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.

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 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.

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.

Review of current literature on the economic burden of Clostridium difficile infection.

Clostridium difficile is well recognized as the most common infectious cause of healthcare-associated diarrhea. Since 2000, this pathogen has demonstrated an increased propensity to cause more frequent and virulent illness that is often refractory to treatment. An analysis by the Centers for Disease Control and Prevention revealed that, in the United States, the number of patients discharged from hospitals who received the International Classification of Diseases, Ninth Revision discharge diagnosis code for C. difficile infection (CDI) more than doubled from 2000 to 2003. Unpublished data indicate that this trend has continued and that more than 250,000 US hospitalizations were associated with CDI in 2005. A previously uncommon hypervirulent strain of C. difficile is thought to contribute, in part, to the dramatic increase in the incidence and severity of the infection. Although the economic impact of the disease is believed to be profound and is expected to increase, data on the costs associated with CDI are scarce. To more completely assess its economic burden, we performed a review of available literature that reported costs associated with the infection.

The determinants of the antibiotic resistance process.

BACKGROUND: The use of antibiotic drugs triggers a complex interaction involving many biological, sociological, and psychological determinants. Resistance to antibiotics is a serious worldwide problem which is increasing and has implications for morbidity, mortality, and health care both in hospitals and in the community. OBJECTIVES: To analyze current research on the determinants of antibiotic resistance and comprehensively review the main factors in the process of resistance in order to aid our understanding and assessment of this problem. METHODS: We conducted a MedLine search using the key words "determinants", "antibiotic", and "antibiotic resistance" to identify publications between 1995 and 2007 on the determinants of antibiotic resistance. Publications that did not address the determinants of antibiotic resistance were excluded. RESULTS: The process and determinants of antibiotic resistance are described, beginning with the development of antibiotics, resistance and the mechanisms of resistance, sociocultural determinants of resistance, the consequences of antibiotic resistance, and alternative measures proposed to combat antibiotic resistance. CONCLUSIONS: Analysis of the published literature identified the main determinants of antibiotic resistance as irrational use of antibiotics in humans and animal species, insufficient patient education when antibiotics are prescribed, lack of guidelines for treatment and control of infections, lack of scientific information for physicians on the rational use of antibiotics, and lack of official government policy on the rational use of antibiotics in public and private hospitals.

An economic evaluation of anticipated costs and savings of a behavior change intervention to enhance medication adherence / Evaluación económica de costes anticipados y ahorros de una intervención de cambio de actuación para mejorar la adhesión a la medicación

Medication adherence across disease states is generally poor. Research has focused on various methods to improve medication adherence, but there is little conclusive evidence regarding specific methods efficacy. The Transtheoretical Model for Behavior Change has been used to modify existing addictive behaviors but not in medication adherence specifically. As a behavioral component is inherently related to medication adherence, it is thought that this model may be applicable. Objective: The purpose of this research is to evaluate the costs and savings of implementing a novel behavioral intervention against the cost of poor medication adherence to determine whether further development is realistic. Methods: The basic tools required to administer this intervention were determined through primary literature review and priced by vendors supplying such materials. Diabetes Mellitus Type 2 (DM2) was used as a vehicle to establish the cost of care for long-term complications of a chronic disease. The primary literature provided information regarding the cost of care for DM2 morbidity and outpatient annual drug therapy expenditure. The total cost of the behavioral intervention components and the cost of care for DM2 morbidity were applied to a theoretical cohort of 1000 patients. By dividing this cost across 1000 patients, a per-patient cost was yielded and multiplied over a 16-year timeframe. Results: It was found that the cost to implement the behavioral intervention and resultant medication costs is USD13,574 per-patient over 16 years. The cost to treat complications of diabetes mellitus is USD 36,528 per patient over the 16 years. The total amount of healthcare dollars potentially saved by utilizing this intervention is USD 22,954 per-patient. Conclusions: It appears that the cost to implement this behavioral intervention is reasonable and permits further evaluation in other chronic conditions with notoriously poor adherence levels (AU)

La adhesión a la medicación es generalmente pobre en las diferentes enfermedades. La investigación se ha centrado en diferentes métodos para mejorar la adhesión a la medicación, pero hay poca evidencia concluyente en cuanto a la eficacia de estos métodos. El Modelo Trans-teórico para el cambio de actuación se ha utilizado para modificar actuaciones adictivas, pero no específicamente en la adhesión a la medicación. Como un componente actuacional está inherentemente relacionado con la adhesión a la medicación, se piensa que este modelo puede ser aplicable. Objetivo: El propósito de esta investigación es evaluar los costes y ahorros de la implantación de una intervención novedosa contra el coste de la mala adhesión a la medicación, para determinar si sería realista un desarrollo posterior. Métodos: Se determinaron las herramientas básicas para administrar esta intervención mediante una revisión de la literatura y se calculó el precio de esos materiales según sus vendedores. Se utilizó la diabetes mellitus tipo 2 como vehículo para establecer el coste del tratamiento para las complicaciones a largo plazo de una enfermedad crónica. La literatura primaria proporcionó información sobre el coste de la atención para la morbilidad de la diabetes 2 y los gastos de medicación de los pacientes ambulatorios. El coste total de los componentes de la intervención actuacional y el coste de la asistencia de la morbilidad de la diabetes 2 se aplicaron a una cohorte teórica de 1000 pacientes. Dividiendo el coste total entre los 1000 pacientes, se obtuvo un coste por paciente que se multiplicó por un periodo de 16 años. Resultados: Se vio que el coste de implantar una intervención actuacional y los costes consecuentes de medicación son de 13.574 USD por paciente durante un periodo de 16 años. El coste de tratar las complicaciones de la diabetes es de 36.528 USD por paciente durante esos 16 años.. La cantidad de dólares de sanidad potencialmente ahorrados al utilizar esta intervención es de 22.954 USD por paciente. Conclusiones: Parece que el coste de implantar esta intervención actuacional es razonable y permite una evaluación posterior en otras enfermedades crónicas con notable poca adhesión al tratamiento (AU)

A discussion paper on self-care and its implications for pharmacists.

Self-care is what people do to themselves to establish and maintain health, prevent and deal with illness. It includes nutrition, lifestyle, self-medication, hygiene, socio-economic and environmental factors. Self-care has been with us for thousands of years, but today there is an opportunity for pharmacists to assist patients with self-care. Society is better educated than ever before and now has access to accurate, understandable and objective, up-to-date information about drug therapies. Moreover, there is a general trend to take back control from physicians and other care-givers, and for patients to make decisions about their own care. Additional drugs are becoming available OTC and some information may require professional interpretation. On a parallel plane, the pharmacist is being recognized as a trustworthy source of information and advice. When these trends interact, there becomes a golden opportunity for pharmacists to demonstrate their worth to their patients. This report provides the perspectives from numerous sources as to the future role of the pharmacist in self-care.

An economic evaluation of anticipated costs and savings of a behavior change intervention to enhance medication adherence.

UNLABELLED: Medication adherence across disease states is generally poor. Research has focused on various methods to improve medication adherence, but there is little conclusive evidence regarding specific methods efficacy. The Transtheoretical Model for Behavior Change has been used to modify existing addictive behaviors but not in medication adherence specifically. As a behavioral component is inherently related to medication adherence, it is thought that this model may be applicable. OBJECTIVE: The purpose of this research is to evaluate the costs and savings of implementing a novel behavioral intervention against the cost of poor medication adherence to determine whether further development is realistic. METHODS: The basic tools required to administer this intervention were determined through primary literature review and priced by vendors supplying such materials. Diabetes Mellitus Type 2 (DM2) was used as a vehicle to establish the cost of care for long-term complications of a chronic disease. The primary literature provided information regarding the cost of care for DM2 morbidity and outpatient annual drug therapy expenditure. The total cost of the behavioral intervention components and the cost of care for DM2 morbidity were applied to a theoretical cohort of 1000 patients. By dividing this cost across 1000 patients, a per-patient cost was yielded and multiplied over a 16-year timeframe. RESULTS: It was found that the cost to implement the behavioral intervention and resultant medication costs is USD13,574 per-patient over 16 years. The cost to treat complications of diabetes mellitus is USD 36,528 per patient over the 16 years. The total amount of healthcare dollars potentially saved by utilizing this intervention is USD 22,954 per-patient. CONCLUSIONS: It appears that the cost to implement this behavioral intervention is reasonable and permits further evaluation in other chronic conditions with notoriously poor adherence levels.

Sources of information for new drugs among physicians in Thailand.

OBJECTIVE: To determine the sources and the types of information about new drugs that Thai doctors at a teaching hospital perceived as important before prescribing and to assess their views on their preferred sources of drug information. METHOD: There were two phases of this study, the quantitative and the qualitative components. For the quantitative study, a descriptive survey using a self-reported questionnaire was mailed. The qualitative component consisted of face-to-face interviews using a semi-structured questionnaire. MAIN OUTCOMES MEASURE: The initial sources of information about new drugs; the reliability scores for each source of information; the types of information that doctors required before prescribing new drugs; and the prescribers' views on their preferred sources. RESULTS: The general findings regarding the doctors' information sources on new drugs were consistent in both the quantitative and qualitative analyses. Conferences, medical journals, and meetings with medical representatives were the initial sources of information for new drugs. Safety and efficacy profiles of new drugs were the most common types of information considered before prescribing new medicines. Although the medical representatives were viewed as very efficient in providing information about new drugs, the interviewees perceived that the information obtained from the persons employed by the pharmaceutical companies was likely to be biased. Consequently, the physicians preferred to have an unbiased resource person who could proactively provide two-sided information for both existing and new drugs at the hospital. CONCLUSION: The information sources on new drugs most frequently used by the physicians include scientific conferences, journals and medical representatives and they yearn for unbiased information regarding safety and efficacy of the promoted drugs before prescribing the new medicines. Thus, there is a window of opportunity for hospital pharmacists to serve the unmet needs of the physicians.