AUTOMATED DISPENSING CABINETS (ADCs) IN LONG TERM CARE FACILITIES (LTCF)

AUTOMATED DISPENSING CABINETS (ADCs) IN LONG TERM CARE FACILITIES (LTCF) DJ SONG, PHARM.D. PHARMACEUTICAL CONSULTANT II CALIFORNIA DEPARTMENT OF PUBLIC HEALTH CENTER FOR HEALTH CARE QUALITY LICENSING AND CERTIFICATION PROGRAM 1

REVIEW THE HSC 1261.5 AND 1261.6 REVIEW ADC REVIEW THE ROLE OF PHARMACEUTICAL CONSULTANT IN LTCF USING ADCs REVIEW WITH AFL 12-06 BE FAMILIAR WITH WHAT TO EXPECT GOING FORWARD OBJECTIVES 2

HEALTH AND SAFETY CODE (HSC) 1261.5 1261.5. (a) The number of oral dosage form or suppository form drugs provided by a pharmacy to a health facility licensed pursuant to subdivision (c) or (d), or both subdivisions (c) and (d), of Section 1250 of this code for storage in a secured emergency supplies container, pursuant to Section 4119 of the Business and Professions Code, shall be limited to 48. The State Department of Public Health may limit the number of doses of each drug available to not more than 16 doses of any separate drug dosage form in each emergency supply. (b) Not more than four of the 48 oral form or suppository form drugs secured for storage in the emergency supplies container shall be psychotherapeutic drugs, except that the department may grant a program flexibility request to the facility to increase the number of psychotherapeutic drugs in the emergency supplies container to not more than 10 if the facility can demonstrate the necessity for an increased number of drugs based on the needs of the patient population at the facility. In addition, the four oral form or suppository form psychotherapeutic drug limit shall not apply to a special treatment program service unit distinct part, as defined in Section 1276.9. The department shall limit the number of doses of psychotherapeutic drugs available to not more than four doses in each emergency supply. Nothing in this section shall alter or diminish informed consent requirements, including, but not limited to, the requirements of Section 1418.9. (c) Any limitations established pursuant to subdivisions (a) and (b) on the number and quantity of oral dosage or suppository form drugs provided by a pharmacy to a health facility licensed pursuant to subdivision (c) or (d), or both subdivisions (c) and (d), of Section 1250 for storage in a secured emergency supplies container shall not apply to an automated drug delivery system, as defined in Section 1261.6, when a pharmacist controls access to the drugs. EMERGENCY SUPPLY KITS (E-KITS) 3

AFL 9-46 4

PYXIS, OMNICELL, ACUDOSE, SIEMENS, MTS MEDLOCKER, ETC. INTRODUCED IN HOSPITALS IN 1980s USE GREATLY EXPANDED NURSING HOMES ALLOWED TO USE ADCs FASTER DELIVERY OF MEDICATIONS GREATER INVENTORY CONTROL REDUCE COST MINIMIZE MEDICATION ERRORS PHARMACIST REVIEW OF ALL MEDICATIONS POSSIBLE (PROFILED SYSTEM) ADC 5

ADCs cannot improve patient safety unless cabinet design and use is carefully planned and implemented to eliminate opportunities for wrong drug selection and dosing errors. ISMP GUIDELINES: INTERDISCIPLINARY SAFE USE OF AUTOMATED DISPENSING CABINETS ADC 6

AB1606 (1998) AB2184 (2004) AB522 (2005) AB2373 (2006) HISTORY OF HSC 1261.6 7

1261.6. (a) (1) For purposes of this section and Section 1261.5, an "automated drug delivery system" means a mechanical system that performs operations or activities, other than compounding or administration, relative to the storage, dispensing, or distribution of drugs. An automated drug delivery system shall collect, control, and maintain all transaction information to accurately track the movement of drugs into and out of the system for security, accuracy, and accountability. (2) For purposes of this section, "facility" means a health facility licensed pursuant to subdivision (c), (d), or (k), of Section 1250 that has an automated drug delivery system provided by a pharmacy. (3) For purposes of this section, "pharmacy services" means the provision of both routine and emergency drugs and biologicals to meet the needs of the patient, as prescribed by a physician. (b) Transaction information shall be made readily available in a written format for review and inspection by individuals authorized by law. These records shall be maintained in the facility for a minimum of three years. (c) Individualized and specific access to automated drug delivery systems shall be limited to facility and contract personnel authorized by law to administer drugs. (d) (1) The facility and the pharmacy shall develop and implement written policies and procedures to ensure safety, accuracy, accountability, security, patient confidentiality, and maintenance of the quality, potency, and purity of stored drugs. Policies and procedures shall define access to the automated drug delivery system and limits to access to equipment and drugs. (2) All policies and procedures shall be maintained at the pharmacy operating the automated drug delivery system and the location where the automated drug delivery system is being used. (e) When used as an emergency pharmaceutical supplies container, drugs removed from the automated drug delivery system shall be limited to the following: (1) A new drug order given by a prescriber for a patient of the facility for administration prior to the next scheduled delivery from the pharmacy, or 72 hours, whichever is less. The drugs shall be retrieved only upon authorization by a pharmacist and after the pharmacist has reviewed the prescriber's order and the patient's profile for potential contraindications and adverse drug reactions. (2) Drugs that a prescriber has ordered for a patient on an as-needed basis, if the utilization and retrieval of those drugs are subject to ongoing review by a pharmacist. (3) Drugs designed by the patient care policy committee or pharmaceutical service committee of the facility as emergency drugs or acute onset drugs. These drugs may be retrieved from an automated drug delivery system pursuant to the order of a prescriber for emergency or immediate administration to a patient of the facility. Within 48 hours after retrieval under this paragraph, the case shall be reviewed by a pharmacist. HSC 1261.6 8

(f) When used to provide pharmacy services pursuant to Section 4119.1 of the Business and Professions Code, the automated drug delivery system shall be subject to all of the following requirements: (1) Drugs removed from the automated drug delivery system for administration to a patient shall be in properly labeled units of administration containers or packages. (2) A pharmacist shall review and approve all orders prior to a drug being removed from the automated drug delivery system for administration to a patient. The pharmacist shall review the prescriber's order and the patient's profile for potential contraindications and adverse drug reactions. (3) The pharmacy providing services to the facility pursuant to Section 4119.1 of the Business and Professions Code shall control access to the drugs stored in the automated drug delivery system. (4) Access to the automated drug delivery system shall be controlled and tracked using an identification or password system or biosensor. (5) The automated drug delivery system shall make a complete and accurate record of all transactions that will include all users accessing the system and all drugs added to, or removed from, the system. (6) After the pharmacist reviews the prescriber's order, access by licensed personnel to the automated drug delivery system shall be limited only to drugs ordered by the prescriber and reviewed by the pharmacist and that are specific to the patient. When the prescriber's order requires a dosage variation of the same drug, licensed personnel shall have access to the drug ordered for that scheduled time of administration. (g) The stocking of an automated drug delivery system shall be performed by a pharmacist. If the automated drug delivery system utilizes removable pockets, cards, drawers, or similar technology, the stocking system may be done outside of the facility and be delivered to the facility if all of the following conditions are met: (1) The task of placing drugs into the removable pockets, cards, or drawers is performed by a pharmacist or by an intern pharmacist or a pharmacy technician working under the direct supervision of a pharmacist. (2) The removable pockets, cards, or drawers are transported between the pharmacy and the facility in a secure tamper-evident container. (3) The facility, in conjunction with the pharmacy, has developed policies and procedures to ensure that the pockets, cards, or drawers are properly placed into the automated drug delivery system. (h) Review of the drugs contained within, and the operation and maintenance of, the automated drug delivery system shall be done in accordance with law and shall be the responsibility of the pharmacy. The review shall be conducted on a monthly basis by a pharmacist and shall include a physical inspection of the drugs in the automated drug delivery system, an inspection of the automated drug delivery system machine for cleanliness, and a review of all transaction records in order to verify the security and accountability of the system. (i) Drugs dispensed from an automated drug delivery system that meets the requirements of this section shall not be subject to the labeling requirements of Section 4076 of the Business and Professions Code or Section 111480 of this code if the drugs to be placed into the automated drug delivery system are in unit dose packaging or unit of use and if the information required by Section 4076 of the Business and Professions Code and Section 111480 of this code is readily available at the time of drug administration. For purposes of this section, unit dose packaging includes blister pack cards. HSC 1261.6 cont. 9

SUNSETING OF HSC 1261.6(f)(7) ADC in LTCF 10

AB 2373 in 2006 amended HSC 1261.6 to include Section (f)(7) 1261.6(f)(7)(A) Systems that allow licensed personnel to have access to multiple drugs and are not patient specific in their design, shall be allowed under this subdivision if those systems have electronic and mechanical safeguards in place to ensure that the drugs delivered to the patient are specific to that patient. Each facility using such an automated drug system shall notify the department in writing prior to the utilization of the system. The notification submitted to the department pursuant to this paragraph shall include, but is not limited to, information regarding system design, personnel with system access, and policies and procedures covering staff training, storage, and security, and the facility's administration of these types of systems. (B) As part of its routine oversight of these facilities, the department shall review a facility's medication training, storage, and security, and its administration procedures related to its use of an automated drug delivery system to ensure that adequate staff training and safeguards are in place to make sure that the drugs delivered are appropriate for the patient. If the department determines that a facility is not in compliance with this section, the department may revoke its authorization to use automated drug delivery systems granted under subparagraph (A). (C) This paragraph shall remain in effect only until January 1, 2012, unless a later enacted statute is enacted on or before January 1, 2012, deletes or extends that date. AB 2373 (AGAZARIAN) 11

AB 2373 in 2006 amended X HSC 1261.6 to include Section (f)(7) 1261.6(f)(7)(A) Systems that allow licensed personnel to have access to multiple drugs and are not patient specific in their design, shall be allowed under this subdivision if those systems have electronic and mechanical safeguards in place to ensure that the drugs delivered to the patient are specific to that patient. Each facility using such an automated drug system shall notify the department in writing prior to the utilization of the system. The notification submitted to the department pursuant to this paragraph shall include, but is not limited to, information regarding system design, personnel with system access, and policies and procedures covering staff training, storage, and security, and the facility's administration of these types of systems. (B) As part of its routine oversight of these facilities, the department shall review a facility's medication training, storage, and security, and its administration procedures related to its use of an automated drug delivery system to ensure that adequate staff training and safeguards are in place to make sure that the drugs delivered are appropriate for the patient. If the department determines that a facility is not in compliance with this section, the department may revoke its authorization to use automated drug delivery systems granted under subparagraph (A). (C) This paragraph shall remain in effect only until January 1, 2012, unless a later enacted statute is enacted on or before January 1, 2012, deletes or extends that date. AB 2373 (AGAZARIAN) 12

NOW UNTIL JANUARY 1, 2012: AFL Policy Review of ADC (REPORTED TO THE DEPARTMENT) AFTER JANUARY 1, 2012: RANDOM INSPECTION OF LTCF FOR COMPLIANCE ASSESSING FOR COMPLIANCE TO 1261.6 WHEN LTCFs IDENENTIFIED DURING RECERTIFICATION SURVEY BY THE CONSULTANTS OR HFENs POLICY REVIEW TO DETERMINE THE PURPOSE OF THE ADC IN LTCF (IF THE DEPARTMENT NOTIFIED BY THE FACILITY) ENSURE ADCs THAT ALLOW ACCESS TO MULTIPLE DRUGS THAT ARE NON-PATIENT SPECIFIC IN DESIGN NOT TO BE USED FOR PHARMACY SERVICES (EMERGENCY AND ROUTINE) WHAT S NEXT? 13

AFL 12-06 14

ADCs in LTCF FACILITY DISTRICT OFFICE ADC TYPE PHARMACY PROVIDER THE VILLAGE HEALTHCARE CENTER IN HEMET RIVERSIDE PYXIS MODERN HEALTH VICTORIA SPECIAL CARE CENTER IN EL CAJON SAN DIEGO PYXIS OMNICARE LIFECARE OF VISTA SAN DIEGO PYXIS NEIGHBORCARE MANOR CARE IN HEMET RIVERSIDE OMNICELL OMNICARE THE FOUNTAINS AT THE CARLOTTA RIVERSIDE OMNICELL OMNICARE INDIO NURSING AND REHABILITATION CENTER RIVERSIDE PYXIS MODERN HEALTH MODERN HEALTH LOS ANGELES PYXIS MODERN HEALTH RAMONA MANOR RIVERSIDE PYXIS MODERN HEALTH OCEANVIEW CONVALESCENT LOS ANGELES PYXIS MODERN HEALTH DESERT KNOLLS CONVALESCENT SAN BERNARDINO PYXIS MODERN HEALTH UNIV. CARE CENTER (DEL CAPRIS TERRACE) SAN DIEGO PYXIS MODERN HEALTH KNOLLS WEST CONVALESCENT SAN BERNARDINO PYXIS MODERN HEALTH LEGACE POST ACUTE REHAB CENTER SAN BERNARDINO PYXIS MODERN HEALTH REHAB CENTER OF BEVERLY HILLS LOS ANGELES PYXIS MODERN HEALTH APPLE VALLEY SAN BERNARDINO PYXIS MODERN HEALTH CLOISTERS OF MISSION HILLS SAN DIEGO PYXIS MODERN HEALTH ANTELOPE VALLEY HEALTHCARE LOS ANGELES PYXIS MODERN HEALTH WHITTIER HILLS LOS ANGELES PYXIS MODERN HEALTH SIERRA VALLEY REHAB CENTER BAKERSFIELD PYXIS MODERN HEALTH SEA CLIFF ORANGE PYXIS MODERN HEALTH HUNTINGON VALLEY HEALTHCARE ORANGE PYXIS MODERN HEALTH JEWISH HOME FOR THE AGING (GRANCELL VILLAGE) VENTURA OMNICELL INDEPENDENT HEALTH CARE JEWISH HOME FOR THE AGING (EISENBERG CAMPUS) VENTURA OMNICELL INDEPENDENT HEALTH CARE ROYALE SANTA ANA ORANGE OMNICELL INDEPENDENT HEALTH CARE NORTH VALLEY BEHAVIORAL HEALTH CHICO PICKPOINT FLEX RX BROADWAY LTC PHARAMCY SEQUOIA PSYCHIATRIC SERVICES CHICO PICKPOINT FLEX RX BROADWAY LTC PHARAMCY MANOR CARE FOUNTAIN VALLEY ORANGE OMNICELL OMNICARE WINDSOR REDDING CARE CENTER CHICO MTS MEDLOCKER PHARMACY ADVANTAGE CRESTWOOD PHF PSYCHIATRIC HEALTH OF BAKERSFIELD BAKERSFIELD MTS MEDLOCKER OMNICARE CRESTWOOD BEHAVIORAL CENTER #2 BAKERSFIELD MTS MEDLOCKER OMNICARE CRESTWOOD BEHAVIORAL SAN JOSE SAN JOSE MTS MEDLOCKER OMNICARE GOLDEN EMPIRE CONVALESCENT FRESNO MTS MEDLOCKER OMNICARE LINCOLN MANOR SACRAMENTO TALYST REMOTE DISPENSING PACIFIC WEST PHARMACY WHITE BLOSSOM SAN JOSE MTS MEDLOCKER SKILLED NURSING PHARMACY WOODLAND SKILLED SNF SACRAMENTO MTS MEDLOCKER OMNICARE OAK RIVER SNF CHICO MTS MEDLOCKER OMNICARE COPPER RIDGE SNF CHICO MTS MEDLOCKER OMNICARE TULARE NURSING & REHAB HOSPITAL FRESNO MTS MEDLOCKER OMNICARE DELTA NURSING & REHAB HOSPITAL FRESNO MTS MEDLOCKER OMNICARE HANFORD NURSING & REHAB CENTER FRESNO MTS MEDLOCKER OMNICARE KINGS NURSING & REHAB CENTER FRESNO MTS MEDLOCKER OMNICARE 15

ADCs in LTCF ADC TYPE 5% 2% 32% 46% 15% Pyxis OmniCell MTS MedLocker Pick Point FlexRx LxS Talyst Remote Dispensing 16

ADCs in LTCF SNF KNOWN TO BE USING ADC 6 5 5 5 5 5 4 4 4 4 NUMBER 3 2 2 3 2 2 1 0 0 0 0 17

Definitions: (1) New orders: A new drug order given by a prescriber for a patient of the facility for administration prior to the next scheduled delivery from the pharmacy, or 72 hours, whichever is less. (2) Review: Process involving the pharmacist screening the prescriber's order and the patient's profile for potential contraindications and adverse drug reactions. (3) Transactions: All user access of the ADC and all drugs added to or removed from the ADC. (4) Pharmacy services: The provision of both routine and emergency drugs and biologicals to meet the needs of the patient, as prescribed by a physician. (5) Emergency or acute onset drugs: Defined by the patient care policy committee or pharmaceutical service committee as such, these drugs may be retrieved from an ADC pursuant to the order of a prescriber for emergency or immediate administration to a patient of the facility. Within 48 hours after retrieval under this paragraph, the case shall be reviewed by a pharmacist. (6) Patient-specific: Refers to limiting access by licensed personnel to the ADC only to a drug or drugs specific to the patient ordered by the prescriber and only after the pharmacist review. ADC must be able to keep the patient's medication profile from which only medications listed in the patient's profile can be accessed by licensed personnel. (7) Multiple-drugs: Refers to access by licensed personnel to more than one medications at a time such as in open pocket drawer systems and MedLockers. (8) ADC design that limits access to multiple drugs: Closed pocket drawer system that limits access to one medication. (9) ADC design that allows access to multiple drugs: Open pocket drawer system that allows access to more than one medication. (10) Automated Dispensing Cabinet: An electronically controlled unit-dose medication storage and dispensing device. (11) Unit-Dose Packaging System/Device: A system/device used for packaging a single dose in a non-reusable container. DEFINITIONS 18

Q1: With the release of AFL 12-06, does all ADCs need to be removed from LTCF (Long Term Care Facilities)? Q2: Can LTCF use ADCs for first dose and emergency medications? Q3: Does an ADC that requires individual patient profiles with pharmacist order entry and check before nurse access to medication meet the requirement for "patient-specific? Q4: Can ADCs only be used for initial dose from a new script prior to the next scheduled delivery? Q5: How many doses can be used for a new order for the same patient prior to the next scheduled delivery? FAQ 19

A1: No. LTCF can use the ADCs to provide either pharmacy services or emergency or acute onset drugs. LTCF can use any commercially available ADCs for provision of emergency and acute onset drugs. However, LTCF can use ADCs for provision of pharmacy services only if they meet the following section of HSC 1261.6(f): "When used to provide pharmacy services pursuant to Section 4119.1 of the Business and Professions Code, the automated drug delivery system shall be subject to all of the following requirements (6) After the pharmacist reviews the prescriber's order, access by licensed personnel to the automated drug delivery system shall be limited only to drugs ordered by the rescriber and reviewed by the pharmacist and that are specific to the patient. When the prescriber's order requires a dosage variation of the same drug, licensed personnel shall have access to the drug ordered for that scheduled time of administration. A2: Yes A3: Yes A4: Yes. A5: However many doses are required per the new order prior to the next scheduled delivery. FAQ 20

Q6: HSC Section 1261.6 (f)(7)(a) authorizes systems that allow licensed personnel to have access to multiple drugs and are not patient specific in their design, shall be allowed under this subdivision if those systems have electronic and mechanical safeguards in place to ensure that the drugs delivered to the patient are specific to that patient. Does the absence of this paragraph mean that these safeguards are no longer required? Q7: Section 1261.6 (f)(7)(a) provides that each facility using [systems that allow licensed personnel to have access to multiple drugs and are not patient specific in their design] shall notify the department in writing prior to the utilization of the system. Is notification no longer required? Q8: HSC Section 1261.6 (f)(7)(b) provides that as part of its routine oversight of these facilities, the department shall review a facility's medication training, storage, and security, and its administration procedures related to its use of an automated drug delivery system to ensure that adequate staff training and safeguards are in place to make sure that the drugs delivered are appropriate for the patient. Is this review process no longer applicable? Q9: If the department determines that a facility is not in compliance with this section, the department may revoke its authorization to use automated drug delivery systems granted under subparagraph(a). Does this change the ability to revoke authorization of use of automated drug delivery systems. FAQ 21

A6: The safeguards described in HSC Section 1261.6(f)(7)(A) along with all other substantive provisions of paragraph (7) of Section 1261.6(f) -- ceased to be effective after December 31, 2011. Therefore, all of the provisions relating to the type of automated drug delivery system (ADDS) previously permitted by paragraph (7) -- i.e., systems that allow licensed personnel to have access to multiple drugs and are not patient specific in their design including the requirement that electronic and mechanical safeguards be included, have expired and are no longer in effect. As to other types of drug delivery systems: To the extent that safeguards are referenced in the policies and procedures developed pursuant to HSC Section 1261.6 (e), or otherwise are required under the remainder of HSC Section 1261.6, those safeguards continue to be required to ensure that all drugs delivered to the patient via those other types of systems are specific to that patient. A7: The notification required in HSC Section 1261.6(f)(7)(A) only applied to the one type of ADDS described in paragraph (7), and that particular type of system, -- i.e., one that allows licensed personnel to have access to multiple drugs and is not patient specific in its design -- is no longer permitted to be utilized in California long term care (LTC) facilities as of January 1, 2012. Therefore, that notification no longer can be given by an LTC facility, inasmuch as the statutory authority to use that specific type of ADDS, at all, no longer exists. To the extent that similar notifications are referenced or required under the remainder of HSC Section 1261.6, those notifications continue to be required. A8: Although the review described in HSC Section 1261.6(f)(7)(B) no longer exists because paragraph (7) is no longer in effect, the California Department of Public Health (CDPH or the Department) continues to have authority under other sections of the HSC, including but not limited to Sections 1421 and 1422, to inspect a facility and review its medication training, storage, and security, as well as its administration procedures related to its use of other still-permitted drug delivery systems, in order to ensure that adequate staff training and safeguards exist to guaranty that the drugs delivered are only those prescribed/ordered for the patient. A9: The statutory quote above is contained in HSC Section 1261.6 (f)(7)(b) and, therefore, only pertained to use of that specific type of ADDS formerly permitted by paragraph (7) i.e., systems that allow licensed personnel to have access to multiple drugs and are not patient specific in their design. Because paragraph (7) is no longer effective, the statutory authority for the continued use of that type of ADDS no longer exists. As of January 1, 2012, the legal ability of any LTC facility in California to continue to use that specific type of ADDS ended. Therefore, facility-specific revocations by CDPH are no longer necessary or appropriate for this specific type of ADDS. The elimination of HSC Section 1261.6(f)(7) does not limit the Department s ability to take appropriate action regarding any facility that fails to comply with the remaining provisions of HSC Section 1261.6, all of which continue to be in effect. FAQ 22

QUESTIONS? 23