers from pharmacies in Canada and other countries, according to operators of stores in Florida that facilitate the transactions...While seizures at the nation’s international mail facilities have periodically spiked during the past two decades, the latest crackdown is distressing many older customers whose goal is to stay home during the coronavirus pandemic...READ MORE

A panel of experts convened by the US National Institutes of Health has published treatment guidelines for the coronavirus disease 2019, providing clinical recommendations for a number of therapeutic options that are currently under investigation...Importantly, the guidelines emphasize that, even though there are several therapies being tested as potential treatments, no drug has been proven to be safe and effective for treating COVID-19. Investigational antiviral agents and host modifiers and immune-based therapies were included in the guidance...READ MORE

Antimalarial hydroxychloroquine has raked in support as a potential wonder drug to treat COVID-19...But small-scale studies have been less than definitive on the drug's chances—and new data haven't cleared matters up much...Department of Veterans Affairs study found that severe COVID-19 patients treated with antimalarial hydroxychloroquine alone or in combination with antibiotic azithromycin showed "no evidence" of reduced risk of death or mechanical ventilation over supportive care, according to data...The researchers noted their analysis was not randomized nor controlled and cautioned patience for several ongoing clinical studies to read out before drawing conclusions on hydroxychloroquine's use for COVID-19...READ MORE

Rite Aid continues to expand COVID-19 testing sites with eleven new locations opening Wednesday, April 22, in Delaware, Idaho, Michigan, New York, New Jersey, Ohio, Pennsylvania, and Virginia through its partnership with the U.S. Department of Health and Human Services...Now spanning eight states and 24 store locations, all of Rite Aid’s self-testing sites will be open from 9 a.m.-5 p.m. seven days a week and expect to be able to conduct approximately 200 tests each day through online appointments. In total, Rite Aid will have the capacity to conduct nearly 5,000 tests daily across all locations...READ MORE

The Board Welcomes New Members
-Helen Park
-Richard Tomasso
-Krystal Freitas
-Rolf Zakariassen

Transferring a Prescription
-NAC 639.713 Transfer of information between pharmacies: Conditions; Prohibitions
-NAC 639.714: Transfer of information between pharmacies: Procedure for oral transfers.
-NAC 639.7145: Transfer of information between pharmacies: Requirements for transfer by facsimile machine.

President Trump Signs Legislation Extending Schedule I Status for Fentanyl Analogues

Drug Overdose Deaths Related to Prescription Opioids Declined by 13% in 2018

Drug-Resistant Infections Are Increasing

NASEM Report Recommends Framework for Opioid Prescribing Guidelines for Acute Pain

New Research Shows Pharmacists Positively Impact Hospital Care Transitions

The FDA is easing its lockdown on compounded drugs to help ease COVID-19 drug shortages...After a series of high-profile failures in the early 2010s, the compounding pharmacy industry took its share of body blows from an FDA looking to impose its will...The FDA will temporarily allow hospitals to source hard-to-find drugs from compounding pharmacies to treat certain patients hospitalized with severe COVID-19...The regulation, meant to last as long as hospitals continue to encounter shortages of key drugs, applies to compounding pharmacies that aren't already sanctioned by the FDA as "outsourcing facilities." To qualify, the copycat drugs must be listed on the FDA's shortages list, and hospitals must have exhausted all other options to access a commercial version of the drug...READ MORE

The biopharma industry has struggled to recruit patients into clinical trials that adequately reflect the diverse patient populations they hope to reach with new products. Failure to improve minority subgroup participation now will cost trial sponsors later...New Research from the Tufts Center for the Study of Drug Development reveals the extent to which minority groups are absent from clinical trials supporting new drug and biologic approvals...Additional tools are emerging to help sponsors effectively recruit and enroll underrepresented patient populations in clinical trials...READ MORE