Clinical Reducing Dosing Errors with Opioid Medicines (Controlled Drug SOP): 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 extracted from previous Controlled Drugs Policy 1 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 Controlled Drug, CD, Opiates, Opioids, morphine, diamorphine, fentanyl, methadone, oxycodone, errors, NPSA, palliative, safety Medicines Code Trust Formulary All other Controlled Drug SOPs Contents 1. Introduction... 3 2. Purpose... 3 3. Scope... 3 4. Procedure... 3 5. Process for Monitoring Compliance and Effectiveness... 5 6. References... 5
Change Control Amendment History Version Dates Amendments 1 December 2015 Reformed as new SOP Page 2 of 5
1. Introduction This Controlled Drug (CD) SOP should be read in conjunction with the other CD SOPs, the Medicines Code and Trust Formulary. It is intended to support services comply with the Misuse of Drugs Regulations and other guidance published to ensure the safe and secure handling of controlled drugs. The responsibility for the content of this SOP lies with the Trust s Controlled Drugs Accountable Officer. All staff who are involved in the handling of CDs are required to adhere to these procedures. The National Patient Safety Agency released a Rapid Response Alert in 2008 highlighting the risks of dosing errors in the prescribing, supply and administration of opioids. The substantial dose ranges available and the inherent potency of some of the opioids increased the risk of patients receiving potentially fatal accidental overdoses. 2. Purpose This CD SOP sets out the process for healthcare professionals to follow when prescribing, supplying and administering opioid medicines (buprenorphine, diamorphine, dipipanone, fentanyl, hydromorphone, meptazinol, methadone, morphine, oxycodone, papaveretum and pethidine) in anything other than an emergency. 3. Scope This CD SOP applies to doctors, nurses and pharmacy personnel of all grades. Clinical leads should have systems in place to ensure that their team can adhere to this SOP. 4. Procedure Healthcare professionals should: Confirm any recent opioid dose, formulation, frequency of administration and any other analgesic medicines prescribed for the patients. This may be done through discussion with the patient, or their representative (although not in the case of treatment for addiction see section below), the prescriber or through medication records Ensure where a dose increase is intended, that the calculated dose is safe for the patient (e.g. for oral morphine or oxycodone in adult patients, not normally more than 50% higher than the previous dose). Ensure that they are familiar with the following characteristics of the medicine and formulation: usual starting dose, frequency of administration, standard dosing increments, symptoms of overdose and common side effects. Standard references include: British National Formulary (BNF), BNF for Children, Palliative Care Formulary or www.palliativedrugs.com, Summaries of Product Characteristics and Trust policies. When prescribing, administering or dispensing opioid medicines for substance misuse, the healthcare practitioner concerned, or their clinical supervisor must abide with the standards above but also refer to Department of Health (England) and the devolved administrations Drug Misuse and Dependence: UK Guidelines on Clinical Management. London: Department of Health (England), the Scottish Government, Welsh Assembly Government and Northern Ireland Executive, 2007 (commonly referred to as the Orange Book) Page 3 of 5
Appropriate diagnosis of opioid dependence and assessment of tolerance is essential in substance misuse and should comply with the Orange Book. In the context of prescribing, it is important to note that the British National Formulary (BNF), which is updated twice a year, is a key reference. The dosages stated in these guidelines and in the BNF are intended for general guidance and represent (unless otherwise stated) the range of dosages that are generally regarded as being suitable for prescribing in the context of treating adults who have become dependent. A clinician who is experienced in the treatment of drug misuse, and in the use of a particular medication, may feel more able to operate at the outer limits of, or even to depart from, these guidelines than an inexperienced clinician. Clinicians should work within a clinical governance framework and be prepared to justify their clinical decisions, and especially when operating outside guidelines should keep comprehensive notes to support their decisions. When preparing patients for discharge or leave, appropriate communication and liaison with community substance misuse teams must take place to ensure that supply of medicines remains appropriate, timely and no unintended duplication occurs. For the inpatient services at St George s Hospital, The Redwoods Centre and George Bryan Centre, patients admitted receiving methadone or sub-lingual buprenorphine for substance dependence, healthcare professionals must confirm the dose prescribed with the CSMT or community pharmacy dispensing the medication. They should also ascertain that the patient has been concordant with the treatment and taken the prescribed dose regularly. The community pharmacy should be informed of the admission so that the instalment prescription can be halted and no further supplies made. The detail of these conversations should be recorded in the patient s notes. Although supplies for the wards are available from the Trust s dispensaries, they are not available out of hours. In the event of requiring methadone or buprenorphine out of hours (due to the timing of admission), contact the regular community pharmacy to see if a supply for one dose can be obtained. If this is not possible, it is considered safer practice to omit the dose until the hospital pharmacy is open. Other hospitals should not be contacted and they will not supply. Once admitted, wards should ensure that enough doses have been received from the hospital pharmacy to continue administration over the weekend. It should be noted that these two treatments have long half-lives and as such can be taken once a day at any time; sourcing supply is not an emergency. The hospital pharmacies will not supply methadone or sub-lingual buprenorphine for leave or discharge from the inpatient setting. Instead, clinical teams should arrange a new instalment prescription to be written by the CSMT and received by the regular community pharmacy which should be advised that the patient will be resuming their attendance. This may take a while to organize so should be put in place prior to leave/discharge being undertaken. Under no circumstances may ward stock be issued to a patient to take away from the ward. Any remaining ward stock following the patient s discharge should be returned to the hospital pharmacy at the earliest convenience. Page 4 of 5
5. Process for Monitoring Compliance and Effectiveness The Pharmacy and Medicines Optimisation Department will ensure compliance with this CD SOP by refusing to supply opioid analgesics until satisfied the steps have been carried out. A regular audit is undertaken across inpatient areas and other teams to ensure compliance with a range of CD regulations and procedures. This is scrutinised by the Medicines Optimisation Committee, the various divisional Quality Governance groups and the Trust s CD Accountable Officer. Where concerns are noted, the Local Intelligence Network for Controlled Drugs may be informed. 6. References Misuse of Drugs Regulations 2007 Orange Book NPSA Alert 04/07/2008. Page 5 of 5