Emergency Anaesthetic Controlled Drug Pack Standard Operating Procedure for Assembly Version: 1 Approval Committee: Formulary and Medicines Date of Approval: 16 January 2015 Lead Job Title of originator/author: Emergency Department Pharmacist Date issued: 26 February 2015 Review date: 31 January 2017 Target audience: Emergency Department/Critical Care Staff Key words: Emergency, RSI, Resuscitation Main areas affected: Emergency Department Summary of most recent changes: N/A Consultation: As above Number of pages: 7 Type of document: Standard Operating Procedure For Emergency Department Is this document to be published in any other format? No The Trust strives to ensure equality of opportunity for all, both as a major employer and as a provider of health care. Fairness and consistency for all those covered by this document has therefore been considered, regardless of their individual differences. Page 1 of 7 Contents 1 Introduction 3 2 Scope 3 3 Purpose 3 4 Definitions 3 5 Related Trust Policies 4 6 Roles and Responsibilities 4 7 Assembling the Emergency Anaesthetic Drug Pack 4 8 Using the Emergency Anaesthetic Drug Pack 5 9 Implementation 6 10 Process for Monitoring Compliance/Effectiveness 6 11 Arrangements for Review of the SOP 6 12 References 6 Appendix Contents of the Emergency Anaesthetic Drug Packs 7 Page 2 of 7 1. Introduction In the Emergency Department, one adult Emergency Anaesthetic Drug Pack (EADP) is kept for emergency anaesthesia when required. Currently this does not contain any controlled drugs that may be required. At the Major Trauma Centre Emergency Department at Southampton General Hospital two anaesthetic drug packs are kept in the Emergency Department for emergency anaesthesia when required. One of these contains controlled drugs, stored within the controlled drug cupboard, the other non-controlled drugs. This has reduced the time taken to obtain and prepare drugs for the administration of emergency anaesthesia in critically ill patients. To improve the efficiency of obtaining and preparing drugs for emergency anaesthesia in the Emergency Department and to provide a more consistent approach across the region for rotational medical staff, two drug bags following this above format are to be introduced into the Emergency Department of this hospital. The two drug packs consist of a fridge box containing non-controlled drugs (containing Propofol, thiopentone, suxamethonium, rocuronium, vecuronium, metaraminol and ephedrine) and a new controlled drug bag (containing ketamine, fentanyl and midazolam) which will be stored in the Controlled drug cupboard. This SOP will focus on the assembly of the EADP controlled drug pack and the documentation required to adhere with the PHT Medicines Management and Controlled Drugs policies. 2. Scope This policy applies to the Emergency Department who will be responsible for assembling the controlled drugs emergency anaesthetic drug pack, maintaining accurate records, recording the use of the pack and ensuring reassembly once the pack has been used. 3. Purpose The purpose of this document is to describe the Standard Operating Procedure for assembling the emergency anaesthetics drug pack which contains the controlled drugs, ensuring that the medicines policy is adhered to. 4. Definitions Standard Operating Procedure (SOP): A SOP is a set of instructions to be followed in carrying out a given operation, or in a given situation, which lend themselves to a definite or standardised procedure without loss of effectiveness. Emergency Anaesthetic Drug Pack (EADP): These are packs that will have been pre-prepared to ensure the Critical Care/Emergency Department team have what they require to sedate and intubate a patient. Controlled Drugs (CDs): These are drugs that are supplied under the Misuse of Drugs Act 1971 and are subject to documentation and storage regulations. Page 3 of 7 5. Related Trust Policies PHT Medicines Management Policy PHT Controlled Drugs Policy 6. Roles and Responsibilities It is the responsibility of the nurse in charge to arrange assembly of the EADP, maintain accurate documentation in the ward CD register and in the EADP register. Once the pack is used it is also the responsibility of the nurse in charge to ensure the EADP register is completed and arrange assembly of the new pack. 7. Assembling the Emergency Anaesthetic Drug Pack: 7.1 Assemble the drugs needed for the EADP pack Drug Ketamine Midazolam Fentanyl Strength 10mg/ml 1mg/ml 50 micrograms/ml Pack Size 200mg/20ml vial 5mg/5ml ampoule 100microgram/2ml ampoule Quantity 1 1 1 7.2 For each controlled drug, enter the drug out of the ward CD register and enter it in to the EADP register. See example below: 7.2.1 Ward CD Register Entry: Name, Form of Preparation and Strength: Midazolam Injection 1mg/ml (5mg/5ml) ampoule Date Time 16/07/13 14:00 17/07/13 09:00 Patient’s Name Amount Given Received from pharmacy 1 x 5mg/5ml ampoule transferred to Emergency Anaesthetic Drug Pack JSmith Witnessed By (Signature) LBrown MJones JSmith Given By (Signature) Stock Balance 10 9 7.2.2 EADP Register Entry: Enter all drugs in the pack into the EADP register, starting a new page each time the bag is restocked, documenting both the batch numbers and expiry dates. See example below: Name, Form of Preparation and Strength: Emergency Anaesthetic Drug Pack Tag No. 5532B Expiry 05/2014 (shortest expiry in bag) Date Time 17/07/13 09:00 18/07/13 21:00 Patient’s Name Amount Given Given By (Signature) Witnessed By (Signature) Stock Balance Ketamine10mg/ml (200mg/20ml) vial BN: XYZ EXP: 07/2014 Midazolam 1mg/ml (5mg/5ml) ampoule BN: LMN EXP: 05/2014 Fentanyl 50 microgram/ml (100microgram/2ml)ampoule BN: RPQ EXP: 03/2015 Assembled by: M Jones JSmith 1 M Jones JSmith 1 M Jones JSmith 1 MJones JSmith EADP Bag Seal checked and Correct LBrown THarvey Page 1 Page 4 of 7 Once the pack has been assembled, seal the pack with a tamper-evident numbered tag and record the tag number in the EADP register. See example above. The EADP will need to be checked daily to ensure the seal remains in place and the contents are still in date. This check needs to be recorded in the EADP register. See example above. 8 Using the Emergency Anaesthetic Drug Pack 8.1 Once the pack is opened, the nurse in charge must ensure that details of the drugs used are recorded in the EADP Register. 8.2 The date, time, patient name, drug, dose given and any wastage needs to be entered and co-signed either by two nurses or by a nurse and a doctor. See example below. The nurse in charge is responsible for arranging the assembly of a replacement pack as described above in part 7.2.2 Name, Form of Preparation and Strength: Emergency Anaesthetic Drug Pack Tag No. 5532B Expiry 05/2014 (shortest expiry in bag) Date Time 17/07/13 Patient’s Name Amount Given Ketamine10mg/ml (200mg/20ml) vial BN: XYZ EXP: 07/2014 Midazolam 1mg/ml (5mg/5ml) ampoule BN: LMN EXP: 05/2014 Fentanyl 50 microgram/ml (100micrograms/2ml) ampoule BN: RPQ EXP: 03/2015 Assembled by: EADP Bag Seal checked and Correct 18/07/13 21:00 19/07/13 14:15 Sam Jones 6759081 14:15 Sam Jones 6759081 Ketamine 20mg(2ml) given, 18ml discarded. Midazolam 5mg given Given By (Signature) Witnessed By (Signature) Stock Balance MJones JSmith 1 MJones JSmith 1 MJones JSmith 1 MJones JSmith LBrown THarvey JSmith LBrown 0 JSmith LBrown 0 Page 1 Start entry for re-assembly of bag on the next page Name, Form of Preparation and Strength: Emergency Anaesthetic Drug Pack. Tag No. 5533B Expiry 06/2014 (shortest expiry in bag) 19/07/13 15:00 Ketamine10mg/ml (200mg/20ml) vial BN: MML EXP: 08/2014 FGrey HMoore 1 Midazolam 1mg/ml (5mg/5ml) ampoule BN:GFH EXP: 06/2014 FGrey HMoore 1 Fentanyl 50 microgram/ml (100micrograms/2ml) ampoule BN: RPQ EXP: 03/2015 Assembled by: FGrey HMoore 1 FGrey HMoore 1 Page 2 Page 5 of 7 9. Implementation This SOP will be made available to the Emergency Department and Critical Care staff who must familiarise themselves with the procedure and ensure that they know their responsibilities. This SOP will also be made accessible on the intranet. 10. Process for Monitoring Compliance/Effectiveness The ward manager will monitor the EADP register to ensure that daily checks are being completed and the ward pharmacist will check both the CD and EADP registers every three months to ensure that the appropriate documentation is in place. 11. Arrangements for Review of the SOP This SOP should be reviewed in 3 years time or earlier if there are any significant changes to the contents of the EADP or to the trust medication policy. 12. References Southampton PICU Retrieval Drugs: Procedure for Controlled Drugs. May 2009 Wessex Major Trauma Network. Children’s Major Trauma Guidelines University Hospital Southampton. 2012 Page 6 of 7 Appendix 1 Contents of the Emergency Anaesthetic Controlled Drug Pack Aide memoire for inclusion on the outside of the drug pack Emergency Anaesthetic Controlled Drug Pack Drug Ketamine Midazolam Fentanyl Strength 10mg/ml 1mg/ml 50 micrograms/ml Pack Size 200mg/20ml vial 5mg/5ml ampoule 100micrograms/2ml ampoule Quantity 1 1 1 Page 7 of 7