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ePortfolio, curriculum & decision aids

Regulation of clinical pharmacology and therapeutics (CPT) training is by the Joint Royal Colleges of Physicians Training Board (JRCPTB). This is on behalf of the three Royal Colleges of Physicians.

CPT training follows the same model of assessments as medical training. Work based assessments (WBAs) and learning events are mapped to the curriculum through the ePortfolio. Success is measured through the Annual Review of Competence Progression (ARCP) system.

Curriculum and ARCP decision aids

The CPT curriculum is split into three areas:

  • Common Competencies
  • Clinical Pharmacology Core Modules
  • Clinical Pharmacology – Advanced Specialist Modules

Common competencies are identical to those in the General Internal Medicine (GIM) curriculum.

Certificate of Completion of Training (CCT)

You must show that you have covered all core modules and at least one advanced module. You can find information on how to do this in the ARCP decision aid.

You will dual accredit with GIM, although other dual specialty training programmes are possible.

Project Based Discussions (PbDs)

PbDs reflect that the CPT workload involves less clinical time than other specialities. It assesses non-clinical elements such as:

  • projects relating to research
  • analysis
  • guideline development

Documentation for PbDs is in four main parts:

i) General
  • a. Module items covered
  • b. Description of project
ii) Reflective comments
  • a. What did you do?
  • b. What supporting documents are available (evidence)?
  • c. What have you learned from this project?
  • d. How does this project fulfil the requirements of the modules or items listed?
iii) Assessors comments
  • a. Summary of what was described and the evidence to support this
  • b. Was the evidence presented satisfactorily?
  • c. Does the project fulfil the requirements of the modules or items listed?
  • d. Key points covered in the discussion
iv) Future development
  • a. Suggestions for development
  • b. Agreed action

PbDs need more detail compared to other assessments. You should have considered suitable content before sitting down with your assessor.

We have compiled the following examples of suitable projects from existing trainees:

Clinical Pharmacology Core Module

Clinical Pharmacology – Advanced Specialist Area Modules

Assessing Clinical Pharmacology literature

Guideline development

Trainees can demonstrate competency against the curriculum through the development of clinical guidelines. For example, one trainee developed a local guideline for the assessment of ‘Blood Pressure Variability Disorders’. This project involved identifying and reviewing published literature. It required the trainee to judge which topics were most important for inclusion on the basis of prevalence and importance that the diagnosis was not delayed. The guideline underwent peer review at the hypertension MDT. It now forms part of the diagnostic framework used by trainees in a tertiary hypertension clinic.

Review articles (or MD/PhD Thesis introduction chapter)

Trainees may use peer-reviewed articles or thesis introductory chapters as evidence against the curriculum. One trainee studied the impact of intracellular pH (and the drugs that affect it) on vascular biology. This required critical analysis of literature around the topic of interest.

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Use of statistical techniques pertinent to Clinical Pharmacology

PhD project

Often trainees have demonstrated statistical skills in their PhD projects. One trainee used various statistical tests to analyse the results in their thesis: The Impact of the Blood Pressure Associated Genetic Locus at SLC4A7 on Gene Expression and Intracellular pH Regulation.

Review of adverse event clinical data from a phase I clinical trial and design of mitigation pathway for phase II study

Trainees may also have gained statistical skills through clinical trial work. For example, one trainee reviewed adverse event data from a phase I clinical trial. This involved undertaking causality assessment for each subject, using photographs, histopathology and clinical trial data. Based on this data, they developed a protocol for the phase II study. This would determine pathophysiology (for example collection of skin biopsy and specific histopathological analysis) and management of future toxicity events.

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Mechanism of drug action

Molecular research in “Intracellular pH and cardiovascular disease”

Trainees can demonstrate knowledge and understanding in this area as a PhD project. For example, one trainee studied the impact of intracellular pH (and the drugs that affect it) on vascular biology.

Involvement in specialist clinics

Trainees may gain exposure to pharmacology and prescribing through their involvement in specialist clinics. For one trainee this opened up the opportunity for a PhD in designing a new protocol for multi-drug intolerance in hypertension.

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Dosing regimens

Pharmacokinetics

Contributions to the development of educational resources can be used to demonstrate compentency against the curriculum. One trainee designed learning materials on the pharmacokinetics of medicines administration.

Review of drugs for local drugs and therapeutic committee

Trainees may gain experience in this area by sitting on committees. One individual sat on a drugs and therapeutics committee. This role required them to review applications for new additions to the hospital formulary. This included reviewing the drug and literature appropriate to its use as proposed in the application. The applications were assessed from both a safety and efficacy perspective. The proposed place in therapy, dose to and likely concomitant therapies were all considered. The trainee was then required to present the recommendation to the committee.

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Rational prescribing - individuals

Adverse event in clinical trial

Trainees are often involved in relevant clinical trials. One individuals reviewed an investigational medicinal product (IMP) to understand its pharmacokinetics and safety. This IMP targets inflammation and osteoclasts in patients already receiving methotrexate therapy. One patient in the trial had a low white cell count and neutrophil count on day three. The trainee reviewed the investigation brochure (IB) to determine if this was an anticipated risk, based on the action of the drug. They took part in discussions to decide whether the patient should continue on the trial. The patient was cleared to continue, but on day six the white cell count and neutrophils had fallen further. The patient was withdrawn from the study due to an adverse event (AE) and referred to a rheumatologist. The trainee discussed causality and contributed to the completion of trial AE paperwork.

Development of a pharmacology curriculum for undergraduate students

Trainees can develop educational resources or deliver lectures or seminars, based on the curriculum. One trainee delivered a set of lectures and seminars to undergraduate students. They covered key areas of prescription, pharmacology of common drugs, as well as common prescription errors.

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Rational prescribing - population

Review article on pharmacogenetics

Trainees can demonstrate competency by writing review articles. One trainee co-wrote a peer-reviewed review on the impact of genomics on hypertension management. They contributed to the molecular and pharmacogenomics aspects of the review.

Pharmacology Essay Prize

A trainee coordinated an undergraduate essay prize on pharmacology. This centred on prescribing on population levels, with regards to pharmaco-economics and ethics.

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Drug regulation

Participation in New Medicines Group

Trainees may present at meetings which consider the clinical and cost-effectiveness of medicines. For example, the New Medicines Group (NMG) is part of the All Wales Medicines Strategy Group (AWMSG). One trainee prepared a short presentation for the NMG, detailing the main issues around the medication of interest. This included analysis of efficacy and cost effectiveness.

Publication on the drug supply chain

Another trainee co-authored a publication on the role of the independent regulator when the drug supply chain is broken.

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Pharmacoepidemiology

Epidemiological study

Trainees sometimes contribute to relevant epidemiological studies which can demonstrate competency against the curriculum. For example, one trainee was involved in a study which reviewed prescription of gabapentinoids and their association with self-harm.

Regional Guidelines Review

Trainees also often contribute to guideline review. One trainee reviewed guidelines for the management of primary hypertension and hypercholesterolaemia.

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Adverse drug reactions

Approval for clinical trial

Trainees can assist in securing the ethical and regulatory approval for Human clinical trial. One individual analysed potential adverse drug reactions for a First-in-Human trial.

Course and exam design for prescribing

Trainees can also get involved in the Prescribing Safety Assessment and teaching. Adverse drug reactions play a large part in the assessment.

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Drug errors

​Prescription Audit

Trainees can make significant contributions to audits within their place of work. One trainee worked on an audit reviewing inpatient insulin prescription and hypoglycaemia management. This included implementing updated paperwork and re-auditing.

Allergy Documentation Audit

Another trainee contributed to an audit on the consistency of allergy documentation. The audit compared recorded information across patient notes, electronic notes and paper drug charts. It aimed to reduce potential for drug errors.

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Drug overdose

Research on toxicology placement

Individuals can demonstrate competency against the curriculum through research projects. One trainee wrote a case series on atypical presentation of overdoses whilst on toxicology placement.

Toxicology placement

Another individual undertook a week long placement in a toxicology unit. This involved assessment of toxicology patients, ward rounds and multidisciplinary team meetings. The trainee had the opportunity to review local protocols, observe National Posions Information Service (NPIS) telephone calls and take part in the weekly review of all NPIS calls. They also gained experience in writing a toxbase entry for a new drug and visted the Yellow Card centre.

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Hypertension

British Pharmacological Society Hypertension Training Day

Trainees can set up and run training courses for peers. For example, one individual ran a Hypertension Training Day for StRs. They produced a programme covering all curriculum areas. Alongside this, they organised speakers, venue and catering.

NEJM SPRINT Data Analysis Challenge

Another trainee was a participant of the SPRINT Challenge. This is a competition that involved analysis of a dataset. The data came from an article in the New England Journal of Medicine on hypertension. The trainee applied for access to SPRINT data through BioLINCC. Then they applied to the NHS Research Ethics Committee for approval. Use of the data also required the trainee to complete the Research Materials Distribution Agreement. They undertook data analysis for both the Qualifying and Challenge rounds, answering a research question and submitting a novel clinical finding.

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​Clinical toxicology

Analysis of tramadol overdose across Europe

Research projects can form a key part of demonstrating competency against the curriculum. One trainee analysed data collected by the European Drug Emergencies Network (Euro-DEN) project. This was in collaboration with the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA). They collected data from 20 emergency departments across 15 countries. The trainee analysed the pattern of presentation and outcomes of overdose that involved tramadol. This project involved database manipulation, statistical analyses and report writing.

Treatment of raised creatinine kinase in poisoning

Another individual collected data on the treatment of patients with raised creatinine kinase on admission to the local poisons unit. They analysed the data which was presented at the national Continuing Professional Development day for the National Poisons Information Service (NPIS).

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Research

Systematic review publication

Systematic review papers can be used to demonstrate relevant competencies against the curriculum. One trainee carried out a review on the association between HLA-A*31:01 and carbamazepine hypersensitivity reactions. This involved a literature review and critically appraising papers. They learned to understand odds ratios, and significance levels. Furthermore, they developed knowledge of characteristics of diagnostic tests such as sensitivity, specificity, PPV, NPV and NNT. The trainee was first author for the manuscript. They took into account peer reviewer comments and submitted for publication.

Review of eligibility criteria for an early phase clinical trial

Another trainee was involved in an early-phase clinical trial. Following enrolment of a subject into the trial, review of eligibility criteria showed there was possible interaction between simvastatin and the investigational medicinal product (IMP). Both are metabolised by CYP3A4. The trainee discussed with the medical monitor, principal investigator and chief investigator. They then reviewed the pre-clinical data to determine inhibitory concentrations. After the IC50 was calculated, the patient was dosed. A sufficient safety margin determined.

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Clinical Trials Research

Risk assessment and management strategy for a novel investigational medicinal product (IMP) in medical oncology as part of a phase III clinical trial

Trainees can demonstrate competency through participation in clinical trial risk assessment. One trainee was involved in a clinical trial on a novel investigational medicinal product (IMP) in medical oncology. Before the start of the trial the trainee completed the clinical risk assessment. This included analysing starting dose, potential safety issues and mitigation. They also looked at the appropriateness of dose escalation protocol. To complete this, the trainee used the investigator brochure and clinical trial protocol. They then presented the findings to the experimental medicines group.

Clinical study of UMOD NKCC2 interaction in hypertension

Another individual had a range of roles in a clinical study. They communicated with MHRA about non-CTIMP status of the trial. They wrote protocols, the PIL, consent forms, letters to GPs and participant invites. They drafted the application to REC and NHS R&D via IRAS and responded to REC comments and requirements. The trainee also attended the REC review meeting and updated the Pharmacovigilance officer. They worked with the Robertson Centre for Biostatistics about building the electronic case report form (eCRF). The trainee also worked with University of Dundee to create a patient website and carried out initial screening and consent. They organised the investigators meeting and purchased BP devices for the trial. Furthermore, they organised research passports for non-clinical members of the study team.

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