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. A
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2. The patient's birth date (or age updated regularly) is gathered and entered into the computer for every patient before dispensing a prescription. A
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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. A
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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. A
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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. A
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6. Patients in the pharmacy database are sent an annual survey to update clinical and demographic information in the computer system. (FAQ) A
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7. When taking orders over the telephone, the prescriber (or designee) is specifically queried about comorbid conditions, allergies, and the patient's weight. A
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8A. A pharmacist enters clinical information including allergies into the computer system and properly codes the information to allow computer screening. A
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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. A
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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). A
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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) A
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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) A
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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. A
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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.). A
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14. The pharmacy takes steps to understand cultural issues and overcome language barriers that are present in the population of patients served. A
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15. The pharmacy takes steps to effectively communicate with patients who are visually or hearing impaired. A
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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.) A
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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. A
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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. A
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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. A
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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. A
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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. A
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22. The computer system warns practitioners about clinically significant drug interactions. (FAQ) A
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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. A
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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. A
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25. A pharmacist reviews clinically significant computer warnings of potential contraindications, even when a pharmacy technician initially enters prescriptions into the computer. A
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26. A pharmacist reviews clinically significant computer warnings of potential drug interactions, even when a pharmacy technician initially enters prescriptions into the computer. A
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27. A pharmacist reviews clinically significant computer warnings of potential drug duplications, even when a pharmacy technician initially enters prescriptions into the computer. A
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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. A
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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. A
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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. A
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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. A
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32. A designated pharmacist or corporate level staff routinely reviews, for quality improvement purposes, reports of computer warnings that are overridden by pharmacists. A
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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.) A
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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. A
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35. The variety of manufacturers from whom generic drugs are purchased is minimized to the fullest extent possible. A
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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. A
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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. A
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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. A
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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) A
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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. A
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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. A
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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. A
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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) A
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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) A
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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. A
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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). A
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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. A
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48. Telephone orders communicated by unauthorized or nonprofessional staff are not permitted and a pharmacist verifies incomplete or unclear prescriptions directly with the prescriber. A
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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. A
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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. A
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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. A
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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. A
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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. A
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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. A
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55. Special alerts are built into the computer as necessary to remind practitioners about problematic or look-alike drug names, packaging, or labeling. A
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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. A
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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. A
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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. A
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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.). A
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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. A
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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. A
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62. All prescription labels include the expiration date or beyond use date. A
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63. The pharmacy uses appropriate foreign language labels for patients who need them. A
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64. Appropriate labels are used for the visually impaired (e.g., larger font, Braille, etc.). A
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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. A
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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. A
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66. If the prescriber provides the purpose of the medication on the prescription, the indication is included on the patient's prescription container label. A
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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. A
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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. A
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69. A mechanism exists to identify the reasons that a prescription has not been picked up after being prepared. A
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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. A
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OR (Respond to 70A or 70B only)
70B. The pharmacy is open 24-hours a day, seven days a week. A
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71. Records are available to identify patients receiving a drug that is recalled by the manufacturer and patients are notified as appropriate. A
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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). A
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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) A
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74. Medications are rotated in the "fast mover" area(s) to reduce the risk of error due to familiarity with placement on shelves. A
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75. Medication container labels face forward when stored upon shelving. A
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76. When stocking shelves, staff ensures that wholesaler price labels do not interfere with critical drug information on the manufacturer's label. A
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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. A
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78. An automated dispensing system that incorporates robotics and/or bar code verification systems is used to support the dispensing system in the pharmacy. A
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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.). A
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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. A
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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). A
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82. Pharmacy does not store chemical substances (e.g., formalin, methanol, etc.) for distribution to a laboratory, doctor's office or hospital. A
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83. Non-drug supplies such as alcohol are not stored or placed near diluents and products that require reconstitution. A
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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. A
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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.). A
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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. A
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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) A
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88. Staff members use appropriate hand washing procedures prior to compounding any prescription products (e.g., liquids, ointments, capsules, etc.). A
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