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Risk Assessment for Infused Prostacyclins ISMP Key Element I Patient Information Risk Assessment Questions II Drug Information III Communication of Drug Orders How is critical patient information obtained including infusion details and comprehensive medication history? How are patients managed during pregnancy? How are patients managed during acute deterioration? How are comorbidities assessed? How are patient specific factors identified including: cognitive ability, health literacy, language, depression, dexterity limitations, and special populations? How is updated and accurate drug information disseminated? What drug references are available for infused prostacyclins? Who is responsible for titrations and dose adjustments? How is critical drug property and dilution requirement information verified? How is staff alerted to medication related problems, such as side effects or drug interactions, in real time? What computer or automatic alerts are available? How are high risk/high alert medications managed? What are the independent checks and process steps that must occur with these medications? Who is responsible for verification of information with the specialty pharmacy? What is the process for contacting the specialty pharmacy and documenting the info obtained? Do electronic order sets contain the necessary infusion information, unique to the drug? How are orders communicated during transitions in care? How are current patient specific infusion orders documented and how do key personnel access these orders? How are the PAH team members notified of admissions, discharges, or any changes in orders? How are post-discharge orders communicated and fulfilled? Adapted from Institute for Safe Medication Practices Assess-ERR form Identified Problems Possible Interventions Follow up Responsibilities ISMP Key Element IV Labeling and Packaging Risk Assessment Questions V Storage and Distribution VI Drug Delivery Device How are mixed cassettes or bags labeled? What necessary information is included on the label? How are they differentiated based on drug, diluent, mixed concentration, and patient to avoid mix-ups? How are the infusions supplies labeled and packaged to avoid mix-ups? What system processes are in place to verify correct preparation, labeling and packaging in the pharmacy? If applicable, how are back up pumps stored? Who is responsible for maintaining backup pumps? Where are back up cassettes/bags stored? What is the process to access the backup cassettes/bags for both scheduled and urgent changes? How many steps and individuals are involved in this process? Who is responsible for this process and what are their roles? How are the various products stored in the pharmacy to avoid mix-ups? How is the process documented? (i.e. dispensing logs, electronic charting, barcode scanning) What time of day do the above processes take place and why? When patients are admitted, do they remain on home pumps or switched to hospital pumps? If hospital pumps, are patients switched to CADD pumps or standard infusion pumps? If home pumps, who is responsible for pump management? And how are cassette changes or dose changes documented in the chart? And who is responsible for verifying this? How often are pumps evaluated for proper working condition? Who is responsible for pump programming? What protocols are in place to transition between pumps if necessary? (E.g. home to hospital pump or vice versa.) Adapted from Institute for Safe Medication Practices Assess-ERR form Identified Problems Possible Interventions Follow up Responsibilities ISMP Key Element VII Environmental Factors Risk Assessment Questions What environmental factors are present that may contribute to medication errors? (i.e. excessive noise, clutter, poor lighting, workflow and staffing patterns, excessive interruptions or distractions, work volume) What is the process for transitioning in and out of the unit? (I.e. hand-offs transitions, etc.) What processes are in place to manage pump alarms? (I.e. avoiding alarm fatigue, appropriate volume, scheduled pump checks, etc.) What processes are in place to manage infused prostacyclins off the unit for tests or procedures? (such as MRI) Adapted from Institute for Safe Medication Practices Assess-ERR form Identified Problems Possible Interventions Follow up Responsibilities ISMP Key Element VIII Staff Education and Competency Risk Assessment Questions IX Patient Education What staff members are responsible for infused prostacyclin management during admissions? What are their roles in management? How is staff training on infused prostacyclins conducted? How is pump and supply competency evaluated? How is medication management competency evaluated? How is disease state management competency evaluated? What policies and procedures are available to staff on infused prostacyclins? Such as: o Pump transitions o Loss of central line access o Management of broken or clotted line o Management of infected line o MRI or other diagnostic procedures o CVC management How are policies and procedures disseminated to key staff members? How are the policies and procedures evaluated and updated regularly? How is staff instructed to handle medication error events? How is new staff oriented to policies and procedures? How are residents, students and other trainees oriented to policies and procedures? What are our patient’s barriers to learning and training? (I.e. low health literacy, dexterity, home environment, social support, language, etc.) How are our patients educated on PAH? How are our patients and their caregivers trained on infused prostacyclin’s? If conducted by external providers such as specialty pharmacy, how to we verify training competency of our patients and their caregivers? Who is responsible for coordinating the training and follow up? Inpatient and outpatient? For patients admitted on home pumps, how is Adapted from Institute for Safe Medication Practices Assess-ERR form Identified Problems Possible Interventions Follow up Responsibilities ISMP Key Element Risk Assessment Questions X Quality Process and Risk Management their ability to self-manage their pump evaluated? How are patients instructed to manage side effects? What medication management tools are provided to our patients? (I.e. manuals, literature, titration orders, med list, etc.) How is medication non-adherence identified? How do we engage and empower patients in medication awareness? How are our patients instructed to handle an emergency such as ER visit? Pump malfunction? CVC complications? What is my safety culture regarding medication error reporting? How are medication errors reported, investigated and evaluated? How are “near miss” events reported, investigated and evaluated? What redundancies and double checks do we currently utilize? How to we measure the effectiveness of these strategies? How are vulnerable system components identified and assessed? Adapted from Institute for Safe Medication Practices Assess-ERR form Identified Problems Possible Interventions Follow up Responsibilities
