Missouri Board Of Pharmacy 2014 Legislative/Rule Update Kim Grinston, J.D. Executive Director Objectives Discuss Missouri pharmacy law. Identify regulatory changes and initiatives related to Missouri law. This CPE is accredited by ACPE for both Pharmacy Technicians and Pharmacists To obtain our objectives of this presentation: Attendees will be informed on the following: Updates on 2014 legislative actions relating to pharmacy practice Update on new and pending Board rules Ms. Kim Grinston does not have conflicts of interest to disclose to the attendees of this meeting or to the CPE Accrediting Body Other Board changes/updates Assessment Questions Can a pharmacy fill a Rx written by a Missouri Assistant Physician after 8/28? Will pharmacists be able to automatically administer hep A, hep B, tetanus, diphtheria and pertussis vaccines on 8/28? Can a RPh submit their renewal application before completing their CE? Naloxone sales to law enforcement agencies should be documented in the pharmacy s prescription records? True or false. Disclaimer This presentation is provided for informational purposes only. The statements provided today are not legally binding and do not constitute opinions of the Board. This presentation does not constitute a comprehensive review of all governing law or controlled substance requirements. To ensure compliance, licensees should thoroughly review Chapter 338, RSMo, 20 CSR 2220 and all applicable state and federal laws. This presentation does not constitute a rule statement of general applicability or binding law. In the event of a conflict or inconsistency, duly promulgated or enacted state or federal law shall control. The Board expressly reserves the right to revise the contents as deemed appropriate or necessary. 1
2014 Legislative Changes SB 808 SB 716 SB 754 HB 2040 SB 808- Assistant Physicians Adds an assistant physician license class. Practice restrictions. Will have authority to prescribe. Authority would include controlled substances (III, IV & V). Asst. physicians different from physician assistants. SB 808- Assistant Physicians Board of Healing Arts Statement: Senate bills 716 & 754...established licensure for Assistant Physicians. These bills will become law effective August 28, 2014. However, before the Board can accept applications, the Board will need to establish rules related to licensure, including submission of applications, renewal, supervision, and other matters necessary to protect the public. The rule promulgation process is lengthy; therefore, we do not anticipate the licensure of Assistant Physicians to begin until at least the summer or fall of 2015. Adds hepatitis A & B and diphtheria, tetanus & pertussis. Expanded immunization authority effective 8/28. New Notification of Intent is NOT required. However, new vaccines must be authorized in the protocol. Amendments must be signed by RPh and authorizing physician. No additional training required at this time. (Notification) PCP notification within 14 days mandatory for all vaccines (includes vaccines administered by prescription). Notification must include: The identity of the patient; The identity of the vaccine or vaccines administered; The route of administration; The anatomic site of the administration; The dose administered; and The date of administration. (Notification) Only required if the PCP s information is known. RPh should make a good faith attempt to collect PCP information from the patient (i.e.,- asking verbally or on the immunization authorization form). RPh should document the patient s record when the patient refuses or is unable to provide PCP information. 2
(Adverse Events) A pharmacist who is administering a vaccine shall request a patient to remain in the pharmacy a safe amount of time after administering the vaccine to observe any adverse reactions. Such pharmacist shall have adopted emergency treatment protocols; Pending final rules, pharmacists should use their professional discretion when determining a safe amount of time. RPh should document patient s refusal to stay. (Emergency Treatment Protocols) Emergency treatment protocols: Protocol: 20 CSR 2220-6.050(5)(A) requires that protocols include a course of action the pharmacist shall follow to address emergency situations including, but not limited to, adverse reactions, anaphylactic reactions, and accidental needle sticks. Rx Order: 20 CSR 2220-6.040(4) already requires written policies and procedures covering all aspects of drug administration, including, the appropriate handling of acute adverse events. Statute provides RPh must post an immunization certificate. Board will not be issuing a separate certificate. Post NOI confirmation page or NOI list published by the Board. Alternatively, NOI list may be electronically maintained/accessible at the pharmacy. SB 808- Hospital Pharmacy Allows joint rulemaking authority with the Department of Health for medication dispensing by the pharmacy and MTS services by a pharmacist. Does not include floor meds/other professionals. Does not give the Board full regulatory jurisdiction over hospital in-patient pharmacy. DHSS still has sole jurisdiction over hospital services purely subject to DHSS jurisdiction. SB 808 (Class B Hospital Pharmacy) Class B Hospital Outpatient Pharmacies- May include clinics/facilities under common control, management or ownership of a hospital/hospital system. Hospital is defined in section 197.020. May dispense by Rx or by medication order. May dispense to a hospital clinic of facility onsite administration/dispensing by a health care provider. SB 808- Military Licenses Formalizes Board s current interpretation. So long as the person involved does not represent or hold himself or herself out as a pharmacist licensed to practice in this state, a Missouri pharmacist license shall not be required for a legally qualified pharmacist serving in the armed forces of the [U.S.] or a legally qualified pharmacist employed by the government of the [U.S.] or any bureau, division, or agency thereof who is engaged in the practice of pharmacy while in the discharge of his or her official duties. 3
SB 808- Military Licenses Can t hold themselves out as a Missouri licensed pharmacist. Must be part of their official duties. Would not exempt pharmacists operating independently or outside of their official activities. HB 2040- Naloxone Section 190.255 authorizes any licensed drug distributor or pharmacy to sell naloxone to a qualified first responder agency. [HB 2040]. A qualified first responder agency is defined as any state or local law enforcement agency, fire department or ambulance service that provides documented training to its staff related to the administration of naloxone in an apparent narcotic or opiate overdose situation. HB 2040- Naloxone Sales should be documented by invoice. Invoices should include: The date of sale; Product name; Quantity sold; The identity of the qualified first responder agency; and The transferring pharmacy s full address. Invoices maintained separate from Rx records. HB 2040- Naloxone Drug distributor license not needed, provided the total amount of all medication sold by the pharmacy without a prescription does not exceed five percent (5%) of the pharmacy s total annual prescription drug sales. [ 338.315.2, 338.330(2)]. The 5% limit is calculated based on all drugs sold by the pharmacy and not just naloxone sales. Other Regulatory Updates Mandatory Reporting- Sec. 383.133 Other Regulatory Updates Mandatory Reporting- Sec. 383.133 Any entity that employs a RPh to provide health care services must report: Any final disciplinary action against the pharmacist that might have led to disciplinary action by the Board under sec. 338.055, and Any RPh voluntary resignation against whom any complaints or reports have been made that might have led to disciplinary action. Reporting is required now. Reports should be submitted online. Reports must be made within 15 days of the final disciplinary action/voluntary resignation. 4
Other Regulatory Updates Mandatory Reporting- Sec. 383.133 Examples: Practicing without a license Falsifying Rx Immunizing/administering w/o a protocol Diverting meds/theft Compounding for office stock Dispensing w/o a valid Rx Unlicensed practice/assisting in unlicensed practice. Other Regulatory Updates Sterile compounding rule still under review Pharmacist renewals (10/31/14) CE between 9/1/12 and 10/31/14 CE must be complete when you renew Renewal fee decrease. Pharmacists $50 Interns $20 Techs (possibly $20) *Rule still pending MTS Renewals Same time as RPh license (10/31) 6-hrs MTM CE required. Can be used as part of 30-overall CE hours. Board or ACPE approved. ACPE Universal Activity Number 01 - Drug Therapy Related. MTS Renewals Don t want to renew: Paper renewal OR Notify the Board in advance. E-Mail: pharmacist@pr.mo.gov DO NOT RENEW MTS in subject line. Include license # & DOB Can t renew online without prior notification. Next Lunch with the Chief Webinar BNDD Update with Michael Boeger August 21, 2014 Noon 1PM Future LWTC webinars: October 15, 2014 Assessment Questions Can a pharmacy fill a Rx written by a Missouri Assistant Physician after 8/28? Will pharmacists be able to automatically administer hep A, hep B, tetanus, diphtheria and pertussis vaccines on 8/28? Can a RPh submit their renewal application before completing their CE? Naloxone sales to law enforcement agencies should be documented in the pharmacy s prescription records? True or false. 5
Missouri Board Of Pharmacy 2014 Legislative/Rule Update Kim Grinston, J.D. Executive Director 6