Christine Blank

The National Association of Boards of Pharmacy (NABP) has issued nearly 50,000 “passports”, or temporary licenses, for pharmacists and pharmacy technicians.

“Launched in response to the [coronavirus disease 2019 (COVID-19)] crisis, this new service supports member state boards of pharmacy in processing requests for temporary and emergency licensure to pharmacists and pharmacy technicians,” NABP said in an email sent to 

NABP Passport allows those seeking temporary or emergency nonresident licensure to submit state-specific requests for an NABP Passport through their NABP e-Profile. NABP then conducts the necessary license verification and disciplinary history review at no cost to the individual or the boards of pharmacy. 

Pharmacy Job Demand Could Grow Because of COVID-19

To streamline the process for applicants, multiple states can be included in each request. As a result, the number of passports issued is higher than the number of requests-which reached 6800 by the end of May.

“Pharmacists must have at least 1 existing license to apply for the Passport, and pharmacy technicians must have a license/registration or hold a certification from the Pharmacy Technician Certification Board or Exam for the Certification of Pharmacy Technicians. Interns and pharmacy businesses can also apply for a Passport if allowed by the state in which they are seeking temporary or emergency licensure,” NABP said.

Currently, 19 jurisdictions have indicated they will make use of the passport program, and 8 states have approved the service for interns. 

Pharmacy licensure testing sites, which were closed at the height of the COVID-19 pandemic, are now reopened, Lemrey “Al” Carter, PharmD, executive director and secretary of NABP, told 

“Most test centers are open and are increasing the capacity in accordance with state and federal regulations,” Carter said. In addition, in late May, 

 gave access to 61 additional select sites to take the NAPLEX and MPJE, Carter said.

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The National Association of Boards of Pharmacy (NABP) has issued nearly 50,000 “passports,” or temporary licenses, for pharmacists and pharmacy technicians.

NABP Issues Nearly 50,000 Temporary Licenses for Pharmacists, Techs

The Trump Administration’s Operation Warp Speed, formed to accelerate the development, manufacturing, and distribution of a coronavirus disease 2019 (COVID-19) vaccine, should rely on the “proven record of pharmacies and pharmacists for the rapid deployment of COVID-19 vaccines when they are available,” NACDS said in a 

“For more than a decade since the 2009 H1N1 pandemic, government planning to distribute and administer federally purchased pandemic vaccine to the American public rapidly, efficiently, and safely has included modeling that heavily draws on the strength of chain pharmacies, pharmacists, and private sector distribution channels,” NACDS President and Chief Executive Officer Steven C. Anderson, FASAE, CAE, IOM, wrote on behalf of NACDS in a 

 to the directors of Operation Warp Speed.

Among other objectives, which include the development of therapeutics and diagnostics for COVID-19, Operation Warp Speed is tasked with facilitating substantial quantities of a safe and effective COVID-19 vaccine by January 2021, according to the US Department of Health & Human Services.

Americans appreciate the opportunity to receive their vaccinations at pharmacies, NACDS noted. “With more than 60,000 community pharmacies nationwide-in which nearly 90% of all Americans live within 5 miles of a pharmacy-pharmacies stand ready to support Operation Warp Speed’s efforts to safely and efficiently bring the COVID-19 vaccine to the American public,” Anderson wrote.

NACDS COVID-19 Report: Top Reopening Priorities and How Pharmacies Can Help

In fact, around 1 in 3 adults, or 38 million, who received the influenza vaccine during the 2018-2019 season did so at their community pharmacy, according to the letter.

The organization’s letter detailed federal government studies showing that pharmacists can help vaccinate 25 million more Americans per week, and can help vaccinate 80% of the country seven weeks sooner than if neighborhood pharmacies were not engaged.

 that community pharmacies can mitigate up to 23.7 million pandemic symptomatic cases, yielding a cost savings of approximately $100 billion.

“Many community pharmacies can also deploy mobile vaccine programs that can be tailored to those in underserved, rural, or vulnerable communities,” NACDS said.

1. NACDS Urges Operation Warp Speed to Prepare Now to Accelerate COVID-19 Vaccinations through Pharmacies. News Release. NACDS; June 2, 2020. Accessed June 2, 2020. https://www.nacds.org/news/nacds-urges-operation-warp-speed-to-prepare-now-to-accelerate-covid-19-vaccinations-through-pharmacies/.
	2. Anderson SC. RE: Accelerate Distribution of COVID-19 Vaccines to Americans through Community Pharmacies. NACDS; June 1, 2020. Accessed June 2, 2020. https://www.nacds.org/pdfs/government/2020/NACDS-COVID-19-Vaccine-Operation-Warp-Speed-Letter-6-1-2020.pdf.
	3. Trump Administration Announces Framework and Leadership for ‘Operation Warp Speed’. News Release. HHS; May 15, 2020. Accessed June 2, 2020. https://www.hhs.gov/about/news/2020/05/15/trump-administration-announces-framework-and-leadership-for-operation-warp-speed.html
	4. Bartsch SM, Taitel MS, DePasse JV, et al. Epidemiologic and economic impact of pharmacies as vaccination locations during an influenza epidemic. Vaccine. November 2018. doi: 10.1016/j.vaccine.2018.09.040

Pharmacies and pharmacists can help the rapid deployment of COVID-19 vaccines when available, NACDS said. 

NACDS Urges Trump Administration to Rely on Pharmacists for COVID-19 Vaccinations

This article has been updated with additional information. 

 of the carcinogenic ingredient N-nitrosodimethylamine (NDMA) in certain extended release (ER) metformin products, the first 2 major recalls are underway. Both Apotex Corp and Amneal Pharmaceuticals have issued a voluntary recall of its metformin hydrochloride extended-release tablets, according to the FDA. 

Apotex Corp is voluntarily recalling all lots of metformin hydrochloride extended-release tablets, USP 500 mg, within expiry to retail level. 

“Apotex was notified by the US Food and Drug Administration (US FDA) that one lot of Metformin Hydrochloride Extended-Release Tablets, USP was tested and showed results for N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI) and recommended recall of the one tested lot,” Apotex said in a company announcement. 

Out of an abundance of caution, the company is extending the recall to all lots of metformin hydrochloride extended-release tablets in the United States, Apotex added. 

However, Apotex stopped selling this product in the United States in February 2019, and there remains only limited product on the market. To date, Apotex has not received any reports of adverse events related to use of that product, it said.

Amneal is voluntarily recalling all lots of metformin hydrochloride extended-release tablets, USP, 500 mg and 750 mg, within expiry to the retail levels. The affected products were distributed nationwide in the United States directly to wholesalers, distributors, retailers, and repackagers. Amneal is notifying its direct customers via mail by mailing a recall notification letter and is arranging for the return of all the recalled product. Anyone with an existing inventory of the product should quarantine the recalled lots immediately. 

 the carcinogenic ingredient NDMA in metformin products, the agency’s testing found elevated levels of NDMA in extended release (ER) metformin but not in the immediate release (IR) formulation, FDA said in a statement issued to 

FDA has contacted a total of 5 manufacturers with ER metformin above the acceptable level and “will continue to take quick and appropriate action when needed to protect American consumers,” the agency said.

The FDA said that patients should not stop taking their prescription medications without first talking to their health care providers. 

In early February, the agency posted the results of its laboratory analysis showing NDMA levels in some samples of the metformin products it tested. Overall, the levels of NDMA found in metformin ranged from “not detectable to low levels” at the time. 

According to the agency, no sample of metformin that was tested by the FDA exceeded the acceptable daily intake of NDMA.

In December, regulatory agencies outside of the United States recalled some metformin drugs due to low levels of the impurity, prompting FDA officials to test samples of metformin sold within the United States 

1. Apotex Corp. Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-release Tablets 500 mg Due to the Detection of N-nitrosodimethylamine (NDMA). Company Announcement. Apotex Corp; May 27, 2020. Accessed May 29, 2020. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/apotex-corp-issues-voluntary-nationwide-recall-metformin-hydrochloride-extended-release-tablets

2. Amneal Pharmaceuticals LLC Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, Due to Detection of N-Nitrosodimethylamine (NDMA) Impurity. Company Announcement. Amneal; May 29, 2020. Accessed June 2, 2020. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceuticals-llc-issues-voluntary-nationwide-recall-metformin-hydrochloride-extended

Apotex Corp is voluntarily recalling all lots of metformin hydrochloride extended-release tablets, USP 500 mg, within expiry to retail level.

First Big Metformin Product Recalled, More on the Way

The Centers for Medicare & Medicaid Services (CMS) is reducing insulin copays for seniors who are eligible for Medicare via an executive order from President Donald Trump.

Participating enhanced Medicare Part D plans in 2021 will provide a broad set of insulins at a maximum $35 copay for a month’s supply of each type of insulin, the White House said in a fact sheet on the new initiative.

CMS estimates that beneficiaries could save $446, or 66%, a year for their insulins, the agency said in a press release.

However, other policies to lower prices are still badly needed, according to Andrea Pivarunas, NCPA’s director of public affairs. Those policies include a pharmacy direct and indirect remuneration (DIR) fee fix, such as the one included in the Senate drug pricing bill, and efforts to reform the “warped rebate program” in Medicare Part D, Pivarunas said.

President Donald Trump announced the Medicare program as he vies for reelection. “I hope the seniors are going to remember it,” he said at a Rose Garden ceremony. He was joined by seniors, diabetes advocates, and executives from insurance and drug companies, 

“Lowering out-of-pocket insulin costs will provide the many Medicare beneficiaries who rely on 1 or more common forms of insulin with plan options that will deliver critical relief,” the White House said.

Insulin Affordability Options Expand During COVID-19

For the first time, CMS is enabling and encouraging Part D plans to offer fixed, predictable copays for beneficiaries, “rather than leaving seniors paying 25% of the drug’s cost in the coverage gap,” CMS said.

Part D sponsors that participate in the model will offer beneficiaries Part D prescription drug plans that provide supplemental benefits for a broad range of insulins, including both pen and vial dosage forms for rapid-acting, short-acting, intermediate-acting, and long-acting insulins.

Participating pharmaceutical manufacturers will continue to pay their current 70% discount in the coverage gap for their insulins that are included in the model, and based on the model’s waiver of current regulations, those manufacturer discount payments will be calculated before the application of supplemental benefits under the model, CMS said.

Average basic premiums for Medicare Part D prescription drug plans are the lowest in 7 years and have fallen by 13.5% since 2017, saving beneficiaries $1.9 billion in premium costs, the White House said.

Medicare Advantage premiums have also fallen 28% since 2017 to a 13-year low.

1. President Donald J. Trump Is Reducing the Cost Of Insulin And Improving Healthcare For Our Nation’s Seniors. Fact Sheet. White House; May 26, 2020. Accessed May 29, 2020. 

https://www.whitehouse.gov/briefings-statements/president-donald-j-trump-reducing-cost-insulin-improving-healthcare-nations-seniors/

2. President Trump Announces Lower Out of Pocket Insulin Costs for Medicare’s Seniors. News Release. CMS; May 26, 2020. Acccessed May 29, 2020. 

https://www.cms.gov/newsroom/press-releases/president-trump-announces-lower-out-pocket-insulin-costs-medicares-seniors

3. Alonso-Zaldivar R. Most Medicare enrollees could get insulin for $35 a month. 

https://apnews.com/e19266951ca46647ce0a589339aa77c1

CMS is reducing insulin copays for seniors who are eligible for Medicare via an executive order from President Donald Trump.

Author | Christine Blank

Articles

NABP Issues Nearly 50,000 Temporary Licenses for Pharmacists, Techs

NACDS Urges Trump Administration to Rely on Pharmacists for COVID-19 Vaccinations

First Big Metformin Product Recalled, More on the Way

CMS Lowers Medicare Insulin Copays