Learning from incidents The Medication Safety Officer or delegated senior pharmacist will review all reported medication incidents for accuracy of the medication-related details, to provide professional input, and to escalate incidents for further investigation if necessary. If any trends are identified, this will be escalated via the Medicines Management Committee. Adverse Drug Reaction Reporting Any drug may produce unwanted or unexpected adverse drug reactions. Detecting and reporting of these is of vital importance. Prompt reporting should be carried out for any suspected adverse drug reactions to new drugs that are subject to additional monitoring by regulatory bodies. These medicines are identified in the BNF and in product literature by the inverted black triangle symbol (▼). Reporting must also be undertaken for unlicensed medicines and for any serious or unusual reactions to established products. Reporting should be carried out for prescribed drugs, and for medicines obtained by patients over the counter/ herbal products. Suspected adverse reactions related to a drug or combination of drugs should be reported to the Medicines and Healthcare Products Regulatory Agency (MHRA) using the national yellow card reporting scheme. Copies of the card can be found at the back of the British National Formulary (BNF), or from the MHRA website (www.mhra.go.uk) Medicine Defect Reporting A defect is present if the product, as supplied by the manufacturer, is not of the expected standard. Defects may relate to inadequate or incorrect labelling, ineffective packaging, contamination, discolouration, breakage, or incorrect contents. If a defect is found or suspected in a medicine, it should be reported to Pharmacy. Any remaining product and associated equipment should be retained and quarantined. If the product has been administered to a patient, the patient’s doctor should be informed, and details of the defect should be recorded in the patient’s medical record. The incident should be reported via DATIX. Medication Safety Alerts and Drug Recalls If a defect is identified in a medicinal product that may pose a hazard to health, the MHRA may issue a ‘drug alert’ letter. These drug alerts will be actioned by Pharmacy; out of hours, this will be led by the on-call pharmacist.
All registered nurses and midwives Safe administration of medicines and knowledge of medicines management To ensure the safe administration of medication Competency assessment and identification of training needs In-house Annual All registered nurses and midwives required to give intravenous drugs IV drug administration To ensure the safe administration of IV medication In-house training programme including a period of supervised practice In-house Once Chemotherapy trained registered nurses Administration of cytotoxic medication To ensure the safe administration of cytotoxic regimens Training programme including a period of supervised practice Canterbury College Once nurses administering intrathecal chemotherapy Intrathecal chemotherapy To ensure correct administration of intrathecal chemotherapy Local training package including video, presentation, reading policy and short assessment. Lead nurse for chemotherapy/ aseptic services manager Annual Registered nurses and midwives delivering care through the use of PGDs Patient Group Directions To ensure that PGDs are used legally and that all supplies made via PGD are safe. Face-to-face teaching/ pack/ e-learning (in development at time of writing) In-house Once
Table 3: Pharmacy staff – see Staff Group Training Requirement Rationale Type of Training / Qualification Training Delivered By Frequency Pharmacy Assistants The Dispensing Assistant Course 2 Equivalent) GPhC Requirement Buttercups Level 2 equivalent Buttercups plus training Once Medicines Management Pharmacy Assistants Medicines Management To improve patient care through completion of medicines reconciliation process HEE LaSE Pharmacy Accredited Medicines Management qualification with portfolio collection and OSCE assessment. HEE LaSE Pharmacy and in-house Once plus biennial Pre-Registration Trainee Pharmacy Technicians National Diploma and NVQ – level 3 GPhC Requirement BTEC National Diploma and National Vocational Qualification level 3 Buttercups, Westminster Kingsway College and training Once Medicines Management Pharmacy Technicians Medicines Management To ensure the safe management of medicines on without supervision HEE LaSE Pharmacy Accredited Medicines Management Qualification with portfolio collection and OSCE assessment HEE LaSE Pharmacy and in-house Once plus biennial reaccreditation Accredited Checking Pharmacy Technicians Accredited Checking To ensure the safe checking of dispensed medicines HEE LaSE Pharmacy Accredited Accuracy Checking Pharmacy Technician qualification with documentation of 1000 accurately checked and OSCE assessment. HEE LaSE Pharmacy and in-house Once plus biennial reaccreditation Aseptic services Pharmacy Technicians Preparation of intravenous medicines, To ensure the safe preparation of medicines In house training manual In-house Once
cytotoxic medicines and parenteral nutrition solutions Aseptic Services Pharmacy Technicians Pre- and checking To ensure the safe checking of aseptically prepared products HEE LaSE Pharmacy PIPC course with documentation of 1000 accurately checked items and OSCE assessment. HEE LaSE Pharmacy and in-house Once plus biennial reaccreditation Warfarin counselling assistants, technicians and pharmacists Warfarin counselling To provide patients newly started on oral anticoagulants on how to take their medication safely plus clinic monitoring arrangements In-house programme In-house Once, with annual reaccreditation Pharmacists Clinical pharmacy practice To ensure the safe management of patients’ medication in order to facilitate optimal outcomes Diploma in General Pharmacy Practice Competency based assessments HEE LaSE Pharmacy, Medway School of Pharmacy and training Once Pharmacists working in aseptic services Checking CIPS, cytotoxics and TPN training programme In-house Once Pharmacists working in aseptic services Intrathecal Chemotherapy To ensure correct administration of intrathecal chemotherapy Local training package including video, presentation, reading policy and short assessment. Lead nurse for chemotherapy/ aseptic services manager Annual TPN Pharmacists Prescribing adult TPN To ensure that TPN solutions are Local training package and short assessment. Lead pharmacist for nutrition. Once
EQUALITY IMPACT ASSESSMENT STATEMENT All public bodies have a statutory duty the Race Relations (Amendment) Act 2000 to “set out arrangements to assess and consult on how their policies and functions impact on race equality.” This obligation has been increased to include equality and human rights with regard to disability, age and gender. The Trust aims to design and implement services, policies and measures that meet the diverse needs of our service, population and workforce, ensuring that none are placed at a disadvantage over others. This strategy was found to be compliant with this philosophy. Equality Impact Assessments will also ensure discrimination does not occur on the grounds of Religion/Belief or Sexual Orientation in line with the protected characteristics covered by the existing public duties. Refer to appendix 1. MONITORING & REVIEW What will be monitored How/ Method/Frequency Lead Reporting to Deficiencies/ gaps Recommendations and actions Implementation of any required change Contents of policy for accuracy and legality To be checked against new legislation or good practice guidance Chief Pharmacist Chair of MMC Policy to be rewritten as needed Changes advertised to all relevant Incident reports of adverse drug events Report compiled quarterly Patient Safety Manager MMC Actions implemented as needed Usually via pharmacy staff. Or specific group set up to action changes. Various aspects of Medicines Management as per audit plan, including audits as required by NPSA and audits of various aspects of antimicrobial therapy. Regular Audit Pharmacy Audit Lead Audit Committee Depends on results of audits By pharmacy or Directorates Antibiotic prescribing Regular audit Lead antimicrobial pharmacist Director of Infection Control Monitored via Quality Improvement Group By directorates and reviewed by pharmacy and infection control teams
Controlled Drugs Audit of CD registers by pharmacy every 3 months. Annual audit of incident reports relating to CDs. Quarterly feedback of CD incidents by CDAO to CDLIN Annual audit of aspect of care by Accountable Officer Accountable Officer Trust Board Accountable Officer and Chief Pharmacist Accountable Officer Dispensing errors/ near misses Continuous reporting via near miss reporting forms and dispensing error forms Dispensary manager and aseptic services manager Chief Pharmacist trends identified and measures identified to reduce risk of reoccurrence. Dispensary manager/ aseptic services manager via change in local procedure and dissemination to staff Administration errors Continuous reporting via DATIX and drug error pack. To be reviewed/ compiled quarterly. Chief Nurse MMC NMAS Any necessary change in procedure/ need for additional training identified. Chief Nurse via Associate Chief Nurses. Safe storage of medicines Continuous reporting via DATIX. To be reviewed/ compiled quarterly Chief Pharmacist MMC Gaps identified by MMC and necessary actions fedback to Directorates/ pharmacy By wards or pharmacy Training requirements To be reviewed at annual appraisals for pharmacy and nursing staff by line managers. Chief Pharmacist MMC Gaps identified by MMC and necessary actions fedback to Directorates/ pharmacy Nursing/Pharmacy Management Safe disposal of medicines Audit of practice Wards Senior Sister Pharmacy Operational Manager MMC Gaps identified by MMC and necessary actions fedback to Directorates/pharmacy Directorates of medicines DATIX to be reviewed quarterly. Audit of missed doses Chief Pharmacist MMC Gaps identified by MMC and necessary actions fedback to Directorates Directorates
Covert administration of medicines (Rare) DATIX Chief Pharmacist MMC Any inappropriate actions to be reviewed with Directorates Directorates Equality Impact Assessment Tool – Appendix 1 Yes/No Comments 1 Does the policy/guidance affect one group less or more favourably than another on the basis of: Race No Disability No Gender No Religion or belief No Sexual orientation including lesbian, gay and bisexual people No Age No 2 Is there any evidence that some groups are affected differently? No 3 If you have identified potential discrimination, are any exceptions valid, legal and/or justifiable? No 4 Is the impact of the policy/guidance likely to be negative? No 5 If so can the impact be avoided? 6 What alternatives are there to achieving the policy/guidance without the impact? 7 Can we reduce the impact by taking different action?