read this page carefully 2018 hospital pharmacy/hospital ... · hospital pharmacy/hospital with...

of 15

Oregon Board of Pharmacy 800 NE Oregon Street, Suite 150

Portland, OR 97232 Phone: 971 / 673-0001

Fax: 971 / 673-0002 E-mail: [email protected]

Web: www.pharmacy.state.or.us

READ THIS PAGE CAREFULLY 2018

HOSPITAL PHARMACY/HOSPITAL WITH RETAIL PHARMACIST-IN-CHARGE

PHARMACY SELF-INSPECTION REPORT

ATTENTION: PHARMACIST-IN-CHARGE (PIC) Oregon law holds the pharmacist-in-charge and all pharmacists on duty responsible for ensuring pharmacy compliance with all state and federal laws governing the practice of pharmacy. Failure to complete this report by February 1, 2018/within 15 days of becoming PIC (as required by OAR 855-019-0300) may result in disciplinary action. Following your self-inspection and completion of the report, please review it with your staff pharmacists, technicians and interns, correct any deficiencies noted, sign and date the report, and file it so it will be readily available to Board inspectors. DO NOT SEND to the Board office. You are responsible for ensuring your completed report is available at the time of inspection. The primary objective of this report, and your self-inspection, is to provide an opportunity to identify and correct areas of non-compliance with state and federal law. (Note: Neither the self-inspection nor a Board inspection evaluates your complete compliance with all laws and rules of the practice of pharmacy.) The inspection report also serves as a necessary document used by Board inspectors during an inspection to evaluate a pharmacy’s level of compliance. When a Board inspector discovers an area of non-compliance, they may issue either a Deficiency Notification or a Notification of Non-Compliance. Both require a written response from the PIC. Identifying and correcting an area of non-compliance prior to a Board inspection may eliminate the receipt of a Notification for that item. Do not assume that you are in compliance with any statement; take the time to personally verify that compliance exists. A situation of non-compliance that “is the way it has been” is the current PIC’s responsibility to immediately correct to avoid the possibility of a Notification and/or disciplinary action. If you have any questions, please call or email your questions, “attention inspectors”, prior to an inspection, to the phone number or email above. The most common reason for issuing a Notification is either not having or not being able to readily retrieve required documents and records. Because Board inspections are unscheduled, it is common for the PIC to be absent or unavailable. For this reason, you are asked to provide a list of the locations of required documents. Having all required documents and records maintained in a well-organized and readily retrievable manner (a binder is recommended) dramatically reduces the chance that you will receive a Notification. By answering the questions and referencing the appropriate laws/rules/CFR provided, you can determine whether you are compliant with many of the rules and regulations. If you have corrected any deficiencies, please write corrected and the date of correction by the appropriate question. **A PIC training course is offered regularly at the Board office. Check the Board website for dates. **The Oregon Board of Pharmacy internet law exam to obtain one CE of credit is available at www.pharmacy.state.or.us.

mailto:[email protected]

http://www.pharmacy.state.or.us/

of 15

2018 PHARMACIST-IN-CHARGE HOSPITAL SELF-INSPECTION REPORT

OREGON BOARD OF PHARMACY TEL: 971-673-0001 FAX: 971-673-0002

www.pharmacy.state.or.us

All PICs of hospital pharmacies MUST complete and sign this inspection report and have it available for inspection within 15 days of becoming PIC and by 2/1/2018 (as required by OAR 855-019-0300). DO NOT SEND TO THE BOARD OFFICE. Date PIC Inspection was performed: _____/_____/_____ Signature of PIC: Print Name & Lic. #. PIC e-mail: ___________________________________ Chief Pharmacy Officer Name & Lic #: _____________________________________________________________ Pharmacy: Telephone: Fax: Address: DEA #: ___________; Exp: ___ /___ /___ Retail Outlet Cert #: ______________________ Institutional Outlet Cert #: _________________________ Nonprescription Drug Outlet Cert #: __________________

Hours of operation: _________________________________________________________________________ Where are the following items located inside the pharmacy? (Be as specific as possible, there can be many filing cabinets and binders. It is recommended to keep these items in an organized and readily retrievable format, such as an indexed three-ring binder or computer hyperlinked files.) PIC Inspection Reports for the last 3 years: _________________________________________________________ Current written Drug Outlet Procedures: ___________________________________________________________ Clean Room Cleaning Logs: ____________________________________________________________________ Current written annual controlled substance inventory: ________________________________________________ Schedule II Invoices for the last 3 years: ___________________________________________________________ Schedule III-V Invoices for the last 3 years: _________________________________________________________ Completed CII order forms (DEA form 222) for last 3 years: ____________________________________________ Perpetual Schedule II inventory & reconciliation: _____________________________________________________ Diversion Prevention P&P and Supporting Documentation: ___________________________________________________________________________________________ Drug Storage Training Documents: _______________________________________________________________ Technician Training Documents: __________________________________________________________________ Aseptic Training/Personnel Sterility Tests: __________________________________________________________ Clean Room Cleaning Logs: ____________________________________________________________________

Inspector Signature: Date: _____/_____/_____ Deficiency Notice: Comments:

of 15

Hood Certification Documents: __________________________________________________________________ Board Approved Shared Service Documents: ______________________________________________________

Carefully confirm whether or not you are compliant and mark the appropriate box to the left of each item. If you find items that need correcting, rectify the deficiency and write the date of correction and then mark the ‘yes’ box. Do not mark ‘yes’ unless the answer is ‘yes’. Note: the correct answer to some questions is ‘no’.

General Requirements Yes No N/A Rule Reference

□ □ □ 1. Is this hospital accredited? If yes, by whom? _________________

Date of their last inspection: ___/___/____ *Please attach all pharmacy recommendations.

□ □ □ 2. Are your current pharmacy license(s), DEA registration, pharmacist

license(s), intern license(s), preceptor license(s), and technician license(s) posted? Photocopies are not permitted.

ORS 689.615

□ □ □ 3. Is the hospital part of a healthcare organization? If yes, who is the

Chief Pharmacy Officer? ________________________________

OAR 855-041-6150(2)

□ □ □ 4. Are you aware that you must report all terminations or in lieu of terminations of licensees to the Board within 10 working days?

OAR 855-041-1010(3)

□ □ □ 5. Does this pharmacy utilize any off-site personnel to verify order

information, perform DURs, or is the pharmacy providing these services to another entity? If yes, explain: ___________________________________________________

OAR 855-019-0100

□ □ □ 6. Has this pharmacy been granted any exceptions by the Board or

DEA to any laws or rules? If yes, please attach a copy. *Please note that rule changes may invalidate an old waiver.

□ □ □ 7. Are your drug outlet procedures current, compliant with Oregon laws and rules, and do they reflect the practice at your outlet? Date you reviewed procedures with staff: ____________________________ Items to be addressed:

• Drug Security • DUR • Pharmacist Verification and Documentation • Drug delivery • Professional advice/consultation • Verifying Licensure and Training of all staff • Continuous Quality Assurance

OAR 855-041-1040

□ □ □ 8. Do your technicians know who is supervising them and do all pharmacists know who they are supervising during any given shift? *Please complete page 15

ORS 689.486

□ □ □ 9. Do your technicians know what duties/tasks they may perform and do you have documentation of their training? This must be available for Board inspection.

OAR 855-025-0025(5) OAR 855-025-0025(6)

□ □ □ 10. Does a pharmacist verify all work performed by technicians and document this verification?

OAR 855-025-0025(4)

of 15

□ □ □ 11. Does your pharmacy quarantine ALL outdated, adulterated,

misbranded, and suspect product?

OAR 855-041-1025 OAR 855-041-1036(1)(d)

□ □ □ 12. Does your inpatient or outpatient pharmacy participate in any

Shared Pharmacy Services with another pharmacy or practitioner? If yes, please keep a copy of the signed *BOARD APPROVED* Shared Service Agreement(s) in a readily retrievable location. Notes: Shared Service Agreements are time limited, not applicable for controlled substance drugs, and are for use in and within Oregon only. Do you receive unit of use drugs from another pharmacy or package unit of use drugs for another pharmacy in hospital system? If yes, a Board approved Shared Service Agreement is needed. Where are these records located? _____________________________________________________

OAR 855-006-0005(28) OAR 855-060-0001

Controlled Substances Yes No N/A Rule Reference

□ □ □ 13. Did you take your controlled substance (CII-V) Inventory on one

day, within 12 months (365 days) of your last inventory? Date of your last CII-CV Inventory: ____________ Note: Inventory may NOT be taken throughout the day – 24 hour pharmacies need to indicate the time frame in which the inventory was completed. It is acceptable to have one page for the central pharmacy then additional pages for other areas that have floor stock, including ADCs, kits, carts, and ER pre-packs.

OAR 855-080-0070

□ □ □ 14. Is your annual CII inventory filed separately from your CIII-CV

inventory and are your CII invoices and prescriptions filed separately from other prescriptions and invoices?

21 CFR 1304.04

□ □ □ 15. How does the pharmacy track every dose of controlled substance

drugs daily? __________________________________________ Be prepared to demonstrate this to Board Inspector.

a. How does your hospital system resolve all controlled substance discrepancies? Please describe: ______________________________________________________________________________________________

OAR 855-041-6600

16. How do you utilize surveillance and/or QA to monitor and prevent diversion? __________________________________________

OAR 855-041-6600

17. Who orders, receives and reconciles CII drugs? Note: The Board recommends that these processes are not done by a single licensee, as it increases opportunity for diversion.

□ □ □ 18. Are you reconciling your invoice with what is added to your

inventory?

of 15

□ □ □ 19. If CIIs are ordered electronically via CSOS, do you create a new

record of the quantity and date received that is electronically linked to the original order and archived? Be prepared to retrieve them for a Board Inspector.

21 CFR 1305.22(g)

□ □ □ 20. Is there a perpetual CII inventory system for drugs received, stored

and distributed by the pharmacy that is reconciled with an actual inventory at least monthly? Where is this kept? ___________________________________________________

OAR 855-041-6610(1)(a)

□ □ □ 21. Is schedule II floor stock controlled with a perpetual inventory

system?

OAR 855-041-6610(1)(b)

□ □ □ 22. Is there a random reconciliation of a sample of CII inventory sheets

conducted, at least quarterly, which includes auditing of dose-by-dose administration? (examples include auditing override reports, discrepancy reports, and comparing floor stock inventory sheet to administration records, etc.) Where is this documentation kept? _____________________________________________________

OAR 855-041-6610(1)(c)

Labeling Yes No N/A Rule Reference

□ □ □ 23. Does the pharmacy identify and document the pharmacist who

verifies a drug? Be prepare to show at time of inspection.

OAR 855-041-6270(1)

□ □ □ 24. Is pre-packed drug/hospital unit-dosed drug labeled to contain:

-Name, strength, and expiration date of drug, and -Drug Manufacturer and lot number or internal pharmacy code that references these items Note: This includes oral syringes.

OAR 855-041-6270(2)

□ □ □ 25. Do you add a bar code or an electronic label to any drug? If yes,

the pharmacist must verify and document the accuracy prior to distribution.

OAR 855-041-6270(6)

Emergency Kit and Code Cart Yes No N/A Rule Reference

□ □ □ 26. An emergency kit consists of those drugs which may be required to

meet the immediate therapeutic needs of in-patients (emergency) and which are not available from any other authorized source in sufficient time to prevent risk of harm to patients. Does a pharmacist verify and document the contents of all emergency kits? (such as a Malignant Hyperthermia Kit, Stroke Kit, or Maternal Hemorrhage Kit) Note: This is a requirement

OAR 855-041-6420(2)

□ □ □ 27. Is kit/cart labeled to indicate it is a drug supply for emergency use

and does the label/list contain the name, strength, and quantity of drugs in kit/cart?

OAR 855-041-6420(6)

□ □ □ 28. Is the kit/cart labeled with appropriate expiration date? (Note: The

label/list must be on the exterior of the cart, not the drawer inside the cart.)

OAR 855-041-6420(7)

of 15

Automated Distribution Cabinets (ADC), Floor Stock, Non-emergency Trays and Kits □ N/A

Yes No N/A Rule Reference

□ □ □ 29. Does the outlet have required P&Ps for inspection of drug storage

areas (at least every 2 months) that includes verification and documentation of proper storage, documentation of distribution and administration of controlled substances, absence of outdated drugs, temperature monitoring and integrity of emergency drug supply? Location? _____________ Who performs this inspection? Does it vary? ___________________________________________________

OAR 855-041-6200(1)(d)

□ □ □ 30. Who do you permit to access ADCs?

Note: A nurse is not permitted to return a drug to an ADC after removing it, except to place in a return bin.

OAR 855-041-6540(4)

□ □ □ 31. Is a count confirmation performed at all times a controlled

substance is accessed (loading, unloading, removing and inventorying) in an ADC? Are discrepancies documented and reconciled?

OAR 855-041-6540(8)

Absence of a Pharmacist □N/A Yes No N/A Rule Reference

□ □ □ 32. Does your pharmacy utilize off-site or non-resident pharmacists to

perform remote verification? Note: This requires Oregon registration/licensure.

OAR 855-041-3300

□ □ □ 33. Does the hospital use a night cabinet or allow after-hours access to

the pharmacy?

OAR 855-041-6300

□ □ □ 34. Is access to night cabinet or pharmacy limited to one authorized

registered nurse on a shift? Where is the authorized nurse’s identity designated in writing with documentation of the nurse(s) training in the proper procedure for access, removal of drugs, and recordkeeping: __________________________________________

OAR 855-041-6305 OAR 855-041-6310

□ □ □ 35. When a drug is removed after hours, is the pharmacist confirming

that: -the nurse has been appropriately trained; and -the nurse’s initials are documented; and -a copy of the practitioner’s order is left for verification; and -either the container from which the drug was removed or an identical unit-dose is left for accuracy verification?

OAR 855-041-6310(2)

Technician Checking Validation Program □N/A Date of Board approval: ________________ Yes No N/A Rule Reference

36. What checking functions are performed by TCVP-validated technicians? Please list all functions. ________________________________________________ ________________________________________________ ________________________________________________

OAR 855-041-5160

of 15

□ □ □ 37. Does technician training include a minimum of 1 year drug

distribution experience, training and Initial Validation Process?

OAR 855-041-5130(1)

□ □ □ 38. Does the training session include trainee observing a technician

checker or pharmacist performing the checking process that the trainee is learning? Does the trainee perform initial check with a pharmacist verifying all doses, trainee completing validation process with a pharmacist verifying all doses, and introduction of artificial errors?

OAR 855-041-5130(2)

□ □ □ 39. How are TCVP-program errors documented?

______________________________________________ OAR 855-041-5130(2)(e)

□ □ □ 40. Did trainee make more than 3 errors in 1500 doses for unit of use

cart fill? (1500 total doses, divided among 5 separate training checks with the pharmacist introducing at least 3 errors in each training check.)

OAR 855-041-5140(1)(a)

□ □ □ 41. Did trainee make more than 1 error in 500 doses for ADC or non-

emergent tray and kits? (500 total doses, divided among 5 separate training checks with the pharmacist introducing at least 3 errors in each training check.)

OAR 855-041-5140(1)(b)

□ □ □ 42. Are quality checks being performed on technician checker(s)?

Where is the documentation kept? _________________________________________

OAR 855-041-5140(3)

□ □ □ 43. Did checker make more than 1 error in any quality check? (If yes,

did they stop working as a checker until criteria met?)

OAR 855-041-5140(2)(c)

□ □ □ 44. What additional specific clinical responsibilities have your

pharmacists been freed up to do since your program began? ___________________________________________________

Collaborative Drug Therapy Management (CDTM) Yes No N/A

□ □ □ 45. Do any pharmacists participate in a Collaborative Drug Therapy

Management (CDTM) agreement? OAR 855-019-0260

□ □ □ 46. Does the written CDTM agreement contain the following: • Identification of the participating pharmacist(s) and

practitioner(s) • The name of the principal pharmacist and practitioner who

are responsible for development, training, administration, and quality assurance of the arrangement

• The types of decisions that the pharmacist is allowed to make and when the pharmacist should initiate communications with the practitioner

Be prepare to show CDTM agreement at time of inspection.

OAR 855-019-0260(2)(a-g) OAR 855-019-0260(3)

□ □ □ 47. Is the CDTM agreement being reviewed and updated at least every two years?

OAR 855-019-0260(2)(h)

□ □ □ 48. Is the practitioner identified on each prescription written by the pharmacist? Note: The practitioner is the individual with prescriptive authority in a CDTM agreement. For a prescription written by a pharmacist to be valid, the practitioner must be identified on the prescription.

OAR 855-019-0260(1)(a-b)

of 15

Medication Reconciliation (Med Rec): Med Rec FAQS attached on last page Yes No N/A Rule Reference

□ □ □ 49. Is the pharmacy involved? If yes, what is the pharmacist’s role?

______________________________________________________ ______________________________________________________

50. Who performs medication history gathering in your hospital? ______________________________________________________

OAR 855-025-0025

51. If a technician is involved, how and when is their work verified by a pharmacist? _________________________________________

ORS 689.486(6)

Drug Storage Yes No N/A Rule Reference

□ □ □ 52. Does each active cold storage system maintain the temperature of

refrigerated products between 2-8°C (35-46°F) and frozen products between -25 to -10°C (-13 to 14°F) or as specified by the manufacturer?

OAR 855-041-1036

□ □ □ 53. Are the thermometers/probes accurate and calibrated?

When is the next calibration due? ____________________

OAR 855-041-1036(2)

54. What is the pharmacy’s role in thermometers/probes accuracy and calibration? _____________________________________________________

□ □ □ 55. Do you have documented training of all your pharmacy personnel

related to the drug storage monitoring plan? Where are these records located? ______________________________________

OAR 855-041-1036(2)

□ □ □ 56. Do you have an emergency plan for all refrigerated and frozen products? Be prepare to show plan at time of inspection.

□ □ □ 57. Do you have a quality assurance plan specific to vaccine storage? Be prepare to show plan at time of inspection.

□ □ □ 58. Does documentation of a drug storage excursion include at least all

the following: -The event date & timeframe; -The name of person(s) involved in response; -How long drugs(s) out of range; and -Temperature variances. Documentation of actions taken for all excursions, to include: -The decision to quarantine for destruction each drug affected or that each drug affected is safe for continued use; -Who made the final decisions; and -The information source for the actions taken. Where are these records located? _____________________________________________________

OAR 855-041-1036(2)

□ □ □ 59. Do you conduct quarterly validations of your vaccine storage units

and their monitoring equipment? What is your process to conduct this and where are these record kept? __________________________________________________

OAR 855-041-1036(3)

of 15

Compounding and Sterile Parenteral Products General Information Yes No N/A Rule Reference

□ □ □ 60. Do you compound low, medium or high risk? If yes, list which

categories: ________________________________________

□ □ □ 61. Do you participate in any Shared Service Agreements with another

pharmacy or practitioner? If yes, please attach a copy of the required Board approved Shared Service Agreements.

OAR 855-045-0200(4)

□ □ □ 62. Do you receive non-patient specific compounds from out-of-state?

If yes, have you verified their Oregon manufacturer registration?

OAR 855-060-0004(8)

□ □ □ 63. Do you have protocols for initial and ongoing training and testing

of all personnel, including Supervising pharmacist, pursuant to their level of compounding? Where is the documentation? _________________________________________________

OAR 855-045-0220(2)

□ □ □ 64. Are policies and procedures relevant to your practice setting

reviewed annually and complied with by all staff?

OAR 855-045-0230(2)

□ □ □ 65. Do you have a QA plan and supporting documentation? What

procedures are you performing to ensure the integrity of your products? _____________________________________________

OAR 855-045-0230(2)(g)

□ □ □ 66. Does your QA plan include record keeping requirements for

cleaning, testing and calibration of all equipment and devices? Where are your records kept? _____________________________

OAR 855-045-0230(4)

□ □ □ 67. Do you have procedures for establishing and/or extending BUD for

your products? How do you determine a product’s BUD? __________________________________________________

Do you extend BUDs? If so, where are your records kept? __________________________________________________

Do you have these products tested for sterility and stability? __________________________________________________

OAR 855-045-0230(2)(k)

□ □ □ 68. Are bulk chemical containers labeled with the date pharmacy

obtained the chemical and an expiration date of not more than 5 years from the date container was opened?

OAR 855-045-0230(6)

□ □ □ 69. Are compounding logs, formula worksheets and documentation of

the preparation, verification, dispensing or transfer of compounded products stored in an organized manner? Note location of the records: ______________________________________________

OAR 855-045-0270(1)

□ □ □ 70. Do formula worksheets include all of the following:

(Note: This is required for batch and non-patient specific compounding, both sterile and non-sterile.) -paper copy of the label used for the compounded product -drug name and strength -quantity prepared -date prepared -pharmacy unique lot number -manufacturers’ lot numbers and expiration dates of all ingredients in compounded product -BUD (watch all ingredients’ expiration dates!) -name of the verifying pharmacist -names of all technicians involved in the process

OAR 855-045-0270(2)

of 15

-mixing instructions -physical evidence of the proper weight of each drug chemical or drug used -pharmacist verification that the correct formula and the correct weights or volumes of chemical or drugs were used -certification of completion of any additional testing that might be required in your policies and procedures

□ □ □ 71. Is the pharmacist confirming the drug, dose, and dosage form are

appropriate and the calculations, drug, and quantity of each drug are correct?

OAR 855-045-0220(5)

□ □ □ 72. Is there documentation of verification that includes the initials of the

pharmacist responsible for the review and accuracy of compounded products?

OAR 855-045-0220(5)(b) OAR 855-045-0240(1)(E)

□ □ □ 73. Do you run the hood for at least 30 minutes prior to compounding?

(at the beginning of the work day, before each batch, etc)

Nonsterile (NS) □ N/A Yes No N/A Rule Reference

□ □ □ 74. Is each product labeled with a physical description for compounds

sold on a prescription? OAR 855-045-0220(5) OAR 855-041-1130(1)(k)

Compounded Sterile Products (CSP) □ N/A Yes No N/A Rule Reference

□ □ □ 75. Are CSP prepared in an ISO 5 certified Biological Safety Cabinet,

Compounding Aseptic Isolator, or Laminar Airflow Hood?

OAR 855-045-0260(2)

□ □ □ 76. Do you test all personnel that prepare and verify CSPs regarding

proper aseptic manipulative skills? Where are the training records kept? ________________________________________________

OAR 855-045-0220(2)

□ □ □ 77. Do you access single dose vials in less than an ISO 5

environment? BUD may not exceed 1 hour from time of initial entry.

OAR 855-045-0250(6)

□ □ □ 78. Do you access single dose vials in an ISO 5 environment? BUD

may not exceed 24 hours from time of initial entry. OAR 855-045-0250(6)

□ □ □ 79. Do you label multi-dose vials with an appropriate BUD from time of

initial entry? How many days? _____________________________ OAR 855-045-0250(7)

□ □ □ 80. Are all ISO classified areas checked and certified at least every 6

months and whenever LAF, BSC, or CAI is relocated or the physical structure of the buffer room or anteroom has been altered? Where are the records kept? _____________________________

OAR 855-045-0260(7)

□ □ □ 81. Do your compounding procedures include requirements for use of

gowns, shoe covers or dedicated shoes, hair covers, gloves and masks? (Note: no makeup, no jewelry, no fingernail polish, no skin exposed)

OAR 855-045-0230(2)(e)

□ □ □ 82. Do you have documentation of environmental monitoring to show

that the compounding environment is properly maintained? Where is this located? __________________________________

OAR 855-045-0230(3)

□ □ □ 83. Does the admixture label contain?

-Rate of infusion (if applicable) -BUD

OAR 855-045-0240(1) OAR 855-041-6270(7)

of 15

-Storage requirements or special conditions -Name, quantity, and concentration of all ingredients contained in the products, including primary solution -Hand written initial of the verifying pharmacist -Identification of the pharmacy, patient name and location, auxiliary labels as needed and date mixed -The expiration date -The scheduled time for administration -The name or initials of person performing admixture

Risk Levels □ N/A Yes No N/A Rule Reference

□ □ □ 84. Are surfaces and furniture in buffer room/anteroom nonporous,

smooth, non-shedding, impermeable, cleanable and resistant to disinfectants?

OAR 855-045-0260(4)

□ □ □ 85. In ISO 7 and 8 areas, are floors and work surface areas cleaned at

least daily and are walls, ceilings, and empty shelving cleaned at least monthly either with a high-level disinfectant or with a medium-level disinfectant that is alternated regularly with another medium-level disinfectant? Be prepared to retrieve for a Board inspector.

OAR 855-045-0260(7)

□ □ □ 86. Are Low Risk CSP prepared in an ISO 5 environment without a

separate buffer room, is there a partitioned area to create a buffer zone (i.e. line of demarcation)?

□ □ □ 87. Are Low Risk manipulations limited to the following?

-No more than 3 sterile products and no more than 2 entries into each sterile container -aseptically opening ampoules -penetrating sterile stoppers on vials with sterile needles and syringes -Transferring sterile liquids in sterile syringes to sterile administration devices, package containers of other sterile products and sterile containers for storage and dispensing

OAR 855-045-0250

□ □ □ 88. Are Low to High Risk CSP’s properly stored and BUDs properly

labeled?

OAR 855-045-0250

□ □ □ 89. Does the buffer room contain a sink or drain (not permitted for

High Risk)?

OAR 855-045-0260(4)

□ □ □ 90. Do you have a positive pressure clean air room for preparing

Medium and High Risk compounds which has an ISO 8 certified or better anteroom, ISO 7 or better buffer room which contains a certified ISO 5 or better compounding cabinet or equivalent environment?

OAR 855-045-0260(3) OAR 855-045-0260(4)

Immediate Use □ N/A Yes No N/A Rule Reference

□ □ □ 91. Does the administration of immediate-use compounded

preparations begin within 1 hour of the time of preparation?

OAR 855-045-0250(4)

□ □ □ 92. Are immediate-use compounds prepared by someone other than

the person who will administer the drug? If yes, labeling must OAR 855-045-0250(4)

of 15

include patient name, name and quantity of ingredients, name of person who prepared compound, and exact one hour BUD.

If you also have a Retail Registration for your Hospital Pharmacy, complete the following:

2018 PHARMACIST-IN-CHARGE

INSPECTION REPORT FOR RETAIL DRUG OUTLETS LOCATED WITHIN HOSPITAL PHARMACIES OREGON BOARD OF PHARMACY

TEL: 971-673-0001 FAX: 971-673-0002

Please note: Complete the following if you have a retail drug outlet registration. Do not use this form if you have a retail drug outlet located outside the physical confines of the hospital pharmacy department. If the pharmacy

prepares ER discharge medications, re-labels patient medications to take home, fills employee prescriptions or dispenses discharge medications to patients, the pharmacy must have a retail registration.

Pharmacy: _______________________________________________ Telephone: ________________________

Address: ____________________________________________________________________________________

DEA #: _______________________ Exp: ___/___/____ Retail Drug Outlet Lic #: ____________________

Hours of Operation: ____________________________________

General Requirements Yes No N/A Rule Reference

□ □ □ 93. Has this pharmacy been granted any exceptions by the Board of

DEA to any laws or rules? If yes, please attach a copy to this report.

94. Please indicate the types of prescriptions dispensed from this retail drug outlet: □ Take-home prescriptions for discharged patients □ Take-home prescriptions for emergency room patients □ Employee prescriptions □ Staff physicians (non-employees) □ Prescriptions for hospice patients □ Walk-in customer prescriptions (emergency only) □ Other (please specify) __________________________________

□ □ □ 95. Are your written drug outlet procedures and technician procedures

developed for your institutional drug outlet applicable to your retail drug outlet? (If yes, it is not necessary to develop additional procedures for your retail outlet)

OAR 855-041-1040

Outpatient Medications (including ER pre-packs)

Yes No N/A Rule Reference

□ □ □ 96. Are all emergency outpatient prepackaged prescriptions verified by

a pharmacist within 24 hours? If the pharmacy is closed, records shall be reviewed during the first day the pharmacy is open but not to exceed 72 hours following the dispensing. This includes verifying: - Name, strength, quantity of medication dispensed, directions for use and performing a DUR

OAR 855-041-6410

of 15

□ □ □ 97. Do you utilize an automated dispensing machine (i.e. Instymed

machine) for emergency room dispensing? How does a pharmacist review these orders for accuracy and are they performing a DUR when doing so? (Please attach policy.)

OAR 855-041-6410

□ □ □ 98. Are all outpatient prescriptions labeled with the name, address, and

telephone number of the hospital, name of drug, strength, number of units, identifier of the manufacturer or distributor for generics without brand names, accessory cautionary information, product identification label and an expiration date?

OAR 855-041-1130

□ □ □ 99. Does the practitioner or nurse label the container for emergency

outpatient prescriptions with the following: name of patient, directions for use, date, identifying number, name of prescribing practitioner, and the initials of the dispensing nurse? How do you audit this? ________________________________

OAR 855-041-6410

□ □ □ 100. Is the quantity of emergency outpatient medications limited by policy

and procedures? May not exceed 48 hour supply with limited exceptions permitted by Board rule.

□ □ □ 101. Is written drug information provided to the patient?

□ □ □ 102. Is the pharmacist/intern documenting counseling on new

prescriptions and refills that require counseling at the time of interaction? (pharmacist/intern must specify if counseling is provided or declined.)

OAR 855-019-0230

□ □ □ 103. Please explain the method used in your pharmacy to identify

prescriptions that require counseling: ________________________ ______________________________________________________

of 15

PHARMACY PERSONNEL—KEEP CURRENT THROUGHOUT THE YEAR AS NEEDED

Have each licensee review this inspection form, corresponding documents and procedures, and be prepared to assist in locating information during an inspection and sign below certifying their review. Please check the box next to the technicians name to indicate you have verified that you have documentation of each individual’s technician training available for Board inspection.

NAME FULL OREGON LICENSE NUMBER

OREGON LICENSE EXPIRATION DATE

LICENSEE’S SIGNATURE

□ Example: Charles Roast RPH-0000001 6/30/2017 Chuck Roast

□

□

□

□

□

□

□

□

□

□

□

□

□

□

□

□

□

□

□

□

of 15

LOCATION OF TECHNICIANS Please use this page to list where technicians are located outside of the central pharmacy (full time or part time). What are they doing at each location? How are they supervised?

LOCATION TASKS/DUTIES SUPERVISION Example: Floor 6

Refilling of cart Supervised by RPh Roast throughout the day

I hereby certify that I have verified this outlet is in compliance with all laws and rules, have read and verified that written policies and procedures reflect current practices, have documented training of technicians, and the answers marked on this report are true and correct. PIC signature: ___________________________________ License #: __________________ Date: _____________

Cut on this line, file in location of each item, and post next to outlet license on the wall.

DO NOT SEND ANY PART OF THIS REPORT TO THE BOARD OFFICE.

KEEP IN THE BOARD OF PHARMACY LAW BOOK, COPIES SENT TO THE BOARD WILL BE DISCARDED.

Location of PIC Self-Inspection Form: _____________________________________________________________ Location of Board of Pharmacy Laws and Rules: ____________________________________________________

Oregon Board of Pharmacy December 2017

Medication Reconciliation FAQ

Preamble

The term “medication reconciliation” is defined by the Joint Commission as “the process of comparing the medications a patient is taking (and should be taking) with newly ordered medications” in order to resolve discrepancies or potential problems. This definition emphasizes the importance of reconciliation, which is the act of comparing medication lists and noting inconsistency versus the act of merely collecting a medication history. It is nationally recommended that pharmacists should be involved in functions including but not limited to developing policies and processes, implementing and continuously improving those processes, and training and assuring the continuing competency of those involved in medication reconciliation. The Board expects a pharmacist to establish roles and responsibilities of heath care providers in medication reconciliation processes, including pharmacy technicians, interns, and other medical support personnel.

When implementing a pharmacy technician medication history program, it is essential to be in compliance with the Oregon Board of Pharmacy laws and rules regarding what pharmacy technicians can and cannot do. Pharmacy technicians are not allowed to make clinical decisions, of any kind, during the medication reconciliation process or otherwise. They may write down the information gathered from the patient, gather information from a secondary source if needed, and present it to the pharmacist for verification. For example, a patient reports taking furosemide as needed based on their weight. However, the pharmacy technician finds that the patient’s prescription has a direction for furosemide 20 mg daily. In this scenario, the pharmacy technician may not make a judgement call to include only the direction from the prescription and omit the information about how the patient is taking it. In a different scenario, a patient tells the pharmacy technician that he/she takes a medication for blood pressure at home and is unable to recall the name. The pharmacy technician then goes down the Prior to Admit (PTA) medication list and picks out a drug that he/she believe is the blood pressure medication. By doing that, the pharmacy technician uses clinical judgement to identify which drug has an indication for high blood pressure, which is not within the scope of pharmacy technician duties and is not permitted by the Board.

Pharmacy technicians who perform medication reconciliation must have proper training on how to collect medication history and interview a patient. Pharmacy technicians may compare the list they gather from medication history to what is currently ordered for the patient in the hospital and make note of differences when updating the patient’s medical record. It is a pharmacist’s responsibility to verify and review any clinical scenarios or discrepancies in the patient medical record prior to prescribing decisions being made.

These FAQs are provided to address pharmacy involvement in the medication reconciliation process. The Oregon Board of Pharmacy does not have jurisdictional oversight over what functions nurses and other non-pharmacy personnel may be permitted to perform.


Q. What is Medication Reconciliation?

A. Medication reconciliation (Med Rec) is the process of creating the most accurate list possible of all medications a patient is taking — including drug name, dosage, frequency, and route — and comparing that list against the physician’s admission, transfer, and/or discharge orders, with the goal of providing correct medications to the patient at all transition points within the hospital.

Q. Are pharmacy technicians allowed to perform medication reconciliation without a pharmacist oversight and review?

A. No. However, a pharmacy technician that has received training appropriate for medication reconciliation process, may assist in the data collection process in order to obtain the best possible medication history for the patient. Please note, that while pharmacy technicians are allowed to assist in the medication reconciliation process, they may not do so independently. A supervising pharmacist must verify a medication history summary collected by a pharmacy technician and be available to assist the technician if requested.

A person licensed to perform the duties of a pharmacy technician may perform the duties of a pharmacy technician only under the supervision, direction, and control of a licensed pharmacist.

Q. Is a pharmacist required to verify the medication history obtained by a pharmacy technician?

A. Yes. A pharmacist is required to verify all medication histories obtained by pharmacy technicians in the medication reconciliation process. This task may not be delegated to non-pharmacist staff.

Q. Are pharmacy technicians allowed to make clinical decisions during the medication reconciliation process?

A. No. Pharmacy technicians are not allowed to make clinical decisions, of any kind, during the medication reconciliation process or otherwise. Making clinical decisions is not in the scope of the pharmacy technicians duties. If a technician makes a clinical decision, the technician, pharmacist and outlet may be subject to discipline for engaging in the practice of pharmacy without a license.

Q. Is the verbal communication of a patient’s medication history from pharmacy technician to pharmacy technician allowed? This could be a request for patient’s medical history printout from a healthcare provider outside of a hospital or health system, such as a patient’s local pharmacy or primary care provider?

A. Yes. However, technician to technician communication would require verifiable documentation (i.e. faxed medication history) for the pharmacist who is verifying the


medication history, to be able to validate the information. Clinical decisions may not be made during communications such as these.

Q. Is the communication of a patient’s medical history between pharmacy technicians, using disease states or medication indications, allowed?

A. No. Pharmacy technicians are not allowed to communicate a patient’s medication history, to another pharmacy technician, by discussing disease states or indications.

The Laws and Rules applicable to utilizing pharmacy technicians in the medication reconciliation process include:

Pharmacists:

OAR 855-019-0200 - General Responsibilities of a Pharmacist

(2) Only a pharmacist may practice pharmacy as defined in ORS 689.005, to include the provision of patient care services. (6) A pharmacist on duty is responsible for supervising all pharmacy personnel, and ensuring that pharmacy personnel only work within the scope of duties allowed by the Board. (7) A pharmacist may not permit non-pharmacist personnel to perform any duty they are not licensed and trained to perform.

Pharmacy Technicians:

ORS 689.005(29) “Pharmacy technician” means a person licensed by the State Board of Pharmacy who assists the pharmacist in the practice of pharmacy pursuant to rules of the board.

ORS 689.486 - When license required; qualifications for licensure; renewal; supervision required.

(6) A person licensed to perform the duties of a pharmacy technician may perform the duties of a pharmacy technician only under the supervision, direction and control of a licensed pharmacist. OAR 855-025-0025 - Use of Pharmacy Technicians and Certified Oregon Pharmacy Technicians

(4) Work performed by Pharmacy Technicians and Certified Oregon Pharmacy Technicians assisting the Pharmacist to prepare medications must be verified by a Pharmacist prior to release for patient use. Verification must be documented, available and consistent with the standard of practice.