Controlled Drugs & Patient Safety - can we prevent another Dr Shipman??

1. Controlled Drugs & Patient Safety - can we prevent another Dr Shipman?? Hira Singh Medicines Optimisation Pharmacist

2. Role • Pharmacist working for NHS North Of England Commissioning Support Unit (NECSU) • Current role includes supporting: - NHS England – controlled drugs agenda / PGDs - Clinical Commissioning Group (CCGs)

3. AIMS OF THE WORKSHOP • To outline arrangements for controlled drug (CD) management across the NHS England - North geographic Area

4. Objectives At the end of the session participants will be able to: • Understandthe role of the Accountable Officer and the NHS England lead Accountable Officer • Describe the role and structure of the local Controlled Drugs “Local intelligence Networks” (CD LIN). • Describe various types of CD incidents • Understand the importance of a whole system approach to CD patient safety, through examples of reported incidents.

5. Quick reminder What is Patient safety? • Its the absence of preventable harm in healthcare • A patient safety incident (PSI) is any unintended or unexpected incident which, could have or did lead to harm for one or more patients receiving NHS care • This is also referred to as an adverse event/incident, mistake or clinical error, and includes near misses • Patient safety – is everyone’s business.

6. Controlled Drugs (CD’s) Why is patient safety important with CDs? • Potential Harm • Can be significant (Schedules 1-5 /various controls) • Can occur quickly • Can be rapidly catastrophic • Historical cases of abuse (Dr Shipman)

7. Why are we here? • CD governance is important! • Linked to fourth report from Shipman enquiry. • Shortcomings identified in audit and management of CDs • Changes to CD legislation started July 2006.

8. Harold Shipman killed at least 218 patients • 1976: Pleaded guilty to 3 counts of obtaining pethidine by deception Asked for 76 other offences to be considered. GMC decided on no disciplinary action / Home Office decided to take no action • 2000:Erased from GMC register after being found guilty of murder How do you judge a GP? • Good “old fashioned” GP, liked by patients, member of LMC, active in audit, regular attended CE events • “ Shipman did not always comply with the official guidance on prescribing. He was unwilling to prescribe generic drugs and preferred … various new and expensive products… his drugs bill consistently 60% above the average… Shipman would produce scientific papers showing the efficacy of the drugs.”

9. At sentencing 31st January 2000 Death Disguised – the judge stated: • “ None of your victims realised that yours was not a healing touch. None of them knew that in truth you had brought her death, death which was disguised as the caring attention of a good doctor.” How Shipman Accessed CDs • Shipman did not hold personal stock • Shipman collected controlled drugs for patients • Gave patients reduced supply? • In some instances he requested scripts after their death • He also removed drugs from patients’ homes after their death

10. Health Act 2006 Strengthened Governance 3 key elements • Appointment of Accountable Officers (AOs) for health boards, independent hospitals and hospices • Duty of co-operation between health bodies and other organisations • New powers of entry and inspection

11. CD Guidance to Regulation 2013 Regulations Aim to: • Support healthcare professionals • Encourage good practice • Identify potential criminality or areas of poor practice • Not deter use of controlled drugs when clinically required for patients

12. Role of the Accountable Officer • Responsible for a range of measures relating to the monitoring of the safe use and management of CDs within the organisation and taking appropriate action where necessary. • Required to develop and implement systems for routinely monitoring the management and use of CDs through pro-active analysis and identifying triggers for concern, and taking action. • Need to ensure that appropriate arrangements are in place for assessing and investigating concerns and that they are alerted to any significant findings.

13. Role of the Accountable Officer (cont) • To establish arrangements for sharing information • To produce quarterly reports of CD occurrences for the lead NHS England AO • To ensure adequate and up to date standard operating procedures (SOPs) are in place in relation to the management and use of CDs • To ensure relevant individuals receive appropriate information, education or training; and • To ensure adequate destruction and disposal arrangements for CDs.

14. NHS England Accountable Officer An overarching role: • responsible for establishing and leading Local Intelligence Networks (LINs) drawn from representatives of designated and responsible local organisations. • The main aims of a LIN continues to be the facilitation and co-operation of responsible bodies in the identification and consideration of concerns and incidents where action may need to be taken in respect of the safe management and use of CDs by relevant persons, and to agree to the actions to be taken in respect of such matters.

15. How is this structured? NHS England (Cumbria & North East sub region) 1 Accountable Officer Dr Mike Prentice (supported by NECs to fulfil responsibilities) 4 Locality LINs Cumbria Chair: Dr Craig Melrose North/South Tyne Chair: Dr Craig Melrose Tees Chair: Dr James Gossow Durham Chair: Dr James Gossow

16. Local Intelligence Networks LINs bring together following organisations: • NHS England • CCGs • Acute and Mental Health trusts • CQC • GPhC (local inspector) • Hospices and private hospitals • Police • NHS protect • Local authority commissioners

17. Role - Tees Police representative Tees police Chemical Drug Liaison Officer (CDLO) • Looks into diversion of Rx drugs in community • Incidents involving Rx drugs /theft loss/fraud forgery • Intelligence gathering regarding controlled drugs /legal highs /diversion of medication • Linking in with NHS /Public Health regarding Drug related deaths • SPOC for NHS provide information /intelligence to LIN • Carry out Inspections and destructions of CDS in Pharmacies /Hospitals

18. CDLO • Use him or loose him!! • Can be contacted by organisations directly for advice PC 828 Andrew Lee Chemical Drugs Liaison Officer Cleveland Police Tel 01642 301745 / Mob 07736085282

19. What are your individual responsibilities? • In any organisation you should: • Report incidents involving CDs using the agreed reporting mechanism. • Report concerns relating to the management or use or prescribing of CDs by a ‘relevant person’ to your Accountable Officer Note: A relevant person is a HCP who provides healthcare services (including medical, dental, pharmaceutical, nursing or midwifery services) including those who provide private services

20. Incidents reported - overview • The incidents reported can be broadly categorised as follows: • Suspected Fraudulent Activity • Balance Discrepancies – with no patient involvement • Dispensing / Administration / Prescribing errors – with patient involvement • Governance concerns

21. 9 months data (CNTW area team)

22. Fraudulent prescription Activity • Most common drugs involved in stolen / fraudulently presented prescriptions are: • Opioids – morphine, diamorphine, oxycodone, tramadol, codeine and dihydrocodeine • Zopiclone • Methadone • Benzodiazepines – temazepam, diazepam, nitrazepam, clonazepam, oxazepam • Non-CDs - Pregabalin and gabapentin (increasing numbers associated with ‘lost’ / stolen prescriptions)

23. Fraudulent Prescription Activity Majority are: • Stolen Prescriptions – sometimes blank ones which are presented as forged prescriptions • Altered Prescriptions • Date altered • Quantity altered • New handwritten product added

24. Recorded Fraudulent Activity • Very good forgeries which pharmacies find hard to spot • Presented at out of area pharmacies / supermarkets • Patients may register at more than one GP surgery in an attempt to obtain medication • Locally, one individual is known to have stolen prescriptions from numerous GPs and presented at out of area pharmacies.

25. Balance Discrepancy Context • Of the 139 balance discrepancies 15 (11%) were resolved. • Reasons identified: • Split bottle counted as full pack • Dropped during dispensing but unable to find / retrieve • Stored in more than one location • Recorded incorrectly in CD register

26. Dispensing / Administration / Prescribing Errors – with Patient Involvement The 157 dispensing / administration / prescribing incidents with patient involvement can be further split as follows

27. Dispensing / Administration / Prescribing Errors – with Patient Involvement Majority of the errors involved patients receiving the incorrect quantity, usually more than requested. Other errors include: • Issuing on expired prescriptions – past 28 day limit • Administering out of date injections – indicating possible lack of stock control • Incorrect strength • Incorrect product / formulation – continued generic prescribing of modified release products

28. Dispensing / Administration / Prescribing Errors Involving Substance Misuse medicines – with Patient Involvement Majority errors involved the client receiving the incorrect quantity either as a single dose or more carry out doses than required. Others errors include: • Incorrect strength • Incorrect product • Incorrect supervision • Incorrectly labelled

29. Governance Issues • Spillages • Breakages • Manufacturing problems or while preparing medication • Soft intelligence / reported concerns • Information that is passed to the police for further investigation • Staff competency • Known inadvertent disposal e.g. Stock CDs • Performance concerns relating to prescribers and pharmacy HCPs

30. Example incidents Prescribing error • GP visited a patient with heart failure and renal failure. • The community prescription sheet for anticipatory end of life injections was checked. • It was noted the alfentanil prescribed for syringe driver - 500-1000mgs instead of 500-1000mcgs. • No medication had yet been administered.

31. Example 2 Dispensing error • Prescription presented for Zomorph 10mg MR caps • No stock in pharmacy so owing slip provided • Owing slip labelled in error as 100mg • 100mg stock was ordered automatically by computer. • Prescription fulfilled following day with 100mg caps • Different carer collected medication • Patient had taken one dose • Error noted when care home phoned to check strength.

32. Example 3 Possible diversion of temazepam and oramorph (patient safety / safeguarding issues) Incident involved sharing info between hospital pharmacist and patient's GP • Patient with multiple medical problems & admissions, OOH services and A&E. • Patient makes multiple requests for medicines at the practice (including artificial saliva spray therefore not just for drugs with known abuse potential) • Pharmacy report that a taxi is often sent to collect the medicines - in particular prescriptions for temazepam and oramorph. • Taxi firm unknown and signature on the back of the prescription is illegible. • Patient’s GP suspects that family may be encouraging patient to ask for temazepam and oramorph. • Patient in respite care and the respite service were managing the medication. • There was a risk the patient will self-discharge.

33. The actions put in place: • Patient to be supplied with medication (where possible) in a multi-compartment compliance aid (medibox) and reduced, regular quantities - to limit the availability of medicines with the potential for misuse whilst also allowing access to medicines for the patient. • Whilst inpatient, temazepam dose was reduced from 20mg to 10mg and sleep was fine, therefore to continue with this dose with a view to reducing further.

34. Thank you Can we prevent another Dr Shipman? – probably not, but with............. 1) increased incident and concern reporting 2) analysis of themes and trends 3) networks to facilitate sharing of information ..............all should help to identify another Dr Shipman earlier rather than later Any Questions?