Rules and Regulations For Pain Management, Opioid Use, and the Registration of Distributors of Controlled Substances in Rhode Island [R21-28-CSD].
|Title||216||Rhode Island Department of Health|
|Part||4||Rules and Regulations For Pain Management, Opioid Use, and the Registration of Distributors of Controlled Substances in Rhode Island [R21-28-CSD].|
|Type of Filing||Amendment|
|Regulation Status||Inactive View Active Rule|
|Effective||03/22/2017 to 03/22/2017|
Regulation Authority :
RIGL Chapter 21-28
Purpose and Reason :
Update minimum requirements for pain management, opioid use, prescriber training and registration of every person who manufactures, distributes, prescribes, administers or dispenses any controlled substance within Rhode Island.
a. RIDOH received one comment suggesting the language in § 3.14 (Prescriber Training Requirement for Best Practices Regarding Opioid Prescribing) was confusing and that ambiguity existed whether the continuing education requirement for prescribers of controlled substance was once (lifetime) or once per renewal cycle. § 3.14 of the proposed amendments reads “This specific training requirement is required only once and must be completed before renewal of controlled substance registration or two (2) years (whichever is longer)”. RIDOH asserts the language is sufficiently clear that the requirement is one time only and not required every renewal cycle.
b. RIDOH received written comment which stated that the regulation fails to address dosage maximums for acute management of pain in pediatric patients. PL 2016-199 required the Director of Health to promulgate regulations for appropriate training in best prescribing practices needed for license renewal by January 1, 2017. However, there was no specific time requirement in PL 2016-199 to promulgate regulations for acute management of pain in pediatric patients. RIDOH needs additional time to work with subject matter experts and stakeholders to create appropriate regulations for pediatric patients due to the unique metabolism of opioids in pediatric patients.
c. RIDOH received testimony and commentary regarding RIDOH establishing CME requirements for prescribers of controlled substances. The testimony cited RIGL 5-37-2.1. This law refers to physicians only and the requirement for certification and recertification for ongoing CME. PL 2016-199 (underlying authority for this specific regulation change, enacted in June of 2016) required the Director to develop regulations for appropriate training in best prescribing practices for all prescribers needed for license renewal. There was no specific mention in PL 2016-199 to engage any stakeholder and it was evident this legislative requirement was specific and unique to the issue of best prescribing practices for all prescribers. RIDOH did engage with the Rhode Island Medical Society and reviewed their comments submitted during the Advanced Notice of Proposed Rule Making period which suggested 5 hours, rather than the proposed 8 hour requirement. RIDOH reviewed other state’s requirements and obtained subject matter expert advice before deciding 8 hours was more in line with the legislative intent.
d. RIDOH received written comment regarding § 3.3.1(a) [“If a patient is given opioids in an inpatient setting and then discharged from an inpatient setting, and prescribed an opioid on discharge, this is considered an initial prescription if they have not otherwise used opioids in the past thirty (30) days.”] Comment suggested the prescriber be required to enforce this regulation and not the pharmacist. RIDOH asserts that enforcement of these regulations is done by the applicable regulatory boards as well as RIDOH and will be done so according to established process and procedures. RIDOH will attempt to educate all prescribers and pharmacists of the responsibility in these regulations.
e. RIDOH received written comment regarding § 3.3 (“The initial prescription for an opioid for acute pain for an individual who has not received opioids in the last thirty (30) days shall not exceed thirty (30) morphine milligram equivalents (MMEs) total daily dose per day for a maximum of twenty (20) doses”). Comment suggested that prescribers should be responsible for enforcing this regulation and not the pharmacists. Comment further stated that pharmacists would not be able to determine if a prescription was an initial prescription. RIDOH asserts pharmacists have access and a responsibility to review the prescription drug monitoring report (PDMP) and should review this prior to dispensing a prescription. The information a pharmacists need to determine if a prescription is an initial prescription is in the PDMP. RIDH also asserts an initial prescription is defined in § 1.19 as a first prescription given to someone who is new to the prescription of opioids from your institution, and has not used opioids in the most recent thirty (30) calendar days.” RIDOH asserts this definition is clear and did not receive any other comment suggesting it was not clear. Pharmacists are expected to make a good faith effort to review the PDMP. Prescribers do have a responsibility to follow this regulation and additional requirements regarding the PDMP. RIDOH asserts that enforcement of these regulations is done by the applicable regulatory boards as well as RIDOH and will be done so according to established process and procedures.
f. RIDOH received written comment regarding § 3.11 (“Transmission of Controlled Substance Prescriptions. A practitioner shall not authorize or allow an unlicensed staff member (e.g., medical assistant) to telephone or otherwise transmit a prescription for a controlled substance to a pharmacy.”) Comment suggested responsibility be placed on the prescriber and not the pharmacist. Comment suggested a pharmacist would not be in a position to determine the licensure status of the transmitting agent. RIDOH maintains a real time easily accessible primary source verified database of all licensees at: http://18.104.22.168/RIDOH_Verification/Search.aspx?facility=N&SubmitComplaint=Y . It is common practice for the pharmacist to identify who they are speaking to on the phone and to verify authenticity of every prescription. The identity of who transmitted a prescription can easily be verified by calling the prescribers office if there is a question. RIDOH asserts that prescribers and pharmacists have a responsibility to maintain minimum safeguards to prevent diversion of controlled substances. RIDOH notes § 3.11 was promulgated in March of 2015 and the language was not changed for this revision. RIDOH has not received notice of ambiguity in § 3.11 for its two years of existence.
RIDOH did not make any changes based on comments received. However, an incorrect cross-reference in § 1.9 was identified during post-hearing legal review and was corrected. In addition, post-hearing legal review identified several technical corrections that were needed in the text of § 3.3, which have also been made.