Leigh BriscoeDwyer Pharm D BCPS FASHP Lawrence Mokhiber

Leigh Briscoe-Dwyer, Pharm. D, BCPS, FASHP Lawrence Mokhiber, MS, RPh Kimberly Zammit, Pharm. D, BCPS, BCCCP, FASHP Update on State and National Practice Issues

NYS Pending Legislation � 7210 � 7217 � CBD � Intern Immunization

https: //nabp. pharmacy/programs/verified-pharmacy-program/

Benefits of VPP � VPP acts as a supplement to state processes for pharmacies that must renew or obtain nonresident licensure to remain compliant � VPP provides state boards of pharmacy with your verified pharmacy data and a uniform inspection service when requested to assist with licensing decisions. � VPP offers inspections for nonresident pharmacies � If an out-of-state board requires a current inspection by a board -approved third party or designated agent, an inspection through VPP may meet this requirement. � VPP can assist compounding pharmacies in demonstrating compliance with USP Chapters <795> and/or <797> � This helpful process is available for resident and nonresident pharmacies.

NYS Pending Legislation � 7210 � 7217 � CBD � Intern Immunization

NYS Pending Legislation � 7210 � 7217 � CBD � Intern Immunization

NYS Pending Legislation � 7210 � 7217 � CBD � Intern Immunization

Pharmacy Technicians Leigh Briscoe-Dwyer, Pharm. D, BCPS, FASHP

National Pharmacy Workforce Survey � Pharmacy Manpower Project � 66% of pharmacists report workload as high or excessively high � 64% report that workload has increased or greatly increased compared to 1 year ago � Most stressful event was “Having so much work to do that everything cannot be done well”

It Is Time To Evaluate � Are the right people doing the right things? � Start/Stop/Continue � Interaction with a product or piece of equipment TECHNICAN � Interaction with a person: patient/prescriber PHARMACIST � Expanding pharmacy technician roles is critical to evolving the pharmacy practice model

What’s Wrong With This Picture?

Certified Pharmacy Technicians � PTCB has granted more than 585, 000 certifications since 1995 � Currently there are more than 275, 000 active PTCB CPh. Ts � 2015 Exam Stats: 57% Pass Rate � 56, 253 administered 31, 823 passed

Clinical Pharmacy Services Technician Hill AFB, Utah � Schedules appointments for patients referred to the pharmacist-run ambulatory care clinic � Screens patients prior to appointments to make sure that appropriate labs have been completed � Notes missing labs so that they can be ordered by the pharmacist before the visit � Checks patients in and prepares documents/charts required for appointments � Scans patient documentation such as home blood glucose or home blood pressure logs into the electronic medical record when the patient checks in � Contacts new patients assigned to the clinic to introduce clinical services � Communicates the status of bridge refill requests to patients

Pharmacy Purchaser Aurora Bay. Care Medical Center, Aurora WI Manage all aspects of daily medication orders from wholesaler � Place specialty drug orders through outside vendors � Coordinate medication procurement for local clinics, EMS, and fire departments � Ensure all medication barcodes are in the formulary database to support BCMA � Optimize medication inventory par levels to avoid stockouts and reduce waste � Record necessary information for compliance with the Drug Supply Chain Security Act � Oversee controlled substances ordering and required documentation � Monitor, communicate, and manage drug shortages � Lead biannual medication inventory � Submit new medications to IT for addition to the EHR to support CPOE �

Medication Reconciliation Technician Tacoma General Hospital, Tacoma WA � Improve medication safety by assisting pharmacists to collect up-to-date prior-to-admission medication lists for patient admitted to the hospital. � Update and clarify allergy information in patients' records in an electronic health record. � To optimize the medication reconciliation process and decrease the number of med errors due to incomplete or inaccurate information.

Tech Check Tech Programs � Tech-check-tech (TCT) programs are authorized by pharmacy boards in at least 9 states � A metaanalysis of 11 studies published since 1978 shows that technicians have comparable accuracy to pharmacists in performing final checks when restocking automated medication dispensing systems Adams AJ, Martin SJ, Stolpe SF. "Tech-check-tech": a review of the evidence on its safety and benefits. Am J Health Syst Pharm. 2011; 68(19): 1824 -1833.

CDTM in NYS Kimberly Zammit, Pharm. D, BCPS, BCCCP, FASHP

CDTM: 1997

CDTM: 2003

CDTM: 2015

CDTM in New York State 2015 � Authorizes pharmacists to perform collaborative drug therapy management � Defines Clinical Services � The collection and interpretation of patient data for the purpose of initiating, modifying and monitoring drug therapy with associated accountability and responsibility for outcomes in a direct patient care setting. � Defines Collaborative drug therapy management � The performance of clinical services by pharmacists relating to the review, evaluation and management of drug therapy to a patient, who is being treated by a physician for a specific disease or disease states, in accordance with a written agreement or protocol with a voluntarily participating physician and in accordance with the policies, procedures, and protocols of a facility.

CDTM in New York State 2015 � Defines scpe of CDTM � Pharmacists may conduct the following activities as authorized in the written order or protocol. � Adjust or manage a drug regimen of a patient which may include adjusting drug strength, frequency of administration or route of administration or selecting a drug which differs from that initially prescribed � Ordering disease state laboratory tests related to the drug therapy management for the specific disease or disease states specified within the written agreement or protocol; � Ordering or performing routine patient monitoring functions as may be necessary in the drug therapy management � Required Documentation � Pharmacists shall be required to document in the patient record changes made to the patient's drug therapy and shall use any reasonable means or method established by the facility or medical practice to notify the patient's other treating physician, physician assistants, nurse practitioners and other professionals as required by the written agreement or protocol

CDTM in New York State 2015 � Defines sites for CDTM � A teaching hospital or general hospital, including any diagnostic center, treatment center, or hospital-based out-patient department as defined in section 2801 of the Public Health Law; or � A nursing home with an on-site pharmacy staffed by a licensed pharmacist � Facility shall not include dental clinics, dental dispensaries, residential health care facilities and rehabilitation centers.

CDTM in New York State 2015 � Informed Consent Requirement � Patient’s right to choose to not participate in CDTM shall be disclosed to any patient � Patient or the patient’s authorized representative must consent, in writing, to such management. Such consent (or its withdrawal) shall be noted on the patient’s medical record. � The existence of the written agreement or protocol and the patient’s consent to such management shall be disclosed to the patient’s primary care physician and any other treating physician or healthcare provider. � Participation in a written agreement or protocol authorizing collaborative drug therapy management shall be voluntary, and no patient, physician, pharmacist, or facility shall be required to participate.

CDTM Qualifications and How should we ensure competence? BOP Credentialing

“It has become increasingly difficult to keep abreast of and to assimilate the investigative reports which accumulate day after day. [My colleague]. . . was ill at ease because he felt unable to control even the area of his own discipline; one suffocates, he once told me, through exposure to the massive body of rapidly growing information. ” Dr. Bernhard von Langenbeck, 1872 Zeiger RF J Gen Intern Med 2004; 20: 91– 94.

Why credentialing in pharmacy? � Increasing complexity in healthcare � Technology advancement � Expectation of pharmacist involvement in patient care teams � Participation / management of advanced practice activities � Demand for safe, effective and high quality care � IOM report – licensure/CE inadequate � Consumer group/public demand � Scrutiny by hospital quality and risk departments

Competency Assessment Method Initial Ongoing Licensure X Residency / Fellowship X Employer X X Board Certifications X X Traineeships X Continuing Education Programs X Self Assessment X X

CDTM in New York State 2015 � Qualifications � Qualified pharmacists may not engage in CDTM without specific approval from SED. � Pharmacists must submit the Pharmacist Collaborative Drug Therapy Management application form along with the required supporting documentation prior to entering into CDTM practice. � Pharmacists who SED determines to meet the requirements and who are employed by or otherwise affiliated with a facility shall be permitted to enter into a written agreement or protocol with a physician authorizing collaborative drug therapy management, and shall be identified as being so authorized by a designation determined by the department.

CDTM Credentialing MANDATORY Requirements � Years of Licensure � Current, active NYS license � Duration of licensure is dependent on the degree � Pharm. D or MS require two years � BS requires three in the last seven � Clinical Experience � Minimum 1 year of clinical experience as a licensed pharmacist. � Not less than 15 hours per week � Residency training may be used to meet this requirement � Defined as the provision of clinical services in a health facility, which involves consultation with physicians with respect to drug therapy and may include a residency at a facility involving such consultation � All clinical experience must have been gained within the 3

CDTM Credentialing Requirements ADDITIONAL Requirements � Board Certification � Residency Training � Certification by an � Completion of an accredited accreditation body approved by the board (e. g. ): � � � Board of Pharmaceutical Specialties National Certification Board for Anticoagulation Providers American Academy of HIV Medicine � Terminal certification programs will not meet this requirement. http: //pharmacycredentialing. org/ http: //www. bpsweb. org/ or accreditation-pending residency program is required if not board certified � If residency training is used to meet mandatory clinical experience then either of the following must be obtained: � � Board certification (criteria 3) OR Additional year of clinical experience

CDTM Credentialing Requirements Criteria 1 Number of Years of Licensure > 2 Must meet BOTH Criteria 1 and 2 Terminal Criteria 2 Clinical Experience > 1 year Degree: Pharm. D or In addition, one of the following must be met: MS in If no must meet Criteria Clinical Criteria 3 Board Certified 4 Pharmacy If no must meet Criteria 4 Residency 3 Criteria 1 Number of Years of Licensure > 3 Terminal Degree: BS in Pharmacy Criteria 2 Clinical Experience > 1 year Must meet BOTH Criteria 1 and 2 In addition, one of the following must be met: Criteria 3 Board Certified Criteria 4 Residency If no must meet Criteria 4 If no must meet Criteria

Board Certification �Pharmacist-only � Board of Pharmaceutical Specialties (BPS) � Ambulatory, Geriatrics, Nuclear, Nutrition Support , Oncology, Pharmacotherapy, Psychiatry, Pediatric and Critical Care � BPS is recognized by the National Commission for Certifying Agencies � Cardiology and Infectious Disease �Multidisciplinary � Various certification bodies � Anticoagulation, Asthma, BLS/ACLS, Clinical Pharmacology, Diabetes (education and management), Health Information Technology, HIV, Lipids, Pain (education and management), Poison information, Toxicology http: //www. pharmacycredentialing. org/Files/Certification. Programs. pdf

http: //www. op. nysed. gov/prof/pharm/

CDTM in New York State 2015 � Pharmacists who do not meet qualifications � A licensed pharmacist may engage in clinical services associated with collaborative drug therapy management, in order to gain experience necessary to meet that qualification � Such practice must be: �Under the supervision of a pharmacist that currently meets the referenced requirement �Authorized under the written agreement or protocol with the physician.

Comprehensive Medication Management � The standard of care that ensures each patient’s medications (includes all Rx, OTC, Herbals, etc) are individually assessed to determine that each medication is: � Appropriate for the patient � Effective for the medical condition � Safe given the comorbidities and other medications � Able to be taken by the patient as intended � Includes an individualized care plan that achieves the intended goals of therapy with appropriate follow-up to determine actual patient outcomes. � The patient understands, agrees with, and actively participates in the treatment regimen, thus optimizing each patient’s medication experience and clinical http: //www. pcpcc. org/sites/default/files/media/medmanagement. pdf

CDTM Demonstration Results Economic Impact Estimated Annual Savings (millions) Diabetes Heart Failure Anticoagulation Asthma 0 200 400 600 800 1000 1200 1400 1600