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1 This document is only valid on the day of printing Title: Purpose: Applicable to: Document Author: Ratified by and Date: Policy for the Secure Management of FP10HP Prescription Forms FP10 prescription forms are controlled stationery and must be handled securely at all times. Loss or misuse of FP10 prescription forms would have clinical and financial impact on individuals and the Trust. These procedures are intended to improve the secure handling of these prescription forms CFT Prescribers and on-medical Prescribers using FP10 prescription pads CFT administration staff ordering and storing FP10 prescription pads Helen Woods, Chief Pharmacist Ellen Wilkinson Medical Director 21 January 2016 Review Date: July months prior to the expiry date Expiry Date: January years after ratification unless there are any changes in legislation or changes in clinical practice Document library location: Related legislation and national guidance: Associated Trust Policies and Documents: Equality Impact Assessment: Training Requirements: Clinical: Medication Management Security of prescription Forms Guidance, HS Security Management Service August 2013 GMC Good Prescribing Guidance 25 February 2013 MC Standards of proficiency for urse & Midwife prescribers Record-keeping CD SOPs Medicines Matters guidelines Reporting of Incidents, accidents & near misses policy Medicines Management Strategy Implementing Supplementary Prescribing within Cornwall Partnership HS Foundation Trust The Equality Impact Assessment Form was completed on 29th May Trust mandatory training programme Page 1 of 22

2 The organisation trains staff in line with the requirements set out in its training needs analysis and published in its Corporate Curriculum. Training which is categorised as statutory or essential must be completed in line with the training needs analysis and Corporate Curriculum. Compliance with statutory and essential training is monitored through the Learning and Development team with monthly manager s reports and staff individual training records twice yearly. Training reports are also submitted quarterly through the Trust Quality and Governance Committee Meeting. Staff failing to complete this training will be accountable and could be subject to disciplinary action. Monitoring Arrangements: The Pharmacy Team will audit epact data for prescribing in CD schedules 2-5 quarterly. Monthly audit of stock holding of FP10s by pharmacy administrator 6 monthly check of FP10 storage in community as part of storage audits. Implementation: Policy will be distributed to MMC members, all prescribers and Service Line Cabinets for implementation. Version Control Version Date Reviewed Changes By Whom Version 2 January 2015 Additions to pages 5, 8 and amendment to appendix C Pharmacy Team / Ellen Wilkinson Version 3 January 2016 Appendix B form updated Helen Woods This document Replaces: MM/005/14 Policy for the Secure Management of FP10HP Prescription Form Page 2 of 22

3 Contents 1. Introduction Background Responsibilities and Requirements Procedure Spoilt or cancelled prescriptions Incident investigations Monitoring References Appendix A Stolen / Lost / Missing Prescription Appendix B - Missing, Stolen and Alterted Alert Appendix C Community FP10 Recording Form Appendix D Inpatient Services FP10 Recording Form (example) Equality Impact Assessment Proforma Initial Screening Page 3 of 22

4 1. Introduction FP10 prescription forms are controlled stationery and must be handled securely at all times. Loss or misuse of FP10 prescription forms would have clinical and financial impact on individuals and the Trust. These procedures are intended to improve the secure handling of these prescription forms. 2. Background The medical director, as head of medicines management, has overall responsibility for access to prescription forms and their secure handling throughout the Trust. All staff involved in handling these prescription forms must ensure that adequate security measures are in place and must identify and address any weakness in local procedures. There must be an audit trail for prescription forms. Security measures will only be adequate if they are capable of preventing misappropriation by: Staff (of all descriptions who may have access to rooms containing FP10 s at any timeincluding outside of hospital / clinic hours e.g. cleaners Contractors (e.g. Locum or agency staff, tradespeople, workmen) Patients Other members of the public The following policy is based on Security of Prescription Forms Guidance, HS Security Management Service, October 2009, updated March 2011, further updated August Responsibilities and Requirements Responsibilities and requirements within the policy are as follows: 3.1 Responsibilities Chief Pharmacist / Accountable Officer for CDs The Chief Pharmacist may delegate responsibility to a nominated person for the management of ordering, receipt, storage, security and distribution to Prescribers but the responsibility for these remains with the Chief Pharmacist. The Chief Pharmacist is responsible for notifying the local security management specialist (LSMS) and HS South West of any lost/missing/stolen prescriptions. Senior Designated Pharmacy staff are responsible for the recovery and destruction of forms and must make regular checks against the list of authorised prescribers. The Accountable officer must inform the local intelligence network of any CD prescription losses. Pharmacy team will monitor epact quarterly for prescribing of schedules 2-5 and complete FP10 storage audits every 6 months. Page 4 of 22

5 LSMS The LSMS is responsible for notifying HS Protect of any lost / missing / stolen prescriptions. The LSMS is responsible for initiating an investigation if required into lost or stolen prescriptions and informing the Director of Finance. Counter Fraud specialist The local Counter Fraud Specialist (LCFS) is responsible for the investigation of any cases of fraud and independent review of this policy and security arrangements. All prescribers The security of prescription forms is the responsibility of both Cornwall Partnership HS Foundation Trust (CFT) and the Prescriber. The Prescriber may choose to delegate responsibility of storage at Team bases to a nominated member of staff but the responsibility for safe storage remains with the Prescriber. All Prescribers have a responsibility to adhere to the CFT policies and procedures regarding the security of prescription forms by treating prescription forms as a valuable HS asset and securing them at all times. Medical staffing department The Medical Staffing Department is responsible for ensuring new doctors are aware of this policy. The Medical Staffing Department is responsible for retrieving FP10 pads from doctors when they leave the employ of the Trust. It is the responsibility of the Prescriber to return all FP10 pads in their keeping when they leave the employ of the Trust. The Medical Staffing Department is responsible for informing CFT s Pharmacy Department of new doctors joining the Trust and doctors who have left the Trust. The Medical Staffing Department is responsible for giving CFT s Pharmacy Department specimen signatures of all new doctors. MP Lead The on-medical Prescribing Lead has responsibility for the register of non-medical prescribers who are employed as such by the Trust and who are currently registered with their professional bodies as non-medical prescribers Medical Director The Medical Director has responsibility for maintaining an up-to-date register of medical prescribers. The Medical Director will inform trust staff of any relevant national or local alerts on missing prescription forms. Page 5 of 22

6 3.2 Requirements Staff who are no longer employed as prescribers must no longer have access to prescription forms. ew prescription forms must not be issued to prescribers who have left or moved employment or have been suspended from prescribing duties and all unused forms relating to that prescriber must be recovered and securely destroyed. 4. Procedure 4.1 Who can write prescriptions? Doctors / Medical Prescribers urse Practitioners who have qualified as independent prescribers. Pharmacist independent prescribers Physiotherapist independent prescribers Podiatrist independent prescribers Health Visitors All prescribing on FP10 prescriptions must use generic drug names except anti-convulsants and Lithium which must be prescribed branded. FP10 prescriptions must not be used to order food items or other preparations which are not drugs, or appliances other than those specified in the Drugs Tariff. CFT Trust policy is that FP10s are only to be used to initiate and stabilise medication and to make urgent changes to medication. on-urgent changes to medication should be facilitated via a formal written letter to the GP. GMC Guidance states that doctors must, wherever possible, avoid treating themselves or anyone with whom they have a close personal relationship and must be registered with a GP outside their family. on-medical Prescribers (MPs) will not prescribe any medicine for themselves or anyone with whom they have a close personal or emotional relationship (other than in exceptional circumstances). The correct route for a staff member to obtain essential medicines is either via Occupational Health or via the GP. 4.2 Ordering The Chief Pharmacist allocates each prescriber a unique RJ8 number. The RJ8 code is entered on to an Organisation Site Code Spread sheet which is sent to the Data Quality Team Leader based at RCHT who in turn forwards it to the Organisation Data Service (ODS). The ODS gives the go ahead to create the specific code which is then set up by a member of the Organisational Data Team. FP10 pads are ordered via the website by the CFT nominated person who is registered with the HS Business Authority. Page 6 of 22

7 Order quantities must not be excessive to reduce security risk of holding too many prescription forms in stock. 4.3 Delivery Delivery is only made by the contracted secure printer for the HSBSA ( HS Business Services Authority) to the agreed delivery point at CFT Trust Headquarters, Fairview House, Corporation Road, Bodmin. Designated staff must always be in attendance when a delivery arrives. Deliveries must only be accepted by designated reception staff at CFT HQ who will immediately notify the Pharmacy Team of their arrival. Deliveries will be held securely at CFT HQ and collected at the earliest opportunity by a Pharmacy Team member who will immediately and thoroughly check against the delivery note to ensure that the appropriate type of prescription form and the correct number of FP10 pads have been received. The delivery must not be signed for if the packaging is broken. Any discrepancies must be noted on the driver s delivery note and immediately queried with the supplier and documented in CFT records. If the forms do not arrive when expected, usually within six working days of the order being placed, the suppliers must be notified so that enquiries can be made at an early stage. 4.4 Receipt On receipt at the Pharmacy Department the serial numbers must be checked against the delivery note, and details of the delivery recorded promptly in the Pharmacy held database. Clear records must be kept of all stock ordered, received and distributed, including: What has been ordered Date of delivery. What has been received, including the first and last serial numbers of each FP10 pad. 4.5 Storage and Security Each CFT consultant is allocated their own unique RJ8 code and only they and prescribers working directly under them should use this code. Prescribers are responsible for the security of prescription forms once issued to them. Stocks should be securely stored as soon as practicable and treated as controlled stationery, with access limited to those responsible for prescription forms. As a minimum, prescription forms should be kept in a locked cabinet within a lockable room or area. Keys or access rights must be strictly controlled and recorded, to allow a full audit trail in the event of any security incident. Regular monthly stock audits must be carried out. Records of serial numbers received and issued should be retained for at least 3 years. Prescribers must hold as few prescription forms as is practical, to reduce the risk of loss or theft or in the event of theft the impact is minimised. Page 7 of 22

8 Blank prescriptions must never be signed in advance and must not be left at care homes. Prescribers must not allow anyone to be left alone with an unsecured and uncompleted prescription. When making home visits or attending outpatient clinics, prescribers working in the community must take suitable precautions to prevent the loss or theft of forms, such as ensuring prescription pads are carried in a lockable carrying case or are not left on view in a vehicle. If they have to be left in a vehicle, they should be stored in a locked compartment such as a car boot and the vehicle should be fitted with an alarm. Prescribers on home visits should also, before leaving their base, record the serial numbers of any prescription forms / pads they are carrying. Only a small number of prescription forms should be taken on home visits or to outpatient clinics, ideally less than 6, to minimise the potential loss. Unused prescriptions must be locked away at the clinical base at the end of the working day or if this is not possible, then alternative arrangements are acceptable provided they are at least as equally secure. Ward FP10 pads should be stored securely and a log completed for each prescription written. The Ward Manager holds responsibility for the security and management of the FP10 pad on ward. The Ward Manager is responsible for checking that all patients supplied with an FP10 are under the care of the Consultant and are on a ward. The urse in Charge and prescriber must record the issue of an FP10 on Annex D. 4.6 Distribution of prescription forms within the Trust Prescribers should be issued with no more than three months supply of FP10 prescription pads, based on their typical usage, unless exceptional circumstances exist (e.g. covering staff shortages or covering additional clinics for a significant period of time). Supplies of FP10 pads must be collected in person from the Pharmacy Department at Bellingham House, Bodmin Hospital. Medical and on-medical Prescribers / Team administrators / medical secretaries must telephone or a request for a supply of FP10 pads to the Trust s nominated person, giving the name of the prescriber authorised to use them, the RJ8 code, number of pads and date required. Medical and on-medical Prescribers / Team administrators / medical secretaries must agree with the Trust s nominated person the name of the staff member who will be collecting the FP10 pad(s) from the Pharmacy Department, together with the date / time of collection. The staff member collecting the FP10 pad(s) must carry and produce photo identification. The staff member will then check the first and last serial numbers of each FP10 pad that is being collected and sign for receipt. Each pad of FP10s will be issued to the prescriber with a Community FP10 Recording Form (see Appendix C). All community FP10 logs should be returned to the Pharmacy Administrator at Bellingham House once they are completed. False or incomplete recording may lead to action being taken against the member of staff responsible. The Trust s nominated person will record the issue of the FP10 serial numbers in the register. Page 8 of 22

9 4.7 Issuing of FP10s The Prescriber is responsible for recording the issue of each FP10 prescription (see Annex C) detailing the prescription number, date, name of issuing doctor and patient ID. The Prescriber is responsible for either uploading the FP10 on to the RiO progress notes or recording details of the prescription number and full details of the medication, including quantity prescribed, on RiO Secure Handling within the Prescriber s base The Prescriber is responsible for the security of prescription forms held within the base but may choose to delegate responsibility of storage to a nominated member of staff, such as a medical secretary. The Prescriber remains responsible. FP10 pads must be kept in a locked storage unit when not in use. These records must be kept at the local base for at least 3 years 5. Spoilt or cancelled prescriptions Spoiled or cancelled prescription forms should be retained for audit purposes with Annex C. Indicate on Annex C that the prescription was cancelled. Personalised forms which are no longer in use should be returned to the Pharmacy Department to be securely destroyed (e.g. by shredding) with clear records kept of serial numbers returned. The Pharmacy Team must make a record of the serial number of the forms destroyed. The destruction of the forms must be witnessed by another member of staff. Both staff must sign for destruction. Records of forms destroyed must be kept for at least 18 months. 5.1 Loss or theft of prescription forms The loss or theft of prescription forms must be investigated immediately, and reported to the Chief Pharmacist. The reporter must detail the prescription number or numbers involved. The Chief Pharmacist will complete an incident form, notify HS South West and notify local security management specialist (LSMS) who will in turn notify HS Protect as appropriate. The LSMS will notify HS Protect using the missing/lost/stolen prescription notification form (Annex B) and initiate an investigation, if required. HS Protect may advise the Prescriber to write and sign all prescriptions in a particular coloured ink for the next two months. The Director of Finance must also be informed. A flowchart of actions required by staff is included as Annex A and the latest HS advice, the Security Management Service document Security of Prescription Forms Guidance OCT 2009, (updated March 2011) further updated August A Trust incident or near miss report must be completed. The Medical Director will inform Trust staff of any relevant national or local alerts on missing prescription forms. The LSMS must also inform the LCFS who, if appropriate, will issue an alert notice to relevant pharmacies. Page 9 of 22

10 6. Incident investigations Trust staff must be encouraged to report any concerns, incident or near-miss involving prescription forms on the Trust s incident reporting system. Incidents involving controlled drugs must also be reported to the Chief Pharmacist as Accountable Officer for Controlled Drugs. The Accountable Officer for Controlled Drugs must share any prescription losses with the local intelligence network. The level of investigation into missing / lost / stolen prescription forms will depend on the nature of the incident. The LSMS / Counter Fraud Specialist with the Chief Pharmacist will assess the motive for the loss / theft as part of the investigation. Trust staff may also report any concerns about fraud to the confidential HS Fraud and Corruption Reporting Line on See latest HS guidance, such as the SMS document Security of Prescriptions Forms Guidance, Oct 2009, (updated March 2011) further updated August Monitoring The Pharmacy Team will review epact data quarterly for all prescribing of Schedule 2-5 controlled drugs. All epact data detailing items prescribed on FP10 will be shared with the individual prescriber, their line manager / supervisor and MP Lead / Medical Director. 8. References Security of prescription Forms Guidance HS Security Management Service, Oct 2009, (updated March 2011) further updated August cription_forms_guidance_updated_august_2013.pdf Page 10 of 22

11 Appendix A Stolen / Lost / Missing Prescription Annex A - Stolen/Lost/Missing Prescription 1. Prescriber/HS staff discovers prescription form is missing/stolen. 2. Designated individual at the health body, Accountable Officer for Controlled Drugs and police notified as required. 3. Health Body initiates local notification/alert process 4. Person responsible at health body for initiating notification/alert process reports the stolen/lost/ missing prescription form(s) to the LSMS using the notification form at Annex B 9. ASMS passes information on to LSMS to start investigation. 5. LSMS initiates investigation as appropriate and sends the notification form to HS Protect by at prescription@nhsprotect. gsi.gov.uk for input on the HS Protect database. 5a. LSMS initiates HS Protect national alert process if necessary. 8. PRS Admin refers information to ASMS if not on database 6. Database is updated with information of stolen/ lost/missing prescription forms by PFT Admin Officer. 5b. LCFS is notified via HS Protect alert process. 7. Pharmacy Reward Scheme Administrator (cases of theft reported via scheme identified). PRS check database Database For Information. HS Protect CIU, CFS Pharmacy Reward Scheme Administrator LCFS and HS Security Management staff all access the database for intelligence, investigation, case management, enquiry and validation. Page 11 of 22

12 Appendix B - Missing, Stolen and Alterted Alert [email protected] Missing, Stolen & Altered Alert Date of Alert Web Availability CFT Tel o Issued By For Circulation to: (Please specify) Cornwall Community Chemists Prescribers Details: Prescribers ame: Prescribers Address: Prescribers Telephone umber: Prescriber will write in red ink until: Details of when the prescription went missing: Prescription details: Prescription Serial umber: Prescription Type: FP10HC, code RJ8 Medication on prescription: Patients Initials & road of address: Action to be taken: If you are presented with a possible stolen prescription please contact the Chief Pharmacist for Cornwall Partnership HS Trust on or the police on 101 or 999 as appropriate. Any pharmacy or dispensing practice detecting and retaining a fraudulent prescription, and informing the correct channels may be eligible for a reward payment of up to For further information regarding the reward scheme, please contact HS Counter Fraud Service on Please return completed form to South Central and West CSU via [email protected] who will Page 12 of 22

13 ensure notification of stakeholders Document Reference Code: MM/005/16 Page 13 of 22

14 Appendix C Community FP10 Recording Form FP10 Code FP10 o. Received by Issuing Doctor Patient ID Date Issued Page 14 of 22

15 I certify that this is a complete and accurate record of usage of the above numbered prescriptions. I understand that if I have given false and / or incomplete information action may be taken against me. Signed: Dated: Page 15 of 22

16 Appendix D Inpatient Services FP10 Recording Form (example) 1-50 FP10 Code FP10 umber Ward Patient ID Ward Manager verification that patient under care of consultant and on ward. Medication prescribed Reason for use of FP10 (e.g. non-delivery of medication from RCHT) Prescriber name (please print) Second urse in Charge name (please print) 1 2 Page 16 of 22

17 Equality Impact Assessment Proforma Initial Screening ame of Procedural document to be assessed: Section: Officer responsible for the assessment: Policy for the secure management of FP10HP prescription forms Clinical: Medication Management Helen Woods Date of Assessment: 24 March 2014 Is this a new or existing procedural document? E 1. Briefly describe the aims, objectives and purpose of the procedural document. 2. Are there any associated objectives of the procedural document? Please explain. 3. Who is intended to benefit from this procedural document, and in what way? 4. What outcomes are wanted from this procedural document? 5. What factors/forces could contribute/detract from the outcomes? 6. Who are the main stakeholders in relation to the procedural document? To ensure the security of prescription forms against theft and abuse in Cornwall Partnership HS Trust. o Prescription form theft and misuse is an area of concern for the HS as these forms can be used to obtain drugs illegally, often controlled drugs (CDs), for misuse. Most patients legitimately obtain a signed prescription form from an authorised prescriber for a medical condition; however a small minority may attempt to obtain prescription forms nonlegitimately (e.g. by theft or fraud) to acquire drugs (particularly CDs for recreational use) and/or medical items or to sell the prescription forms illegally so that others might obtain drugs. Stolen prescription stationery, forgeries and drugs that are fraudulently obtained from a forgery are likely to be sold for substantial financial gains. Secure management of prescription forms in Cornwall Foundation Trust. CFT staff not being aware of the potential for abuse of blank prescription forms and not managing prescription forms securely. Prescribers, on Medical Prescribers and their administration teams Page 17 of 22

18 7. Who implements the procedural document, and who is responsible for the procedural document? 8. Are there concerns that the procedural document could have a differential impact on RACIAL groups? What existing evidence (either presumed or otherwise) do you have for this? Medicine Management Committee Helen Woods Chief Pharmacist Ellen Wilkinson Medical Director All CFT staff who order,hold or manage supply of HS prescriptions forms must do so securely irrespective of racial group. ational guidelines HS Security Management Service Security of Prescription Forms Guidance Are there concerns that the procedural document could have a differential impact due to GEDER What existing evidence (either presumed or otherwise) do you have for this? 10. Are there concerns that the policy could have a differential impact due to DISABILITY? What existing evidence (either presumed or otherwise) do you have for this? 11. Are there concerns that the policy could have a differential impact due to SEXUAL ORIETATIO? What existing evidence (either presumed or otherwise) do you have for this? 12. Are there concerns that the procedural document could have a differential impact due to their AGE? What existing evidence (either presumed or otherwise) do you have for this? All CFT staff must follow Trust guidance irrespective of gender to ensure the security of prescription forms. All CFT staff must follow Trust guidance irrespective of disability to ensure the security of prescription forms. All CFT staff must follow Trust guidance irrespective of sexual orientation to ensure the security of prescription forms. All CFT staff must follow Trust guidance irrespective of age to ensure security of prescription forms Page 18 of 22

19 13. Are there concerns that the procedural document could have a differential impact due to their RELIGIOUS BELIEF? What existing evidence (either presumed or otherwise) do you have for this? 14. Are there concerns that the procedural document could have a differential impact due to their MARRIAGE OR CIVIL PARTERSHIP STATUS? (This MUST be considered for employment policies). What existing evidence (either presumed or otherwise) do you have for this? 15. Are there concerns that the procedural document could have a differential impact due to GEDER REASSIGMET OR TRASGEDER ISSUES? What existing evidence (either presumed or otherwise) do you have for this? 16. Are there concerns that the procedural document could have a differential impact due to PREGACY OR MATERITY? What existing evidence (either presumed or otherwise) do you have for this? All CFT staff must follow Trust guidance irrespective of age to ensure security of prescription forms All CFT staff must follow Trust guidance irrespective of their marriage or civil partnership status to ensure security of prescription forms All CFT staff must follow Trust guidance irrespective of their Gender reassignment or transgender issues to ensure security of prescription forms All CFT staff must follow Trust guidance irrespective of their pregnancy or maternity status to ensure security of prescription forms Page 19 of 22

20 17. How have the Core Human Rights Values of: All CFT staff must follow Trust guidance to ensure security of prescription forms and this will not infringe their Core Human Rights Values. Fairness; Respect; Equality; Dignity; Autonomy Been considered in the formulation of this procedural document/strategy If they haven t please reconsider the document and amend to incorporate these values. Page 20 of 22

21 18. Which of the Human Rights Articles does this document impact? What existing evidence (either presumed or otherwise) do you have for this? How will you ensure that those responsible for implementing the Procedural document are aware of the Human Rights implications and equipped to deal with them? 19. Could the differential impact identified in 8 13 amounts to there being the potential for adverse impact in this procedural document? 20. Can this adverse impact be justified on the grounds of promoting equality of opportunity for one group? Or any other reason? If Yes, describe why, and then proceed to a full EIA. The right: To life; ot to be tortured or treated in an inhuman or degrading way; To be free from slavery or forced labour; To liberty and security; To a fair trial; To no punishment without law; To respect for home and family life, home and correspondence; To freedom of thought, conscience and religion; To freedom of expression; To freedom of assembly and association; To marry and found a family; ot to be discriminated against in relation to the enjoyment of any of the rights contained in the European Convention; To peaceful enjoyment of possessions and education; To free elections Ensuring security of prescription forms will not impact on CFT staff Human Rights Articles. Trust mandatory training programme Page 21 of 22

22 21. Should the procedural document proceed to a full equality impact assessment? If o, are there any minor further amendments that should take place? 22. If a need for minor amendments is identified, what date were these completed and what actions were undertaken o Signed (completing officer) Helen Woods Date 29 May 2014 Signed (Service Lead) Date Page 22 of 22