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Pharmacy Law, Ethics and Practice

  • Module code: PY5020
  • Year: 2018/9
  • Level: 5
  • Credits: 30
  • Pre-requisites: None
  • Co-requisites: None

Summary

This module covers a number of core concepts for the MPharm degree and requires you to demonstrate proficiency in use of your learning at a higher level than other modules. It is a module that reflects the key professional regulations, law and obligations required to become a pharmacist, as dictated by the governing professional body and government legislation. The module advances your knowledge in relation to legal and ethical practices related to pharmacy. It builds on teaching you the skills you will need for professional practice such as analysing prescriptions and dispensing relevant products, interpretation and application of law using problem solving, and using professional judgement. Approximately 20% of the teaching time is spent in practicals and workshops to emphasise these concepts.

Aims

  • To further develop an understanding of the law and ethics relating to pharmacy practice by allowing the application of knowledge through problem solving
  • To further develop an understanding of prescribing and dispensing processes within a legal and ethical framework
  • To gain an understanding of what is required to run a retail pharmacy business
  • To place students for two days in a hospital and community pharmacy, in order to gain work-based pharmacy and inter-professional experience.

Learning outcomes

On successful completion of the module, students will be able to:

  • demonstrate a full understanding of the Standards and Guidance Documents, including the Standards for pharmacy professionals
  • demonstrate knowledge of the main Laws, Acts and Regulations relevant to the practice of pharmacy such as the Human Medicines Regulations 2012, Medicines Act 1968, Misuse of Drugs Act 1971, Poisons Act 1972 and Data Protection Act 1998
  • accurately analyse, label, dispense, and endorse items in accordance with given prescriptions
  • fully understand the legal factors that are involved in the journey of a prescription when written by a prescriber to dispensing to a patient
  • further explore the ethical perspectives that may be encountered when dealing with medicines
  • demonstrate enhanced communication skills required for patient and inter-professional interaction

Curriculum content

  • a review of law and the legal system in the UK
  • a review of the Standards for pharmacy professionals and other guidance documents
  • an exploration of healthcare ethics, professionalism and professional empowerment
  • a review of prescriptions and labelling of medicines
  • an examination of the Misuse of Drugs Act 1971 and The Human Medicines Regulations 2012 (S1 2012/1916) as relevant to practicing pharmacists
  • analysis of different types of prescriptions, their labelling, dispensing, clinical checks, endorsement and appropriate record keeping
  • introduction to the Poisons Act 1972 THE EFFECT OF THE Deregulation Act 2015 on the sale of poisons, Denatured Alcohol Regulations 2005 (SI 12005/1524), Control of Substances Hazardous to Health Regulations 2002 (COSHH) and European Regulation on Classification, Labelling and Packaging of Substances and Mixtures (CLP regulations) as relevant to practicing pharmacists
  • introduction to veterinary medicines regulations
  • a review of the medicine licensing system (marketing authorisations for medicines and unlicensed/off-label use)
  • an overview of emergency supply of POMs at the request of a patient and the request of a prescriber. 
  • an overview of the different types of prescribers
  • an introduction to patient group directions
  • an introduction to consumer rights such as the Data Protection Act 1998, Human Rights Act 2000, Environmental Protection Act 1990, Health and Safety at Work Act 1974
  • the overview of communication skills needed when undertaking a consultation (taking a medication history)
  • an opportunity to undertake inter-professional learning during the placement through interaction with other healthcare workers
  • dispensing a range of prescriptions
  • an overview of the regulations and procedures required to run a retail pharmacy business including procedures for reporting concerns, promoting a just culture and responding to complaints
  • an opportunity to experience a community and hospital pharmacy

Teaching and learning strategy

This module is delivered through a variety of lectures, workshop, practical and simulation sessions, and placements. Lectures are designed to introduce students to the key features of each topic and to lay the preparatory ground for the application of knowledge and expanded discussion via workshops, where students will be given the opportunity to work through scenarios and present back their viewpoints. The practical sessions provide students with the environment to develop and refine core professional dispensing practice skills and to develop their understanding through the application of knowledge to the practical environment. This will be augmented by two 1 day placements in a practice setting, the learning of which will be demonstrated in a reflective feedback diary. The placements will also form part of the academic professional skills portfolio in which all tasks therein required completion. This portfolio is assessed by the student's personal tutor and formative feedback provided on the student's reflection.

Breakdown of Teaching and Learning Hours

Definitive UNISTATS Category Indicative Description Hours
Scheduled learning and teaching 43 one hour lectures 10 workshops and 8 tutorials (workshops are 3 hours each) 10 practical sessions of 3 hours each 43 38 30
Guided independent study Directed and student self-directed study 173
Study abroad / placement Practice placement 16
Total (number of credits x 10) 300

Assessment strategy

A range of formative assessments undertaken both in-class (workshop and practical) and during independent study, of relatively short duration will be set periodically on content determined by the module leader. These will provide regular and detailed feedback to students so that they can develop an awareness of their rate and level of progress and of their strengths and weaknesses. On-going discussion via the personal tutor and module leader will assist the student in the development of strategies for improvement and enhancement.

A feature of this module is that it develops a range of practical skills and competences associated with the learning outcomes that are essential for pharmacy practice as well as ensuring the student can meet the General Pharmaceutical Council's outcome standards at the appropriate level. Formative and summative assessment in practicals and workshops occurs throughout the module and involves both tutor and peer assessment and feedback. Summative assessment of practical skills is typically through a portfolio of practical assessment, including the assessment of dispensing competence. The portfolio will consist of 4 in-class assessments, each worth 5%. Two of these will be assessed prescriptions and two case based problems.

Summative assessment is also made through an in module assessment, consisting of an in class test, worth 20%. Detailed feedback from this in module assessment will be provided to students so that they reflect on their rate and level of progress in the module.

A three hour end of module examination (written exam) will require students to typically answer MCQ/SBA/EMQs, a range of short answer questions and long answer questions. The end of module exam is worth 60% of the module.

As this is a professional pharmacy practice module the assessment standard is more stringent, requiring a pass mark of 50% overall and in its components.

Level 5 MPharm students are required to pass a synoptic OSCE style assessment and a synoptic calculations test before they can progress to Level 6. These are to assure that even at this Level the student is demonstrating the appropriate skills, knowledge, understanding and attributes to become a future pharmacist. Learning in this module feeds forward into these synoptic assessments. In particular calculations ability, a fundamental pharmaceutical skill will be developed in practicals where they will be formatively and summatively assessed, along with questions in the in module assessment, feeding forward into the synoptic calculations assessment. The assessed prescriptions and case based problems feed into the synoptic OSCE.

Mapping of Learning Outcomes to Assessment Strategy (Indicative)

Learning Outcome Assessment Strategy
1) demonstrate a full understanding of the Standards and Guidance Documents, including the Standards for pharmacy professionals. In-class formative assessments - MCQs In class test End of module exam (MCQ, short and long answer question) Feed forward to synoptic OSCE
2) such as the Medicines Act 1968, Misuse of Drugs Act 1971, Poisons Act 1972 and Data Protection Act 1998. In-class formative short answer test and tutor assessment In class test End of module exam (MCQ, short and long answer question) Feed forward to synoptic OSCE
3) accurately analyse, label, dispense, and endorse items in accordance with given prescriptions. Formative assessments - MCQs Formative tutor/peer assessment in practicals In class test End of module exam (MCQ, short and long answer question) Feed forward to synoptic OSCE
4) fully understand the legal factors that are involved in the journey of a prescription when written by a prescriber to dispensing to a patient. In-class formative short answer test and tutor assessment In class test End of module exam (MCQ, short and long answer question)
6) demonstrate enhanced communication skills required for patient and inter-professional interaction. Formative peer/tutor assessment in practicals Placement logbook (part of academic professional skills portfolio) Feed forward to synoptic OSCE.

Elements of Assessment

Description of Assessment Definitive UNISTATS Categories Percentage
Written exam 3 hour end of module exam 60%
Written exam In class test (In module assessment) 20%
Coursework Portfolio of practical assessments 20%
Total (to equal 100%) 100%

Achieving a pass

It is a requirement that the elements of assessment are passed separately in order to achieve an overall pass for the module.

Bibliography core texts

You are expected to have your own copy of the latest editions.

Dale and Appelbe's Pharmacy Law and Ethics. Gordon E Appelbe and Joy Wingfield.  Pharmaceutical Press.  ISBN: 978 0 85369 827 2

Medicines, Ethics & Practice: A Guide for Pharmacists.  You should register with the RPS to be able to view/print this document. Or alternatively buy a copy.

British National Formulary (latest edition can be found on the BNF website.)

Applied Pharmaceutical Practice. C. Langley and D. Belcher. Pharmaceutical Press.  ISBN 978 0 85369 746 6

MCQs in Pharmaceutical Calculations. R. Donnelly and J. Barry. Pharmaceutical Press.  ISBN 978 0 85369 836 4

Bibliography recommended reading

The Drug Tariff, latest edition can be found on the website.

Pharmacy Ethics and Decision Making. Gordon Appelbe, Joy Wingfield and D. Badcott. Pharmaceutical Press. ISBN: 978 0 85369 689 6

The NPA Guide to the Drug Tariff and NHS Dispensing for England and Wales, National Pharmaceutical Association

ABPI Medicines Compendium, published by the Association of British Pharmaceutical Industries (also available at Electronic Medicines Compendium.

Sweetman, Sean, Martindale: the complete drug reference. (Book and CD-ROM), Pharmaceutical Press

Drug and Therapeutics Bulletin

MeRec Bulletin, National Prescribing Centre

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