Guidelines for Stock Management of Coagulation Factor ...€¦ · Guidelines for Stock Management of Coagulation Factor Concentrates ... 1. Background ... concentrates differs from

Guidelines for Stock Management of Coagulation Factor Concentrates

within the Hospital Setting in Scotland

Scottish Inherited Bleeding Disorders Network

Version 3.0 (October 2016)

Date of next review: October 2018

Guidelines for Stock Management of Coagulation Factor Concentrates within the Hospital Setting in Scotland v3.0 (Oct 2016)

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Document Control Page Title:

Guidelines for Stock Management of Coagulation Factor

Concentrates within the Hospital Setting in Scotland

Author:

Haemophilia Nurses Data Managers

Approver:

Scottish Inherited Bleeding Disorders Network

Owner:

Haemophilia Nurses Data Managers

Version History

Version Date of Revision Summary of changes

V1.0 29th November 2011

V1.2 16th December 2011 Amendments

V1.3 8th February 2012 Amendments

V1.4 28th February 2012 Amendments

V2.0 12th December 2012 Amendments

V3.0 26th October 2016 Updated following full review of policies and protocols

Distribution List Scottish Haemophilia Centre Directors Haemophilia Nurses and Data Managers Group Scottish Inherited Bleeding Disorders website National Services Division National Procurement Review Biennially (next review date October 2018)

Contents

1. Background ............................................................................................................. 4 2. Procedure for Ordering, Receipt and Storage of Coagulation Factor Concentrate ... 4 3. Procedure for Issuing of Coagulation Factor Concentrate ....................................... 5 4. Issues of Home Treatment Supply from Hospital ..................................................... 6 5. Protocol for Supplying Coagulation Factor to Outreach Areas ................................. 6 6. Procedure for the Return of Coagulation Factor Concentrate .................................. 7 7. Procedure for the Documentation of Coagulation Factor Concentrate Wastage ...... 8 8. Procedure for Withdrawal of Coagulation Factor Concentrate ................................. 8

Appendix 1: Example of list of Coagulation Factor Concentrates held.............................. 10 Appendix 2: Example of Coagulation Factor Concentrate Minimum Stock Levels Sheet .. 11 Appendix 3: Example Purchase Order Form .................................................................... 13 Appendix 4: Storage Guidance of Coagulation Factor Concentrate ................................. 14 Appendix 5: Example of Coagulation Factor Concentrate Fridges Alarm Protocol ........... 15 Appendix 6: Example of Blood Fridges Daily Checks ....................................................... 17 Appendix 7: Sample: Product Wastage/Non Infused Factor Form .................................... 18 Appendix 8: Example Coagulation Factor Issue Record Sheet ........................................ 19 Appendix 9i: Example Home Treatment Record Sheet – HAEMTRACK .......................... 20 Appendix 9ii: Example Home Treatment Record Sheet ................................................... 21 Appendix 10: Example Product Return Form ................................................................... 23

Guidelines for Stock Management of Coagulation Factor Concentrates within the Hospital Setting in Scotland

1. Background The guidelines should be used alongside the Royal Pharmaceutical Society –“The Safe and Secure Handling of Medicines: A Team Approach – March 2005 – whose key principles are:

Compliance with current legislation

Adherence to guidance issued by the Health Departments for England, Wales, Scotland and Northern Ireland and other national guidance e.g. NPC Guide

Management of the risks to patients and staff arising from the use of medicines.

As defined in Chapter 4 of the Royal Pharmaceutical Society –“ The Safe and Secure Handling of Medicines : A Team Approach – March 2005, the medicines trail is a multistage process which needs the introduction of controlled links at the relevant stages from initiation of treatment through a prescription to the administration of the medicine and the disposal of any waste material. These guidelines highlight the local procedures required in the specialist treatment products, namely coagulation factor concentrates. 2. Procedure for Ordering, Receipt and Storage of Coagulation Factor Concentrate A variety of coagulation concentrates are supplied for the Haemophilia Service (see example coagulation factor product list - Appendix 1). The central store of these concentrates differs from Centre to Centre and may include blood bank, pharmacy departments, the Blood Transfusion Service or the actual haemophilia centre itself. It is important that robust communication between the linked area of storage and the local Haemophilia Centre is maintained. Minimum stock levels for each product should be agreed with the local Haemophilia Centre and monitored regularly, according to usage patterns (see example minimum stock level template – Appendix 2). Routine frequency of stock checking should be agreed locally and may include daily/ weekly/ monthly checks. Hospital stock levels should sit between one month and three months issue volume. Ordering from Suppliers Frequent stock level checks will ensure triggering of the ordering process. Orders for product should ensure that stock of the coagulation factor concentrate are brought back to minimum levels required (taking into consideration any outpatient and inpatient treatment that may be required and any planned procedures or surgery). Storage personnel should liaise with Centre staff to ensure stocks are adequate. The order request is then processed and should include which coagulation factor is required, the amount and potency (see example purchase order – Appendix 3) NB The process for this will vary from Centre to Centre dependant on how stock is held and managed.


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Delivery and Receipt into Storage The delivery of the product should be checked, according to local policy, against the delivery note and the delivery note signed off. Checks should include product, actual potency, batch number, number of vials received and expiry date. All products should have a minimum of one year’s expiry unless a previous agreement has taken place with the company of supplier. The delivery note should then be processed according to local arrangement for payment as per individual Health Boards Standing Financial instructions (SFI). The delivery details should then be entered into the stock management system and then the product stock level should be checked again. This will ensure data entry has been correct. Storage Coagulation factor concentrates should be stored within a secure setting Factor concentrate should be stored according to the manufacturers specification (see coagulation factor storage guidance – Appendix 4) This may be within specialist fridges. If fridges are used temperature recording should be carried out to ensure product is kept within safe limits. Stock should be rotated to ensure the product with shortest expiry is issued first and “use me first” stickers should be used as appropriate. If fridges are used then a Coagulation Factor Concentrate Fridge Alarm Protocol should be in place to cover a temperature failure (See example Fridge alarm protocol - Appendix 5) Stock Checks Stock levels checks should include current stock level against minimum stock level. They should include product, individual batch, potency, number of vials and expiry. Checks should routinely trigger orders, highlight products which have a short expiry and ensure that all issues have been documented correctly. Frequency should be as agreed with local Centre however at least once per week. (See example fridge check – Appendix 6) Communication with the haemophilia service will ensure that no stock is wasted as patients can be asked to take hospital stock for home treatment supply. This will minimise wastage and subsequent unnecessary financial costs. Expired Stock Any product that has expired should be removed from the fridge and a product/waste return form completed (see example product waste form - Appendix 18). This will ensure an audit trail is maintained as to why the product was wasted. The expired stock should be labelled “not for use” and removed from the fridge to prevent issue. The haemophilia service will decide if the expired product is to be kept for teaching and research purposes or destroyed. If product is destroyed then there should be appropriate documentation/ audit trail to record this. 3. Procedure for Issuing of Coagulation Factor Concentrate Blood Bank/BTS / Pharmacy / Haemophilia Centre issue coagulation factor concentrates during normal working hours, for example, Monday – Friday, 08.30 – 16.30 hrs. Each issue should be checked against the prescription / request form for the patient and should be checked by two members of staff or according to local policy. Local policy may include the guidance that Haemophilia Service staff only may prescribe clotting factor concentrates. It should be noted that coagulation factor concentrates are prescribed by the product name and not generically.


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Identify the correct factor concentrate required. Check stock level in store is correct before removing issue. This will ensure stock is correct. Remove amount requested from the fridge.

The same batch number should be issued if possible, but dependent on dose or number of vials required it may be necessary to issue more than one batch number. Please locate batch which has nearest expiry date.

Check expiry date and exact potency. Record details of issue on the appropriate documentation i.e. date, time, patient’s name, reason for issue, batch no., units and number of vials issued. This will allow the complete information required for entry into the local haemophilia clinical database. (see example issue form – Appendix 8)

It is the responsibility of the Haemophilia Centre to ensure all issues have been administered to the patient. This will ensure data collection is correct. Data input into the local haemophilia clinical system should only record product which has been administered to ensure accurate tracking of product / batch numbers. Any product not infused should be returned according to local policy.

Local guidance should also be available as to how coagulation factor concentrate can be obtained out of hours. This may include authorisation from the on-call haematologist.

4. Issues of Home Treatment Supply from Hospital Although a home delivery service of treatment to patients has been established there may be relevant issues of supplies from the hospital. Issuing of product should be carried out as above but patients should also receive a home treatment record form with their issue (see example home treatment record form Appendices 9i and 9ii). Patients should be asked to return their record forms either electronically via Haemtrack or posting/bringing the paper copy to the Centre. This data is invaluable in reviewing bleeding patterns and prophylaxis.

Patients can be asked to sign for the treatment they are removing from the hospital. This then easily allows tracking of return of home treatment records. If the patient is not registered with this centre, i.e. a visitor, valid identification, e.g. passport / driving licence, must be produced. This also applies to any person picking up treatment on behalf of a patient.

A completed home treatment record (electronic or paper) for the previous issue should be handed in before the new issue is given out (if there are a small numbers of vials not yet used from the previous issue it is acceptable that the patient returns the home treatment record previous to this one). This is recorded on the annual record sheet. If a patient fails to return a home treatment record they will be asked to forward /send / fax it to the Centre. If this happens on two or more occasions the patient will be reminded of the home treatment agreement and further issues of home treatment will be suspended until records have been produced. 5. Protocol for Supplying Coagulation Factor to Outreach Areas Emergency stocks of coagulation factor concentrate may be held in hospitals in more remote areas in Scotland where patients live long distance from their Haemophilia Care provider. Robust communication must be established with the hospitals holding the emergency stocks which may be held within Blood Bank, Blood Transfusion Service, Pharmacy or Haematology Departments. The responsibility for these concentrates remain with the local Centre. Details of product, batch numbers, potency, number of vials and dates of expiry should be held by both the storage area and also the local Centre.


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Products should not be issued unless under the guidance of a haematologist. Written local guidance should be agreed with the storage area with regard to this. If a product is issued then details of the issue must be sent to the local Haemophilia Centre. This should include the patients name, CHI number, date and time of issue, reason for issue, product, batch number, potency and number of vials. This will ensure appropriate recording of the issue into the clinical information system and also trigger the replenishment of stock. It is the responsibility of the local Haemophilia Centre to ensure that these stocks are checked on at least a monthly basis before data provision of patient usage is finalised. This will ensure that all patient’s issues are recorded in real time. Due to location of the outreach hospital, staff within the storage area may be required to carry out the physical check itself. Routine stock checks will highlight:

If the expiry date of a product is within six months the coagulation factor should be rotated, with new stock being sent out and the factor nearing expiry being returned to the Haemophilia & Thrombosis Centre so that it can be used.

As the coagulation factor has been stored within a controlled environment this can be returned for usage. The responsible person returning the coagulation factor should complete and sign a product return form and return it to the local Centre

(see Appendix 10).

Any “missed issue” will be highlighted and details obtained. 6. Procedure for the Return of Coagulation Factor Concentrate Coagulation factor can only be returned to storage for re-issue if it has been stored and transported under appropriate conditions within a hospital / clinical setting i.e. in a blood fridge at outreach hospitals / other areas. The reissue of returned product carries an element of clinical risk as it may have been exposed to inappropriate conditions (e.g. temperature, microbiological contamination) and therefore resulting in loss of potency or the presence of toxic degradation products. The responsible person returning the coagulation factor should complete and sign a product return form and return it with the coagulation factor (see example returns form – Appendix 10). This will provide the audit trail that the product has been stored correctly. It is essential that a “guilty until proven innocent “approach is adopted. Any product returned should be thoroughly inspected to ensure suitability for reissue according to local policy. This should include:

Discarding any product which is out of date and returning the appropriate paper work to the named person on the Product Wastage/Non Infused Factor Form (Appendix 7).

Ensuring there is a clear audit trail and that the product has been maintained within its appropriate storage conditions.

Ensuring the product is not damaged and any seals broken

Confirming that the product was originally supplied by the storage dept.

Return of coagulation factor concentrate direct from a patient - i.e. the product has left the hospital setting and been issued direct to a patient - must not be returned for reissue.

Any product returned by a patient – e.g. it has expired / patient no longer requires product - should be recorded for audit purposes. A product wastage / non infused factor form should be completed (see example waste / non-infused form Appendix 7) and the local


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Haemophilia Centre should decide if the expired product is to be kept for teaching and research purposes or destroyed. The product return should be recorded on the clinical database against the patient’s product issue entry as “not infused”. It is important that there is robust documentation of all product returns and waste. This will identify any procedural issues which may need to be addressed and will allow appropriate education to be planned. 7. Procedure for the Documentation of Coagulation Factor Concentrate Wastage If for any reason coagulation factor concentrate is wasted and not administered to a patient then a product wastage /non infused factor form must be completed. (See example waste / non infused form – Appendix 7) Examples of wastage are:

1. Fault identified with product 2. Once reconstituted a foreign body is seen in the product 3. Product is made up in error and not given 4. Product is not stored at specified conditions 5. Product has expired

A report should also be written if the factor has been made up in error. The report should give full details of the error, including who requested the treatment. At all times the product must be kept and the local Haemophilia Centre contacted. If appropriate the product may be returned to the manufacturer and replacement product obtained if a genuine fault is identified. This is also important to ensure quality control issues are brought to the manufacturer’s notice.

All wastage should be recorded on the clinical database. Wastage is also reported back to finance at the end of each month due to the financial implications. Ensuring robust documentation will allow audit of wastage and any risk identified. This will allow an action plan to be implemented - e.g. education of staff – to ensure wastage is kept to a minimum. 8. Procedure for Withdrawal of Coagulation Factor Concentrate Following notification from the manufacturer the named batch of concentrate should be removed from the fridges in the storage area – Blood Bank/Pharmacy / BTS / Haemophilia Centre and any outreach areas / hospitals. Inform the duty Consultant Haematologist immediately. Stocks retrieved must be isolated from the main stock and “quarantined” immediately according to local policy. Haemophilia Centre Staff should consult their local databases to identify which patients have potentially received the product. (If the product is withdrawn out of hours or at weekends the on call Haematology SpR and Consultant should have access to an up to date list). Details of which patients the product/batch has been issued to as inpatient/outpatient treatment should be obtained from the local clinical database. Details, of which patients have been issued the product/batch as home delivery, for the current month, will be obtained from the home delivery company. Home delivery issues for previous months can be obtained from the clinical database.

The patients who have received the withdrawn batch and who may still have some, as home treatment, should be contacted as soon as possible, by phone, to ask them to return


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any remaining product. A doctor should see these patients to explain why the product has been recalled and a detailed record of this should be made in the patient’s health records. The duty consultant haematologist should be notified about any patients who have only been treated in hospital (i.e. do not have any of the batch at home) and about patients who have received it at home, used up their stores and have been issued subsequently with a different batch. These patients should be considered on an individual basis as to whether or not they should be informed of the recall and this will be dependent as to why the recall has taken place and whether the patient has been put “at risk”. During situations of recall it is important to follow UKHCDO (United Kingdom Haemophilia Centre Doctors Organisation) guidance. There may also be guidance from the Dept of Health. It is important to document all communication with the patient within their medical notes.


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Appendix 1: Example of list of Coagulation Factor Concentrates held

Coagulation Factor Concentrates held for the Haemophilia Service

CONCENTRATE MANUFACTURER Advate Baxalta

Helixate NexGen CSL Behring

Refacto AF Pfizer Ltd

Kogenate Bayer

Elocta SOBI Uk

Nuwiq Octapharma

Benefix Pfizer Ltd

RIXIBUS Baxalta

Alprolix SOBI UK

Idelvion CSL Behring

Alphanine Grifols

Replenine BPL Ltd

Factor XI BPL Ltd

Fanhdi Grifols

FEIBA Baxalta

Obizur (rPorcine FVIII) Baxalta

Coagadex (FX) BPL Ltd

Optivate BPL Ltd

Fibrogammin P ( FXIII ) CSL Behring

Voncento CSL Behring

Riastap (Fibrinogen) CSL Behring

Kybernin P (ATIII) CSL Behring

Novo Seven (FVIIa) Novo Nordisk


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Appendix 2: Example of Coagulation Factor Concentrate Minimum Stock Levels Sheet

Product Vial Size Number of vials (agreed locally)

Advate 250

500

1000

2000

Refacto AF 250

500

1000

2000

Kogenate 250

500

1000

Elocta 250

500

1000

1500

2000

Nuwiq 250

500

1000

2000

Obizur 500

Fandhi 500

1000

BeneFIX 250

500

1000

2000

RIXUBIS 250

500

1000

2000

Alprolix 250

500

1000

2000

IDELVION 250

500

1000

2000


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Product Vial Size Number of vials (agreed locally)

Alphanine 1000

1500

Novo Seven 1mg

2mg

5mg

Feiba 500

1000

Voncento 500

1000

Fibrogammin P 250

1250

COAGADEX (FX) 250

500

Riastap (Fib Conc) 1g

Optivate 500

1000

FXI 750

Appendix 3: Example Purchase Order Form


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Appendix 4: Storage Guidance of Coagulation Factor Concentrate

Product Manufacturer Recombinant

/Plasma Derived

Shelf Life

Storage Temp

Room temp stable

Period Use after reconstitution

8Y BPL Ltd Plasma 36 months 2-8°C Yes 2-3 months below 25°C Within 1 hour

Advate Baxalta Recombinant 24 months 2-8°C Yes 6 months Within 3 hours

Alphanine Grifols Plasma 30 months 2-8°C Yes 3 months Immediately

Alprolix Sobi Ltd Recombinant 48 months 2-8°C Yes 6 months Within 3 hours

BeneFIX Pfizer Ltd Recombinant 24 months 2-30°C Yes until expiry date Within 3 hours

COAGADEX BPL Ltd Plasma 36 months Below 30° Yes 36 months Immediately

Elocta Sobi Ltd Recombinant 36 months 2-8°C Yes 6 months Within 6 hours

Factor XI* BPL Ltd Plasma N/K 2-8°C No N/A Within 1 hour

Fanhdi Grifols Plasma 36 months Below 30°C Yes until expiry date Within 12 hours

Feiba Baxalta Plasma 24 months 2-8°C Yes up to 6 months below 25° Immediately

Fibrogammin CSL Behring Plasma 36 months 2-8°C No N/A Immediately

Helixate NexGen CSL Behring Recombinant 30 months 2-8°C Yes up to 12 months below 25°C Immediately/within 24 hours

IDELVION** CSL Behring Recombinant See below 2 - 25° Yes 24 months Immediately

Kogenate Bayer Recombinant 30 months 2-8°C Yes up to 3 months below 25°C Up to 48 hours

Kybernin P CSL Behring Plasma 36 months Below 25°C Yes until expiry date Within 8 hours

Nuwiq Octapharma Ltd Recombinant 24 months 2-8°C Yes 1 month Within 24 hours

Novo Seven Novo Nordisk Recombinant 36 months Below 25°C Yes until expiry date 6 hours at 25°C

Obizur Baxalta Recombinant 24 months 2-8°C No N/A Within 3 hours

Refacto AF Pfizer Ltd Recombinant 48 months 2-8°C Yes up to 3 months below 25°C Within 3 hours

Replenine BPL Ltd Plasma 36 months 2-8°C Yes up to 3 months below 25°C Within 1 hour

Riastap CSL Behring Plasma 60 months Below 25°C Yes until expiry date Within 8 hours

RIXUBIS Baxalta Recombinant 36 months Below 30° Yes 6 months Within 3 hours

Voncento CSL Behring Plasma 36 months Below 25°C Yes until expiry date Within 8 hours

Wilate Octapharma Plasma 36 months 2-8°C Yes 2 months at 25°C Within 12 hours

* Factor XI stored in RIE at time of publication, also no shelf life information available

**Idelvion – 250 iu & 500 iu vials have shelf life of 24 months, 1000 iu and 2000 iu have shelf life of 36 months

Appendix 5: Example of Coagulation Factor Concentrate Fridges Alarm Protocol

COAGULATION FACTOR CONCENTRATE

FRIDGE ALARM PROTOCOL

THE NORMAL TEMPERATURE RANGE FOR THESE FRIDGES IS 2°C- 8°C

The Haemophilia Centre Coagulation Factor Concentrate Fridges are located within room G1143 in the Haemophilia & Thrombosis Centre, on the ground floor of the Royal Infirmary (at the back of OPD1). The factor concentrates stored in them are very costly.

1. If the blood fridge alarms the system will automatically dial Switchboard to notify them there is a potential problem.

2. During normal working hours (Monday – Friday, 08.30 – 16.30) Switchboard will

telephone the Centre on XXXXX to ensure staff are aware of the alarm. If there is a genuine problem the haemophilia centre staff will in turn contact the WGH Helpdesk (Monday – Thursday 08.00 – 16.00, Friday 08.00 – 15.30) telephone number XXXXX

3. Out with these working hours Switchboard will contact the WGH Estates Officer, who

will send out the on-call engineer to check whether or not the fridge is working. Balfour Beatty Workplace Security on XXXXX will assist with access to the area. The temperature should be checked to see if it is within range (see above). If out with range and the fridge is clearly warming up go to point 4. If temperature within range please monitor over next few hours.

4. If required the WGH Estates Officer will contact the contracted company, currently

Medicool telephone number ----------------------- and quote contract reference ----------------- (this number will be revised on an annual basis).

5. Should the problem persist i.e. new parts required, the stock may have to be

removed and taken to BTS where it will be stored within cold room 2.

Out of Hours the Capacity & Site Management Team on bleep 1590 should be contacted to inform them of the failure. They will decide if stock has to be removed & transferred to BTS fridge.

If stock has to be transferred to BTS contact the Blood Bank Supervisor on XXXXX to make them aware of the transfer.

Balfour Beatty Workplace, portering services can be contacted on XXXXX to carry out the transfer. This also involves assisting in the removing of stock.

Contact the Haemophilia Centre on XXXXX and leave a message on the answer machine with details of the failure

6. If stock is removed out of hours please contact the Haemophilia Service on -------------- to inform them of the problem.


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COPIES HELD BY CONTACT EXT

SWITCHBOARD xxxxxxx XXXXX

WGH ESTATES xxxxxxx XXXXX

SECURITY xxxxxxx XXXXX

BALFOUR BEATTY WORKPLACE PORTERING SERVICES

xxxxxxx XXXXX

CAPACITY & SITE MANAGEMENT TEAM FOR OUT OF HOURS, BLEEP 1590

xxxxxxx XXXXX

BTS xxxxxx XXXXX

HAEMOPHILIA & THROMBOSIS CENTRE xxxxxx XXXXX

Example as supplied by Royal Infirmary Edinburgh, protocols from other hospital facilities may differ slightly.


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Appendix 6: Example of Blood Fridges Daily Checks

COAGULATION FACTOR CONCENTRATE

WEEKLY COAGULATION FACTOR STOCK CHECK FRIDGE DIAL CHANGE &

TEMPERATURE RECORD SIGN-OFF SHEET PLEASE SIGN TO SAY THAT YOU HAVE CHANGED THE TEMPERATURE DIALS AND CARRIED OUT A FORMAL STOCK CHECK.

DATE FRIDGE TEMERATURE

STOCK CHECK SIGNATURE


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Appendix 7: Sample: Product Wastage/Non Infused Factor Form

Scottish Haemophilia Product Wastage / Non Infused Factor Form (Recombinant Policies & Procedures)

Hospital: Department:

Patient Details: (If appropriate)

Product Wasted:

No Of Vials :

Batch Number:

Expiry Date :

Total Wastage in units :

Reported Date:

Reason for Wastage :

Reported by - Name: Designation :

Signature :

Comments :

Authorised By:

Name: _____________________ Designation: ____________ Signature: ________________

Appendix 8: Example Coagulation Factor Issue Record Sheet

Sheet Expiry:

PRODUCT: MONTH:

Date Time Name

S/T

Reason Location Batch Vials Units Issued Balance Stock Signature HCIS

Transferred from January

HOSPITAL ISSUE:

Plus Emergency Supply:


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Appendix 9i: Example Home Treatment Record Sheet – HAEMTRACK


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Appendix 9ii: Example Home Treatment Record Sheet

HAEMOPHILIA & THROMBOSIS CENTRE

ISSUED BY: DATE ISSUE: ID LABEL HERE DIAGNOSIS: PRODUCT: BATCH: CHECKED BY:

POTENCY: VIALS:

DATE & TIME OF BLEED ONSET

DATE & TIME OF INFUSION

REASON FOR BLEED

SITE OF BLEED LEFT OR

RIGHT NUMBER OF VIALS USED

BATCH NUMBER COMMENTS: E.G. INFUSED BY/ REACTIONS/ RESPONSE

1

2

3

4

5

6

7

8

9

10

11


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DATE & TIME OF BLEED ONSET

DATE & TIME OF INFUSION

REASON FOR BLEED

SITE OF BLEED LEFT OR

RIGHT NUMBER OF VIALS USED

BATCH NUMBER COMMENTS: E.G. INFUSED BY/ REACTIONS/ RESPONSE

12

13

14

15

16

17

18

19

20

Please note:

1. This form should be completed and returned when a new supply of home treatment is requested; otherwise a full supply cannot be issued. 2. Home Treatment supplies will be issued between the hours of 08:30 and 16:30 Monday to Friday.

Phone Requests: Please give 24 hours notice when ordering more supplies, so we can ensure they are ready for collection at the agreed time. Contact a member of the nursing team or Barry on 0131-242-1270(Direct Line).

E-Mail requests: Please give 48 hours notice when ordering more supplies. We will acknowledge every e-mail request to confirm that we have received your order. E-Mail us at: -----------------------------------------

Report immediately to the Haematology Registrar on-call ------------------- asking for the on-call Haematologist) or Haemophilia Sister on bleep #6218 if you experience any reactions during or following the infusion, if difficulty is experienced with the injection or you have any doubts about the course of action to take, i.e. how much treatment to give. All factor concentrate should be infused within 30 minutes of preparation.

Appendix 10: Example Product Return Form

Product Return Form. Date:

Hospital:

Department :

Product Returned :

No. of Vials :

Batch Number :

Expiry Date :

Total Units Returned :

Value of Product :

* 1. This product has been maintained in the storage conditions specified on the product label since issue from the Edinburgh haemophilia & Thrombosis Centre.

Reason for return : * Please delete as appropriate.

* 2. This product has not, or may not have been maintained in the storage conditions specified on the product label since issue from the Edinburgh haemophilia & Thrombosis Centre.

Reported by : Designation :

Signature :

Product placed back into Haemophilia Centre Stock :

YES / NO

Comments :

Authorised By:

Name: _____________________ Designation : __________________ Signature : ____________________

Hospital: Department :

Documents

Guidelines for Stock Management of Coagulation Factor ...€¦ · Guidelines for Stock Management of Coagulation Factor Concentrates ... 1. Background ... concentrates differs from