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Interprofessional Medicines Governance WorkshopTUTOR Study Guide

2009 - 2010

Centre for Excellence in Interprofessional Education

Preface

Preface

The Centre for Excellence in Interprofessional Education (CEIPE) aims to develop research-informed opportunities for healthcare students to learn together. Through learning together it is expected that students will understand more about the healthcare professionals in the workplace and so enhance team work and communication skills, promote collaborative practice and ultimately improve patient care.

The CEIPE team includes students and staff from the Schools of Medicine, Dentistry and Biomedical Sciences, Nursing and Midwifery, and Pharmacy who work together to identify and develop areas of the curriculum that will benefit from such an interprofessional approach.

A series of uniprofessional Medicines Governance workshops are conducted with all final year medical, nursing and pharmacy students which are followed-up with either live or on-line interprofessional Medicines Governance workshops. Within the interprofessional workshops students are provided with a series of case studies relating to issues of medication safety to discuss within an interprofessional group. Feedback on the medication incidents is disseminated to the whole group and facilitated by the workshop leader.

As part of the e-learning dimension of CEIPE, the ‘live’ interprofessional feedback sessions were video recorded for use in the on-line interprofessional workshop.

Students are invited to participate in an interprofessional Medicines Governance on-line chat board to discuss three medication incidents. During and following discussion, a wiki report is written and the pre-recorded medication incident feedback presentations are viewed.

The combined approach of the live and on-line interprofessional Medicines Governance workshops provides students from each discipline with an opportunity to engage with one another in an interprofessional context on the issue of medication safety.

Thanks are extended to all who contributed to the development of the Interprofessional Medicines Governance workshops and to this Study Guide.

Professor P S Collier

Prof Paul Collier School of Pharmacy, QUBMs Sharon Haughey School of Pharmacy, QUBDr Stanley Hawkins School of Medicine, Dentistry and Biomedical Sciences, QUBMs Karen Page School of Nursing & Midwifery, QUBMs Angela Carrington Belfast Health and Social Care TrustMr Daryl Connolly Western Health and Social Care TrustMs Anna Lappin Northern Health and Social Care TrustMs Sharon O’Donnell Belfast Health and Social Care TrustMs Jilly Redpath Southern Health and Social Care TrustMs Hazel Cuene-Grandidier CEIPE, School of Medicine, Dentistry and Biomedical Sciences, QUBMr Mark McCalmont CEIPE, School of Medicine, Dentistry and Biomedical Sciences, QUB

1 © 2009 Queen’s University Belfast

Contents

Contents Page

Copyright----------------------------------------------------------------------------------------------------- 31 Introduction------------------------------------------------------------------------------------------------- 42 Aims and Learning Outcomes--------------------------------------------------------------------------- 53 IPE Medicines Governance Workshop---------------------------------------------------------------- 6

3.1 Live Format------------------------------------------------------------------------------------------ 63.2 On-Line Format------------------------------------------------------------------------------------ 63.3 On-Line Facilitator Instructions---------------------------------------------------------------- 73.4 On-Line Student Instructions------------------------------------------------------------------- 9

3.4.1 Chat Board-------------------------------------------------------------------------------- 103.4.2 Group Wiki Report---------------------------------------------------------------------- 103.4.3 Points for Discussion------------------------------------------------------------------- 103.4.4 Ask a facilitator for help--------------------------------------------------------------- 10

4 Interprofessional Medication Safety Presentation------------------------------------------------ 115 Case Studies------------------------------------------------------------------------------------------------- 13

5.1 Medication Incident 1 - Vincristine----------------------------------------------------------- 135.1.1 Facilitator’s Notes - Vincristine------------------------------------------------------ 14

5.2 Medication Incident 2 - Methotrexate Toxicity-------------------------------------------- 155.2.1 Facilitator’s Notes - Methotrexate Toxicity -------------------------------------- 18

5.3 Medication Incident 3 - Heparin--------------------------------------------------------------- 195.3.1 Facilitator’s Notes - Heparin---------------------------------------------------------- 22

6 RPSGB - Professional Standards and Guidance for the Sale and Supply of Medicines---- 237 NMC - Standards for Medicines Management - Summary-------------------------------------- 338 GMC - Good Practice in Prescribing Medicines----------------------------------------------------- 40


Copyright

Copyright Statement

The following items in this study guide are copyright © 2009 Queen’s University Belfast, Belfast Health and Social Care Trust, Northern Health and Social Care Trust, Southern Health and Social Care Trust and Western Health and Social Care Trust:

Aims Learning outcomes IPE Medicines Governance workshop Live and On-line Format On-line Facilitator Instructions On-Line Student Instructions Case studies 1-3

The copyright ownership in this study guide does not include the following external sources, individually acknowledged or referenced within this study guide:

Royal Pharmaceutical Society Great Britain: Professional Standards and Guidance for the Sale and Supply of Medicines

Nursing and Midwifery Council: Standards for Medicines Management British Medical Council: Good Practice in Prescribing Medicines

All rights reserved. This study guide can only be used for academic research and/or private study purposes. No part of this study guide can be reproduced in any form without prior permission of the copyright owner. Use of any material from this study guide for commercial purposes requires the permission of the relevant copyright owner.

Disclaimer:

Material from external sources is accurate and correct at the time of production, but may be subject to amendment by the copyright owner thereafter.


Introduction

1. Introduction - why medication safety?

The National Patient Safety Agency1 (2007) published a report of Safety in doses: medication safety incidents in the NHS and recommended actions for the NHS to improve medication safety. One of these actions was to improve staff skills and competences to use medicines safely. Furthermore, the Department of Health2 (2004) recognised that the development of the knowledge and skills required for this complex process of prescribing, dispensing and administering medication may be inadequate in current undergraduate healthcare education.Errors in medication safety can occur at all stages of the medication process; prescribing, dispensing and administration2. Deficiencies in high quality patient care have been attributed to poor communication and teamworking skills3.More recently the National Patient Safety Agency4 (2009) reported that over 70,000 medication incidents had been reported in England and Wales in 2007, representing 9% of all patient safety incidents during that year. While the majority of these incidents resulted in no harm or low harm, there were 100 incidents reported that resulted in death or serious harm.

CEIPE, in collaboration with the Schools of Medicine, Nursing and Pharmacy at Queen’s University, and the NI Medicines Governance team recognised the potential for interprofessional education in medication safety to facilitate learning clinical competences, communication and teamworking skills. This further develops existing uniprofessional education in medication safety delivered to medical, nursing and pharmacy students.An Interprofessional Education (IPE) Medicines Governance workshop was developed for final year medical, nursing and pharmacy students by an interprofessional group which included representatives from the NI Medicines Governance team to ensure the requirements of each professional regulatory body were met. The workshop encompassed application of existing knowledge, the development of communication and teamworking skills and the acquisition of further knowledge and skills required for prescribing, dispensing and administration of drugs.This study guide provides information to enable students to participate in either ‘live’ or ‘virtual’ interprofessional Medicines Governance workshops.References:

1. National Patient Safety Agency. (2007) Safety in doses: medication safety incidents in the NHS. [Online] Available at: http://www.nrls.npsa.nhs.uk/EasySiteWeb/getresource.axd?AssetID=60117&type=full&servicetype=Attachment [Accessed 9th October 2009].

2. Department of Health. (2004) Building a safer NHS for patients: Improving Medication Safety. [Online] Available at: http://www.dh.gov.uk/dr_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_4084961.pdf [Accessed 9th October 2009].

3. Department of Health (2001) Learning from Bristol: The Report of the Public Health Enquiry into Children’s Heart Surgery at the Bristol Royal Infirmary 1984 - 1995. TSO: London.

4. National Patient Safety Agency (2009) Safety in Doses: Improving the use of medicines in the NHS [Online] Available at: http://www.nrls.npsa.nhs.uk/EasySiteWeb/getresource.axd?AssetID=61626&type=full&servicetype=Attachment [Accessed 9th October 2009]


http://www.nrls.npsa.nhs.uk/EasySiteWeb/getresource.axd?AssetID=61626&type=full&servicetype=Attachment


http://www.dh.gov.uk/dr_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_4084961.pdf

http://www.dh.gov.uk/dr_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_4084961.pdf



Aims & Learning Outcomes

2. Aims and Learning Outcomes

AimsThe purpose of the workshop is for medical, nursing and pharmacy students to work through case scenarios; identify the issues and contributing factors to the incidents and apply the knowledge gained from uniprofessional workshops in an interprofessional context.1. To explore the relationship between prescribing, dispensing and administration in

medication safety.

2. To develop an appreciation of one's own role and that of other professions in medication safety.

3. To develop an understanding of one's own role and other professions in contributing to or preventing a medication incident.

Learning Outcomes

On completion of the workshop, students will be aware of:

1. the collective and individual responsibilities in prescribing, dispensing and administration of medicines

2. the importance of information and communication with other professionals and patients

3. and recognise that accurate prescribing, dispensing and administration of medicines are essential skills in safe clinical practice.


Workshops Format

3. IPE Medicines Governance Workshop

All final year medical, nursing and pharmacy students participate in either a ‘live’ or an on-line workshop.

3.1 Live Format

The live workshops are in the School of Pharmacy, with forty students from each profession (n=120) being divided into four groups of 30 students (medical (n=10), nursing (n=10) and pharmacy (n=10).

a. All students watch a presentation on medication safety which also details the format of the live workshop.

b. Each interprofessional group of 30 students, facilitated by a member of the Northern Ireland Medicines Governance Team, is subdivided into three interprofessional groups of ten students.

c. Each small interprofessional group discusses one medication incident and the role of each profession in relation to medication safety, particularly in terms of how they may contribute to, or prevent medication incidents.

d. Feedback on all medication incidents is provided to the larger IP group (n=30) at the end of the workshop.

3.2 On-Line Format

The on-line workshops are in the Elmwood Learning and Teaching Centre, with medical, nursing and pharmacy students who do not participate in the live workshop. Within each PC suite there is an IP student group and as each student logs on to participate in the IPE workshop, they are automatically allocated to a smaller IP group of 10 students i.e. medical (n=4), nursing (n=3) and pharmacy (n=3).

A number of medical, nursing and pharmacy facilitators are each responsible for four IP on-line groups, to monitor the on-line discussion and to provide expertise to any student queries. The following on-line tasks are completed by the students in the workshop:a. Students log-on to the IPE on-line Medicines Governance workshop.

b. Watch a presentation on medication safety which also details the format of the workshop.c. Register on the chat board.

d. Automatically allocated to an on-line chat group.e. Read allocated medication incident case study.

f. Discuss the medication incident on-line.g. Nominate a chat group member to write a wiki based report on the chat group discussion.

h. This report can be edited up to a week later by chat group members by following the link provided in the registration confirmation email. Students log-on to the wiki using the “wikiname and password” provided in the student allocation document available on-line at www.qub.ac.uk/ceipe/currproj/medgov.html.

i. Observe previously recorded feedback presentations of all medication incidents.


http://www.qub.ac.uk/ceipe/currproj/medgov.html

On-line Facilitator Instructions

3.3 On-Line - Facilitator Instructions

1. Open your internet browser (e.g. Firefox or Internet Explorer) and type the following address into the address bar:- http://www.qub.ac.uk/ceipe/medgov/admin_login.php

2. Enter the username and password you have been given, make sure you enter them case sensitively

3. This will take you to a page with a list of active groups and which groups are occupied by a facilitator(s), for example:-

4. Tick which groups you want to view and click “Submit”. If you chose to open more than one group and they haven’t opened, you should do the following:-

a. A bar will have appeared across the top of the window saying “Pop-ups blocked”. Click on this bar and choose “Always allow pop-ups from this site”

b. If the groups still don’t open, you may also have to hold down the “Ctrl” key on your keyboard while clicking submit , until all groups are open - that’s if Google toolbar is installed on your PC

5. The groups you have chosen will open in separate windows

6. To send a message to a group, enter your message in the space provided in that group window and click “Send Message”

7. Students are given the option to request help privately from a facilitator, if you receive a message it will appear as an alert in all the group windows you have opened, as follows, only you will be able to see that message:-


http://www.qub.ac.uk/ceipe/medgov/admin_login.php

On-line Facilitator Instructions

8. “Click here to reply” to open a window where you can reply to that student

9. Any further responses to you from that student will be sent to this window and as another alert to the group windows

10. When you’ve finished observing a group discussion click “Close window”

11. When you’ve finished observing all groups click “Log out >>”


On-line Student Instructions

3.4 On-Line Student Instructions

Please follow the instructions below

1. Open Internet Explorer

2. Enter the following address into the address bar and press enter:

3. On the introductory page read the instructions and click on “Go to Introductory Presentation”

4. Click on the image in the Introductory Presentation page

5. This will open a new window with the title “IPE Workshop on Medication Safety”, click on “Play” (this will only play in Internet Explorer)

6. Watch the presentation, it may be slow to load so please be patient!

7. When the presentation has finished close that window

8. Return to the workshop window and click on “Go to chat board registration”

9. Complete all fields and click “Submit” (the username you create will then be displayed in the chat board, the password you create should be at least 6 characters long)

10. You will then be shown your case study and your discussion group

11. Click on the relevant case study - a word document which you should read

12. Keep the case study open after reading and click on “Go to chat board”

For instructions please see section 3.4.1 ‘Chat Board’

13. Discuss relevant case study

Write a Group Wiki Report (one person to volunteer) please see section 3.4.2 ‘Group Wiki Report’

14. Please spend around 40 minutes in discussion please see section 3.4.3 ‘Points for Discussion’

15. If you have a query or require expert guidance

Please see section 3.4.4 ‘Ask a facilitator for help’

16. When you’ve finished the discussion, click on “Log out”

17. This will return to the “log in” screen and a new link to the feedback presentations

18. Click on “Watch the group feedback presentations”

19. Watch each video starting with case study 1

20. Complete the online questionnaire by clicking on link at bottom of “Concluding Presentation” page


On-line Student Instructions

3.4.1 Chat Board

1 In the chat board you will see a list on the right of the screen of your group participants and their profession.

2 To send a message - type it into the space provided and click “Send Message”, the message will be displayed to everyone in your group.

3 From the group discussion a brief report should be written on the wiki; one person in your group should volunteer or be chosen to do this.

3.4.2 Group Wiki Report

To write the Wiki Report, follow these simple instructions:-

1. Click on “Open group wiki” - this will open your group’s wiki page; you will see a message “You don’t have access to write to this page”.

2. To log in, click on “Log In/Register”.3. Enter the “wikiname” and “password” you received in the “Student Allocations” document

and click “Log In” – you can access this document here:www.qub.ac.uk/ceipe/StudentAllocations.doc.

4. Simply type your report as you would in a word document.5. When finished, click “Store” at the bottom of the page or “Preview” to see how it will look.

6. You can go back and change the report by clicking on “Edit” at the bottom of the page.7. Check your Queen’s e-mail account for a link to your group wiki, should you wish to edit it

after the workshop - this is open to anyone in the group for up to a week.

3.4.3 Points for Discussion

1. This is meant to be a discussion; do not write a 500 word essay.2. The purpose is not to find a single individual to blame for the incident

3. Identify points in the sequence of events where appropriate interventions would have prevented the incident.

4. At what points could a member of your profession have intervened?5. What influences or pressures might have prevented someone from your profession from

intervening?6. What changes to procedures would you suggest to prevent a similar incident occurring in the

future?7. What changes in attitudes or interactions between healthcare professionals are required to

prevent a similar incident occurring in the future?

3.4.4 Ask a facilitator for help

Should you need some one-on-one guidance during the discussion do the following:-1. Click on “Ask a facilitator for help”.

2. This will open a new window in which you will see the facilitators who are logged on.3. Click on any of the facilitators and their name will appear in the message space.

4. Enter your query after the facilitator’s name in the message space and click “Submit”.5. The only person who will see this message is your chosen facilitator.

6. The facilitator’s response to your query will appear in this window - not on the main chat board, so keep this window open.

7. Close this window when you’ve finished talking to the facilitator.


http://www.qub.ac.uk/ceipe/StudentAllocations.doc

4. Interprofessional Medication Safety Presentation

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11© 2009 Belfast Health and Social Care Trust, Northern Health and Social Care Trust, Southern Health and Social Care Trust and Western Health and Social Care Trust

Interprofessional Medication Safety Presentation

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Medication Incident 1 - Vincristine

5. Case Studies

5.1 Medication Incident - Vincristine

In June 1999 Wayne Jowett, 17, was diagnosed with acute lymphoblastic leukaemia and treated at Queen’s Medical Centre, Nottingham; by June 2000 his disease was in remission. He was prescribed maintenance treatment of IV vincristine, intrathecal cytosine and oral prednisolone every 3 months. He was also taking daily 6-mercaptopurine and weekly oral methotrexate.

Between June - December 2000, he missed 2 appointments and there were concerns that he was not taking his medication.

On 22/12/00 he was seen by Dr Myers, a specialist registrar, and chemotherapy was deferred until after Christmas and New Year at Mr Jowett’s request. It was written in the clinical notes that chemotherapy would be ‘4/1/01’. This information was transferred to the ward diary but it was not entered in the ward manager’s chemotherapy diary. This meant chemotherapy was not ordered in advance as was usual practice.

Early on 04/01/01, the day case co-ordinator brought it to the ward manager’s attention that Wayne Jowett’s chemotherapy, like 2 other patients, was due that day and had not been ordered in advance. A prescription was then written by the consultant and sent to Pharmacy. Vincristine was written up for ‘5.1.1.’, and cytosine for ‘4.1.1.’

At 11.30 that day it was realised that Wayne Jowett had not arrived for his appointment with the consultant.

The ward pharmacist had not been informed of the unplanned chemotherapy when he was on the ward, and found the prescription charts on his desk when he returned to Pharmacy. A colleague informed him that someone had called from the ward. This made the pharmacist think that the patient was on the ward or would be soon. As a result, he believed the cytosine was urgently required and made a verbal request that it be sent straight way and that the vincristine be sent afterwards. The pharmacist noted from the prescription chart that Mr Jowett’s vincristine was due for 05/01/01, so he made a note in the pharmacy log that it would be required ‘Fri. am’ and ‘send separately’.

Later in the day, pharmacy received a call from the ward asking for the chemotherapy and the ward day case co-ordinator brought them to the ward in separate clear plastic bags and they were placed in the ward pharmaceutical fridge.

Wayne Jowett arrived unexpectedly on the ward around 1530 for administration of his chemotherapy (usually chemotherapy would be administered in the morning when more of the regular staff were on duty).

A SHO asked Dr Mulhem, a newly appointed registrar, to supervise his administration of the chemotherapy and a staff nurse retrieved both drugs from the pharmaceutical fridge and handed them over to the medical staff.

The SHO administered cytosine intrathecally and then was handed the second syringe by the registrar. This syringe containing vincristine was then administered, in error, intrathecally.

At around 17.15 the error was realised and urgent remedial treatment commenced.

On 2/2/01 Wayne Jowett died as a result of the maladministration.

13© 2009 Queen’s University Belfast

Facilitator’s Notes - Vincristine

5.1.1 Facilitator’s Notes - Vincristine

When incident could have been stopped

Chemo not ordered in usual manner so made in a hurry. No direct communication with the ward pharmacist re the chemo Patient did not attend on time. Desire of staff to help the patient when he turned up late; possibly because of their concerns

that he was non-compliant with his medicines. Intrathecal cytosine and intravenous vincristine made up at the same time and released from

pharmacy at the same time because unconfirmed idea that the patient was on the ward or soon would be.

Pharmacist note in log overlooked re vincristine not needed until ‘Fri am’ and to send separately.

Person issuing did not realise significance of storing separately and neither did person collecting.

Not separated at ward level. Knowledge/awareness of SHO and SpR. Staff nurse not involved in check –saw her role as to get meds from fridge and nothing else.

Again meds not separated so now intrathecal and IV chemo in same room. When handed 2nd syringe SHO may not have questioned because reg handing over –

hierarchy?

Recommendations to stop recurrence

Administration is separated, if possible on different days/times. Pharmacy doesn’t release IV chemo until written documentation that it has been given. IV and IT chemo is administered in different areas. IT chemo is issued directly to the administering doctor. IT is stored separately from any IV chemo. Formal checking of e.g. drug, route, patient etc between Dr and Nurse. Nurse who checks has been trained in checking chemo. Concerns listened to regardless of

grade of staff. Patient also involved and if appropriate relative or guardian. Defined grade of Dr who can administer - SpR and above. National mandatory protocols that all who administer, dispense and prescribe are trained

and show annually updated competence. Also Trusts keep up-to-date register of who can administer, dispense, prescribe and check. Coloured syringes, syringe caps, prescription charts for IT so as to provide visual cue that is

something different. Labelling of syringe of IT drug ‘for intrathecal use only’ and of IV drug ‘For intravenous use

only – fatal if given by other routes’ also route in bold and large font. Also IV chemo not labelled ‘Not for intrathecal use’

IV chemo diluted so that there is a cue that e.g. 20ml too much for IT route. All trained and inducted in intrathecal chemo and also those that have nothing to do with it

know why they cannot become involved in it. Ideally a spinal needle that doesn’t fit an IV syringe so that the connection cannot be made. Realisation that these measures are in place to prevent a catastrophic incident and should

not be worked around; often incidents happen when people go out of their way to be helpful e.g. facilitating late in the day administration of chemo.


Medication Incident 2 – Methotrexate Toxicity

5.2 Medication Incident - Methotrexate Toxicity

The patient developed rheumatoid arthritis in 1982. In 1984 the patient was prescribed Penicillamine by a hospital consultant. Shared care arrangements were put in place between the hospital and primary care. This included the patient holding a results booklet to assist with the monitoring of her treatment. In 1997, after stopping Penicillamine the patient was prescribed Methotrexate by a hospital consultant for treatment of her rheumatoid arthritis. Shared care arrangements were put in place. As part of this arrangement the GP Practice took responsibility for monitoring methotrexate (performing regular blood tests and reporting to hospital). The hospital consultant was responsible for any change in dose. Subsequent repeat prescriptions were provided by the GP and the regular dosage was 17.5 mg Methotrexate per week (7 x 2.5 mg tablets) taken once weekly.

In January 2000, the patient is admitted to hospital for a right total knee replacement. During this admission the patient’s Methotrexate dose and regime was altered with the effect that whilst in hospital the patient took just one Methotrexate tablet during her 8 day admission. The hospital notes indicate this was one 2.5 mg tablet of Methotrexate.

On Thursday 6 April 2000, the patient together with her daughter has a consultation with GP A for phlebitis in her left leg and pain in her right knee. GP A is a locum GP. At the end of the consultation the daughter comments on the change in regime for methotrexate whilst patient was in hospital in January 2000 and explains that this suited her mother well. The daughter asked the GP if methotrexate could be prescribed in such a way that her mother could take fewer methotrexate tablets. GP A agrees and issues a prescription for methotrexate 10mg daily although the intention had been 10 mg ‘as directed’. No record is made in the written patient notes of the change in prescription but 10 mg daily is recorded on the current computer record and the signed prescription shows 10 mg once daily.

Later that day, the patient’s husband visits the local community pharmacy to obtain the revised methotrexate prescription. A Locum Community Pharmacist is on duty, practising alone, and dispenses 30 tablets of Methotrexate 10mg to be taken daily. As this was a new prescription, this action would have required the pharmacist to type into their computer a new dose for the first time.

On Friday 7 April 2000, the patient starts to take one 10mg tablet daily following the directions printed on the medicine bottle.

On Wednesday 12 April 2000, GP B is on duty in the practice signing repeat prescriptions and received a repeat prescription request from the patient. GP B recognised that the dose of methotrexate was incorrect, and interpreted this as a one off error by the staff producing the prescription. It seemed impossible to GP B that such a dose could have been previously prescribed or dispensed. He therefore crossed out the methotrexate on the prescription anticipating that a correct prescription would consequently be presented for signing. GP B did not inspect or change the patient’s computer drug record. A note was attached to the prescription asking practice staff to check the request. The practice is unable to explain why this was not acted upon.

On Thursday 13 April 2000, the patient begins to feel unwell. The following day, the patient’s daughter telephones GP practice and speaks with GP C regarding the patient’s sore mouth and vagina. GP C gives telephone advice and issues treatments on the basis of the telephone conversation. GP C refers to patient’s written medical records during this conversation and records action in those notes; however electronic computer based prescription records were not referred to.



On Saturday 15 April 2000, the General Practice receives a request for home visit to the patient. GP C, the doctor on duty, visits and offers to arrange patient’s admission to hospital. This is



declined by the patient and her family. It is agreed the practice would telephone the patient on Monday if the family have not called sooner. The home visit is conducted with no patient notes to refer to which would be usual practice for a Saturday. GP C makes contemporaneous notes which were stuck into the patient’s medical notes on the following Monday.

On Monday 17 April 2000, GP A visits patient at home (following a request) and takes patient notes. Patient has sore throat and inflammation in her groin area.

On Tuesday 18 April 2000, there is message for GP A from daughter that patient’s condition has worsened. GP A contacts the daughter and discusses patient’s condition over the telephone. GP A arranges admission to a hospital ENT ward because patient’s main symptoms related to her sore throat. GP A has a telephone conversation with Dr D, an ENT junior doctor, at the hospital. GP A faxes Dr D information relevant to the patient’s admission. This fax was not received by Dr D and not followed up. The fax contained no specific reference to methotrexate, but did indicate that the patient would “bring all medication with her’.

At 4.00pm: patient admitted to hospital by Dr D who recorded patient history and drugs brought in by patient (Patient Own Drugs – PODs). Methotrexate 10 mg was noted in the drug history but the frequency was not recorded. Dr D also completed a drugs chart which included a prescription for 100 mg of methotrexate daily. As methotrexate is not held as a stock drug on the ENT ward, the ward decided to use the patient’s own drug which is within hospital procedure. In addition, blood tests were ordered. The full blood count was not analysed by the laboratory, as the sample was not satisfactory. During the night Dr E reviews patient, notes the blood test had been unsuccessful as it had clotted. Dr E takes a second blood sample and sends off to laboratory.

On Wednesday 19 April 2000 at 3.37 am the test on the second blood sample was reported on by the laboratory, when it was recorded as “insufficient for testing, please repeat”. During the morning drug round, Staff Nurse F notes 100mg Methotrexate daily recorded on the patient’s drug chart. Staff Nurse F realised this dose must be incorrect and confirmed with the patient that this should be 10 mg daily. Staff Nurse F then administered 10mg. Staff Nurse F leaves a post-it note for ENT SHO to amend the drug chart. No change is made by SHO on this day.

On Thursday 20 April 2000, Staff Nurse G is responsible for drugs round and notices prescription for Methotrexate 100mg whereas drug bottle marked 10 mg. Staff Nurse G checks with patient, notes Staff Nurse F administered 10 mg. Written ‘post-it’ note for ENT SHO to amend drug chart still attached. Drug chart sent down to Pharmacy later that morning for other drugs that the patient needed. At lunchtime the hospital pharmacy queries methotrexate on receipt of patient’s drug chart. Hospital Pharmacist H realises methotrexate 100mg is wrong and crosses methotrexate off drug chart. Pharmacist H tells Staff Nurse F that the doctor needs to clarify the correct and intended dose. Staff Nurse F passes message to Dr D who telephoned the GP Surgery to check dose and someone (not a GP) at the surgery confirms the dose as 10mg per day after checking the computer records. Dr D amends the dose on the prescription chart to re-prescribe 10 mg Methotrexate once per day. Dr D asks Staff Nurse F why she had not been asked to amend the prescription earlier. Staff Nurse F explained that she had written a note but that this had not been seen and was no longer attached to the drug chart.

On Friday 21 April 2000 (Good Friday), during the ward round, doctors thought the patient’s condition much improved. By this stage patient has been reviewed by two Specialist Registrars (SpRs) and two Senior House Officers (SHOs) during her stay but no evidence yet of consultant review. Ibuprofen was stopped but other drugs not obviously considered. Methotrexate 10mg dose administered.

On Saturday 22 April 2000, Staff Nurse G notes patient had developed a rash over her trunk. The senior nurse on duty asks Staff Nurse G to review the patient’s medication in the BNF. Staff Nurse G contacts Dr E and suggests that methotrexate might be the cause of the patient’s


Medication Incident 2 - Methotrexate Toxicity

problems. Dr E said he thought this was unlikely, however said he would review the patient when he was available and arrives to see the patient 40 minutes later. Dr E examines the patient and reviews the drug history.

Notes blood count results are still outstanding and need to be chased. A third blood sample taken which reveals abnormalities (low blood platelets and low white blood cells). Arrangements are made to transfer the patient to the specialist haematologist team.

On Sunday 23 April 2000, a Haematology/oncology doctor explains poor prognosis to relative(s)

On Wednesday 26 April 2000, the patient’s daughter contacts Cambridgeshire Health Authority Complaints Department

On Sunday 30 April 2000, the patient dies. Death certificates show causes of death to have been

• Gastrointestinal haemorrhage

• Pancytopenia

• Methotrexate toxicity


Facilitator’s Notes - Methotrexate Toxicity

5.2.1 Facilitator’s Notes - Methotrexate Toxicity

When incident could have been stopped

First prescribing First dispensing Patient taking them Repeat prescription request Patient feels unwell

• Telephone consultation• Saturday visit• Monday visit• Admission

Drug history and medical history 100mg daily on Kardex Administration of 10mg daily Blood test Kardex seen in Pharmacy and methotrexate crossed off Dose queried with GP practice Dose re-prescribed Signs of rash Medical review Transfer to haematology ward

Recommendations to stop recurrence

Recommendations to prevent recurrence Prevent daily prescribing Prevent daily dispensing Knowledge of dose and frequency Recognising signs and symptoms of toxicity Patient counselling and understanding of dose,

frequency and side effects Not using POD Follow-up of blood tests Querying dose with GP and reference sources


Medication Incident 3- Heparin

5.3 Medication Incident - Heparin

DAILY MAIL 20 December 2006

‘Inquest told of baby's overdose death’

A baby died after being given an overdose of a blood-thinning drug, an inquest heard today.

Madison Perry, who was two-and-a-half months old, was given 10 times the correct dose of Heparin after nurses misread her prescription.

The premature baby, from Salford, Greater Manchester, was being treated at Liverpool's Alder Hey Children Hospital after undergoing surgery on a heart defect in February last year.

Liverpool Coroners Court heard that the prescription read 1500u, but the nurses mistook the 'u' for an extra zero and administered 15,000 units of the drug accidentally.

The error was not realised until the following day when Madison's condition deteriorated and she died.

Madison's mother, Natalie Perry, wept in court as she heard details of her daughter's death.

The court heard that Nurse Ceri Evans initially calculated the dose correctly at 1500 units. But senior nurse Gavin Proctor read the prescription as 15,000 and corrected her.

The pair then administered the drug via a syringe pump, which delivers the drug over a 24-hour period.

Mr Proctor refused to tell the inquest whether there was anyone more senior with whom the dose could have been checked.

In a statement he added: "I would like to express my sincere sympathy to Madison's family. I am devastated by the events."

The court heard that two other nurses, Kelly Black and Russell Ashworth, took over Madison's care after Nurses Proctor and Evans finished their shifts.

Madison was bleeding from a wound in her back, and blood tests were ordered at around 7.40am on February 26 but not carried out until after 2pm.

Later that day, Madison's heart rate and oxygen levels dropped, and she died at the hospital, the court heard.

Nurse Russell Ashworth said that he was told of the error in the dosage by a colleague, and informed Nurses Proctor and Evans.

He told the inquest: "I have seen the prescription note, and the u is written in such a way that it could be interpreted as a zero.

"I can not say what I would have done in that situation, but they are competent nurses and very professional in my opinion."

The inquest was adjourned until 10.30am tomorrow.


Medication Incident 3 - Heparin

DAILY MAIL 27 Dec 2006

Parents blame 'devastating failures' for baby's death

The parents of a baby killed by an accidental overdose at a children's hospital claimed today she died of "exceptionally poor care".

Two-month-old Madison Perry was given 10 times the correct dose of blood-thinning drug Heparin after nurses at Liverpool's Alder Hey Hospital misread her prescription.

The premature baby, from Salford, Greater Manchester, needed the drug after undergoing successful surgery for a congenital heart defect.

The prescription read 1500U - 'U' meaning units -but the nurses mistook the 'U' for a zero and administered 15,000 units.

The error should have been spotted the following day but blood tests were delayed for a further seven hours, because labels had not been printed. Madison died later that day, February 26, 2005.

Liverpool Coroner Andre Rebello recorded a narrative verdict today, following a two-day inquest in which it emerged that one of the nurses, Ceri Evans, initially calculated the correct dose but was wrongly corrected by the more senior nurse, Gavin Proctor.

It also heard evidence from independent nursing expert, Irene Waters, who criticised the nurses involved.

She said: "Up to the point where Mr Proctor came in there was no apparent confusion.

"I think they needed to highlight that there was a confusion and then, because they were talking about ten times the difference, I would have expected them to look in the BNF (British National Formulary) to confirm the dosage and then ask for the prescription to be changed."

Mrs Waters said Nurse Evans should have challenged Nurse Proctor over the different calculation, even though she was his junior.

She added: "The checking process is for the two nurses to go through together, not for someone to waft in, tick a box and waft out again."

Mrs Waters also criticised Nurse Kelly Black, who failed to collect blood samples.

She said: "She knew she had to get the bloods and I would have expected her to bother someone to get that done.

"It was not negotiable. She had been told to do it and it was required for the care of Madison.

"As it turned out, it was a critical piece of information which might have made a difference."

Nurse Black wiped away tears as Mrs Waters spoke.

Part of Mr Rebello's narrative read: "On the evening of the 25 February the prescription was checked by two nurses and 15000 units of Heparin was administered, in part because when there was a difference in their reading of the prescription, they did not clarify the prescription nor recalculate the appropriate dose.

"An opportunity to detect and treat the overdose of Heparin was missed when appropriate blood ordering and sampling was not appropriately or timely carried out."

In a statement released after the inquest, Madison's parents Nick and Natalie Jones lashed out at Alder Hey, Nurse Proctor and the inquest itself.


Medication Incident 3 - Heparin

They said: "We placed our trust in what we were told would be 'the best hands' at Alder Hey, only for Madison's life to be cut short by exceptionally poor care.

"Since Madison's death we have spent almost two years battling against the hospital trust's obstruction, the continuing arrogance of Gavin Proctor and the constant feeling of being let down at each stage of the investigation, excluding Merseyside Police, including today's inquest.

"We hope the General medical Council and Nursing and Midwifery Council, the regulatory bodies, will apportion the appropriate discipline in answer to the levels of negligence of the staff involved, and also that hospital procedures are enforced to ensure such devastating failures never happen again."

The couple, have married and had another daughter since Madison's death.

They previously won an undisclosed, out-of-court settlement from the Royal Liverpool Children's NHS Trust, which runs Alder Hey.

A spokeswoman for the Trust said today: "The Trust extends its deepest condolences to the family involved.

"Madison's death must be impossible for her parents to bear and the circumstances surrounding her death must make it even more difficult to comprehend.

"We very much regret that this happened and we have undertaken a thorough investigation of the circumstances, with the aim of preventing it happening in the future."

The Trust has imposed new rules since the tragedy, including extra measures to eradicate use of the abbreviation 'U' for units.


Facilitator’s Notes - Heparin

5.3.3 Facilitator’s Notes - Heparin

When the incident could have been stopped

Prescribed as units Check of dose being prepared against reference sources Second check of dose being prepared Pharmacy check of prescription Blood test

Recommendations to prevent recurrence

Prevent units being abbreviated not for prescribing, queried if seen on prescription Use reference sources If not sure about dose clarify with prescriber Training in second check Dose calculators for complex doses Other staff print labels for blood tests Responsibility for checking that tests are taken Responsibility for checking test results


6 PROFESSIONAL STANDARDS AND GUIDANCE FOR THE SALE ANDSUPPLY OF MEDICINES

CONTENTS

Status of this document

About this document

1 Pharmaceutical stock

2 Supply of over the counter (OTC) medicines

3 Supply of prescribed medicines

4 Extemporaneous preparation or compounding

5 Repeat Medication Services

6 Delivery services

7 Prescription Collection Service

8 Complementary Therapies and Medicines

9 Emergencies

10 Patient Group Directions (PGDs)

Guidance that supports this document

Acknowledgement

STATUS OF THIS DOCUMENT

This guidance is addressed to pharmacists but may also help patients and the public understand what they can expect when medicines are either purchased over the counter or supplied on prescription.

Principle 8.8 of the Code of Ethics states that the pharmacist must comply with legal requirements, mandatory professional standards and accepted best practice guidance.This document contains: mandatory professional standards (indicated by the word ‘must’ and ‘have

to’) for all registered pharmacists;

24© 2009 Royal Pharmaceutical Society of Great Britain

and guidance on good practice (indicated by the word ‘should’, ‘might’, ‘may’,

‘would’, ‘will’ and ‘could’) which the pharmacist should follow in all normal circumstances.

Serious or persistent failure to follow this guidance will put a pharmacist’s registration at risk. The pharmacist1 must, therefore, be prepared to explain and justify his actions.If a complaint is made against a pharmacist, the Pharmaceutical Society of Northern Ireland’s (hereinafter named the Society) Fitness to Practise process will take account of the requirements of the Code of Ethics and underpinning documents, including this one. The pharmacist will be expected to justify any decision to act outside the terms set down in these documents

1 ‘Pharmacist’ appears with masculine pronoun and is understood to refer to male/female gender

ABOUT THIS DOCUMENTThe Code of Ethics sets out eight principles of ethical practice that a pharmacist must follow. It provides a framework for professional decision-making and it is the pharmacist’s responsibility to apply the principles to daily work situations, using his professional judgement. The guidance is not meant to be exhaustive, nor can it be.

Principle 1 of the Code of Ethics states that the pharmacist must ‘Make the safety and welfare of patients your prime concern’.

In adhering to this principle, the pharmacist is expected to: ensure the provision of a high standard of professional service by him or those

working under his direct supervision;

provide appropriate treatment and care based on relevant information he has available to him. Where appropriate, consult with other agencies and signpost or refer patients to other health and social care professionals and/or relevant organisations;

ensure as far as possible the clinical appropriateness of medicines supplied to patients and their safe and timely access to them;

promote the safe, effective and rational use of medicines by controlling the sale or supply of all medicinal and related products, especially those with a potential for abuse or dependency;

purchase medicines only from suppliers and sources known to be reputable to ensure the safety, quality and efficacy of products supplied to patients;

ensure he has the facilities, equipment and materials necessary to provide services to professionally acceptable standards; and

ensure he records patient consent either in writing or electronically before providing a professional service.

This document expands on the principles of the Code of Ethics to set out the pharmacist’s professional responsibilities if he is involved in the sale and supply of medicines. It is designed to meet Society’s obligations under relevant legislation.


This document does not detail legislative requirements, but when selling or supplying medicines the pharmacist must comply with relevant legislative and contractual requirements, including Health Service terms of service where appropriate.

1 PHARMACEUTICAL STOCK

STANDARDSPatients, members of the public and other healthcare professionals are entitled to expect that medicines sold or supplied within the course of professional pharmacy practice are obtained from a reputable source, that appropriate distribution processes are followed and that the medicines are fit for the intended purpose.The pharmacist must ensure that:1.1 if he suspects he has been offered or supplied a counterfeit or defective

medicine, this is reported to the Medicines and Healthcare products Regulatory Agency (MHRA), the Department of Health Social Services and Public Safety (DHSSPS) Inspectorate, the Pharmaceutical Society of Northern Ireland (PSNI), the Veterinary Medicines Directorate (VMD) or the marketing authorisation holder as appropriate to the individual situation. Any such stock must be segregated from other pharmacy stock and must not be sold or supplied for the treatment of any person(s) or animal(s);


Professional Standards and Guidance for the Sale and Supply of Medicines

1.2 pharmaceutical stocks is stored under suitable conditions, taking into consideration the stability of the drug and any manufacturers recommendations;

1.3 particular attention is paid to protection of pharmaceutical stock from contamination, sunlight, atmospheric moisture and adverse temperatures;

1.4 in cases of concern about the stability of a medicine, it must be segregated from the rest of the pharmacy stock and not sold or supplied for patient or animal use;

1.5 refrigerators used for pharmaceutical stock must be capable of storing products between 2°C and 8°C, thereby ensuring the maintenance of the “cold chain” and integrity of fridge lines supplied. They must be equipped with a maximum/minimum thermometer, or other suitable alternative, which is checked on each day the pharmacy is open and the maximum and minimum temperature recorded. Steps must be taken to rectify discrepancies and to appropriately dispose any pharmaceutical stock that has been subjected to temperatures outside the terms of SPC recommendations;

1.6 the labelling of all stocks of medicines in the pharmacy with batch and expiry details;

1.7 the removal of medicines from blister or foil packs only, where required, at the time of dispensing, to assist an individual patient. In so doing, the integrity of the medicine must not be impaired;

1.8 the segregation of date-expired stock from the rest of the pharmacy stock and its appropriate disposal;

1.9 the installation of procedures to reduce the risk of short dated or out-of-date stock being accidentally supplied to a patient or member of the public;

1.10 a ban on the sale or supply of products, from registered pharmacy premises, that may be injurious to a person’s health, for example, tobacco products, alcoholic beverages and products intended to mask the signs of alcohol or drug consumption;

1.11 the segregation and appropriate disposal of medicines returned to the pharmacy from a patient’s home, a care home or a similar institution; these medicines must not be supplied to another patient.

1.12 within the hospital setting, all medicines returned to the pharmacy department from a ward or other hospital department are examined under the direction of a pharmacist to assess their suitability for being returned to stock. This also includes ensuring patients’ own medicines brought into hospital with them are not returned to pharmacy stock or supplied to another patient. (Refer to “Use and Control of Medicines”(DHSSPS) 2004 and the “Duthie Report, UK.”)

2 SUPPLY OF OVER THE COUNTER (OTC) MEDICINES

STANDARDSWhen purchasing medicines from pharmacies patients expect to be provided with high quality, relevant information in a manner they can easily understand.The pharmacist must ensure that:



2.1 procedures for sales of OTC medicines enable intervention and professional advice to be given whenever this can assist in the safe and effective use of medicines;

2.2 Pharmacy (P) medicines are not accessible to the public by selfselection;2.3 for a patient or their carer who requests advice on treatment, sufficient

information is obtained to enable an assessment to be made of whether self-care is appropriate, and to enable a suitable product(s) to be recommended;



2.4 if a sale is not considered suitable, the reasons for this are explained to the patient and he/she is referred to another healthcare professional where appropriate;

2.5 on supplying an OTC medicine, sufficient verbal advice is given to ensure its safe and effective use, including specific information on aspects such as safe storage, or short expiry dates;

2.6 all staff involved in the sale or supply of an OTC medicine are trained, or are undertaking the training required for their duties, and are aware of situations where referral to the pharmacist or other registered healthcare professional may be necessary;

2.7 consideration is given to the types of OTC medicines that may require the personal intervention of a pharmacist, for example, those that have recently become available without prescription, those that may be subject to abuse or misuse2, or where the marketing authorisation for non-prescription use is restricted to certain conditions or circumstances;

2.8 all persons involved in the sale of OTC products are aware of the abuse potential of certain OTC medicines and other products including being alert to requests for large quantities and abnormally frequent requests, and knowing to refuse to make a supply where there are reasonable grounds for suspecting misuse and/or abuse;

2.9 the exercise of particular care when supplying products for children, the elderly and other special groups or individuals, or where the product is for animal use;

2.10 the sensitive handling of requests for certain medicines such as emergency hormonal contraception and the respecting of the patient’s right to privacy and confidentiality;

2.11 any information provided about OTC medicines is up-to-date, accurate and reliable;

2.12 he keeps up to date with developments regarding new products and policies for health promotion and is aware of local and major national health promotion initiatives.

GOOD PRACTICE GUIDANCE

Medicines should not be sold to children under 16 years except in exceptional circumstances.

3 SUPPLY OF PRESCRIBED MEDICINES

STANDARDSPatients are entitled to expect the dispensing service provided to be accurate, accessible and reasonably prompt. Appropriate standard operating procedures (SOPs) must be in place for the dispensing services the pharmacist provides3, or is responsible for.

2 For more detailed information refer to:

Substances of Misuse. RPSGB. February 2008. Letter on “Sale and Supply of Medicines Liable to Abuse,” by Dr Michael Mawhinney, Head of Inspection and

Investigation,



DHSSPSNI, posted to all registrants and dated 4 July 2008

3 It is mandatory for a pharmacist to have SOPs in the pharmacy covering all stages of the ‘prescription journey’. Members of

the National Pharmacy Association (NPA) can download a “Guide to writing SOPs – step by step, for community pharmacists.”

Template SOPs are also available from http://www.npa.co.uk.

With the introduction of Responsible Pharmacist Regulations from 1 October 2009, the responsible pharmacist must establish (where these are not already in place) pharmacy procedures designed to ensure the safe and effective running of the pharmacy. These procedures will need to be maintained and regularly reviewed. Refer to www.psni.org.uk/responsiblepharmacist.



The pharmacist must ensure that:3.1 adequate stock holdings are maintained;3.2 a clinical assessment of every prescription is undertaken, by a pharmacist,

to determine the suitability of the medication, the appropriateness of the quantity and its dose frequency for the patient;

3.3 the patient receives sufficient information and advice to enable the safe and effective use of the prescribed medicine;

3.4 appropriate records of clinical interventions are maintained;3.5 patients or their carers are informed if the patient’s prescription can not be

dispensed in its entirety and are given the opportunity to take their prescription to another pharmacy;

3.6 when medication is outstanding, the patient, carer or their representative is provided with a legible note detailing the name and quantity of medicine outstanding and, where possible, informed when the balance will be available for collection. A record of the medicine owed must be kept in the pharmacy. The supply of controlled drugs must be completed within 28 days of the date of issue of the prescription or other appropriate date as indicated by the prescriber on the prescription;

3.7 a product with a marketing authorisation is supplied where such a product exists in a suitable formulation and is available, in preference to an unlicensed product or food supplement;

3.8 except in an emergency, a specifically named product is not substituted for any product without the approval of the patient or carer and the prescriber, a hospital drug and therapeutics committee, or other similar locally-agreed protocols and a record is made in the Patient Medication Record (PMR);

3.9 when providing services for drug misusers the pharmacist does not deviate from the instructions given on the prescription. Sugar and/or colour-free products have a greater potential for abuse than syrup based and coloured products and must not be dispensed unless specifically prescribed;

3.10 all solid dose and all oral and external liquid preparations are dispensed in suitable re-closable child resistant containers unless: the medicine is in an original pack or patient pack such as to make this

inadvisable; the patient has difficulty in opening a child resistant container; a specific request is made by the patient, their carer or representative

that the product is not dispensed in a child resistant container; no suitable child resistant container exists for a particular liquid

preparation; or the patient has been assessed as requiring a compliance aid.

3.11 labelling of dispensed products is clear and legible, computer-generated and where appropriate includes any cautionary and advisory labelling recommended by the current British National Formulary (BNF);

3.12 appropriate systems and procedures are in place if he prepares monitored dosage systems;

3.13 reimbursement claims for Health Service or other professional services are honest and accurate;



3.14 procedures are in place to minimise the risk of dispensing errors or contamination of medicines and a record of errors and ‘near-miss’ incidents must be made and practices reviewed in light of such incidents.

3.15 a patient information leaflet (PIL) is issued with a medicine at the time of dispensing.



GOOD PRACTICE GUIDANCE Where verbal information is provided to a patient about a prescribed medicine

a record of this should be maintained, when clinically appropriate.

4 EXTEMPORANEOUS PREPARATION OR COMPOUNDING STANDARDSThis standard is not intended to cover the reconstitution of dry powders with water or other diluents.Patients are entitled to expect that products extemporaneously prepared in a pharmacy are prepared accurately and are suitable for use.If the pharmacist chooses to be involved in extemporaneous preparation he must ensure that:4.1 a product is extemporaneously prepared only when there is no product

with a marketing authorisation available and where he is able to prepare the product in compliance with accepted standards;

4.2 the pharmacist and any other staff involved are competent to undertake the tasks to be performed;

4.3 the requisite facilities and equipment are available and the equipment is maintained in good order to ensure that it is fit for the intended purpose;

4.4 he is satisfied as to the safety and appropriateness of the formula of the product and its suitability for the patient;

4.5 ingredients are sourced from recognised pharmaceutical manufacturers and are of an acceptable quality for use in the preparation and manufacture of pharmaceutical products, in compliance with relevant legislation;

4.6 particular attention and care is paid to substances which may be hazardous and require special handling techniques;

4.7 the product is labelled with the necessary particulars, including an expiry date and any special requirements for the safe handling or storage of the product;

4.8 if he is undertaking large scale preparation of medicinal products, all relevant standards and guidance must be followed;

4.9 records are kept for a minimum of two years. The records must include: the formula; the ingredients; the quantities used; their source; the batch number; the expiry date the patient’s and prescription details; and the date of dispensing, the personnel involved, including the identity of

the pharmacist taking overall responsibility.4.10 the manufacture of nostrums should take account of guidance issued by

the Society, DHSPPS and other professional bodies and comply with all legal requirements.




Where possible, all calculations and measurements should be double checked by a second appropriately trained member of staff



Where possible, try to validate the formula for the product being prescribed before dispensing from an appropriate source, for example, contact Victoria Pharmaceuticals, Royal Victoria Hospital, Belfast.

5 REPEAT MEDICATION SERVICESSTANDARDSA repeat medication service is operated in co-operation with local prescribers, in which pharmacists will provide professional support to assist in the rational, safe, effective and economic use of medicines.In order to provide a repeat medication service, the pharmacist must:5.1 ensure consent is obtained from the patient or carer before requesting a

repeat prescription from a surgery. The pharmacist may himself establish a patient reminder system;

5.2 ensure the pharmacy operates a patient medication record system notified to the Information Commissioner’s Office4;

5.3 ensure that an audit trail exists to identify each request and supply;5.4 establish, at the time of each request, which items the patient or carer

considers are required and ensure that unnecessary supplies are not made. At this stage the pharmacist must also use his professional judgement to decide whether concordance or other problems encountered by the patient may require early reference to the prescriber;

5.5 record all interventions in order to be able to deal with any queries that may arise. It is good practice to keep records of interventions for up to a year after the intervention occurs.

6 DELIVERY SERVICESSTANDARDSA delivery service is where the medicine is handed to the patient or their carer other than on registered pharmacy premises. When providing medicines via a delivery service the pharmacist still has a professional responsibility to ensure that patients or their carers know how to use the medication safely, effectively and appropriately and to check that they are not experiencing adverse effects or compliance difficulties.The pharmacist must ensure that:6.1 on each occasion a delivery service is provided he uses his professional

judgement to determine whether direct face-to-face contact with the patient or their carer is necessary;

6.2 he obtains consent from the patient to provide the delivery service, confirms consent on each occasion, as appropriate, and maintains appropriate records of requests for the service;

6.3 the delivery mechanism used: enables the medicine to be delivered securely and promptly to the intended

recipient with any necessary information to enable safe and effective use of his medicine;

4 The Information Commissioner’s Office – Northern Ireland, 51 Adelaide Street, Belfast, BT2 8FE. Telephone: 028 9026 9380, Fax: 028 9026 9388, Email: [email protected]


mailto:[email protected]


provides for any special security/storage requirements of the medicine; incorporates a verifiable audit trail for the medicine from the point at which it

leaves the pharmacy to the point at which it is handed to the patient or their carer, or returned to the pharmacy in the event of a delivery failure;

safeguards confidential information about the medication that a patient is taking.


Wherever possible a signature should be obtained to indicate safe receipt of the medicines.

Systems should be in place to inform a patient who is not at home that delivery was attempted.

Refer to the HSC Board’s Guidance on Collection and Delivery services.

7 PRESCRIPTION COLLECTION SERVICESTANDARDSA prescription collection service encompasses any scheme where a pharmacy receives prescriptions other than directly from the patient, their carer or their representative.When providing such a service the pharmacist must:7.1 obtain consent to collect/receive patients’ prescriptions. The request for

the ongoing service must be from the patient or their carer and procedures must exist for maintaining records of the initial request for the service;

7.2 explain fully to patients, or their carers, what the service involves, including the time period required to collect/receive and dispense their prescription;

7.3 ensure that any members of staff who collect prescriptions on his behalf are acting in accordance with his directions;

7.4 take all reasonable steps to ensure patient confidentiality and the security of prescriptions;

7.5 ensure he obtains consent from the patient or carer before requesting a repeat prescription from a surgery. The pharmacist may himself establish a patient reminder system;

7.6 on receipt of prescriptions, including electronic prescriptions, be satisfied that he is authorised to collect/receive and dispense them. Any prescription, for which he does not have the authority, must be returned to the surgery for collection by the patient or carer, or be directed to the pharmacy authorised to receive it;

7.7 where more than one pharmacy is involved in supplying prescriptions a SOP must be in place with detailed governance arrangements.

8 COMPLEMENTARY THERAPIES AND MEDICINESSTANDARDSThe pharmacist must ensure that he is competent in any area in which he offers advice on treatment or medicines.



If the pharmacy sells or supplies homeopathic or herbal medicines, or other complementary therapies, the pharmacist must:8.1 assist patients in making informed decisions by providing them with

necessary and relevant information;8.2 ensure any stock is obtained from a reputable source



8.3 recommend a remedy only where he can be satisfied of its safety and quality, taking into account the MHRA registration schemes for homeopathic and herbal remedies. (Refer to www.mhra.org.uk).

9 EMERGENCIESSTANDARDSThere may be occasions when the pharmacist is required to assist members of the public or patients in an emergency.In such situations the pharmacist must:9.1 give consideration, where appropriate, to using the provision that allows

pharmacists to make an emergency supply of medicines in line with the Medicines Act legislation;

9.2 give consideration to the medical consequences, if any, of not making the supply and be satisfied that his decision will not lead to patient care being compromised;

9.3 make relevant records in relation to emergency supplies in the PMR and in the ‘prescription only record’ book;

9.4 advise the patient on how to obtain essential medical care where he does not consider an emergency supply to be appropriate;

9.5 assist persons in need of emergency first aid or medical treatment whether by administering first aid within his competence or by summoning assistance.

10 PATIENT GROUP DIRECTIONS (PGDS)The legal definition of a PGD is:‘a written instruction for the sale, supply and/or administration of named medicines in an identified clinical situation. It applies to groups of patients who may not be individually identified before presenting for treatment.’Guidance5 issued along with this definition sets the overall context in which PGDs should be viewed:‘the majority of clinical care should be provided on an individual, patient-specific basis. The supply and administration of medicines under PGDs should be reserved for those limited situations where this offers an advantage for patient care without compromising patient safety, and where it is consistent with appropriate professional relationships and accountability.’STANDARDSIf the pharmacist is involved in the supply and/or administration of a medicine under a patient group direction (PGD) he must:10.1 be satisfied that the PGD is legally valid and that it has been approved by

the relevant authorising body for the organisation in which it is being used;10.2 ensure that when supplies are made the agreed protocol is followed and

the information specified in the PGD is recorded. These records must include the identity of the pharmacist assuming responsibility for each supply;

10.3 ensure that he has up-to-date knowledge relating to the clinical situation covered by the PGD, the medicine and its use for the indications specified;



10.4 ensure that PGDs are reviewed, updated and re-authorised, in line with changes to clinical practice;

5 Patient Group Directions: A practical guide and framework of competencies for all professionals using patient group directions. March

2004. www.npc.co.uk/pdf/pgd.pdf


http://www.npc.co.uk/pdf/pgd.pdf


10.4 ensure that he has undertaken any training required for operation of the PGD;

10.5 ensure that the staff training specified will enable safe operation of the PGD.If the pharmacist is involved in writing and/or approving PGDs the pharmacist

is accountable for the content and must ensure that:10.6 he is familiar with his role and responsibilities and the advice set out in

relevant Guidance5;10.7 only PGDs which comply with legal requirements are approved;10.8 the appropriate people have been involved in the drafting, approving and

signing of the PGD. The PGD must be signed by: the doctor and pharmacist involved in developing the PGD; the authorising body for the organisation in which it is being used.

GUIDANCE THAT SUPPORTS THIS DOCUMENTThe Society has produced documents or guidance on the following which should be considered in conjunction with these standards: Code of Ethics for pharmacists Professional Standards and Guidance for Patient Consent Professional Standards and Guidance for Patient Confidentiality.These documents can be downloaded from the Society’s website www.psni.org.uk or telephone us on 02890 326 927 for more information or a hard copy(ies).

ACKNOWLEDGEMENTRPSGB


7 NURSING & MIDWIFERY COUNCIL: STANDARDS FOR MEDICINES MANAGEMENT - SUMMARY

Contents

Summary of standards

Introduction 20

SECTION 1 - Methods of supplying and/or administration of medicinesIncludes standards 1 - 3 21

SECTION 2 - DispensingStandards 4 and 5 22

SECTION 3 - Storage and transportation Standards 6 and 7 22

SECTION 4 - Standards for practice of administration of medicines Standard 8 - 16 22

SECTION 5 - Delegation Standards 17–20 24

SECTION 6 - Disposal Standard 21 24

SECTION 7 - Unlicensed medicines Standard 22 24

SECTION 8 - Complementary and alternative therapies Standard 23 25

SECTION 9 - Management of adverse eventsStandards 24 and 25 25

SECTION 10 - Controlled Drugs Standard 26 25

41© 2009 Nursing & Midwifery Council

Nursing & Midwifery Council: Standards for Medicines Management - Summary

IntroductionStandards for medicines management consists of the following text and a CD-Rom. The booklet provides a summary of all 26 standards, whilst on the CD-Rom you can find the standards, their guidance, and additional information (annexes 1–8) including relevant legislation, additional guidance, and a glossary.

The Nursing and Midwifery Council (NMC) is the UK regulator for two professions: nursing and midwifery. The primary purpose of the NMC is protection of the public. It does this through maintaining a register of all nurses, midwives and specialist community public health nurses eligible to practice within the UK and by setting standards for their education, training and conduct.

One of the most important ways of serving the public interest is through providing advice and guidance to registrants on professional issues. The purpose of this booklet is to set standards for safe practice in the management and administration of medicines by registered nurses, midwives and specialist community public health nurses.

Standards for medicine management replace the Guidelines for the administration of medicines 2004, although many of its principles remain relevant today, for example:

“The administration of medicines is an important aspect of the professional practice of persons whose names are on the Council’s register. It is not solely

a mechanistic task to be performed in strict compliance with the written prescription of a medical practitioner (now Independent / supplementary prescriber). It requires thought and the exercise of professional judgement...”

Many government and other agencies are involved in medicines management from manufacture, licensing, prescribing and dispensing, to administration. As the administration of a medicinal product is only part of the process these standards reflect the process from prescribing, through to dispensing, storage, administration and disposal. There exists an extensive range of guidance on medicines management from a range of relevant bodies and sources of information can be found on the CD-Rom. One of the best sources of advice locally is the pharmacist.

As with all NMC standards, this booklet provides the minimum standard by which practice should be conducted and will provide the benchmark by which practice is measured. Due to the complexity, speed and extent of change in contemporary health care, it is not intended to cover every single situation that you may encounter during your career. Instead, it sets out a series of standards that will enable you to think through issues and apply your professional expertise and judgement in the best interests of your patients. It will also be necessary to develop and refer to additional national/local policies or protocols to suit local needs.

Definitions

A Medicinal product is:“Any substance or combination of substances presented for treating or preventing disease in human beings or in animals. Any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings or animals is likewise considered a medicinal product.” Council Directive 65/65/EEC

Medicines management:“The clinical, cost effective and safe use of medicines to ensure patients get the maximum benefit from the medicines they need, while at the same time minimising potential harm.” (MHRA 2004)

Blood and blood productsBlood is not classified as a medicinal product although some blood components are. Products derived from the plasma component of blood such as blood clotting factors, antibodies and albumin are licensed and classified and are considered to be medicinal products. For the purpose of the



administration of medicinal products registrants would be expected to apply the standards for medicines management to all medicinal products but should consider additional guidance by the National Patient Safety Agency - guidance launched on 09 November 2006; “Right patient, Right blood” (available at www.npsa.nhs.uk). A key requirement of this guidance is that all staff involved in blood transfusion undergoes formal competency assessment on a three yearly basis.

Use of the word “Patient” throughout the documentThroughout this document where the word “patient” is used this refers to whoever the medication may be administered to e.g. patient, client, user, woman (midwifery).

Use of the word “Registrant” throughout the documentThroughout this document where the word “registrant” is used this refers to nurses, midwives and specialist community public health nurses who are registered on the Nursing and Midwifery Council Register.

Summary of standardsThis section provides a summary of the standards, for easy reference. For further detail you should read, follow and adhere to the standards as detailed on the CD-Rom. It is essential that you read the full guidance and you must follow the advice.

SECTION 1Methods of supplying and/or administration of medicines

Standard 1Registrants must only supply and administer medicinal products in accordance with one or more of the following processes:

Patient Specific Direction (PSD)

Patient Medicines Administration Chart (may be called Medicines Administration Record MAR)

Patient Group Direction (PGD)

Medicines Act Exemption

Standing Order

Homely Remedy Protocol

Prescription Forms

Standard 2Registrants must check any direction to administer a medicinal product.

Standard 3As a registrant you may transcribe medication from “one direction to supply or administer” to another form of “direction to supply or administer”.

SECTION 2Dispensing

Standard 4Registrants may in exceptional circumstances label from stock and supply a clinically appropriate medicine to a patient, against a written prescription (not PGD), for self-administration or administration by another professional, and to advise on its safe and effective use.

Standard 5Registrants may use patients’ own medicines in accordance with the guidance in this booklet Standards for medicines management.



SECTION 3Storage and transportation

Standard 6Registrants must ensure all medicinal products are stored in accordance with the patient information leaflet, summary of product characteristics document found in dispensed UK-licensed medication, and in accordance with any instruction on the label.

Standard 7Registrants may transport medication to patients including Controlled Drugs, where patients or their carers/representatives are unable to collect them, provided the registrant is conveying the medication to a patient for whom the medicinal product has been prescribed (e.g. from a pharmacy to the patient’s home).

SECTION 4Standards for practice of administration of medicines

Standard 8As a registrant, in exercising your professional accountability in the best interests of your patients:

You must be certain of the identity of the patient to whom the medicine is to be administered.

You must check that the patient is not allergic to the medicine before administering it.

You must know the therapeutic uses of the medicine to be administered, its normal dosage, side effects, precautions and contra-indications.

You must be aware of the patient’s plan of care (care plan/pathway)

You must check that the prescription or the label on medicine dispensed is clearly written and unambiguous.

You must check the expiry date (where it exists) of the medicine to be administered.

You must have considered the dosage, weight where appropriate, method of administration, route and timing.

You must administer or withhold in the context of the patient’s condition (e.g. digoxin not usually to be given if pulse below 60) and co-existing therapies e.g. physiotherapy.

You must contact the prescriber or another authorised prescriber without delay where contra-indications to the prescribed medicine are discovered, where the patient develops a reaction to the medicine, or where assessment of the patient indicates that the medicine is no longer suitable (See Standard 25).

You must make a clear, accurate and immediate record of all medicine administered, intentionally withheld or refused by the patient, ensuring the signature is clear and legible; it is also your responsibility to ensure that a record is made when delegating the task of administering medicine.

In addition:

Where medication is not given the reason for not doing so must be recorded. You may administer with a single signature any Prescription Only Medicine (POM), General

Sales List (GSL) or Pharmacy (P) medication.

In respect of Controlled Drugs:

These should be administered in line with relevant legislation and local standard operating procedures.

It is recommended that for the administration of Controlled Drugs a secondary signatory is required within secondary care and similar healthcare settings.



In a patient’s home, where a registrant is administering a Controlled Drug that has already been prescribed and dispensed to that patient, obtaining a secondary signatory should be based on local risk assessment.

Although normally the second signatory should be another registered health care professional (for example doctor, pharmacist, dentist) or student nurse or midwife, in the interest of patient care, where this is not possible a second suitable person who has been assessed as competent may sign. It is good practice that the second signatory witnesses the whole administration process. For Guidance, go to: www.dh.gov.uk and search for Safer Management of Controlled Drugs: Guidance on Standard Operating Procedures.

In cases of direct patient administration of oral medication from stock in a substance misuse clinic, it must be a registered nurse who administers, signed by a second signatory (assessed as competent), who is then supervised by the registrant as the patient receives and consumes the medication.

You must clearly countersign the signature of the student when supervising a student in the administration of medicines.

Standard 9As a registrant you are responsible for the initial and continued assessment of patients who are self-administering and have continuing responsibility for recognising and acting upon changes in a patient’s condition with regards to safety of the patient and others.

Standard 10In the case of children, when arrangements have been made for parents/carers or patients to administer their own medicinal products prior to discharge or rehabilitation, the registrant should ascertain that the medicinal product has been taken as prescribed.

Standard 11In exceptional circumstances, where medication has been previously prescribed and the prescriber is unable to issue a new prescription, but where changes to the dose are considered necessary, the use of information technology (such as fax, text message or email) may be used but must confirm any change to the original prescription.

Standard 12As a registrant, you must ensure that there are protocols in place to ensure patient confidentiality and documentation of any text received include: complete text message, telephone number (it was sent from), the time sent, any response given, and the signature and date when received by the registrant.

Standard 13Where medication has been prescribed within a range of dosages it is acceptable for registrants to titrate dosages according to patient response and symptom control and to administer within the prescribed range.

Standard 14Registrants must not prepare substances for injection in advance of their immediate use or to administer medication drawn into a syringe or container by another practitioner when not in their presence.

Standard 15Registrants should never administer any medication that has not been prescribed, or acquired over the internet without a valid prescription.

Standard 16Registrants must assess the patient’s suitability and understanding of how to use an appropriate compliance aid safely.



SECTION 5Delegation

Standard 17A registrant is responsible for the delegation of any aspects of the administration of medicinal products and they are accountable to ensure that the patient or carer/care assistant is competent to carry out the task.

Standard 18Students must never administer/supply medicinal products without direct supervision.

Standard 19In delegating the administration of medicinal products to unregistered practitioners, it is the registrant who must apply the principles of administration of medicinal products as listed above. They may then delegate an unregistered practitioner to assist the patient in the ingestion or application of the medicinal product.

Standard 20Wherever possible two registrants should check medication to be administered intravenously , one of whom should also be the registrant who then administers the IV medication.

SECTION 6Disposal

Standard 21A registrant must dispose of medicinal products in accordance with legislation.

SECTION 10

Controlled Drugs

Standard 26Registrants should ensure that patients prescribed Controlled Drugs are administered these in a timely fashion in line with the standards for administering medication to patients. Registrants should comply with and follow the legal requirements and approved local Standard Operating Procedures for Controlled Drugs that are appropriate for their area of work.

CD-Rom

For full details of the standards for medicines management and their accompanying guidance, as well as additional information (annexes 1–8) including relevant legislation, additional guidance, and a glossary, run the CD-Rom.



SECTION 7Unlicensed medicines

Standard 22A registrant may administer an unlicensed medicinal product with the patient’s informed consent against a patient-specific direction but NOT against a patient group direction.

SECTION 8Complementary and alternative therapies

Standard 23Registrants must have successfully undertaken training and be competent to practise the administration of complementary and alternative therapies.

SECTION 9Management of adverse events

Standard 24As a registrant, if you make an error you must take any action to prevent any potential harm to the patient and report as soon as possible to the prescriber, your line manager or employer (according to local policy) and document your actions. Midwives should also inform their named Supervisor of Midwives.

Standard 25As a registrant, if a patient experiences an adverse drug reaction to a medication you must take action to remedy harm caused by the reaction. You must record this in the patient’s notes, notify the prescriber (if you did not prescribe the drug) and notify via the Yellow Card Scheme immediately.

Contacts

Nursing & Midwifery Council

23 Portland PlaceLondon W1B 1PZ

020 7333 [email protected]

This is Version 1 of Standards for medicines management, which replaces Guidelines for the administration of medicines. This edition was reprinted in August 2008. The standards are essentially broad principles for practice and registrants will need to apply the principles to their own areas of practice. The NMC will keep these standards under review and will notify all registered nurses, midwives and specialist community public health nurses whenever further amendments are made. Review date: August 2010.


8 Good Practice in Prescribing Medicines (2008)September 2008Our booklet Good Medical Practice (2006) sets out in paragraphs 1 to 3 and 20 to 22 the principles that doctors must follow when prescribing medicines.

The guidance below explains how these principles apply in situations that doctors often meet, or find hard to deal with. We propose to review this guidance regularly to ensure that it is up to date and relevant to problems doctors face, and reflect any legal differences across the UK countries. We will publish updated versions on our website. Printed copies are available on request.

The GMC expects doctors to comply with the standards of good practice set out in our guidance. You must be prepared to explain and justify any decision not to follow this advice on good practice in prescribing.

Content

Principles of Prescribing o Avoid treating yourself and those close to you

Keeping up to date and prescribing in patients' best interests Keeping patients' general practitioners informed Doctors' interests in pharmacies Prescribing situations requiring special consideration

o Prescribing controlled drugs for yourself or someone close to you o Prescribing for patients to whom you also dispense o Prescribing unlicensed medicines o Prescribing medicines for use outside the terms of their licence (off-label) o Information for patients about the licence for their medicines o Responsibility for prescribing medicines for hospital outpatients

Patient Group Directions Procedures to simplify the work involved in issuing repeat prescriptions Repeat dispensing Remote prescribing via telephone, email, fax, video link or a website Obesity and private slimming clinics Other published regulations, guidance and information relevant to prescribing

Principles of Prescribing

1. Doctors with full registration may prescribe all medicines, but not those drugs in Schedule 1 of the Misuse of Drugs Regulations 2001. If you have provisional registration you may prescribe medicines in line with the supervisory conditions of your employment. (With the introduction of the licence to practise doctors will have to be both registered and licensed with the GMC to prescribe medicines).

2. For information about the relevant legislation, including the Medicines Act 1968 and the Misuse of Drugs Act 1971, see the Home Office website: www.homeoffice.gov.uk and the British National Formulary: www.bnf.org. Medicines legislation applies throughout the UK.

3. You should only prescribe drugs to meet identified needs of patients and never for your own convenience or simply because patients demand them.

48© 2009 General Medical Council

Good Practice in Prescribing Medicines (2008)

Avoid treating yourself and those close to you

4. Objectivity is essential in providing good care; independent medical care should be sought whenever you or someone with whom you have a close personal relationship requires prescription medicines.

Keeping up to date and prescribing in patients' best interests

5. When prescribing medicines you must ensure that your prescribing is appropriate and responsible and in the patient's best interests. To do this you must: a. Ensure you are familiar with current guidance published in the British National Formulary and

BNF for Children, including the use, side effects and contraindications of the medicines that you prescribe. You should be aware of the guidance about the clinical and cost-effectiveness of interventions published by the National Institute for Health and Clinical Excellence (NICE) in England & Wales; in Wales by the All-Wales Medicines Strategy Group; in Northern Ireland by Department of Health, Social Services and Public Safety; and in Scotland by the Scottish Medicines Consortium and NHS Quality Improvement Scotland (including Scottish Intercollegiate Guidelines Network). In addition the Department of Health has published a report Building a Safer NHS: Improving Medication Safety on the safe use and administration of medicines.

b. Be in possession of, or take, an adequate history from the patient, including: any previous adverse reactions to medicines; current medical conditions; and concurrent or recent use of medicines, including non-prescription medicines.

c. Reach agreement with the patient on the use of any proposed medication, and the management of the condition by exchanging information and clarifying any concerns. The amount of information you should give each patient will vary according to factors such as the nature of the patient's condition, risks and side effects of the medicine and the patient's wishes. Bearing these issues in mind, you should, where appropriate: i. Establish the patient's priorities, preferences and concerns and encourage the patient

to ask questions about medicine taking and the proposed treatment ii. Discuss other treatment options with the patient iii. Satisfy yourself that your patient has been given appropriate information, in a way

they can understand, about: any common adverse side effects; potentially serious side effects; what to do in the event of a side-effect; interactions with other medicines; and the dosage and administration of the medicine; (see Consent: patients and doctors making decisions together)

iv. Satisfy yourself that the patient understands how to take the medicine as prescribed v. Satisfy yourself that the patient is able to take the medicine as prescribed.

6. When prescribing for a patient you should: a. Prescribe dosages appropriate for the patient and their condition b. Agree with the patient arrangements for appropriate follow-up and monitoring where

relevant. This may include: further consultations; blood tests or other investigations; processes for adjusting the dosage of medicines, changing medicines and issuing repeat prescriptions.

c. You should inform the Committee on the Safety of Medicines of adverse reactions to medicines reported by your patients in accordance with the Yellow Card Scheme. You should provide patients with information about how to report suspected adverse reactions through the patient Yellow Card Scheme.

d. Make a clear, accurate, legible and contemporaneous record of all medicines prescribed.



7. If you prescribe at the recommendation of a nurse or other healthcare professional who does not have prescribing rights, you must be satisfied that the prescription is appropriate for the patient concerned and that the professional is competent to have recommended the treatment.

Keeping patients' general practitioners informed

8. If you are not the patient's general practitioner and you accept a patient for treatment without a referral from the patient's general practitioner, then you must: a. Explain to the patient the importance and benefits of keeping their general practitioner

informed b. Inform the patient's general practitioner unless the patient objects c. Where possible inform the patient's general practitioner before any treatment is started,

unless the patient objects to this disclosure.

9. If the patient does not want their general practitioner to be informed, or has no general practitioner, then you must: a. Take steps to ensure that the patient is not suffering from any medical condition or receiving

any other treatment that would make the prescription of any medicines unsuitable or dangerous

b. Take responsibility for providing all necessary aftercare for the patient until another doctor agrees to take over.

Doctors' interests in pharmacies

10. You should ensure that your patients have access to information about your own and (where known) your employers' financial or commercial interests in any pharmacy they are likely to use.

11. Patients should be free to choose from which pharmacy to have their prescribed medicines dispensed. Advice about specialist pharmacies or those that offer collection and delivery services, for example, can be helpful. It might not be practical or clinically appropriate for patients to use alternative pharmacies when in hospital or visiting clinics at which medicines are dispensed free of charge.

12. You must not allow your own or your employers' financial or commercial interests in a pharmacy to influence the way you advise patients. You should not accept any inducement which may affect or be seen to affect the advice you give patients. You must not pressurise patients to use a particular pharmacy in any event, either personally or through an agent, nor should you disparage or otherwise undermine patients' trust in a pharmacy or pharmacist by making malicious or unfounded criticisms.

Prescribing situations requiring special consideration

Prescribing controlled drugs for yourself or someone close to you

13. Doctors should, wherever possible, avoid treating themselves or anyone with whom they have a close personal relationship and should be registered with a GP outside their family. Controlled drugs can present particular problems, occasionally resulting in a loss of objectivity leading to drug misuse and misconduct.

14. You should not prescribe a controlled drug for yourself or someone close to you unless:



a. No other person with the legal right to prescribe is available to assess the patient's clinical condition and to prescribe without a delay which would put the patient's life or health at risk, or cause the patient unacceptable pain, and

b. That treatment is immediately necessary to: i. Save life ii. Avoid serious deterioration in the patient's health, or iii. Alleviate otherwise uncontrollable pain.

15. You must be able to justify your actions and must record your relationship and the emergency circumstances that necessitated your prescribing a controlled drug for yourself or someone close to you.

16. The National Prescribing Centre has published A guide to good practice in the Management of Controlled Drugs in Primary Care (England).

Prescribing for patients to whom you also dispense

17. Your primary duty is to act in your patient's best interests; you must also make efficient use of the resources available to you; you should not prescribe in a manner that conflicts with either of these duties. You should respect patients' freedom to choose where to have their prescribed medicines dispensed. You should not prescribe differently for patients to whom you also dispense for your own or your employers' commercial or financial benefit.

Prescribing unlicensed medicines

18. You can prescribe unlicensed medicines but, if you decide to do so, you must: a. Be satisfied that an alternative, licensed medicine would not meet the patient's needs b. Be satisfied that there is a sufficient evidence base and/or experience of using the medicine

to demonstrate its safety and efficacy c. Take responsibility for prescribing the unlicensed medicine and for overseeing the patient's

care, including monitoring and any follow up treatment (see also paragraphs 25-27 on prescribing for hospital outpatients)

d. Record the medicine prescribed and, where you are not following common practice, the reasons for choosing this medicine in the patient's notes.

Prescribing medicines for use outside the terms of their licence (off-label)

19. You may prescribe medicines for purposes for which they are not licensed. Although there are a number of circumstances in which this may arise, it is likely to occur most frequently in prescribing for children. Currently pharmaceutical companies do not usually test their medicines on children and as a consequence, cannot apply to license their medicines for use in the treatment of children. The use of medicines that have been licensed for adults, but not for children, is often necessary in paediatric practice.

20. When prescribing a medicine for use outside the terms of its licence you must: a. Be satisfied that it would better serve the patient's needs than an appropriately licensed

alternative b. Be satisfied that there is a sufficient evidence base and/or experience of using the medicine

to demonstrate its safety and efficacy. The manufacturer's information may be of limited help in which case the necessary information must be sought from other sources



c. Take responsibility for prescribing the medicine and for overseeing the patient's care, monitoring and any follow up treatment, or arrange for another doctor to do so (see also paragraphs 25-27 on prescribing for hospital outpatients)

d. Make a clear, accurate and legible record of all medicines prescribed and, where you are not following common practice, your reasons for prescribing the medicine.

Information for patients about the licence for their medicines

21. You must give patients, or those authorising treatment on their behalf, sufficient information about the proposed course of treatment including any known serious or common side effects or adverse reactions. This is to enable them to make an informed decision (for further advice, see Consent: patients and doctors making decisions together).

22. Some medicines are routinely used outside the scope of their licence, for example in treating children. Where current practice supports the use of a medicine in this way it may not be necessary to draw attention to the licence when seeking consent. However, it is good practice to give as much information as patients, or those authorising treatment on their behalf, require or which they may see as significant. Where patients, or their carers express concern you should also explain, in broad terms, the reasons why medicines are not licensed for their proposed use. Such explanations may be supported by written information, including the leaflets on the use of unlicensed medicines or licensed medicines for unlicensed applications in paediatric practice produced by the Royal College of Paediatrics and Child Health/Neonatal and Paediatric Pharmacists Group Standing Committee on Medicines.

23. However, you must explain the reasons for prescribing a medicine that is unlicensed or being used outside the scope of its licence where there is little research or other evidence of current practice to support its use, or the use of the medicine is innovative.

24. For specific information on prescribing medicines for children see the websites of the Royal College of Paediatrics and Child Health and the British National Formulary for Children.

Responsibility for prescribing medicines for hospital outpatients

25. Where a patient's care is shared between clinicians, the doctor with the responsibility for the continuing management of the patient must be fully competent to exercise their share of clinical responsibility. They also have a duty to keep themselves informed about the medicines that are prescribed for their patient. They should take account of appropriateness, effectiveness and cost when prescribing any medicine. They should also keep up to date with any relevant guidance on the use of the medicine and on the management of the patient's condition.

26. If you are the doctor signing and issuing the prescription you bear responsibility for that treatment; it is therefore important that, as the prescriber, you understand the patient's condition as well as the treatment prescribed and can recognise any adverse side effects of the medicine should they occur.

27. There should be full consultation and agreement between general practitioners and hospital doctors about the indications and need for particular therapies. The decision about who should take responsibility for continuing care or treatment after initial diagnosis or assessment should be based on the patient's best interests rather than on the healthcare professional's convenience or the cost of the medicine.



Patient Group Directions

28. The majority of clinical care should continue to be provided on an individual, patient-specific basis. The use of Patient Group Directions (PGDs) should be reserved for those limited situations where this offers a distinct advantage for patient care and where it is consistent with appropriate professional relationships and accountability.

29. Patient Group Directions may be suitable for the supply and administration of some injectable medicines. However, the administration of medicines (such as Botox®, Vistabel® or Dysport®) to paralyse muscles which cause wrinkles requires assessment of individual patients’ suitability and (in the event that administration is delegated to a nurse or other person) patient specific directions; general directions which would apply to any patient with an appointment on a particular day are not sufficient.1

Procedures to simplify the work involved in issuing repeat prescriptions

30. Getting repeat prescriptions prepared by other members of the general practice healthcare team/staff or generated by computer can be an efficient way of meeting patients' needs, while reducing demands on doctors' time.

31. It is important that any system for issuing repeat prescriptions takes full account of the obligations to prescribe responsibly and safely and that the doctor who signs the prescription takes responsibility for it. Before signing a repeat prescription you must be satisfied that it is safe and appropriate to do so and that secure procedures are in place to ensure that: a. The patient is issued with the correct prescription; b. Each prescription is regularly reviewed so that it is not issued for a medicine that is no longer

required; c. The correct dose is prescribed for medicines where the dose varies during the course of the

treatment.

32. Arrangements for issuing repeat prescriptions should include suitable provision for monitoring each patient's condition and for ensuring that patients who need a further examination or assessment do not receive repeat prescriptions without being seen by a doctor. This is particularly important in the case of medicines with potentially serious side effects.

Repeat dispensing

33. Repeat dispensing can relieve pressure on doctors' time and make better use of pharmacists' professional skills, as well as being more convenient for patients.

34. You should offer repeat dispensing only to patients for whom it is appropriate, such as those with chronic conditions who are likely to remain stable for the duration of the dispensing period and who take stable, long term medication. Patients on a large number of medicines or who are likely to be hospitalised may be less suited to inclusion in a repeat dispensing scheme.

35. Patients must give consent to be included in a repeat dispensing scheme. You should satisfy yourself that patients understand the implications for confidentiality as well as the clinical and practical effects of inclusion.

36. You should make a record of the dispenser holding the original repeatable prescription form, when you know who they are, so that you can contact them as necessary.



37. As with repeat prescribing, you should ensure that secure procedures are in place to regularly review the prescription, monitor the patient's condition and for further examination or assessment of the patient as necessary.

38. The National Prescribing Centre in England has published Saving time, helping patients: A good practice guide to quality repeat prescribing, Repeat Prescribing Service Improvement Guide, and Dispensing with repeats.

Remote prescribing via telephone, email, fax, video link or a website

39. From time to time it may be appropriate to use a telephone or other non face-to-face medium to prescribe medicines and treatment for patients. Such situations may occur where: a. You have responsibility for the care of the patient b. You are deputising for another doctor who is responsible for the continuing care of a patient

or c. You have prior knowledge and understanding of the patient's condition/s and medical history

and you have authority to access the patient's records.

40. In all circumstances, you must ensure that you have an appropriate dialogue with the patient to: a. Establish the patient's current medical conditions and history and concurrent or recent use of

other medications including non-prescription medicines; b. Carry out an adequate assessment of the patient's condition c. Identify the likely cause of the patient's condition d. Ensure that there is sufficient justification to prescribe the medicines/treatment proposed.

Where appropriate you should discuss other treatment options with the patient e. Ensure that the treatment and/or medicine/s are not contra-indicated for the patient f. Make a clear, accurate and legible record of all medicines prescribed.

41. If you are not providing continuing care for the patient, do not have access to the patient's medical records, or are not deputising for another doctor, you must follow the advice above and, additionally you must: a. Give an explanation to the patient of the processes involved in remote consultations and

give your name and GMC number to the patient b. Establish a dialogue with the patient, using a questionnaire, to ensure that you have

sufficient information about the patient to ensure you are prescribing safely c. Make appropriate arrangements to follow the progress of the patient d. Monitor the effectiveness of the treatment and/or review the diagnosis e. Inform the patient's general practitioner or follow the advice in paragraph 9 if the patient

objects to the general practitioner being informed.

42. Where you cannot satisfy all of these conditions you should not use remote means to prescribe medicine for a patient.

43. If you prescribe for patients who are overseas, you should also have regard to differences in a product's licensed name, indications and recommended dosage regimen. The Medicines and Healthcare products Regulatory Agency issues guidance on import/export requirements and safety of delivery, which you might also need to consider. You should ensure that you have adequate indemnity cover for such practice. You may need to be registered with a local regulatory body in the country in which the prescribed medicines are to be dispensed.



Obesity and private slimming clinics

44. The prescription of anti-obesity medicines should be considered only as part of an overall management plan that includes dietetic assessment and lifestyle management. Specific guidance on medicines used in the treatment of obesity is available in the British National Formulary, from the Royal College of Physicians of London, the National Institute for Health and Clinical Excellence and the Scottish Intercollegiate Guidelines Network, among others.

45. You should note that: a. In England private clinics and doctors who practise solely in the independent sector must be

registered with the Healthcare Commission. Failure to register is a criminal offence. b. The Regulation and Quality Improvement Authority is responsible for registering and

inspecting independent hospitals, clinics and other care services in Northern Ireland. c. The Scottish Commission for the Regulation of Care (also known as the Care Commission)

regulates independent specialist clinics and healthcare services in Scotland. d. Healthcare Inspectorate Wales is the regulator of independent healthcare in Wales.

Other published regulations, guidance and information relevant to prescribing

46. The following organisations all have published material that it is important and relevant to various aspects of prescribing and related issues:

UK Wide British National Formulary (BNF)British National Formulary for Children (BNFC)NHS National Prescribing Centre (NPC) Royal College of Paediatrics and Child Health (RCPCH) Royal College of General Practitioners (RCGP) Royal College of PhysiciansRoyal Pharmaceutical Society (RPS) Home OfficeMedicines and Healthcare products Regulatory Agency (MHRA) Electronic Medicines CompendiumNational Patient Safety Agency (NPSA) British Medical Association (BMA) Dispensing Doctors AssociationMedicines PartnershipDrug and Therapeutics Bulletin

England & Wales National Institute for Health and Clinical Excellence (NICE)

England Healthcare Commission

Wales Healthcare Inspectorate WalesAll-Wales Medicines Strategy Group



N Ireland Department of Health, Social Services & Public Safety

Scotland Scottish Medicines ConsortiumNHS Quality Improvement Scotland (NHS QIS), including Scottish Intercollegiate Guidelines Network (SIGN) Care Commission

Footnotes

1. See Supply and administration of Botox®, Vistabel®, Dysport® and other Injectable medicines in cosmetic procedures, Medicines and Healthcare products Regulatory Agency, and Medicines Matters – a guide to mechanisms for the prescribing, supply and administration of medicines, Department of Health, 2006.

© Copyright General Medical Council 2008. All rights reserved.


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