Lesson 1Counseling and informed consent changes required by new warnings or labelingDetails how new warnings and labeling changes alter counseling content, consent forms, and documentation. Emphasizes risk communication, shared decision-making, and consistent messaging that aligns with current regulatory and legal expectations.
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 pharmacists to interpret safety communications and extract concrete action items. Emphasizes triage, risk assessment, and translating regulatory language into clear operational steps, timelines, and responsibilities.
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 pharmacyProvides practical tools to operationalize new regulations in hospital pharmacies. Covers building and validating templates, checklists, and logs that standardize practice, support audits, and ensure consistent implementation 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 changesReviews major regulatory mechanisms that affect pharmacy practice, including REMS, boxed warnings, scheduling changes, and labeling updates. Clarifies triggers, timelines, and typical pharmacy obligations for each type of regulatory action.
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 implicationsAnalyzes how controlled substance reclassification affects prescribing, inventory, and recordkeeping. Addresses reconciliation, security, and legal risks, and outlines steps to update systems, policies, and staff practices promptly.
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 eventsExamines legal, regulatory, and patient-safety risks of non-compliance, including liability, sanctions, and harm. Covers adverse event detection, documentation, and reporting pathways, and how to embed risk management into routine pharmacy practice.
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 regulations reshape dispensing, documentation, storage, and inventory controls. Focuses on mapping rules to workflows, minimizing errors, and building auditable processes that withstand inspection and support 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: enrollment, patient/provider responsibilities, and pharmacy documentationDetails operational requirements of REMS and restricted distribution programs. Covers enrollment, verification, documentation, and coordination among prescribers, patients, and pharmacies to maintain access while meeting safety obligations.
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 stability, refrigeration, and hazardous drug rules drive storage and handling changes. Focuses on SOP revisions, engineering controls, labeling, and targeted staff training to maintain safety and regulatory 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 alertsExplains how to systematically monitor FDA, EMA, and national alerts, including REMS updates. Describes tools, subscriptions, and governance structures that ensure timely review, decision-making, and implementation in pharmacy practice.
Key regulatory websites and portalsEmail alerts, RSS feeds, and bulletinsVendor and professional society resourcesGovernance committees and workflowsMaintaining a regulatory change log
