Institute for Safe Medication Practices

Part I - Patient Information

Core distinguishing characteristic # 1: Essential patient information is obtained, readily available in useful form, and considered when dispensing medications.

1. Basic patient information (patient's first and last name, address, home telephone number, alternate contact number, gender, physician's name) is gathered and entered into the computer for every patient before dispensing a prescription.

2. The patient's birth date (or age updated regularly) is gathered and entered into the computer for every patient before dispensing a prescription.

3. A drug history, including vitamins, prescription medications, and over-the-counter medications is obtained for patients when initially encountered (via a questionnaire or other means) and entered into the computer system.

4. A history of the use of herbal products, dietary supplements, homeopathic medications and alternative medicines is obtained for patients when initially encountered (via a questionnaire or other means) and entered into the computer system.

5. Basic information about comorbid and/or chronic conditions (e.g., diabetes, hypertension, renal or liver impairment, pregnancy, lactation, etc.), allergies, height and weight is obtained when the patient is initially encountered (via a questionnaire or other means) and entered into the computer system.

6. Patients in the pharmacy database are sent an annual survey to update clinical and demographic information in the computer system. (FAQ)

7. When taking orders over the telephone, the prescriber (or designee) is specifically queried about comorbid conditions, allergies, and the patient's weight.

8A. A pharmacist enters clinical information including allergies into the computer system and properly codes the information to allow computer screening.

OR (Respond to 8A or 8B only)

8B. If a technician enters clinical information including allergies into the computer system, a pharmacist verifies that the information is accurate and that the names of allergens are spelled correctly and properly coded to allow computer screening.

9. Prescription orders cannot be entered into the pharmacy computer system until the patient's allergies (or "no known allergies") have been properly entered and coded (patient allergies is a required field).

10. Recent patient-specific clinical data such as blood glucose levels, liver enzymes, renal function, blood pressure, and cholesterol levels are available to pharmacists to support clinical drug monitoring. (FAQ)

11. Pharmacists routinely consider the need for dose adjustments for medications that may be toxic based upon specific recent clinical data available (e.g., patient with renal impairment is identified when prescribed a potentially toxic drug that is excreted by the kidney). (FAQ)

12. The clinical purpose of each prescription is ascertained before the medication is dispensed to assure that the prescribed therapy is appropriate for the patient's condition and to help distinguish medications with similar packaging and look-alike or sound-alike names.

13. A standard process is followed to help ensure that medications are being dispensed to the proper patient (such as saying patient's full name aloud, verifying the patient's name, address, phone number, etc.).

14. The pharmacy takes steps to understand cultural issues and overcome language barriers that are present in the population of patients served.

15. The pharmacy takes steps to effectively communicate with patients who are visually or hearing impaired.

Part II - Drug Information

Core distinguishing characteristic # 2: Essential drug information is readily available in useful form and considered when dispensing medications.

16. Dispensing areas are well stocked with easily accessible, updated drug reference texts and all outdated texts are removed from use. (Texts are outdated after one year of publication or whenever the next edition is available.)

17. Pharmacy computers that are used for order entry allow seamless, easy access to the Internet to search for information about disease processes, drug dosing and availability, unusual uses of drugs, and other drug-related information.

18. A computerized drug information system (e.g., Drug Facts and Comparisons, Micromedex, AHFS Drug Information, USP DI, other reputable sources) is available on each order entry computer and requires minimal effort and time to access.

19. Pharmacists who are dispensing prescriptions have easy access to a drug information center staffed with a clinical pharmacist to answer questions during all hours of operation.

20. The computer system automatically performs adult dose range checks and warns practitioners about overdoses and underdoses for targeted high-alert or narrow therapeutic index medications and for most other drugs.

21. The computer system automatically performs pediatric dose range checks and warns practitioners about overdoses and underdoses for targeted high-alert or narrow therapeutic index medications and for most other drugs.

22. The computer system warns practitioners about clinically significant drug interactions. (FAQ)

23. The computer system automatically screens and detects drugs to which patients are allergic (including cross allergies) and provides a clear warning to staff during order entry.

24. All prescription orders are entered into a computer and screened electronically against the patient's current clinical profile for potential contraindications, interactions, duplications and appropriateness of frequency and dose before drugs are dispensed.

25. A pharmacist reviews clinically significant computer warnings of potential contraindications, even when a pharmacy technician initially enters prescriptions into the computer.

26. A pharmacist reviews clinically significant computer warnings of potential drug interactions, even when a pharmacy technician initially enters prescriptions into the computer.

27. A pharmacist reviews clinically significant computer warnings of potential drug duplications, even when a pharmacy technician initially enters prescriptions into the computer.

28. A pharmacist reviews clinically significant computer warnings of potential inappropriate frequency or dose, even when a pharmacy technician initially enters prescriptions into the computer.

29. Pharmacy staff tests the computer system at least twice annually to assure that maximum dose alerts are present for high-alert and narrow therapeutic index drugs and builds alerts for those that are not present or provides feedback to corporate level staff or drug information system vendors when appropriate.

30. At least quarterly, an updated interactive database for the pharmacy computer system is received from a drug information vendor and loaded into the system.

31. The pharmacy computer system warns staff when a new drug has been entered for which there is no screening information in the interactive database.

32. A designated pharmacist or corporate level staff routinely reviews, for quality improvement purposes, reports of computer warnings that are overridden by pharmacists.

33. The pharmacy computer system maintains ongoing patient profiles, which include basic demographic and clinical information and drug therapy records for each episode of care at the pharmacy. (Purging of information beyond the mandated state or third party minimum for retention, or after two years, whichever is sooner, is acceptable.)

Core distinguishing characteristic # 3: The inventory system promotes safe use of new drugs added to the inventory and limits choice to minimize the variety of brands and dosage forms with which practitioners must be familiar.

34. At least quarterly, current drug inventory on shelves is reviewed and reduced as appropriate to minimize duplication of generically equivalent products.

35. The variety of manufacturers from whom generic drugs are purchased is minimized to the fullest extent possible.

36. When a new item is added to the pharmacy inventory, the potential for error with that drug (e.g., sound-alike names, look-alike packaging, complex instructions for patients, confusing dosing parameters, rigorous clinical monitoring requirements, etc.) is evaluated. Published medication error features in journals or newsletters are used to supplement the evaluation process.

37. When new drugs with heightened error potential are identified, safety enhancement(s) (e.g., check systems, alert labels, reminders, limitations on use, sequestered storage and location, etc.) are established before initial use.

38. After a drug is on the market for several months, a staff or corporate level pharmacist is assigned responsibility to determine if medication errors or adverse reactions have been reported internally or externally since product launch, and safety enhancements are established in the pharmacy as necessary.

Part III - Communication of Drug Orders and Other Drug Information

Core distinguishing characteristic # 4: Methods of communicating prescription orders and other drug information are standardized and automated to minimize the risk for error.

39. The pharmacy is able to receive prescriptions sent electronically from the physician's office (e.g., from a hand-held device or computer) to a pharmacy computer in a standard format. (FAQ)

40. To avoid handwritten prescriptions, prescribers served by the pharmacy use an office computer or handheld device to print, fax or electronically transfer prescriptions to the pharmacy.

41. If the prescription is received on paper, scanning and prescription imaging is used in the dispensing process to show the original prescription on the computer screen.

42. A list of prohibited, dangerous abbreviations (e.g., "U" for units, etc.) and error-prone dose designations (e.g., using trailing zeros for whole number doses, or lack of using a leading zero for doses less than one, etc.) is established for internal communication and documentation of drug information or prescription orders, computer systems and pharmacy labels.

43. "Sig" codes used by pharmacists and technicians during order entry are standardized in each pharmacy (and throughout a chain of stores) and reviewed regularly to evaluate error potential. (FAQ)

44. At least annually, feedback is provided to the community of physicians to educate them about unsafe prescription writing practices (e.g., use of dangerous abbreviations and dose designations, handwriting that could or has resulted in confusion over a drug's identity, improper dose expressions, serious drug interactions, etc.). (FAQ)

45. The pharmacy has established a list of drugs (e.g., controlled substances, selected high-alert drugs, etc.) for which telephone prescriptions cannot be accepted from the prescriber's clerical office staff.

46. Telephone or voice mail prescription orders are received directly by a pharmacist (or pharmacy student listening along with the pharmacist) and written down immediately on a pharmacy prescription blank (not on scrap paper which requires an added transcription step).

47. When telephone orders must be taken, the pharmacist receiving the order repeats it back to the prescriber for verification. If voice mail prescriptions are accepted, a pharmacist verifies incomplete or unclear prescriptions directly with the prescriber.

48. Telephone orders communicated by unauthorized or nonprofessional staff are not permitted and a pharmacist verifies incomplete or unclear prescriptions directly with the prescriber.

49. Pharmacists have a clear, written policy to guide the process that should be followed to resolve conflicts easily and effectively when prescribers do not agree with their expressed concerns about the safety of an order.

50. A formal review process has been established to assess and clarify any unusual drugs, unusual doses, and unusual uses of drugs before pharmacists dispense the medication.

51. The pharmacist who initially investigates an unusual drug, dose, or indication easily communicates his/her conclusions to other pharmacy staff by writing an informative and clearly visible note on the patient's drug profile, prescription, or computerized order.

Part IV - Drug Labeling, Packaging and Nomenclature

Core distinguishing characteristic # 5: Strategies are undertaken to minimize the possibility of errors with drug products that have similar or confusing manufacturer labeling/packaging and/or drug names that look and sound alike.

52. Pharmacists regularly review current professional literature (at the corporate level also, if applicable) to identify drug labeling, packaging, and nomenclature problems and action is taken to prevent errors with these drugs.

53. Pharmacists regularly examine the package and label of new drugs that are being considered for inventory addition (at the corporate level also, if applicable) to identify any potential for confusion.

54. When two different products exist that have dangerously similar labeling/packaging, a conscious effort is made by the pharmacy (and corporate purchasing staff, if applicable) to seek an alternate manufacturer for one of the products.

55. Special alerts are built into the computer as necessary to remind practitioners about problematic or look-alike drug names, packaging, or labeling.

56. Auxiliary warnings, labels with exaggerated fonts, or other label enhancements are used on packages and storage bins of drugs with problematic names, packages, and labels.

57. When drugs have the same name but different routes of administration (e.g., ophthalmic vs. otic), steps are taken (e.g., auxiliary labels, change in storage location, purchase from different manufacturer, notation in the computer, etc.) to prevent dispensing errors.

58. Products with known look-alike drug names are stored separately and not alphabetically, or are otherwise clearly differentiated from one another if they remain next to each other.

59. Computer mnemonics are designed to minimize selection of the wrong medication or strength (e.g., arranged to prevent look-alike drug names from appearing in alphabetical order on the computer screen at the same time, or differentiated from one another through use of font enhancements on the computer screen, etc.).

Core distinguishing characteristic # 6: Prescription labels clearly identify the patient, product, directions for use, the dispensing pharmacy, and any other important information that the patient may need to take the medication accurately and safely.

60. A prescription label is generated from a laser printer with font enhancements used for critical information such as name of drug and dose.

61. The pharmacy computer system produces clear and distinctive labels that are free of abbreviations or dose expressions that may not be easily understood by a patient.

62. All prescription labels include the expiration date or beyond use date.

63. The pharmacy uses appropriate foreign language labels for patients who need them.

64. Appropriate labels are used for the visually impaired (e.g., larger font, Braille, etc.).

65A. The pharmacy computer system automatically prints appropriate auxiliary labels (e.g., for the ear, for the eye, take with milk, etc.) when prescription labels are generated.

OR (Respond to 65A or 65B only)

65B. During prescription order entry, the pharmacy computer system suggests appropriate auxiliary labels to be affixed manually prior to dispensing.

66. If the prescriber provides the purpose of the medication on the prescription, the indication is included on the patient's prescription container label.

Part V - Drug Standardization, Storage and Distribution

Core distinguishing characteristic # 7: Prescribed medications are accessible to patients and dispensed in a safe and secure manner.

67. When patients have a legitimate need for prescription medications, but have exhausted their supply while traveling, lost their medications, or cannot afford them, all pharmacists are empowered to take appropriate action to ensure that critical doses are not missed.

68. There is an efficient and timely process in place to obtain critically needed medications when they are not immediately available in pharmacy stock to dispense prescriptions.

69. A mechanism exists to identify the reasons that a prescription has not been picked up after being prepared.

70A. An on-call pharmacist is available to come back to the pharmacy if needed to fill crucial prescriptions, or there is another 24-hour pharmacy (same ownership not required) available to patients in the community served within 30 minutes driving distance from the pharmacy.

OR (Respond to 70A or 70B only)

70B. The pharmacy is open 24-hours a day, seven days a week.

71. Records are available to identify patients receiving a drug that is recalled by the manufacturer and patients are notified as appropriate.

Core distinguishing characteristic # 8: Medications and other necessary drug supplies are stored, dispensed, and returned to stock in a manner that reduces the likelihood of an error.

72. Drug inventory is organized according to frequency and volume of use to separate less frequently used doses from those dispensed more frequently (e.g., two dosage strengths of the same medication are separated if one strength is used predominantly).

73. Access to targeted high-alert medications such as anticoagulants and oral hypoglycemic drugs, and other problem products, has been safeguarded through constraints (such as drug placed in locked area, removal from "fast mover" areas where it might be "grabbed" incorrectly, etc.) to reduce the potential for dispensing errors. (FAQ)

74. Medications are rotated in the "fast mover" area(s) to reduce the risk of error due to familiarity with placement on shelves.

75. Medication container labels face forward when stored upon shelving.

76. When stocking shelves, staff ensures that wholesaler price labels do not interfere with critical drug information on the manufacturer's label.

77. To guide selection of the proper drug, a computer graphic appears on the screen with each prescription to show the appearance of the product.

78. An automated dispensing system that incorporates robotics and/or bar code verification systems is used to support the dispensing system in the pharmacy.

79. If completed prescriptions are not ultimately dispensed to patients, the medications are returned to stock in a consistent manner that reduces the 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; returned to stock bottles after one individual pulls the appropriate stock bottles and another verifies accuracy via visual examination of the labels and products in each container, etc.).

Core distinguishing characteristic # 9: Hazardous drugs and chemicals are safely sequestered and not accessible in drug preparation areas.

80. Bulk chemicals used in the pharmacy for compounding are assessed at least annually and those that are not regularly used or considered dangerous are eliminated from stock.

81. Bulk chemicals used in the pharmacy for compounding are clearly labeled with contents, the date the product was first opened, and the manufacturer's expiration date (if applicable).

82. Pharmacy does not store chemical substances (e.g., formalin, methanol, etc.) for distribution to a laboratory, doctor's office or hospital.

83. Non-drug supplies such as alcohol are not stored or placed near diluents and products that require reconstitution.

84. All topical substances, caustics, and other non-drug substances are clearly labeled and stored separately from all other medications and supplies in the pharmacy's drug inventory.

85. To reduce the potential for mishaps, pharmacy prescription bottles and labels are not used to package non-drug substances (e.g., liquid chemicals, cleaning compounds, insecticides, soaps, etc.).

86. 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.

Part VI - Use of Devices

Core distinguishing characteristic # 10: Sanitary practices are followed when using devices and equipment to store and prepare medications.

87. Staff members use gloves or proper hand washing when handling individual loose oral solid products (e.g., capsules, tablets, etc.). (FAQ)

88. Staff members use appropriate hand washing procedures prior to compounding any prescription products (e.g., liquids, ointments, capsules, etc.).

89. Dispensing devices (e.g., counting trays, mortar and pestle, etc.) are washed after being used to prepare chemotherapy, penicillin, sulfonamide, opiate, or NSAID prescriptions.

90. Only clean (washed) measuring devices are used for compounding liquids, ointments and capsules.

Part VII - Environmental Factors

Core distinguishing characteristic # 11: Medications are prepared and dispensed in a safe and orderly physical space and in an environment that allows practitioners to remain focused on medication use without unnecessary distractions.

91. Lighting at points where prescriptions and product labels must be read and verified is perceived by pharmacy staff as adequate for their needs at all times during a work shift so that labels and other important information can be read clearly.

92. To meet their needs, pharmacy personnel are able to adjust the lighting at points in a workstation where prescription information and product labels must be read and verified.

93. Temperature and humidity are comfortable for workers.

94.Temperature and humidity conform to drug storage requirements.

95. To minimize distractions, all telephone calls to the pharmacy are electronically or manually triaged and forwarded to the dispensing area only when necessary.

96. Pharmacy telephones have adjustable volume to decrease confusion among sounds.

97. To minimize staff interruptions and enhance the workflow, technology such as fax machines, voice mail, touch tone telephone prompts, and e-mail is used by patients to request refills.

98. Areas where drug orders are transcribed and/or entered into computer systems are isolated and relatively free of distractions, noises, and unnecessary chatter.

99. The physical layout of the pharmacy is designed to minimize distractions for pharmacists during the final check in the prescription verification process.

100. The pharmacy has adequate space for storage of drugs and drug supplies.

101. Workspaces where medications are prepared are clean, orderly, and free of clutter.

102. When filling multiple prescriptions for one patient, work in progress is not clustered together but is separated by dividers, baskets, or other means to ensure that prescriptions are not mixed up.

103. 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 (including dangerous medications that require refrigeration and segregation from other medications).

104. Management efforts to control distractions and work-related stress experienced by staff are visible to front line pharmacists and technicians (e.g., pharmacy management has reasonably done what it can to reduce distractions, interruptions, time spent with adjudication requirements from third parties and pharmacy benefits managers, etc.).

105. In the past year, an educational program on stress management has been provided to staff.

106. An employee assistance program is available and participation is encouraged to help staff who are experiencing stress that may affect work performance.

Core distinguishing characteristic # 12: The processes and flow of work have been designed to enhance safety and worker efficiency.

107. Pharmacy management provides proper balance between operational objectives (e.g., cost-containment, efficiency, productivity, turnaround-time, profit and loss, etc.) and pharmaceutical care responsibilities.

108. Pharmacists are able to maintain a safe balance between time spent in dispensing prescriptions and counseling patients compared to time spent with claims processors and pharmacy benefits managers in clarifying insurance claims and formulary coverage issues.

109. Plans for new and/or expanded services are well communicated to all affected personnel and appropriate consideration of resources is addressed prior to implementation so that the additional work volume will be met without compromising patient safety.

110. A consistent process, which is guided by written criteria, is used to prioritize the workflow so that prescriptions are filled in an order based upon the patient's clinical and educational needs, customer satisfaction, and the availability of qualified staff.

111. A predictive refill program anticipates the need for potential refills on daily medications that are current (no longer than 6 months since last prescription) to enhance the workflow.

112. The pharmacy utilizes an automated, off-site, centralized dispensing operation to help reduce workload at peak hours in the pharmacy.

113. When dispensing prescriptions, pharmacists and technicians work with one drug product at a time and affix the label to the patient's prescription container before working on the next prescription.

114. Pharmacy technicians assist pharmacists by performing routine functions within the scope of their training and as state law permits (e.g., insurance administration, prescription data entry, preparing prescriptions for dispensing, telephoning physician offices for refill authorization, etc.).

115A. A device is available and used to hold prescription information near the computer monitor, at eye level, in order to improve visibility when entering orders.

OR (Respond to 115A or 115B only)

115B. Prescriptions are scanned into the computer or received electronically via a hand held device or computer.

116. A magnifying box or lens is in a fixed location and used to facilitate readability of prescriptions and labels.

Core distinguishing characteristic # 13: The complement of qualified, well-rested practitioners and supportive staff matches the workload without compromising patient safety.

117. Pharmacy personnel undergo an annual physical examination, including eye and hearing screenings.

118. Pharmacy personnel are not sleep deprived.

119. Pharmacists work no more than 12 consecutive hours. Exception: isolated situations outside of usual operations.

120. Pharmacists have at least 8 hours of rest between shifts worked. Exception: isolated situations outside of usual operations.

121. Schedules and workload permit pharmacists to take at least one 15-minute break and one 30-minute break (for a meal) per shift of work each day. Exception: isolated situations outside of usual operations.

122. Pharmacy personnel have time to eat a well-balanced meal (i.e., lunch, dinner) during a work day.

123A. The pharmacy does not ask pharmacists to meet a specific quota for prescription dispensing or track pharmacy productivity via prescription dispensing rates.

OR (Respond to 123A or 123B only)

123B. If prescription quotas are suggested and tracked, the pharmacy considers available technology, technician support, workflow efficiency, patient counseling needs and appropriate staff breaks when determining quotas.

124. An effective back-up plan has been established for days when staffing is short due to illness, vacation, educational absences, and fluctuations in workload.

125. Staffing patterns in the pharmacy are adequate to provide safe pharmaceutical care on most days.

126. When temporary agency staff are used, they have been properly oriented and trained in the particular pharmacy environment.

127. Technician and pharmacist staffing (or pharmacy student, intern or resident) takes into account use of supportive dispensing technology and prescription volume, and pharmacist/technician ratios are ideally suited to minimize dispensing errors.

128. Prescription volume data is examined periodically to determine appropriate staffing levels, even during peak times when demand is highest.

Part VIII - Staff Competency and Education

Core distinguishing characteristic # 14: Practitioners and support staff receive sufficient training and orientation to the dispensing process and undergo baseline and annual evaluation of knowledge and skills related to safe medication practices.

129. All new pharmacy staff undergo a period of supervision, training, observation while performing typical functions, and evaluation of skills and knowledge before participating independently in dispensing activities.

130. Those who train new staff have a significantly reduced workload to accomplish the goals of orientation safely and thoroughly.

131. The length of time for orienting new pharmacists, technicians, and management staff is individualized and based on an ongoing assessment of their needs.

132. 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.

133. During orientation, pharmacists and technicians are educated about system-based strategies to reduce the risk of such errors.

134. At least annually, a supervisor evaluates each pharmacy staff member to assess his/her skills and knowledge related to safe medication practices.

Core distinguishing characteristic # 15: Practitioners are provided with ongoing education about medication error prevention and the safe use of drugs and devices that have the greatest potential to cause harm if misused.

135. Pharmacists and technicians are educated about new drugs added to the pharmacy inventory (e.g., via email messages, package insert placed in mailbox, written memo or alert, drug monograph, etc.), and any associated guidelines, restrictions, and special precautions are understood before the drugs are dispensed.

136. Pharmacy staff is sufficiently trained on the proper use and maintenance of devices dispensed from the pharmacy (e.g., glucose monitors, humidifiers, spacers used with inhalers, etc.).

137. 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.

138. Medication errors and ways to avoid them are routinely discussed at staff meetings and in conversations between pharmacists, technicians, and managers.

139. At least annually, pharmacists and technicians are provided with a live educational program on ways to avoid errors with high-alert drugs and narrow therapeutic index drugs and other problem products.

140. 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.

141. Pharmacy management supports educational programs for staff, such as live continuing education courses, professional meetings, journal club or inservices on new drugs and/or important drug safety issues.

Part IX - Patient Education

Core distinguishing characteristic # 16: Patients are included as active partners in their care through education about their medications and ways to avert errors.

142. Adequate time is budgeted by management for patient counseling activities.

143. A suitable private area with minimal distractions is available to provide patient counseling.

144. Patients are encouraged to ask questions about the medications they are receiving.

145. Clerks fully disclose the intent of the proof of counseling log before asking patients or caregivers to sign the log.

146. Criteria have been established (e.g., targeted high-alert drugs, high-risk patient populations) to trigger required medication counseling and a system is in place to alert the pharmacist of this need when the patient comes in to pick up the prescription (e.g., bold alert on the bag, etc.). (FAQ)

147. In as confidential a manner as possible, pharmacists inquire about the patient's understanding of the purpose of new medications and refilled prescriptions.

148. In as confidential a manner as possible, a pharmacist provides medication counseling to the patient/caregiver to educate them about the name of the drug, its purpose, the prescribed dose, directions for use, the expected benefits and potential risks, and important safety concerns before dispensing all new prescriptions.

149. When counseling is provided, the patient's drug container is opened in front of the patient/caregiver to verify the appearance of the medication.

150. Patients are informed about the potential for error with drugs that have been known to be problematic (e.g., look-alike names, warfarin drug interactions, etc.) and are provided with strategies to help prevent such an occurrence.

151. A pharmacist offers counseling to patients who receive high-alert or potentially problematic over-the-counter drugs (e.g., insulin, high concentration steroid creams, etc.).

152. Pharmacists fully investigate all patient/caregiver concerns (e.g., affordability, inability to swallow, difficulty adhering to directions, etc.) and questions about a medication prior to dispensing."

153. Cultural issues that may effect compliance with prescribed therapy are identified and considered when counseling patients about their medications.

154. Patients are provided with the pharmacy's telephone number and the number of an on-call pharmacist or a 24-hour pharmacy if a pharmacist on site cannot be reached after hours for an emergency, and patients are told to call for any concerns or questions about their drug therapy after they leave the pharmacy.

155. When dispensing oral liquid medications for children or geriatric patients, a proper measuring device is provided (e.g., dropper) or suggested (e.g., oral syringe) and caregivers are instructed on its use to measure the prescribed dose.

156. Doses that require splitting tablets are dispensed only to patients who have demonstrated their ability to manipulate the dose properly. Otherwise, the pharmacist seeks authorization for an appropriate tablet strength from payers that mandate tablet splitting for economic reasons, or splits the doses before dispensing the drug if necessary.

157. Patients are instructed on the proper use and maintenance of any devices dispensed from the pharmacy (e.g., glucose monitors, humidifiers, spacers used with inhalers, etc.).

158. If someone other than the patient or caregiver picks up the prescription, a reasonable effort is made to contact the patient directly to provide medication counseling (e.g., call the patient at home, written suggestion placed in or on the bag for the patient to call the pharmacy for counseling, etc.).

159. Patients are provided with up-to-date, useful, written information about drugs that they are receiving.

160. Useful written information about drugs is available to patients in the community who do not speak English.

161. Pharmacists design drug administration schedules (in cooperation with the patient's physician as necessary) that consider the patient's lifestyle and minimize the number of times per day that medications must be taken for patients at high risk for non-adherence with prescribed medications.

162. The pharmacy or its personnel develops and conducts at least one annual educational program or other proactive public health effort designed to improve safe use of medications in the community.

Core distinguishing characteristic # 17: Pharmacists establish and participate in community-based disease prevention and monitoring programs to promote health and ensure appropriate therapy and outcomes of medication use.

163. Pharmacists participate in clinical disease management programs for conditions such as asthma, hypertension, diabetes, or hypercholesterolemia.

164. In the past year, pharmacists have participated in at least one screening clinic locally to promote early detection of disease.

165. Pharmacists have participated in promoting, facilitating, and providing immunizations to the local community to improve public health.

Part X - Quality Processes and Risk Management

Core distinguishing characteristic # 18: A non-punitive, system-based approach to error reduction is in place and supported by pharmacy owners or senior management.

166. Error prevention strategies in the pharmacy target the system, not individual practitioners (e.g., in addressing problems, a change in the pharmacy's process or practice is sought, rather than focusing on the role of the specific individual(s) involved).

167. Practitioners and other staff report and openly discuss errors without undo embarrassment or fear of reprisal from pharmacy management.

168. Pharmacists and technicians are trained in the clinical and administrative procedures for responding to a serious medication error.

169. If the pharmacy discovers that an error has led to improper medication dispensing, regardless of the level of harm that results, the error is honestly disclosed to the patient/caregiver/family in a timely manner.

170. If the pharmacy discovers that an error has led to improper medication dispensing and self-administration, regardless of the level of harm that results, the error is honestly disclosed to the prescriber in a timely manner.

171. In the post-event process, no disciplinary action is taken against practitioners who make an error. Exceptions: malicious or illegal behavior that results in an error; drug diversion; chemical dependence; intentional breech of confidentiality; other egregious behavior.

172. No reference is made to errors in employees' personnel files, and errors are not considered as a performance measure during competency assessments and annual performance appraisals. Exceptions: malicious or illegal behavior that results in an error; drug diversion; chemical dependence; intentional breech of confidentiality; other egregious behavior.

173. Practitioners do not accumulate demerits or points for making a dispensing error.

174. In the individual pharmacy or for chains of pharmacies, error rates are not determined or calculated from practitioner error reports and are not used for internal (pharmacist-to-pharmacist) or external (pharmacy-to-pharmacy) comparisons.

175. Management provides positive incentives for individuals to report errors and pharmacists and technicians are thanked and praised for detecting and reporting errors.

176. Pharmacists and technicians are periodically and anonymously surveyed to determine their level of anxiety and fear with making and reporting errors.

177. Pharmacists and technicians involved in serious errors that cause patient harm are emotionally supported by their colleagues and offered psychological counseling.

178. Management actively demonstrates its commitment to patient safety (and safe medication practices) by approving a patient safety plan, encouraging pharmacist/technician error reporting, and supporting system enhancements, including technology, that are likely to reduce errors.

179. Specific medication safety objectives (e.g., staff reporting without fear of punishment; careful analysis of the system-based causes of errors, etc.), are included in the management's strategic plans, directly communicated to all staff, and acknowledged in a positive manner when met.

Core distinguishing characteristic # 19: Practitioners are stimulated to detect and report errors, and teams (or individual practitioners in small pharmacies) regularly analyze errors that have occurred within the organization and in other organizations for the purpose of redesigning systems to best support safe practitioner performance.

180. A clear definition and examples of medication errors and hazardous situations that should be reported has been established and disseminated to staff.

181. A formal system for reporting events in the pharmacy includes both hazardous situations that could lead to an error and actual errors including those that have been detected and corrected before they reach a patient.

182. One pharmacist in the individual pharmacy has responsibility for enhancing detection of medication errors, overseeing analysis of their causes, and coordinating an effective error reduction plan (with corporate support as applicable).

183. A trusted person facilitates at least one, annual, announced focus group for "off the record" discussions to learn about perceived problems with the dispensing system.

184. The dispensing system (e.g., drug procurement and storage, receipt of prescriptions, obtaining important patient information, prescription filling, patient education, monitoring the effects of drugs, etc.) is proactively assessed at least annually to identify potential risk factors that could lead to errors and system changes that would make it less likely for an error to reach a patient.

185. Staff who are directly involved in a serious or potentially serious medication error participate in analyzing those failures in the system that allowed the error to happen, and they are encouraged to recommend system enhancements to reduce the potential for future errors.

186. "Near misses" and hazardous situations that have the potential to cause patient harm are given the same high priority for analysis and error prevention strategies as errors that actually cause patient harm.

187. Management and staff pharmacists/technicians routinely read and use published error experiences from other organizations to proactively target improvements in the medication dispensing process.

188. Pharmacists and technicians are provided with regular feedback about errors reported in the pharmacy, hazardous situations, and error reduction strategies that are being implemented.

189. Pharmacists recognize the value of reporting to external reporting programs such as the USP-ISMP Medication Errors Reporting Program and the CDC Vaccine Adverse Event Reporting System.

190. Pharmacy management supports practitioner reporting to external reporting programs such as the USP-ISMP Medication Errors Reporting Program and the CDC Vaccine Adverse Reaction Reporting System.

Core distinguishing characteristic # 20: Simple redundancies that support a system of independent double checks or an automated verification process are used for vulnerable parts of the dispensing system to detect and correct serious errors before they reach patients.

191. For selected patient groups (e.g., pediatric patients and patients receiving drugs dosed according to age, weight or body surface area), a double check of the prescriber's calculated dose is made before preparing and dispensing the drug.

192A. Prescriptions are dispensed using the prescription order itself and the computer-generated drug label together, and a pharmacist compares the label and product with the original prescription before drugs are dispensed.

OR (Respond to 192A or 192B only)

192B. Where electronic prescribing (e.g., prescription sent electronically via computer/hand held device) is available and used, a pharmacist reviews the order in the computer before generating a label from which the drug order is filled.

193. A system that compares computer-generated NDC codes on prescription labels and NDC codes on manufacturer's containers is employed to verify that the appropriate drug has been selected and dispensed.

194. All completed prescriptions are checked and documented (with initials) by at least a pharmacist and one other person (pharmacist or technician) before being dispensed. Note: Pharmacists who work alone should answer A.

195. Both the medication base product and the mixing solution/diluent used for reconstituted products are checked and documented with initials on the prescription by at least a pharmacist and one other person. Note: Pharmacists who work alone should answer A.

196. A pharmacist verifies all over-the-counter insulin with the patient/caregiver before the product is dispensed.

197. On a daily basis or more frequently, a pharmacist compares the previous day's prescription orders listed on a computer-generated printout with hard copies of the prescriptions to verify accuracy.

198. Pharmacists periodically perform quality control checks by reviewing completed prescriptions in the will-call area, examining typed labels, computer entries, and location of stock bottles replaced in inventory, and other forms of random checks that promote detection of errors.