Storing medicines at the correct temperature: a policy for all acute and community locations. Contents

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1 Storing medicines at the correct temperature: a policy for all acute and community locations Classification: Policy Lead Authors: Selwa Elrouby, Medicines Management Pharmacist Steve Gillibrand, Directorate Clinical Pharmacist; Ageing and Complex Medicine and Radiology. Clinical Audit Pharmacist. Grainne Lundrigan, Community Services Pharmacist Additional author(s): Danielle Timoney, Locum Medicines Management Pharmacist Alison Fryer, Rotational Clinical Pharmacist Authors Division: Clinical Support, Tertiary Medicine and Renal Unique ID: TWGOP14(16) Issue number: 1 Expiry Date: October 2018 Contents Who should read this document?... 2 Key Messages... 2 Background & Scope... 3 Temperature Monitoring of Medicines... 3 Duties, responsibilities and accountability... 3 Standards... 4 Receipt of medicines from pharmacy... 4 General standards for the use of medicines refrigerators... 4 Temperature monitoring of refrigerated medicines... 5 Refrigerator problems... 6 Thermometer battery replacement... 6 Accidental disconnection of electrical supply... 6 Temperature fluctuations out of range... 7 Persistent out of range temperatures... 8 Refrigerator breakdowns... 8 Buying new refrigerators... 9 Explanation of terms & Definitions... 9 References Appendices Page 1 of 12

2 Appendix Appendix Document Control Information... Error! Bookmark not defined. Policy Implementation Plan... Error! Bookmark not defined. Monitoring and Review... Error! Bookmark not defined. Endorsement... Error! Bookmark not defined. Screening Equality Analysis Outcomes... Error! Bookmark not defined. Who should read this document? Qualified nurses, healthcare professionals and healthcare assistants who work with medicines requiring refrigerated storage in any acute, community or intermediate care based location. Pharmacists, Pharmacy technicians and Pharmacy assistant technical officers. Key Messages Failure to store medicines at the correct temperature can lead to product deterioration and subsequent patient harm. There is also a financial risk to individual directorate drugs budgets if medicines are wasted due to exposure to inappropriate temperatures. All clinical staff working with medicines have a personal responsibility to ensure that they are stored safely and securely at all times. This includes appropriate refrigeration. Each acute and community location is required to maintain an up to date daily log of the temperatures to which medicines stored in refrigerators have been exposed.refrigerator This log should be available for inspection whenever so requested. The four Rs of monitoring refrigerator temperatures: Read: Record: Reset: React: Read temperatures at least daily Record temperatures on a standard form, including signing Reset after each temperature reading React by taking action if temperature is outside +2 C to +8 C and document this action Page 2 of 12

3 Background & Scope This policy has been written to ensure that: medicines are stored in a safe and secure manner that protects both staff and patients. a designated medicines refrigerator is used specifically for the storage of pharmaceutical products requiring refrigerated storage. deliveries of medicines requiring refrigeration and the breakdown/disruption of electrical supplies to the refrigerator are appropriately managed. a system is in place to ensure that each medicines refrigeratorrefrigerator is kept locked and is appropriately monitored. Temperature Monitoring of Medicines Duties, responsibilities and accountability All healthcare practitioners are personally responsible for ensuring that medicinal products are stored in accordance with the manufacturers summary of product characteristics (SPC). These may be found at Qualified nurses, healthcare professionals and healthcare assistants are responsible for the medicines refrigerator on their ward or clinic or base. This responsibility includes; ensuring that the refrigerator is locked when not in use, that the contents of the refrigerator are appropriate, that temperature monitoring is carried out and documented and that any discrepancies are appropriately actioned. Pharmacy staff are responsible for the annual replacement of refrigerator monitoring thermometers. Each location must nominate a member of staff to be responsible for monitoring and documenting medicines storage temperatures. This person is responsible for informing the ward manager, nurse/healthcare professional in charge or shift leader of any identified temperature discrepancy. The ward manager, nurse/healthcare professional in charge or shift leader is responsible for the actioning of any discrepancy communicated to them. This responsibility includes the documentation of all actions taken in the appropriate monitoring log and the completion of an adverse incident form. Page 3 of 12

4 Standards Receipt of medicines from pharmacy If an order is delivered that is marked as containing items requiring refrigeration but contains controlled drugs it MUST be received, verified and unpacked by an healthcare professional (HCP) member of the ward/service team who is employed by SRFT. Otherwise the person who receives a delivery of medicines from pharmacy where the delivery is marked as containing items requiring refrigeration is responsible for signing for receipt of the delivery. Administrative staff should immediately pass such deliveries, unopened, to a HCP or healthcare assistant (HCA) member of the ward/service team. The HCP or HCA is then responsible for checking the contents of delivery against the order and for the immediate unpacking and putting away of any refrigerated items in the medicines refrigerator. If a member of the administrative staff signs for the delivery of an order of medicines marked as containing items requiring refrigeration and an HCP or HCA is not immediately available the delivery should be placed, unopened, in a secure area such as the locked ward/service clinic. The member of staff who has done this remains responsible for informing an HCP or HCA of the presence of this order at the earliest opportunity that one becomes available. General standards for the use of medicines refrigerators Medicines refrigerators should be stored in a locked room to allow maximum security against unauthorised entry. There should be sufficient space for the refrigerator. Refrigerators to store medicines should maintain an internal air temperature of 2-8 C with the minimum of intervention, and must be lockable. The refrigerator should not be sited in an environment where extremes of temperature (< 10 C or > 32 C) will affect their performance. The refrigerator should allow sufficient space to be maintained between the goods held in them and the internal surfaces to allow adequate airflow (i.e. is the refrigerator large enough for the needs of the clinical area). Medicines must only be stored in pharmaceutical grade and NOT domestic refrigerators. Medicines refrigerators must only be used to store medicines and NOT food or pathological specimens. Page 4 of 12

5 Refrigerated products should be stored in an orderly fashion on shelves - not on the floor of the unit. This ensures adequate air circulation and consistent temperatures throughout the cabinet. The power supply to the refrigerator must be clearly identified to avoid accidental interruption of electrical power. Ideally, the supply of electricity to the refrigerator should be via a hard-wired fuse. Refrigerators must be maintained and defrosted in line with manufacturers guidelines. The refrigerator should be cleaned regularly (as part of a general cleaning rota) and serviced at least annually. If fitted with an audible or visual alarm this should routinely tested to confirm correct operation. Where the refridgerator is shared by more than one service, each service should be responsible for its own stock of medicines. Each service s stock must be stored separately (e.g. on a separate shelf of the refridgerator). In services/clinics where it is not possible to check the refridgerator temperature daily due closure, then the monitoring form should be marked as closed against these days and recordings should be made on the day that the service/clinic is open. Where the refridgerator is used by more than one service it should be clear who is responsible for monitoring Temperature monitoring of refrigerated medicines Temperature monitoring must take place on a daily basis (preferably at the same time each day). The following data must be recorded: o the actual current temperature o the maximum temperature attained in the previous 24 hours o the minimum temperature attained in the previous 24 hours This data should be recorded on the Ward/clinic storage temperature record for medicines requiring refrigeration (see Appendix 1). Following recording the thermometer should always be reset. (see appendix 2 for how to do this) Temperature records should identify any temperature deviations and detail any corrective actions taken. For instances where there has been a temperature deviation, a further reading should be taken later the same day to provide assurance that the corrective action has been successful and demonstrate that the temperature is back within the required parameters. Temperature monitoring should be by an electronic maximum/minimum thermometer, with an accuracy of C. This should be readable Page 5 of 12

6 from outside of the refrigerator and set to alarm should the required temperature range be exceeded. It is advised that the thermometer has a battery back-up (if mains powered) so that it will continue to function for 48 hours in the event of a power failure. All new equipment must have a backup system. Temperature monitoring probes should be sited in a central location within the refrigerator and, preferably, between the products. They should not be placed in the door. A thermal break should be placed over the probe to minimise the impact of minor temperature fluctuations arising from the refrigerator door being opened. All thermometers used to monitor refrigerator temperatures should be calibrated by their manufacturer and replaced or recalibrated every 12 months. Under no circumstances should batteries be removed from thermometers. If thermometers are alarming then actions should be taken as per documented in this policy. Areas should ensure they have sufficient spare batteries if replacements are needed. Refrigerator problems Staff trained in recording refrigerator temperatures should be aware of the action needed to be taken if the temperature falls out of range or if there is any deviation from storage requirements. Thermometer battery replacement Batteries may need replacing if the reading become erratic or the display clarity fades (if the thermometer keeps showing Lo and Lo in the min and max readings then this is an indication the batteries need changing). This requires two AAA batteries or the 1.5v equivalent. Contact the pharmacy technician team immediately to replace batteries as the thermometer will also need resetting. Accidental disconnection of electrical supply If the refrigerator temperature has remained inside the range of 2-8 c Reconnect the power supply and no further action is required. If the refrigerator temperature is outside the range of 2-8 c Reconnect the power supply. Place the medicines in a bag marked DO NOT USE. Mark outside of refrigerator with a notice contains quarantined stock do not use. The notice should be dated and should direct enquiries to the ward manager, nurse/healthcare professional in charge or shift leader. Note the refrigerator current maximum and minimum temperatures. Page 6 of 12

7 Check the monitoring form for when the refrigerator was last working properly. Try and establish how long the medicines have been stored outside the required range of temperatures. Record the names of each medicine and it s manufacturers name. During the working day contact your ward pharmacist. Staff within Community can contact the pharmacy department directly. If the incident occurs at the weekend or outside of pharmacy opening times please contact the oncall pharmacist. Manufacturers advice changes continually and the pharmacy should be contacted for advice after every incident. Do not administer any refrigerated produce when it is unclear whether the storage temperature of the medicine has been maintained between 2 and 8 degrees centigrade (or if the continuity of the cold chain has been compromised). If (after seeking advice) you are advised that it is safe to use the drugs which have been exposed to storage temperatures outside of the recommended range, these stocks must be marked use first and marked with a new expiry date if applicable. If after seeking advice the medicines can no longer be used then obtain advice from the pharmacist at the time to on how to best discard the affected medicines. Complete an incident form as a record of the incident. Temperature fluctuations out of range As a start, check if the refrigerator seems cold/items inside feel cold it will be very clear if a refrigerator is completely broken and no longer at low temperatures indicating stock has been compromised and should not be used. If the products do not feel cold and the refrigerator appears to be broken, an urgent request for facilities to review should be logged by the nurse in charge. Check refrigerators are not over filled this can have a great impact on the internal temperature. If appropriate remove any items that are not required and reset thermometer. Check the general state of the refrigerator are there any obvious defects such as a perished seal. If this is the case, the ward/service manager will need to log an urgent request with facilities. Check the thermal seal on the probe is properly in place a problem with this may be indicated by frequent and fast fluctuations in temperature. If a perceived problem has been dealt with e.g. door not closed properly, refrigerator cleared out, log this on the comments section of the recording form, then reset temperature min/max and check again if problem has Page 7 of 12

8 been resolved within minutes if so continue with daily checks as per usual. If it is suspected readings may be erroneous due to a problem with the actual refrigerator thermometer then the ward pharmacy tecnhinican or relevant pharmacist can be contacted for advice. Persistent out of range temperatures Refrigerators that are persistently out of range must not be used as the integrity of medicines cannot be guaranteed. As a general rule the nearest available medicines refrigerator should be used. This may have a significant impact on nurse time and patient s receiving their medicines in a timely manner therefore any jobs raised with facilities should be urgent. If a new refrigerator is required again this needs to be raised via procurement urgently. The responsibility for overseeing this lies with ward manager/lead nurse for that area. Refrigerator breakdowns In addition to the actions above, if the medicines refrigerator breaks down: Make prompt arrangements for repair of the refrigerator Mark the refrigerator CLEARLY as NOT IN USE. The notice should be dated and should direct enquiries to the ward manager, nurse/healthcare professional in charge or shift leader. Place the medicines in a bag marked DO NOT USE and, if possible, transfer them to another refrigerator (preferably an alternative medicines refrigerator) if available. Ensure the quarantined medicines are kept separate from the rest of the contents. Mark outside of refrigerator with a notice contains quarantined stock do not use. The notice should be dated and should direct enquiries to the ward manager, nurse/healthcare professional in charge or shift leader. If no alternative refrigerator is available, quarantine the medicines as above and leave the medicines in the malfunctioning refrigerator and keep the door of the refrigerator closed. Mark outside of refrigerator with a notice contains quarantined stock do not use. The notice should be dated and should direct enquiries to the ward manager, nurse/healthcare professional in charge or shift leader. Note the current refrigerator maximum and minimum temperatures. Check the monitoring form for when the refrigerator was last working properly. Try and establish how long the medicines have been stored outside the required range of temperatures. Record the name of each medicine and it s manufacturers name. Page 8 of 12

9 During the working day contact your ward pharmacist. Staff within Community can contact the pharmacy department directly. If the incident occurs at the weekend or outside of pharmacy opening times please contact the oncall pharmacist. Manufacturers advice changes continually and the pharmacy should be contacted for advice after every incident. If, after seeking advice, it is safe to use the drugs which have been exposed to higher than storage temperatures, the stock concerned must be marked use first and mark with a new expiry date (if applicable). Complete an incident form as a record of the incident. The cost of any wasted stock should be documented on the incident form (costs can be obtained from pharmacy). Buying new refrigerators Procurement and Pharmacy are able to advise upon suitable refrigerators and their cost. All refrigerators used for storing medicines should be of pharmaceutical grade and meet the Medicines and Health Regulatory Agency (MHRA) guidelines on Control and monitoring of storage and transportation temperatures of medicinal products. Ward/Service mangers should raise orders via E Series / Integra Staff should pick the refrigerator closest in size to the one they currently have to ensure that it will fit. Once delivered refrigerators cannot be returned and wards will be required to meet any costs. The products already set up should be selected as this will ensure a quicker lead time. The refrigerators are from Glen Dimplex. More detail on the specifications and dimensions of suitable refrigeratosr can be found on the following website LEC Medical. Explanation of terms & Definitions Not applicable Page 9 of 12

10 References SRFT Medicines Policy. 163TD(C)(33)_-_Issue_No_11_-_Medicines_Policy Refrigerated medicinal products: what pharmacists need to know, MHRA, Recommendations on the control and monitoring of storage and transportation temperatures of medicinal product Vaccine cold storage, January 2010, National Patient Safety Agency Guidance on vaccine storage and handling, NHS National Services Scotland, Health protection Scotland 5. Fridge failures and stock incidents /ImmForm_Helpsh eet18_fridgefailures_stockincidents_acc.pdf The Green Book Page 10 of 12

11 Appendices Appendix 1 WARD/CLINIC STORAGE TEMPERATURE RECORD FOR MEDICINES REQUIRING REFRIGERATION Ward/Area Refrigerator Ref Month Year Ward Manager Refrigerator Temperatures should be between 2 0 C and 8 0 C Date Minimum Current Maximum Reading Reset Signature Action Taken Temp Temp Temp s OK? Should be more than 2 0 C Should be between 2 0 C and 8 0 C Should be less than 8 0 C 1 Yes / No Yes / No 2 Yes / No Yes / No 3 Yes / No Yes / No 4 Yes / No Yes / No 5 Yes / No Yes / No 6 Yes / No Yes / No 7 Yes / No Yes / No 8 Yes / No Yes / No 9 Yes / No Yes / No 10 Yes / No Yes / No 11 Yes / No Yes / No 12 Yes / No Yes / No 13 Yes / No Yes / No 14 Yes / No Yes / No 15 Yes / No Yes / No 16 Yes / No Yes / No 17 Yes / No Yes / No 18 Yes / No Yes / No 19 Yes / No Yes / No 20 Yes / No Yes / No 21 Yes / No Yes / No 22 Yes / No Yes / No 23 Yes / No Yes / No 24 Yes / No Yes / No 25 Yes / No Yes / No 26 Yes / No Yes / No 27 Yes / No Yes / No 28 Yes / No Yes / No 29 Yes / No Yes / No 30 Yes / No Yes / No 31 Yes / No Yes / No 1. Record Temperatures DAILY. Start a new log sheet each month. The log from the previous month should be filed on the ward. 2. Excursions over 8 0 C may occur during loading/dispensing/cleaning. Keep this time to a minimum. 3. If any temperature excursions (below 2 0 C and above 8 0 C) occur, a note of the time, duration and actions taken must be made in the action taken column of the temperature log. Out of range results should be reported to the ward pharmacist/pharmacy department. 4. If the cause of temperature deviation cannot be corrected immediately, move medicines to an alternative pharmacy refrigerator until the problem is solved. Page 11 of 12

12 Appendix 2 Page 12 of 12