New York Codes, Rules and Regulations › Title 14 - DEPARTMENT OF MENTAL HYGIENE › Chapter XIV - Office for People With Developmental Disabilities › Part 633 - Protection of Individuals Receiving Services in Facilities and Services Operated and/or Certified by OPWDD › Section 633.17 - Medication (including vitamins)

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
Principles of compliance.
(1)
				The management and administration of medication (see glossary) shall take place
				in the safest possible manner, while at the same time enabling facilities to
				access the services of health care professionals (see glossary) and pharmacists
				in the community without imposing undue or unenforceable requirements on such
				parties or the facility itself. However, the very fact that a person (see
				glossary) who is developmentally disabled is entrusted to the care and
				supervision of a facility (see glossary) operated or certified by OPWDD means
				that certain precautions must be taken and certain procedures observed that
				might not be considered necessary in a familial home environment.
(2) Adherence to this section shall be
				required of all residential facilities after January 1, 1990.
(3) After January 1, 1990, adherence to this
				section shall be required of any nonresidential facility that is responsible
				for the administration of medication while a person is in attendance. For those
				nonresidential facilities which are not required, by regulation, to be
				responsible for the administration of medication and whose governing body has
				adopted a policy not to administer medication, the following shall apply:
(i) There is written policy/procedure to this
				effect.
(ii) There is written
				policy/procedure as to the responsibilities of persons in attendance, and/or
				those where such persons reside, to ensure the administration of medication,
				should it become necessary (
e.g.,
the person in attendance
				will be responsible for self-administration of medication [see glossary] and
				therefore must be capable of independent self-administration of medication;
				arrangements are made for someone from a person's place of residence to
				administer medication or supervise or assist in the self-administration of
				medication).
(iii) The above
				policies/procedure are conveyed to applicants, persons in attendance, parents,
				guardians or correspondents in conformance with section
				633.4(a)(7) 
				of this Part.
(iv) The facility
				periodically assesses its policy relative to the needs of persons currently
				served.
(4) This section
				applies to the management and administration of medication to individuals (see
				glossary) while in a facility or while under the facility's direct
				supervision.
(5) Each
				agency/facility shall develop its own policies/procedures relative to
				prescribed (see glossary) and over-the-counter medication (see glossary) as is
				relevant to its needs. Family care homes shall adhere to policies/procedures as
				developed by their sponsoring agency. All such policies/procedures shall be in
				conformance with this Part. ICF/DD's shall also ensure compliance with Part
				681.
(6) This section does not
				address the requirements to be met by a pharmacy located in a
				facility.
(7) All medication shall
				be prescribed or ordered, obtained, provided, received, administered,
				safeguarded, documented, refilled and/or disposed of in a manner that ensures
				the health, safety, and well-being of the people being served and in
				conformance with all applicable Federal and State statute or regulations. Where
				requirements are more restrictive in Part 681 (for ICF/DD's), they shall be
				controlling.
(8) Every person has
				the right to be free from the unnecessary use of medication.
(9) Every effort shall be made to ensure that
				medication is prescribed or ordered in the lowest dosage possible to achieve
				the desired effect(s).
(10) No
				medication shall be used for the convenience of staff or as a substitute for
				programming.
(11) Special attention
				shall be given to those individuals receiving psychotropic medication to detect
				and prevent possible medical problems.
(12) Medication purchased with an
				individual's own personal funds shall be used by or for that person only. A
				facility may purchase an over-the-counter medication for use by more than one
				person.
(13) The use of
				over-the-counter medication is permitted when administered in accordance with
				the following to ensure that the medication is appropriate and that there will
				be no expected contraindications:
(i) Approval
				for a specific individual to use or be administered a medication is received in
				writing on no less than an annual basis (but in conformance with any other
				facility specific controlling regulations) from that individual's
				practitioner(s) (see glossary).
(ii) There is information in an individual's
				record, and available to staff or the family care provider, as to the condition
				for which a medication is to be used, the dosage, the frequency with which it
				may be administered, and any specific instructions related to the
				medication.
(iii) Administration of
				an over-the-counter medication does not exceed two days unless so specified by
				a practitioner; or the practitioner is contacted for instructions for extended
				use. Exceptions are certain vitamins and over-the-counter medications that a
				practitioner instructs to be given on a daily basis.
(iv) Nothing in this section shall prevent a
				person residing in a supportive community residence or a family care home, who
				is capable of independent self-administration of medication, from obtaining and
				using over-the-counter medication at his or her discretion. However, the
				individual shall be given appropriate guidance relative to obtaining and self-
				administering over-the-counter medications.
(14) Administration of prescribed and
				over-the-counter medication shall be in conformance with the following:
(i) A prescribed medication shall be
				administered only to the person for whom it is prescribed, and in compliance
				with the prescribing practitioner's instructions.
(ii) If there is a significant adverse
				reaction, a significant change in behavior, or any other significant
				indication(s) of a problem that may be related to a medication currently being
				administered to or by an individual, the use of the medication is to be
				suspended. The indicated problem is to be reported to the prescribing
				practitioner immediately. If the prescribing practitioner is not available,
				medical treatment is to be obtained elsewhere, if indicated. However, the
				prescribing practitioner shall receive notification as soon as possible of all
				adverse reactions, behavior changes, etc., that may be related to a medication
				administered to or by an individual, and any treatment received for the adverse
				reaction.
(iii) Medication shall be
				self-administered or administered only by the following:
(a) a person capable of independent
				self-administration of medication;
(b) a health care professional (a physician,
				dentist, physician's assistant, registered nurse, or licensed practical nurse
				holding current New York State licensure);
(c) staff (see glossary) providing direct
				care services (see glossary), as documented by job description, who have:
(1) successfully completed an OPWDD approved
				training course in medication; and
(2) successfully completed the required
				practicum; and
(3) been certified
				or recertified within the year to administer medication; or
(d) a family care provider whose
				name appears on the operating certificate for the family care home, and who has
				received training in medication administration in conformance with an OPWDD
				approved curriculum; or a sponsoring agency approved substitute, in the absence
				of the family care provider.
(iv) Nothing in this section shall prevent a
				person residing in a supportive community residence or a family care home, who
				is capable of independent self-administration of medication, from obtaining and
				using prescribed and/or over-the-counter medications. However, the individual
				shall be given appropriate guidance relative to obtaining and
				self-administering medications.
(15) Supervision and monitoring of staff.
(i) Medical or nursing supervision of those
				staff responsible for administering medication shall be provided.
(ii) Supervision and monitoring shall be in
				accordance with agency/facility policies/procedures.
(16) Evaluation of persons for
				self-administration of medication (see glossary).
(i) If, upon admission, a person has not been
				evaluated as to his or her ability to self-administer medication, staff or the
				family care provider are responsible for the administration of
				medication.
(ii) Each person at a
				residential facility is to be evaluated by a program planning team (with input
				from a registered nurse, physician, or physician's assistant) at the first case
				review, but no later than three months after admission, to determine his or her
				current ability to self-administer medication. Other providers of services to
				the person, and his or her physician, shall be informed of the person's
				designation. A nonresidential facility that assumes responsibility for the
				administration of medication while a person is in attendance shall:
(a) accept the determination made at a
				person's place of residence in accordance with subparagraph (ii) of this
				paragraph, if the facility is OPWDD operated or certified; or
(b) evaluate the person; and
(c) evaluate all persons' who do not reside
				in an OPWDD operated or certified facility.
(iii) Evaluations shall be part of each
				person's plan of services and shall designate whether the person is:
(a) capable of independent
				self-administration of medication; or
(b) capable of self-administration of
				medication with supervision; or
(c)
				capable of self-administration of medication with assistance; or
(d) incapable of self-administration of
				medication (administration of medication must be done by others).
(iv) Evaluations shall be reviewed
				no less than annually and may be incorporated into the program planning review
				process.
(v) For a person who is
				not capable of independent self-administration of medication, a plan shall be
				developed by his or her program planning team. A nonresidential facility that
				assumes the responsibility for the administration of medication, shall assume
				this obligation for those persons not residing in an OPWDD operated or
				certified facility. The purpose of the plan is to assist the person to
				ultimately reach his or her optimum level of capability in the
				self-administration of medication, unless:
(a)
				the program planning team determines that other programmatic needs are of
				greater priority and are to be addressed first; or
(b) the program planning team determines that
				such a plan is not appropriate; or
(c) a physician determines that a plan should
				not be developed for the person, and the program planning team concurs.
All such determinations, and the justification, shall be
				  documented in each person's plan of services.
(vi) The method used to verify a person's
				level of self-administration and the documentation required shall be determined
				by agency/facility policy/procedures.
(vii) When a person, designated as capable of
				independent self-administration of medication, must be frequently reminded to
				take his or her medication, or there are other indications of lessening of
				skills related to self-administration, there shall be a reevaluation of the
				person's ability and a decision made as to whether the degree of supervision or
				assistance is to be increased.
(17) Records.
(i) Except as provided for in subparagraph
				(ii) of this paragraph, there shall be a separate record for the administration
				of medication for each person receiving medication. The record documenting
				administration shall specify at least the following:
(a) name of person receiving the
				medication;
(b) name of medication,
				dosage, and route of administration;
(c) time and date of administration;
				and
(d) signature of the party who
				supervised, assisted, administered, or independently self-administered the
				medication (or initials that correspond to those on a signature
				sheet).
(ii) In
				supportive community residences and family care homes:
(a) there shall be documentation as described
				in subparagraph (i) of this paragraph; or
(b) for persons who are capable of
				independent self-administration there shall be documentation in the person's
				clinical record of the supervision provided to ensure that the person is taking
				medication as required. Such supervision may be in the form of occasional
				verbal checks, checks on the amount of medication remaining, or in any manner
				or frequency deemed appropriate by the program planning team.
(iii) For the safety of the people
				residing in or attending a facility and as a support to those staff who have
				medication administration related responsibilities, there shall be information
				specific to each person on all medications to be administered to that person
				while at or under the supervision of the facility and its staff. The sponsoring
				agency shall ensure maintenance of this information for people in family care
				homes and provide the information to the family care provider. For each
				medication a person is taking, this information shall include:
(a) name of person taking the
				medication;
(b) name of
				medication;
(c) directions with
				regard to correct dose, form, method/route of administration, time of
				administration;
(d) start and stop
				dates, if applicable;
(e) expected
				therapeutic effects for the person taking the medication;
(f) possible side effects to the person
				taking the medication; and
(g) name
				of prescribing, ordering or approving practitioner.
(18) Medication regimen review.
(i) 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 review shall be made by a
				registered nurse, physician, physician's assistant or pharmacist.
(ii) The medication regimen review shall
				include, at a minimum:
(a) A review of the
				person's medication record for potential adverse reactions, allergies,
				interactions, contraindications, or irregularities; related laboratory work
				shall be included in this review.
(b) An assessment of the person's response to
				medication therapy to determine if the medication is achieving the stated
				objectives established by the prescribing practitioner.
(c) Recommendations to the primary and/or
				consulting practitioner of any indicated changes in the person's medication
				regimen.
(d) Determination of the
				need for a more frequent review depending upon the person's medical
				status.
(e) Documentation of the
				review, findings, and any recommendations made.
(iii) To the extent that requirements of
				section
				633.16(j)(5) 
				of this Part are more rigorous than the requirements of this paragraph, the
				requirements of section
				633.16(j)(5) 
				of this Part are controlling.
(19) Storage of medication at the facility.
(i) Medication shall be maintained in the
				original container in which it was received. All containers shall be labeled.
				Labels shall be clear and legible.
(ii) Safe, secure, appropriate, and adequate
				storage space shall be provided.
(a) Other
				than in a supportive community residence or a family care home, medication
				shall be kept in a secure, locked storage area.
(b) Persons who are capable of independent
				self-administration of medication may have their medication stored so as to be
				personally accessible to themselves and staff who are currently certified to
				administer medication, those who are health care professionals and family care
				providers, or their substitutes, if such a procedure does not expose other
				residents to harm.
(c) Other than
				in a supportive community residence or a family care home, medication stored in
				a refrigerator containing food shall be placed in a separate locked container
				clearly marked to indicate that it contains medication.
(d) Other than in a supportive community
				residence a family care home, or as specified in clause (e) of this
				subparagraph, all medication packaged and labeled by the issuing pharmacy as a
				"controlled substance," and syringes and needles, shall be kept in secure,
				double-locked storage unless all persons in the residence are capable of
				independent self-administration of medication, and such a procedure does not
				expose other residents to harm. In family care homes, controlled substances and
				syringes and needles shall be kept in locked storage.
(e) In all facilities other than supportive
				community residences, when all persons in the residence are capable of
				independent self-administration of medication, a controlled substance,
				syringes, and needles shall be stored in a locked area or container so as to be
				accessible only to the person for whom it was prescribed, staff who are
				currently certified to administer medication or who are health care
				professionals, and family care providers or their substitutes.
(iii) Outdated medication shall
				not be retained by a facility.
(iv)
				Discontinued medication shall not be retained by a facility unless specific
				instructions are received from a prescribing practitioner to do so.
(v) Medication removed from a storage area
				shall never be left unattended.
(20) Disposal.
(i) Noncontrolled medication. Medication
				shall be destroyed on the premises in conformance with agency/facility specific
				policy and procedure which ensures that disposal is carried out only by
				physicians, physician's assistants, registered nurses, licensed practical
				nurses, or staff who are certified in medication administration, and (in family
				care homes) family care providers; the disposal shall be documented.
(ii) Controlled medication. For facilities
				not holding a Health Department dispensing license, the disposal of controlled
				substances is to be carried out by two persons. These persons must either be a
				physician, physician's assistant, registered nurse, licensed practical nurse, a
				pharmacist, a staff person certified in medication administration, or (in a
				family care home) a family care provider with a nurse or the family care case
				manager. One person is to dispose of the medication and the other is to
				complete the documentation. For facilities holding a Health Department
				dispensing license, controlled substances are to be either sent directly to the
				Bureau of Controlled Substances at the New York State Department of Health,
				using the current controlled substance surrender form; or destroyed on site
				after receiving written approval from the bureau in conformance with its
				current requirements.
(iii) Needles
				and syringes. All needles and syringes are to be placed in puncture resistant
				containers immediately after use. When filled, the container should be taken or
				sent to an approved site for incineration. The disposal shall be
				documented.