Medicine Management Standard Operating Procedures (SOP) September 2015

Transcription

1 Medicine Management Standard Operating Procedures (SOP) September 2015 Responsible Committee: Clinical Governance Committee Date Effective: September 2015 Supersedes: December 2014 Next Review Done: December 2017

2 Contents KEY CONTACTS... 3 BACKGROUND... 4 SCOPE... 4 RESPONSIBILITIES... 4 (MM SOP 01): ORDERING MEDICINES FROM KINGS COLLEGE HOSPITAL PHARMACY DEPARTMENT... 5 INTRODUCTION... 5 PROCEDURE... 5 (MM SOP 02): RECEIPT OF MEDICINES ORDERED INTO SELDOC... 7 INTRODUCTION... 7 PROCEDURE... 7 (MM SOP 03): PLACING THE ORDER INTO STOCK AT SELDOC... 8 INTRODUCTION... 8 SELDOC STOCK CUPBOARDS... 8 PROCEDURE... 8 (MM SOP 04): MEDICATION STORAGE... 9 INTRODUCTION... 9 PROCEDURE... 9 (MM SOP 05): STOCKING, TRANSPORTING AND USING DOCTORS (BLUE) BAGS12 INTRODUCTION PROCEDURE (MM SOP 06): MEDICINES RETURNED TO SELDOC AND DISPOSAL OF PATIENTS OWN MEDICINES INTRODUCTION PROCEDURE (MM SOP 07): PRESCRIBING, DISPENSING AND ADMINISTRATION OF MEDICINES BY THE DUTY DOCTOR INTRODUCTION PROCEDURE Medicine Management SOP

3 KEY CONTACTS Name Role within this SOP Contact details Dr Belinda Medical Director for SELDOC Coker Mob: Denise Grant Trevor Dietrich Anita Brookman Operations Managers for SELDOC Tel: Tel: Medicine Management SOP

4 BACKGROUND Medicines are the most common healthcare intervention: they are used every day by millions of people to treat a wide range of simple (e.g. headache) and complex (e.g. cancers) conditions. However medicines usage comes with an element of risk. For example prescribing penicillin to someone who is allergic to penicillin or issuing medication that has passed its expiry date to a patient. Medicines are carefully formulated by pharmaceutical companies in compliance with their MHRA (Medicines and Healthcare Products Regulatory Agency) marketing authorisation. However a process error can occur during any part of the medication journey from manufacturing factory to wholesaler to SELDOC storage to patient administration whereby the integrity and hence suitability for use may be affected. Medicines management is a tool for mitigating these risks. It covers everything from ordering medicines to transportation, storage, prescribing, administration and disposal. It also encompasses clinical audit, risk management and formulary and guideline development. The underlying principles of medicines management are the Safe, effective and efficient use of medicines Regulation 13 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2010 specifically asks for providers to protect service users against the risks associated with the unsafe use and management of medicines by means of making appropriate arrangements to obtain, record, handle, use, safely keep, dispense, safely administer and dispose of medicines. SCOPE These SOPs establish robust medicines systems, underpinned by the relevant legislation, for obtaining, storing, supplying, recording, monitoring and disposing safely of medicines. The governance requirements of this policy apply to all members of staff who deal in any way with medicines, including supplying, transporting, storing, prescribing, preparing and administering and disposing of medicines. This is irrespective of grade, professional background or contract status within the Organisation. Controlled drugs (CD) are not included in this SOP. Please refer to the CD SOPs saved on the intranet. RESPONSIBILITIES It is the responsibility of all staff assigned a role in this SOP to follow it at all times and where unsure to seek immediate advice from a supervisor Medicine Management SOP

5 (MM SOP 01): ORDERING MEDICINES FROM KINGS COLLEGE HOSPITAL PHARMACY DEPARTMENT INTRODUCTION This procedure explains how we order medicines from the pharmacy department at Kings College Hospital PROCEDURE 1. The Operations Manager enters the stock room (this must be kept locked at all times with access by authorised staff only) 2. The Operations Manager then retrieves the pharmacy order sheet stored in the stock room. This is a pre-printed, manual entry sheet generated by Kings Pharmacy listing all the medicines in the SELDOC stocked medicines formulary 3. The order sheet is also used as a written order history for medicines and therefore must be retained by SELDOC and kept secure at all times. Completed sheets are official records and must be retained for two years at SELDOC 4. The Operations Manager retrieves the keys to the main brown bulk medicines cupboard and checks the quantity in the cupboard of each item listed on the pharmacy order sheet 5. If the quantity of a medicine falls below the minimum agreed level more medicine must be ordered, the quantity ordered being enough to get the level back up to the maximum agreed level. Maximum-minimum levels must be monitored on a routine basis and adjusted based on quantities used as well as quantities returned or destroyed due to expiry on the shelf. 6. The operations manager completes each medicine line on the order sheet with the number of packs required. The quantity should be written in figures and a zero must be entered where no stock is required. Verbal orders to Kings for stock medicines are not allowed. 7. When complete the Operations Manager signs and dates the legend at the base of each order sheet using the line corresponding to the column in which the order quantities have been written. 8. The order is then faxed to Kings Pharmacy on Orders are faxed during the normal working day, Monday Friday 9 to 5pm Medicine Management SOP

6 9. Kings pharmacy should be telephoned soon after on to confirm the order has been received and will be processed as normal practice. Orders usually take 2 days to process. If urgent a next day delivery can be arranged. 10. The original order sheet is then secured back into file to wait for the order to be delivered. This original will act as a check to reconcile the order against when it arrives should there be any queries. 11. The Operations Manager locks the main brown bulk medicines cupboard and retains the keys for the remainder of their shift. The door to the stock room must be kept locked at all times when the room is not in use. 12. Kings Pharmacy will process the order and deliver this to SELDOC. END OF PROCEDURE Please refer to MM SOP 02 for the next step in the process Medicine Management SOP

7 INTRODUCTION (MM SOP 02): RECEIPT OF MEDICINES ORDERED INTO SELDOC This procedure explains how we receive medicines from Kings College Hospital into SELDOC and continues from (MM SOP 01): Ordering medicines from Kings College hospital pharmacy department PROCEDURE 1. Medicines ordered from Kings are usually delivered within 2 working days. The delivery must be received by a member of staff authorised to do so and must be accepted and secured into the stock room immediately. Deliveries should not remain unattended and outside of a secure area particularly areas where patients may be present. 2. The Operations Manager accepts the delivery from the Kings driver. Any delivery boxes/totes from a previous order are given to the driver for return to Kings. The Operations Manager then signs the Kings transport log as evidence that the order has been received by SELDOC. 3. The Operations Manager takes the order into the stock room, shuts the door to prevent unauthorised access and proceeds to unpack the order. Containers transporting fridge items should be unpacked first and the contents transferred to the medicines refrigerator immediately. 4. The Operations Manager checks the seal of the boxes/totes in the delivery for any signs of tampering or damage. Evidence that the seal or other areas of the box may have been tampered with should be reported to Kings. 5. The Operations Manager breaks the seal, opens the box and retrieves the delivery note inside. The original pharmacy order sheet stored in the stock room is retrieved and checked against the quantity of each medicine actually received and the delivery note. Discrepancies should be discussed with Kings urgently via telephone: If the order is correct, the Operations Manager signs and dates the delivery note and files securely with the original pharmacy order sheet. (LEGALLY these must be retained by SELDOC for TWO years) 7. The order is then placed into stock Medicine Management SOP

8 END OF PROCEDURE Please refer to MM SOP 03 for the next step in the process (MM SOP 03): PLACING THE ORDER INTO STOCK AT SELDOC INTRODUCTION This procedure explains how orders are placed into stock and continues from (MM SOP 02): Receipt of Medicines Ordered into SELDOC. There are four main stock holding areas: Stock Holding Area The Main (Brown) Stock Cupboard The Supervisors (Black) Stock Cupboard The Doctors (Blue) Bags The Quarantine (Damaged) Stock Cupboard Information The main storage area for drugs. Used to stock the Supervisors Stock Cupboard and Doctors Bags. (Accessible by Operations Managers only) Mainly used to issue medication to Drs who are prescribing from stock. (Accessible by Operations Managers and Duty Supervisors) Sealed units which are taken on home visits (Accessible by Doctors only once sealed) For damaged stock to be sent for destruction SELDOC STOCK CUPBOARDS The Main (Brown) Stock Cupboard The Supervisors (Black) Stock Cupboard Seldoc Order The Doctors (Blue) Bags Delivered The Quarantine (Damaged) Stock Cupboard PROCEDURE 1. Operations Managers are responsible for ensuring deliveries are placed into stock appropriately and can delegate this activity to duty supervisors while retaining oversight. 2. The condition of the stock should be checked to ensure that the outer package is not damaged. The medicine container inside the packaging must be intact: i.e. the seal Medicine Management SOP

9 is not broken and there is no evidence of leakage of medicines from a container, broken glass bottle, vial e.tc. 3. Damaged stock must be removed and destroyed on site IF it is unfit for transportation back to Kings for example a broken glass bottle. This is to reduce the risk of harm to operators. 4. Stock is first transferred into the Main (Brown) Stock Cupboard. Only the Operations Managers have access to this cupboard. Stock is arranged in alphabetical order 5. The Operations Manager or delegate places stock on the cabinet shelf in order so that the shorter date expiry products are brought to the front row and are thus used first. If the delivered stock is nearing its expiry date or has expired, it must be removed to a quarantine area for stock that is to be returned to Kings for disposal 6. The Operations Manager transfers stock from the Main (Brown) Stock Cupboard to the Supervisors (Black) Stock Cupboard when the minimum stock level is reached. 7. Ensure stock is arranged in alphabetical order and rotate stock as described in step 5 above END OF PROCEDURE Please refer to MM SOP 04 for the next step in the process MM SOP 04): MEDICATION STORAGE INTRODUCTION This procedure explains how we store medicines at SELDOC. It continues from (MM SOP 03): Placing the order into stock at SELDOC. If medicines are not stored properly they may not work in the way they were intended, and so pose a potential risk to the health and wellbeing of the person receiving the medicine. Medicines should be stored under conditions which ensure that their quality is maintained. The temperature of storage is one of the most important factors that can affect the stability of a medicine. The storage requirements for a medicine can be found either on the product itself and/or the patient information leaflet that accompanies each dispensed medicine. Storage conditions for most medicines can be satisfied by either cold storage (between 2-8 C) OR storage that is not above 25 C. PROCEDURE Medicine Management SOP

10 1. The Operations Manager is responsible for ensuring that all medicines are stored safely in such a way that they can be used efficiently (i.e. stock rotation) 2. The stock room must be kept locked at all times when not in use to prevent inappropriate access. Furthermore, the Main (Brown) Stock Cupboard and the Supervisors (Black) Stock Cupboard must be kept locked at all times when not in use 3. The (a) Stock room temperature and (b) the refrigerator temperature MUST be monitored every morning by recording the temperatures on the respective Stock room and Refrigerator daily record sheets. Follow the FOUR Rs (see box below) AN IMPORTANT NOTE ABOUT RECORDING FRIDGE TEMPERATURES There are three temperatures to record: 1. The Maximum (MAX) temperature: This is the highest temperature to have occurred during the past 24 hours Should NOT exceed 8 C 2. The Minimum (MIN) temperature: This is the lowest temperature to have occurred during the past 24 hours Should NOT exceed 2 C 3. The At Observation temperature: This is temperature at the time you take the reading The FOUR Rs Read: daily reading of the thermometer s maximum, minimum and current temperatures at the same time every day during the working week Record: recording temperatures in a standard fashion and on a standard form, including signing each entry on the recording sheet Reset: resetting the thermometer after each reading. The thermometers should also be reset when temperatures have stabilized after periods of high activity React: the person making the recording should take action if the temperature falls outside +2 C to +8 C and document this action. At least one maximum-minimum thermometer that is independent of mains power should be used (as well as any integrated thermometer), so temperatures can be measured in the event of electricity loss. The maximum-minimum thermometer should be calibrated annually to confirm that it is giving accurate readings. 4. If the Stock room temperature rises above 25 C, the Operations Manager should be informed immediately. Then estimate the length of time the temperature has been above 25 C as this will be important in determining whether temperature sensitive medicines remain fit for use. If an Operations Manager is not available (e.g. 2 am in the morning) the on call senior manager should be informed 5. If the Refrigerator temperature goes outside the range of 2-8 C, the Operations Manager should be informed immediately. Then estimate the length of time the temperature has been outside of range as this will be important in determining whether temperature sensitive medicines remain fit for use. If an Operations Manager is not available (e.g. 2 am in the morning) the on call senior manager should be informed Medicine Management SOP

11 6. All medicines stored at the incorrect temperature must be quarantined from use immediately pending advice by the Operations Manager, Pharmaceutical Adviser or Medical Director. 7. Measures should be taken to rectify the cause of the change in temperature immediately and temporary arrangements should be made to place the (now quarantined) affected stock at the correct temperature. For example another fridge can be used to store fridge items while the medicines fridge fault is being rectified. 8. The Operations Manager, Pharmaceutical Adviser or Medical Director will contact the local hospital medicines information department and(or) the manufacturer and may also use online sources such as the fridge database to determine if medicines are fit for use and what their expiry date should now be. 9. Where medicines are deemed fit for use, they should be returned to stock in an order that enables them to be used first, irrespective of their expiry date. It may help to mark each affected packet. 10. Medicines deemed not fit for use should be placed in the quarantine (Damaged) stock cupboard 11. All Stock room or Refrigerator temperature incidents must be logged on an incident form END OF PROCEDURE Please refer to MM SOP 05 for the next step in the process Medicine Management SOP

12 (MM SOP 05): STOCKING, TRANSPORTING AND USING DOCTORS (BLUE) BAGS INTRODUCTION This procedure explains how we stock doctors (blue) bags. It continues from (MM SOP 04): Medication storage. The doctors (blue) bags have a specific layout that allows each bag to accommodate most of the drugs on the SELDOC formulary. Medicines are divided into modules based on their drug class and therapeutic indication with an outer label detailing the contents of each module. This allows drugs to be grouped into separate pre-packs so that it is easy to identify which drugs have been used up. Each bag has a unique identification number that corresponds with the other home visiting bags. PROCEDURE 1. The Operations Manager is responsible for checking and replenishing doctors bags 2. All bags (whether used or unused) must be stored safely in a designated area of the medicines stock room. Used bags should not be issued to Drs until they have been checked and replenished and should be clearly marked as such to prevent inadvertent use. 3. Medicines to replenish each bag are taken from the Main (Brown) Stock Cupboard. Expiry dates of each medicine being used to restock the doctors bags should be checked. 4. Once a medicine has been replaced the module must be resealed and a new label placed on the outside if the original has become damaged. 5. A new contents sheet (lists all the medicines in the bag) is placed in the bag. The bag is sealed and transferred to the area of the stock room designated for bags that are ready for use. 6. A sealed doctors bag follows the duty doctor when attending to patients at external sites. The authorised driver must transport the bag to their car immediately, with no breaks in transit 7. The bag is secured in the boot of the car by the authorised driver. The authorised driver is responsible for security of the car keys and the bag for the whole of their shift 8. Some cases may require the bags to remain in the car when it is unmanned e.g. the driver is required to chaperone the duty Dr. This is considered acceptable providing Medicine Management SOP

13 the car is not left for longer than absolutely necessary, and it is secured upon leaving. 9. Under no circumstances is a bag to remain in a car that is not being used during a shift. When a bag is not required for immediate use, or likely to remain unused for a significant period of time it must be secured back into the boot of the car by the authorised driver where the duty Dr considers there to be a risk otherwise. In most cases the authorised driver will remain with the car at all times where bags are secured in the boot. 10. A signatory should be kept for the issue and receipt of bags during a shift. This should be signed by the driver and duty supervisor to ensure the location of a bag and who is responsible for it is known at any given time. Signatory logs are official records and must be retained for two years by SELDOC. 11. When accessing a bag from the car during a visit the duty Dr takes responsibility for its safe handling. The bag must remain in the duty Dr s possession and supervision at all times. 12. Duty doctors have a duty of care to protect themselves from physical threat that may predispose as a result of carrying drug bags. Bags should be designed to reduce the risk of association with drugs by onlookers. The duty Dr should never put him / herself at risk of physical threat. It is often safer to surrender drugs than mount a defence. 13. A duty doctor may issue medicines from the doctors bag (e.g. 3am in the morning when the pharmacy is shut). In all cases the doctor must complete the contents sheet (which lists all the medicines enclosed) to state which medicines have been dispensed or administered by them to a patient. 14. The duty doctor should indicate the quantity of each pack and the case number corresponding to the patient the pack has been issued to. These medicines will need to be replaced during replenishment of the bag. 15. The duty Dr must handover the bag to the authorised driver as soon as possible on return from seeing a patient. The bag then becomes the responsibility of the authorised driver. 16. The authorised car driver must secure the bag into the car boot immediately and is responsible for returning all bags to the duty supervisor at the end of the Dr s shift 17. Bags should never remain in a car following a shift, when the car is not in use Medicine Management SOP

14 18. The duty supervisor must return all bags to the stock room ready for checking and replenishing if necessary 19. Bags with their seal remaining intact can be returned to the area of the stock room designated for storage of useable bags (this must be distinct to the area for bags that require replenishing). 20. Bags with a broken seal will require replenishing as described in step 3 END OF PROCEDURE Please refer to MM SOP 06 for the next step in the process Medicine Management SOP

15 (MM SOP 06): MEDICINES RETURNED TO SELDOC AND DISPOSAL OF PATIENTS OWN MEDICINES INTRODUCTION This procedure explains how medicines in doctors bags are returned to SELDOC and also covers the exceptional case of handling patients own medicines. It continues from (MMSOP 05): Stocking, transporting and using doctors (blue) bags. Duty doctors returning from home visits may have issued or administered medicines to patients whilst in their home, therefore the doctors (blue) bags being returned to SELDOC would need to be checked and restocked. Duty Doctors may also encounter exceptional situations whereby medicines prescribed by another doctor are no longer required and pose a safety risk to patients, their relatives or carers. This risk applies to non-controlled as well as controlled drugs (CD) although CDs often pose a great risk. The risk can also apply to medicines that are still being taken but have been stockpiled by the patient as a result of repeat prescribing. In these situations, the best option is to arrange for the medicines to be returned to the patient s regular pharmacy however there will be rare occasions when it is safer for the duty doctor to bring the medicines to SELDOC for destruction. The procedure for handling these exceptional cases is outlined in the latter part of this SOP. PROCEDURE 1. At the end of each evening shift, the authorised car driver is responsible for transporting the doctors (blue) bags from the car to the medicines stock room and handing over to the duty supervisor. 2. The duty supervisor is responsible for overseeing the transfer of doctors (blue) bags to the medicines stock room and must accompany the authorised car driver into the medicines stock room. 3. The duty supervisor and authorised driver must both sign and date the bag issue log 4. The duty supervisor then checks the seal on the returned bags. If the seal has not been broken, the bags can be placed in the area of the stock room designated for bags that are ready to issue. If the seal has been broken, the bags should be placed in the area of the stock room for bags that need to be checked and replenished. 5. The duty supervisor must ensure that any bag with the seal broken contains a contents sheet completed by the duty doctor during their visit. The completed contents sheet will detail stock that has been used up and hence needs to be replenished. 6. The completed contents sheet from any bags with the seal broken should be filed in a secure place Medicine Management SOP

16 7. The duty supervisor then restocks the doctors (blue) bags as outlined in MMSOP 05, Stocking, Transporting and using doctors (blue) bags. EXCEPTIONAL CASES ONLY - Disposal of patients own medicines In very exceptional circumstances, the duty Dr may decide to remove a patient s own medicines from their home during a visit. Usually these medicines will no longer be required by the patient. The duty Dr must remove these medicines only if he/she decides that the risk of leaving them with the patient, family or carer for disposal outweighs that for removal and transport back to SELDOC for destruction 8. Assessing the Risk The duty Dr has a professional responsibility to manage any risk they perceive to the patient, family or carers of medicines that are no longer required being left in their possession 9. The duty Dr must first agree with the patient, family or carer that the unwanted medicines should be removed and disposed of on the grounds of safety. It is good practice to gain a signature of agreement from the patient, family or carer that the medicines may be removed as the medicines will be the patient s property. 10. The duty Dr should be aware of options open to them to manage the unwanted medicines. This could include encouraging the patient, family or carer to return the medicines to a pharmacy. Preferably this should be the pharmacy that dispensed the medicines as they will know the patient and may manage medicines reconciliation for them. Other pharmacies would normally also accept medicines for destruction and some pharmacies offer a collection service for unwanted medicines. 11. The final choice should be based on whichever route ensures the safe, secure and timely disposal of the medicines given the resources available and the existing degree of risk whilst also minimising inconvenience to the patient and professional in doing so. 12. If the only feasible option is for the Dr to accept unwanted medicines for destruction, the first step is to attempt to hand the medicines over to a nearby pharmacy for destruction but if this option is not available (e.g. 1am when all pharmacies are shut), the duty Dr may bring the medicines to SELDOC for destruction 13. The Duty Dr must then hand the medicines to the duty supervisor for transfer to the quarantine (damaged) stock cupboard 14. Medicines removed by the Duty Dr should be transported to their destination as soon as is practical and under no circumstances should medicines remain in cars over night. 15. There may be cases where it is preferable for unwanted medicines to remain with the Duty Dr until they can safely reach a pharmacy (e.g. possession overnight). Medicine Management SOP

17 16. In all cases the medicines remain the duty Dr s responsibility, must be under their direct supervision at all times and should be secured between transit points. 17. Duty Drs have a duty of care to protect themselves from physical threats that may predispose as a result of transporting medicines. The Duty Dr must take precautions to reduce the risk of association with drugs (especially controlled drugs) by onlookers. END OF PROCEDURE Please refer to MM SOP 07 Medicine Management SOP

18 (MM SOP 07): PRESCRIBING, DISPENSING AND ADMINISTRATION OF MEDICINES BY THE DUTY DOCTOR INTRODUCTION This procedure explains how medicines are prescribed, dispensed and administered by duty doctors. It should be read along with the Administration and Supply of Medicines Policy Prescribing/Dispensing of medicines can follow one of three processes (see table below): A. Issuing an FP10 prescription for a patient to take to a community pharmacy for dispensing B. Issuing medication to a patient from the SELDOC stock at the Dulwich base C. Issuing medication to a patient during a home visit from the Doctors (blue) bags 19:00 to 23:00 GPs to prescribe FP10 prescriptions to be dispensed at any community pharmacy. Some pharmacies open till 11pm and some till 12 midnight 23: 01 to 07:00 (Non CD Meds) ONLY if not appropriate to issue FP10 Px for 8am dispensing in community pharmacy 23:01 07:00 (CD Meds) ONLY if not appropriate to issue FP10 Px for 8am dispensing in community pharmacy At Base Issue medication from the SELDOC stock at the Dulwich base Home Visits - Issue medication from the Doctors (blue) bags At Base and Home Visits - Use CD stock from the Dulwich base Security of Prescriptions The theft of prescriptions and their consequent misuse is an area of concern for a number of reasons. A prescription form is an NHS asset that has a financial cost attached. Prescription forms should be treated as blank cheques which, in the wrong hands, can lead to a misuse of NHS resources. Stolen forms, or indeed whole pads, can be used to illegally obtain controlled drugs (CDs), as well as other medicines either for illegitimate personal use, which might lead to a clinical incident, or for the purpose of selling them on. The forms themselves are items of value which can be sold to a third party. Please read the Security of Prescription Forms Guidance for more details rms_guidance_updated_august_2013.pdf PROCEDURE 1. Strict security measures are required to manage FP10 prescriptions whilst in storage at SELDOC and when issued for use by the duty Dr. 2. Blank prescriptions should never be pre-signed by the duty doctor Medicine Management SOP

19 3. The duty supervisor is responsible for issuing the duty Dr with a stock of blank FP10 prescriptions at the beginning of the shift and reconciling returned (unused and damaged/voided) prescriptions at the end of the shift. 4. The FP10 Daily prescription control sheet must be used to record issues and receipts of FP10s at the beginning and end of shifts. 5. Upon issue, the duty supervisor must ensure that the following sections of the FP10 Daily prescription control sheet are completed: (i) (ii) (iii) (iv) (v) Time of session Name of duty doctor for the shift Number of prescriptions issued Serial number of first and last prescription in the batch issued to the doctor (the serial number on the prescriptions forms is positioned at the bottom of the form. The first 10 numbers are the serial number (these numbers run in sequence); the last (the 11th) character is the check digit and does not run in sequence The receiving duty doctor s signature and the date and time 6. The security of prescriptions is both the responsibility of the SELDOC and the duty doctor when in their possession 7. Upon receipt, the duty supervisor must ensure that the following sections of the FP10 Daily prescription control sheet are completed: (i) (ii) (iii) (vi) (iv) The number of prescriptions issued The number of prescriptions returned unused in the batch Serial number of the first and last prescription in the batch The returning duty doctor s signature and the date and time Damaged or voided prescriptions (enter their corresponding serial numbers) 8. Damaged or voided prescriptions must be returned with the completed log to the operations manager at the end of the shift for reconciliation 9. The duty doctor should confirm that a community pharmacy is open or that the course of treatment can commence at the next available time a community pharmacy is open to dispense the prescription. 10. The duty doctor should comply with all best practice standards for the writing of FP10 prescriptions including legal requirements and managing patient allergies, sensitivities and adverse drug reactions 11. The duty doctor must record details of medicines prescribed in patients (adastra) clinical records Medicine Management SOP

20 Dispensing medicines from stock (i.e. at Dulwich Base or from Doctors (blue) bags during home visits 12. Only whole packs should be dispensed. That is, there must be no breaking of packs by the duty doctor. 13. The duty doctor must ensure each pack issued contains a patient information leaflet and must complete details on the medication label (a) Patient s name (b) Dosage instructions (c) Warning instructions (d) Expiry date 14. The duty doctor should complete medicine administration authorisation charts where necessary e.g. a variable dose range for an injectable medicine given by a syringe driver where the nurse decides on the dose depending on the clinical situation. Details on medicine labels must match the authorisation chart 15. The duty doctor must record details of medicines dispensed in patients (adastra) clinical records 16. The duty Dr must complete the Home Visiting Drugs Bag Contents Sheet each time a medicine is dispensed Administration of Medicines (Oral Liquid Medicines) Oral liquid medicines are often administered to babies, young children and adults who have impaired ability to swallow tablets and capsules. These medicines may be measured and administered using a 5mL medicine spoon, a graduated measure, or a graduated oral syringe. They may be administered by mouth or, when indicated, via a licensed feeding tube. Incorrect intravenous administration of oral liquid medicines has resulted in reported deaths and harm. It is important to never use intravenous syringes to measure and administer oral liquid medicines. If intravenous syringes are used to measure and administer oral liquid medicines, there is an increased risk of wrong route errors by connecting to intravenous or other parenteral lines. Please see the following patient safety alert for more details Some oral medicines intended for administration as a liquid are presented in powder form that must be reconstituted first with a suitable diluent. In most cases the diluent used is water. Tap water is appropriate providing it is drinkable (potable) tap water. The volume of diluent may vary between products. The manufacturer s label on the outside of the bottle will state the diluent and volume to add in order to obtain a final liquid of the appropriate strength. Once the diluent is added the bottle must be shaken until all the powder has dissolved, this may take several minutes depending on the product. 18. Complete the outer patient label with the appropriate details: (i) Patient s name (ii) Date product was reconstituted, in some cases the time this is done may be asked for. (iii) Dose (as a volume stated as ml ) and frequency. (iv) Length of course over which to take the medicine. Medicine Management SOP

21 (v) (vi) Expiry based on the shelf life of the product once reconstituted. The manufacturer s label on the outside of the bottle will state the expiry once reconstituted. 19. Instruct the patient on how to take their medicine including: (i) (ii) (iii) (iv) (v) (vi) (vii) The prescribed dose in ml, and frequency How long to take the medicine for Special storage instructions e.g. fridge or room temperature Possible side effects and what to do if they experience any of them. Who to contact with further questions or if symptoms do not improve and/or worsen. Where to obtain further supplies. What to do with any left-over medicine. 20. Supply the patient with either a 5mL measuring spoon, or appropriate size oral syringe depending on the dose in ml. Press-in bottle adapters that facilitate the use of oral syringes when withdrawing the medicine from the bottle are also available Administration of Medicines (Injectable Medicines) The use of injectable medication has many healthcare benefits for patients. The complexities associated with the prescription, preparation and administration of injectable medicines means that there are greater potential risks for patients than for other routes of administration. Please see the following patient safety alert for more details Promoting the Safer Use of Injectable Medicines All prescriptions for injectable medicines must specify the following: (i) Patient s name (ii) Prescriber s signature (iii) The approved medicine name (iv) The dose and frequency of administration (v) The date and route of administration (vi) The allergy status of the patient 22. Where relevant, the prescription, or a readily available local protocol, must specify the following: (i) Brand name and formulation of the medicine. (ii) Concentration or total quantity of the medicine in final infusion container, or syringe (iii) Name and volume of diluent and / or infusion fluid (iv) Rate and duration of administration (v) Stability information to determine the expiry of the final product (vi) Type of rate-control pump or device(s) to be used Medicine Management SOP

22 (vii) (viii) (ix) The age and weight of any patient under 16 years of age, where relevant. Date on which treatment should be reviewed Arrangements for fluid balance or clinical monitoring should be made on an individual patient basis and according to local protocol and clinical need 23. Before administering any injection, check all of the following: (i) Patient s name, hospital / NHS Number or date of birth or address. (ii) Prescriber s signature. (iii) The approved medicine name. (iv) The dose and frequency of administration. (v) The date and route of administration. (vi) The allergy status of the patient. (vii) The brand name and formulation of the medicine. (viii) Concentration or total quantity of medicine in the final infusion container or syringe. (ix) Name and volume of diluent and / or infusion fluid. (x) Rate and duration of administration. (xi) Type of rate control pump or device(s) to be used. (xii) The age and weight of any patient under 16 years of age, where relevant. (xiii) Date on which treatment should be reviewed. (xiv) Check that the medicine is due for administration at that time and has not already been given. 24. Assemble everything you need including any flushing solution(s) needed. Explain and discuss the procedure with the patient. Check any infusion already in progress. It should be free of haziness, particles and discolouration. Check that an appropriate access device is in place. Flush it immediately before and after administration of a medicine, and between doses of different medicines administered consecutively, according to local policy. Also check the administration site for signs of leakage, infection or inflammation. 25. After administration (i) (ii) (iii) (iv) Ask the patient to report promptly any soreness at the injection site or discomfort of any sort. Make a detailed record of administration. Discard the empty ampoules/vials from which the injection was prepared and any unused medicine. Ampoules or vials should never be used to prepare more than one injection unless specifically labelled by the manufacturer for multi-dose use. Medicine Management SOP

23 (v) (vi) (vii) Re-check the administration site for signs of leakage, infection or inflammation. Check that arrangements for monitoring fluid balance or other relevant clinical parameters have been made according to local policy. Ensure that relevant documentation is made available for subsequent regular monitoring to take place. 26. Preparation - Read all prescription details carefully and confirm that they relate to the patient to be treated. Ensure that the area in which the medicine is to be prepared is as clean, uncluttered and free from interruption and distraction as possible. Assemble all materials and equipment: sharps bin for waste disposal, medicine ampoule(s) / vial(s), diluent, syringe(s), needle(s), alcohol wipes, disposable protective gloves, clean re-usable plastic tray. Check the following: (a) expiry dates (b) damage to containers, vials or packaging (c) that medicines were stored as recommended e.g. in the refrigerator. 27. Beware of the risk of confusion between similar looking medicine packs, names and strengths. Read all labels carefully. This is particularly important for various strengths of strong opioids e.g. morphine and diamorphine. 28. Check that (a) the formulation, dose, diluent, infusion fluid and rate of administration correspond to the prescription and product information, (b) the patient has no known allergy to the medicine and (c) you understand the method of preparation. 29. Calculate the volume of medicine solution needed to give the prescribed dose. It is good practice to write the calculation down and if possible obtain a second, independent check. It is accepted that there may be occasions where the separation of tasks is not possible. Where this is the case, it is important that accurate records are kept by the practitioner. 30. Prepare the label for the prepared medicine. Cleanse your hands according to local policy. Put on a pair of disposable protective gloves. Use a 70% alcohol wipe or spray to disinfect the surface of the plastic 31. Assemble the syringe(s) and needle(s).peel open wrappers carefully, do not tear as this will introduce paper filaments into the environment that may contaminate the product. 32. Arrange all ampoules / vials, syringes and needles neatly on the tray. Use a nontouch technique i.e. avoid touching areas where bacterial contamination may be introduced e.g. syringe tips, needles, vial tops. Never put down a syringe attached to an unsheathed needle. Medicine Management SOP

24 33. Prepare the injection by following the manufacturer s product information or local guidelines 34. To withdraw solution from an ampoule (glass or plastic) into a syringe - tap the ampoule gently to dislodge any medicine in the neck. Snap open the neck of glass ampoules, using an ampoule snapper if required. Attach a needle to a syringe and draw the required volume of solution into the syringe. Tilt the ampoule if necessary. Invert the syringe and tap lightly to aggregate the air bubbles at the needle end. Expel the air carefully. Remove the needle from the syringe and fit a new needle or sterile blind hub. Label the syringe. Keep the ampoule and any unused medicine until administration to the patient is complete to enable further checking procedures to be undertaken. If the ampoule contains a suspension rather than solution, it should be gently swirled to mix the contents immediately before they are drawn into the syringe. The neck of some plastic ampoules is designed to connect directly a syringe without use of a needle, after the top of the ampoule has been twisted off 35. To withdraw a solution or suspension from a vial into a syringe - Remove the tamper-evident seal from the vial and wipe the rubber septum with an alcohol wipe. Allow to dry for at least 30 seconds. With the needle sheathed, draw into the syringe a volume of air equivalent to the required volume of solution to be drawn up. Remove the needle cover and insert the needle into the vial through the rubber septum. Invert the vial. Keep the needle in the solution and slowly depress the plunger to push air into the vial. Release the plunger so that solution flows back into the syringe. If a large volume of solution is to be withdrawn, use a push-pull technique. Repeatedly inject small volumes of air and draw up an equal volume of solution until the required total is reached. This equilibrium method helps to minimise the build-up of pressure in the vial. Alternatively, the rubber septum may be pierced with a second needle to let air into the vial as solution is withdrawn. The tip of the vent needle must always be kept above the solution to prevent leakage. With the vial still attached, invert the syringe. With the needle and vial uppermost, tap the syringe lightly to aggregate the air bubbles at the needle end. Push the air back into the vial. Fill the syringe with the required volume of solution then draw in a small volume of air. Withdraw the needle from the vial. Expel excess air from the syringe. Remove the needle and exchange it for a new needle or a sterile blind hub. The vial(s) and any unused medicine should be kept until administration to the patient is complete. If the vial contains a suspension rather than solution, it should be gently swirled to mix the contents, immediately before they are drawn into the syringe. 36. To reconstitute powder in a vial and draw up the resulting solution or suspension into a syringe - Remove the tamper-evident seal from the vial and wipe the rubber septum with an alcohol wipe. Allow to dry for at least 30 seconds. Withdraw the required volume of diluent (e.g. water for injections or sodium chloride Medicine Management SOP

25 0.9%) from ampoule(s) into the syringe. Inject the diluent into the vial, and keeping the tip of the needle above the level of the solution in the vial, release the plunger. The syringe will fill with the air which has been displaced by the solution (if the contents of the vial were packed under a vacuum, solution will be drawn into the vial and no air will be displaced). If a large volume of diluent is to be added, use a pushpull technique (see above). With the syringe and needle still in place, gently swirl the vial(s) to dissolve all the powder, unless otherwise indicated by the product information. This may take several minutes. Withdraw the required volume of solution from the vial into the syringe. Alternatively, the rubber septum may be pierced with a second needle to let air into the vial as solution is withdrawn. The tip of the vent needle must always be kept above the solution to prevent leakage. If a purpose-designed reconstitution device is used, the manufacturer s instructions should be read carefully and followed closely. 37. To add a medicine to an infusion - Prepare the medicine in a syringe. Check the outer wrapper of the infusion container is undamaged. Remove the wrapper and check the infusion container itself in good light. It should be intact and free of cracks, punctures / leaks. Check the infusion solution, which should be free of haziness, particles and discolouration. Where necessary, remove the tamper-evident seal on the additive port according to the manufacturer s instructions or wipe the rubber septum on the infusion container with an alcohol wipe and allow to dry for at least 30 seconds. If the volume of medicine solution to be added is more than 10% of the initial contents of the infusion container (more than 50ml to a 500ml or 100ml to a 1litre infusion), an equivalent volume must first be removed with a syringe and needle. Inject the medicine into the infusion container through the centre of the injection port, taking care to keep the tip of the needle away from the side of the infusion container. Withdraw the needle and invert the container at least five times to ensure thorough mixing before starting the infusion. Do not add anything to any infusion container other than a burette when it is hanging on the infusion stand since this makes adequate mixing impossible. Before adding a medicine to a hanging burette, administration must be stopped. After the addition has been made and before administration is re-started, the contents of the burette must be carefully swirled to ensure complete mixing of the contents. Check the appearance of the final infusion for absence of particles, cloudiness or discolouration. Label the infusion 38. To dilute a medicine in a syringe for use in a pump or syringe driver - Prepare the medicine in a syringe using one of the methods described above. Draw the diluent into the syringe to be used for administration by the pump or syringe-driver. Draw in some air (slightly more than the volume of medicine needed) and remove the needle. Stand the diluent syringe upright. Insert the needle of the syringe containing the medicine into the tip of the diluent (administration) syringe and add the medicine to it. Alternatively, a disposable sterile connector may be used to Medicine Management SOP

26 connect two syringes together directly. Check that the total volume of injection solution in the syringe is as specified in the prescription and that the infusion can be delivered at the prescribed rate by the administration device chosen. Also check that the rate of administration is set correctly on the administration device and according to the manufacturer s instructions. Fit a blind hub to the administration syringe and invert several times to mix the contents. Remove the blind hub. Tap the syringe lightly to aggregate the air bubbles at the needle end. Expel the air and refit the blind hub. Carefully check the syringe for cracks and leaks and then label it, especially noting the requirements specific to syringe drivers. Check that the rate of administration is set correctly on the device before fitting the syringe, priming the administration set and starting the infusion device. END OF PROCEDURE Medicine Management SOP