CDC Issues Updated Guidance for Pharmacies During Pandemic
Centers for Disease Control and Prevention (CDC) has issued updated guidance for pharmacies during the coronavirus disease 2019 (COVID-19) pandemic to help minimize risk to staff and customers. The guidance, published on April 14, 2020, includes recommendations that:
- Everyone entering the pharmacy should wear a face covering, regardless of symptoms.
- Pharmacists and pharmacy technicians should always wear a face mask while they are in the pharmacy for source control.
- Pharmacies should postpone and reschedule delivery of some routine clinical preventive services, such as adult immunizations, which require face-to-face encounters.
“As a vital part of the health care system, pharmacies play an important role in providing medicines, therapeutics, vaccines, and critical health services to the public. Ensuring continuous function of pharmacies during the COVID-19 pandemic is important,” the guidance states. “During the pandemic, pharmacy staff can minimize their risk of exposure to the virus that causes COVID-19 and reduce the risk for customers by using the principles of infection prevention and control and social distancing.”
New York Launches Widespread Antibody Testing to Determine True Extent of COVID-19 Infections
Governor Andrew Cuomo of New York announced that the state will begin rolling out the “largest antibody testing ever done” to indicate whether a person has had COVID-19 in the past and was either asymptomatic or recovered. President Donald J. Trump’s recently released guidelines for states included a recommendation that hospitals have an antibody testing system in place before a state begins relaxing social distancing restrictions. However, World Health Organization (WHO) warned that there is no evidence antibody testing can show whether a person has immunity or is no longer at risk of becoming reinfected.
Additional recent developments include:
- Food and Drug Administration (FDA) issued guidance to help expand the availability of telethermographic systems used for body temperature measurements for triage use.
- Testing conducted by the National Institutes of Health’s (NIH’s) National Institute of Allergy and Infectious Diseases showed early use of experimental antiviral drug remdesivir may reduce progression of COVID-19.
- NIH launched a public-private partnership to speed COVID-19 vaccine and treatment options.
Daily updates on the spread of the virus, including a state-by-state breakdown of known infections and fatalities, are available from CDC. International information is available from WHO.
NABP continues to collect information about how boards of pharmacy are responding to COVID-19 in the Coronavirus Updates section of the NABP website. Pharmacists are also encouraged to check their state board(s) of pharmacy websites for jurisdiction-specific information. Additional resources for pharmacists and other health care providers are available from the American Pharmacists Association’s Pharmacists’ Guide to Coronavirus.
Temporary Injunction Against Organization Selling Chlorine Dioxide Products to Treat COVID-19
A federal court has entered a temporary injunction against the Genesis II Church of Health and Healing and four associated individuals to immediately stop distributing Miracle Mineral Solution (MMS), an unproven and potentially harmful treatment offered for sale to treat COVID-19. When combined with the included activator, the product has a chlorine dioxide content equivalent to industrial bleach. FDA has received reports of people experiencing serious adverse events, including respiratory failure, life-threatening low blood pressure, acute liver failure, and QT prolongation after drinking certain chlorine dioxide products.
FDA and the Federal Trade Commission (FTC) have repeatedly warned consumers not to purchase or drink chlorine dioxide products sold as medical treatments over the last decade. The injunction against Genesis comes after an April 8, 2020 warning letter to Genesis in which FDA and FTC requested a response within 48 hours that would describe specific steps being taken to correct the violations. In response, Genesis made it clear that they had no intention of taking corrective action and would continue to sell MMS in violation of the law.
“Americans expect and deserve proven medical treatments and today’s action is a forceful reminder that the FDA will use its legal authorities to quickly stop those who have proven to continuously threaten the health of the American public. It is vital that sellers of drug products comply with the FD&C Act and do not sell products with false and misleading claims, especially to treat COVID-19 and other debilitating diseases, such as autism and Alzheimer’s disease,” said FDA Commissioner Stephen M. Hahn, MD, in a press release. “Despite a previous warning, the Genesis II Church of Healing has continued to actively place consumers at risk by peddling potentially dangerous and unapproved chlorine dioxide products. We will not stand for this, and the FDA remains fully committed to taking strong enforcement action against any sellers who place unsuspecting American consumers at risk by offering their unproven products to treat serious diseases.”
FDA Encourages Recovered COVID-19 Patients to Donate Plasma
FDA is encouraging those who have recovered from COVID-19 to donate blood and plasma so that it can be used to potentially treat others with the disease. The use of antibody-rich convalescent plasma is one of many possible treatments for COVID-19 that is currently being researched, with more than 1,800 sites and 2,400 physician investigators nationwide participating in an expanded access protocol led by the Mayo Clinic.
To encourage donations, FDA has launched a new web page to guide recovered COVID-19 patients to local blood or plasma collection centers to discuss their eligibility and potentially schedule an appointment to donate. The web page also provides information for those interested in participating in the expanded access protocol, conducting clinical trials, or submitting emergency investigational new drug applications.
“During this challenging time, many people are asking what they can do to contribute to the COVID-19 response. Those individuals who have recovered from COVID-19 could have an immediate impact in helping others who are severely ill,” the agency said in an update. “In fact, one donation has the potential to help up to four patients. Convalescent plasma can also be used to manufacture a biological product called hyperimmune globulin, which can similarly be used to treat patients with COVID-19.”
Individuals who have fully recovered from COVID-19 for at least two weeks can contact their local blood or plasma collection center today to schedule an appointment.