Prescribing Safety Assessment Implementation Guide for Foundation Schools

Prescribing Safety Assessment Implementation Guide for Foundation Schools June 2016 Contents

Produced by Health Education England All information was correct at the time of production.

Author: Katie Reygate, Prescribing Lead, Health Education England working across Kent Surrey and Sussex

Contributors: Dr Jan Welch, Director South Thames Foundation School Marc Terry, Manager, South Thames Foundation School Professor Simon Maxwell, PSA Medical Director Nic Blackwell, Director OCB Media Sarah Pontefract, SCRIPT eLearning Content and Editorial Manager, University of Birmingham

Acknowledgements The author would like to thank all the contributors South Thames Foundation School, OCB media, HEE KSS Pharmacy team, the British Pharmacological Society, Foundation School Directors and the Medical Schools Council for their support.

Edition: 2016 Date: June 2016

of 18 1. Introduction The Prescribing Safety Assessment (PSA) has been developed jointly by the British Pharmacological Society and the Medical Schools Council, with the aim of enabling students to demonstrate competencies in relation to the safe and effective use of medicines. It was developed based on the competencies identified by the General Medical Council outlined in Tomorrow's Doctors (2009). This guidance has since been superseded by the General Medical Council’s undergraduate standards and guidance, specifically the outcomes for graduates, produced in July 2015. It states, within the “doctor as a practitioner” section: Prescribe drugs safely, effectively and economically. a) Establish an accurate drug history, covering both prescribed and other medication. b) Plan appropriate drug therapy for common indications, including pain and distress. c) Provide a safe and legal prescription. d) Calculate appropriate drug doses and record the outcome accurately. e) Provide patients with appropriate information about their medicines. f) Access reliable information about medicines. g) Detect and report adverse drug reactions. h) Demonstrate awareness that many patients use complementary and alternative therapies, and awareness of the existence and range of these therapies, why patients use them, and how this might affect other types of treatment that patients are receiving.

The GMC guidance can be found here: http://www.gmc-uk.org/education/undergraduate/undergrad_outcomes_2.asp The PSA was first piloted in 2010, and by 2014 was taken by all final year UK medical students. All medical schools in the UK participate, along with five in Ireland and one in Malta. The PSA is held in medical schools between February and June each year. Passing the PSA is now an essential part of successful completion of the F1 year (from August 2016 entry).

As most of those entering foundation training will already have passed the PSA during medical school, only a small number will need to take it during foundation training. These will be doctors who failed to pass or did not have the opportunity to sit the PSA during their undergraduate medical training, including non-UK trainees.

If the PSA was passed more than 2 years before starting foundation training then it will need to be successfully retaken before completion of the F1 year (applies from August 2016 F1 entry).

of 18 2. The Prescribing Safety Assessment

The PSA is an online assessment, delivered on a secure platform. The assessment is nationally developed but conducted locally by medical schools. The content of each item is relevant to the prescribing tasks expected of an F1 doctor, i.e. the questions refer to conditions and drugs likely to be encountered in year one of the Foundation Programme.

The PSA includes 60 items and is 2 hours in length. There are eight prescribing areas covered as shown below1:

The format of the questions vary depending on the skill being assessed; some ask the candidate to 'write' an appropriate prescription for a given problem, others ask the candidate to choose the most appropriate option from a list or to perform a calculation. Trainees with a form of disability covered by the Equality Act 2010 may be considered for reasonable adjustments. Those with a temporary or long term health condition may also be considered, provided their Foundation School and assessment centre has been made aware of their condition before the PSA sitting. More information on the assessment and the prescribing areas can be found at: https://prescribingsafetyassessment.ac.uk/

In addition, the following videos have been produced to assist candidates undertaking the PSA assessment Please note that these were primarily intended for a medical school audience.

PSA 2016 video for candidates: Registering and activating your account https://vimeo.com/150768703

1 Picture reproduced with permission of Professor Simon Maxwell. Page 4 of 18 For Apple devices: https://player.vimeo.com/video/150768703

PSA 2016 video for candidates: Back ground to the PSA https://vimeo.com/150780292 For Apple devices: https://player.vimeo.com/video/150780292

PSA 2016 video for candidates: Preparing for your PSA event https://vimeo.com/150790915 For Apple devices: https://player.vimeo.com/video/150790915

PSA 2016 video for candidates: PSA Assessment Environment https://vimeo.com/150812431 For Apple devices: https://player.vimeo.com/video/150812431

PSA 2016 video for candidates: Using the British National Formulary https://vimeo.com/150734395 For Apple devices: https://player.vimeo.com/video/150734395

PSA 2016 video for candidates: Prescribing Question Items https://vimeo.com/151039705 For Apple devices: https://player.vimeo.com/video/151039705

PSA 2016 video for candidates: Prescription Review Question Items https://vimeo.com/151065182 For Apple devices: https://player.vimeo.com/video/151065182

PSA 2016 video for candidates: Planning Management Question Items https://vimeo.com/151072712 For Apple devices: https://player.vimeo.com/video/151072712

PSA 2016 video for candidates: Providing Information Question Items https://vimeo.com/151075459 For Apple devices: https://player.vimeo.com/video/151075459

PSA 2016 video for candidates: Calculation Skills Question Items https://vimeo.com/151086966 For Apple devices: https://player.vimeo.com/video/151086966

PSA 2016 video for candidates: Adverse Drug Reaction Question Items https://vimeo.com/151162112 For Apple devices: https://player.vimeo.com/video/151162112

PSA 2016 video for candidates: Drug Monitoring Question Items https://vimeo.com/151172957 For Apple devices: https://player.vimeo.com/video/151172957

PSA 2016 video for candidates: Date Interpretation Question Items https://vimeo.com/151167910 For Apple devices: https://player.vimeo.com/video/151167910

of 18 3. Implementing the PSA in Foundation “Prescribing Safety Assessment 2016, Administrators’ Guidance” sent to all schools by the PSA provides information about the practical elements of implementing the PSA for Foundation Trainees. Within it is a timeline for the PSA 2016 (located on page 4) which indicates that foundation schools should have identified a PSA lead and assessment centre as soon as possible. This document is available on the UKFPO website.

Recommendations The following recommendations should be considered, agreed and recorded by the foundation school before the implementation of the PSA for the upcoming cohort. Further information on issues raised within this section has been provided later in this guide, together with a diagram in appendix 1: PSA deadlines and milestones, which gives deadlines and milestones to assist foundation schools in planning.

Foundation School Administration o There should be a nominated lead within the foundation school to provide leadership for the PSA (PSA Lead).

o There should be a nominated lead within the foundation school to lead on the administration of information for the PSA on behalf of the foundation school (see appendix B of the “Prescribing Safety Assessment 2016, Administrators’ Guidance”)

o The administrator must access and read the “Prescribing Safety Assessment 2016, Administrators’ Guidance” as soon as possible.

Practical implications for the PSA test before induction:  The foundation school should decide on an assessment centre (this can be a local medical school) to facilitate the PSA. o The centre must fulfil the requirements of a PSA assessment centre as in the “Prescribing Safety Assessment 2016, Administrators’ Guidance”.

 A nominated lead will be responsible for the coordination of the PSA sitting at the foundation school and assessment centre.

 The foundation school will need to decide how the PSA results will be cascaded to trusts. [NB: foundation schools will be notified within 3 weeks of the assessment and trainees two days after this, via their online accounts. If the foundation school does not wish candidates to see results individually or wishes to arrange a different time of release, the lead should contact the PSA team.

 The foundation school will need to decide what action will be taken if trainees fail to attend the assessment (DNA), including who will be informed and when.

Communication to Trainees  The foundation school should decide a communication strategy to inform the trainees about the PSA. (NB: Standard letter in the “Prescribing Safety Assessment 2016, Administrators’ Guidance”) o This should include when the information will be cascaded and an explanation of the implications of failure to pass the PSA on the trainee’s foundation training outcomes.

 The foundation school should provide a point of contact for trainees with concerns regarding the PSA. Page 6 of 18  When will the information be cascaded? Further information is in Chapter 5 and 7.

Communication to Trusts Foundation schools should communicate to trusts information including: 1. Trainees who are required to undertake the PSA on the 22nd July 2. Assessment arrangement information & communication sent to trainees, including the implications of failure to pass the PSA on training outcomes. 3. Pass list and dissemination process 4. Suggested remediation (if a common approach is decided by the foundation school) 5. Retake dates as in the “Prescribing Safety Assessment 2016, Administrators’ Guidance” Further information is in Chapter 5 and 7.

Impact of the PSA on local prescribing training on Induction Foundation schools may wish to consider the impact of the PSA on local inductions, including prescribing training and assessments. It is important to distinguish the aims of PSA from those of local training and assessment, and that the PSA is not a tool to help familiarisation with local prescribing systems. It is therefore vital that trusts continue with local prescribing training.

Local prescribing assessments may continue to be used, but there should be regular review to ensure they are relevant to safe practice and to minimise duplication with the PSA.

of 18 4. Remediation for trainees who fail the PSA

The 2008 Health and Social Care Act includes regulation to protect patients against the risks associated with the unsafe use and management of medicines. If a trust is aware that a trainee is not competent to prescribe on commencing employment they must therefore ensure that there are appropriate support arrangements in place to ensure patient safety.

There are two aspects to consider when a trainee fails the PSA; 1. How to ensure the trainee is a safe prescriber in practice 2. How to assist the trainee to pass the PSA

The choice of method for remediation of trainees will depend on resource and capacity. If a foundation school determines a common approach then it is recommended that trusts are engaged in stakeholder meetings about the capacity to provide support.

Feedback provided by the PSA PSA feedback is provided for each candidate as the total percentage mark gained in the PSA, with performance data for each section of the assessment. Each section of the PSA can incorporate a variety of topics, outlined in Appendix 2. This can be used to guide areas for the trainee to focus on.

Methods of support / remediation Examples of methods used are considered below. This is not an exhaustive list and foundation schools / trusts may choose more than one:

PSA resources These are resources to help trainees orientate to the assessment and topics before they sit the assessment. They are available on the PSA website https://www.prescribingsafetyassessment.ac.uk (see also introduction and chapter 7). Trainees should work through these before the 22nd July assessment to maximise their chance of passing.

Local prescribing assessments Prescribing assessments administered to foundation trainees within trusts should continue to be used, especially if they facilitate orientation to local prescribing systems. Local assessment can be an alternative route to identify additional learning and perceived prescribing weakness. This assists both trainees and those supporting them to target support / interventions.

SCRIPT SCRIPT (Standard Computerised Revalidation Instrument for Prescribing and Therapeutics) is an innovative e-Learning programme providing a series of modules to explore prescribing and therapeutics. SCRIPT is easily accessible, web based and includes over 45 modules covering competencies defined by the GMC and required within the Foundation Curriculum.

SCRIPT is currently available to the foundation schools listed in chapter 6.

SCRIPT modules can be used to fulfil learning needs identified by the PSA. Further information on the use of SCRIPT is in chapter 6. Appendix 2 maps SCRIPT modules to the PSA sections. e-learning Other e-learning platforms are available to foundation doctors, such as e-learning for health and the Learning in Foundation training - LIFT system in Scotland. Trusts may also have e-learning

of 18 modules and others are available online. Any online modules used should be up to date and endorsed by the foundation school as a suitable resource.

Utilising support from other Health Care Professionals Dependant on multi-professional educational relationships, trusts may ask other professionals, such as pharmacists within trusts, to provide assistance but this should be considered before PSA implementation. NB: Pharmacist education timelines and demands mirror medical education and therefore they may have reduced capacity to support trainees in August.

Other supportive methods ‘Friendly pharmacist’ schemes are used to pair foundation trainees with experienced pharmacists with expertise in the area in which the foundation doctor is working. They can assist the doctor as they acclimatise to prescribing, and provide timely feedback on their prescribing in practice. These schemes are valuable but resource intensive.

The ‘Promoting Practical Prescribing Course’ at the Dudley Group NHS Foundation Trust aims to establish inter-professional learning between foundation doctors and pharmacists, using SCRIPT modules. More information can be found here: http://safeprescriber.org/bettertraining/

Monitoring While the performance of all foundation trainees is monitored by local medical education systems, consideration should be given to monitoring those who fail the PSA in two additional areas:

Prescribing performance All foundation trainees’ prescribing errors should be included in governance monitoring at trust level. Depending on the systems for prescribing and reporting, errors by trainees may not be notified to them or their clinical supervisor. It is especially important to monitor prescribing errors by trainees who fail the PSA, and so trusts must ensure that supervisors are informed of trainees’ performance through local governance systems. Foundation schools may ask whether this is common practice in their trusts as part of quality monitoring.

Remediation adherence Trainees offered remediation and support after failing the PSA should be monitored to ensure their adherence. Failure to engage may indicate wider issues. Foundation schools and trusts may wish to consider what actions / procedures they would wish to implement in such cases.

of 18 5. Trust and trainee support for those who fail the PSA

Foundation schools in collaboration with stakeholders should develop a strategy for trusts supporting trainees who have failed to pass the PSA. In doing so, foundation schools should consider the aspects discussed in chapters 3, 4 (and 6 if applicable). This strategy should be decided and clearly communicated to trusts before the 22nd July.

The following should be set out:

- Who is responsible for communicating support mechanisms to trainees? - When the information will be communicated. - The information cascade process regarding trainees who failed the PSA, including: o Who is included within the trust, including level of staff e.g. director of medical education, educational supervisors and/or clinical supervisors. o How and when to inform trainees about these processes before the release of results. - Who is responsible for communicating: o The details of the second PSA arrangements and results o Information about third attempt and beyond - How to manage trainees who fail a second and third attempt o Additional support mechanisms o Review of current support and performance management

of 18 6. Using SCRIPT for remediation This chapter is divided into two sections:  Introduction to SCRIPT and  Using SCRIPT for remediation

Introduction to SCRIPT

What is SCRIPT and how is it structured? SCRIPT (Standard Computerised Revalidation Instrument for Prescribing and Therapeutics) is an innovative e-Learning programme that provides trainees with a series of modules to explore prescribing and therapeutics. It is an easily accessible web-based programme covering competencies defined by the GMC and required within the Foundation Curriculum.

A total of 47 modules are available, equivalent to 30 to 70 hours of learning.

All modules have a similar structure and are designed to be interactive. Each module includes a variety of activities, the quantity and type of which vary between modules. If the activities are undertaken as intended, each module is estimated to take 30 to 90 minutes, depending on the trainee’s prior experience and confidence in the topic. The typical structure of a module consists of: - Overview and learning outcomes - Pre-test - Knowledge content - In-module activities - Post-test - Certificate

Who has access to SCRIPT? Current (April 2016) institutions with access to SCRIPT (including medical schools):

HEE – West Midlands Medical school – Queen Mary’s HEE – East Midlands Medical school – Birmingham HEE – North East Medical school – Keele HEE – Yorkshire and Humber Medical school – Southampton HEE – Kent, Sussex and Surrey Medical school – Warwick HEE – Wessex Medical school – Kings HEE – North, Central and East Medical school – Liverpool London HEE – North West London NHS Trust – Isle of Wight NHS Trust – West Suffolk NHS Trust – Norfolk and Norwich

How do trainees access SCRIPT? Foundation trainees can self-register on the website; first they must select the region in which they are training: http://www.safeprescriber.org/specialty/foundation/

of 18 Can Foundation Schools and Trusts monitor the use of SCRIPT by trainees? Each foundation school and trust can monitor trainees’ performance on SCRIPT using “manager’s access”.

Within the manager’s function administrators and those with access (restricted to a maximum of one per trust) can see trainees’ pre- and post-test results for each module, along with the time taken to complete the learning and when this was completed (date/time).

Foundation schools can set their own criteria for successful completion of modules, so certificates are not automatically generated even if trainees score poorly. For example the criteria might be that a trainee must spend at least 10 minutes on a module and score at least 70% on the post-test assessment. Trainees who fail to pass a module using these criteria will be required to reset the module and start again.

What is the cost of SCRIPT? An individual trainee can purchase a single user license for £39.99. If so, there are no set criteria for successful completion of a module and trusts / foundation schools cannot monitor performance.

SCRIPT can be purchased by regions, which can then access the managers’ site and monitor trainees. The cost per trainee is reduced with bulk purchases. For further details contact Dr. Nic Blackwell, 07977 216640, [email protected]

What are the IT requirements for SCRIPT? SCRIPT requires computers with the following technical specification: Resolution 1024x768 or above Browsers Internet Explorer 8+ (9+ Recommended) Mozilla Firefox 5+ Google Chrome 20+ Opera 11 Apple Safari 6+ Platforms Windows XP, Vista, 7 Apple Mac OSX 10.x Connection Speed ADSL 2 mbps Adobe Flash Player Flash Player 10.3+ JavaScript enabled Required Cookies Enabled Required Video/Audio Mp3/Flv: Flash Player 9.0, 10 Memory 128MB of RAM * iPad compatible (HTML5) course player was released in January 2013. Whether exported as a SCORM package or used in nimbleLMS®, courses will automatically toggle to HTML5 when Flash is not available.

Using SCRIPT for remediation The large variety of modules available could be overwhelming for a trainee who has never used the system before.

The SCRIPT modules are presented in one of seven units. The eight PSA sections have been mapped to SCRIPT modules (Appendix 2), to help direct the trainee following an unsuccessful PSA result. Some sections of the PSA are mapped to several modules, however, so some trainees may require support from a senior person to direct their learning. The pre-test function of each of the modules identifies trainees with poor knowledge in that specific area.

of 18 The following is recommended for those using SCRIPT for remediation:

The manager’s section of SCRIPT can be utilised to monitor trainee’s progress. Before implementing this you need to decide: - Who will monitor the trainee’s progress? (School level or trust level). - Will trusts be given access to SCRIPT manager’s access? - Who will lead on this within trusts? - Who will lead at the foundation school?

Within SCRIPT a foundation school can determine set criteria for successful completion of a module. Before implementing this you should decide: - What would be the minimum recommended criteria? - Would this be decided at foundation school or trust level?

Foundation schools can mandate the number and specific modules that trainees need to undertake during training. Before implementing this you should decide: - Would the foundation school wish to mandate a minimum number of modules for a trainee who fails the PSA? - Would the foundation school wish to select the mandated modules? - Who would monitor the completion of mandated modules? Would there be an associated timeline for this? - Who would be responsible if a trainee was not performing using SCRIPT? - Would the trainee be expected to complete the modules within a specific timeframe? - Would the trainee be given protected time to undertake these modules? - Would there be one approach for all trainees or would the decision be made locally at trust level? Who would be responsible at trust level if the latter option was decided? - Would there be set expectations?

Remediation SCRIPT for schools where it is fully implemented Many regions have granted access to SCRIPT as part of the foundation programme.

Foundation schools already using SCRIPT should consider whether using it for remediation will affect how it is otherwise used. For example, the use of modules may need to be reviewed if trainees are undertaking modules for remediation that would normally be signposted for use during F2.

The SCRIPT modules have been mapped to the eight PSA sections in appendix 1; from this analysis the most important modules to undertake are (in priority order):

1. Rational Drug Choice 2. Utilising the BNF 3. Prescription Documentation 4. Fluids 5. Taking a Safe and Effective Drug History

In addition the following are beneficial: 6. Adverse Drug Reactions 7. Dosing and Calculation 8. Drug Interactions 9. Adherence and Concordance

More information is in appendix 1.

of 18 7. Non-UK Trainees entering Foundation Training

Non-UK trainees will generally not be familiar with the Prescribing Safety Assessment. After the foundation school has completed the registration list and returned this to the PSA on 24th June 2016, the PSA will create accounts so trainees can access information about the PSA and practice questions via https://www.prescribingsafetyassessment.ac.uk.

In addition, non-UK trainees entering foundation training require orientation to the NHS on starting the programme, if not before. NHS practice includes complex processes, procedures and practices. For prescribing these include:

- Awareness and practical application of the British National Formulary and sources of information (Athens account required which can be obtained from the trust library): https://www.bnf.org/products/bnf-online/ - UK products available, regular doses and indications - Local prescribing formularies - Prescribing guidelines both local and national (NICE - https://www.nice.org.uk/ ) - Licensed and unlicensed medications

Orientating themselves with the topics above will assist trainees with the PSA. Trainees can access training on these topics via SCRIPT, and there is an open access module created by the UK Medicines Information team that may also help. http://www.medicineslearningportal.org/2016/01/managing-medicines.html

of 18 Appendix 1: PSA deadlines and milestones

of 18 Appendix 2: Prescribing topics per PSA section mapped to SCRIPT modules

This matrix has been created by mapping the topics of the relevant sections of the PSA to the SCRIPT module learning outcomes. When a trainee receives their results, their performance is broken down by PSA section. Some PSA sections have greater weight than others and this should be considered when deciding which modules a trainees will be required to undertake as part of the remediation process.

In trainees who have under-performed in several PSA sections, it may be helpful to undertake the following recommended modules in priority order (as there are 18 SCRIPT modules within the matrix). These have been decided based on the weight of the section in which they appear and the number of times they occur in the matrix:

1. Rational Drug Choice 2. Utilising the BNF 3. Prescription Documentation 4. Fluids 5. Taking a Safe and Effective Drug History 6. Adverse Drug Reactions 7. Dosing and Calculation 8. Drug Interactions 9. Adherence and Concordance

PSA Prescribing Area / Topics included SCRIPT Module Prescribing Weight 40% Drug history Taking a Safe and Effective Drug History Fluid management Fluids Prescription Documentation Prescription Documentation Rational Drug Choice Rational Drug Choice Utilising information to inform prescribing Utilising the BNF / BNFc Prescription Review Weight 16% Adherence Adherence and Concordance Adverse Drug Reactions Adverse Drug Reactions Dosing Dosing and Calculation Drug history Taking a Safe and Effective Drug History Hepatic Impairment Prescribing in Hepatic Dysfunction Interactions Drug Interactions Medication Errors Medication Errors Polypharmacy Prescribing in Older Adults Rational Drug Choice Rational Drug Choice Renal impairment Prescribing in Renal Dysfunction Utilising information to inform prescribing Utilising the BNF / BNFc Planning Management Weight 8% Adherence Adherence and Concordance Drug history Taking a Safe and Effective Drug History Rational Drug Choice Rational Drug Choice

of 18 Page 17 of 18 PSA Prescribing Area / Topics included SCRIPT Module Providing Information Weight 6% Adherence Adherence and Concordance Adverse Drug Reactions Adverse Drug Reactions Dosing Dosing and Calculation Formulation and Administration Formulation and Administration Interactions Drug Interactions Calculation Skills Weight 8% Administration Formulation and Administration Calculations Dosing and Calculation Adverse Drug Reactions Weight 8% Adverse Drug Reactions Adverse Drug Reactions Anaphylaxis Drug Allergy and Anaphylaxis Interaction Drug Interactions Management of ADRs Parenteral Poisons Management of ADRs Toxic Tablets Utilising information to inform prescribing Utilising the BNF / BNFc Drug Monitoring Weight 8% Adverse Drug Reactions Adverse Drug Reactions Rational Drug Choice Rational Drug Choice Therapeutic Drug Monitoring Monitoring Drug Therapy Utilising information to inform prescribing Utilising the BNF / BNFc Data Interpretation Weight 6% Hepatic Impairment Prescribing in Hepatic Dysfunction Rational Drug Choice Rational Drug Choice Renal impairment Prescribing in Renal Dysfunction Therapeutic Drug Monitoring Monitoring Drug Therapy Utilising information to inform prescribing Utilising the BNF / BNFc