Endocrine disruptors: a new scientific role for clinical pharmacologists? Impact on human health, wildlife, and the environment.

It is important for the clinical pharmacologist to understand the potential human health implications of exposure to environmental chemicals that may act as hormonally active agents. It is necessary to have an understanding of how pharmaceutical and personal care products and other chemicals affect the ecosystem of planet Earth and to understand how they may negatively contribute to human disease. Clinical pharmacologists must understand the various definitions of endocrine disruptors and be able to "decipher" these terms for their patients. Understanding the need for the EPA endocrine disruptor screening program and possessing knowledge of the screening assays used to assess endocrine activity potential are two essential components relevant to the topic of endocrine disruptors. Clinical pharmacologists have an opportunity to play an important role in resolving the question of what role endocrine disruptors play in initiating human disease since some scientists argue that the present evidence is not compelling. Clinical pharmacologists can also play an important role in the evaluation of the risk assessment and use of risk management and risk communication tools required to address public health concerns related to actions of endocrine disruptors. It is important that clinical pharmacologists work with veterinary clinical pharmacologists, toxicologists, industrial chemists, regulators, the scientific community, the general public, and environmental groups to understand the impact of endocrine disruptors on human health, wildlife, and the environment with an ultimate goal to minimize and/or alleviate the unwanted, detrimental effects of the endocrine disruptors.     

Clinical Pharmacology in Denmark in 2016 – 40 Years with the Danish Society of Clinical Pharmacology and 20 Years as a Medical Speciality

The Danish Society of Clinical Pharmacology was founded in 1976, and mainly thanks to the persistent efforts of the society, clinical pharmacology became an independent medical speciality in Denmark in 1996. Since then, clinical pharmacology has gone from strength to strength. In the Danish healthcare system, clinical pharmacology has established itself as an indispensible part of the efforts to promote the rational, safe and economic use of drugs. Clinical pharmacologists are active in drug committees both in hospitals and in the primary sector. All clinical pharmacology centres offer a local medicines information service. Some centres have established an adverse drug effect manager function. Only one centre offers a therapeutic drug monitoring service. Clinical pharmacologists are responsible for the toxicological advice at the Danish Poison Information Centre at Bispebjerg University Hospital in the Capital Region. The Department of Clinical Pharmacology at Aarhus University Hospital works closely together with forensic toxicologists and pathologists, covering issues regarding illicit substances, forensic pharmacology, post‐mortem toxicology, expert testimony and research. Therapeutic geriatric and psychiatric teach‐inns for specialist and junior doctors are among the newest initiatives organized by clinical pharmacologists. Clinical pharmacologists work also in the Danish Medicines Agency and in the Danish pharmaceutical industry, and the latter has in particular a great growth potential for creating new jobs and career opportunities for clinical pharmacologists. As of July 2016, the Danish Society of Clinical Pharmacology has 175 members, and 70 of these are specialists in clinical pharmacology corresponding to approximately 2.5 specialists per 1000 doctors (Denmark has in total 28,000 doctors) or approximately 12 specialists per one million inhabitants.     

The roles of clinical pharmacologists in UK universities

Clinical pharmacologists in universities play major roles in research and teaching and provide important contributions to National Health Service (NHS) activities, such as work for research ethics, drug and therapeutics, and clinical governance committees. Their research extends from preclinical studies using drugs to understand physiology and the mechanisms of disease to large-scale clinical trials and population studies. This work is truly translational, with a focus on drugs and medicines and an emphasis on efficacy and safety. The lack of an organ base has allowed clinical pharmacologists to follow their interests wherever they lead, but their visibility has been hampered by successive earlier versions of the General Medical Council's Tomorrow's Doctors document, which undermined some of the necessary scientific underpinning of medical practice and reduced the time clinical pharmacologists had to interact with medical students and recently qualified doctors at the point of choosing their careers. Additional problems have arisen from the stifling effect of the European Union Clinical Trials Directive, and its UK interpretation, on clinical research. For future success, clinical pharmacologists need to embrace translational research, use recent changes to Tomorrow's Doctors, linked to the creation of safe prescribing skills, to spend more face-to-face time with their students, fight for a simplification and proportionate regulation of research, and persuade doctors, health service planners and the government of the importance of clinical pharmacology for UK clinical research, the NHS, patient safety and creation of health and wealth.     

Factors influencing the implementation of clinical pharmacy services for hospitalized patients: A mixed-methods systematic review

BackgroundDespite the evidence of benefits, clinical pharmacy services (CPS) are not uniformly implemented across healthcare institutions. Understanding the influencing factors and identifying the domains in which they act is the first step to a successful implementation.ObjectiveTo identify the factors that affect the implementation of CPS for inpatients and to categorize them.MethodsCochrane Library, Embase, CINAHL, IPA, Medline/PubMed, and Lilacs databases were researched up until January 2018. The search strategy was developed using text words or MESH terms related to the following four domains: “clinical pharmacy,” “influencing factors,” “implementation,” and “hospital.” Two reviewers selected original research articles that reported the factors influencing the implementation of CPS in hospitals, extracted data, and assessed the quality of the studies. After framework synthesis and categorization of the factors, a diagrammatic approach was used to present the results.ResultsFifty-three factors were identified in the 21 studies that were included in this review. The most cited influencing factors were uniformly distributed across the following four domains: Attitudinal, POlitical, TEChnical and Administrative (APOTECA domains). However, in terms of level (pharmacist, healthcare team, patient, institution, and national organization), the “pharmacist” group had the highest concentration of factors. “Clinical skills and knowledge” was the most frequently cited implementation factor, followed by “time to implement CPS.”ConclusionOur findings showed the multifactorial nature of CPS implementation process. We suggest that factors from all four APOTECA domains need to be fully considered and strategies need to be addressed for all five groups of interest to successfully implement CPS in hospitals. Future studies on the influence of implementation stages, interrelationships of implementing factors, and strategies to overcome barriers could accelerate the successful adoption of these services.RegistrationPROSPERO register CRD42016050140.     

Clinical pharmacologist wanted--where?

Many people could define with ease the job of a cardiologist, a paediatrician or an obstetrician. However, only a few would have any clear idea of how a clinical pharmacologist might fill a day. Indeed, within the medical profession, and often within the scientific community, there has been a sneaking suspicion that clinical pharmacologists are themselves unsure of their remit. This article describes the possible role for clinical pharmacologists and different areas where they can make significant contributions to medical services.     

The role of the clinical pharmacologist in the management of adverse drug reactions.

The classical definition of clinical pharmacology is the study or the knowledge of the effects of drugs in humans. The activities of a clinical pharmacologist can vary from country to country, usually ranging from involvement in clinical trials, especially fundamental pharmacodynamic studies, to studies of pharmacokinetics and drug metabolism, to pharmacogenetics. Most clinical pharmacologists outside industry are in hospitals or university hospitals and research centres. In addition to research, this implies teaching of clinical pharmacology, and interacting with other medical staff: in the field of research, giving advice on clinical trials methodology and often managing a therapeutic drug monitoring centre. Some clinical pharmacologists have clinical departments with beds or consulting offices. Can there be another role for the clinical pharmacologist that would increase his or her usefulness for the medical community? Adverse drug reactions (ADRs) are remarkably complex events, related to drug effects, patient characteristics (background diseases, genetics), and drug/disease interactions. Evaluation of ADRs requires understanding of drug mechanisms and interactions, and of disease diagnostics, especially in the discussion of alternative diagnoses. This implies expertise as a pharmacologist and a clinician. In addition, because not all adverse reactions or interactions are in the Summary of Product Characteristics, and because problems arise long before they report in the literature, it is necessary for the clinical pharmacologist to have knowledge of ongoing regulatory processes, in addition to having access to the published literature. Helping clinicians cope with individual patient problems will also improve the clinical pharmacologist's integration into the healthcare process.     

Using economic evaluations to reduce the burden of asthma and chronic obstructive pulmonary disease

There is increasing interest in the use of economic evaluations in healthcare, because of the need to maximise health benefits from limited resources. The focus of most economic evaluations is on efficiency, though they may also consider the issue of equity. In an economic evaluation, it is important to consider all the relevant costs, not just the acquisition cost of the treatment. Likewise, it is important to include all the benefits in the economic appraisal, although the outcomes of relevance to decision-makers may differ according to their perspective. If an intervention costs less but delivers fewer benefits than the comparator or, more commonly, a new intervention increases benefits compared with standard therapy but at increased cost, decision-makers must consider whether the extra cost is worth the extra benefit. This depends on the opportunity cost of introducing the new intervention - i.e. the benefit forgone by doing less of something else to fund it. In other words, decision-makers need to decide on the maximum amount they are willing to pay for an additional unit of health benefit. The result of an economic evaluation will be strongly influenced by the information used in the analysis. Currently, clinical trials are the most common source of data for economic evaluations. Yet there are a number of limitations in the information generated by clinical trials, which are primarily designed for regulatory approval. Consequently, decision analytical models are being increasingly used to synthesise data from various sources and to manage uncertainty in input parameters. When using economic evaluations, decision-makers may be unwilling to take a broad perspective on costs, focusing instead on their narrow budgetary concerns. Incentives may be required within healthcare systems to ensure that decision-makers adhere more strictly to the results of formal analysis.     

Pharmacoeconomic considerations of treating patients with advanced Parkinson's disease

Introduction: Parkinson's disease (PD) is one of the most common neurodegenerative diseases. In the later (advanced) stages of PD, the initial treatment of early PD becomes less effective and long-term side effects of dopaminergic treatment become apparent. In advanced PD, motor and non-motor complications occur, which increase treatment costs. Increasing disability and impaired activities of daily living concomitantly raise indirect costs, due to loss in productivity. Hence, the economic burden of advanced PD is substantial for both the society and the patients with their caregivers.

Areas covered: A systematic literature search was performed involving the databases NHS CRD (National Health Service Centre for Reviews and Dissemination) and PubMed until July 15, 2011. “Parkinson” [Mesh] and “cost” were used as search terms in PubMed and only “Parkinson” in the CRD database.

Expert opinion: Economic evaluations are scarce and heterogeneous, and their interpretation may be limited due to methodological shortcomings. Dopamine agonists, COMT and MAO-B inhibitors as well levodopa infusion and deep brain stimulation are reported to be cost-effective in the respective decision frameworks. However, these results are heavily dependent on assumptions of drug costs and effect sizes used in the models. More detailed real-life information from long-term clinical trials is needed to feed the economic models, especially for head-to-head comparisons. To date, no economic evaluation has been undertaken for possible neuroprotective/disease modifying effects, and further research is needed for evaluations of interventions for non-motor symptoms.     

Increasing engagement in pharmacology and pharmacogenetics education using games and online resources: The PharmacoloGenius mobile app

Mobile applications represent useful instruments to convey information and engage the users even during traveling, thanks to the wide diffusion of smartphones, tablets, smartwatches, and similar devices. As such, they have high potential as learning tools that can act complementary to traditional teaching approaches. In the field of pharmacology, mobile applications are increasingly being used to improve adherence of patients or to help them report suspect adverse drug reactions. However, they have been scarcely applied to pharmacology education. In this article, we present PharmacoloGenius, a free Android mobile application integrating resources useful for students as well as healthcare professionals or researchers to expand knowledge on pharmacological topics. We gave particular emphasis to pharmacogenetics, as it is a fundamental tool to achieve personalized treatment. The application offers original games such as pharmacological trivia based on textbooks or special “journal club” trivia based on research articles conveying the state of the art on specific topics. Additionally, the app offers a curated list of online resources to study pharmacology and pharmacogenetics (e.g., free online courses, videos, and databases) as well as updated news on conferences, grants, and opportunities for pharmacologists. In conclusion, PharmacoloGenius aims to be a useful instrument for people interested in expanding their knowledge on pharmacology in an engaging way.     

Developing and delivering clinical pharmacology in the UK National Health Service

Clinical pharmacologists are active in the delivery of general and specialist medical services across the UK. They also make major contributions, both locally and nationally, to medicines management and appraisal in the National Health Service. Most are also heavily involved in the organization and delivery of teaching and training of a range of healthcare professionals, both undergraduates and postgraduates. In the past, these contributions may not have been fully recognized, perhaps in part because the discipline is small. However, the British Pharmacological Society, particularly through its Clinical Section, is committed to initiatives to ensure that all clinical pharmacologists (whatever their background, training or subsequent working environment) can work together to improve patient care, nationally and internationally. Effective engagement with universities, the National Health Service and pharmaceutical companies will be vital if these initiatives are to have sustained benefits and improve health outcomes for patients.     

Exploring the challenges for clinical pharmacists in Sudan

Background Clinical pharmacy practice in hospitals is a new role for pharmacists in Sudan. Pharmacists have to face the challenge of moving from their traditional roles within the pharmacy premises to new roles on the wards with direct contact with patients and other healthcare professionals. Objectives To explore the role and challenges facing the clinical pharmacists of Sudan. Settings Two of the main government hospitals in Sudan and an online survey. Method This study applied a two phase mixed method, a focus group discussion and a survey. A FGD was conducted with the clinical pharmacists in two of the main government hospitals in Sudan. This was followed by an on-line survey among the clinical pharmacists of Sudan. Main outcome measure The role of the clinical pharmacists of Sudan and the challenges facing clinical pharmacy practice. Results Four pharmacists participated in the focus group and 51 out of 140 pharmacists (34%) completed the on-line survey. The roles that were perceived by the majority of pharmacists as part of their duties in hospitals in Sudan were identifying drug-related problems (100%, n = 51), providing drug-related information to healthcare professionals by (96%, n = 47), and educating patients about their medicines (96%, n = 48). The pharmacists identified a number of obstacles that hindered their progress in practice. These obstacles were related to the pharmacists themselves, the lack of senior clinical pharmacists for leadership, the environment they were working in and the training they had received in clinical pharmacy. Conclusion The new clinical pharmacists in Sudan faced several challenges that need to be overcome in order to move forward in their clinical practice. To do so they will require support from pharmacy educational institutions, other healthcare professionals and the healthcare institutions they are working within.     

Examining the association between the “My Pharmacist” model and the service quality of community pharmacies

BackgroundIn Japan, patients can freely choose medical facilities. Many visit different medical facilities for different diseases, and for convenience, often utilize the pharmacies neighboring these facilities. Accordingly, a “My Pharmacy” model was recommended, in which patients select a single pharmacy using their own judgement to receive proper medication services. A “My Pharmacist” model, in which the pharmacist is constantly involved in the treatment of a patient, was also proposed. However, patients’ evaluations of pharmacist/pharmacy services under these models have not been investigated.ObjectiveTo examine how a patient's constant involvement with the same pharmacist and pharmacy is associated with their evaluation of the quality of pharmacy services.MethodsA cross-sectional survey using a self-administered questionnaire was conducted among patients who used pharmacies periodically. Patients evaluated the pharmacist/pharmacy services and were classified into 4 groups (“My Pharmacy/My Pharmacist,” “My Pharmacy/Multiple Pharmacists,” “Multiple Pharmacies/My Pharmacist,” and “Multiple Pharmacies/Multiple Pharmacists”) according to the form of their usage of pharmacies and pharmacists. An intergroup comparison was then performed and correlations within each group analyzed.ResultsData from 3,492 individuals using 147 pharmacies were analyzed. “My Pharmacy” users had significantly higher scores than did “Multiple Pharmacies” users on patient experience of proper medication services (e.g., identifying duplicate medication) (p < 0.001). “My Pharmacy/My Pharmacist” users scored higher than the other three groups on four evaluation factors, including “pharmacy/pharmacist's interpersonal services” (“sharing and utilizing patient information,” “enhanced health support function,” and “consideration towards patients”), “patient satisfaction with the pharmacy,” “placing more emphasis on quality of interaction with pharmacist than on waiting time,” and “attitude when visiting healthcare facilities” (all p < 0.001).ConclusionThe findings indicate that highly tailored, in-person services provided by “My Pharmacists” are associated with not only with the degree of patients’ overall satisfaction, but also their evaluation of “the quality of pharmacist services.”     

Clinical pharmacology confounders in older adults

Major advances produced by healthcare research have resulted in an increasing number of drugs that may be used to modify disease expression and improve quality of life. These discoveries have been used by clinical pharmacologists as a basis to identify new drug candidates and to develop strategies for their optimal delivery to maximize benefit while simultaneously minimizing adverse events. Unfortunately, many of these studies do not include sufficient older persons in whom most of these drug therapy interventions are likely to apply. This article examines selected physiological, pathological and healthcare interventional changes with age that impact clinical drug studies and the decision to use drugs as therapy in older adults. Clinical examples are provided that illustrate confounders to the accomplishment of an ideal outcome, the improved quality of life that remains for this population.     

Analysis sans frontières: can we ever make economic evaluations generalisable across jurisdictions?

Over the last decade or so, a number of healthcare systems have used economic evaluations as a formal input into decisions about the coverage or reimbursement of new healthcare interventions. This change in the policy landscape has placed some important demands on the design and characteristics of economic evaluation and these are increasingly evident in studies being presented to decision makers. One challenge has been to make studies specific to the context in which the decision is being taken. This is because of the inevitable geographical variation in many of the parameters within an analysis. There has been a series of important contributions to the published literature in recent years on how to quantify geographical heterogeneity within economic analyses based on randomised controlled trials. However, there are good reasons for economic evaluation for decision making to be undertaken using methods of evidence synthesis and decision analytical modelling, but issues of geographical variation still need to be handled appropriately. The key requirements of economic evaluations for decision making within healthcare systems can be defined as follows: (i) a design that meets the objectives and constraints of the healthcare system; (ii) coherent and complete specification of the decision problem; (iii) inclusion of all relevant evidence; and (iv) recognition and appropriate handling of uncertainty. In satisfying these requirements, it is important to be aware of variation between jurisdictions, and this imposes some important analytical requirements on economic studies. While many agencies have produced guidelines on preferred methods for healthcare economic evaluation, these exhibit considerable variation. Some of this variation can be justified by genuine differences between systems in clinical practice, objectives and constraints, while some of the variation relates to differences of opinion about appropriate analysis given methodological uncertainty. However, some of the variation in guidance is difficult to justify and is inconsistent with the aims and objectives of the systems the analyses are seeking to inform. Decision makers and analysts need to work together to streamline and where possible harmonise guidelines on methods for economic evaluations, whilst recognising legitimate variation in the needs of different healthcare systems. Otherwise, there is the risk that scarce resources will be wasted in producing country-specific analyses in situations where these are not justified. Expected value of information analyses are also emerging as a tool that could be considered by decision makers to guide their policy on the acceptance or non-acceptance of data from other jurisdictions.     

The cost of adverse drug reactions

In addition to their impact on human health, adverse drug reactions (ADRs) also have significant impact on healthcare costs. These costs are essentially hospital costs, in particular arising from an increase in length of stay caused by an ADR. Although it has been estimated that the occurrence of an ADR during hospitalisation or leading to hospitalisation is responsible for a cost of ～ € 2800, several studies have also pointed out that the structure of ADR cost is heterogeneous, a factor which must be taken into account when developing preventive strategies. ADR cost evaluation remains difficult from a methodological point of view given that most studies have only evaluated the direct cost. Because of the substantial annual estimated cost of ADRs in industrialised countries, it is necessary to implement preventive programmes, with different strategies consisting of: educational programmes; identifying risk groups; implementing good drug practice; and clinical and laboratory monitoring for ADRs. Promoting pharmacoeconomic studies and co-operation between clinicians, medical pharmacologists and pharmacists remains the key factor for preventing ADRs and decreasing their costs.     

Challenges to the economic evaluation of new biotechnological interventions in healthcare.

The next century is likely to bring unforeseen genetic and biotechnological discoveries, with new benefits, risks and costs. This paper explores some of the problem areas that healthcare biotechnologies are likely to encounter. Biotechnological interventions may present particular difficulties when they promise a major breakthrough in therapy, since economic evaluation early in the development of such technologies is inherently uncertain. Given the structure of the biotechnology industry, the perception of the high cost of new products and unknown uncertainties, governments may need to be proactive to ensure that meaningful clinical and economic data are generated in the product research phase and to manage the introduction and diffusion stages with further evaluation and surveillance. Progress usually comes at a price: both governments and the industry should prepare for this rather than offering bland reassurances about safety.     

Ensuring rigour and trustworthiness of qualitative research in clinical pharmacy

The use of qualitative research methodology is well established for data generation within healthcare research generally and clinical pharmacy research specifically. In the past, qualitative research methodology has been criticized for lacking rigour, transparency, justification of data collection and analysis methods being used, and hence the integrity of findings. Demonstrating rigour in qualitative studies is essential so that the research findings have the “integrity” to make an impact on practice, policy or both. Unlike other healthcare disciplines, the issue of “quality” of qualitative research has not been discussed much in the clinical pharmacy discipline. The aim of this paper is to highlight the importance of rigour in qualitative research, present different philosophical standpoints on the issue of quality in qualitative research and to discuss briefly strategies to ensure rigour in qualitative research. Finally, a mini review of recent research is presented to illustrate the strategies reported by clinical pharmacy researchers to ensure rigour in their qualitative research studies.