Standard Operating Procedure for the Regular and Systematic Checking of Expiry Dates and for the Presence of Non-conforming Medicinal Products Purpose: To set a standardised protocol of procedures for the regular and systematic checking of expiry dates and for the presence of non-conforming medicinal products. Scope: This SOP covers all medicinal products within a retail pharmacy business, including veterinary products. Responsibility: It is the responsibility of the supervising pharmacist to ensure that regular checking occurs and that appropriate remedial action is taken where necessary. Date of Preparation: Date of next review: Prepared by: Signature: Version number: Date review takes place and initials This SOP has been designed to be used in a working pharmacy environment; however, we recommend that the SOP is tailored to reflect processes in your pharmacy where appropriate. This SOP is dynamic, and should be constantly updated when and where necessary. If no errors, incidences or PSI recommendations occur a review should be carried out every six months starting from the creation date. This review will update the SOP content and format with the goal to enable reduction of error within the pharmacy. Stage of Procedure Check if a current date checking matrix is in use and if not construct one. Construct a quarterly date checking matrix using Appendix 1 as a template. Fill in the applicable year Fill in the applicable quarter Fill in the schedule with the week commencing (w/c) dates Fill in the areas of the pharmacy to be checked according to the requirements within your pharmacy remembering that all medicines must be covered by the date checking matrix including those stored in the fridge or safe. Include over-the-counter medicines within the date checking matrix or use a separate date checking matrix to include all over-the-counter medicines. Include veterinary medicines within the date checking matrix or use a separate date checking matrix to include all veterinary medicines. All pharmacy stock must be date checked every 3 months according to the schedule detailed in Appendix 1. Remove all the pharmacy stock from the area which is to be date checked. Wipe and clean the date check area. Check the expiry date for the products. Isolate any pharmacy stock with an expiry of less than 1 month. Also isolate any stock which would expire before it could be fully used if it were dispensed now – for example where the pack is for a quantity for more than a month supply such as a triple pack. o Make a record of this stock for stock check purposes and write off the stock o Dispose of this stock following the SOP: Storage and Disposal of waste medicinal products For any other pharmacy stock which will expire within the next 4 months, write down details and batch numbers in a copy of Appendix 2 – the monthly expiry table for the appropriate month. Use a small sticky coloured label to “flag” the short dated stock. Stock which is due to expire within 2 months must be removed from stock and placed in a designated “close to expiry date stock” area. Expired controlled drugs should be stored in a segregated and clearly labelled manner in the CD safe pending destruction and disposal. Check each item of stock for damage, defect or contamination and isolate any stock where this is suspected. Where damage, defect or contamination has occurred due to an incident in the pharmacy: o Make a record of this stock for stock check purposes and write off the stock. o Dispose of this stock following the SOP: Storage and Disposal of waste medicinal products. Where you believe the damage, defect or contamination may have occurred before the stock reached the pharmacy or due to a manufacturing or distribution fault: o Report this to the HPRA o Return the stock to the supplier Person(s) Responsible Stage of Procedure Return remaining stock to the shelf making sure that stock with the shortest expiry date is placed where it will be used first. Complete the date checking matrix by signing to declare that the pharmacy stock has been date checked for that area. On a monthly basis check the relevant monthly expiry table for products expiring in that month. o Locate and remove any products which have not been dispensed in the interim. o Make a record of this stock for stock check purposes and write off the stock. o Dispose of this stock following the SOP: Storage and Disposal of waste medicinal products. Person(s) Responsible APPENDIX 1 Date Checking Matrix Year: Quarter: Scheduled Areas of the pharmacy or medicines to be checked * Completed (initials of staff member) 1st week of quarter w/c 2nd week of quarter w/c 3rd week of quarter w/c 4th week of quarter w/c 5th week of quarter w/c 6th week of quarter w/c 7th week of quarter w/c 8th week of quarter w/c 9th week of quarter w/c 10th week of quarter w/c 11th week of quarter w/c 12th week of quarter w/c * Examples – Fridge, CD cupboard, liquid medicines, dressings, inhalers, creams, medicines A to D, high-tech, upper shelf, drawer storage area I certify that the stock check has been has been completed for this quarter Signature of Supervising Pharmacist: Date: APPENDIX 2 Table showing a list of medicines which are due to expire in the month of ____________________________________________________________ Medicinal product details (name, quantity and batch number) Removed (date and initial) I have signed to say that I have read and understood the Standard Operating Procedure for Regular and Systematic Checking of Expiry Dates and for the Presence of Non-conforming Medicinal Products. Name Signature Date