Category:

The American Federation of Teachers successfully lobbied the Centers for Disease Control and Prevention to change its guidance on school reopenings, emails show...As the CDC was preparing to issue guidance that it was safe to reopen schools fully in February, emails obtained through a Freedom of Information Act request revealed that the AFT was behind the scenes, lobbying the agency and the Biden administration to adjust the guidance to make it friendlier to school closures and hybrid learning...The CDC was preparing to update its guidance to reflect its belief that schools could fully reopen, regardless of community spread of COVID-19...READ MORE

The FDA released a warning to health care providers concerning an update on potential drug reactions for remdesivir, an antiviral drug that is being evaluated as a potential treatment for the novel coronavirus disease 2019 and has also been granted emergency use authorization status for treating hospitalized patients with severe COVID-19...The FDA is also revising their fact sheet for health care providers to include the warning that co-administration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate may result in less effective antiviral activity of remdesivir. The revised fact sheet also clarifies dosing and administration recommendations, and will provide additional safety data and updates from clinical trials from the National Institutes of Health and Gilead Sciences, Inc, the company that sponsors the drug and has donated 607,000 vials of remdesivir to the United States government...READ MORE

The Food and Drug Administration and Federal Trade Commission have drawn a line on anticompetitive practices in the complex biosimilar market...The agencies have announced their intent to enforce false or misleading claims about biosimilars and their reference products. They also plan to educate consumers and doctors about biosimilars…the FDA...released a draft guidance this week, advising the industry how to properly label and promote biosimilars and reference products...The guidance focuses on how biologic and biosimilar labels and promotions should reference the other product. The agency is particularly intent on ensuring that biologic makers don’t suggest their product is safer, more effective or clinically different than its biosimilar...READ MORE

The Food and Drug Administration...issued a reminder to drug manufacturers that data integrity remains high on the regulator's agenda of Good Manufacturing Practice-related concerns, publishing new guidance aimed at helping drugmakers meet its standards...The document, which updates a 2016 version, lays out a series of questions and answers for drugmakers explaining how companies can ensure manufacturing data sets are complete, consistent and accurate. While a technical concern, the FDA makes clear that data errors carry real risk to patient health...Guidance isn't the only lever the FDA can pull to help companies comply. In recent years, the agency has flagged data integrity issues in numerous warning letters following inspections and pre-approval assessments.

Coronavirus vaccine developers now have some advice from the FDA: To win approval, any vaccine must be at least 50% effective in preventing the disease...FDA Commissioner Stephen Hahn plans to roll out that guidance...It sets a bar about on par with a flu shot's performance in a good year—but it falls short of some expert recommendations for arresting the virus' spread...The agency also won’t approve a shot based on its ability to create antibodies in patients’ blood...Despite the urgency of this particular vaccine hunt, the FDA “will not reduce its standards or cut corners in its review to approve a vaccine,”...READ MORE

The two-month casino shutdown in Nevada seems to have an end in sight...On Friday afternoon, Gov. Steve Sisolak gave Nevada casinos a tentative date they could plan to reopen: June 4. Seventy-eight days after casinos first closed down to help stem the spread of COVID-19...The move comes as the state has faced an increasing amount of pressure to reopen; Nevada’s unemployment rate hit record highs in April, and casinos in 12 other states had opened their doors ahead of those in Sin City...Virginia Valentine, president and CEO of the Nevada Resort Association, said Sisolak’s announcement is “fantastic news” for Nevada’s gaming industry...“Our members have spent more than two months preparing for this day,” she said in an emailed statement. “They’ve put in place enhanced health and safety plans and protocols … Our members are excited to show off the enhancements they’ve made that preserve the experience while ensuring the well-being of our employees and visitors.”...Casinos have been preparing for this day for weeks, publishing updated health and safety guidelines and setting tentative booking dates online to make sure they’d have guests ready to fill rooms...READ MORE

‘We’re ready to go back’
Tourists ready to return
All eyes on the Gaming Control Board

...In too many cases, branded drugs that are no longer protected by patents or other exclusivities do not face expected competition. In fact, there are several hundred of such branded drugs that do not have any generic competition. Instances like these may keep prices high and ultimately hurt American patients...We’ve been taking new policy steps at the FDA to support downward pressure on drug prices by helping to clear a path for more efficient generic development...We’re working to reduce barriers to generic development and to lower the cost of generic entry so that more of the generic medicines that the FDA approves are launched and reach patients...

- issue draft guidance with recommendations on establishing active ingredient sameness.

- development of new analytical tools and in vitro tests to provide additional accurate, sensitive and reproducible tools to support approval of complex generic drugs.

- laying out new, efficient guidelines for the use of a novel pathway that provides incentives for developing generic versions of drugs that currently face little or no competition - Competitive Generic Therapies

FDA published guidance on June 19, 2020 detailing the agency’s recommendations for current good manufacturing practices (CGMP) requirements for addressing COVID-19 infection in employees engaging in drug manufacturing. The guidance was issued to help mitigate and prevent effects on drug safety and quality by employees confirmed to be either infected with COVID-19 or potentially exposed to someone with 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.

READ MORE

Board Members
Leo Basch, PharmD, RPh, Las Vegas
Robert Sullivan, Reno
Jason Penrod, PharmD, RPh, Reno
Kevin Desmond, RPh, Reno
Wayne Mitchell, PharmD, RPh, Carson City
Melissa Shake, PharmD, RPh, Las Vegas
Jade Jacobo, PharmD, JD, RPh, Las Vegas

Retirement of the Executive Secretary
- Larry L. Pinson, PharmD, RPh

New Reno Office -
985 Damonte Ranch Parkway, Suite 206, Reno, NV 89521.

Board Member Update

Nevada Medicaid Initiates Antibiotics Prior Authorization Criteria - Nevada Department of Health and Human Services

National Pharmacy Compliance News

Final Guidance Documents Address FDA Policies Related to DSCSA

First FDA-Approved Drug Containing Extract From Cannabis Plant to Be Placed in Schedule V

ASHP Guidelines Provide Recommendations for Preventing Patient Harm From Medication Errors

FDA’s Final Guidance Documents Address Compounding and Repackaging of Radiopharmaceuticals

Pharmacy Toolkit Encourages Conversations With Patients About Prescription Opioids

Biosimilars Added to FIP’s Policy on Pharmacists’ Right to Substitute a Medication

FDA Offers CE Course on Reducing Hypoglycemic Events in Patients With Type 2 Diabetes - Leveraging Health Literacy and Patient Preferences to Reduce Hypoglycemic Events in Patients with Type 2 Diabetes