NABP Announces Accreditation Program for Home Infusion Therapy Pharmacy
NABP is pleased to announce the addition of Home Infusion Therapy Pharmacy Accreditation. The addition of a Home Infusion Therapy Pharmacy Accreditation to the Association’s already robust offerings enables NABP to provide customers with the most comprehensive set of pharmacy accreditation options of any organization.
Read more in the full press release available on the NABP website.
FDA Releases MOU on Human Drug Compounding Regulation and Oversight
Acknowledging the vital role states play in reducing the risks associated with compounded drugs, Food and Drug Administration (FDA) has made available for public viewing a Final Standard Memorandum of Understanding (MOU) Addressing Certain Distributions of Compounded Human Drug Products, intended to be entered into between the agency and the states. The release of the MOU is required as part of its submission to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. The MOU was developed in close consultation with NABP, as described in the Federal Food, Drug, and Cosmetic Act. The agency also engaged with states, pharmacies, associations, pharmacists, and other stakeholders.
Among the issues addressed in the MOU is the definition of the statutory term “inordinate amounts,” which refers to compounded drugs that are distributed interstate. In addition, the MOU includes the risk-based oversight model from the 2018 revised draft MOU. States that sign the document agree to identify pharmacy compounders that distribute inordinate amounts (greater than 50%) of compounded drug products interstate, as well as report certain information to FDA about those compounders. FDA also provided clarity in the MOU on state investigations of complaints associated with compounded drugs distributed out of state. States that enter into the MOU will investigate complaints about drugs compounded at a pharmacy within their state and distributed outside of the state and advise FDA when they receive reports of serious adverse drug experiences or serious product quality issues, like drug contamination.
To help states to better investigate these issues, FDA has also announced an agreement with NABP to make an information sharing network available to the states. Through this network, states will be able to obtain information from pharmacies in their states and transmit that information to FDA.
“We anticipate the final MOU, once signed, will help to facilitate increased collaboration between the FDA and the states that sign it,” said Janet Woodcock, MD, Director, Center for Drug Evaluation and Research in an FDA Voices article. “Working together, we can help promote quality compounding practices and better address emerging public health concerns that may affect patients.”
First Shipments of Remdesivir Distributed to States for Treatment of COVID-19
The United States Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response has announced an allocation plan for remdesivir, a drug that has received emergency use authorization (EUA) from FDA for the treatment of coronavirus disease 2019 (COVID-19) among hospitalized patients. According to an HHS announcement, the allocation, donated by the drug’s manufacturer, will be used to treat patients in areas of the country hit hardest by the COVID-19 pandemic. State health departments will distribute the doses to appropriate hospitals in their states.
Gilead Sciences, Inc, the drug’s manufacturer, has committed to supplying approximately 607,000 vials of the experimental drug over the next six weeks to treat an estimated 78,000 hospitalized COVID-19 patients under the EUA granted by FDA. The donation to the US is part of 1.5 million vials of remdesivir the company is donating worldwide.
Preliminary results of research conducted by National Institutes of Health and Gilead suggest that remdesivir was associated with faster recovery from COVID-19, although the data was not sufficient to determine if the drug was associated with lower mortality.
Additional information on the drug is available in an FDA fact sheet for health care providers and a separate fact sheet for patients and caregivers.
CDC Study Shows Decline in Child Vaccinations Since National Emergency Declared
A new study has found that routine vaccination of children has dropped significantly in the wake of the COVID-19 pandemic. As a result, Centers for Disease Control and Prevention (CDC) is warning that other diseases may begin to spread in addition to COVID-19. The study measured vaccination coverage in Americans under age 18 and how it had changed since a national emergency was declared on March 13, 2020, and found notable decreases in orders for measles-containing vaccines. In fact, vaccines for children aged two or younger declined from more than 2,000 vaccine doses administered per week to about 1,000 by March 23. In the weeks since, vaccinations for this age group have slowly increased. For children ages two to 18, the decline in vaccinations was significantly larger, with less than 500 vaccinations per week compared to pre-pandemic vaccinations at about 2,500 per week.
The authors of the study credited the decline to parents who are concerned about possibly exposing their children to COVID-19 during visits to health care providers. Despite the pandemic, they advise providers to remind parents of the need to protect their children against vaccine-preventable diseases, even with the pandemic.
“The identified declines in routine pediatric vaccine ordering and doses administered might indicate that US children and their communities face increased risks for outbreaks of vaccine-preventable diseases,” the authors also wrote. “Assessment of state and local vaccination coverage is needed to quantify the impact among US children of all ages and prioritize areas for intervention.”
Rite Aid Adds 46 Additional COVID-19 Testing Sites
Rite Aid has significantly expanded its COVID-19 testing effort with 46 additional testing sites, most of which are operating via drive-through windows. Rite Aid has also expanded COVID-19 testing criteria at all testing sites to include adults who are not exhibiting symptoms of the virus, in accordance with CDC guidance. According to a press release, Rite Aid is now providing free testing at 71 testing sites across 12 states and has a testing capacity of approximately 10,000 per day. Hours of operation and additional information about registration and other testing requirements are available via the Rite Aid website.
Other chain pharmacies, including CVS Health and Walgreens are also providing testing to patients at multiple locations in various states. According to CDC, those who wish to be tested for COVID-19 should contact a health care provider or state health department to learn what options are available in their location.
Use of Telemedicine Accelerated by COVID-19 Pandemic, Case Study Finds
As a result of social distancing and stay-at-home measures, patients and health care providers are both using telemedicine to limit unneeded in-person interactions during the COVID-19 pandemic, according to a new case report published in the Journal of the American Informatics Association. The case study examined an expansion of virtual video visits at NYU Langone Health for all of its ambulatory care settings. The study examined the impact of the pandemic on telemedicine throughout the system using the electronic health record system Epic to capture COVID-19-related visits using relevant diagnostic codes over six weeks.
The study found that virtual urgent care visits at NYU Langone Health increased by 683% and non-urgent virtual care visits jumped by 4,345% in daily averages. Of all telemedicine visits, 56.2% of urgent care and 17.6% of non-urgent visits were COVID-19-related. Additionally, the data showed that telemedicine use was highest among patients aged 20 to 44 years old, particularly for urgent care. However, patients of all ages demonstrated use of the technology, as reported in Drug Topics.
As part of a wave of regulatory changes spurred by the pandemic, Centers for Medicare & Medicaid Services (CMS) recently directed an expansion of telehealth services, so that doctors, pharmacists, and other health care providers can deliver a wider range of care to Medicare beneficiaries in their homes. Among other provisions, CMS waived limitations on the types of clinical practitioners that can furnish Medicare telehealth services. Prior to this change, only doctors, nurse practitioners, physician assistants, and certain others could deliver telehealth services.