Lesson 1Counseling and informed consent changes required by new warnings or labelingExplains how new warnings and label changes affect advice to patients, consent papers, and records. Stresses sharing risks, joint decisions, and steady messages that fit current rules and legal needs in Gambia.
Identifying new warnings and key messagesUpdating standard counseling scriptsDocumenting counseling and patient refusalDesigning and storing consent formsCommunicating risks to vulnerable groupsLesson 2Reading and extracting actionable items from safety communicationsTeaches Gambian pharmacists to read safety messages and pull out real steps to take. Stresses sorting, risk checks, and turning rule words into clear work steps, times, and duties.
Types of safety communications and sourcesRapid triage and risk prioritizationExtracting operational requirementsAssigning owners and due datesDocumenting decisions and follow-upLesson 3Templates and checklists for implementing regulatory changes in a hospital pharmacyGives useful tools to make new rules work in hospital pharmacies in Gambia. Covers making and checking templates, lists, and logs that make practice standard, help checks, and ensure steady use across shifts and services.
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, labeling changesLooks at main rule changes that hit pharmacy work, like REMS, strong warnings, changes in control lists, and label updates. Makes clear what starts them, times, and usual pharmacy duties for each.
Overview of REMS and core elementsUnderstanding boxed warning updatesScheduling and rescheduling processesLabeling and package insert revisionsCoordinating responses across sitesLesson 5Controlled substance reclassification: inventory reconciliation, prescription requirements, and legal implicationsLooks at how changing control lists for substances affects writing scripts, stock checks, and record keeping. Handles matching stocks, safety, legal risks, and steps to update systems, rules, 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 eventsChecks legal, rule, and patient safety risks of not following, including blame, punishments, and harm. Covers finding bad events, recording, and reporting ways, and putting risk handling into daily pharmacy work.
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 controlsLooks at how new rules change giving medicines, recording, storage, and stock controls. Focuses on linking rules to work flows, cutting errors, and making checkable processes that hold up to inspections and keep patients safe.
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: enrollment, patient/provider responsibilities, and pharmacy documentationExplains work needs for REMS and limited giving programs. Covers joining, checking, recording, and working with doctors, patients, and pharmacies to keep access while meeting safety duties.
Core components of REMS programsPrescriber and pharmacy enrollment stepsPatient enrollment and education dutiesDispensing authorization and verificationREMS documentation and audit readinessLesson 9Storage and handling changes (stability, refrigeration, hazardous drugs): SOP updates and staff trainingCovers how rules on lasting, cooling, and dangerous drugs change storage and handling. Focuses on updating work guides, safety setups, labeling, and staff training to keep safety and follow rules.
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 alertsShows how to steadily watch FDA, EMA, and local alerts, including REMS changes. Describes tools, sign-ups, and setups that ensure quick reviews, choices, and putting into pharmacy work.
Key regulatory websites and portalsEmail alerts, RSS feeds, and bulletinsVendor and professional society resourcesGovernance committees and workflowsMaintaining a regulatory change log
