Clinical Prescribing Controlled Drugs: Standard Operating Procedure Document Control Summary Status: Version: Author/Owner/Title: Approved by: Ratified: Related Trust Strategy and/or Strategic Aims Implementation Date: Review Date: Key Words: Associated Policy or Standard Operating Procedures New Reformatted from original Controlled Drugs Policy v1.0 Date: December 2015 Mo Azar Deputy Director of Pharmacy Policy and Procedures Committee Date: 18/02/2016 Policy and Procedures Committee Date: 18/02/2016 Medicines Optimisation Strategy January 2016 January 2019 CD, controlled drugs, prescribing, prescription, legal requirements, discharge, leave, substance misuse, CSMT, methadone, buprenorphine, instalment, FP10, methylphenidate Medicines Code Trust Formulary All other CD SOPs Non-Medical Prescribing Policy Trust s Leave/Discharge CD Prescription Form Contents 1. Introduction... 3 2. Purpose... 3 3. Scope... 3 4. Procedure... 4 4.1 Prescribing Controlled Drugs for In-Patients... 4 4.2 Prescribing for Leave or Discharge... 4 4.3 Prescribing for Outpatients... 5 4.4 Prescribing for Prisoners... 7 4.5 Private Prescribing... 7
5. Process for Monitoring Compliance and Effectiveness... 8 6. References... 8 Change Control Amendment History Version Dates Amendments 1 December 2015 Reformatted and updated to new SOP layout. Page 2 of 8
1. Introduction In order for the safe and secure handling of controlled drugs to be robust, there are a number of restrictions placed upon the healthcare professionals who prescribe them as well as restrictions on the prescriptions themselves. The restrictions are intended to aid identification of fraudulent prescriptions from persons attempting to obtain controlled drugs from legitimate providers for criminal purposes. This procedure should be read in conjunction with all other CD SOPs, the Trust Formulary and the Medicines Code. Non-Medical Prescribers should also work within the context of the Non-Medical Prescribing Policy and Procedures and, for this area of practice, must be registered with the Trust (see that policy). 2. Purpose This SOP attempts to provide healthcare professionals within the Trust an easy to follow reference point for the legal requirements set out in the Misuse of Drugs Regulations 2001. Prescriptions for CDs that do not comply with all the requirements set out in the Regulations will not be dispensed and must be returned to the prescriber for correction/replacement. Pharmacists working with hospitals and community pharmacies have the right to refuse to dispense a prescription that does not meet all legal requirements and on the whole are not able to accept verbal alterations or make corrections themselves. It would be illegal for them to attempt to dispense from an illegally written prescription. It is not legal to dispense from faxed prescriptions either; as such incorrectly written CD prescriptions result in significant delays and inconvenience for the patient and/or their carers. 3. Scope This SOP sets out who has the authority to prescribe controlled drugs within the Trust. Prescriptions must only be written by practitioners legally able to prescribe and must be clearly legible, indelible and signed by hand. This SOP also only refers to Schedule 2 and Schedule 3 CDs. Prescribing of Schedule 4 and 5 CDs do not have additional prescribing restrictions to other medicines except however they are valid for only twenty-eight days from the date of prescription and no more than one month s supply should be prescribed at any time. Schedule 1 CDs have no established medicinal purpose and are therefore excluded from this SOP and may only be utilised with special Home Office permission. Within such a large organisation as SSSFT with its broad range of services, there will be a number of scenarios where controlled drugs may need to be prescribed. This procedure sets out the basic requirements; however, local procedures may be required to ensure safe practice can be undertaken. Local SOPs around CD prescribing shall not, however, permit practice outside of the law or be less restrictive than this SOP. The Trust s Controlled Drugs Accountable Officer (supported by the Medicines Optimisation Committee) shall be informed of local procedures and is required to sign them off along with the clinical lead for the service. For inpatient mental health and specialist services at St George s Hospital, The Redwoods Centre and George Bryan Centre, doctors of all grades including FY1 may prescribe controlled drugs on the Medicines Treatment and Record Sheet (or other Trust approved medicine card) for administration to inpatients. FY1 doctors (and any other doctor without Page 3 of 8
full UK registration with the GMC) may not prescribe for leave or discharge or for any outpatient. With regards to Non-Medical Prescribers (NMPs), supplementary NMPs of all professions working under clinical management plans (where the controlled drug is specified) may prescribe in any patient setting. Independent NMPs (nurses or pharmacists) may also prescribe controlled drugs provided it is included within their personal service-specific formulary as agreed with the Trust s NMP Lead and Medicines Optimisation Committee. 4. Procedure 4.1 Prescribing Controlled Drugs for In-Patients For inpatients at St George s Hospital, The Redwoods Centre and George Bryan Centre, CDs can be prescribed on the Trust s Medicines Treatment and Record Sheet (or other Trust approved medicines card) by any grade of medical staff employed at the Trust. The written prescribing requirements are the same as for other medicines see details set out in the Medicines Code. NB: as with all other treatments, when prescribed for as required use in the PRN section the full details for the reason for administration, minimum interval between doses and maximum daily dose permitted must be stated for the prescription to be valid. 4.2 Prescribing for Leave or Discharge Prescriptions for CDs (Schedules 2 and 3) for patients who are going home (leave or discharge requests/prescriptions) should be written on locally approved prescription forms for dispensing by pharmacy (for the hospital pharmacies at St Georges Hospital and The Redwoods Centre see the CD Prescription Form associated with this SOP). The Form has been laid out to support prescribers to meet the legal requirements in full; no sections should be left blank. It is not permissible to try to use the Medicines Treatment and Record Sheet for prescribing Schedule 2 or 3 CDs; whether this be the numerical codes used for leave requests or the back page used for discharge. However, in order for a complete record of prescribing to be collated for purposes of medicines reconciliation at discharge, the CDs in question shall be stated with the rest of the medicines in any communication to GPs and clinicians in the community teams. Nursing staff (and other professionals not granted prescribing rights for CDs) may not request Schedule 2 or 3 CDs when ordering leave medicines on the Medicines Treatment and Record Sheet. This applies no matter what quantity of supply is requested or periods as short as one dose; a completed CD Prescription Form is required. Medical staff employed by the Trust who have not achieved full registration with the GMC are not permitted to prescribe CDs for leave or discharge or for outpatients. Ordinarily a maximum of 14 days supply should be prescribed as a matter of good practice; however smaller quantities may be appropriate where risks to the patient are identified. Where the prescriber believes that it is in the clinical interest of the patient to prescribe for more than 14 days and would not pose an unacceptable threat to patient safety, the prescriber should make a note of the reasons in the patient s notes, and fulfil criteria set out in the Medicines Code. No CD prescriptions (i.e. Schedules 2, 3 and 4) shall be for longer than 30 days supply. Page 4 of 8
Leave or discharge prescriptions for substance misuse patients (e.g. for methadone, generic buprenorphine sublingual tablets, Subutex or Suboxone ) should only be written in exceptional circumstances, with a clear rationale documented in the notes, and then only in sufficient quantity to cover until the patient can access their regular supply. Discuss the situation with a member of the Pharmacy and Medicines Optimisation Department and maintain clear communication to the community substance misuse team (CSMT) involved with the patient s care. It is best practice for adequate liaison to be made with the CSMT, prior to leave or discharge being arranged (i.e. from admission), so that prescribing, dispensing and any supervised administration arrangements can be re-instated at the usual community pharmacy. Supplies for leave or discharge from the hospital carry a number of risks The community supply not being re-instated in a timely manner (and separate from the GP) Duplication with the supply from the CSMT/community pharmacy and risk of overdose or diversion to improper uses The service user should be informed of the arrangements so that they know from where their next supply will be available. It is also important to liaise with the CSMT if the service user is re-admitted. The risks posed from omission of a dose are always considered lower than the risks of overdose from repeated doses or for those whose concordance, and as such tolerance, has been impaired. 4.3 Prescribing for Outpatients Prescriptions for CDs for outpatients must be written in accordance with the requirements of the Misuse of Drugs Regulations 2001 (i.e. prescriptions for Schedule 2 and 3 CDs must conform to the particulars required for a controlled drug). For NHS services which are not involved in the supply of substitute opioids for substance misuse, a FP10 prescription form shall be used and forwarded to a community pharmacy to dispense. The original prescription must be used; it shall not be faxed to the community pharmacy. Until such time as the service level agreement is ceased, where the hospital pharmacies at Queen s Hospital Burton, Sir Robert Peel Hospital Tamworth and Samuel Johnson Hospital Lichfield are accessed to dispense controlled drugs for outpatients, then their locally approved outpatient prescription forms may be used in accordance with the procedures of those hospitals. A prescription for Schedule 2 and 3 CDs must contain the following details, written so as to be indelible, i.e. written by hand in permanent ink, typed or computer-generated: The patient s full name, address and, where appropriate, age. If the patient is homeless then NFA is considered acceptable in place of the address The name and form of the drug, even if only one form exists The strength of the preparation, where appropriate The dose to be taken (NB: as directed on its own is not acceptable. Aim to be as specific as possible but at the minimum state one as directed or one each day ) The total quantity (max 30 days supply) must be written in both words and figures. If the medicine is in dosage units (e.g. tablets, capsules, millilitres etc.) the Home Office advises this must be expressed as the number of dosage units (e.g. 10 tablets of 10mg rather than 100mg total quantity). The total quantity can be expressed as the multiplication of two numbers, e.g. 2 packs of 30 tablets; two packs of thirty tablets ). Liquids should be expressed as millilitres In addition, it is good practice to include the patient s NHS number on the prescription. Page 5 of 8
The prescription must be signed by the prescriber with their usual signature, in their own handwriting (this must be handwritten, not computer generated) and dated by them at the time of signing (the date does not have to be handwritten). The prescriber should sign and date any manuscript changes. If the prescription is generated/prepared by someone other than the prescriber then that person should, ideally, be a registered healthcare professional in their own right. The use of pre-printed sticky labels on FP10 prescriptions is not allowed. If a sticker is used on hospital outpatient forms, the doctor should initial across the edge to show it has not been tampered with. Up to a maximum of 30 days supply should be prescribed as a matter of good practice. There may be circumstances where there is a genuine need to prescribe a supply for more than 30 days. Where the prescriber believes that it is in the clinical interest of the patient to prescribe a supply for more than 30 days and would not pose an unacceptable threat to patient safety, the prescriber should make a note of the reasons in the patient s notes. Prescriptions for Schedule 2, 3 and 4 CDs are only valid for 28 days from the date on the prescription if no separate start date is specified. A start date, even if more than 28 days after the date of signing, will ensure the prescription is still valid. CSMTs have site-specific SOPs for their prescribing processes, including the provision of instalment prescriptions, which are agreed with the Trust s Controlled Drugs Accountable Officer. Where the prescribing of CDs is initiated by a specialist within the Trust (e.g. methylphenidate for the management of Attention Deficit Hyperactivity Disorder) then, if it is in accordance with an Essential Shared Care Agreement, it should be considered appropriate for transferring the ongoing prescribing to the patient s GP. If prescribing responsibility for CDs (schedule 2, 3 or 4) remains with the Trust prescriber (e.g. shared care refused and notified to the Pharmacy and Medicines Optimisation Department or not suitable for shared care), the prescriber remains responsible for the operation of robust systems around the issuing of prescriptions and their security. The requirements set out in the separate Prescription Security Policy should be followed, including being aware: Of any early requests for controlled drug prescriptions, and only (exceptionally) issue an early prescription after a face to face consultation, with the rationale for early issue documented in the clinical record. More than one early request for a controlled drug prescription should prompt a full review in relation to dependence and diversion, with a management plan documented in the patient records. Of any uncollected prescriptions, which should be shredded and documented as uncollected in the patient s records; adherence should be questioned at the next consultation if appropriate. If a prescription is returned by a pharmacy for replacement because it is past its 28 day validity period, it must be forwarded to the prescriber for shredding and documented fully in the patient records as prescription returned but not dispensed ; adherence should be questioned at the next consultation if appropriate. Prescribers are responsible for ensuring local systems for collection of controlled drug prescriptions are robust (i.e. local clear procedure in place to allow for the safe handing over of the correct prescription to the correct patient): Page 6 of 8
Check the identity and address of the patient collecting the prescription. Prescriptions for CDs awaiting collection are entered into a log book The member of trust staff handing over the prescription and the person collecting are both required to sign for the prescription in the log book. The security code for the prescription (on bottom of FP10) must also be recorded. The identity of the patient should be confirmed before handing over the prescription. This procedure should also be extended to any other drugs subject to abuse which are not currently covered by the Misuse of Drugs Regulations. If prescriptions are collected by staff from community pharmacies, following the written request of the patient, then the community pharmacy representative should also sign for collection out of the log book. A record should also be kept of which patients have granted permission for the named community pharmacy to collect their prescriptions. The prescriber will also be responsible for ensuring robust systems for the posting of prescriptions via Royal Mail (or other postal/courier service); NB: collection of prescriptions is preferred either by the patient or representative from a community pharmacy: The name and address of the patient should be checked against the addressed envelope in which it will be posted to ensure it is going to the correct person (or agent in the case of a manager of a care home). Name, address and number of items on the prescription, and security number (at bottom of FP10) should be logged in the prescription log book, including the date of sending and the name of the person who prepared the post. Prescriptions for controlled drugs can be sent by normal post however if the patient claims that they have not received a prescription then ALL subsequent prescriptions should be sent using recorded delivery methods (with all details recorded). Substance misuse services shall routinely use recorded delivery methods. The cost of postage shall be borne by the prescribing team. 4.4 Prescribing for Prisoners This is outside the scope of this CD SOP since individual prisons may have their own specific restrictions around controlled drugs and are often determined in co-ordination with the Prison Governor. Refer to the separate SOPs for the prescribing of controlled drugs in prisons which are held by the Prison In-reach Teams of the Inclusion Services Directorate in conjunction with the Trust s Controlled Drugs Accountable Officer. 4.5 Private Prescribing Private prescribing does not normally form part of Trust business, and as such is not allowed without approval from the Trust Board. If this private practice is to include the prescribing of CDs (Schedules 2, 3 and 4) then the Trust s Controlled Drugs Accountable Officer must be consulted. For Information only Private prescriptions for Schedule 2 or 3 Controlled Drugs that are to be supplied by a pharmacist in a hospital do not need to specify the prescriber identification number and do not need to be on a standardised form provided by the primary care trust for the purposes of private prescription. Page 7 of 8
Private prescriptions which will be dispensed in a community pharmacy need to be written on standardised private prescription forms obtained from the local Primary Care Trust, and specify the prescriber identification number. 5. Process for Monitoring Compliance and Effectiveness The prescribing of CDs for inpatients, leave and discharge shall be monitored by the routine operation of the Pharmacy and Medicines Optimisation Department. For outpatients, the prescriptions will be dispensed either by another hospital Trust (whilst the SLA remains in place) or by a Registered Community Pharmacy. These pharmacies will have their own procedures; however, since prescribing of CDs is covered by the Misuse of Drugs Regulations, then they should be robust enough to identify improper prescribing. Where incidents occur and submitted on the incident reporting system, they will be periodically reviewed by the Medicines Optimisation Committee and Controlled Drugs Accountable Officer. The Pharmacy and Medicines Optimisation Department also receives the prescription data back from the NHSBSA Prescription Pricing Authority. This e-pact data can be used to monitor the prescribing of controlled drugs for outpatients. Where concerns are identified, the actual prescriptions in question can be recalled and assessed. The regular CD and Prescription Security audits also monitor prescribing practices against the standards required to ensure safe and secure handling of controlled drugs. These audits are undertaken at all Trust premises where CDs are stored and FP10 pads distributed; additionally prescribers are expected to maintain a log of all their prescriptions. The audits are undertaken by the Pharmacy and Medicines Optimisation Department and supported by the Clinical Audit Department. The results are reviewed by the Medicines Optimisation Committee and other high level committees within the Trust. Any concerns identified around the prescribing (or other practices) of CDs will also form part of the Trust s Controlled Drugs Accountable Officer s report to the Local Intelligence Network for Controlled Drugs. 6. References The Misuse of Drugs Regulations 2001 Page 8 of 8