Medication Safety Best Practices Guide for Ambulatory Care Use

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1 for Ambulatory Care Use Instructions Inventory your safety practices by using the tool below. Once you have identified areas for improvement, you may establish an action plan for implementation. The tool is intended to provide you guidance on the resource requirements to consider when evaluating your environment for medication safety. The implementation level described below is intended to assist you with identifying the level of additional resource needs you may have. For additional assistance please contact: Kim Galt or Ann Rule Implementation. Implementation requires no additional resources. The solution is accomplished through changes in individual behavior to achieve safety improvement.. Implementation requires no additional resources. The solution is accomplished through change in policy or system(s).. Implementation requires additional resources. The solution is accomplished through additional financial or expert resources beyond those currently available to the office-based practice. Permission Statement This document may be downloaded from This document may be copied and distributed without permission.

2 MEDICATION USE PROCESS Chart The following information is always entered or confirmed as entered into the patient chart prior to any action that would result in a patient receiving a drug: patient s first and last name, address, telephone number, date of birth, and gender. Any action includes issuing a new prescription, renewal of a prescription or refills between office visits. The following information is always entered into the chart at each patient encounter (visit or phone call) when a change occurs: co-morbid and/or chronic conditions, pregnancy and lactation status, allergies, height, weight, smoking status and alcohol consumption.,, Patients should be surveyed to update their health history and demographic information in their chart at least annually. When a medication sample is given to a patient, the name and strength of the medication, instructions for use and the quantity or duration of therapy is always documented in the patient s chart. Therapeutic Decision Prescribers write prescriptions that are patient centered: the patient s lifestyle, frequency of use and cost are always considered. Prescribers expect to take the time necessary to answer questions that improve the safety of prescribing. Questions or concerns of pharmacists about prescription orders are always handled by the professional deemed most appropriate by the pharmacist making the request. If the pharmacist requests to speak to the prescriber, this is honored. 4,5 When a new medication is initiated that is either contraindicated or dose-adjusted based upon renal or hepatic function, this is assessed and entered into the chart. 6, 7 The medication history obtained from patients and entered into the chart includes prescription medications, over-the-counter medications, vitamins, herbal products, dietary supplements, alternative medicines and homeopathic medications. Prescribing When giving prescription orders over the telephone, the individual telephoning in the order specifically informs the pharmacy about co-morbid conditions, allergies, patient s weight, date of birth, and the indication for use. 8 Kimberly A. Galt Pharm. D. and Ann M. Rule Pharm. D. 004 Creighton University Health Services Research Program

3 MEDICATION USE PROCESS Transmission of Prescription Orders When telephone orders are given, the pharmacist is always requested to repeat it back for verification. 9 When telephoning prescription orders in to a pharmacy, individuals always request to speak with a pharmacist. Dispensing A prescription label for medication samples is prepared each time a sample is given to the patient to take home. Counseling Medication counseling given to the patient/caregiver includes the drug name, purpose, dose, directions for use, expected outcomes, risks and, 0- safety outcomes. Written information is given about medications prescribed by this office. Patients are encouraged to speak with their pharmacist for further information about their prescribed medications. 4,8 Patients are encouraged to ask us questions about the medications they are receiving. Patients are taught how to use and maintain any devices they get from the clinic as well as being provided with written information. Patients are encouraged to speak with their pharmacist for further education regarding the use and care of any devices. 4,8 If a patient is hearing impaired, information: is provided in writing. is provided to family members accompanying patient. is provided by sign language if necessary. by use of a relay phone system. 4 Patients who are hearing impaired are given the TDD (telecommunications device for the deaf) telephone number for the office. 4 Patients are provided language-appropriate written information about drugs to patients who do not speak English. If a patient is visually impaired, information is provided to family members accompanying patient. Kimberly A. Galt Pharm. D. and Ann M. Rule Pharm. D. 004 Creighton University Health Services Research Program

4 MEDICATION USE PROCESS Counseling If a patient has language barriers, information: is provided via interpreter. is provided in writing in the patient s language. is provided to family members accompanying patient. If the patient is illiterate, information is provided verbally with adequate time for the patient and family to ask questions. Prescription Renewal The patient s chart is always reviewed prior to prescription renewal. There is a method for patients to have their prescriptions renewed after hours/when the clinic is closed. The on-call physician notifies the clinic when a prescription renewal has occurred for one of the patients after hours. Only a qualified health professional (physician, nurse, physician assistant, nurse practitioner, or pharmacist) is allowed to phone refill prescriptions for patients. On-call physicians should not renew prescription for patients who are not in their care. Memo Kimberly A. Galt Pharm. D. and Ann M. Rule Pharm. D. 004 Creighton University Health Services Research Program

5 OFFICE ENVIRONMENT Adequate time is allocated to counsel patients about medications in this office. Drug information resources are kept up to date. Drug information resources are adequate in scope, breadth and depth to answer medication related questions. Drug information resources are easily accessible at the point of care. Examples of easily accessible locations for drug information resources are: centrally accessible location outside the patient exam room, in each patient encounter room, and/or accessible via an easily accessible 0,, 5-7 computer or handheld computer. The current medication sample inventory is reviewed monthly to remove expired products. When a new sample item is added to the clinic s drug inventory, we check to see: if its name looks or sounds like other products it might be confused with. if its packaging looks similar to other products it might be confused with. if the storage location we are choosing is away from products it might be confused with. if its storage location is away from packages of the same drug with different routes of administration. if it is shelved so that their labels face forward and are readable. 8 Practitioners and other staff report and openly discuss errors without 0,, 5-7, 9 undo embarrassment or fear of reprisal from clinic management. Sample medications should be stored in a locked medication storage room or cabinet. 8 Sample medications that require refrigeration should be stored in a medication-only refrigerator. Sample medications for clinic use should be stored in an area separate from medications used in the clinic. Sample medications should be arranged alphabetically by name. The current inventory of medications for clinic use is reviewed on a monthly basis to remove expired products. Kimberly A. Galt Pharm. D. and Ann M. Rule Pharm. D. 004 Creighton University Health Services Research Program

6 OFFICE ENVIRONMENT When a new medication for clinic use is added to the clinic s drug inventory, we check to see: if its name looks or sounds like other products it might be confused with. if its packaging looks similar to other products it might be confused with. if the storage location we are choosing is away from products it might be confused with. if its storage location is away from packages of the same drug with different routes of administration. if it is shelved so that their labels face forward and are readable. Medications for clinic use are stored in a locked medication storage room or cabinet. Medications for clinic use that require refrigeration are stored in a medication-only refrigerator. Medications for clinic use should be stored in an area separate from medication samples.they should be arranged alphabetically by name and stored in a locked room or cabinet. Patient care areas are clean, orderly and free from distractions and excessive noise. The clinic has adequate space for storage of drugs and drug supplies. When obtaining information from pharmaceutical representatives, the following questions are always asked: are there any other products that have a name that look or sound similar? are there any other products that have packaging that looks similar? Management actively demonstrates its commitment to patient safety. 9 This clinic keeps patient safety in mind when deciding on whether or not to offer new or expanded services. Memo Kimberly A. Galt Pharm. D. and Ann M. Rule Pharm. D. 004 Creighton University Health Services Research Program

7 ERROR MANAGEMENT When medication errors or adverse reactions come to the attention of the clinic staff, the following takes place: staff involved with the error or adverse reaction review the circumstances involved. entire staff are provided with service education and training. policies and procedures are reviewed and revised if necessary to prevent a reoccurrence. Prescribers and clinic staff involved in serious errors that caused a patient harm are offered psychological counseling as well as emotional support by their colleagues. Staff who are directly involved in a serious or potentially serous medication error participate in analyzing those failures in the system that allowed the error to happen and are encouraged to recommend system enhancements to reduce the potential for errors. As a matter of practice, medication errors and ways to avoid them are openly discussed between prescribers and clinic staff. Individuals are not dismissed from employment because of a medication error in this office. 9 Prescribers and nurses receive ongoing information regarding medication errors occurring within the organization, error-prone situations, errors occurring in other clinics, and strategies to prevent such errors. 9 Ongoing information regarding medication errors is communicated to staff members: verbally at the time of the medication error. by written communication. at regularly scheduled clinical staff meetings. Reference to errors is not included in employee personnel files. 9 Errors are not considered as a performance measure during either annual performance appraisals or during competency assessments. 9,0 Management provides positive incentives for individuals to report errors. Prescribers and clinic staff are reacted to in a positive manner for detecting and reporting errors. There is an integrated plan to detect, analyze and reduce medication errors in the clinic with at least one staff member responsible for the plan. 9 Kimberly A. Galt Pharm. D. and Ann M. Rule Pharm. D. 004 Creighton University Health Services Research Program

8 ERROR MANAGEMENT The patient care process is specifically evaluated for opportunities to reduce errors at least annually. 9 Clear definitions and examples of medication errors and hazardous situations that should be reported have been established for use in this clinic. A formal system is in place for reporting hazardous situations that could lead to an error. A formal system is in place for reporting actual errors. Near misses that have potential to cause harm are given the same high priority for analysis and error prevention strategies as errors that actually cause patient harm. 0 Prescribers use published error experiences from their organization to proactively target improvement in the prescribing process. Prescribers report to external voluntary reporting programs such as the USP Medication Errors Reporting Program, FDA MedWatch or the CDC Vaccine Adverse Reaction Reporting Program. If the prescriber discovers that an error has led to improper medication prescribing regardless of the level of harm that results, the error is disclosed to the patient/caregiver/family. Memo Kimberly A. Galt Pharm. D. and Ann M. Rule Pharm. D. 004 Creighton University Health Services Research Program

9 WORKPLACE CONDITIONS This clinic keeps workload issues in mind when deciding on whether or not to offer new or expanded services. Clinic staff have time to eat a well-balanced meal (i.e. lunch or dinner) during a work day. An effective back-up plan is in place for days when staffing is short due to illness, vacation, educational absences, and fluctuations in workload. Staffing patterns in the clinic are adequate to provide safe patient care on most days. Patient volume data is examined periodically to determine appropriate staffing levels, even during peak times when demand is highest. The level of physician staffing is adequate to meet our patient care needs. The staff in this office works on how to make our work flow more smoothly. The number of non-physicians on duty is usually sufficient to meet patient care needs. This office has adequate administrative support (for example: support drug sample inventory control and ordering, scheduling and computer upgrades). The flow of work in this office is very well organized. Primary care providers are rarely interrupted when working with a patient or with another health care provider. It is possible to adjust the volume on the clinic telephones. Lighting is adequate for your work needs in the clinic. 8 The clinic staff perceives the temperature and humidity in the office to be comfortable. There is a specific effort made in the clinic environment to reduce work related stress. Schedules and workload permit prescribers to take at least one 0-minute break per shift of work each day. Kimberly A. Galt Pharm. D. and Ann M. Rule Pharm. D. 004 Creighton University Health Services Research Program

10 WORKPLACE CONDITIONS In general, communication of important information in this office is very good. Those who train new staff have their workload reduced in other areas so they can accomplish the goals of orientation. The length of time for orienting new clinic staff is individualized and based on an ongoing assessment of their needs. Memo Kimberly A. Galt Pharm. D. and Ann M. Rule Pharm. D. 004 Creighton University Health Services Research Program

11 SAFETY EDUCATION Prescribers and clinic staff are trained about appropriate procedures in the event of a serious medication error. All office staff, including physicians, physician assistants, nurse practitioners, nursing staff and office assistants attend educational programming on ways to avoid medication errors at least annually. The clinic staff received education about important drug safety issues on a regular basis as well as after a medication safety event or near-miss. New clinic staff underwent a period of training and evaluation of their knowledge, skills and performance prior to participating independently in patient care activities. Clinic staff received training on the proper use and maintenance of devices used in the clinic (e.g., glucose monitors, humidifiers, spacers used with inhalers, etc.) in a structured manner such as vendor presentation at the clinic or on-the-job training by a qualified clinic colleague. During orientation, clinic staff was taught strategies designed to reduce the risk of errors. When temporary agency staff was used, they have undergone appropriate training and orientation. Each staff member is assessed on skills and knowledge related to safe medication practices at least annually. The non-physicians are competent and well-trained for their jobs. SAFETY PERCEPTIONS A systematic process that proactively identifies/screens for contraindications or precautions to medications for patients before prescribing a new medication or renewing an existing medication for a patient is in place. PATIENTS Patients are provided with the clinic s telephone number Kimberly A. Galt Pharm. D. and Ann M. Rule Pharm. D. 004 Creighton University Health Services Research Program

12 REFERENCES. Bates DW, Cullen DJ, Laird N, Petersen LA, Small SD, Servi D, et al. Incidence of adverse drug events and potential adverse drug events: implications for prevention. JAMA. 995:74:9-4.. Gandhi TK, Burstin HR, Cook EF, Puopolo AL, Haas JS, Brennan TA, et al. Drug Complications in Outpatients. J Gen Intern Med. 000:5: U.S. Pharmacopeia. Statement of Scientific Policy, Council of Experts Information Executive Committee: Guiding Principles Supporting Appropriate Drug Use at the Patient and Population. [updated 00 March ]. Available at: Principles.html. [Accessed /4/04]. 4. Beney J, Bero LA, Bond C. Expanding the roles of outpatient pharmacists: effects on health services utilization, costs and patient out comes (Cochrane Review). In: The Cochrane Library, Issue, 004. Chichester, UK: John Wiley & Sons, Ltd. 5. Folli HL, Poole RL, Benitz WE, Russo JC. Medication error prevention by clinical pharmacists in two children s hospitals. Pediatrics. 987;79: Kelly WN. Potential risks and prevention. Part : Fatal adverse drug events. Am J Health Syst Pharm. 00;58: McDonnell PJ, Jacobs MR. Hospital admissions resulting from preventable adverse drug reactions. Ann Pharmacother. 00;6: Kaushal R, Bates DW.The Clinical Pharmacist s Role in Preventing Adverse Drug Events. Chapter 7 in: Making Health Care Safer:A Critical Analysis of Patient Safety Practices. Markowitz AJ, editor. Rockville (MD):Agency for Healthcare Research and Quality Publication 0-E058; July 0, Joint Commission on Accreditation of Healthcare Organizations. 004 Comprehensive Accreditation Manual for Ambulatory Care (CAMAC). Oakbrook Terrace, IL: Joint Commission on Accreditation of Healthcare Organizations; Massachusetts Coalition for the Prevention of Medical Errors. MHA best practice recommendations to reduce medication errors. Available at: documents/best_practice_medication_errors.pdf. [Accessed /8/04]..The Massachusetts Coalition for the Prevention of Medical Errors.Your Role in Safe Medication Use Consumer Guide. Available at: [Accessed /8/04].. Joint Commission on Accreditation of Healthcare Organizations. 004 Comprehensive Accreditation Manual for Hospitals:The Official Handbook (CAMH). Oakbrook Terrace, IL: Joint Commission on Accreditation of Healthcare Organizations; American Society of Hospital Pharmacists. ASHP Guidelines on Preventing Medication Errors in Hospitals. Am J Hosp Pharm. 99:50: Iezzoni LI, O Day BL, Killeen M, Harker H. Communicating about health care: observations from persons who are deaf or hard of hearing. Ann Intern Med. 004;40: Leape LL, Bates DW, Cullen DJ, Cooper J, Demonaco HJ, Gallivan T, et al. Systems Analysis of Adverse Drug Events. JAMA. 995; 74: Cohen MR,Anderson RW,Atfilio RM, Green L, Muller RJ, Pruemer JMPreventing Medication Errors in Cancer Chemotherapy.Am J Health-Syst. Pharm. 996; 5: Leape LL, Cullen DJ, Clapp MD, Burdick E, Demonaco HJ, Erickson JI, et al. Pharmacist participation on physician rounds and adverse drug events in the intensive care unit. JAMA. 999 Jul ; 8(): American College of Physicians [homepage on the Internet]. Safety and Medication Samples. Available from: [Accessed /4/04]. 8. Pizzi LT, Goldfarb NI, Nash DB. Promoting a Culture of Safety. Chapt. 40 in: Making Health Care Safer:A Critical Analysis of Patient Safety Practices. Markowitz AJ, editor. Rockville (MD): Agency for Healthcare Research and Quality Publication 0-E058; July 0, Wald H, Shojania KG. Incident Reporting. Chapt. 4 in: Making Health Care Safer: A Critical Analysis of Patient Safety Practices. Markowitz AJ, editor. Rockville (MD): Agency for Healthcare Research and Quality Publication 0-E058; July 0, Cullen D, Bates D, Small S, Cooper J, Nemeskal A, Leape L.The incident reporting system does not detect adverse events: a problem for quality improvement. Jt Comm J Qual Improv. 995:: Barach P, Small S. Reporting and preventing medical mishaps: lessons from non-medical near miss reporting systems. BMJ. 000; 0: Kimberly A. Galt Pharm. D. and Ann M. Rule Pharm. D. 004 Creighton University Health Services Research Program

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