1. Reporting Patient Focused Products David Cousins

2. What Is Patient Safety? Patient safety is the freedom from accidental injury in health care. A patient safety incident is any unintended or unexpected incident which could have or did lead to harm for one or more patients receiving NHS funded healthcare. This is also referred to as an adverse event/incident, mistake or clinical error, and includes near misses.

4. ERROR TYPES – based on the work of James Reason Unsafe acts Unsafe acts Unintended actions Intended actions Mistakes Violations Basic error types Skill based errors Attentional failures Skill based errors Memory failures Rule & Knowledge Based errors Routine Reasoned Reckless & Malicious Slips Lapses

7. Learning from other safety critical industries To minimise patient safety incidents, the NHS should learn from other safety-critical industries and target the underlying systems failures.

8. The Importance of Design for Patient Safety 2003 http://www-edc.eng.cam.ac.uk/medical/

9. Human factors – confront two myths The perfection myth. –If people try hard enough they will not commit patient safety incidents. The punishment myth. –If we punish people when they make patient safety incidents they will make fewer of them. The Seven Steps to Patient Safety.NPSA (2003).

10. EU DIRECTIVES ON MEDICINE PRODUCTS Currently do not require design or user testing to: Take into consideration human factor considerations Safety in use Or pharmacovigilence of these factors – which are usually classified as ‘user error’

11. European Initiatives for Improving Medication Safety Committee of Experts On Safe Medication Practice Council of Europe Report 2006

12. Forms of NPSA Advice A patient safety alert requires prompt action to address high risk safety problems A safer practice notice strongly advises implementing particular recommendations or solutions Patient safety information suggests issues or effective techniques that healthcare staff might consider to enhance safety

13. NPSA Safe Medication Practice Activity Potassium chloride Oral methotrexate Confusing labelling, packaging and presentations Vaccines Diamorphine and morphine Epidural infusions Wrong route errors Injectable Medicines Anticoagulants Paediatric Infusions Dispensed medicines Psychotropic medicines Insulin Lithium Medication histories on admission and discharge

14. Purchasing for Safety Risk assessment of products as part of healthcare contracting and purchasing. Safety before price; purchase products with the following: –Clear labelling and packaging. –Well differentiated from similar products to prevent misidentification. –Appropriate secondary and warning labels. –Bar codes. –Ready to administer/use or simple preparation and administration. –Adequate information for practitioners, patients and carers.

16. Diamorphine and Morphine Injections Between 2000 and 2005 there have been seven published case reports of deaths due to the administration of high dose (30mg or greater) diamorphine or morphine to patients who had not previously received doses of opiates. Between January and October 2005, the NPSA received 16 reports of similar patient safety incidents of which two had resulted in the death of the patients.

17. Diamorphine and Morphine Injections Many of these incidents involved diamorphine and morphine 30mg ampoules being selected in error for lower strength ampoules and overdoses were administered. In addition 30mg doses or higher were sometimes prescribed as first doses for patients who had not previously received doses of opiates and this can result in overdose, respiratory depression, loss of consciousness and death if support procedures are not implemented.

18. Problems with labelling Ampoule Labelling

21. Repevax and Revaxis Vaccine In January 2005 the NPSA received a report that 93 teenage school children were vaccinated with Repevax instead of Revaxis. Repevax (diphtheria, tetanus, 5 component acellular pertussis, and inactivated polio vaccine dTaP/IPV) This vaccine is supplied as a pre-filled syringe and is administered by intramuscular injection as a pre-school booster following primary vaccination. The vaccine may be given from the age of three years onwards. Revaxis (tetanus, diphtheria and inactivated polio vaccine Td/IPV) This vaccine is supplied as a pre-filled syringe. The vaccine may be administered by intramuscular injection from the age of six years, and may be used for adolescents and adults as a booster following primary vaccinations.

22. Royal College of Arts / NPSA January 2006 www.npsa.nhs.uk

23. Critical Information In The Same Field of Vision On At Least Three Non-Opposing Faces

24. Orientate Text In The Same Direction

25. Use Blank Space To Emphasise Critical Information

26. Use Colours To Differentiation to Highlight Information

27. Optimum Font Size, Font, and Spacing

28. Do Not Use Trailing Zero’s

29. Use of Tall Man Lettering to Differentiate Look Alike and Sound Alike Names

30. Allocate Space for a Dispensing Label

31. Put Medicine Name and Strength Clearly on Each Blister Use Non-reflective Foil

32. Match Styles of Primary and Secondary Packaging

33. Machine Readable Codes On Medicines

34. Poor Systems of Use

35. Ready to Administer Products

37. Conclusion It cannot be assumed that all medicine products are equally safe in use. Risk assessment and purchasing for safety initiatives are integral to the NHS Patient Safety Strategy The NHS should clearly specify to industry the patient safety requirements for medicine products ( these may exceed those required by the EU Medicines Directive) NPSA safer practice recommendations will increasingly include purchasing for safety and supply chain initiatives.