PA 17-131—sHB 7052
General Law Committee
Public Health Committee
AN ACT PREVENTING PRESCRIPTION OPIOID DIVERSION AND ABUSE
SUMMARY: This act makes various changes to prevent and treat opioid drug abuse. Principally, it:
1. allows the Department of Consumer Protection (DCP) commissioner to share certain prescription drug monitoring program information with other state agencies for certain drug abuse studies (§ 1);
2. generally requires prescriptions for controlled substances to be transmitted electronically to a pharmacy, which must have the technology to accept such prescriptions (§ 3);
3. limits access to controlled substances by (a) allowing certain registered nurses employed by home health care agencies to destroy or dispose of them, (b) creating a process for patients to ask that opioids not be prescribed, and (c) generally reducing the amount of opioid drugs a minor may be prescribed (§§ 2, 4, & 5);
4. requires practitioners, when prescribing opioids, to discuss with all patients, rather than only minors, the risks associated with opioid drug use (§ 5);
5. requires the Department of Public Health (DPH), by October 1, 2017, to state on its website how a prescribing practitioner may obtain certification to prescribe take-home medications to treat opioid use disorders (e.g., Suboxone) (§ 6);
6. requires the Alcohol and Drug Policy Council (ADPC) to take certain actions to address opioid drug abuse (§ 7);
7. requires certain individual and group health insurers to cover specified medically necessary, inpatient detoxification services for an insured or enrollee diagnosed with a substance use disorder (§§ 8 & 9);
8. requires alcohol or drug treatment facilities to use admissions criteria developed by the American Society of Addiction Medicine (§ 10);
9. extends the date by which municipalities must amend their local emergency medical services (EMS) plans to require at least one EMS provider likely to arrive first on the scene of a medical emergency to carry an opioid antagonist and complete a training on how to administer it (§ 11); and
10. allows a prescribing practitioner authorized to prescribe an opioid antagonist to issue a standing order (i.e., non-patient specific prescription) to a pharmacy for dispensing opioid antagonists under certain conditions (§ 12).
The act also makes technical and conforming changes. A section-by-section analysis follows.
EFFECTIVE DATE: July 1, 2017, except that the provisions on (1) insurance coverage for substance use disorder and electronic prescription requirements take effect January 1, 2018; (2) standing orders for opioid antagonists and non-opioid directive provisions take effect October 1, 2017; and (3) drug monitoring information sharing and drug disposal took effect June 30, 2017.
§ 1 — PRESCRIPTION DRUG MONITORING PROGRAM INFORMATION SHARING
The act allows the DCP commissioner to provide certain controlled substance prescription information obtained as part of the prescription drug monitoring program (e.g., pharmacy records and certain patient information) to other state agencies. The sharing must be through an agreement between the DCP commissioner and the agency head and the information must be obtained for a study of (1) disease prevention and control related to opioid abuse or (2) morbidity and mortality caused by controlled substance overdose. The information transfer must be done in accordance with all applicable state and federal confidentiality requirements (e.g., the 1996 Health Insurance Portability and Accountability Act).
By law, under the prescription drug monitoring program, DCP collects information on controlled substance prescriptions to prevent improper or illegal drug use or improper prescribing.
§ 2 — CONTROLLED SUBSTANCE DISPOSAL BY CERTAIN NURSES
The act allows a registered nurse employed by a home health care agency, with a patient's designated representative's permission, to oversee the destruction and disposal of the patient's controlled substances. The nurse must use the recommendations for proper disposal of prescription drugs on DCP's website (e.g., adding undesirable substances such as salt, sawdust, or used coffee grounds).
The nurse must maintain written or electronic documentation of such destruction and disposal on a DCP-prescribed form for three years. This documentation must be kept with the patient's medical record.
The act specifies that these provisions do not prevent the nurse and patient's designated representative from depositing the patient's controlled substances in a statutorily authorized prescription drop box.
§ 3 — ELECTRONIC PRESCRIPTIONS FOR CONTROLLED SUBSTANCES
The act, with various exceptions, requires prescriptions for controlled substances to be electronically transmitted. “Electronically transmit” means to transmit by computer modem or other similar electronic device. Prior law allowed prescribers to issue prescriptions for controlled substances in writing, orally, or by electronic transmission. For written prescriptions, under prior law and the act, only original prescriptions are considered valid. Oral prescriptions must, among other things, be promptly reduced to writing.
Under the act, prescribing practitioners of controlled substances, within the scope of their license, generally must electronically transmit controlled substance prescriptions to a pharmacy. The prescriber must promptly print a hard copy of the prescription or create it in an electronic record. Electronically transmitted prescriptions must be consistent with the requirements of the federal Controlled Substances Act (21 U.S.C. § 801). All records must be kept on the prescriber's premises for three years and maintained in a form that is readily available for inspection, at reasonable times, by the DCP commissioner, her authorized agent, or other authorized personnel.
Under the act, as further explained below, prescribing practitioners are not required to electronically transmit a prescription when:
1. there are temporary technological or electrical failures making electronic transmission unavailable;
2. the prescriber reasonably determines that it is impractical for the patient to obtain substances prescribed by an electronically transmitted prescription in a timely manner and the delay would adversely impact the patient's medical condition;
3. the prescription is to be dispensed by an out-of-state pharmacy;
4. the prescription needs special attention and electronic transmission could negatively impact patient care (e.g., compounding); or
5. the prescriber demonstrates that he or she does not have the technological capacity.
The act allows any prescription under any of these exceptions to be issued as a written order or, to the extent allowed by federal law, as an oral order or transmitted by fax. Any oral or faxed order must be promptly written on a prescription blank or hardcopy printout, or created as an electronic record and filed by the pharmacist filling the order. Under the act, as under prior law, duplicates, carbon or photographic copies, and printed or rubber-stamped orders are not valid prescriptions.
Temporary Technological or Electrical Failure. Under the act, a prescribing practitioner is not required to electronically transmit a prescription when electronic transmission is not available because of temporary technological or electrical failures. Instead, the prescriber must, without undue delay, reasonably attempt to correct any cause for the failure that is within his or her control. A prescriber who issues a prescription under this exception must document the reason for failing to electronically transmit the prescription in the patient's medical record as soon as practicable, and must do so within 72 hours after the end of the technological or electrical failure.
“Temporary technological or electrical failure” means a computer system, application, or device failure or the loss of electrical power or any other service interruption to such system, application, or device that reasonably prevents the prescriber from using his or her certified application to electronically transmit the prescription.
Delay that Adversely Impacts Patient's Health. The act does not require electronic prescriptions when the prescriber reasonably determines that it would be impractical for the patient to obtain the prescribed substances by an electronically transmitted prescription in a timely manner and that such delay would adversely impact the patient's medical condition. If it is a controlled substance, the quantity must not exceed a five-day supply. A prescriber who issues a prescription under this exception must document the reason in the patient's medical record.
Out-of-state Pharmacy. The act allows a prescribing practitioner to issue a prescription that is not electronically transmitted if the prescription will be dispensed by an out-of-state pharmacy. The prescriber who issues a prescription under this exception must document the reason in the patient's medical record.
Certain Prescriptions that Need Special Attention. Under the act, a practitioner is not required to electronically transmit a prescription when doing so may negatively impact patient care, such as a prescription:
1. containing two or more products that a pharmacist must compound;
2. for direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous, or intraspinal infusion;
3. that contains long or complicated directions;
4. that the federal Food and Drug and Administration (FDA) requires include certain elements; or
5. that is orally communicated to a pharmacist for a patient in a chronic and convalescent nursing home.
Lack of Technological Capacity. Under the act, prescribing practitioners are not required to electronically transmit prescriptions when they demonstrate, in a DCP-prescribed form and manner, that they do not have the technological capacity to do so.
“Technological capacity” means possessing a computer system, hardware, or device that can be used to electronically transmit controlled substance prescriptions consistent with the federal Controlled Substances Act.
The act requires pharmacies to accept a prescribing practitioner's electronically transmitted controlled substances prescription. All records must be kept on the pharmacy's premises and maintained separately from other business records in a form readily available for inspection, at reasonable times, by the DCP commissioner, her authorized agent, or other authorized personnel. The records must be kept on file for three years and may be stored electronically, provided they are maintained in the pharmacy's computer system for at least three years. If the electronically transmitted prescription is printed, it must be filed in the same way as pharmacies file filled controlled substance prescriptions, which is separately from other prescriptions.
§ 4 — VOLUNTARY NON-OPIOID DIRECTIVE FORM
The act requires DPH, in consultation with DCP and the Department of Mental Health and Addiction Services (DMHAS), to establish a voluntary non-opioid directive form and publish it on the DPH website for public use.
A “voluntary non-opioid directive form” means a form voluntarily filed by a patient with a prescribing practitioner that indicates the patient asks to not be issued a prescription or medication order for an opioid drug.
Under the act, anyone who does not wish to be issued a prescription or medication order for an opioid drug may file such a form with a prescribing practitioner. Upon receiving the form, the practitioner must document it in the patient's medical record.
The form must allow a patient to appoint a duly authorized guardian or health care proxy to override a previously recorded voluntary non-opioid directive form. The patient, guardian, or health care proxy may revoke the directive orally or in writing at any time and for any reason.
Presumption of Valid Prescription
An electronically transmitted prescription to a pharmacy is presumed to be valid for the purposes of complying with these provisions. A pharmacist must not be held in violation of these provisions for dispensing a controlled substance contrary to a voluntary non-opioid directive form.
Immunity from Liability
The act immunizes prescribing practitioners acting with reasonable care from damages in a civil action for refusing to issue a prescription or medication order for an opioid pursuant to a voluntary non-opioid directive form. They also cannot be subject to criminal prosecution or be deemed to have violated their professional standard of care on the basis of such a refusal.
Under the act, no one acting in good faith as a duly authorized guardian or health care proxy may be held liable for civil damages or subject to criminal prosecution for revoking or overriding a voluntary non-opioid directive form.
The act also immunizes emergency departments' prescribing practitioners acting with reasonable care as either a patient's practitioner or the medical control officer for emergency medical services personnel. They are immunized from liability for civil damages, criminal prosecution, or being deemed to have violated the standard of care for issuing a prescription or administering a controlled substance with an opioid to a person who has a voluntary non-opioid directive form if in the professional's medical judgment an opioid was necessary and he or she had no knowledge of the form at the time of issuance or administration.
Under the act, a prescribing practitioner who willfully fails to comply with a patient's voluntary non-opioid directive form may be subject to DPH disciplinary action.
By law, DPH can take the following actions, among others:
1. suspend or revoke the person's DPH license or permit,
2. issue a letter of reprimand to or censure the person,
3. place him or her on probation, or
4. impose a civil penalty of up to $25,000 (CGS § 19a-17).
§ 5 — OPIOID DRUG PRESCRIPTIONS
Prescription Supply for Minors
The act generally reduces, from a seven-day supply to a five-day supply, the maximum amount of an opioid drug a practitioner may prescribe to a minor (i.e., under age 18).
As under existing law, practitioners may prescribe a larger supply of opioid drugs to a minor if, in their professional judgment, the drug is required (1) for palliative care or (2) to treat the person's acute medical condition, chronic pain, or cancer-associated pain.
Discussion of Opioid Addiction Risk
Existing law requires a prescribing practitioner, when issuing an opioid prescription, to discuss with minor patients along with their custodial parent, guardian, or legal custodian, if present, the risks associated with opioid drug use. The act additionally requires prescribers to have such discussions with adult patients. As under existing law, the act requires the practitioner to discuss:
1. the associated risks of addiction and overdose;
2. the dangers of taking opioid drugs with alcohol, benzodiazepines, and other central nervous system depressants; and
3. why the prescription is necessary.
§ 6 — CERTIFICATION TO PRESCRIBE AT-HOME OPIOID USE DISORDER TREATMENTS
By October 1, 2017, the act requires DPH to post information on its website about the ability of a prescribing practitioner to obtain certification to prescribe at-home medication to treat opioid use disorder (e.g., Suboxone). (The act does not specify the type of certification or the certifying organization.) This information must include a list of educational requirements, available courses, and any waivers from these requirements.
§ 7 — ALCOHOL AND DRUG POLICY COUNCIL (ADPC)
By law, the ADPC is charged with (1) reviewing state policies on substance abuse treatment programs and criminal sanctions and programs and (2) developing and coordinating a statewide plan for these matters.
Opioid Fact Sheet
By October 1, 2017, the act requires the ADPC to develop a one-page fact sheet on opioid drugs that must:
1. be written in clear and readily understandable language and in at least 12-point font,
2. include the risks of taking an opioid drug and the symptoms of opioid use disorders, and
3. include services available in Connecticut for people experiencing these symptoms or who are otherwise affected by an opioid use disorder.
The council must make the fact sheet available on the DMHAS website for health care providers and pharmacists to use and encourage them to disseminate it to anyone the (1) provider treats for opioid use disorder symptoms, (2) provider issues a prescription for or administers an opioid drug or opioid antagonist, or (3) pharmacist dispenses an opioid drug or issues a prescription for or dispenses an opioid antagonist.
The act requires the ADPC to examine the feasibility of (1) developing a marketing campaign and making monthly public services announcements (PSAs) on opioid drugs and (2) establishing an electronic portal on the availability of substance use disorder treatment beds in Connecticut facilities. The council must report the results of the study to the Public Health Committee by January 1, 2019.
Marketing Campaign and PSAs. The council must examine the feasibility of developing a marketing campaign and making monthly PSAs on appropriate state agencies' websites and social media accounts and any radio and television stations broadcasting to Connecticut residents on:
1. the risks of taking opioid drugs and symptoms of opioid use disorder,
2. the availability of opioid antagonists in the state, and
3. services in Connecticut for people with or affected by opioid use disorder.
Electronic Information Portal. The council must also examine the feasibility of establishing an electronic information portal (i.e., Internet website or application) to serve as a single point of entry for information on the availability of:
1. beds at a Connecticut facility for people needing medical treatment for (a) detoxification for potentially life-threatening symptoms of alcohol or drug withdrawal and (b) rehabilitation or treatment for alcohol or drug dependency or intoxication and
2. slots for outpatient treatment using opioid medication, including methadone and buprenorphine, to treat opioid use disorder.
The examination must also include the portal's ability to be publicly accessible and provide real-time data on the availability of these beds and slots, including their types and location and wait times, if available.
Working Group on Safe Disposal of Opioid Drugs
The act requires the ADPC to convene a working group to advise the council on any legislative or policy changes to enable first responders or health care providers to safely dispose of a person's opioid drugs on the person's death. The council must report to the Public Health Committee on the working group's recommendations by February 1, 2018.
Working Group on Substance Abuse Treatment Referral Programs
The act requires the ADPC to convene a working group to study municipal police departments' substance abuse treatment referral programs. These programs refer people with an opioid use disorder or who are seeking recovery from drug addiction to treatment facilities. The study must identify any barriers these programs face as well as the feasibility of implementing such programs statewide. The council must report on the working group's findings to the Public Health and Public Safety and Security committees by February 1, 2018.
§§ 8 & 9 — INSURANCE COVERAGE FOR SUBSTANCE USE DISORDER
The act requires certain individual and group health insurance policies to cover medically necessary (1) medically monitored inpatient detoxification services and (2) medically managed intensive inpatient detoxification services for insureds or enrollees who have been diagnosed with a substance use disorder.
Under the act, “medically monitored inpatient detoxification” and “medically managed intensive inpatient detoxification” are defined in the same way as in the most recent edition of the American Society of Addiction Medicine Treatment Criteria for Addictive, Substance-Related and Co-Occurring Conditions.
The act applies to individual and group health insurance policies delivered, issued, renewed, amended, or continued in Connecticut that cover (1) basic hospital expenses; (2) basic medical-surgical expenses; (3) major medical expenses; or (4) hospital or medical services, including those provided under an HMO plan. Because of the federal Employee Retirement Income Security Act (ERISA), state insurance benefit mandates do not apply to self-insured benefit plans.
§ 10 — SUBSTANCE ABUSE TREATMENT FACILITY ADMISSIONS
The act requires an alcohol or drug treatment facility to use admissions criteria developed by the American Society of Addiction Medicine to assess whether to admit a person to the facility based on the services the facility is licensed to provide and the appropriate services required to treat the person.
§ 11 — LOCAL EMS PLANS
Under existing law, local EMS plans must require that EMS providers carry an opioid antagonist and complete a DPH-approved training on how to administer it if they are likely to arrive first on the scene of a medical emergency. The act clarifies that at least one EMS provider who is likely to arrive first on the scene, not all such providers, must carry an opioid antagonist and complete the training.
Under the act, “EMS provider” means a person, association, or organization that provides immediate or life-saving transportation and medical care away from a hospital to a victim of sudden illness or injury, and who may also provide invalid coach services. Providers include EMS personnel (e.g., paramedics, emergency medical technicians, and advanced emergency medical technicians) and resident state troopers.
Prior law required each municipality to amend its local EMS plan to include this requirement by October 1, 2016. The act extends the deadline to October 1, 2017.
§ 12 — STANDING ORDERS FOR OPIOID ANTAGONISTS
The act allows a prescribing practitioner authorized to prescribe an opioid antagonist (such as Narcan) to issue a standing order (i.e., non-patient specific prescription) to a pharmacy allowing licensed pharmacists to dispense an opioid antagonist that is:
1. administered nasally or by auto-injection;
2. approved by the FDA; and
3. dispensed by the pharmacist to a (a) person at risk of an opioid drug overdose or (b) family member, friend, or other person who may assist a person at risk of such an overdose.
Under the act, a pharmacist may dispense an opioid antagonist under a standing order only if he or she completes a DCP-approved training and certification program. Additionally, when dispensing the opioid antagonist, the pharmacist must train the person to administer it and keep a record of the dispensing and training under the law's recordkeeping requirements. (Existing law already requires this for pharmacists trained by DCP to prescribe opioid antagonists, see BACKGROUND.) The pharmacist must also send a copy of the dispensing record to the prescribing practitioner who entered into the standing order agreement with the pharmacy. Additionally, the act requires the pharmacy to provide DCP with a copy of each standing order it enters into with a prescribing practitioner. Under the act, a prescribing practitioner who issues a standing order for an opioid antagonist is considered to have done so for a legitimate medical purpose in the usual course of his or her professional practice. And a pharmacist who accepts the standing order and dispenses the opioid antagonist is deemed not to have violated his or her professional standard of care. The act also authorizes the DCP commissioner to adopt regulations to implement its standing order provisions.
Controlled substances are drugs whose use and distribution are monitored because of their abuse potential or risk. Controlled substances are categorized in order of their abuse risk and placed into schedules. Drugs with the highest abuse potential, no medical use, and not prescribable are placed in Schedule I and those with the lowest abuse potential are placed in Schedule V.
By law, an opioid antagonist is naloxone hydrochloride (e.g., Narcan) or any other similarly acting and equally safe drug approved by the FDA to treat an opioid drug overdose (CGS § 17a-714a).
Prescriptive Authority for Pharmacists
By law, pharmacists may prescribe opioid antagonists if they do the following:
1. complete a DCP-approved training and certification program,
2. act in good faith,
3. train the recipient of the opioid antagonist to administer it,
4. maintain a record of the dispensing and training under the law's recordkeeping requirements, and
5. refrain from delegating or directing another person to prescribe the medication or provide the training to the recipient (CGS § 20-633c).