Modifying Pharmacy Enrollments by Employment Realities.

Objective: The objective of this commentary is to consider the fluctuations in pharmacy school enrollments and to review some of the strategies employed in other health care professions, as well as to consider policies that might lead to a closer balance between admissions to PharmD programs and employment opportunities. This balance provides job stability, decreased underemployment, and greater attractiveness to study pharmacy. Discussion: Pharmacy school entry requirements have been relaxed to enroll as many students as possible due to current declining applicant numbers. As a result, there are more pharmacist graduates than there are available jobs each year. As a result, the job outlook for pharmacists may go down in the future unless action is taken. Stricter entry requirements could help produce a higher quality pharmacy workforce in the future and relieve this disparity. Summary: Pharmacy schools try to accommodate as many students as possible, which can create a job disparity between the number of available jobs and pharmacists seeking work. Suggestions can include stricter entry requirements, certificate of need programs, required fellowships and other means to balance this misalignment.

Factors that Influence Healthcare Professionals' Intentions towards Biosimilars.

Background: Physicians often prescribe original biologic products to patients who have not used them before and are reluctant to switch to biosimilars. Biosimilars are highly similar versions of already-approved biologics, but healthcare professionals typically hesitate to transition patients from the original products to biosimilars. This study aims to investigate the factors that influence U.S. healthcare professionals' intentions to use biosimilars. Methods: A cross-sectional study was conducted. 510 participants were eligible healthcare professionals (279 physicians and 231 pharmacists). The theory of planned behavior (TPB) is used to identify which factors affect healthcare professionals' intentions. Descriptive statistics, chi-square, and the logistic regression model tested the TPB constructs as predictors of intentions toward biosimilars. Results: Among 279 physicians, most were aged 61 and above, with high (n = 142) and low (n = 137) intentions. Male physicians constituted 71% of the population. Attending physicians (66.3%) showed consistent perceptions towards biosimilars, primarily in the private sector (76.3%). Pharmacists (n = 231), a higher percentage of females demonstrated higher intentions compared to males (35.5% vs. 28.1%); the majority were community pharmacists. Associations between years of practice and intentions were significant. Positive correlations existed between beliefs and intentions, except for normative beliefs. Conclusions: This study revealed diverse attitudes among healthcare professionals towards biosimilars in the USA. Pharmacists and physicians, especially those with limited experience, require ongoing education on biosimilar manufacturing pathways. This education supports the appropriate use of biosimilars and helps standardize federal and state legislation.

Narrative Review: The FDA's Perfunctory Approach of Dietary Supplement Regulations Giving Rise to Copious Reports of Adverse Events.

Background: The Food and Drug Administration (FDA) originated from the passage of the 1906 Pure Food and Drugs act aimed to rein in the long-standing abuse in the consumer product marketplace. The act was passed to prohibit interstate commerce of misbranded and adulterated foods, drinks, drugs. Thus, promoting the FDA's mission to protect the public health by regulating human and veterinary drugs, biological products, medical devices, food supply, cosmetics, and tobacco to ensure safety, efficacy, and security. Progressing further in 1994, the Dietary Supplement Health and Education Act (DSHEA) was established designating specific label requirements, providing regulatory framework, and authorizing the FDA to promulgate good manufacturing practices for dietary supplements. This act defined and classified "dietary supplements" and "dietary ingredients" as food requiring all over the counter products (OTC) products to consist of labeling that is easy to understand and meets the FDA quality, effectiveness, and safety standards. However, under the umbrella of OTC products, the FDA fell short in its regulation of the expansive dietary supplement market. The objective of this study is to discern how the lack of efficacy in the FDA's regulations of OTC dietary supplements inevitably inspired more harm than benefit. Methods: This review comprised of case studies including young adolescents and adult consumers who experienced adverse events from the use of dietary supplements. Products which showed highest prevalence in adverse event reports through the Food and Drug Administration CFSAN Adverse Event Reporting System (CAERS) included but not limited to; Vitamin E (vitamin derivative), Beta-sitosterol (plant sterol) Yohimbine, Kava Kava Kratom, Garcinia Cambogia, (herbal products) and OxyElite Pro (marketed weight loss product). The primary endpoint was evaluating the FDA's regulations on dietary supplement safety protocols. The secondary endpoint was assessing the actions of the FDA in response to these case events. Results: Overall, between 2004 to 2021, a total of 79,071 adverse events related to the use of dietary supplements were reported to the Center for Food Safety and Applied Nutrition. Vitamin E products for example, marketed for decades for their antioxidant benefits in turn have shown significant evidence of toxicity and an increased risk of bleeding outweighing its potential benefit. The FDA's response was simply implementing a label guideline update, yet this update had evidence of minimal effect as the number of cases gradually continued to increase. Likewise, herbal products such as Kava Kava, Yohimbine, Kratom, and Garcinia Cambogia, in addition to weight regulating products, such as OxyElite Pro and HydroxyCut, have been linked to organ failure, hepatic, renal, cardiac toxicity, and death respectively. The FDA merely responded through instating public consumer warnings of their effects with consumption and limited recalls of certain products. Conclusion: With the easy accessibility of these products, the general public is more inclined to its use without proper guidance and monitoring from their healthcare team, posing as a major concern for possible interactions, contraindications and unfavorable outcomes. With proper implementation of stringent regulations post findings from increased studies on efficacy and safety, cases of adverse events could have been reduced significantly or averted completely. The FDA's minimalistic efforts consisting of only post-marketing monitoring and retrospective actions of label modifying have time and time again shown flaws as seen in the growing series of reports. By emending the over-the-counter supplement review process to reflect that of prescription medication, the magnitude of adverse events can be diminished. The process should include preclinical research in addition to clinical research, FDA thorough examination of data prior approval and post marketing surveillance.

A qualitative study on female executive pharmacists with convergent roles.

BACKGROUND: Although women's participation is relatively high in the pharmacist workforce, women remain underrepresented in executive positions. The rate of executive female pharmacists in diversified pharmaceutical areas, from education and research to politics, is recognized as being disproportionately low. OBJECTIVES: In this study, we aimed to explore female executive pharmacists' roles and identify reasons for their being underrepresented in such executive positions in Turkey. METHODS: Semistructured in-depth interviews were conducted from a feminist standpoint with female executive delegates working in the Grand National Assembly of Turkey, pharmacy chambers, and public pharmacy faculties. A thematic data analysis of transcriptions was conducted using MAXQDA 2020 software and was reported according to Consolidated Criteria for Reporting Qualitative Research. RESULTS: The researchers interviewed 19 participants. Three primary themes emerged: gender roles, being an executive, and being a pharmacist. Eight roles came to the surface: mother, child, wife, pharmacist, manager, homemaker, cook, and planner. Taking the responsibility for an executive position involves a continued and simultaneous performance of all other roles as well. CONCLUSION: In this context, female pharmacists' views on gender roles in relation to motherhood, inequalities, and their dedication to their profession came to the fore. This study can be considered as a starting point for studying the underlying causes of the limited representation of female pharmacists in executive positions.

History, status, and politicization of the FDA.

The Center for Drug Evaluation and Research (CDER) performs an essential role in public health by ensuring, evaluating, and monitoring the safety and efficacy of drugs before they are sold in the US. Before approving new drug applications, CDER ensures that therapeutic benefits of both prescription and over-the-counter drugs (brand name and generic) provide more health benefits than the potential risks. First passed by Congress in 1992, the Prescription Drug User Fee Act (PDUFA) allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund new drug approvals. The law allowed the FDA to expedite drug approvals, but possibly lowered standards for safety and brought potential conflicts of interest within the FDA and pharmaceutical industry. To examine the conflicts of interest, we conducted a review using the Excerpta Medica database, US National Library of Medicine National Institutes of Health Database (PubMed), Scopus, and Google. Our search yielded Vioxx (rofecoxib) and Exondus-51 (eteplirsen) as examples of consequence when the FDA and pharmaceutical industry are too closely aligned. We further examine how the pharmaceutical industry may indirectly influence the FDA by lobbying to Congress or directly by hiring ex-FDA commissioners.

Comparison of Drug Withdrawal Processes in the U.S. and Other Nations.

Medications have been withdrawn from as early as the 1900's in several countries due to a variety of reasons. Most drugs have been withdrawn due to safety, efficacy, manufacturing issues, or the toxicities they address. While safety and efficacy of each new drug is taken into account, so is the process of drug withdrawal. Worldwide each country has its own medical agency which have different approaches on drug discovery and method of removal from the market. This removal process is simpler in several nations while more prolonged in others. Nevertheless, we still don't know an effective method of drug removal from the market and therefore that is the focus of this paper. This paper explores the drug withdrawal process in several countries due to hepatic and cardiovascular toxicities using the WITHDRAWN database. It also summarizes and compares the drug removal processes in the U.S., Australia, UK, EU, and Canada. Consequently, there was no data or evidence that supported one country more favorable or rapid than the other. However, based on the results from drug withdrawal processes, it appeared the U.S., UK, and EU were most comparable. Meanwhile, Australia appeared to have the lengthiest process.

Training Community Pharmacy Staff How to Help Manage Urgent Mental Health Crises.

Nearly 44 million Americans are affected by mental illness every year. Many individuals, however, are not diagnosed and/or do not receive treatment. The present manuscript reviews the incidence of mental illness, the continuum from mental wellness to mental illness, and the role of the pharmacy staff in helping individuals manage different mental health needs. In particular, there is discussion of stigma of mental illness that those with mental health needs experience by those around them including health professionals such as pharmacy staff. One way to resolve such stigma is through training such as Mental Health First Aid (MHFA). The paper reviews key aspects of MHFA, the evidence supporting MHFA, and how MHFA relates specifically to pharmacy practice and services. A conceptual framework for MHFA and its relationship to individual factors, attitudes, behaviors, and outcomes. Lastly, a discussion is presented that briefly compares MHFA to other similar approaches to helping those in mental health crises, the limits of what is known about MHFA, and what future research might explore to better understand the outcomes of pharmacy staff providing mental health education, support, and referral to care.

The Effect of Zero Copayments on Medication Adherence in a Community Pharmacy Setting.

BACKGROUND: Prescription medication copayments can be a financial burden to many patients. When patients cannot afford their medications, they may become nonadherent, and as a result, this can lead to an increase in chronic disease complications and healthcare costs. OBJECTIVE: The objective of this study was to determine if zero copayments have an effect on medication adherence in a community pharmacy. METHODS: This retrospective cohort study examined the prescription refill records of patients who filled specific generic medications for hypertension, hyperlipidemia, and gastroesophageal reflux disease (GERD) in 2016 at the NSU Clinic Pharmacy. The adherence rates of patients with zero copayments were compared to the adherence rates of patients with copayments greater than $0. Adherence was determined by calculating the proportion of days covered (PDC). Patients were considered adherent if their PDC was greater than or equal to 80%. RESULTS: GERD patients with no copayments had average PDC ratios of 87.4% and were statistically significantly more adherent than GERD patients with copayments, who had average PDC ratios of 76.7% (P = 0.042). Hyperlipidemia and hypertension patients with no copayments had average PDC ratios of 89.3% and 90.3%, respectively, and those with copayments had PDC ratios of 85.3% (P = 0.314) and 87.9% (P = 0.534). CONCLUSION: Overall, patients with $0 copayments had higher adherence rates than patients with copayments greater than $0. GERD patients with no copayments were significantly more adherent than GERD patients with copayments. However, no statistically significant difference was found between patients with or without copayments in the hyperlipidemia and hypertension cohorts. Further studies are recommended to analyze additional factors that may influence medication adherence.

A Review of the Pharmacist as Vaccinator.

OBJECTIVE: The aim of this study is to review literature about how the pharmacist's role as vaccination providers has been financially and clinically measured. METHODS: A broad literature search was conducted up to May 2016 to identify economic or clinical data on pharmacy vaccinations. MEDLINE® and PUBMED databases were searched for publications useful or potentially useful for this review. The NIH and CDC websites were also searched for relevant materials. Search terms included vaccination, pharmacist, economic, pharmacoeconomics, cost, benefits cost-effectiveness, physicians, immunizations, vaccinations, pharmacy vaccines, cost, physician vaccines, financial, benefit, ambulatory pharmacist vaccination, clinical pharmacist, economics, pharmacist vaccine impact. RESULTS: The search yielded a total of 68 articles of which 12 met the criteria to be included in this review. After examining articles for relevance to pharmacy vaccinations, two tables were created to highlight the clinical and economic advantages of the pharmacist as a vaccinator. CONCLUSION: Pharmacists who administer vaccines are an underutilized provider. This literature review reveals a pattern among studies measuring the pharmacist's impact on vaccination rates, patient preferences, and cost savings. Pharmacists have a history of demonstrated dependability, accuracy, and cost effectiveness. State laws, collaborative agreements, and health plans have continued to prevent patients from using the pharmacy to receive the CDC recommended vaccines. These barriers ultimately delay the Healthy People 2020 goals.

An Overview of the Orphan Medicines Market in Turkey.

BACKGROUND: The health policies of many countries and regions have already defined orphan drugs for rare diseases. Although there is no official definition of orphan drugs in Turkey, all orphan drugs are covered by reimbursement, regardless of their market authorization status. Thus, a pharmacoeconomic analysis does not have to be presented to the Social Security Institution (Sosyal Güvenlik Kurumu) for reimbursement decisions on orphan drugs. OBJECTIVE: The aim of this study was to shed light on the use of orphan drugs to aid classifications of rare diseases and assessments of orphan drugs in Turkey. METHODS: Data for sales of authorized orphan drugs and all other drugs were extracted from the IMS Turkey for 2008, 2009, and 2010. Nonauthorized orphan drug sales data were extracted from records of the Turkish Pharmacists' Association for the same years. Government prices were obtained from the Sosyal Güvenlik Kurumu. RESULTS: The European Medicines Agency has classified more than 60 orphan drugs for rare diseases. Of these, 50 entered the Turkish market in recent years, half of which were authorized. The remaining drugs were imported through the early access procedure. Antineoplastic agents accounted for the largest percentage of orphan drugs, with 58% of the total market share. In 2010, there were 18 such agents in use, at a cost of €120 million. CONCLUSIONS: Although legislation is not yet in place for orphan drugs in Turkey, recognized pricing and reimbursement policies are in operation. This situation facilitates an analysis of orphan drug prices and reimbursement policies in Turkey.

A revised estimate of the burden of illness of gout.

BACKGROUND: Gout is a chronic, inflammatory arthritis characterized by painful and debilitating acute/episodic flares. Until recently, gout has been regarded as a minor medical problem, in part because the associated economic burden has not been appreciated. Previous literature on this subject focused on the costs associated with acute episodes of gout rather than on the long-term medical and economic implications of this chronic disorder. OBJECTIVE: Our aim was to estimate the current impact of gout in the United States with respect to disability and economic costs. METHODS: THE FOLLOWING DATA SOURCES WERE USED: published data on the incremental economic burden of gout; statistics from the US Census Bureau and the US Bureau of Labor Statistics; and recent epidemiological and clinical literature concerning the course, treatment, and outcomes of the disease. Disability is expressed as days of lost productivity. Charges for gout-related treatments were used as direct cost inputs. RESULTS: Gout affects an estimated 8 million Americans, among whom those working have an average of almost 5 more absence days annually than workers without gout. On average, the incremental annual cost of care for a gout patient is estimated at >$3000 compared with a nongouty individual. Even though comorbidities common in gout patients account for a portion of this increased economic burden, the total annual cost attributable to gout patients in the United States is likely in the tens of billions of dollars and comparable to those of other major chronic disorders, such as migraine and Parkinson's disease. CONCLUSIONS: The economic burden of gout is most readily assessable in patients whose acute arthritic flares result in emergency department visits, bedridden days, and episodic loss of productivity. Chronic progression of the disease can also result in long-term impairment of function and health-related quality of life, but the contribution of chronic gout to the economic burden is more difficult to quantitate because gout is frequently associated with serious cardiovascular, metabolic, and renal comorbidities. Recent demonstration that successful gout management can reverse functional deficits in many chronic gout patients, however, supports the views that chronic gout contributes substantially to the medical and thus economic costs of these patients and that early and aggressive efforts to improve gout outcomes are likely to reduce the associated economic burden.

A fixed-dose combination of adapalene 0.1%-BPO 2.5% allows an early and sustained improvement in quality of life and patient treatment satisfaction in severe acne.

INTRODUCTION: Acne has a significant negative impact on quality of life (QoL): lack of self-confidence, depressive symptoms and suicidal thoughts. The objective was to assess the impact of an initial and continued therapy in severe acne patients through patient-related outcomes (PRO). METHODS: In two sequential double-blind randomized studies, patients received either adapalene 0.1% and benzoyl peroxide 2.5% (A-BPO) or vehicle, associated with doxycycline 100 mg for 12 weeks. Patients having obtained at least a good improvement according to investigator global assessment were re-randomized for a 24-week therapy with A-BPO or vehicle. PROs were assessed using the Acne-QoL and a patient treatment satisfaction questionnaire. RESULTS: QoL was improved at week 12 in all domains with a significant difference for the Acne-symptoms domain (p < 0.001) in favor of the A-BPO regimen. Additional 24-week A-BPO treatment showed a sustained improvement, significant (p < 0.001) for all domains except for Acne-symptoms. In the vehicle arm, QoL significantly worsened for all domains (p < 0.03). At weeks 12 and 36, a significantly higher proportion of patients receiving A-BPO vs. vehicle reported high satisfaction for five out of six treatment satisfaction items. CONCLUSIONS: The early and sustained improvement of these PROs is correlated to the fast onset of action of A-BPO, the treatment effectiveness and a good safety profile.