Lesson 1Counselling and informed consent changes required by new warnings or labellingExplains how new warnings and label updates change counselling, consent forms, and records. Focuses on risk sharing, joint decisions, and uniform messages meeting regulatory and legal standards.
Identifying new warnings and key messagesUpdating standard counselling scriptsDocumenting counselling and patient refusalDesigning and storing consent formsCommunicating risks to vulnerable groupsLesson 2Reading and extracting actionable items from safety communicationsTrains pharmacists to analyse safety notices and pull out specific actions. Stresses sorting priorities, risk checks, and turning regulatory terms into clear steps, deadlines, and duties.
Types of safety communications and sourcesRapid triage and risk prioritisationExtracting operational requirementsAssigning owners and due datesDocumenting decisions and follow-upLesson 3Templates and checklists for implementing regulatory changes in a hospital pharmacySupplies useful tools to put new rules into hospital pharmacy operations. Includes creating and checking templates, lists, and logs to standardise practice, aid audits, and ensure steady rollout across shifts.
Designing policy and SOP templatesMedication-use process checklistsHigh-risk medication verification toolsRegulatory audit and inspection checklistsStaff training logs and competency formsLesson 4Common types of regulatory changes affecting pharmacies: REMS, black box warnings, scheduling/rescheduling of controlled substances, labelling changesLooks at key regulatory actions impacting pharmacies, like REMS, boxed warnings, scheduling shifts, and label changes. Explains triggers, timelines, and usual pharmacy duties for each.
Overview of REMS and core elementsUnderstanding boxed warning updatesScheduling and rescheduling processesLabelling and package insert revisionsCoordinating responses across sitesLesson 5Controlled substance reclassification: inventory reconciliation, prescription requirements, and legal implicationsReviews how reclassifying controlled substances affects prescribing, stock, and records. Covers matching stock, security, legal risks, and steps to update systems, policies, and staff quickly.
Identifying scope of reclassificationUpdating prescribing and refill rulesInventory reconciliation and variance reviewRecordkeeping and storage requirementsStaff education and prescriber outreachLesson 6Risk management: legal and patient-safety consequences of non-compliance and reporting adverse eventsLooks at legal, regulatory, and safety risks from non-compliance, including lawsuits, penalties, and harm. Includes spotting, recording, and reporting bad events, and building risk management into routine pharmacy.
Civil, criminal, and board consequencesLinking safety culture to complianceDetecting and documenting adverse eventsInternal escalation and root-cause reviewExternal reporting to regulators and firmsLesson 7Impacted pharmacy processes: dispensing workflows, documentation requirements, storage and inventory controlsExamines how new rules change dispensing, records, storage, and stock controls. Focuses on linking rules to processes, cutting errors, and creating checkable systems for inspections and patient safety.
Mapping new rules to dispensing stepsUpdating verification and double-check stepsRevising documentation and record retentionAdjusting storage and segregation practicesInventory counts, audits, and discrepancy handlingLesson 8REMS programs and restricted distribution: enrolment, patient/provider responsibilities, and pharmacy documentationOutlines REMS and limited distribution needs. Covers signing up, checking, records, and teamwork among doctors, patients, and pharmacies to keep access while fulfilling safety rules.
Core components of REMS programsPrescriber and pharmacy enrolment stepsPatient enrolment and education dutiesDispensing authorisation and verificationREMS documentation and audit readinessLesson 9Storage and handling changes (stability, refrigeration, hazardous drugs): SOP updates and staff trainingDiscusses how stability, cooling, and hazardous drug rules affect storage and handling. Covers SOP changes, controls, labelling, and staff training for safety and compliance.
Revising stability and beyond-use datingCold-chain storage and monitoring updatesHazardous drug handling and segregationEnvironmental controls and spill responseDesigning and tracking staff trainingLesson 10How to track regulatory updates: FDA safety communications, risk evaluation and mitigation strategies, EMA and national health authority alertsGuides on monitoring FDA, EMA, and local alerts, including REMS changes. Covers tools, sign-ups, and structures for quick reviews, decisions, and rollout in pharmacy.
Key regulatory websites and portalsEmail alerts, RSS feeds, and bulletinsVendor and professional society resourcesGovernance committees and workflowsMaintaining a regulatory change log
