2016 Pharmacy Law Update Steven Saxe, R.Ph., FACHE Executive Director Pharmacy Quality Assurance Commission Department of Health Presentation Topics Pharmacy Quality Assurance Commission Vision and Mission 2015 / 2016 legislation relevant to pharmacy Overview of PQAC subcommittee rules work Patient counseling Pharmacy technicians Pharmacy inspections Complaint and discipline process Commission Members Tim Lynch, PharmD, MS, Chair Nancy Hecox, PharmD, CDP, Vice Chair Cheryl Adams, PharmD Jerrie Allard, Public Member Steve Anderson, R.Ph. Chris Barry, R.Ph. Olgy Diaz, Public Member Teri Ferreira, R.PH Judy Guenther, Public Member Elizabeth Jensen, PharmD Kenneth Kenyon, PharmD Matthew Ronayne, R.Ph. Maureen Sparks, CPhT Arun Sambataro, Public Member Sepi Soleimanpour, R.Ph., MBA HA 1
Commission Staff Members Steven Saxe, RPh, FACHE Executive Director (360) 236 4853 Doreen Beebe Program Manager (360) 236 4834 Lisa Roberts PharmD Pharmacist Consultant (360) 236 4999 Rich Cieslinski, RPh Pharmacist Consultant / Rules Coordinator (360) 236 4861 Leann George Senior Secretary (360) 236 4946 Irina Tiginyanu Pharmacy Tech Analyst (360) 236 4827 Office of Investigation & Inspections Pharmacist Investigators Grace Cheung NW King (253) 395 6714 Julie Faun E King & NC WA (253) 395 6719 Tina Lacey NW WA (360) 236 4648 Greg Lang Seattle (253) 395 6721 G Stan Moore Pierce & SE King (360) 236 4635 Pam Sanders Olympic Peninsula (360) 236 2923 Heidi McKinnon SW King (253) 395 6718 Brad Dykstra SW WA (360) 236 4833 Tyler Varnum Near East WA (509) 574 0140 Eleanor Doss Far East WA (509) 329 2206 Chris Humberson (253) 395 6790 Gordon MacDonald Pharmacist Investigator Supervisor (360) 236 4817 PQAC Mission and Vision Mission Statement: The mission of PQAC is to promote public health and safety by establishing the highest standards in the practice of pharmacy and to advocate for patient safety through effective communication with the public, profession, Department of Health, Governor, and the Legislature. Vision Statement: The Washington State Pharmacy Commission leads in creating a climate for the patient focused practice of pharmacy as an integral part of an accessible, quality based health care system. As a result, the citizens of Washington State: Are well informed about their medication therapy; Take responsibility and actively participate in their health outcomes; Utilize pharmacists and other health care providers appropriately; and Experience the highest level of health and wellness. 2
2015 Legislation SHB 1625 Providing Drugs to Ambulances: Effective July 24, 2015 Allows hospital pharmacies to provide drugs to ambulance or aid services for use associated with providing emergency medical services provided: same or adjacent county to the county; Drugs requested by the medical program director are based on agreed patient care protocols. ESHB 1671 Opioid Overdose Medications: Effective July 24, 2015 The law is intended to increase access to opioid overdose medications. Health care practitioners may administer, prescribe, and dispense opioid overdose medications to people at risk of experiencing a drug overdose. Pharmacist dispensing provide written instruction on proper response. 3
SSB 5268 Eye Drop Refills: Effective July 24, 2015 Permits a pharmacist to obtain a new prescription, or to refill a prescription for topical ophthalmic products, at 70% of the predicted days of use. This legislation does not require the insurance carrier to pay for the early refills. ESSB 5441 Patient Medication Coordination: Effective July 24, 2015 Health benefit plans with prescription coverage to implement a medication synchronization. Inform the patient of the change in quantity. May deny if patient safety or abuse concerns. ESSB 5460 Prepackaged ER Medications (Multiple Parts): Effective May 11, 2015 Permits dispense prepackaged emergency medications to patients discharged from a hospital emergency room (ER) when: community or outpatient hospital pharmacies are not available within 15 miles by road, or a patient has no reasonable ability to reach the local or community pharmacy. The pharmacy director must develop policies and procedures. Dispensing limit is set to no more than a 48 hour supply, at a maximum, except when community or outpatient hospital pharmacy services will not be available. In no case may the policy allow a supply exceeding 96 hours. 4
ESSB 5460 Prepackaged ER Medications (cont.) Other provisions of the law: Permits a hospital pharmacy to distribute medication intracompany (common ownership or control) without a wholesaler s license. Permits single or multi practitioner clinics owned or operated by a hospital to be listed under the hospital pharmacy license for the possession of drugs. Redefines what facilities may be licensed as a health care entity (HCE) to include residential treatment facilities. SB 5935 Biologic Products: Effective July 24, 2015 When authorized by the prescriber, law allows a biological product to be substituted if the federal Food and Drug Administration (FDA) has determined the product is interchangeable. If dispense as written indicated, substitution is not allowed. New Pharmacy Sign Required RCW 69.41.160 Under Washington law, a less expensive interchangeable biological product or equivalent drug may in some cases be substituted for the drug prescribed by your doctor. Such substitution, however, may only be made with the consent of your doctor. Please consult your pharmacist or physician for more information. 5
SSB 5293 Use of Hydrocodone Products by Licensed Optometrists: Effective July 24, 2015 Law allows WA licensed optometrists to prescribe, dispense, purchase, possess, or administer Schedule II hydrocodone combination products. ESSB 5557 Pharmacists as Providers: Effective July 24, 2015 The law prohibits a health plan from denying benefits for health care services performed by a pharmacist under certain circumstances. ESSB 5577 Pharmaceutical Waste: Effective July 24, 2015 Requires the WA State Department of Ecology (DOE) to convene a workgroup by September 1, 2015 Identify problems with proper management of pharmaceutical waste Develop recommendations to the legislature by December 31, 2015. 6
ESSB 6052 Budget Proviso Long Term Care Pharmacies Pharmacy Commission working with stakeholders to develop recommendations for long term care pharmacies. Report recommended definitions and standards. Was incorporated into legislation in 2016. 2016 Legislation HB 1528 Epinephrine Autoinjectors Allows prescribe epinephrine autoinjectors to authorized entities Authorized entities can be a restaurant or sports league. The department must develop a form for tracking incidents using epinephrine autoinjectors The department will annually publish a report. 7
SB 6238 Prescribing Non narcotic Schedule II Amends RCW 69.50.402 Allows prescribing of a non narcotic schedule II for any disease state or condition approved by the FDA Not only those listed in the current law. ESHB 2458 Prescription Donation Program Effective on January 1, 2017 Allows a patient or representative to donate certain prescriptions and supplies to a pharmacy for redistribution Redistribution is free to other uninsured patients. Donations are limited to those with a time temperature indicator. The department must develop forms for release of drugs and certifying the condition of the drugs HB 2681 Pharmacist prescribe and dispense contraceptives Effective January 1, 2017 Pharmacy Commission to create a sticker or sign for pharmacy's Sticker indicates a pharmacist can prescribe and dispense over the counter self administered contraception. 8
HB 2793 Providing Suicide Awareness Establishes UW lead safe homes task force. Requires training for pharmacists on suicide assessment, treatment, and management. Requires state schools of pharmacy to develop curriculum for pharmacy students. Requires distribution of medication safe storage and disposal information. SSB 6569 Creating a task force on high out of pocket Rx costs The department must convene a task force by July 1, 2016 to examine high out of pocket medication costs. Recommendations must be summarized to the legislature by December 1, 2016. Kathy Lofy, MD, State Health Officer, will confene the task force. SB 6203 Updating Long Term Care Statutes This bill establishes standards for the practice of pharmacy in long term care facilities. 9
SB 6558 Hospital Pharmacy Licensing This bill clarifies SB5460 from 2015 Allows clinics associated with hospitals to be licensed under the hospital pharmacy license. The bill requires an emergency rule for full implementation by September 8, 2016 SB 5549 Registration and discipline of Pharmacy Assistants Allows the secretary to establish fees for pharmacy assistants. Current law states that the fee is covered by ancillary pharmacy fees. Costs of credentialing this group needs more funding. Fees should be in place by February 1, 2017. SHB 2448 Practice of East Asian Medicine Therapies Requires the department to work with the East Asian Advisory Committee to define point injection therapy. Point injection therapy includes injection of substances like sterile water or vitamin B12 (Aquapuncture) Does not include steroids or controlled substances. 10
SSB 5857 Regulation of Pharmacy Benefit Managers Moves the regulation of Pharmacy Benefit Managers from the Department of Revenue to the Office of the Insurance Commissioner. The Insuracnce Commissioner will now set the fees and allow an appeal process Rules in Progress The Commission re prioritized rulemaking efforts in October 2015 to focus on: Pharmacy Technology Pharmacy Inspections Automated Drug Dispensing Devices (ADDDs) March April 2016, 2 nd Preliminary Draft and review period take place. May 12, 2016 Subcommittee recommends preliminary draft be presented to full commission. May 26, 2016 Commission will consider draft language to move forward to the next formal step of rulemaking. Dec. 15 Feb. 16 1 st Preliminary Draft and review period take place. Nov. 15 Subcommittee recommends ADDDs rule move forward as first technology rule. 11
Inspection Process Rulemaking Inspections subcommittee has met 3 times for open discussion meetings. Different models and ideals regarding a future inspection process were discussed. At the final meeting, it was generally agreed to recommend to the full commission to enter into rule drafting. The rule drafting would change pharmacy inspections from a point categorization to a notice of deficiency/plan of correction, similar to other facilities inspected in WA. Sterile Compounding Checklist The United States Pharmacopeia (USP) <797> is the national standard written into Washington state law, RCW 18.64.270 (2), to require safe and appropriate pharmacy compounding services. This checklist is designed to be a tool to guide and aid in evaluating and self assessing compliance with USP <797>, and does not replace U.S. Pharmacopeia (USP) <797> Pharmaceutical Compounding Sterile Preparations. This checklist includes the shalls in U.S. Pharmacopeia (USP) <797> Pharmaceutical Compounding Sterile Preparations. Investigators will not use the checklist to measure compliance, but may use it as a reference document. Additional Rules in Progress Safe Compounding Practices Continuity of Care During a Declared Emergency Sexual Misconduct Controlled Substance Updates Electronic Transmission of Rx Information 12
Additional Rules in Progress (continued) Remote Order Processing / Telepharmacy Identification of Legend Drugs for Purposes of Chapter 69.41 RCW Update WAC 246 886 180 Chemical Capture Programs Participate in Rulemaking The Commission welcomes stakeholders to become involved in rulemaking efforts. Sign up to receive ListServ notices on the Commission website. Patient Counseling WAC 246 869 220 In Washington State, the pharmacist must counsel their patients about their medications. The pharmacist must counsel patients about new prescriptions and when required on refill prescriptions. A renewal of an old prescription is considered a new prescription for which counseling is required. Only the pharmacist can accept the rejection of a counsel by the patient. 13
Pharmacy Technician Ratio RCW 18.64A. 010(6)(a) and 40 The ratio of one pharmacist to a maximum of three technicians is established for each pharmacy, provided an ancillary utilization plan (AUP) is submitted to the Commission. Pharmacy technicians in training are counted in 3:1 ratio per RCW and must work under the immediate supervision of a pharmacist preceptor or a delegated alternate pharmacist. AUPs must be on file in the pharmacy and must be up to date. Responsible Pharmacy Manager and entity license are held accountable. Pharmacy Technician Functions WAC 246 901 020 Pharmacy technicians may perform certain non discretionary and specialized functions consistent with their training in pharmacy practice while under the immediate supervision of a pharmacist. Entry of new medication orders; Retrieval of the drug product to fill a prescription; Provide medication data when no interpretation is required Pharmacy Technicians CANNOT initiate transfer of prescriptions, either by phone or fax. Initiation must be done by a pharmacist, not delegated. Only a pharmacist may review a patient drug order, examine the patient s drug profile, and approve the drug order after taking into account pertinent drug and disease information for a specific patient which must be verified by an audit trail. Technician Specialized Functions WAC 246 901 035 WAC 246 901 035 Pharmacy technician specialized functions. A pharmacy technician who meets established criteria for employment, experience, training and demonstrated proficiency may perform specialized functions. The criteria shall be specified in the utilization plan of the pharmacy for pharmacy technicians. See WAC 246 901 100 for specific requirements needed with the utilization plan submitted to the Commission. Technician Specialized Functions include, but are not limited to: Unit Dose medication checking Intravenous admixture and other parenteral preparations Medication reconciliation 14
Pharmacy Inspection Process WAC 246 869 190 (1) All pharmacies shall be subject to periodic inspections to determine compliance with the laws regulating the practice of pharmacy. (2) Each inspected pharmacy shall receive a classification rating which will depend upon the extent of that pharmacy's compliance with the inspection standards. Top Violations Community/Retail Inspections 1. WAC 246 875: Patient Medication Record Systems (35%) 2. WAC 246 869 230: Child resistant containers (9%) 3. WAC 246 869 150: Physical Standards for Pharmacies Outdated Stock (9%) Top Violations Community/Retail Inspections 4. Violations of WAC 246 869 210: Prescription Labeling (8%) 5. WAC 246 869 100: Prescription Record Requirements (7%) These five violations represent 68% of all violations cited in community/retail pharmacy inspections 15
Complaint Process Complaint Intake. http://www.doh.wa.gov/licensespermitsandcertificates/filecomplaint AboutProviderorFacility Case Management Team (CMT) review. Reviewed by panel of three commission members. Determine whether to investigate, refer, or close. If opened, assigned to an Investigator. The findings are sent to a Reviewing Commission Member Presented by Reviewing Commission member to a Commission panel to determine if action needed. Final action Notice of Correction Stipulation for Informal Disposition Agreed Order Final Order (Sanction Guidelines) Pharmacy Commission Info Receiving the Quarterly Newsletter, and listserv and email notices: Washington Pharmacists, Technicians, Interns, & Assistants (Meeting & Agendas, Newsletter) Join the Commission listservs for stakeholders: For newsletters: http://listserv.wa.gov/cgi bin/wa?subed1=wsbop NEWSLETTER&A=1 For forms and info: http://listserv.wa.gov/cgi bin/wa?subed1=wsbop RULES&A=1 Mail: PO Box 47852, Olympia, WA 98504 7852 Questions? 16
Mandatory Reporting WAC 246 16 200 thru 265 What must be reported: Any conviction, determination, or finding that a license holder has committed an act that constitutes unprofessional conduct. Who must report: All DOH licensees are required to report; others are encouraged to report. Who Can Prescribe? RCW 69.41.030 & RCW 69.50.101(w)(3) Who can prescribe and administer prescriptions in Washington state? Click on More Resources (right side of PQAC webpages), then on link Who can prescribe and administer RX in Washington State? http://www.doh.wa.gov/portals/1/documents/pubs/690158.pdf Washington Pharmacies can accept prescriptions from any out of state ARNP or PA after ascertaining that their scope is the equivalent to Washington State. Different states may call them different names. For controlled substances, the DEA publishes a Mid Level Practitioners document on Authorization by State. http://www.deadiversion.usdoj.gov/drugreg/practioners/ Prescriptions CANNOT be filled for out of state Naturopathic Physicians. 17
Patient Specific Information WAC 246 863 095 & 246 875 070 It is unprofessional conduct for a pharmacy or any pharmacy staff to violate a patient s privacy. Is your counseling area HIPPA compliant? What about your clinical areas? Do not discuss patient info inappropriately Safeguard information stored in computer? Properly dispose of leaflets and labeled vials? Immunizations behind a dedicated/private space? You should also consider the proper disposal of pharmacy information WAC 246 869 230 The patient or his agent may sign a statement on a patient medication record requesting containers that are not child resistant 18