8.3.4. Controlled Drug Registers

Each Ward / Department that holds stocks of CDs must keep a record of CDs received and administered in the CD Register or Patient’s Own CD Register. The Senior Charge Nurse / Midwife / Operating Department Practitioner is responsible for keeping these CD Registers up to date and in good order. CD Register and Patient’s Own CD Register must be stored where practical in the CD Cabinet. Where this is not possible, it must be kept in a secure area that is locked, for example, a locked Cabinet or drawer where access is restricted. For ‘High flow areas’, such as A&E, should refer to Local Policies regarding Controlled Stationary.

All entries must be signed by a registered nurse or midwife and best practice would be that this is countersigned witnessed by a second registered nurse, midwife. If any of the secondary staff mentioned are unavailable, then the transaction can be witnessed by another registered practitioner or a suitably trained competent witness if available.

Only one CD Register must be in use for recording Ward stock at any time, unless under exceptional circumstances, for example, large amounts of CDs in use.

Where an area accepts Patient’s Own CD, a Patient’s Own CD Register must be used for this purpose.

Entries in all CD Registers must be made in black ink and must be indelible (markings that cannot be removed). Red ink should only be used for stock level checks by Pharmacy staff or error corrections.

Entries must be made in chronological order with no empty lines between entries (Wards and Departments only, not Theatre CD Register)

The drug, form and strength must be written clearly and legibly at the head of each page. Each different drug must be written on a separate page, for example Morphine Sulfate 10mg (Modified Release) tablets on a separate page from Morphine Sulfate 10mg Immediate Release tablets. Entries for both receipt and supply for each drug preparation should be made on the same page, enabling best practice in the maintenance of running balances.

On reaching the end of a page in the CD Register, the balance must be transferred to another page. The new page number must be recorded in the index in the front of the CD Register corresponding to the appropriate drug, form and strength. The new page number must be annotated at the bottom of the finished page. “Carried forward from” relevant page number must be inserted at the top of the new page.

Entries must be clear and unambiguous. Entries and errors must never be altered or obliterated. Correction fluids should also never be used. Any errors must be bracketed and the correct entry made in an adjacent space or next line. A brief explanation, for example, entered in error must be made in the margin or at the bottom of the page and then signed and dated. Pages or part pages must never be torn out of the CD Register.

Writing in the CD Register must be the last task to be completed when, for example, when CDs are dispensed, they must not be signed out of the CD Register until they leave the Dispensary and are in the possession of the Ward / Department / Theatre or Patient.

All CD Registers must be kept securely (see Section 8.3.12.) for two years (7 years for a CD Register containing Patient Own CDs which have been destroyed) from the date the last entry was made, and then disposed of as confidential waste.

8.3.5. Closing or Starting a Controlled Drug Register

Closing a CD Register:

When closing a CD Register, use a ‘Lazy Z’ to close off all incomplete pages. On the external front cover of the CD Register write the date of the last entry made in the CD Register and the retention time this should be kept for.

Write the words “CD Register closed DD-MMM-YYYY (date). Balances Transferred to CD Register Serial Number (which can be found on the inside of the new CD Register)”.

Starting a New CD Register:

Write the CD, strength and formulation on the Index page of the CD Register with the corresponding page number.

Enter the date the CD Register is opened. Balances transferred from CD Register, including serial number (serial numbers not present in Patient’s Own CD Registers).

On the top of the page, write the name of the CD, strength and formulation.

Complete the date, time and write ‘Balance Carried Forward’, update ‘Running Balance’ and then sign this entry.

Repeat for all CDs recorded within this CD Register.

8.3.6. Controlled Drug CD Register Discrepancy Recording

NAME, FORM OF PREPARATION AND STRENGTH....OXYCODONE 20mg TABLETS                 5

8.3.7. Controlled Drug Order Book

CDs must be ordered in the CD Order Book, ensuring that a carbon paper is inserted between the top white and pink copy sheet. Block capitals must be used stating the name of the CD, strength, form and quantity required (words and figures). A separate page must be used for each preparation ordered.

The order must have the signature and printed name of the registered healthcare professional authorised to order CDs; initials are not acceptable.

If necessary, a registered Pharmacist or Pharmacy Technician may have to alter quantities supplied, for example, part pack or blister strip or a complete pack or to clarify formulation when supplied. Where this happens, the quantity stated must be altered, with the quantity change in both words and figures, signed and dated on both copies of the CD requisition by the Pharmacy member making the alteration. Pharmacy staff must contact the Ward / Department who has placed the order to discuss any changes to their order before it is assembled in Pharmacy. The member of staff consulted must be documented on the order page. Where other aspects are incorrect, the Ward must be contacted to correct the order. Corrections can be made by the Ward Pharmacist or Senior Charge Nurse / Midwife and signed accordingly.

Where a patient requires a CD that is not stocked by Pharmacy, Pharmacy must contact the Ward / Department to discuss an alternative supply.

If an order has been written incorrectly or is no longer required to be supplied to the Ward / Department, it must be cancelled. Two parallel lines must be drawn across the order, ‘CANCELLED’ written between the lines in indelible ink and the cancellation signed and dated by the registered member of staff.

Cancelled orders must not be torn out of the CD Order Book.

The cancellation must appear on both the white original and the pink copy of the CD Order Book.

8.3.8. Receiving Controlled Drugs - Controlled Drug Order Book

When CDs are delivered onto the Ward / Department, a registered Nurse must check the contents of the order immediately and write through the CD Register, witnessed by a second Registered Nurse, Pharmacist or Doctor. As a matter of good practice and whenever possible, the person ordering the CDs should be different to the person receiving the CDs into stock.

The CDs should then be locked away in the CD Cabinet.

Receipt of orders must be confirmed by the Nurse signing the relevant pink page in the CD Order Book.

8.3.9. Ordering New Controlled Drug Order Book

When a Ward / Department require a new CD Order Book, a Registered Healthcare Professional from that Ward / Department will approach Pharmacy hatch and complete CD Order Book Request form.

The Registered Healthcare Professional from Ward / Department requiring new CD Stationery will take the completed Book to show Pharmacy the CD Order Book is complete. There should be no more than one CD Order Book in circulation for the Ward / Department (unless there is a specific reason – approval will be sought from the Ward / Department Pharmacist). The complete CD Order Book is returned to the Registered Healthcare Professional and stored on the Ward / Department.

Once the Registered Healthcare Professional completes the form, a member of Pharmacy staff will sign out the CD Stationery requested and the Registered Healthcare Professional will sign for this. At this point, a Stock Check of Controlled Stationery is undertaken by a member of the Pharmacy Team.

CD Order Book Request Forms to be archived (see Section 8.3.12.) in the Pharmacy Department for a minimum of 2 years.        

8.3.10. Controlled Stationery Request Form

8.3.11. Documentation of Receipts in the Controlled Drug Register

·         Amount written in digits and words. Words to be written in capitals.

·         Record the date in which the CDs are received

·         Record the serial number of requisition. This is also the page number in the CD Order Book.

·         Record the, the serial tab number of the envopak. Both persons must check this and ensure it has not been tampered with. This number should collate with the CD Order Book. If these numbers do not match, an investigation should begin to ascertain why. A DATIX must be submitted

·         Record the time and where the CDs have been received from.

·         Both members of staff must check the order against the delivery and the running stock balance.

·         Signatures represents that staff have completed all the relevant checks.

·         Any discrepancy or concern must be reported immediately to the supplying Pharmacy and recorded on DATIX.

·         CDs must never be unattended.

·         CDs that require safe storage must be immediately placed into the CD Cabinet on delivery following appropriate signage of paperwork with Pharmacy staff.  Details of CDs (agreed by local policies and procedures to be recorded in a CD Register) must be entered in the CD Register as soon as practically possible.

NAME, FORM OF PREPARATION AND STRENGTH....MORPHINE SULFATE MST 10mg TABLETS   9
AMOUNT(S) OBTAINED			AMOUNT(S) ADMINISTERED
Amount	Date Received	Serial No Of Requisition	Date		Time	Patient’s Name	Amount given		Given by (signature)	Witnessed by (signature)	STOCK BALANCE
Carried forward from Page Number.......8...... Balance on          transfer
			24/04/2020	1830		BALANCE B/F FROM PREVIOUS PAGE			A Nurse	B Nurse	20
60 (SIXTY)	24/04/2020	001	Envopak No.79003125	1831		RECEIVED FROM PHARMACY			A Nurse	B Nurse	80

8.3.12. Retention Times for CD Records

Document	Retention Time	Derivation of Recommendation
Requisition Sheets	2 Years	Misuse of Drugs Regulations 2001
External Orders and Delivery Notes	2 Years	Misuse of Drugs Regulations 2001
CD Order Book	2 Years	Misuse of Drugs Regulations 2001
CD Ward Orders or Requisitions	2 Years	Misuse of Drugs Regulations 2001
Copy of signature for Ward CD Ward Order or Requisition	Duration of Employment
CD Registers	2 Years from Last Entry	Misuse of Drugs Regulations 2001
CD Registers containing Destructions	2 Years from Last Entry	Misuse of Drugs Regulations 2001
Patient’s Own CD Registers containing  Destructions	7 Years from Last Entry
CD Stock Check	2 Years from Last Entry
Extemporaneous Preparation Worksheet	13 Years	GMP, but consider keeping for longer due to consumer liability legislation
Aseptic Worksheet (Adult)	13 Years	NHS Code of Practice Part 2 Second Edit
Aseptic Worksheet (Paediatric)	26 Years	NHS Code of Practice Part 2 Second Edit
Prescriptions	2 years	Misuse of Drugs Regulations 2001
Clinical Trials	25 Years	Good Clinical Practice
Invoices	6 Years	Controlled Drugs: Safe Use and Management
CD Transport via road vehicle	Driver ID – minimum 3 months Recipient signature, documents – minimum 6 months All requisitions, signed orders, orders and private prescriptions – 2 years	Guidance for the Safe Custody of Controlled Drugs and Drug Precursors in Transit