Medication Regimen Review

NY-ADR

4/28/21 N.Y. St. Reg. PDD-04-21-00006-A
NEW YORK STATE REGISTER
VOLUME XLIII, ISSUE 17
April 28, 2021
RULE MAKING ACTIVITIES
OFFICE FOR PEOPLE WITH DEVELOPMENTAL DISABILITIES
NOTICE OF ADOPTION
 
I.D No. PDD-04-21-00006-A
Filing No. 420
Filing Date. Apr. 12, 2021
Effective Date. Apr. 28, 2021
Medication Regimen Review
PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following action:
Action taken:
Amendment of Parts 633.16 and 633.17 of Title 14 NYCRR.
Statutory authority:
Mental Hygiene Law, sections 13.07, 13.09(b) and 16.00
Subject:
Medication Regimen Review.
Purpose:
Makes technical corrections to align with current regulation allowing for an annual medication regimen review or more frequently.
Text of final rule:
• Existing subparagraph 633.16(j)(5)(d) is amended to read as follows:
(d) A [semi-annual] medication regimen review that includes any medications prescribed to treat a co-occurring diagnosed psychiatric disorder, or to prevent, modify, or control challenging behavior(s), must be conducted in accordance with section 633.17 of this Part. The results of these medication regimen reviews shall be shared with the person’s program planning team and the prescriber, and documented in the person’s record, in order to assist healthcare providers and the team to evaluate whether the benefits of continuing the medication(s) outweigh the risk inherent in potential side effects.
Existing paragraph 633.17(b)(8) is amended to read as follows:
(8) OPWDD shall verify that the medication regimen of each person in a certified residential facility has been reviewed at least [semi-]annually by a registered nurse, physician, physician[‘s] assistant, or pharmacist.
Final rule as compared with last published rule:
Nonsubstantive changes were made in section 633.17(b)(8).
Text of rule and any required statements and analyses may be obtained from:
Mary Beth Babcock, Office for People With Developmental Disabilities, 44 Holland Avenue, Albany, NY, (518) 474-7100, email: [email protected]
Additional matter required by statute:
Pursuant to the requirements of the State Environmental Quality Review Act, OPWDD, as lead agency, has determined that the action described herein will have no effect on the environment and an E.I.S. is not needed.
Revised Regulatory Impact Statement, Regulatory Flexibility Analysis, Rural Area Flexibility Analysis and Job Impact Statement
A revised Regulatory Impact Statement, Regulatory Flexibility Analysis, Rural Area Flexibility Analysis and Job Impact Statement is not required since the changes made to this rule are not substantive changes. The changes made to the rule text clarify the language of the rule.
Initial Review of Rule
As a rule that requires a RFA, RAFA or JIS, this rule will be initially reviewed in the calendar year 2024, which is no later than the 3rd year after the year in which this rule is being adopted.
Assessment of Public Comment
Comment: Reducing from a bi-annual review to an annual review would lead to an increased risk of harm to the resident, the review will not have a meaningful impact, the review would require significantly more time than bi-annually, and a bi-annual review ensures compliance with changing best practices and clinical guidelines.
Response: The proposed rule does not require only one review per year. Under 14 NYCRR 633.17(a)(18)(i) the language states “Residential facilities shall ensure that a review of a person’s medication regimen is conducted on no less than an annual basis, or more frequently as needed.” The proposed rule amends 14 NYCRR 633.16 and 633.17 to coincide with the annual requirement under 14 NYCRR 633.17(a)(18)(i). However, the proposed rule does not change the requirement to only once per year but rather required at least once per year. Under the language of 14 NYCRR 633.17(a)(18)(i) a review could happen as frequently as needed.
This comment was reviewed, and the text will not be changed. Under the statutory language a review can be done as frequently as needed.
Comment: Reducing the medication review to annually would increase paperwork as a “medication related issue could continue for a longer period without the pharmacist intervention.”
Response: As noted above the medication review can occur as frequently as needed but must occur at least once per year.
This comment was reviewed, and the text will not be changed. Under the statutory language a review can be done as frequently as needed.
Comment: The text of the rule uses the term “physician’s assistant” rather than “physician assistant.”
Response: OPWDD does not want to create any confusion as to who this term applies.
This comment was considered, and the text will be changed.
End of Document