1. NHS | Presentation to [XXXX Company] | [Type Date]1 Medicines Shortages The Patient Safety View Dr David Cousins Associate Director Safe Medication Practice and Medical devices

5. Domain 5 Patient Safety

6. National Patient Safety Agency Identifying National Risks and Actions Organisations – Identifying Local Risks and Actions - Implementing and Evaluating National and Local Initiatives Local National The Top Down – Bottom Up Approach To Patient Safety NRLS Analysis Quality improvement methods NHS Commissioning Board Quality improvement methods

7. NRLS medication incidents 2005 - 2010 Cousins D, Gerrett D, Warner B. Br J Clin Pharmacol. 2012

9. Four in five NHS trusts in England and Wales say patients are suffering “unacceptable” delays for drugs to treat life-threatening conditions including cancer, Parkinson’s disease, schizophrenia and organ failure. survey of 60 NHS authorities found that the shortage was doing patients “serious harm”, with some having to be admitted to hospital for emergency treatment after they were unable to get their medicines Lives put at risk by shortage of drugs, NHS leaders warn 22 nd June 2012

11. Foreign anaesthetic alternatives

12. Water for humidifiers There was no stock of respiratory water to humidify breathing systems. Pharmacy stores were contacted and stated that there was a national shortage and that this problem had been known about for the last two weeks. There was an enquiry as to whether their were any alternatives and the answer was no. This is a serious clinical risk as the water is needed to humidify patients on ventilators and breathing systems to prevent blockage of their airways. The problem should have been relayed sooner. Interim measure of using bottled sterile water. Underlying causes: Shortage of supplies, poor communication in alerting the ward to the problem.

13. Thiopentone given instead of augmentin Due to the national shortage of thiopentone, our usual protocol of drawing up and labelling thiopentone prior to a shift was changed to not drawing up thiopentone. A category 1 section was called. After transferring the patient onto the operating table the AAGBI monitoring was attached and the level of block was confirmed as a T2 sensory block. As required by the change in protocol of administrating IV Augmentin, IV Augmentin was administered immediately prior to knife to skin and shortly afterwards Dr R noticed the patient was unresponsive.

14. Wrong dose of IV diazepam Child in status epilepticus - jerking and twitching movements lasting longer than 10 minutes. Staff contacted the Neuro SHO who came to review the patient. Originally prescribed dose of IV Lorazepam but there was no Lorazepam in the hospital, due to a national shortage, so IV Diazepam was prescribed The doctor prescribed 17mg of Diazepam. The dose given should have been 5.3mg (300 micrograms / kg). 14

15. Shortage of IV esmolo A patient on the ward was prescribed esmolol IV to run at 50mcg / kg - 2.5gm in 250 ml ( patient weight 86kg ). Due to underlying renal failure and issues of fluid intake, the doctors did not wish to use the weaker solution. Pharmacy supplied 2.5gm ampoules on 17th December, 2 of which expired in November. Pharmacy were not able to supply any other ampoules due to a national shortage of the drug. We were asked to return the expired ampoules to pharmacy, which were in the possession of the Consultant. The Consultant on call for the weekend wished to use the ampoules supplied by pharmacy if they were the only ones in the Trust. The Assistant Chief Pharmacist said it would be an SUI if those ampoules were used

16. Medicine not available Patient prescribed sinemet slow release, our pharmacy is out of stock, they say due to a national shortage of the medication. The patient has therefore missed out on 8 days doses so far. Medical staff are aware. Patient admitted to ED Resus, ICU reg attended patient and requested Sodium Bicarbornate 1.26% infusion. No soda bic in department apart from 2x 500ml 1.4% which was out of date. Patient treatment delayed as had to ring other wards for soda bic. Also out of IV lorazepam, same patient fitting unable to give prescribed drug.

17. Shortage of heavy marcain Informed by Directorate Pharmacist of national shortage of Heavy Marcaine. No additional stock to be received by the Trust until weeks in the future. Current stock level is approximately 100 ampoules across all theatre sites. This drug is used for neuraxial anaesthesia predominantly within the Obstetric operating theatre for caesarian sections, retained placenta and suturing procedures. Concerns pertain that if a shortfall of this drug is realised due to the shortage that potential patient care can be affected as general anaesthetic would have to become the primary option for anaesthetic, this then presents a staffing issue due to the need for recovery of patients and appropriately trained personnel.

18. The Pharmaceutical Journal 11 th September 2012; 289: 306 Failure Modes and Effects Analysis

20. Risks known via the NRLS

21. Criticality score = severity x frequency x detectability 100 = 5 x 5 x 4 FMEA – criticality scores In total there were 61 failure modes identified and scored for the fourteen process steps for managing medicine shortages.

22. Risks with highest criticality scores

23. High criticality scores by process

24. Risk assessment of alternative products

25. Risk assessment checklist for alternative

27. Hospital procedures for managing medicines shortages No national NHS procedure for managing medicine shortages Relatively few hospitals have written procedures NHS South-West trialling a regional approach to managing shortages An electronic tool to gather and disseminate information on medicine shortages in the region A risk assessment tool provides a ‘traffic light’ classification for medicine shortages.

28. Internal communications Multidisciplinary hospital steering group to manage medicine shortages (more involvement/oversight of senior staff) Regular medicines shortages briefing Use of verbal, written and electronic methods to advise doctors, nurses and pharmacy staff of medicine shortages issues Alternative products, prescribing, storage, storage, preparation, administration and clinical monitoring issues

29. External communications - NHS Gaining information externally about the extent and length of the medicine shortage is problematic and information is often incorrect and even misleading. Occasional briefings from the DH Commercial Medicines Unit www.uclhsolutions.com Regional NHS medicines procurement leads also provide proactive and reactive information and advice on medicines shortages These solutions are informal at best and rely on good quality information from the manufacturers which is not always available.

30. External Communications - Industry Pharmaceutical manufacturers and wholesalers also appear to have ad hoc systems to communicate with hospitals concerning medicine shortages. It is usually unclear to customers which department, or individual they should contact to obtain accurate information about medicine shortages. Pharmaceutical manufacturers and wholesalers need to do more to clarify a single point of contact on medicine shortage issues for their customers.

31. External Communications - USA ASHP – Medicines shortages site www.ashp.org/DrugShortages/Current/ FDA – Medicines shortages site www.fda.gov/Drugs/DrugSafety/DrugShortages These sites including information on current shortages and resolved shortages as well as other information for example information for patients and consumers. Hospitals and others can review and share information about medicines shortages on these sites.

32. Although it is often not possible to predict when medicine shortages will occur; effective processes for dealing with them and communicating internally and externally can be defined beforehand; we can all improve our systems to better manage medicine shortages.