MARYLAND BOARD OF PHARMACY

MARYLAND BOARD OF PHARMACY CONTRACEPTION REGULATIONSAnd Other Legislative Initiatives THE ROAD FROM CONCEPTUALIZATION TO IMPLEMENTATION Deena Speights-Napata Executive Director Maryland Board of Pharmacy STAKEHOLDER PARTICIPATION Maryland Board of Pharmacy Maryland Pharmacists Association Rite Aide University of Maryland Eastern Shore School of Pharmacy Maryland Board of Nursing American College of Nurse Midwives Maryland Planned Parenthood Maryland Association of Chain Drug Stores Baltimore City Health Department Maryland House of Delegates Representative Shelly Hettleman American Academy of Pediatrics University of Maryland School of Pharmacy, Baltimore Veru Healthcare Maryland Medicaid Maryland Insurance Administration The Maryland State Medical Society Maryland Chapter American Maryland Academy of Pediatrics College of Obstetricians and Gynecologist Mid-Atlantic Association of Community Health Centers 1

Stakeholder Meeting Schedule Five Stakeholder Meetings 7/20/2017 Contraceptive Workgroup Meeting (Live) 9:00 12:00 held at University of Maryland, School of Pharmacy, Baltimore, Md. 8/1/2017 Contraceptive Workgroup 2:00-5:00, Teleconference 8/3/217 Contraceptive Workgroup (Live) 9-12, held at University of Maryland, School of Pharmacy, Baltimore, Md. 8/15/17 Contraceptive Workgroup (Live) 9-12, held at University of Maryland, School of Pharmacy, Baltimore, Md. and Contraceptive Workgroup 1:00-4:00, Teleconference Meeting 9/28/17 Contraceptive Workgroup Meeting (Live), 4201 PattersonAve., Baltimore, Md. CHALLENGES TO THE PROCESS Scheduling of meetings Inclusion of teleconferences and live meetings Competing interests among stakeholders: reconciliation and clarification of positions Different positions within individual stakeholder groups Reaching consensus KEY ELEMENTS OF THE REGULATIONS Attestation Form: At least 15 days before prescribing contraceptives, shall submit to the Board a notification form, which includes an attestation of the pharmacist s formal education program. A pharmacist may not prescribe contraceptives until the pharmacist receives a written confirmation from the Board accepting the pharmacist s notification form. Continuing Education Requirement: A pharmacist who prescribes contraceptives in Maryland shall earn 1 hour of Board-approved continuing pharmaceutical education related to contraception before the pharmacist s license renewal date 2

Key Elements Board Responsibilities. The Board shall develop and adopt the following items, in consultation with stakeholders to be determined by the Board: (1) A self-screening risk assessment questionnaire that a patient shall complete before a pharmacist may prescribe contraceptives for a patient; (2) A standard procedure contraceptive algorithm which the pharmacist shall use to perform a patient assessment for purposes of determining: (. a) Whether to prescribe contraceptives; and (b) Which contraceptive options to prescribe; (3) A notification form to be submitted by a pharmacist before prescribing contraceptives; and (4) Other forms and procedures for: (a) The prescription of contraceptives; and (b) Referral to a primary care or reproductive health care practitioner for treatment At a minimum, a Board-approved training program shall contain the following elements: A. An overview of contraceptive medications and selfadministered contraceptive devices; B. An overview of the self-screening risk assessment questionnaire; C. An overview of the standard procedure contraceptive algorithm; and D. An overview of the U.S. Medical Eligibility Criteria 3

for Contraceptive Use and other Center For a minimum of 5 years, the pharmacy whose pharmacists prescribe contraceptives shall maintain documentation, in electronic or other form, which includes: A. The type of contraceptive prescribed, and dosage, if applicable, or the basis for not prescribing a contraceptive; B. The name, address, and date of birth of the patient; for Disease Control guidance on contraception. C. The name of the pharmacist who prescribed the contraceptive or determined a contraceptive would not be prescribed; D. The date the contraceptive was prescribed or that the patient was advised that a contraceptive would not be prescribed; E. A copy of the patient s visit summary; F. A copy of the patient s self screening risk assessment questionnaire; and G. The name and address of the: (1) Patient s primary care practitioner or reproductive health care practitioner, if provided by the patient; or (2) Family planning provider or licensed clinician who provides reproductive health care services referred by the pharmacist, if the patient does not have a primary care practitioner or reproductive health care practitioner 4

NEXT STEPS Presentation at NABP Annual Meeting Denver, CO May 4-8, 2018 Stakeholder Meeting: Monday, May 14, 2018 9:30 AM-1 PM Board of Pharmacy 4201 Patterson Avenue, Baltimore, MD 21215 Adoption of regulations mandated to occur by September 1, 2018 Other Significant Bills in 2018 Legislative Session 5

PASSED BILL NO: SB 549/HB 591 TITLE: Health Occupations PhysicianAssistants Dispensing of Drug Under a Delegation Agreement The Maryland Board of Pharmacy ( Board ) supported SB 549 (Health Occupations Physician Assistants Dispensing of Prescription Drugs Under a Delegation Agreement), but requests that the bill limit the dispensing authority given to PAs to include only non-cds medications. While current law allows a PAto prescribe drugs, including Schedule II through V CDSs, in accordance with the PA s delegation agreement, SB 549 would allow supervising physicians to delegate dispensing authority of such drugs to PAs. Notably, SB 549 would allow PAs to personally prepare and dispense Schedule II CDS opioids such as oxycodone, fentanyl, and hydromorphone. While granting PAs authority to prepare and dispense certain drugs may prove convenient in certain situations to patients and physicians, it is the Board s opinion that allowing PAs to personally prepare and dispense CDSs, especially opioids, is inconsistent with the State of Maryland s efforts to combat the opioid crisis. On May 25, 2017, Governor Hogan signed the Prescriber Limits Act of 2017, in which the General Assembly declared that the rise in overdose deaths attributable to opioids stemmed, in part, from a dramatic increase in the number of opioid prescriptions issued by the medical community. At a time when the focus of the legislature is on combating the scourge of opioid addiction, providing authority to PAs to dispense CDSs increases the availability of these dangerous substances. Accordingly, the Board supports SB 549, but respectfully asks that the proposed language be amended to prohibit PAs from dispensing Schedules II through V CDSs. PASSED HB 88 Prescription Drug Monitoring Program Requiring instead of authorizing, theprescription Drug Monitoring Programto review prescription monitoring data for indications ofa possible misuse or abuseof a monitored prescription drug; requiring, insteadof authorizing, the Programto reportthe possible misuse or abuseto the prescriber ordispenserof the monitored prescription drug under certain circumstances; requiring the Programto provide education to theprescriber or dispenser of the monitored prescription drug under certain circumstances; requiring, insteadof authorizing, the Programto review prescription monitoring datafor indications of a possible violation of law or a possible breach of professional standards by a prescriber or a dispenser; requiring, instead of authorizing, the Program to notify the prescriber or dispenserof the possible violation of law or possible breach of professional standardsandprovide education to theprescriber or dispenser; authorizing the Program to notify the appropriate law enforcement agency or health occupations boardof a possible violation of law or a possible breach of professional standards by a prescriber or dispenser 6

requiring the Program, under certain circumstances, to provide the law enforcement agency or health occupations board with the prescription monitoring data necessary for an investigation; altering the circumstances under which the Program is required to obtain certain guidance and interpretation from the technical advisory committee; requiring the Program to take into account certain factors in making a certain determination; prohibiting the obtaining of certain guidance and interpretation from the technical advisory committee from delaying the reporting of a possible violation of law or a possible breach of professional standards to a law enforcement agency or a health occupations board under certain circumstances; REGULATIONS NEEDED Must specify data required Must specify means by which data is to be submitted, without unduly increasing the workload and expense on dispensers; and In a manner as compatible as possible with existing data submission practices of dispensers; Must specify that the information be submitted by dispensers once every 24 hours Specify that the Program: 28 Shall provide the information technology software to dispensers 29 necessary to upload prescription drug monitoring data to the Program; and 30 May not impose any fees or other assessments on prescribers or dispensers to support the operation of the Program; Must Identify the mechanism by which prescription monitoring data are disclosed to a person, in accordance with 21 2A 06 of this subtitle; Must Identify the circumstances under which a person may disclose prescription monitoring data received under the Program Specify the process for the Program s review of prescription monitoring data and reporting of: (i) Possible misuse or abuse of a monitored prescription drug under 8 21 2A 06(c) of this subtitle; or (ii) A possible violation of law or possible breach of professional standards under 21 2A 06(d) of this subtitle; (8) Establish requirements for Program retention of prescription monitoring data for 3 years; and (9) Require that: i) Confidential or privileged patient information be kept confidential; and (ii) Records or information protected by a privilege between a health care provider and a patient, or otherwise required by law to be held confidential, be filed in a manner that, except as otherwise provided in 21 2A 06 of this subtitle, does not disclose the identity of the person protected. 7

PASSED BILL NO: HB 1558 COMMITTEE: Health and Government Operations POSITION: Letter of Concern TITLE: Pharmacists Dispensing of Prescription Drugs Single Dispensing of Dosage Units The Maryland State Board of Pharmacy wishes to express concern about HB 1558 (Pharmacists Dispensing of Prescription Drugs Single Dispensing of Dosage Units). Under current law, when dispensing drugs to patients, a pharmacist is limited to the dosage units provided in a prescription. If a patient requests that a pharmacist dispense a greater number of dosage units than that authorized by the prescriber in a prescription, the pharmacist may not dispense more than the number of dosage units prescribed, even if the prescription allows for refills. Rather, the pharmacist must contact the prescriber and receive authorization to provide a number of dosage units beyond that authorized in the original prescription. This bill would provide pharmacists with discretion in certain situations to dispense the total number of dosage units authorized by the original prescription and any refills up to 90 days (6 months for contraceptives) without contacting the prescriber for authorization. While granting a pharmacist such discretion may prove convenient for patients, HB 1558 presents concerns for public safety. A prescriber, in determining the appropriate number of dosage units to give to a patient for any given period of time, bases the decision on patient information to which he or she is privy. The prescriber would have greater knowledge of the patient s background, including their medical history, personal and social background, family history and genetic risk factors, and other factors that are not likely to surface within a pharmacist-patient relationship. Accordingly, prescriber may have written the prescription providing for refills intentionally to limit the patient s access to a large quantity at any given time. Allowing a pharmacist to unilaterally change the mode of dispensing without consultation with the prescriber may not be in the best interests of the patient. While attempting to provide a convenience to the patient, this bill may have unintended consequences that could be harmful. For this reason, the Maryland Board of Pharmacy wishes to express its concern. PASSED HB 922 Maryland Department of Health Pill Mill Tip Line On or before 12-1-18: Requires MDH to establish a tip line through which a person may report prescribers who the reporting person suspects is prescribing medication or overprescribing medication. The Department is responsible for ensuring that certain reports are investigated by the appropriate licensing board 8

FAILED BILL NO: HB 1716 COMMITTEE: Health and Government Operations POSITION: Letter of Concern TITLE: Prescription Drug Monitoring Program Prescription Monitoring Data Insurance Carriers HB 1716 would require the Prescription Drug Monitoring Program ( PDMP ) to disclose prescription drug monitoring data to a carrier, as defined in the Insurance Article, for determining the medical necessity of a drug claim, enhancing or coordinating patient care, or assisting the treating medical provider s clinical decisionmaking. HB 1716 would expand access to and use of the PDMP in a manner not intended by the initial legislation. The preamble of the 2011 bill which created the PDMP- SB 883- states that the PDMP was intended to support the lawful use of controlled substances without disrupting legitimate medical practice and patient care, and for use by health care and public health professionals to identify and prevent abuse of controlled substances. There is no indication that lawmakers intended for insurance companies to use PDMP data as a tool for determining medical necessity and potentially interfering with accepted medical care. Indeed, the law as currently written, specifically provides: Prescription monitoring data may not be used as the basis for imposing clinical practice standards. Moreover, providing insurance carriers with this information could result in rehabilitation coverage denials, which defeats a primary purpose of PDMP to combat opioid abuse. Additionally, carriers already have access to patients medical records, which would provide information that is more relevant for determining medical necessity than would PDMP monitoring data. Finally, as a practical matter, patients who abuse opioids generally pay cash for their medication and do not seek insurance coverage; thus, the carriers would not be harmed financially by not having PDMP data. FAILED HB 1730 Distribution of Heroin or Fentanyl Resulting in Death Would have prohibited a person from distributing heroin or fentanyl that contributed to the death of another FAILED HB 1764 Dispensing of Naloxone by Paramedics Would have allowed a paramedic the authority to dispense naloxone in a non-emergency environment 9