Benefits of pharmacist-led flu vaccination services in community pharmacy.

Seasonal influenza is a major cause of excess winter deaths and increased hospital admissions. There is a high level of economic burden associated with the infection. Although vaccination targets have been set to tackle this international issue, many countries struggle to reach these coverage targets for their at-risk populations using traditional delivery methods. Traditional providers include family doctors and nurses; however, pharmacist-led influenza vaccination has become a more commonly utilised aid to support vaccination targets. Community pharmacies are convenient and widely accessible and evaluations consistently demonstrate that patients are satisfied with pharmacist-led vaccinations. Allowing community pharmacists to administer influenza vaccination as an alternative option for delivery helps to increase the coverage rate of vaccination. In addition, commissioning community pharmacists to provide this service has been shown to contribute to achieving targets for those at-risk. Pharmacist-led influenza vaccination services can create value for payors and reduce pressure on health systems. This review aims to demonstrate the success of pharmacy-led influenza vaccinations, and the impact it has had in driving up immunisation rates within other countries. Experiences of countries such as England, Portugal and the United States provide evidence to demonstrate the benefit to both the patient and the health system.

Implementation of flu vaccination in community pharmacies: Understanding the barriers and enablers.

Improving influenza vaccination coverage has been, and still remains a challenge internationally. There are now many examples where countries have pursued a pharmacist-led influenza vaccination service in order to enhance vaccination coverage of at-risk populations. England, Portugal and the United States are successful examples where their experience implementing this service can now be explored retrospectively and learnt from. This review aims to provide evidence to help overcome barriers to commissioning and implementation of such services in countries new to the experience. Implementation is influenced by differing regulatory frameworks underpinning the provision of pharmacist-led influenza vaccination, methods of remuneration, training, and operating procedures. Practical aspects such as the facilities required, how patient records are maintained and how patients and other healthcare professionals are engaged also have an impact. These examples illustrate how community pharmacists can be trained to deliver influenza vaccinations safely, and coupled with their accessibility and convenience, can provide a complementary service to that already provided by family doctors and nurses to deliver influenza vaccinations for the benefit of patients.

[Fecal microbiota transplantation in recurrent Clostridium difficile infections. Framework and pharmaceutical preparation aspects]. / Le transfert de microbiote fécal lors d'infections récidivantes à Clostridium difficile. Cadre et aspects pharmacotechniques.

The fecal microbiota transplantation consists in introducing a preparation constituted by a dilution of stools of a healthy donor in the digestive tract of a patient recipient, to restore his intestinal physiological balance. This therapeutic approach was the subject of numerous studies showing its efficiency in the treatment of the recurrent infections with Clostridium difficile. The fecal microbiota transplantation has now a high level of clinical evidence, which explains that it appears in various international recommendations. In France, the fecal microbiota transplantation responds to the definition of a medication and can be executed as a pharmaceutical preparation or as an experimental drug for clinical trials under the responsibility of a hospital pharmacy. The objective of this paper is to propose a definition of a framework and to describe the methods of preparation of the fecal microbiota transplantation in the treatment of the recurrent infections with C. difficile and the interactions to consider for hospital pharmacies that do not have technical means to operate this technique.

[Why could gut microbiota become a medication?]. / Pourquoi la flore intestinale a-t-elle vocation à devenir médicament ?

The gut microbiota (or gut flora) is a set of bacteria living in symbiosis with the host. Strictly associated with the intestinal tract and interacting with it, the gut microbiota is not a tissue nor an organ, but a supra-organism. A disruption of dialogue between bacteria and human cells is a risk factor or a possible cause of various diseases. The restoration of this dialogue, thanks to the transfer of the gut microbiota of a healthy individual to a patient whose balance of gut flora has been broken, is a new therapeutic approach. If its exact effect still eludes scientific understanding, its clinical benefit is well established for an indication, and is recently being tested for many others. The proven contribution of gut microbiota in the human physiological balance calls for intensifying research throughout the world about the state of knowledge and technologies, as well as on the legal and ethical dimension of fecal microbiota transfer. This didactic paper updates the questions in relation with this therapeutic act.

[Faecal microbiota transplantation in France: what applicable law?]. / Le transfert de microbiote intestinal à finalité thérapeutique : quel droit applicable en France ?

The transplantation of gut microbiota addresses a critical gap in the treatment of recurrent severe Clostridium difficile infection, and clinical trials are ongoing throughout the world for other potential broader clinical indications. As the fecal flora inoculum has currently no legal status under European law, we consider it provisionally a sui generis biological drug rather than a human tissue transplantation, with major implications in terms of legal liability in France. The inoculum obeys a derogation to the pharmaceutical preparation rules, is processed under microbiological control, and therefore should carry a special obligation for informed consent from recipients. Failing industrializable solutions to date, this practice for the modulation of human microbiome suggests that the current legal definition of the biologic drug as well as the rules for donation and use of human-originated substances should be complemented. A new category of therapeutic products could be considered in European law, unless a rapid technological progress (the French Agency ASNM classified FMT as a drug in March 2014).

Faecal microbiota transplantation: a sui generis biological drug, not a tissue.

Responding to Smith et al. (Nature, 2014), this paper argues that for medical use, faecal microbiota transplantation (FMT) should be considered a sui generis biological drug, rather than a tissue. Smith and colleagues' thesis is based on possible undesirable economic consequences of this designation--not on its scientific and conceptual basis. The faecal transplant (including gut microbiota, metabolites, mucus, human cells, viruses, fungi, etc.) is not a tissue; it is of topographic--not cellular--human origin. We consider the donor a bioreactor, producing the faecal substrate of therapeutic interest. The debate is of singular importance as the FDA considers FMT a drug and released a new guidance for public consultation in February 2014, whereas to date the European Medicines Agency has not promulgated its position. The UK's National Institute for Heath and Care Excellence does not consider FMT to involve the transplantation of body tissue, and in March 2014 the French regulatory agency ANSM expressly declared it to be a drug. As FM is a complex and highly variable admixture, its components cannot be completely characterized, and to date, compositional quality cannot be assessed. We consider FMT to be a sui generis biologic drug, albeit one prepared with unconventional raw material under microbiologic control. The possibility of associating identified bacterial species with particular diseases and cultivating selected bacteria of therapeutic interest would certainly define a second generation of microbiome therapeutics, but is still speculative.

[Conditional pricing for innovative medicines in France: stop telling about risk-sharing!]. / Médicaments innovants et prix conditionnels : le contrat de performance, à l'opposé du partage de risques.

Across global borders and throughout the various sectors of health care, the search for viable methods to pay for value has intensified. Driven by soaring costs and constrained budgets, public and private payers are seeking innovative ways to incentivize providers and product manufacturers to focus on effective outcomes for patients according to key performance indexes. Conditional pricing and performance-based payment for innovative medicines could facilitate access to quasi-monopsonic french market, in a context of financial crisis, loss of reciprocal confidence, and growing aversion for therapeutic and economical uncertainty. However, we consider these new methods of payment should not be termed "risk-sharing agreements", a misleading term despite its common use today. They also should not impact the national list prices of medicines, that is a decisive tool for stabilizing international trade.

[Community pharmacist and vaccination: actuality and opportunity]. / Le pharmacien d'officine et la vaccination : actualité et opportunité

Improving the vaccinal policy has become a major stake in France as in many other developed countries. The neglect of vaccination strategies by citizens has complex and multiple causes. Some are directly linked with recent media controversies about vaccination and with a global lack of confidence toward producers and regulators. Other causes are directly linked with individual behaviors, professional practices and primary care organization. Community pharmacists have a good observing position of this phenomenon, as they are prepositioned on the territory, in constant contact with both outpatients and healthy people. Pharmacist's sociological and technical observations appear to be useful in designing new approaches for improving vaccinal strategies. While the 2012-2017 "vaccine policy" should emphasize the central role of general practitioners in France, these observations invite to develop innovative collaboration with pharmacists in the search of a better vaccine coverage.

[Vaccination and French community pharmacists: from innovative actions to innovative organisations?]. / La vaccination et le pharmacien d'officine en France: pour des actes innovants, vers des organisations innovantes?

The situation report of vaccination in France and a methodology of vaccination suggests that some vaccines may opportunely be injected in the pharmacy where and when the relevant vaccine is dispensed. Vaccination by pharmacist could hence mean dispensation, traced administration and documented follow-up. This perspective requires the normative framework, information systems and vocational training to be somewhat adapted, and financial incentives to be aligned. The challenges are cultural and organisational. Pharmacist's optional implication along with the prescriptor would have a major interest in terms of individual protection and cost-effectiveness of public health strategies. It would allow to release and to value medical and nursing time for the benefit of patients. Thanks to gain-sharing organizations, healthcare providers could explore dynamic cooperation.