Course Syllabus Fall 2016 Spring 2017

Transcription

1 Course Syllabus Fall 2016 Spring 2017 Course Numbers & Titles IPPE 305 Quality and Safety in Community Practice IPPE 307 Quality and Safety in Health-System Practice Course Manager Mark Brueckl, RPh, MBA Assistant Director ELP 20 N. Pine Street, 730D Baltimore, MD Office: (410) Fax: (410) Course Manager Response Time Response to phone calls and s will be within two business days, unless out of office. Experiential Learning Office Contact Information Experiential Learning Office Experiential Learning Office phone: (410) Experiential Learning Fax Number: (410) Experiential Learning Program Website: Credit Hours & Length of Rotation 3 credits each (each experience is 3 weeks, 120 experiential hours) Eligible Class Standing P3 Prerequisites Successful completion of IPPE 100 Introduction to Pharmacy and IPPE 200 Introduction to Patient Care, or by approval of the IPPE 305/307 course manager. Prior Learning Skills The student must have successfully completed the second year of the Doctor of Pharmacy curriculum of the University of Maryland School of Pharmacy. Page 1 of 24

2 Catalog Description These Introductory Pharmacy Practice Experience (IPPE) courses will provide student pharmacists with opportunities to assess quality pharmacy operations and safe medication use practices in community and health-system environments. Students will participate in pharmacy practice activities and will apply the knowledge and skills from Abilities Labs 1-4 and previous IPPEs to meet the course objectives, which promote patient safety. Required Readings Community Practice (IPPE 305) Spears T. Community pharmacists play key role in improving medication safety. Pharmacy Times (November 23, 2010). Available at: ts_medsafety. Accessed May 2, Jackson T. Decreasing medication errors in the community pharmacy. Drug Store News 2004;66. Available at: F35A D94C4B FE. Accessed May 2, Additional readings as required by preceptors Health-System Pharmacy Practice (IPPE 307) Readings as assigned by the course manager(s) or ELP office Additional readings as required by preceptors Useful Resources Agency for Healthcare Research and Quality. Available at: Institute for Safe Medication Practices. Available at: Institute of Medicine. Preventing Medication Errors. Report Brief. July Available at: Chasm-Series/medicationerrorsnew.ashx U.S. Pharmacopeia Convention. Medication Safety & Labeling. Available at: Healthy People Available at: National Guideline Clearinghouse. Available at: Required Attire Clean, pressed laboratory coat The School of Pharmacy name badge must be worn during all rotations. Students are expected to comply with the dress code policies outlined in the Experiential Learning Program Policies and Procedures Manual and the Student Honor Code. Course Objectives Upon completion of this experiential course, the student pharmacist will be able to: 1. Demonstrate a commitment to and a valuing of patient safety by assuring accurate preparation, labeling, dispensing and distribution of prescriptions and medication orders. 2. Demonstrate knowledge of and accept responsibility for that knowledge of commonly used medications, formulations, self-care regimens and drug products. Page 2 of 24

3 3. Utilize pharmaceutical and pharmacokinetics mathematics to perform accurate medication calculations. Value the importance of total accuracy in performing and applying these calculations. 4. Demonstrate effective communication abilities in interactions with patients, their families and care givers, and/or other health care providers. Communication should be consistent with and empathetic to education level, cultural beliefs and practices. Elicit feedback validating understanding of communication. 5. Assess information needs of patients and health providers and apply knowledge of study design and literature analysis and retrieval to provide accurate, evidence based drug information 6. Demonstrate proficient use of technology used in the management of patients and the medication distribution process 7. Demonstrate acceptable qualities and characteristics of professional behavior of altruism, honesty and integrity, respect for others, professional presence and dedication and commitment to excellence. Terminal Performance Outcomes TPO 3 Provide Drug products to patients TPO 4 Use technology effectively to carry out professional functions TPO 5 Prepare Medications for Patient Use TPO 11 Answer Patient Specific questions TPO 12 Identify payment sources and mechanisms for professional services and products TPO 13 Participate in quality assurance processes related to drug use TPO 14 Participate in Health Education TPO 16 Maintain Professional Competence TPO Self-care When appropriate, recommend self-care regimens that optimize the benefit-to-risk ratio of the selected therapy(ies). TPO Management Supervise pharmacy technician activities. TPO Formulary Utilize drug formularies to optimize drug therapy recommendations. Understand the process for developing drug formularies at an organization/health-system. TPO Cultural Competence Incorporate patients cultural beliefs and practices into patient care activities while maintaining patient safety. TPO Drug Approval Process/Investigational Explain the steps involved in the drug-approval process in the United States, including specialty and investigational drugs. Drug Activities and Assignments The student pharmacist will be assigned to an approved preceptor, who will provide an orientation to the site and will organize, facilitate, and assess the student's activities. Page 3 of 24

4 Students are expected to complete the activities on each checklist for IPPE 305 Community and IPPE 307 Health-System. Students are expected to work with preceptors and pharmacy personnel to complete the patient and medication safety assessment tools. The site assessment and activity checklist should be submitted online using the appropriate Google forms. If the pharmacy stocks vaccines, the Vaccine Storage and Handling checklist should be completed. Medication error reporting and drug information requests may be required when applicable. Preceptors may assign additional activities in support of the course outcomes. Through observation, demonstration (skills), discussion, role-playing (behaviors), reflection, question and answer session(s), and self-directed learning, the student will be expected to have completed all course outcomes. Student Assessment and Grading A weekly review of the evaluation form and checklist is encouraged to assure successful course completion. The student will be assessed by the preceptor on performance and professionalism at the midpoint and at the end of the rotation. Midpoint evaluations are required to be completed in RXpreceptor for each rotation to document student performance and allow for areas of focus and improvement during the latter half of the rotation. The midpoint evaluation will NOT be used in the calculation of the student s final grade. Within one week of completion of the rotation, the Preceptor Evaluation of Student must be submitted to the Experiential Learning Office. Failure to do so may result in an Incomplete. Evaluations will be completed online in RXpreceptor. The professionalism/behavioral items do not contribute toward the letter grade. However, an Unacceptable rating on any professionalism/ behavioral item at the end of the rotation will result in automatic course failure. The following rubric will be used to assign a letter grade for the rotation: Absent 0.0 Beginning 9.0 Developing 10.5 Intermediate 12.0 Proficient 13.2 Directions for the Checklist and ISMP site assessment: The Checklist and the ISMP site assessment documents are available as Google Forms. o Quality and Safety in Community Practice o Patient and Medication Safety Assessment Tool for Community Pharmacies o Quality and Safety in Health-System Practice o Patient and Medication Safety Assessment Tool for Health-System Pharmacies The Checklist and the ISMP site assessment are to be submitted on-line. Upon submission, a copy of the document will be ed to the preceptor and the student. The preceptor will acknowledge the completion of the documents in the student s final evaluation. Page 4 of 24

5 Letter Grade: The letter grade is determined by the percentage of total points earned for the combined objectives in RXpreceptor (total possible = 80 points) plus 10 points each for completion and timely submission of the ISMP site assessment and quality and safety checklist. Final Letter Grade A red box indicates a professionalism failure or incomplete abilities checklist. Letter grades will be based on final scores as follows: A >90-100% B > % C > % F % Remediation Policy This course follows academic policies for remediation established by the School of Pharmacy. Please refer to the School s website here. (view Remediation policy ) Preceptor Criteria The preceptor must have a clinical faculty appointment from the University of Maryland School of Pharmacy and practice in community or health-system setting which offers sufficient opportunities for students to meet the course outcomes. The preceptor will assure effective student learning based on the following Gagne's Nine Events of Instruction: Gain attention- orient student to site, personnel, policies/procedures, expectations, schedule, facility tour Inform learner of objectives- review course syllabus Stimulate recall of prior learning- questions Present learning stimulus- assignments, demonstrations, role-playing Provide learner guidance Elicit performance- outcomes-based Provide feedback- constructive, frequent Assess performance- mid-point, final Enhance retention and transfer- summation, wrap-up The preceptor is responsible for the guidance, supervision, and assessment of the student in the dayto-day conduct of the course. The preceptor may assign students to other site personnel, if applicable for the objectives, as long as those individuals provide input for the student s assessment. The preceptor is encouraged to develop a learning contract(see example provided in ELP policy and procedures) to include site-specific requirements, such as expectations, the rotation schedule, policies, and assignments; and he or she may require additional projects and/or exercises to ensure the student s successful completion of the course objectives. The preceptor should provide face-toface feedback for the final evaluation and assure that the course objectives, including the required hours of participation, were accomplished. Preceptor Assessment The student will submit the Student Evaluation of Self/Preceptor/Site through RXpreceptor no later than seven days following the completion of the rotation. Each summer, preceptors will be provided Page 5 of 24

6 summaries of their evaluations from the previous year in order for them to improve rotations. Preceptors should solicit student input for site and preceptor feedback during face-to-face evaluation. Policies Students and preceptors are expected to comply with the ELP Policies and Procedures Manual, available in the Document Library in RXpreceptor. Page 6 of 24

7 Preceptor s Evaluation of Student IPPE 305 Quality and Safety in Community Practice IPPE 307 Quality and Safety in Health-System Practice Student Name: Preceptor s Name: Rotation Start Date: Final Review Date: Evaluating/Rating Student Performance (Enter in RXpreceptor): Preceptors are encouraged to provide at least weekly formative feedback for students to improve performance, and to guide activities for the remainder of rotation. Select appropriate rating (AB, BG, DV, IN, P) in each column for each item and add comments as needed. Comments are strongly encouraged and must be included for any rating of AB for any item. Grades will be assigned based on the final evaluation of the student s performance and requirements. Performance Outcomes Criteria The preceptor should evaluate the student at both the mid-point and at the conclusion of the rotation, using the following competency levels and descriptors. Each performance item on the assessment tool, with the exception of professionalism items will be rated using the competency levels of Absent, Beginning, Developing, Intermediate, or Proficient. The student may fit into more than one category; please select the competency level using the corresponding examples that best describe the student s performance at the point of assessment. Absent Beginning Developing Intermediate Proficient Awareness Not aware of how to approach the skill Aware of the deficiency in the skill and attempts to determine effort required to become competent Initiates practice of the skill Not able to consistently perform the skill. Rarely able to identify or solve problems related to the skill Familiarity with skill develops through practice Mostly consistent in identifying or solving problems related to the skill Consistently demonstrates accurate performance of the skill Can identify and solve problems related to the skill Ability Lacks ability to independently complete the skill Sporadically, but rarely able to perform the skill Sometimes able to complete this skill Ability to complete this skill is adequate, but not independent Able to independently complete the skill Page 7 of 24

8 Supervision Requires major supervision to complete the skill Constant supervision and feedback are required to completed the skill Supervision and feedback are required but need is decreasing Supervision needed to master major concepts Supervision is minimal May seek feedback from preceptor with specific questions about performance Mistakes Major mistakes are many when student attempts to complete the skill Patient safety is at risk Major mistakes are common when student attempts to complete the skill Unable to selfcorrect Major mistakes are limited Minor mistakes occur Unable to self-correct most errors No major mistakes Minor mistakes occur Able to selfcorrect Occasional minor mistakes Following are the course outcomes and skills that the preceptor will assess on the midpoint and final evaluations: Outcome 1: Demonstrate a commitment to and a valuing of patient safety by assuring accurate preparation, labeling, dispensing and distribution of prescriptions and medication orders. Given a set of basic written or verbal prescription/medication orders, the student is able to: Follow preceptor guidance for site-specific processes. Review and interpret basic prescriptions/medication orders for patients. Prepare, label, and verify prescriptions/medication orders for patients under preceptor supervision. Given practice activities, the student is able to: Articulate the decision points (e.g., safety, legitimacy of order, drug strength, prior authorization, non-formulary prescription order, ethical dilemma) observed during prescription/medication order processing at least once daily during the rotation. Reflect on alternatives (if applicable). Discuss appropriate actions relative to the decision. Given a patient, the student is able to: Systematically review patient medications. Reconcile discrepancies. Correctly document findings for PMR or medication reconciliation. Given practice activities, the student is able to: Describe quality and safety concerns (e.g., dangerous abbreviations, high alert medications, etc.) relative to the practice site using ISMP recommendations. Identify appropriate resources to address concerns. Discuss potential actions to prevent medication errors and promote quality processes. Outcome 2: Demonstrate knowledge of and accept responsibility for that knowledge of commonly used medications, formulations, self-care regimens and drug products. Summarize key information related to the use of common (Top 200) medications Identify brand and generic names, dosage forms and usual dosing ranges for common (Top 200) medications When appropriate recommend self-care regimens that optimize the benefit to risk ratio of the selected product Outcome 3: Utilize pharmaceutical and pharmacokinetics mathematics to perform accurate medication calculations. Value the importance of total accuracy in performing and applying these calculations. Page 8 of 24

9 Given a problem, the student is able to: Accurately calculate the appropriate quantity of medication/ingredient/additive for at least 5 prescription orders. Document calculation for preceptor verification. Outcome 4 Demonstrate effective communication abilities in interactions with patients, their families and care givers, and/or other health care providers. Communication should be consistent with education level, cultural issues, and be empathetic. Elicit feedback validating understanding of communication. Given a device or drug delivery system, the student is able to: Accurately show appropriate steps. Confirm ability to perform technique Correct technique if needed. Relate the importance of proper technique to the therapeutic outcome. Outcome 5: Assess information needs of patients and health providers and apply knowledge of study design and literature analysis and retrieval to provide accurate, evidence based drug information Given a question and resources, the student is able to: Re-state the basic drug information query. Collect pertinent background information with preceptor input. Respond to the query in a timely manner as directed by the preceptor using available resources. Outcome 6:Demonstrate proficient use of technology used in the management of patients and the medication distribution process Given a medication record system, the student is able to Demonstrate proficient use of the system Identify basic flags for medication errors or problems Take steps to resolve potential errors or problems Professionalism Criteria By the end of the rotation, a student must earn Acceptable for all five professionalism criteria in order to pass the rotation. These criteria do not count toward the evaluation points for a grade. An Unacceptable rating on any professionalism metric at the final evaluation will result in a failure in the course. Altruism: Student makes an unselfish commitment to serve the best interests of the patient and rotation via prioritizing rotation requirements, demonstrating effective listening skills, interacting with others in a compassionate manner, and developing trusting relationships. Honesty and Integrity: Student displays honesty and integrity via abiding by patient (HIPAA) and student (FERPA) confidentiality requirements, and maintaining academic honesty. Respect for Others: Student treats others as he/she would want to be treated via arriving on time for rotation activities, respecting the feelings, needs, thoughts, and opinions of the preceptor/faculty /colleagues, demonstrating ability to receive constructive feedback, and providing constructive feedback in a respectful and educational manner. Professional Presence: Student instills trust via attending and participating in rotation requirements, dressing appropriately for the rotation, and accepting responsibility for one s own actions. Dedication and Commitment to Excellence: Student strives for excellence and assume responsibility for his/her learning and professional development via adequately preparing for all rotation sessions, embracing responsibility for one s own learning, and actively seeking guidance and mentoring as needed. Page 9 of 24

10 IPPE 305 Quality and Safety in Community Practice Checklist Student Name: Students are expected to work with their preceptors to complete the items on the checklist during the rotation experience. Students must be appropriately supervised. Students will complete and submit the Google Forms version this document. Pharmacy Operations Completed Not Applicable Describe the roles of each member of the pharmacy team at the site. Receive prescriptions/orders and verify they are complete, legal, and appropriate. Identify the legal/regulatory criteria for generic substitution. Enter data into the pharmacy database, including medication order, patientspecific information, third party information, pharmacist intervention documentation. Review patient records for compliance, duplication, potential interactions, etc. (prospective drug utilization review) Interact with a prescriber to clarify prescriptions/medication orders. Select the appropriate drug product and supplies. Appropriately label prescriptions/medication orders. Dispense a variety of solid and liquid multi-dose medications and/or unit-of-use medications. Compound non-sterile, extemporaneously prepared medications. Demonstrate sterile compounding technique. Deliver completed prescriptions/orders to patients. Assist with selection of non-prescription medications, supplies, devices. Counsel patients regarding the use of prescription and nonprescription products. Demonstrate proper use of pharmacy equipment (e.g., counting machines, ScriptPro, Baker cells, scanners, etc.). Explain the formulary system for insurance plans. Explain the procedures for filing/retention of order forms, invoices, and other pharmacy documents. State the security safeguards for ordering, receiving, stocking, and dispensing Schedule II-V drugs. Safety Complete the Patient and Medication Safety Assessment tool and provide suggestions for improvement. Shadow a technician or other personnel for a day and solicit ideas to improve safety, efficiency, and productivity in the medication order process. If the pharmacy stocks vaccines, complete the vaccine storage and handling checklist. Cite safety goals applicable to the site (e.g., ISMP, USP 797, COMAR, Joint Commission, National Patient Safety Goals). Discuss procedures for medication error reporting and error prevention at the site. If the pharmacy accepts electronic prescriptions, discuss the types of errors that may occur with e-prescriptions. Discuss safe, cost-effective disposal of expired medications, recalled medication, & biohazard waste. Quality Review the pertinent Board of Pharmacy inspection form, including recommendations for best practices and preparing for inspections. Discuss strategies for assuring that staff members are competent (training, certification, etc.) Preceptor Signature Page 10 of 24

11 IPPE 307 Quality and Safety in Health-System Practice Checklist Student Name: Students are expected to work with their preceptors to complete the items on the checklist during the rotation experience. Students must be appropriately supervised. Students will complete and submit the Google Forms version this document. Pharmacy Operations Completed Not Applicable Describe the roles of each member of the pharmacy team at the site. Receive prescriptions/orders and verify they are complete, legal, and appropriate. Identify the legal/regulatory criteria for generic substitution. Enter data into the pharmacy database, including medication order, patientspecific information, third party information, pharmacist intervention documentation. Review patient records for compliance, duplication, potential interactions, etc. (prospective drug utilization review) Interact with a prescriber to clarify prescriptions/medication orders. Select the appropriate drug product and supplies. Appropriately label prescriptions/medication orders. Dispense a variety of solid and liquid multi-dose medications and/or unit-of-use medications. Compound non-sterile, extemporaneously prepared medications. Demonstrate sterile compounding technique. Deliver completed prescriptions/orders to patients. Demonstrate proper use of pharmacy equipment (e.g., dispensing machines, etc.). Explain the formulary system (third party or institutional). Explain the procedures for filing/retention of order forms, invoices, and other pharmacy documents. State the security safeguards for ordering, receiving, stocking, and dispensing Schedule II-V drugs. Safety Complete the Medication Safety Self-Assessment for Hospitals. Shadow a nurse, technician, or other personnel for a day and solicit ideas to improve safety, efficiency, and productivity in the medication order process. If the pharmacy stocks vaccines, complete the vaccine storage and handling checklist. Cite safety goals applicable to the site (e.g., ISMP, USP 797, COMAR, Joint Commission, National Patient Safety Goals). Discuss procedures for medication error reporting and error prevention at the site. If the pharmacy is involved with computerized provider order entry (CPOE), discuss the types of errors that may occur with electronic medical orders. Discuss safe, cost-effective disposal of expired medications, recalled medication, & biohazard waste. Quality Review the pertinent Board of Pharmacy inspection form, including recommendations for best practices and preparing for inspections. Discuss strategies for assuring that staff members are competent (training, certification, etc.) Discuss accreditation pertinent to the site and CMS Pay for Performance (Core Measures). Preceptor Signature Page 11 of 24

12 Patient and Medication Safety Assessment Tool for Community Pharmacies Students are expected to work with their preceptors to complete the items on the checklist during the rotation experience. Students must be appropriately supervised. Students will complete and submit the Google Forms version this document. Student Name Date(s) of assessment: Indicate the number of individuals who participated in this assessment: Staff pharmacist Pharmacy manager/owner Pharmacy technician Student pharmacist Other ( ) Check the category that best describes this pharmacy: Independent pharmacy (1 3 pharmacies) Chain pharmacy (4 or more pharmacies) Grocery chain pharmacy Mass merchandiser Hospital outpatient pharmacy Other Approximately how many prescriptions are dispensed per week? Less than Greater than 2000 Indicate the number of FTEs (full-time equivalent) employed at this pharmacy for each personnel category: Staff pharmacist Pharmacy manager/owner Pharmacy technician Student pharmacist Other ( ) Check the category that best describes the location of this pharmacy: Urban Rural Based on the assessment, provide three recommendations for the pharmacy to improve patient and medication safety: 1) 2) 3) a Adapted from the Institute of Safe Medication Practices (ISMP) Medication Safety Self Assessment for Community/Ambulatory Pharmacy. Available at: Page 12 of 24

13 Student Name Date(s) of assessment: For each element listed, select the most appropriate description to identify the degree to which the activity has been implemented and incorporated into pharmacy operations. N/A = not applicable; NI = not implemented or seldom occurs; PI = partially implemented or occurs some of the time; FI = fully implemented or occurs all of the time Prescription Processing N/A NI PI FI Prescription orders cannot be entered into the pharmacy computer system until the patient s allergy information has been entered. The clinical purpose of each prescription is determined before the medication is dispensed to ensure the prescribed therapy is appropriate for the patient s condition. A standard process is followed to help ensure that medications are being dispensed to the proper patient (e.g., verifying patient s name, address, date of birth, etc.). The pharmacy uses tools or resources to communicate with patients who are visually or hearing impaired. Pharmacy computers that are used for order entry allow easy access to reputable resources for drug and disease information (e.g., Facts and Comparisons, Micromedex, Lexicomp). The computer system automatically performs adult and pediatric dose range checks and warns pharmacists about improper dosing for medications. The computer system warns pharmacists about clinically significant drug interactions. The computer system automatically screens for and detects potential drug allergies. A pharmacist is required to review all clinically significant computer alerts pertaining to dosing, interactions, and contraindications. Pharmacy staff tests the computer system as least twice per year to assure that maximum dose alerts are present for high-alert and narrow therapeutic index drugs. When alerts are not present, measures are taken to add them to the system. An updated interactive database for the pharmacy computer system is received from a drug information vendor and uploaded to the system at least quarterly. The pharmacy computer system warns staff when a new drug has been entered for which there is no screening information available. The variety of manufacturers from which generic drugs are purchased is minimized to the fullest extent possible. When new drugs with heightened error potential are identified, safety enhancements (e.g., alert labels, tall-man lettering, reminders, sequestered storage, etc.) are established. The pharmacy is able to receive electronic prescriptions from the prescriber s office to a pharmacy computer in a standard format. Page 13 of 24

14 The format of electronic prescriptions received by the pharmacy is similar to the way paper prescriptions are organized and entered into the system. If a prescription is received on paper, scanning and prescription imaging is used in the dispensing process to show the original prescription on the computer screen. The pharmacy has created a list of drugs (e.g., controlled substances, certain high-alert drugs) for which telephone or electronic prescriptions cannot be accepted from the prescriber s office staff. Telephone or voice mail prescription orders are received directly by a pharmacist and written down immediately on a prescription blank (not scrap paper, which requires an additional transcription step). When telephone orders must be taken, the pharmacist receiving the order repeats it back to the prescriber for verification. The pharmacist who has resolved an issue with an unclear or incorrect prescription clearly communicates the resolution to other pharmacy staff by writing an informative note on the patient s profile or prescription order. Special alerts are built into the computer program to remind pharmacy staff about problematic or look-alike drug names, packaging, or labeling. Auxiliary warnings, labels with exaggerated fonts, or other label enhancements are used on packages and storage bins for drugs with problematic names, packages, or labels. When drugs have the same name but different routes of administration (e.g., ophthalmic vs. otic), steps are taken (e.g., auxiliary labels, different storage locations, different manufacturers, notation in computer system) to prevent dispensing errors. Products with known look-alike drug names are stored separately and not alphabetically, or are otherwise clearly differentiated from one another. The pharmacy uses appropriate foreign language labels for patients who need them. The pharmacy computer system automatically prints appropriate auxiliary labels (e.g., for the eye, take with food, may cause drowsiness) when prescription labels are generated AND the pharmacist reviews these for appropriateness for each patient. Prescription Filling and Compounding N/A NI PI FI There is an efficient and timely process in place to obtain critically needed medications when they are not immediately available in the pharmacy stock. A mechanism exists to identify the reasons that a prescription has not been picked up after being prepared. Records are available to identify patients receiving a drug that is recalled by the manufacturer and patients are notified as appropriate. Medications are rotated in the fast mover area(s) to reduce the risk of error due to familiarity with placement on shelves. When checking in the shipment, staff ensures that wholesaler price labels do not interfere with critical drug information on the manufacturers labels. If a manufacturer s stock bottle is to be dispensed to a patient, the pharmacist checks that the original seal is still intact. Page 14 of 24

15 When refilling a prescription with a medication from a different manufacturer, a system is in place to notify patients of the change in appearance of the drug product. To guide selection of the proper drug, a computer graphic appears on the screen with each prescription to show the appearance of the product. An automated dispensing system that incorporates robotics and/or bar code verification is used to support the dispensing system in the pharmacy. If electronic counting machines are used during the filling process, they are routinely cleaned and calibrated for accuracy. If completed prescriptions are not ultimately dispensed to patients, the medications are returned to stock in a consistent manner that reduces risk of an error (e.g., maintained on the shelf in the original prescription vial with drug, dose, and expiration date highlighted and specific patient information redacted. An appropriately secured area of the pharmacy has been established to temporarily place discontinued, outdated, or recalled medications until they are destroyed or removed from the pharmacy in a timely fashion. Staff members use gloves or proper hand washing when handling individual loose oral solid products (e.g., capsules, tablets). Staff members use appropriate hand washing procedures or gloves prior to compounding any prescription products. Dispensing devices (e.g., counting trays, spatulas, mortar and pestle) are washed after being used to prepare chemotherapy, penicillin, sulfonamide, opiate, or NSAID prescriptions. Only clean (washed) measuring devices are used for compounding liquids, ointments, and capsules. Pharmacy Environment and Workload N/A NI PI FI To meet their needs, pharmacy personnel are able to adjust the sound and lighting at specific points in the prescription filling and dispensing area(s). Temperature and humidity are comfortable for workers AND conform to drug storage requirements. Areas where drug orders are transcribed and/or entered into computer systems are isolated and relatively free of distractions, noises, and unnecessary chatter. The physical layout of the pharmacy is designed to minimize distractions for pharmacists during the final check in the prescription verification process. Workspaces where medications are prepared are clean, orderly, and free of clutter. When filling multiple prescriptions for one patient, dividers, baskets, or other means are used to ensure that prescriptions for other patients are not inadvertently mixed together. Medication refrigerators are used only for medical product storage and are of sufficient size to allow all drugs to be refrigerated in an organized manner. When dispensing prescriptions, staff work with one drug product at a time and affix the label to the patient s prescription container before working on the next prescription. Schedules and workload permit pharmacists to take at least one 15-minute break and one 30-minute meal break per shift. Pharmacy personnel have time to eat a well-balanced meal during a work day. Page 15 of 24

16 The pharmacy does not ask pharmacists to meet a specific quota for prescription dispensing or track pharmacy productivity via dispensing rates. Staffing patterns in the pharmacy are adequate to allow for appropriate pharmacist-patient interaction and counseling. Personnel Training and Error Reporting N/A NI PI FI When temporary agency staff are used, they have been properly oriented and trained. Prescription volume data is analyzed periodically to determine appropriate staffing levels throughout the work week. An employee assistance program is available and participation is encouraged to help staff who are experiencing stress that may affect work performance. Those who train new staff have a significantly reduced workload to accomplish the goals of orientation safely and thoroughly. During orientation, pharmacists and technicians receive information about the pharmacy s actual error experiences as well as published errors that may have occurred in other facilities. During orientation, pharmacists and technicians are educated about systembased strategies to reduce the risk of errors. As least annually, a supervisor evaluates each pharmacy staff member to assess his/her skills and knowledge related to safe medication practices. Pharmacists and technicians receive ongoing information about medication errors occurring within the organization, error-prone situations, errors occurring in other pharmacies, and strategies to prevent such errors. Medication errors and ways to avoid them are routinely discussed at staff meetings and in conversations between pharmacists, technicians, and managers. When errors occur, educational efforts are widespread among all pharmacy personnel who may make a similar error, rather than remedial and directed at only those who were involved in an error. Pharmacists and technicians are trained in the clinical and administrative procedures for responding to a serious medication error. A clear definition and examples of medication errors and hazardous situations that should be reported has been established and disseminated to staff. Management provides positive incentives for individuals to report errors and pharmacists and technicians are thanked and praised for detecting and reporting errors. The pharmacy has a system for reporting events in the pharmacy includes both hazardous situations that could lead to an error and actual errors that were detected and corrected before reaching the patient. Pharmacists and technicians involved in serious errors that cause patient harm are emotionally supported by their colleagues and offered psychological counseling. Management actively demonstrates its commitment to patient safety and safe medication practices by approving a patient safety plan, encouraging error reporting, and supporting processes/technology that are intended to reduce errors. Page 16 of 24

17 Staff who are involved in a serious or potentially serious medication error participate in analyzing those failures in the system that led to the error, and they are encouraged to recommend system enhancements to reduce the potential for errors. Pharmacy management supports reporting to external programs such as the ISMP s National Medication Errors Reporting Program, FDA s MedWatch, and the Vaccine Adverse Event Reporting System. Patient Counseling and Education N/A NI PI FI Adequate time is budgeted by management for patient counseling activities. Each patient receiving a new prescription receives counseling. A suitable private area with minimal distractions is available to provide counseling. Patients are verbally encouraged to ask questions about the medications they are receiving. Staff fully disclose the intent of the proof of counseling log before asking patients to sign the log. Criteria have been established (e.g., targeted high-alert drugs, high-risk patient populations, new therapies) to trigger required medication counseling and a system is in place to alert the pharmacist of this need when a patient picks up the prescription (e.g., alert or sticker on bag). When counseling is provided, the patient s prescription product is shown to the patient to verify the medication dispensed. When dispensing oral liquid medications, a proper measuring device is provided or suggested AND instructions regarding its use are communicated. Doses that require splitting tablets are dispensed only to patients who have demonstrated their ability to split the tablet. Patients are instructed on the proper use and maintenance of devices dispensed from the pharmacy (e.g., glucometers, humidifiers, spacers). If someone other than the patient or caregiver picks up the prescription, a reasonable effort is made to communicate directly with the patient to provide counseling. The pharmacy offer medication therapy management (MTM) services, whereby eligible patients receive annual comprehensive medication reviews. Page 17 of 24

18 Patient and Medication Safety Assessment Tool for Health-System Pharmacies Students are expected to work with their preceptors to complete the items on the checklist during the rotation experience. Students must be appropriately supervised. Students will complete and submit the Google Forms version this document. Student Name Date(s) of assessment: Indicate the number of individuals who participated in this assessment: Staff pharmacist Pharmacy manager/owner Pharmacy technician Student pharmacist Other ( ) Check the category that best describes the number of inpatient beds currently set up and staffed for use in this hospital: Fewer than 100 beds 100 to 299 beds 300 to 499 beds 500 beds and over Check the category that best describes the type of organization that is responsible for establishing policy for the overall operation of this hospital. State or local government Non-government, not-for-profit Investor-owned, for-profit Military Check the category that best describes the location of this pharmacy: Urban Rural Based on the assessment, provide three recommendations for the pharmacy to improve patient and medication safety: 1) 2) 3) a Adapted from the Institute of Safe Medication Practices (ISMP) Medication Safety Self Assessment for Hospitals. Available at: Page 18 of 24

19 Student Name Date(s) of assessment: For each element listed, select the most appropriate description to identify the degree to which the activity has been implemented and incorporated into pharmacy operations. N/A = not applicable; NI = not implemented or seldom occurs; PI = partially implemented or occurs some of the time; FI = fully implemented or occurs all of the time Patient Information N/A NI PI FI Pharmacists can easily and electronically access inpatient laboratory values while working in their respective locations Recent inpatient and outpatient laboratory values are automatically displayed on Computer Order Entry System screens for medications that typically require dose adjustments based on pending laboratory results (e.g., if warfarin is ordered, the most recent INR is displayed) Medication orders cannot be entered into the Computer Order Entry System until the patient s allergies have been entered and coded (i.e., orders cannot be entered until the allergy filed has been populated). Computer Order Entry Systems automatically screen and detect drugs to which patients may be allergic (including cross allergies), provide a clear warning to staff during order entry, and require practitioners to enter an explanation to override the warning. Computer Order Entry Systems have a tiered severity rating for allergies, based on the patient's reaction to the drug, which is used to limit alert fatigue from drug intolerances that are not true allergies. Machine-readable coding (e.g., bar-coding) is used to verify patient identity during drug administration. OR Two patient identifiers (not the patient's room number or location) from the MAR (paper or electronic) or the original order are manually verified against the patient identification bracelet and/or when possible, with the patient, before medications are administered. Basic information (e.g., patient name, hospital unit location, medical record number, birth date, physician) is clear and easily visible on orders transmitted to the pharmacy via addressograph imprints or labels on paper copies, or is sent electronically. Information about the patient's comorbid and/or chronic conditions (e.g., hypertension, diabetes, renal or liver impairment, pregnancy, lactation) is obtained, communicated to pharmacists, and available in the pharmacy computer system for reference. Medication orders cannot be entered into the Computer Order Entry System until the patient's weight has been entered (i.e., orders cannot be entered until the weight field has been populated). All weights and heights are measured and documented in written and electronic systems in metric units (i.e., grams or kilograms for weight, centimeters for height). All documented weights and heights in written and electronic systems are Page 19 of 24

20 designated as actual, estimated by practitioners, or stated by patients. Drug Information N/A NI PI FI A complete drug history, including a current list of prescription and over-thecounter medications (with dose, frequency, route, time of last dose taken, indication), vitamins, herbal products, illicit drugs and alcohol and tobacco use is obtained for every inpatient and outpatient upon admission or initial encounter (including during the pre-admission process). A process is in place in both inpatient and outpatient units (e.g., ED, ambulatory surgery, outpatient radiology) to obtain a list of the medications that the patient has been taking at home before admission or outpatient encounter and compare (reconcile) the list to the medications prescribed upon admission, during the encounter, upon transfer within the hospital, and upon discharge, to identify and resolve discrepancies (e.g., omissions, duplications, contraindications, unclear information). All drug reference texts, including commercially available charts and guidelines in the organization are checked annually; all outdated reference materials are removed from use and replaced if necessary. (Reference materials are outdated after 1 year of publication or whenever the next edition is available). Pharmacists and pharmacy technicians have easy access (e.g., on each computer terminal, electronic handheld devices) to user-friendly, up-to-date, computerized drug information systems, which include information on overthe-counter, herbal and alternative medications High-alert drugs used within the organization have been identified, highleverage error-reduction strategies have been established for these drugs, and these have been communicated to all practitioners who prescribe, dispense and administer the products and/or monitor their effects. Current protocols, guidelines, dosing scales, and/or checklists for high-alert drugs (e.g., chemotherapy, anticoagulants, opioids, insulin) are readily accessible to prescribers, pharmacists, and nurses, and used when high-alert drugs are prescribed, dispensed, and administered. Equianalgesic dosing charts for oral, parenteral, and transdermal (e.g., fentanyl patches) opioids have been established and are easily accessible to all practitioners when prescribing, dispensing, and administering opioids. Minimum and maximum dose limits have been established for parenteral medications titrated to effect (e.g., insulin infusions DOPamine, DOBUTamine), which when approached (fall below minimum doses or exceed maximum doses), require notification of the prescriber for further instructions. Information technology systems used in the hospital (e.g., pharmacy computer system, computerized prescriber order entry (CPOE) system, smart pump technology, automated compounding devices) are routinely tested to assure that maximum dose alerts are present for high-alert drugs, and alerts are built for those that are not present. Computer order entry systems perform dose range checks and warn practitioners about overdoses and under doses for all high-alert drugs and for most other medications. Computer order entry systems require practitioners to enter an explanation upon overriding a serious allergy (e.g., exceeding a maximum dose for a highalert drug, a serious drug interaction, an allergy). Page 20 of 24

21 A designated pharmacist routinely reviews, for quality improvement purposes, reports of selected computer order entry system warning (e.g., maximum dose alerts, serious drug interactions, allergy alerts) that are overridden. Pharmacists regularly (e.g., at least one 8-hour shift per 24 hours) work directly in inpatient care units performing clinical activities such as reviewing patient records and drug orders, attending interdisciplinary rounds, providing input into the selection and administration of drugs, educating patients, and monitoring the effects of medications on patients. The hospital formulary contains minimal duplication of therapeutically equivalent products. Non-formulary products are used only when therapeutically necessary and appropriate (e.g., a patient experiences and adverse effect to a formulary medication; use of an alternative, non-formulary medication during a drug shortage). Communication of Drug Orders and Other Drug Information N/A NI PI FI In hospitals WITH CPOE systems: The system includes decision support and standardized order sets that guide the use of formulary drugs and established protocols. OR In hospitals WITHOUT CPOE systems: Preprinted order forms for commonly encountered disease states and procedures (e.g., preoperative and postoperative patients, inpatient critical care admissions, chemotherapy protocols) are used to guide the use of formulary drugs and established protocols. Standard order sets (electronic or preprinted) for complex, compounded products (e.g., total parenteral nutrition (TPN)) list additives in the same sequence, dosing units (e.g., mg, meq), and concentrations (e.g., mg/ml, mg/liter) as in the pharmacy order entry system and automated compounder order entry system. A list of prohibited, error-prone abbreviations (e.g., u, qd, MSO4) and unacceptable methods of expressing doses (e.g., by volume or number of tablets only instead of weight, using trailing zeros for whole number doses, not using a leading zero for doses less than one) is established for all communication of drug information and orders (including in handwritten or preprinted orders, MARS, chart notations, organization-development drug references, and in electronic formats, including computer screens). Drug Labeling, Packaging and Nomenclature N/A NI PI FI Products with look-alike drug names and packaging that are known by the hospital staff to be problematic are segregated and not stored alphabetically, and a system clearly redirects staff to where the products have been placed. Look-alike drug names do not appear on the same computer screen when selecting a drug during order entry (even when mnemonics are used); or lookalike drug names are clearly distinguished in a way that differentiates them (e.g., use of tall man letters) if they appear sequentially on the same computer screen. Different manufacturers are sought for products with labels/packages that look like other products to help differentiate the labels/packages. Auxiliary warnings or other label enhancements (e.g., tall man letters to Page 21 of 24