New v1.0 Date: December 2015 Cathy Riley - Director of Pharmacy Policy and Procedures Committee Date: 18/02/2016

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1 Clinical Storage of Medicines & Checking of Stock Balances 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 v1.0 Date: December 2015 Cathy Riley - Director of Pharmacy Policy and Procedures Committee Date: 18/02/2016 Policy and Procedures Committee Date: 18/02/2016 Medicines Optimisation Strategy : Making the Most of Medicines February 2016 December 2018 Medicines, Storage, Stock Medicines Code Contents 1. Introduction Purpose Scope Procedure Process For Monitoring Compliance And Effectiveness References... 6 Appendix 1...7

2 Change Control Amendment History Version Dates Amendments V1.0 Dec 15 SOP created from existing Medicines Code V6.10 Page 2 of 7

3 1. Introduction This SOP is required to ensure that medicines are stored safely and appropriately within the Trust and that the balances of medicine stocks are checked regularly and balance checks recorded. 2. Purpose This SOP outlines the responsibilities of Authorised Practitioners and Authorised Pharmacy Staff for the safekeeping of medicines within the Trust and the checking of stock balances. 3. Scope This SOP is applicable to all members of staff within the Trust who are involved with medicines and their usage. 4. Procedure The Appointed Practitioner in Charge is responsible at all times for the safekeeping of all medicines on their ward or department. The design and location of all ward or department medicine storage cupboards must be approved by Authorised Pharmacy Staff, and regularly monitored All internal and external medicines, disinfectants, and reagents must be stored in locked cupboards, trolleys or other secure cabinets - all reserved solely for the purpose. The only exceptions to this requirement are medicines for clinical emergencies, intravenous fluids, sterile topical fluids and nutritional products and some bulky medicated dressings that, because of their bulk, are stored in a clean area (as agreed between the Appointed Practitioner in Charge and an Authorised member of the Pharmacy Staff). Internal medicines must be stored separately from other medicines. Under no circumstances must medicines be transferred from one container to another, nor must they be taken out of their container and left loose. All medicines in transit must be in a sealed tamper evident container. Controlled drugs must be stored in a separate designated controlled drugs cupboard Where cold storage of medicines is necessary, a lockable, temperature controlled/monitored medicines fridge must be made available, which must be reserved solely for the purpose. Page 3 of 7

4 Siting of Cupboards and Trolleys Cupboards and trolleys must be sited where most convenient for staff, allowing adequate space and permitting surveillance to afford maximum security against unauthorised access. Medicine cupboards must generally be sited in a clean utility room to which the general public does not have access. Cupboards must not be sited where they may be subjected to higher than recommended humidity or temperature. Reagent cabinets must be sited in areas where testing is carried out. Review of Storage of Medicines The quantities, range and storage of medicines stocked will be reviewed regularly by the Authorised Pharmacy Staff together with the Appointed Practitioner in Charge. Controlled Drugs No ward or department must store Controlled Drugs unless there is an Appointed Practitioner in Charge responsible for their storage and administration. Samples of Medicines No samples (of medicines or dressings) may be left on wards or departments. Representatives of pharmaceutical companies wishing to leave samples must be referred to the Pharmacy Department. Representatives from the pharmaceutical industry should not normally have access to clinical areas without the necessary authorisation from a consultant or pharmacy manager. Closure of a Ward or Department If a ward or department is to close, the Controlled Drugs must be handed over by an Assigned Practitioner in Charge to an Authorised member of the Pharmacy Staff who will sign the appropriate section of the register and return the Controlled Drugs to the pharmacy. If a ward or department is to close for more than a few days, all other medicines must also be returned to the pharmacy. However, if a ward is to close for only a few days, the medicines (other than Controlled Drugs) may, with the agreement of the Authorised member of the Pharmacy Staff and the Appointed Practitioner in Charge, stay on the ward provided there is adequate security to prevent unauthorised access to the cupboards. Breach of Security Any incident must be reported immediately and investigated as soon as practical by the Appointed Practitioner in Charge together with an Authorised member of the Pharmacy Staff, in liaison with the Security Manager. Storage Accommodation: Clinical areas may have some or all of the following medicine storage units. Controlled Drug Cupboards - reserved solely for the storage of Controlled Drugs and secured to the wall. These cupboards may be separate from others or be inside other locked medicines cupboards used to store internal medicines. The lock must not be the same as any other lock in the hospital. Internal Medicine Cupboard(s) - for the storage of tablets, liquid medicines, injections etc. Medicines should not be stored at temperatures above 25oC unless stated otherwise on the label. They should be stored in alphabetical order Page 4 of 7

5 according to approved name. External Medicine Cupboard(s) - for the storage of creams, lotions etc. Medicine Refrigerator - medicines must not be stored together with food or pathological specimens, but in a separate small locked fridge. Medicines requiring storage below room temperature will be marked "Store between 2ºC and 8ºC, in a refrigerator." The temperature of medicine fridges must be continuously monitored and recorded Reagent Cupboard(s) - situated in the area where urine testing is carried out. Some wards may not require a separate cupboard if urine testing is only very rarely carried out but in such circumstances there should be an agreement about where such testing is to take place. They must not be stored with internal medicines A Clean Storage Room for intravenous fluids and sterile topical fluids, if no suitable cupboard is available. Medicine Trolley - Where used for storage of medicines in current use on the medicine administration round. When not being used the medicine trolley must be locked and secured to the wall. The trolley must not be left unattended during the medicine round. If the Designated Practitioner leaves the trolley, it must be locked immediately. Medicines for Clinical Emergency - must be readily accessible and in a position to afford supervision to prevent unauthorised access. For further details refer to the Clinical Emergency Policy for your locality. Flammable Liquids, Gases, Aerosols - advice is obtainable from the local Fire and Safety Officer. Refrigerated Storage of Vaccines & Medicines It is essential that vaccines and medicines are stored under the recommended storage guidelines to maintain their potency and effectiveness, therefore: The medicines fridge must be a lockable medicine refrigerator, not a domestic refrigerator and must only be used for storing medicines (not food or samples). The fridge s power supply should be via a socket with no integrated on/off switch, and should minimise the risk of the power supply being inadvertently switched off. All vaccine/medicine fridges should have a maximum and minimum thermometer,, and when these record maximum and minimum temperatures that fall near the limits of the 2-8 o C range, the refrigerator should always be checked for any signs of ice build-up. Refrigerated medicines should be stored between 2 and 8 o C, unless otherwise specified by the manufacturer. A temperature check should be done daily and recorded by a designated person (see Appendix 9). Vaccines/medicines must not be kept at temperatures below 0 degrees centigrade as freezing can cause deterioration of the vaccine/medicine and breakage of the container. N.B. Always Page 5 of 7

6 refer to the operating instructions to ensure that it is the operating temperature that is being recorded/ monitored, rather than the maximum or minimum temperature only. If when recording the temperature, the maximum or minimum temperatures are too high or too low it should be reported immediately and the pharmacist contacted for further advice on usage of these vaccines/medicines. The vaccine/medicine fridge should be defrosted regularly and kept clean and locked when defrosting, alternative arrangements should be made for storage of vaccines/medicines and the pharmacist contacted for further advice. Vaccines/medicines should not touch the side of the fridge or be packed too tightly together. Stocks of vaccine/medicine should be rotated to ensure that use by dates are not exceeded. Unused and outdated vaccine/medicine should be returned to pharmacy for disposal. Spillages of vaccines should be wiped using a paper towel soaked in 1% sodium hypochlorite solution and disposed of as clinical waste. The area of spillage should also be cleaned with general purpose detergent. CHECKING OF STOCK BALANCES Controlled Drugs See SOP CD checks/audits, stock reconciliation and handling discrepancies. Other Medicines Any need for checking stock balances of other medicines must be left to the discretion of the Appointed Practitioner in Charge. If, however, there is suspicion of abuse of medicines this must be reported to the department manager and Pharmacy Manager. In such cases it is advised that a stock balance must be recorded and regular checking introduced. If this shows discrepancies the medicine must be made subject to similar procedures as Controlled Drugs and register entries must be made whenever the medicine is administered. Due to concerns both nationally and locally, as well as recent and possibly impending changes in the legislation, all benzodiazepines, together with zopiclone, zolpidem and zaleplon are treated as controlled drugs. 5. Process For Monitoring Compliance And Effectiveness Annual audit 6. References Medicines Code Page 6 of 7

7 Appendix 1 Daily Monitoring of Medicines Refrigerator Log-Book Month Medicines should be stored between 2 o C 8 o C & monitoring completed daily. In the event of the fridge temperature not being maintained at the necessary temperature, the local pharmacy should be contacted, prior to any medicines being used. Date Time Signature/ Operating Max/Min temp Action Initials Temperature recorded between range 2 o C 8 o C (please tick) Page 7 of 7