Disclosure of payments by pharmaceutical companies to healthcare professionals in the UK: analysis of the Association of the British Pharmaceutical Industry's Disclosure UK database, 2015 and 2016 cohorts.

OBJECTIVES: To analyse the section of Disclosure UK that pertains to healthcare professionals (HCPs) in order to provide insight into the database's structure and content and suggest ways to improve its transparency. DESIGN AND PARTICIPANTS: Cohort study of drug companies and HCPs in the 2015 and 2016 versions of Disclosure UK. RESULTS: Companies report transfers of value (ToVs) to named HCPs or, where an HCP declines to consent, in aggregate. Only a limited number of variables describe the recipient HCP and the ToV, precluding refined analyses. In 2015, 107 companies reported 54 910 ToVs worth £50 967 728. In 2016, 109 companies reported ToVs but spending decreased by 7.3%. The spending was concentrated: the top 10 spenders reported about 50% of the total value, with consultancy-related payments comprising over 70%, and the rest being costs for events. In 2015, 55.5% (30 478) of ToVs worth £24 428 619 (47.9%) were disclosed at the individual HCP level, increasing to 64.5% (32 407) and £28 145 091 (59.2%) in 2016. Despite increased individual-level disclosure in 2016, the median number of ToVs reported by each company at the individual level was only 57.7%, with 25% of companies reporting less than 38.6%. We found little agreement (62%-48% in 2015 and 46%-30% in 2016) between HCP consent rates that we calculated based on information in the database and those provided by companies. CONCLUSIONS: Key deficiencies in Disclosure UK include: insufficient information on payments and recipients, a relatively low HCP consent rate for individual-level disclosure, differences in consent rates across companies and payment types, and reporting ambiguities or inconsistencies. We employ these findings to develop recommendations for improving transparency, including an easily interpretable consent rate statistic that allows for comparison across years, firms and countries. If deficiencies remain unresolved, the UK should consider introducing legislation requiring mandatory disclosure to allow for adequate tracking of industry payments.

A model for a drug distribution system in remote Australia as a social determinant of health using event structure analysis.

BACKGROUND: The social determinants of health include the health systems under which people live and utilize health services. One social determinant, for which pharmacists are responsible, is designing drug distribution systems that ensure patients have safe and convenient access to medications. This is critical for settings with poor access to health care. Rural and remote Australia is one example of a setting where the pharmacy profession, schools of pharmacy, and regulatory agencies require pharmacists to assure medication access. Studies of drug distribution systems in such settings are uncommon. This study describes a model for a drug distribution system in an Aboriginal Health Service in remote Australia. The results may be useful for policy setting, pharmacy system design, health professions education, benchmarking, or quality assurance efforts for health system managers in similarly remote locations. The results also suggest that pharmacists can promote access to medications as a social determinant of health. The primary objective of this study was to propose a model for a drug procurement, storage, and distribution system in a remote region of Australia. The secondary objective was to learn the opinions and experiences of healthcare workers under the model. METHODS: Qualitative research methods were used. Semi-structured interviews were performed with a convenience sample of 11 individuals employed by an Aboriginal health service. Transcripts were analyzed using Event Structure Analysis (ESA) to develop the model. Transcripts were also analyzed to determine the opinions and experiences of health care workers. RESULTS: The model was comprised of 24 unique steps with seven distinct components: choosing a supplier; creating a list of preferred medications; budgeting and ordering; supply and shipping; receipt and storage in the clinic; prescribing process; dispensing and patient counseling. Interviewees described opportunities for quality improvement in choosing suppliers, legal issues and staffing, cold chain integrity, medication shortages and wastage, and adherence to policies. CONCLUSION: The model illustrates how pharmacists address medication access as a social determinant of health, and may be helpful for policy setting, system design, benchmarking, and quality assurance by health system designers. ESA is an effective and novel method of developing such models.

Pharmaceutical care: past, present and future.

Since the concept of Pharmaceutical Care was introduced from United States about twenty years ago, this initiative has become a dominant form of practice for thousands of pharmacists around the world. Currently, pharmaceutical care is understood as the pharmacists' compromise to obtain the maximum benefit from the pharmacological treatments of the patients, being therefore responsible of monitoring their pharmacotherapy. As the profession has moved from a product orientation (dispensing medications) to a patient focus, clinical training requirements have expanded. This is a slow but ongoing process, which started from a philosophical point of view, in order to transform the concept of Pharmacy from commodity-based, mercantile operations into a clinical profession in the community pharmacies. Since its introduction, there has been an ample debate on the definition of pharmaceutical care due to differences in Pharmacy systems and in health care structure among the different countries. Moreover, several implementation barriers exist, which are attributable to problems in education, skills, resources and environment. Indeed, an awareness of the problem resulting from the use of medicines exists and numerous studies reflect that drug use control is necessary since there is an important relationship between morbidity / mortality and pharmacotherapy. Thus, it is possible to evaluate the benefits of pharmaceutical care on patients' health and ultimately on society. Many studies have been conducted, which show that the provision of pharmaceutical care has its value in common pathologies such as diabetes, hypertension, asthma, hyperlipidemia, chronic pain, rheumatic diseases or psychiatric disorders, as well as in polymedicated patients. A large amount of data is currently being published in biomedical journals, in an effort to establish the clinical, economic and humanistic viability of pharmaceutical care. Thus, the aim of this review is to study the evolution of this practice from its beginning until nowadays. Furthermore, we have analyzed a number of implementation programs performed in countries of Europe, the United States and Latin America, focusing on clinical, economical and humanistic outcomes, and also, on the current concept of drug therapy problems (DTP) considered as failures in drug therapy. We conclude that the positive outcomes obtained with different programs of pharmaceutical care are making a beneficial change in patients' health but still more research projects should be conducted to support this change.

Structural process and implementation programs of pharmaceutical care in different countries.

Pharmaceutical care started in the nineties in the United States and has rapidly extended in many other countries. Although there are different trends, such as clinical pharmacy services, cognitive services, medication management, medication review, they all share the same philosophy and objectives, namely "the responsible provision of drug therapy for the purpose of achieving definite outcomes that improve a patient's quality of life". To attain these objectives, a pharmaceutical care process has to be followed point-by-point in order to detect possible medication-related problems. Furthermore, pharmacists have to work together with patients, and ultimately with physicians to establish a care plan. This methodology requires basic skills of documentation and communication and therefore, it is important to establish implementation programs aimed at community-, hospital-, and consultant pharmacists, and to consider PC as a basic element of University teaching programs and postgraduate studies. Moreover, there are still barriers that hinder the provision of this service and have to be overcome. In this article, we have revised the implementation process and the existing projects in many countries and we conclude that despite the enormous amount of work, there is still much to be done from sides of Administration and pharmacists themselves.

ISPOR Code of Ethics for Researchers background article--report of the ISPOR Task Force on Code of Ethics for Researchers.

In 2001, ISPOR convened a Task Force on Code of Ethics for Researchers (The Task Force). This Task Force was to build on the previous work of ISPOR Health Science Policy Task Forces and develop a code of ethics that would be applicable to all ISPOR members and to ISPOR itself. The Task Force developed a code of ethics that was subsequently adopted by the ISPOR Board of Directors. The Code of Ethics is appended to this article and can be found on ISPOR's Web page at http://www.ispor.org/workpaper/code_ethic.htm. This article provides supportive information and justification for the ISPOR Code of Ethics for Researchers and includes a discussion of the stakeholders as well as ethical considerations for the researcher on research practices, research sponsorship, research publication and dissemination, and relationships with others. It also includes a discussion of the ethical considerations for the Society.