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.

The economic burden.

Not only is chemo fog a troublesome medical problem for the sufferers, but in addition it is the source of nearly $300 million in direct and indirect expense in the United States alone each year. And since it often persists for extended periods of time, the indirect costs, which stem mainly from lost productivity, continue to accumulate with another nearly $250 million added to the overall cost each year. This is not the highest economic burden for common diseases, but it is a significant amount that could be mostly avoided if biomedical scientists were to find a means to employ safer chemotherapeutic agents.

Safeguarding against substandard/counterfeit drugs: mitigating a macroeconomic pandemic.

BACKGROUND: Counterfeiting and the sale of substandard pharmaceutical products can no longer be ignored. At 10% of global trade, counterfeiting is affecting many countries, causing serious downstream expenses and resource shortages. OBJECTIVE: To describe the nature and impact of drug product counterfeiting and substandard product sale and to present strategies that may have value in ameliorating these phenomena. METHODS: A literature review was conducted, supplemented by interviews of key leaders/experts in the field and the search of relevant web sites. All of the data were combined, integrated, and coordinated to present the complete picture of this problem. RESULTS: In addition to known corruption in some of the least developed countries, the trail through developed countries was detected. This report identifies means to detect faulty products and describes efforts toward resisting and ending these corrupt practices. CONCLUSIONS: Counterfeit drugs, if not stopped, can be responsible for a macroeconomic pandemic where major portions of some populations may be too ill to work and where the health sector resources are completely overwhelmed, as with the case of HIV/AIDS.

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.

Comparative drug effects: the case of GERD therapies.

The results of clinical trials and approved Food and Drug Administration Drug Applications inform decision makers that a drug was effective in its labeled indications without causing unacceptable side effects. But purchasers for large medical organizations and members of health insurer or managed care organizations need relative effectiveness data to enable them to select the product from among the four, six, or ten competing alternative drug products available in that family. Retrospective studies are capable of providing this data after about a year of use by utilizing a database containing a large number of patients. An alternative means of determining this was explored using a new technique from a nationwide patient satisfaction study. Using GERD as an example, the authors were able to determine differences in patient satisfaction between proton pump inhibitors (PPIs), H(2) antagonists, and antacids, and even within the PPI category, down to individual products. The piloted method is rapid and inexpensive and can be an alternative for clinicians developing disease management protocols for specific conditions.

Drug delivery systems improve pharmaceutical profile and facilitate medication adherence.

Innovations in dosage forms and dose delivery systems across a wide range of medications offer substantial clinical advantages, including reduced dosing frequency and improved patient adherence; minimized fluctuation of drug concentrations and maintenance of blood levels within a desired range; localized drug delivery; and the potential for reduced adverse effects and increased safety. The advent of new large-molecule drugs for previously untreatable or only partially treatable diseases is stimulating the development of suitable delivery systems for these agents. Although advanced formulations may be more expensive than conventional dosage forms, they often have a more favorable pharmacologic profile and can be cost-effective. Inclusion of these dosage forms on drug formulary lists may help patients remain on therapy and reduce the economic and social burden of care.

A literature review of the epidemiology and treatment of acute gout.

BACKGROUND: Gout is the most common cause of inflammatory arthritis in men aged >40 years and is frequently encountered in clinical practice. OBJECTIVE: The goal of this article was to review the published literature on the epidemiology, treatment, and estimated burden of illness of acute gout. METHODS: Articles on gout published in English between 1980 and June 2002 were identified through a MEDLINE search. Relevant clinical studies and review articles were found using the text- and keyword-search term gout alone and in combination with epidemiology, prevalence, incidence, complications, outcome, quality of life, economics, cost, prevention or drug therapy. The reference lists of identified articles, especially review articles, were checked for any additional studies that might have been missed in the original MEDLINE search. RESULTS: The epidemiology of gout in various geographic regions has been well documented. Data suggest that environmental, racial, and hereditary factors may influence the development of gout, and that the prevalence of gout appears to be on the rise worldwide. Evidence from well-designed clinical studies evaluating drug therapies for gout is limited. Therapies for acute gout include corticotropin, corticosteroids, colchicine or, more often, nonsteroidal anti-inflammatory drugs (NSAIDs), which have shown comparable efficacy. A recent study suggests that etoricoxib, a new cyclooxygenase-2-selective inhibitor, may be as effective as and better tolerated than traditional NSAIDs in the treatment of gout. Urate-lowering therapy, prophylactic colchicine, and low-dose NSAIDs are used for the long-term prophylaxis of gout. However, all acute and prophylactic therapies are associated with adverse events. Using an economic model for gout, the annual direct burden of illness for new cases of acute gout can be estimated at 27,378,494 US dollars in the United States. CONCLUSIONS: Gout is an increasingly prevalent condition worldwide and creates a heavy economic burden. Available treatments are generally effective; however, they are not devoid of adverse events. Well-designed, long-term, controlled clinical trials evaluating the comparative efficacy and tolerability of treatments for gout are needed.

Combination strategies for pain management.

At least two factors relating to pain management using oral analgesics suggest that combination strategies merit consideration: many pains arise from more than one physiological cause and current analgesics have adverse effect profiles that might be reduced by combination with another agent in smaller doses or with less frequent dosing. In addition to increased convenience, combinations sometimes also result in the unexpected benefit of synergy. But not all pains, clinical settings or combinations merit the extra expense or other potential negative features of fixed-ratio products. This review examines the multiple basic science, clinical and pharmacoeconomic issues relating to analgesic combinations and the methodologies available for assessing these issues.

Pharmaceuticals and worker productivity loss: a critical review of the literature.

Many chronic illnesses that affect the working population can cause losses in productivity. The extent to which these productivity losses can be reduced by pharmacological treatment is of particular interest to employers, who bear the productivity costs and subsidize the cost of employees' health care. In the past several years, the effects of pharmaceuticals on productivity losses have been tested in numerous studies, including randomized, double-blind, placebo-controlled trials. In this article, we summarize and critically review these studies and, where appropriate, provide quantitative overviews. The evidence is very good for about a dozen drug classes that pharmaceuticals reduce productivity losses caused by respiratory illnesses (ie, asthma, allergic disorders, bronchitis, upper respiratory infections, and influenza) diabetes, depression, dysmenorrhea, and migraine. We also discuss the calculation of productivity costs, reductions in which may partially or completely offset the costs of treatment. This information should be helpful to occupational physicians who are increasingly providing recommendations on employer benefit plan designs and pharmaceutical benefits.

Successful public/private donation programs: a review of the Diflucan Partnership Program in South Africa.

A review of the partnership between Pfizer Inc. and the South African Ministry of Health to distribute free Diflucan (fluconazole) in the Diflucan Partnership Program (DPP) demonstrates that product donations may be a useful response to AIDS if they are coupled with efforts to build means of drug distribution and enhance professional healthcare capacity to treat patients. Equally important is the creation of a new set of productive working relationships between stakeholders who came to the project with different backgrounds and perspectives, as well as a frankly disparate set of objectives. A decision tree illustrates how these relationships were built into the DPP. This review concludes with a few lessons learned in providing medicines not only to South Africa, but also to the 77 other African countries now participating in the DPP. As the search for new treatments and vaccines continues, increasing access to existing medicines through targeted donations--including training and infrastructure support--is the most practical way for the health community to address the problem of ill health among the poor. In addition to a detailed analysis of the DPP, there is also a discussion of the benefits of a donation program that addresses the AIDS crises on a global scale. This review may serve as a blueprint for establishing programs that are successful in fighting AIDS and improving the lives of millions of people.

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 new perspective on the pharmacoeconomics of colchicine.

BACKGROUND: Gout is a common inflammatory arthritis that affects ∼4% of the US population. Most patients with gout are >50 years of age and have multiple comorbidities. Gout is caused by the deposition of monosodium urate crystals in joints secondary to hyperuricemia. Gout typically presents as an acute painful inflammation (flare) involving one or more joint. Left untreated it can progress into a more chronic polyarthritis. Acute gout flare treatment options include colchicine, non-steroidal anti-inflammatory drugs (NSAIDs), and corticosteroids. The safety and efficacy of colchicine, especially in the presence of comorbidity and potential contraindications, has only recently been systematically investigated. METHODS: Through the use of a systematic computer-based literature analysis, this pharmacoeconomic review evaluated costs, risks, and benefits of Colcrys (colchicine) compared with other treatments for gout in the US. RESULTS: Both colchicine and NSAIDs are historically associated with gastrointestinal (GI) adverse events (AEs). Colchicine has very low risk for AEs, even in patients with GI disorders; whereas, NSAIDS are contraindicated in patients with GI disorders, renal insufficiency, and heart failure. The monthly cost of treating 100 patients with Colcrys was $33,100 compared with $3000 for NSAIDs. However, hospitalization for GI complications (1.8%) and heart failure (1.9%) is common with NSAIDs and can increase the monthly cost of treating 100 patients with NSAIDs to $161,000, considering $15,000-20,000 per day of hospitalization. CONCLUSIONS: Considering high costs associated with treating patients with gout, it seems prudent to choose the treatment with greatest benefit, lowest cost, and least risk. Despite higher cost per dose, colchicine appears to be more cost effective for management of gout flares than NSAIDs.