Lesson 1Counseling an' informed consent changes required by new warnings or labelin'Detail how new warnings an' labelin' changes alter counselin' content, consent forms, an' documentation. Emphasize risk communication, shared decision-makin', an' consistent messagin' dat align wid current regulatory an' legal expectations, mi fren.
Identifying new warnings and key messagesUpdating standard counseling scriptsDocumenting counseling and patient refusalDesigning and storing consent formsCommunicating risks to vulnerable groupsLesson 2Readin' an' extractin' actionable items from safety communicationsTeach pharmacists fi interpret safety communications an' extract concrete action items. Emphasize triage, risk assessment, an' translate regulatory language inna clear operational steps, timelines, an' responsibilities, yuh know.
Types of safety communications and sourcesRapid triage and risk prioritizationExtracting operational requirementsAssigning owners and due datesDocumenting decisions and follow-upLesson 3Templates an' checklists fi implementin' regulatory changes inna a hospital pharmacyProvide practical tools fi operationalize new regulations inna hospital pharmacies. Cover buildin' an' validatin' templates, checklists, an' logs dat standardize practice, support audits, an' ensure consistent implementation across shifts an' services, yuh see.
Designing policy and SOP templatesMedication-use process checklistsHigh-risk medication verification toolsRegulatory audit and inspection checklistsStaff training logs and competency formsLesson 4Common types a regulatory changes affectin' pharmacies: REMS, black box warnings, schedulin'/reschedulin' a controlled substances, labelin' changesReview major regulatory mechanisms dat affect pharmacy practice, includin' REMS, boxed warnings, schedulin' changes, an' labelin' updates. Clarify triggers, timelines, an' typical pharmacy obligations fi each type a regulatory action, mi bredda.
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, an' legal implicationsAnalyze how controlled substance reclassification affect prescribin', inventory, an' recordkeepin'. Address reconciliation, security, an' legal risks, an' outline steps fi update systems, policies, an' staff practices promptly, yuh know.
Identifying scope of reclassificationUpdating prescribing and refill rulesInventory reconciliation and variance reviewRecordkeeping and storage requirementsStaff education and prescriber outreachLesson 6Risk management: legal an' patient-safety consequences a non-compliance an' reportin' adverse eventsExamine legal, regulatory, an' patient-safety risks a non-compliance, includin' liability, sanctions, an' harm. Cover adverse event detection, documentation, an' reportin' pathways, an' how fi embed risk management inna routine pharmacy practice, yuh see.
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: dispensin' workflows, documentation requirements, storage an' inventory controlsExplore how new regulations reshape dispensin', documentation, storage, an' inventory controls. Focus pon mapin' rules to workflows, minimizin' errors, an' buildin' auditable processes dat withstand inspection an' support patient safety, mi fren.
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 an' restricted distribution: enrollment, patient/provider responsibilities, an' pharmacy documentationDetail operational requirements a REMS an' restricted distribution programs. Cover enrollment, verification, documentation, an' coordination among prescribers, patients, an' pharmacies fi maintain access while meetin' safety obligations, yuh know.
Core components of REMS programsPrescriber and pharmacy enrollment stepsPatient enrollment and education dutiesDispensing authorization and verificationREMS documentation and audit readinessLesson 9Storage an' handlin' changes (stability, refrigeration, hazardous drugs): SOP updates an' staff trainin'Cover how stability, refrigeration, an' hazardous drug rules drive storage an' handlin' changes. Focus pon SOP revisions, engineerin' controls, labelin', an' targeted staff trainin' fi maintain safety an' regulatory compliance, yuh see.
Revising stability and beyond-use datingCold-chain storage and monitoring updatesHazardous drug handling and segregationEnvironmental controls and spill responseDesigning and tracking staff trainingLesson 10How fi track regulatory updates: FDA safety communications, risk evaluation an' mitigation strategies, EMA an' national health authority alertsExplain how fi systematically monitor FDA, EMA, an' national alerts, includin' REMS updates. Describe tools, subscriptions, an' governance structures dat ensure timely review, decision-makin', an' implementation inna pharmacy practice, mi bredda.
Key regulatory websites and portalsEmail alerts, RSS feeds, and bulletinsVendor and professional society resourcesGovernance committees and workflowsMaintaining a regulatory change log
