medicine management standard operating procedures (sop) · medicine management standard operating...

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

Medicine Management SOP 2015 - 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 ....................................................................................................... 12

PROCEDURE ............................................................................................................ 12

(MM SOP 06): MEDICINES RETURNED TO SELDOC AND DISPOSAL OF PATIENTS’

OWN MEDICINES......................................................................................................... 15

INTRODUCTION ....................................................................................................... 15

PROCEDURE ............................................................................................................ 15

(MM SOP 07): PRESCRIBING, DISPENSING AND ADMINISTRATION OF

MEDICINES BY THE DUTY DOCTOR ......................................................................... 18

INTRODUCTION ....................................................................................................... 18

PROCEDURE ............................................................................................................ 18


KEY CONTACTS

Name Role within this SOP Contact details

Dr Belinda Coker

Medical Director for SELDOC [email protected] Mob: 07535 052134 Tel: 020 8299 2619

Denise Grant Trevor Dietrich Anita Brookman

Operations Managers for SELDOC

[email protected] [email protected] [email protected] Tel: 020 8299 2619

mailto:[email protected]





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


(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 020 3299 3200. Orders are faxed

during the normal working day, Monday – Friday 9 to 5pm


9. Kings pharmacy should be telephoned soon after on 020 3299 1596 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


(MM SOP 02): RECEIPT OF MEDICINES ORDERED INTO SELDOC

INTRODUCTION 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:

020 3299 1596.

6. 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


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 Information

The Main (Brown) Stock Cupboard

The main storage area for drugs. Used to stock the Supervisors’ Stock Cupboard and Doctors’ Bags. (Accessible by Operations Managers only)

The Supervisors’ (Black) Stock Cupboard

Mainly used to issue medication to Drs who are prescribing from stock. (Accessible by Operations Managers and Duty Supervisors)

The Doctors’ (Blue) Bags Sealed units which are taken on home visits (Accessible by Doctors only – once sealed)

The Quarantine (Damaged) Stock Cupboard

For damaged stock to be sent for destruction

SELDOC STOCK CUPBOARDS

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

The Main (Brown) Stock Cupboard

Seldoc Order

Delivered

The Supervisors’ (Black) Stock Cupboard

The Doctors’ (Blue) Bags

The Quarantine (Damaged) Stock Cupboard


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


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


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)

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

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.


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

www.ukmi.nhs.uk/applications/fridge/ 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


http://www.ukmi.nhs.uk/applications/fridge/


(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


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


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


(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


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).


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


(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

At Base – Issue medication from the SELDOC stock

at the Dulwich base

Home Visits - Issue medication from the Doctors’

(blue) bags

23:01 – 07:00 (CD Meds) ONLY if not appropriate to issue FP10 Px for 8am dispensing in community pharmacy

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 http://www.nhsbsa.nhs.uk/Documents/SecurityManagement/Security_of_prescription_forms_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

http://www.nhsbsa.nhs.uk/Documents/SecurityManagement/Security_of_prescription_forms_guidance_Updated_August_2013.pdf

http://www.nhsbsa.nhs.uk/Documents/SecurityManagement/Security_of_prescription_forms_guidance_Updated_August_2013.pdf


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) Time of session

(ii) Name of duty doctor for the shift

(iii) Number of prescriptions issued

(iv) 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

(v) 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) The number of prescriptions issued

(ii) The number of prescriptions returned unused in the batch

(iii) Serial number of the first and last prescription in the batch

(vi) The returning duty doctor’s signature and the date and time

(iv) 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


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 http://www.nrls.npsa.nhs.uk/resources/?entryid45=59808 17. 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.

http://www.nrls.npsa.nhs.uk/resources/?entryid45=59808


(v) Expiry based on the shelf life of the product once reconstituted.

(vi) 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) The prescribed dose in mL, and frequency

(ii) How long to take the medicine for

(iii) Special storage instructions e.g. fridge or room temperature

(iv) Possible side effects and what to do if they experience any of them.

(v) Who to contact with further questions or if symptoms do not improve

and/or worsen.

(vi) Where to obtain further supplies.

(vii) 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’ http://www.nrls.npsa.nhs.uk/resources/?entryid45=59812 21. 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

http://www.nrls.npsa.nhs.uk/resources/?entryid45=59812


(vii) The age and weight of any patient under 16 years of age, where

relevant.

(viii) Date on which treatment should be reviewed

(ix) 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) Ask the patient to report promptly any soreness at the injection site or

discomfort of any sort.

(ii) Make a detailed record of administration.

(iii) Discard the empty ampoules/vials from which the injection was prepared

and any unused medicine.

(iv) Ampoules or vials should never be used to prepare more than one

injection unless specifically labelled by the manufacturer for ‘multi-dose’

use.


(v) Re-check the administration site for signs of leakage, infection or

inflammation.

(vi) Check that arrangements for monitoring fluid balance or other relevant

clinical parameters have been made according to local policy.

(vii) 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 ‘non-

touch’ 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.


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


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


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