Federal Pharmacy Research Articles

Cold chain experts look to future during latest ASHP forum.

ASHP’s third Executive Forum on Cold Chain Management convened virtually March 28 to share strategies for anticipating and responding to drug product integrity and supply challenges in an evolving marketplace. The meeting was the third in a series of events that brought together cold chain experts and pharmacy leaders to share ideas on optimizing the handling, storage, and transportation of medications. Forum attendees represented health systems, specialty pharmacies, wholesalers, distributors, pharmaceutical manufacturers, federal pharmacy, and other stakeholders. The March 28 session was moderated by Jason Chou, system vice president of pharmacy operations for Ochsner Health in New Orleans, LA. The main discussion topics were: In an opening poll, 76% of forum participants indicated they felt somewhat prepared for future cold chain requirements, and 6% said they were very prepared. Amanda Frick, senior clinical manager of Vizient’s Center for Pharmacy Practice Excellence, opened the forum with an overview of anticipated storage requirements for drug products that are expected to enter the market in the near future. Frick said the developmental pipeline includes a growing share of vaccines and other products that will require cold storage and transit.

Surveillance of COVID-19 Vaccination in Nursing Homes, United States, December 2020-July 2021.

Monitoring COVID-19 vaccination coverage among nursing home residents and staff is important to ensure high coverage rates and guide patient-safety policies. With the termination of the federal Pharmacy Partnership for Long-Term Care Program, another source of facility-based vaccination data is needed. We compared numbers of COVID-19 vaccinations administered to nursing home residents and staff reported by pharmacies participating in the temporary federal Pharmacy Partnership for Long-Term Care Program with the numbers of COVID-19 vaccinations reported by nursing homes participating in new COVID-19 vaccination modules of the Centers for Disease Control and Prevention's National Healthcare Safety Network (NHSN). Pearson correlation coefficients comparing the number vaccinated between the 2 approaches were 0.89, 0.96, and 0.97 for residents and 0.74, 0.90, and 0.90 for staff, in the weeks ending January 3, 10, and 17, 2021, respectively. Based on subsequent NHSN reporting, vaccination coverage with ≥1 vaccine dose reached 73.7% for residents and 47.6% for staff the week ending January 31 and increased incrementally through July 2021. Continued monitoring of COVID-19 vaccination coverage is important as new nursing home residents are admitted, new staff are hired, and additional doses of vaccine are recommended.

The [underutilized] power of independent pharmacies to promote public health in rural communities: A call to action

Independent community pharmacies are in a unique and powerful position to promote public and individual health in their communities. Independent pharmacies are particularly important in rural communities where there are few chain pharmacies and accessible health clinics. West Virginia received national attention recently when they opted out of the Federal Pharmacy Program collaborating with CVS and Walgreens and developed their own plan for COVID-19 vaccine distribution and administration, heavily relying on independent pharmacies and the infrastructure they already have in local communities. However, in other areas of public health with urgent, unmet need, such as pregnancy prevention, there is considerable room for independent pharmacies to improve. The pandemic has allowed independent pharmacies to shine during the vaccination effort and has demonstrated what can be accomplished when policymakers, providers, and pharmacists work together for the benefit of community health. Expanding such collaboration to include contraceptive provision and counseling in a timely, nonjudgmental manner could play a pivotal role in preventing unintended and unwanted pregnancies.

Disparities in COVID-19 Vaccination Coverage Among Health Care Personnel Working in Long-Term Care Facilities, by Job Category, National Healthcare Safety Network - United States, March 2021.

Residents of long-term care facilities (LTCFs) and health care personnel (HCP) working in these facilities are at high risk for COVID-19-associated mortality. As of March 2021, deaths among LTCF residents and HCP have accounted for almost one third (approximately 182,000) of COVID-19-associated deaths in the United States (1). Accordingly, LTCF residents and HCP were prioritized for early receipt of COVID-19 vaccination and were targeted for on-site vaccination through the federal Pharmacy Partnership for Long-Term Care Program (2). In December 2020, CDC's National Healthcare Safety Network (NHSN) launched COVID-19 vaccination modules, which allow U.S. LTCFs to voluntarily submit weekly facility-level COVID-19 vaccination data.* CDC analyzed data submitted during March 1-April 4, 2021, to describe COVID-19 vaccination coverage among a convenience sample of HCP working in LTCFs, by job category, and compare HCP vaccination coverage rates with social vulnerability metrics of the surrounding community using zip code tabulation area (zip code area) estimates. Through April 4, 2021, a total of 300 LTCFs nationwide, representing approximately 1.8% of LTCFs enrolled in NHSN, reported that 22,825 (56.8%) of 40,212 HCP completed COVID-19 vaccination.† Vaccination coverage was highest among physicians and advanced practice providers (75.1%) and lowest among nurses (56.7%) and aides (45.6%). Among aides (including certified nursing assistants, nurse aides, medication aides, and medication assistants), coverage was lower in facilities located in zip code areas with higher social vulnerability (social and structural factors associated with adverse health outcomes), corresponding to vaccination disparities present in the wider community (3). Additional efforts are needed to improve LTCF immunization policies and practices, build confidence in COVID-19 vaccines, and promote COVID-19 vaccination. CDC and partners have prepared education and training resources to help educate HCP and promote COVID-19 vaccination coverage among LTCF staff members.§.

Pharmacists in Action

Pharmacists in Action

COVID-19 Vaccine: Updates and Role of Pharmacists

The 2019 novel coronavirus (SARS-COV-2 or 2019-nCoV) and coronavirus disease-2019 (COVID-19) pandemic is a global health crisis. As of December 31, 2020, there are over 83.5 million cases and 1.8 million deaths globally(1) and 2.2 million cases and 25,300 deaths in California.(2) The addition of a vaccine to prevent COVID-19 is an essential addition to the public health and safety toolkit alongside recommendations for physical distancing, hand hygiene, masks and face coverings, testing, tracing, quarantining or isolation, and therapeutics. There are currently two vaccines that have received emergency use authorization (EUA) in the United States to prevent COVID-19: the Pfizer-BioNTech mRNA COVID-19(3) and Moderna mRNA COVID-19 vaccines.(4) In the first 3 weeks since its authorization, the U.S. has distributed over 12.4 million and 2.7 million first doses had been administered.(5)The Pfizer-BioNTech (BNT162b2) vaccine, authorized on December 11, 2020, was reviewed and authorized or recommended by the US Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC)(6), and the Western States Scientific Safety Review Workgroup(7) for the prevention of COVID-19 in individuals 16 years and older. The Phase 3 trial for the BNT162b2 included 43,548 participants from the US, Argentina, Brazil, and South Africa.(8) BNT162b2 was found to be 95% effective in preventing COVID-19 with similar vaccine efficacy observed across subgroups defined by age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions. The incidence of serious adverse events was low and the safety profile was characterized by local and systemic reactions. Following two reports of anaphylaxis in the United Kingdom, the CDC identified six cases after 272,001 doses were administered in the U.S. and continues to monitor through its surveillance programs.(9) See Table 1 for summary of vaccine characteristics, inducing information on dosing, storage, preparation, and administration.The Moderna (mRNA-1273) vaccine, authorized on December 18, 2020, was reviewed and authorized or recommended by the FDA, CDC(10), and the Western States Scientific Safety Review Workgroup(11) for the prevention of COVID-19 in individuals 18 years and older. The Phase 3 trial for the mRNA-1273 included 30,420 participants from the US.(12) The interim efficacy analysis of BNT162b2 demonstrated vaccine efficacy of 94.5% in preventing symptomatic COVID-19 with similar vaccine efficacy observed across subgroups defined by age, sex, race, ethnicity, and occupational risk factors. The incidence of serious adverse events was low and the safety profile was characterized by local and systemic reactions. See Table 1 for summary of vaccine characteristics, inducing information on dosing, storage, preparation, and administration.See Table 2 for list of clinical resources for both vaccines, including FDA fact sheets, CDC recommendations, and manufacturer resources.Vaccine distribution and allocation is largely being overseen at the federal level with subsequent delegated responsibility to the state, local, and provider level. Both the CDC(13,14,15) and the California Department of Public Health (CDPH)(16) have established guidelines for the phased distribution of COVID-19 vaccine to prioritized groups. The CDC and CDPH have identified populations for Phase 1A, 1B, and 1C while the remaining phases are still to be determined. See Table 3 for the list of phases and tiers of prioritized and sub-prioritized groups.The current phase and tier of allocation may vary on the local level. Generally, most California counties are currently in Phase 1A, tier 1 or 2.Pharmacists are playing a major role in the implementation and distribution of the COVID-19 vaccine. Pharmacists can order and administer the COVID-19 vaccine and intern pharmacists and pharmacy technicians can administer the COVID-19 vaccine.(17,18,19) Pharmacies can receive vaccine allocation through three methods: participation in the Federal Pharmacy Partnership for Long-Term Care (LTC) Program(20,21), participation in Federal Retail Pharmacy Partnership(22,23), or invitation from the local health department (LHD). For more information about provider enrollment through the local jurisdictions, visit the COVIDReadi Platform(24) and contact your LHD.(25)The current status of each program may vary on the local level. Generally, the federal LTC program has been activated and the federal retail and invitations to pharmacies from LHD have not yet been activated in California.The distribution and allocation of the COVID-19 vaccine are still in its initial stages. Ass vaccine supply increases, the remainder of the plans will be activated and pharmacies, pharmacists, pharmacy technicians, and intern pharmacists will play a crucial role in ensuring quick and equitable access to nearly 40 million Californians across all 58 counties.

Arcabouço legal para implantação e execução dos serviços farmacêuticos relacionados à farmácia clínica

The clinical pharmacist's activities are crucial to the process of patient care. The implementation and execution of these activities must be guided by technical criteria and legal regulations. Therefore, this study aims to identify and compile legal norms which supports the implementation of pharmaceutical care services. National legal norms were addressed to the following topics: sanitary control of medicines and pharmaceutical supplies; patient safety; rational drug use; quality of health services; pharmaceutical care; health information technology; users rights, duties and access to pharmaceutical care and inspection practice of pharmaceutical activities. Then, legal regulations with relevant information for the pharmacist's clinical performance were selected and a list of legal references was created. Eleven federal laws were found, ten ordinances from the Ministry of Health, ten resolutions from the Federal Pharmacy Council (CFF), seven resolutions from the National Health Surveillance Agency (ANVISA) and one from the World Health Organization (WHO). Finally, from this study it was possible to elaborate a compilation of regulations that subsidize pharmaceutical care performance.

SELF-MEDICATION IN BRAZIL'S PUBLIC HEALTH: THE IMPORTANCE OF PHARMACEUTICAL PERFORMANCE IN THE MULTIPROFESSIONAL TEAM AND AS AN ADVISOR IN THE RATIONAL USE OF MEDICATIONS

Self-medication is one of the main public health problems that has been growing in Brazil and in the world in recent years. Thus, the present study aims to verify and evaluate self-medication in public health in Brazil, its risk factors and the role of the pharmacist in the multidisciplinary team as an advisor in the rational use of medications. A bibliographic review was carried out using SciELO and Google Scholar databases with the intention of collecting data on the numbers of registered cases and deaths. According to the reviewed literature, self-medication in Brazil is linked to several factors. Among them, it can be highlighted the excessive advertising and easy access to medications in pharmacies. Moreover, the analysis pointed out that 77% of the population adhere to this practice; males represent about 40% of the cases. The indiscriminate use of these drugs and their associations can cause several adverse effects and intoxications that can lead the patient to death. According to the National Toxic-Pharmacological Information System (SINITOX) (SINITOX- Sistema Nacional de Informacoes Toxico-Farmacologicas), only in 2017, about 27.11% of the registered intoxications were caused by medications, with 20,637 cases e 50 deaths. One way of controlling self-medication is the humanization of health services, especially in the public network. Therefore, The Federal Pharmacy Council (Conselho Federal de Farmacia- CFF) implemented the Resolution 586 on August 29 th , 2013, a guideline about the prescription of over-the-counter medications. In this context, the pharmacist has great relevance as an advisor and health agent. This professional collaborates for the rational use of medicines and the reduction of self-medication cases. Finally, pharmaceutical assistance projects intended to guide the correct use of medicines would be of paramount importance to the population, thus reducing public health problems, mainly related to self-medication.

Reexamining the Academic Partnerships with Federal Pharmacy: 2018-19 Argus Commission Report

The Argus Commission examined the history and current status of progressive pharmacy patient care services across several federal branches of government, including the Veterans Administration, Department of Defense, and the U.S. Public Health Service where officers and civilian pharmacists practice in the Indian Health Service, Bureau of Prisons, Area Health Education Centers and other locations. The engagement of pharmacy faculty, students and residents in these practices was assessed. Colleges and schools of pharmacy advocate for the expansion of the capacity for placement of learners in these progressive practices. AACP is encouraged to establish on going collaborations with federal pharmacy leaders to create new opportunities for partnerships that advance patient care, especially for special populations served in these federal programs.

The Role and Experience of Sudan in Assisting To Develop and Implement National Drug Policies

The strategy of price liberalisation and privatisation had been implemented in Sudan over the last decade, and has had a positive result on government deficit. The investment law approved recently has good statements and rules on the above strategy in particular to pharmacy regulations. Under the pressure of the new privatisation policy, the government introduced radical changes in the pharmacy regulations. The 2001 Pharmacy and Poisons Act and its provisions established the Federal Pharmacy and Poison Board (FPPB). All the authorities of the implementation of Pharmacy and Poisons Act were given to this board. This article provides an overview of the impact of the pharmaceutical regulations on the quality of medicines on the Sudanese market from the perspective of the pharmacists working with drug importing companies. The information necessary to conduct the evaluation was collected from 30 pharmacists who are the owners or shareholders in medicines’ importing companies. The participants were selected randomly. 89% of respondents considered the medicines on the Sudanese market are generally of good quality. The design of the research itself may be considered inadequate with regard to selection process. However, the authors believe it provides enough evidence, and the current pharmaceutical regulations have some loopholes. The Pharmacy, Poisons, Cosmetics and Medical Devices Act-2001 and its regulation should be enforced. The overall set-up including the Act itself needs to be revised. The emerging crisis in pharmacy human resources requires significant additional effort to gather knowledge and dependable data that can inform reasonable, effective, and coordinated responses from government, industry, and professional associations. Furthermore research should be carried out to understand the scope, magnitude directions of the migratory flows, within and outside the country, as well as the characteristics and skills of the emigrated pharmacists.

A steadfast bond between APhA and federal pharmacy: Serving with distinction

A steadfast bond between APhA and federal pharmacy: Serving with distinction

In honor of those who served: The history of APhA and Federal pharmacy

In honor of those who served: The history of APhA and Federal pharmacy

Pharmaceuticals in Sudan: Developments in Regulation and Governance

The strategy of price liberalisation and privatisation had been implemented in Sudan over the last decade, and has had a positive result on government deficit. The investment law approved recently has good statements and rules on the above strategy in particular to pharmacy regulations. Under the pressure of the new privatisation policy, the government introduced radical changes in the pharmacy regulations. The 2001 Pharmacy and Poisons Act and its provisions established the Federal Pharmacy and Poison Board (FPPB). All the authorities of the implementation of Pharmacy and Poisons Act were given to this board. This article provides an overview of the impact of the pharmaceutical regulations on the quality of medicines on the Sudanese market from the perspective of the pharmacists working with drug importing companies. The information necessary to conduct the evaluation was collected from 30 pharmacists who are the owners or shareholders in medicines’ importing companies. The participants were selected randomly. 89% of respondents considered the medicines on the Sudanese market are generally of good quality. The design of the research itself may be considered inadequate with regard to selection process. However, the authors believe it provides enough evidence, and the current pharmaceutical regulations have some loopholes. The Pharmacy, Poisons, Cosmetics and Medical Devices Act-2001 and its regulation should be enforced. The overall set-up including the Act itself needs to be revised. The emerging crisis in pharmacy human resources requires significant additional effort to gather knowledge and dependable data that can inform reasonable, effective, and coordinated responses from government, industry, and professional associations. Furthermore research should be carried out to understand the scope, magnitude directions of the migratory flows, within and outside the country, as well as the characteristics and skills of the emigrated pharmacists.

Pharmacists in Action: Ohio lawmaker visits medication management program; Joint Federal Pharmacy Seminar; compounding

Pharmacists in Action: Ohio lawmaker visits medication management program; Joint Federal Pharmacy Seminar; compounding

News You Can Use: Surgeon General on addiction; first cases of Candida auris; CMS’s enhanced MTM model; federal pharmacy community at JFPS; DEA take-back day

News You Can Use: Surgeon General on addiction; first cases of Candida auris; CMS’s enhanced MTM model; federal pharmacy community at JFPS; DEA take-back day

Pharmacists in Action: Joint Federal Pharmacy Seminar; A minute with …; APhA members in motion; APhA2017

Pharmacists in Action: Joint Federal Pharmacy Seminar; A minute with …; APhA members in motion; APhA2017

Pharmacists in Action: A minute with …; Joint Federal Pharmacy Seminar; free publications from APhA; nuclear pharmacists

Pharmacists in Action: A minute with …; Joint Federal Pharmacy Seminar; free publications from APhA; nuclear pharmacists

ARMAZENAMENTO DE MEDICAMENTOS EM UNIDADES BÁSICAS DE SAÚDE DE MACAÍBA, RN, BRASIL

<p>Este estudo avaliou o armazenamento de medicamentos em 22 unidades básicas de saúde do município de Macaíba, Estado do Rio Grande do Norte, no período de janeiro a março de 2012. Para isto, foi realizada verificação in loco da infraestrutura e observação da rotina do serviço destas unidades, além de aplicação de Roteiro de Inspeção, com base na RDC nº 44/09, o que proporcionou subsídios para contextualização do papel do farmacêutico frente à assistência farmacêutica no local.<br />Para identificação e análise dos medicamentos com prazo de validade expirado, foram utilizadas a Relação Nacional de Medicamentos Essenciais e a Relação Municipal de Medicamentos Essenciais do município. Nenhuma das farmácias destas unidades apresentava responsável técnico farmacêutico, manual sobre armazenamento de medicamentos, controle de umidade e temperatura. Em todas as farmácias havia medicamentos com prazo de validade expirado, abrangendo 1395 unidades mínimas não fracionadas, pertencendo a 31 classes farmacológicas diferentes e abrangendo 34 especialidades<br />farmacêuticas. Os resultados revelam a precariedade em que se encontram estas unidades e, consequentemente, de suas respectivas farmácias, o que pressupõe a necessidade de atuação mais intensa por parte de gestores, vigilância sanitária e Conselhos Regional e Federal de Farmácia.</p>

APhA2016; Advanced Preceptor Training; APhA member spotlight; BPS specialty certification

APhA2016; Advanced Preceptor Training; APhA member spotlight; BPS specialty certification

Technicians move up the ranks in federal pharmacy

Giving pharmacy technicians more responsibility has been a growingtrend for some time. As pharmacists provide more clinical care, techniciansare stepping in to fill some of the tasks that might not necessarilyrequire a pharmacist's skills.