Lesson 1Counselling and informed consent changes required by new warnings or labellingExplains how new warnings and label updates change patient advice, consent papers, and records. Focuses on sharing risks, joint decisions, and steady messages that fit current rules and legal needs in Namibia.
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 Namibian pharmacists to understand safety messages and pull out clear actions. Stresses sorting priorities, risk checks, and turning rule language into simple steps, times, and duties for pharmacy teams.
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 apply new rules in Namibian hospital pharmacies. Covers making and checking templates, lists, and logs that standardise work, aid checks, and ensure even rollout across shifts and areas.
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 main rule changes impacting pharmacies, like REMS, strong warnings, controlled drug shifts, and label updates. Clarifies what starts them, times, and usual pharmacy tasks for each in Namibian context.
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 implicationsExamines how shifting controlled drugs affects writing scripts, stock checks, and records. Covers matching stock, security, legal risks, and steps to update systems, rules, and staff quickly in Namibia.
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, rule, and patient safety risks from not following rules, including blame, penalties, and harm. Covers finding bad events, recording, reporting paths, and adding risk checks to daily Namibian 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 controlsExplores how new rules change giving medicines, records, storage, and stock controls. Focuses on linking rules to work flows, cutting errors, and making checkable processes that pass inspections and aid patient safety in Namibia.
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 documentationDetails work needs for REMS and limited supply programs. Covers joining, checking, records, and linking with doctors, patients, and pharmacies to keep access while meeting safety rules in Namibian settings.
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 stability, cooling, and dangerous drugs change storage and handling. Focuses on updating procedures, controls, labels, and staff training to keep safety and rule following in Namibia.
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 alertsExplains tracking FDA, EMA, and local Namibian alerts, including REMS changes. Describes tools, sign-ups, and structures for timely checks, choices, and applying updates in pharmacy work.
Key regulatory websites and portalsEmail alerts, RSS feeds, and bulletinsVendor and professional society resourcesGovernance committees and workflowsMaintaining a regulatory change log
