Guidance on CD discrepancies July 2014

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CONTROLLED DRUGS: WHAT YOU NEED TO KNOW

BY JULIE MCC ANN , CDA O FOR BG SW AREA TEAM

1.

WHEN DO I CARRY OUT CD BALANCE CHECKS?

Regular balance checks of all Schedule 2 CDs are recommended to ensure that any discrepancies are identified as quickly as possible. It is recommended that a full balance check should be undertaken weekly or more frequently if there is a high level of CD dispensing (or there have been recent irregularities that are a cause for concern). The frequency of reconciliation between register and stock should be clearly specified in a SOP. Ideally, all stock movement and balance checks should be undertaken by two members of staff.

2.

WHAT DO I DO IF THERE IS A DISCREPANCY?

Begin by following the checklist in Appendix 1 .

Consider the following reasons why there might be a discrepancy:

 overage in delivered containers

 measurement slippage

 wrong product selection (e.g. sugar-free dispensed but an entry made for a sugared product)

 theft.

All healthcare providers should have standard operating procedures that clearly define what action should be taken if a discrepancy arises between the actual and recorded stock balance for controlled drugs (Schedule 2).

All discrepancies, whether under or over, should be investigated and reported if not resolved

(see ‘ When do I report to the accountable officer ?’).

 For discrepancies involving liquids, unopened bottles may contain an underage or more likely an overage which has resulted during the manufacturing process. As a rule, a 1-

2% overage can be expected for liquid preparations- balances should be checked and adjusted regularly to account for this overage. The CD register should be clearly annotated when the recorded balance is adjusted. If a regular overage (or underage) of more than 2% is identified, in the first instance the manufacturer should be contacted to see if they operate within a wider range. Overages within the expected range do not need to be reported to the CDAO.

Please note that it should be assumed that an unopened bottle contains the specified amount. It is not recommended to open sealed bottles for the purpose of balance checks.

Regular measuring in itself can also lead to balance discrepancies due to both the small amount left in the measure and also inaccuracies in the measurement itself.

 If, following an investigation into a discrepancy, it is identified that a patient received the wrong amount such as 30 tablets instead of 28 or the wrong item, all reasonable steps should be taken to retrieve additional stock dispensed. This stock should be

accounted for in the register and should not be re-used but segregated until destruction can take place.

It should not be destroyed as ‘patient return’ but as a witnessed stock destruction with the register clearly annotated. Under no circumstances should a prescription be obtained to

‘cover’ the additional stock issued.

3.

WHEN DO I REPORT TO THE ACCOUNTABLE OFFICER?

If the source of the discrepancy cannot be identified during routine checks, a nominated member of the relevant organisation should be informed and a formal internal investigation undertaken. This process may include discussion with the relevant professional body or other inspectors. If this then fails to resolve the discrepancy, the Controlled Drug Accountable Officer

(CDAO) should be informed. Where theft is suspected, this should be reported to the police as soon as possible in addition to reporting to the CDAO.

4.

…AND WHAT WILL HAPPEN THEN?

Reports of discrepancies made to the CDAO will be recorded. Any reported discrepancy will be logged by the CDAO and will appear on the quarterly CD occurrence report. Often an explanation is proposed for the discrepancy. Professional judgement should be used by the

CDAO to decide if the explanation is reasonable or whether further investigation is required. All decisions will be logged and be open to scrutiny by the CD Local Intelligence Network (LIN). The log will enable trends to be identified such as consistent poor procedures or frequent small quantities going missing.

The BGSW CDAO procedures for dealing with discrepancies are detailed below. The procedure will enable appropriate staff to follow a consistent approach when investigating such discrepancies. A check list has been devised to enable further investigations. The ‘discrepancy form’ is generic, i.e. it is to be used across all locations (community pharmacies, GP practices etc.). Hence, some checks may not be required, such as ‘owings’ when dealing with practice stock.

If, after investigation, a reason cannot be found for the discrepancy, the CDAO may need to take further action. This may on rare occasions involve instigating a police investigation, primarily if there are reported suspicions or there is a likelihood of theft.

Serious causes for concern include:

 Large quantity missing.

 Frequent balance discrepancies.

 Discrepancy of unusual / rarely used items

 Staff concerns (ensure ‘Whistle Blowing’ policies are followed).

By taking a consistent approach and maintaining a log of all investigated discrepancies, it should be possible to identify more potentially serious problems at an early stage.

APPENDIX 1: CHECKLIST TO INVESTIGATE

CONTROLLED DRUG DISCREPANCIES

Section 1

1 Location of discrepancy

2

3

4

Date identified

Date investigated

Name of person undertaking the investigation

Section 2 - Details of discrepancy

5 Drug name

6 Strength

7

8

Formulation (tabs/amps etc.)

Quantity in stock

9 Quantity in the register

10 Discrepancy (+/-)

Please now complete the relevant section.

Section 3 - More in stock than recorded in the register

11 Has the stock been counted correctly?

Check done? Yes/ No Error found? Yes / No

12 Has there been a calculation error in the register?

Check done? Yes/ No Error found? Yes/ No

13 Is it possible that some CDs have not been written into the register when received (e.g. as stock)?

Check the CD register against recent invoices/ ordering data held. (It may be necessary to request copies of invoices for obtained stock).

Check done? Yes/ No Error found? Yes / No

14 Is it possible that patient returned medicine may have been included in standard stock?

Check ‘Patient Returned’ book (where kept) and check held stock for signs of being a patient return.

Check done? Yes / No

Check done Yes/ No

16 Now complete Section 5

Error found? Yes/ No

15 Is it possible that only a part prescription has been dispensed but all of the stock has been deducted from the running balance?

Check ‘owings’ records

Error found? Yes/ No

Section 4 - Less in stock than recorded in the register

17 Has the stock been counted correctly?

Check done Yes/ No Error found? Yes / No

18 Is an original pack or multiple of original packs missing?

Yes/ No Error found? Yes / No

19 Has there been a calculation error in the register?

Check done? Yes/ No Error found Yes/ No

20 Is it possible that a CD has been issued and an entry has not been made in the register?

Check administration records (such as PMR and filed prescriptions). It may be necessary to request copies of scripts submitted to the PPD.

Check done? Yes/ No Error found Yes /No

21 Is it possible that an ‘owing’ has been issued that has not been made in the register?

Check ‘owings’ records

Check done? Yes/ No Error found? Yes/ No

22 Is it possible that out of date stock has been destroyed and not been entered in the CD register?

Check records of destruction

Check done? Yes /No Error found? Yes / No

23 Do the staff have any suspicions about where the missing stock may be that has not yet been investigated?

Yes/ No (if yes give details below)

Details:

24 Now complete Section 5

Section 5 - SUMMARY

25 Tick one of the following:

 I have investigated the incorrect stock balance and have found the discrepancy.

Brief Summary:

 I have investigated the incorrect balance and been unable to find a reason for the discrepancy

26 Signed:

27 Date:

28 Follow-up required Yes/ No

30 Details of follow-up:

31 Follow-up completed Yes / No Date completed:

32 Please use this space to record any notes taken during investigating the discrepancy and any calculations undertaken:

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