1. The Safe Management of Medicines in Adult Social Care Settings Stephanie West MRPharmS CQC Pharmacist Specialist

2. CQC PURPOSE “We make sure health and social care services provide people with safe, effective, compassionate, high-quality care and we encourage care services to improve.”

3. Key Questions We will ask the following five questions when inspecting services: Are they ?  Safe  Effective  Caring  Well led  Responsive to people's needs

4. Is the service SAFE? How are people’s medicines managed so that they receive them safely? Does the service follow current and relevant professional guidance about the management and review of medicines? Do people receive their medicines as prescribed (including controlled drugs)? Are medicines stored, given to people and disposed of safely, in line with current and relevant regulations and guidance? Are there clear procedures for giving medicines, in line with the Mental Capacity Act 2005? How does the service make sure that people’s behaviour is not controlled by excessive or inappropriate use of medicines? How are people supported to take their own medicines safely? What guidance is given to staff about non-prescribed medicines that people may choose to use?

5. Purpose of Today Information about what the Regulations and Guidance say. 5

6. Legislation Human Medicines Regulations 2012 Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (from 1 April 2015) Medicines Act 1968 Misuse of Drugs Act 1971 and Regulations 2001 The Controlled Drugs (Supervision of Management and Use) Regulations 2013 6

7. Regulation 12: Safe care and treatment What do the regulations say? 12.—(1) Care and treatment must be provided in a safe way for service users. The intention of this regulation is to prevent people from receiving unsafe care and treatment and prevent avoidable harm or risk of harm.

8. Regulation 12: Safe care and treatment Providers must assess the risks to people’s health and safety during any care or treatment and make sure that staff have the qualifications, competence, skills and experience to keep people safe. Providers must make sure that the premises and any equipment used is safe and where applicable, available in sufficient quantities Medicines must be supplied in sufficient quantities, managed safely and administered appropriately to make sure people are safe. 8

9. Providers must prevent and control the spread of infection. Where the responsibility for care and treatment is shared, care planning must be timely to maintain people’s health, safety and welfare. CQC understands that there may be inherent risks in carrying out care and treatment, and we will not consider it to be unsafe if providers can demonstrate that they have taken all reasonable steps to ensure the health and safety of people using their services and to manage risks that may arise during care and treatment. 9 Regulation 12: Safe care and treatment

10. 12.—Care and treatment must be provided in a safe way for service users. Without limiting paragraph (1), the things which a registered person must do to comply with that paragraph include— b) doing all that is reasonably practicable to mitigate any such risks; f) where equipment or medicines are supplied by the service provider, ensuring that there are sufficient quantities of these to ensure the safety of service users and to meet their needs; g) the proper and safe management of medicines; 10 Regulation 12: Safe care and treatment - Medicines

11. CQC Guidance 11 Regulation 12: Providers should consult nationally recognised guidance about delivering safe care and treatment and implement this as appropriate

12. Guidance CQC: Guidance for providers on meeting the regulations NICE: Managing medicines in care homes RPS: The Handling of Medicines in Social Care RPS: The better use of multi compartment compliance aids NICE: Medicines optimisation: the safe and effective use of medicines to enable the best possible outcomes NICE: Transition between inpatient hospital settings and community or care home settings for adults with social care needs. Publication expected November 2015. NICE Managing medicines for people receiving social care in the community April 2017 12

13. Medicines Policy 13 Regulation 12 (2)(g) Staff must follow policies and procedures about managing medicines, including those related to infection control. These policies and procedures should be in line with current legislation and guidance and address: supply and ordering storage, dispensing and preparation administration disposal recording.

14. In practice Is the medicines policy up-to-date and kept under review.? Have staff read and understood the policy? Is it actually reflective of practice in the service? Is it reflective of current national guidance? 14

15. Training Regulation 12 (2)(g) Staff responsible for the management and administration of medication must be suitably trained and competent and this should be kept under review. 15

16. In practice Are all staff who manage medicines trained and competent in: Managing the medicines used in the service? Following service procedures? Any additional roles and responsibilities? Is medicines management included in staff supervision and appraisal? 16

17. Obtaining Regulation 12 (2)(f) People's medicines must be available in the necessary quantities at all times to prevent the risks associated with medicines that are not administered as prescribed. This includes when people manage their own medicines. Sufficient medication should be available in case of emergencies. Sufficient equipment and/or medical devices that are necessary to meet people's needs should be available at all times and devices should be kept in full working order. They should be available when needed and within a reasonable time without posing a risk. The equipment, medicines and/or medical devices that are necessary to meet people's needs should be available when they are transferred between services or providers.

18. In practice Medicines normally obtained from community pharmacy. What happens when someone is admitted or returns to the service from hospital? No record of receipt required in Domiciliary Care but good practice in some circumstances. Is there effective communication with pharmacy(s), GP, other care providers? Delivery and collection: are arrangements defined? Do care plans and records include enough information about where, when, how and who will obtain medicines? 18

19. Safe administration Regulation 12(2)(b) Medication reviews must be part of, and align with, people's care and treatment assessments, plans or pathways and should be completed and reviewed regularly when their medication changes. Medicines must be administered accurately, in accordance with any prescriber instructions and at suitable times to make sure that people who use the service are not placed at risk. When it is agreed to be in a person's best interests, the arrangements for giving medicines covertly must be in accordance with the Mental Capacity Act 2005.

20. Safe administration The 6 R's of medicine administration:  right person  right medicine  right route  right dose  right time  person's right to refuse

21. Covert Administration Covert is the term used when medicines are administered in a disguised format without the knowledge or consent of the person receiving them. Never appropriate when people have capacity to decide about their treatment. Is sometimes necessary and justified, in line with a best interests decision. Must be given in accordance with instructions on how to give safely, including information from pharmacist.

22. Covert Administration Royal Pharmaceutical Society: The Handling of Medicines in Social Care: ‘’Normally tablets should not be crushed and capsules should not be opened either to make them easier to swallow or to hide them from the patient because this may affect the way that the medicine works’’.

23. People can administer their own medicines safely. People are supported to look after their own medicines when they wish and are able to do so in a way that is safe Clear records to show responsibility Risks are assessed, both for the individual and others Safe storage is provided, can include CDs Monitoring is in place

24. People can administer their own medicines safely. Royal Pharmaceutical Society: The Handling of Medicines in Social Care: ‘’In domiciliary care, if it has been agreed with the patient and it is in the care plan, doses can be left out for that individual to take at a later time, e.g. sleeping tablet’’.

25. People’s behaviour is not controlled by excessive use of medicines. Do people appear sedated? Are any medicines prescribed ‘prn’ being given regularly or without explanation? If ‘prn’ usage increases, is this being reviewed by a doctor? If concerned, note the medicines’ names and ask us

26. Monitored dosage systems RPS Guidance: July 2013, The better use of multi compartment compliance aids There are many ways in which patients can be helped to take their medicines safely, or carers supported to administer medicines correctly, and a broad range of alternative interventions (of which MCA are one type) are discussed within this report. The choice of an MCA must be considered within the range of alternative intervention options, and must not be regarded as the only solution. Health and social care professionals must collaborate to ensure that: 1. The use of original packs of medicines with appropriate support is the preferred option of supplying medicines to patients in the absence of a specific need requiring an MCA as an adherence intervention.

27. Monitored dosage systems Royal Pharmaceutical Society: The Handling of Medicines in Social Care: ‘’MDS are merely a convenient form of packaging for a limited group of medicines’’. ‘’Safe practice is not guaranteed by use of a system alone but is promoted by only allowing care workers who are trained and competent to give medicines’’. ‘’Even when medicines are supplied in MDS, there may be other medicines in the fridge and remember that this person may have different medicines since the last time you were on duty. This is why it is so important to refer to the MAR chart instead of relying on memory’’. ‘

28. Records The Royal Pharmaceutical Society: The Handling of Medicines in Social Care “Care staff know which medicines each person has and the social care service keeps a complete account of medicines.” “When care is provided in the person’s own home, the care provider must accurately record the medicines that care staff have prompted the person to take, as well as the medicines care staff have given.” “Even when medicines are supplied in MDS, there may be other medicines in the fridge and remember that this person may have different medicines since the last time you were on duty. This is why it is so important to refer to the MAR chart instead of relying on memory.”

29. Records - Regulation 12 (2)(g) It’s not Just About Administration Records: KLOE: People’s risk assessments/care plans medication reviews/records best interest decisions staff competency records. Quality audits of medicines and checks both internal and external, and action plans

30. Safe Storage Does the policy [-Regulation 12 (2)(g)] define how medicines are stored? Is it: Safe Appropriate temperature maintained Sufficient stocks and within expiry date To enable ease of selection 30

31. Disposal Procedures –[Regulation 12 (2)(g)] Care plan Records

32. Errors and Incidents Regulation 12 (2)(b) Incidents that affect the health, safety and welfare of people using services must be reported internally and to relevant external authorities/bodies. They must be reviewed and thoroughly investigated by competent staff, and monitored to make sure that action is taken to remedy the situation, prevent further occurrences and make sure that improvements are made as a result. Staff who were involved in incidents should receive information about them and this should be shared with others to promote learning. Incidents include those that have potential for harm. 32

33. Errors and Incidents Outcomes of investigations into incidents must be shared with the person concerned and, where relevant, their families, carers and advocates. This is in keeping with Regulation 20, Duty of candour. There must be policies and procedures in place for anyone to raise concerns about their own care and treatment or the care and treatment of people they care for or represent. The policies and procedures must be in line with current legislation and guidance, and staff must follow them. 33

34. Errors and Incidents Recommendations NICE Meds Optimisation: Two of the key priorities for implementation are directly relevant to Adult Social Care Providers: Systems for identifying, reporting and learning from medicines-related patient safety incidents Organisations should consider using multiple methods to identify medicines-related patient safety incidents – for example, health record review, patient surveys and direct observation of medicines administration. They should agree the approach locally and review arrangements regularly to reflect local and national learning. 34

35. In practice Do staff know how to report errors and incidents? Is the patient supported after the incident? Are individuals supported following incidents? Are reports used to promote learning? 35

36. Audit Audit of all processes relating to medicines to ensure safe and legal systems Review of procedures Regular checks Random audits Investigation of incidents / errors 36

37. Audit Implementing the NICE guideline on managing medicines in care homes Case scenarios for health and social care staff managing medicines in care homes Checklist for health and social care staff developing and updating a care home medicines policy Baseline Assessment tool https://www.nice.org.uk/guidance/sc1/resources 37

38. Controlled Drugs Ordering Storage Records Disposal Stock checks 38

39. 39 www.cqc.org.uk