BAVIS_1170X120_10-19-20

Pharmacy Outlook: Ronald Piervincenzi, USP

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2020 has been especially challenging, particularly for frontline health care workers like pharmacists. COVID-19 quickly evolved from a localized disease in one part of the world to a pandemic that, according to the Johns Hopkins Coronavirus Resource Center, has infected over 63 million people worldwide and killed over 1.4 million, as of December 1. We are deeply grateful for the leadership and sacrifice of health care workers, including pharmacists, around the country and the world who are leading our response to the COVID-19 pandemic and helping ensure patients receive uninterrupted therapy to support their health.

Ronald Piervincenzi

The early months of 2020 were frantic, as the pandemic spread globally. People emptied grocery store and pharmacy shelves, not knowing what the future would hold. The grounding of commercial and cargo flights, as well as the sweeping actions by nations to close borders and restrict certain critical exports contributed to shortages of medicines and medical supplies. Researchers and the medical community scrambled to find existing treatments to help those who contracted COVID-19 and prevent others from becoming infected. In the desperation for answers, contradictory and sometimes inaccurate information began to circulate, fueling public skepticism and distrust.

While the health care system overall is highly trusted, some segments are more trusted than others. According to Gallup polls, for decades the public has ranked pharmacists as among the most trustworthy and ethical professions. Their direct, personal contact with patients means that these trusted caregivers not only deliver medicines but also shoulder the responsibility for fostering public confidence by educating consumers on the measures in place to safeguard the quality of dietary supplements, vaccines and medicines, protecting their health and safety.

Dietary supplements

As the spread of the pandemic accelerated, people around the world desperately sought ways to better support their overall health and especially strengthen their immune system. For many, this included adding or increasing the use of supplements in their diets.

A USP survey of more than 1,900 consumers in 2020, however, found that over 60% lacked confidence in the quality of U.S. dietary supplements. Nearly two out of three believe that there are differences between brands, but many are skeptical about the accuracy of the information on the label. The Dietary Supplement Health and Education Act of 1994 (DSHEA) provides a framework for the Food and Drug Administration to regulate supplements differently than prescription or over-the-counter medicines. The law puts the responsibility on supplement manufacturers to evaluate the safety and labeling of their products before marketing. This presents an opportunity for a trusted health care professional — the pharmacist — to educate consumers and provide recommendations that empower patient decision making about their overall health.

Because many people pick up dietary supplements from local pharmacies, pharmacists can have an outsized impact, informing customers about the ways dietary supplement quality is ensured and sharing their extensive knowledge on appropriate use of supplements. For example, quality standards and verification programs enable manufacturers to test and verify the quality of dietary supplement ingredients and products. Consumers can check labels for verification marks that identify products from manufacturers that have undergone an independent, third-party quality assessment and verification of their processes, ingredients and products, such as the USP Dietary Supplement Verification Program and other quality assurance programs.

The FDA has indicated its desire to modernize regulation and oversight of dietary supplements and USP applauds manufacturers who act responsibly to ensure that their products are safe and of high quality, but we cannot assume that quality is universal. At this time, consumers and pharmacists lack the analytical tools, technology, and capability to perform the complex tests needed to assure quality. Given the potential of supplements to contribute to the overall health and wellness of consumers, pharmacists are especially trusted to help guide their patients to quality products that help support their health and well-being while building the public’s trust in the quality of dietary supplements.

Vaccines

The convenience and easy access to flu vaccines at local pharmacies has undoubtedly contributed to increases in flu immunization rates in recent years. Having pharmacists administer flu vaccines during the current season is especially critical, not only to help people stay healthy but also to preserve the critical resources of our health care system to care for COVID-19 patients. Leveraging this trusted health care resource, the Department of Health and Human Services is expanding pharmacist, technician and pharmacist intern scope of practice to deliver flu immunizations and a partnership with pharmacies to administer COVID-19 vaccines, once they are available.

With any new therapy, the speed with which it is brought to market cannot come at the expense of quality and safety. Fortunately, quality standards and analytical methods — testing protocols, acceptance criteria and physical reference standards against which to compare test results — exist for many drug manufacturing processes and in some cases for active pharmaceutical ingredients, excipients and finished products. By using independently vetted, science-based standards as a frame of reference to compare their own processes and products, manufacturers can help ensure the overall quality of these novel vaccines and ­treatments.

As vaccines receive approval, more challenges lie ahead in manufacturing scale-up, distribution and storage. Plans for sourcing high-quality raw materials, injection and delivery devices, glass vials, and other materials as well as cold chain controls across the supply chain are actively being built up and strengthened. Standards for packaging, labeling, storage and other parameters will help practitioners ensure that the effectiveness and safety of a vaccine is maintained so it delivers optimal protection against infection. With the current vaccine candidates bringing logistical storage and handling conditions that may differ from traditionally widely distributed vaccines, improper storage or administration can have serious consequences for patients, notably a lack of protection.

Furthermore, a vaccine will only help curb the spread of COVID-19 if people are willing to take it. Multiple surveys have indicated that public adoption is likely to be tenuous. A poll conducted by the Associated Press-NORC Center for Public Affairs Research in mid-2020 suggested that 20% of Americans would be unwilling to receive the vaccine, while another 31% said they weren’t sure. Some of this uncertainty may stem from concern that speed to market was influenced by politics rather than science, as well as concern that the urgent need for the vaccine could mean compromised quality.

Pharmacists, as one of the most trusted health care professionals, will be looked upon to support vaccine uptake by helping patients understand the data on the vaccines, the new manufacturing technology and the steps undertaken to support quality including at the pharmacy level during the administration process, or “the last 25 feet.” Health care practitioners, including pharmacists, will be important sources of trusted information, critical to educating patients and consumers about vaccine options while increasing access to COVID-19 vaccines as they become more widely available.

Partners in trust

COVID-19 has resulted in unprecedented worldwide collaboration to confront a common public health challenge. Despite international and political tensions, scientists at public and private institutions have established partnerships during this global public health emergency directed at bringing an end to the pandemic and mitigating its debilitating effects on patients and economies worldwide.

COVID-19 vaccine develop­ment, approval, distribution and ongoing monitoring require transparent and scientifically rigorous processes to build public trust.

Achieving high vaccination rates will require the public’s trust in the coronavirus vaccines’ quality. Because of their direct interactions with consumers and the level of trust people place in them, pharmacists will be important in both distribution of the vaccine and in reassuring the public by conveying critical information about the measures in place to safeguard quality and safety. They will also face unprecedented logistical challenges in ensuring that vaccines are stored, handled and administered properly to maximize their effectiveness for the more than 328 million Americans that will need to be immunized against COVID-19.

Pharmacists are called upon once again to exert their influence, capability and knowledge to help mitigate the COVID-19 pandemic through education of patients and distribution of vaccines, and as a part of the patient care team across communities and health systems.

Ronald Piervincenzi is the chief executive officer of U.S. Pharmacopeia.


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