OLR Bill Analysis
AN ACT PREVENTING PRESCRIPTION OPIOID DIVERSION AND ABUSE.
This bill contains various provisions on controlled substance abuse prevention, particularly as it relates to opioid drugs. It:
1. generally requires prescriptions for controlled substances to be transmitted electronically to a pharmacy, which must have the technology to accept such prescriptions;
2. allows the Department of Consumer Protection (DCP) commissioner to share certain prescription drug monitoring program information with other state agencies for certain studies involving drug abuse;
3. allows certain registered nurses to destroy or dispose of their patient's controlled substances;
4. creates a process by which patients may request to not be prescribed an opioid drug; and
5. requires practitioners, when prescribing opioids, to discuss with all patients, rather than only minors, the risks associated with opioid drug use.
By law, the following health providers may prescribe medication within the scope of their practice: physicians, dentists, podiatrists, optometrists, physician assistants, advanced practice registered nurses, nurse-midwives, and veterinarians.
The bill also makes minor, technical, and conforming changes.
EFFECTIVE DATE: Upon passage for drug monitoring information sharing and nurse drug disposal; July 1, 2017 for discussion of opioid risks; October 1, 2017 for voluntary nonopioid directive forms; and January 1, 2018 for electronic prescription requirements.
§ 3 — ELECTRONIC PRESCRIPTION FOR CONTROLLED SUBSTANCES
The bill, with exceptions, requires prescriptions for controlled substances to be electronically transmitted. “Electronically transmit” means to transmit by computer modem or other similar electronic device. Current law allows prescriptions to be written or given orally. Written prescriptions must, among other things, be in ink, indelible pencil, or by typewriter and only original prescriptions are considered valid. Oral prescriptions must, among other things, be promptly reduced to writing.
Under the bill, prescribing practitioners of controlled substances, within the scope of their license, must electronically transmit controlled substance prescriptions to a pharmacy. The prescriber must promptly print the prescription in hardcopy or create it in an electronic record. The electronic 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 and maintained in a form that is readily available for inspection, at reasonable times, by the DCP commissioner, his authorized agent, or other authorized personnel. These files must be kept for three years.
Under the bill, prescribing practitioners are not required to electronically transmit a prescription when (1) there are temporary technological or electrical failures; (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 could negatively impact the patient care (e.g., compounding); and (5) the prescriber demonstrates, until July 1, 2019, that he or she does not have the technological capacity.
The bill 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 order or order transmitted by fax must be promptly reduced to writing on a prescription blank, a hardcopy printout, or created as an electronic record and filed by the pharmacist filling the order. The bill prohibits duplicates, carbon or photographic copies, and printed or rubber-stamped orders from being considered a valid controlled substance prescription.
Temporary Technological or Electrical Failure. Under the bill, a prescribing practitioner is not required to electronically transmit a prescription when electronic transmission is not available because of temporary technological or electrical failures.
In the event of a temporary technological or electrical failure, 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, but 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 bill 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. The bill specifies that if the prescription is for 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 and place it in the patient's medical record.
Out-of-state Pharmacy. The bill allows a prescribing practitioner to provide a prescription that is not electronically transmitted, if the prescription is going to be dispensed by an out-of-state pharmacy. The prescriber who issues a prescription under this exception must document the reason and place it in the patient's medical record.
Certain Prescriptions that Need Special Attention. Under the bill, 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 compounds; (2) for direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous, or intraspinal infusion; (3) that contains long or complicated directions; (4) that requires certain elements to be included by the federal Food and Drug and Administration; or (5) that must be orally communicated to a pharmacist for a patient in a chronic and convalescent nursing home.
Lack of Technological Capacity. Under the bill, prescribing practitioners are not required to electronically transmit a prescription when the practitioner demonstrates, until July 1, 2019, that he or she does not have the technological capacity. The practitioner must demonstrate this in a DCP-prescribed form and manner.
"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 (21 U.S.C. § 801).
The bill 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 in a form that is readily available for inspection, at reasonable times, by the DCP commissioner, his authorized agent, or other authorized personnel. The records must be kept on file for three years and such records may be stored electronically, provided the files 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 when pharmacies transfer controlled substance prescriptions to other pharmacies.
§ 1 — PRESCRIPTION DRUG MONITORING PROGRAM INFORMATION SHARING
The bill allows the DCP commissioner to provide certain controlled substance prescription information obtained as part of the prescription drug monitoring program (e.g., pharmacy and vender records) to other state agencies. The sharing must be through an agreement between the DCP commissioner and the head of the other agency, provided that the information is obtained for a study of (1) disease prevention and control related to opioid abuse or (2) morbidity and mortality caused by overdoses of controlled substances. The transfer of such information must be done in accordance with all applicable state and federal confidentiality requirements (e.g., Health Insurance Portability and Accountability Act of 1996).
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 bill allows a registered nurse employed by a home health care agency, along with a patient's designated representative, to oversee the destruction and disposal of the patient's controlled substances. They must use the recommendations for proper disposal of prescription drugs on DCP's website (e.g., add undesirable substances such as salt, sawdust, or used coffee grounds).
The nurse must maintain written or electronic documentation of such destruction or disposal on a DCP-prescribed form for three years. This documentation must be kept with the patient's medical record.
Nothing in the bill prevents the nurse and patient's representative from depositing the patient's controlled substances in a police department prescription drop box.
§ 4 — VOLUNTARY NONOPIOID DIRECTIVE FORM
The bill requires the Department of Public Health (DPH), in consultation with DCP and the Department of Mental Health and Addiction Services, to establish a voluntary nonopioid directive form and publish it on its Internet website for public use.
A "voluntary nonopioid directive form" means a form that is voluntarily filed by a patient with a prescribing practitioner that indicates such patient's request not to be issued a prescription or medication order for an opioid drug.
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 prescribing practitioner must document receipt of the form 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 nonopioid directive form. The patient, duly authorized 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 this form and a pharmacist must not be held in violation for dispensing a controlled substance in contradiction to a voluntary nonopioid directive form.
The bill immunizes prescribing practitioners acting with reasonable care from damages in a civil action. They also cannot be subject to criminal prosecution or be deemed to have violated the standard of care for refusing to issue a prescription or medication order for an opioid pursuant to a voluntary nonopioid directive form.
Under the bill, no one acting in good faith as a duly authorized guardian or health care proxy may be held liable for damages in a civil action or subject to criminal prosecution for revoking or overriding a voluntary nonopioid directive form.
Under the bill, a prescribing practitioner who willfully fails to comply with a patient's voluntary nonopioid directive form may be subject to certain DPH disciplinary actions.
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. take summary action against the person's DPH license or permit if he or she has been found guilty of a state or federal felony or is subject to disciplinary action in another jurisdiction.
§ 5 — DISCUSSION OF RISK ON OPIOID ADDICTION
The bill requires a prescribing practitioner to discuss with all patients the risks associated with opioid drug use. Current law requires such discussion with minor patients (i.e., under age 18) along with their custodial parent, guardian, or legal custodian. As under current law, the bill 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.
Controlled substances are drugs whose use and distribution is 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.
General Law Committee