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2 Specialties Pharmaceutical medicineInstitute for Health Research (NIHR). Many of thedisease-specific charities also provide advice andinformation for patients who are already undergoingor thinking about becoming involved in clinicaltrials.The issue of post-trial patient information is consideredto be an integral part of patient rights and has beenmentioned as part of the World Medical Association’sDeclaration of Helsinki on the Ethical Principles forMedical Research Involving Human Subjects, 5 whereparagraph 33 states:At the conclusion of the study, patients entered intothe study are entitled to be informed about the outcomeof the study and to share any benefits that resultfrom it.Despite this, patients are still not routinely kept up todate with the outcomes of trials that they have beeninvolved in. The main reason for this is that often manymonths or years have elapsed before the analysis of atrial is complete and the communication channelsbetween the investigators and patients and theirconsultants have often broken down. Clinical trialparticipants are coded and thus the responsiblepharmaceutical physician does not have access toindividual patients. At the end of the trial, the outcomesare reported to the investigators involved and it is theirresponsibility to pass this information on to theparticipants from their centre.4 Interspecialty and interdisciplinaryliaisonAlthough their contact is often limited, pharmaceuticalphysicians work with clinicians across almost the entirespectrum of medicine. They are available to talk toclinicians working in a particular field and to discuss theuse of medicines in a particular condition. Clinicaldoctors always have a route of contact with a company’smedical information department when issues aroundmedicinal products arise, and these circumstances arelikely to involve a pharmaceutical physician.Increasingly, pharmaceutical physicians are also actingas direct sources of expert information on the medicinesthat their companies provide to doctors working in theNHS. This interaction is usually initiated by theconsulting clinician and can act to greatly enhancepatient care but is currently an underusedrelationship.5 Delivering a high-quality serviceWhat is a high-quality service?Due to the diverse nature of their roles, it is difficulthere to define precisely what constitutes a high-qualityservice as delivered by pharmaceutical physicians.Beyond phase 1, the running of a safe and efficientclinical trial requires close collaboration of the trialsponsor, the hospital or clinic where the patients arelocated and the consultant or GP responsible for them,the chief investigator and other healthcare professionalssupporting the research and the ethics committeeresponsible.To ensure a safe, rigorous and well-executed trial thesponsor or chief investigator must go through severalauthorisation procedures before, during or after aclinical trial:1 The sponsor or investigators must first apply to theMHRA for clinical trial authorisation (CTA). Theythen usually register the trial for an internationalstandard randomised controlled trials number(ISRCTN) and although this is not compulsory itensures that the trial complies with the requirementsof the International Committee of Medical JournalEditors (ICMJE) – a prerequisite for publishing trialdata in most journals.2 Ethical approval for the trial must be sought by theprincipal investigator through a research ethicscommittee (REC), part of the National ResearchEthics Service (NRES).3 Once a trial is under way, safety and progressreporting must be carried out to the appropriateREC both on a periodic basis (both 6-monthlyand annually) and also whenever there is anunexpected or dangerous event, known as asuspected unexpected serious adverse reaction(SUSAR).4 When a trial is finished it must be reported to theMHRA and the relevant REC (within 90 days of itsconclusion or within 15 days of early termination)and a summary of the final report on the researchshould be sent to the main REC within 12 months ofthe end of the project.Those pharmaceutical physicians who work for theregulatory agencies have a very different remit andtherefore different definitions of a quality service.Their prime responsibility is to protect publichealth.C○ Royal College of Physicians 2013 201
Consultant physicians working with patientsMaintaining and improving the quality of carePharmaceutical physicians are predominantly employedby private companies which will have their own strictcodes of conduct, ethical principles and protocols forensuring the ongoing high quality of work carried outunder their sponsorship. These practices are furthersupported by professional codes of practice 6 andstatutes that enshrine good clinical practice (GCP) andthe safety and well-being of the patient and/or researchsubject.The majority of pharmaceutical physicians in the UKare members of the Faculty of Pharmaceutical Medicine(FPM), a Faculty of the Royal Colleges of Physicians ofthe UK. The FPM conducts pharmaceutical medicinespecialty training (PMST) which enables qualifieddoctors to obtain specialist registration inpharmaceutical medicine with the General MedicalCouncil (GMC). The overall aim of PMST is to produceaccredited pharmaceutical physicians, who areequipped with specialist knowledge and comprehensiveskills and competencies to practise to the highest ethicaland professional standards, for the benefit and safety ofpatients and the public, in the development andmaintenance of medicines. The earliest entry point intoPMST is at ST3 level.The FPM also coordinates the continuing professionaldevelopment (CPD) of its members, though it does notcurrently provide modules for CPD accreditation. TheFPM is currently developing the framework for therevalidation of pharmaceutical physicians andrecommends that all practising pharmaceuticalphysicians registered with the GMC should have aLicence to Practise and therefore make themselvesavailable for revalidation. Because of the diverse natureof pharmaceutical physicians’ roles, coupled with thefact that they work outside the NHS and that themajority of their work does not involve direct patientcontact, their revalidation process is going to be verydifferent to the majority of doctors. It is vitallyimportant that the revalidation of pharmaceuticalphysicians is carried out in a manner that is as objective,transparent and robust as possible. The FPM willcontinue to develop guidance on revalidation and towork closely with the GMC.6 Clinical work of consultantsApart from the few pharmaceutical physicians whocontinue to work part time in a wide variety of otherspecialties and general practice, the profession is notengaged in clinical work.7 Opportunities for integrated careThis does not directly apply to pharmaceuticalphysicians, but contact between nurse and pharmacistprescribers and pharmaceutical physicians will occurwhere the healthcare professional is seeking informationor advice from the sponsor of the product.8 Workforce requirements for the specialtyThe FPM has over 1,100 UK-based members, but hasestimated that there are over 1,500 pharmaceuticalphysicians currently practising in the UK. It is difficultto give a more precise figure for this, again due to thediverse and extra-NHS nature of the profession.As of October 2012 there were 177 trainees inpharmaceutical medicine with a national trainingnumber undertaking training in 60 approvedorganisations. A total of 193 physicians have nowcompleted specialty training in pharmaceuticalmedicine and can be awarded the Certificate ofCompletion of Training (CCT) with eligibility forSpecialist Registration with the GMC; two physicianshave also completed training through the Certificate ofEligibility for Specialist Registration CombinedProgramme (CESR-CP) route. There are 34 seniorspecialty advisers whose role is one of governance andquality management of the training programmes withintheir allocated sites. There are 92 trained and approvededucational supervisors (ESs) and associate educationalsupervisors (AESs) who are actively supervisingtrainees.The revised PMST curriculum, launched in August2010, is now established for newly enrolling trainees.Trainees following PMST2, as it is known, undertakeworkplace-based assessments (WPBA) and use ane-portfolio to collect evidence of competency andsupporting information to record their trainingprogression.9 Consultant work programme/specimenjob planPharmaceutical physicians can be self-employed, workfor a multinational pharmaceuticals company or a202 C○ Royal College of Physicians 2013
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AbbreviationsA&EAACsAMUsARCPCCGsCCS
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