Medicines Management SOP
Standard Operating Procedure
1.1 This Standard Operating Procedure (SOP) describes the process for medicines management by doctors, nurses and paramedics employed by TrailMed Ltd or “The Company” for the purposes of this SOP.
1.2 This SOP provides additional guidance which is specific to the issue, handling, destruction and administration of scheduled drugs and in particular Schedule 2 Opiates.
1.3 The use of the terms doctor, nurse and paramedic within this SOP refer to registered clinicians only.
2.1 The Directors have overall responsibility for this Standard Operating Procedure and the safe management and use of controlled drugs within TRAILMED.
2.2 It is the responsibility of all company clinicians to adhere to this Standard Operating Procedure. It must be noted that an SOP does not remove a clinician’s inherent professional responsibility and accountability.
2.3 It is the responsibility of the clinician to use their professional judgement to manage medication appropriately and to record the use, the rationale and decision in the patient’s clinical record.
2.4 Individual clinicians are responsible for ensuring that scheduled drugs administered safely in accordance with nationally recognised best practice, current legislation and TRAILMED Policy.
3.1 The overall legislative framework which applies to all medicines is the Human Medicines Regulations 2012 and associated legislation.
3.2 Controlled drugs (CDs), are additionally defined and governed by the Misuse of Drugs Act (MDA) 1971 and associated regulations - principally the Misuse of Drugs Regulations (MDRs) 2001 and The Controlled Drugs (Supervision of Management and Use) Regulations 2013.
3.3 The MDRs 2001 divide controlled drugs (CDs) into five Schedules, which dictate the degree to which a CD’s use is regulated. The Schedule in which a CD is placed depends upon its medicinal or therapeutic benefit balanced against its harm when misused. Schedule 1 CDs are subject to the highest level of control, morphine sulphate 10mg injection is a Schedule 2 CD, whilst oral morphine solution 10mg in 5ml is a Schedule 5 CD.
3.4 The use of CDs in medicine is permitted by the MDRs. The current version of the Regulations made under the MDA 1971 are the MDRs 2001, which came into operation in February 2002 and The Controlled Drugs Regulations 2013. The MDRs and CDRs are periodically amended and revised and they have been subject to a number of amendments since inception.
4.1 Prior to an event, a clinician will be issued with a drugs pack. The clinician must check that the contents of the pack agree with the company’s drug pack list of medications and that the vials/ampoules/containers are intact and in date.
4.2 Scheduled drugs must be checked and counted and entered into the clinician’s personal scheduled drug book and then signed for by both the issuing officer and the clinician.
4.3 The stock scheduled drug register held in the drug safe must be updated to reflect remaining stock and countersigned by the receiving clinician.
5. On duty
5.1 Any drugs used during treatment of patients should be clearly documented in the patient’s clinical record. This should include the rationale, the time, dose and the route of administration.
5.2 Use of scheduled drugs must be recorded in the clinician’s personal scheduled drug book. This should include date, time, patient’s name, PCR number, dose administered, route, amount of drug disposed.
6. Post Duty
6.1 Clinicians must check that the patient’s clinical record (PCR) is up to date and signed.
6.2 Drug packs are returned and signed in, used drugs are re-stocked and checked against the PCRs.
6.3 Any unused scheduled drugs are checked and returned to stock and appropriately recorded in the stock scheduled drug register.
6.4 Scheduled drugs administered to patients whilst on duty should be recorded in the stock scheduled drug register together with the name and PCR number.
7. Disposal of Unused Scheduled Drugs
7.1 The clinician is responsible for ensuring that any remaining scheduled drug in a parenteral or oral syringe is disposed of safely following an episode of care. The drug must be discharged into a sharps bin containing absorbent material to render it irretrievable.
7.2 Disposal must be witnessed by another member of staff, another healthcare professional, police officer or carer/parent.
7.3 An entry must be made to record the disposal in the clinician’s personal scheduled drug book. The entry must be signed by the witness (where present) with their name, position or profession printed next to their signature.
8. Record Keeping
8.1 Every administration of scheduled drug must be recorded in the nurse or paramedic’s personal scheduled drug record book. Administration of oral morphine must be recorded in the appropriate schedule controlled drug record book. The entry in the personal scheduled drug book must state:
Incident number (PCR number)
Dose administered Running balance updated
8.2 Entries must be made consecutively in the order that they occurred and may not be made retrospectively. All entries must be completed before the clinician leaves at the end of the shift.
8.3 As indicated above, all disposal must be recorded and witnessed. The entry must record:
Amount disposed of
Running balance updated
9. Adverse Reactions and Adverse Incidents
9.1 All adverse reactions to morphine administered by Company clinicians or adverse incidents involving Company morphine must be recorded on the Company Incident Reporting System.
9.2 Adverse reactions to morphine must be recorded on the Yellow Card system which can be accessed at http://yellowcard.mhra.gov.uk/
10.1 This document was developed and validated within the Company by staff who deliver the service. It was approved by the Directors of TrailMed Ltd 14 September 2016, reviewed in January 2018 and again in January 2019.
10.2 Any constructive feedback to improve this SOP should be made in writing to the Directors TRAILMED Ltd.
11. Professional Accountability
11.1 Standard Operating Procedures do not remove inherent professional obligations, accountability or responsibility. It is the responsibility of each professional to practice only within the bounds of their own competence.
11.2 You cannot delegate responsibility for any task under this SOP to anyone else.