17.A.
Pharmaceutical Services
Pharmaceutical services shall be conducted in accordance with
currently accepted professional standards of practice and in accordance with
all applicable laws and regulations.
Facilities shall develop policies and procedures for the
prescribing (including standing orders), obtaining, dispensing, administering,
controlling, storing, and disposing of all drugs and biologicals with the
advice of a staff pharmacist or a consultant pharmacist and approved by the
professional policy group.
17.B.
Definitions
17.B.1.
Adverse Drug
Reaction - is any undesired or unintended effect of a medication, to
include:
a. Hypersensitivity or allergic
reactions: a reaction due to a patient's immune response,
b. Idiosyncrasy: a susceptibility or
sensitivity peculiar to a rare phenotype (extreme sensitivity to low
doses),
c. Toxicity: a "poisoning"
due to overdosage or accumulation,
d. Side Effect: an undesired pharmacologic
effect which is predictable.
17.B.2.
Psychoactive Drugs or
Agents - As defined in medical literature, are medications subdivided
into five (5) therapeutic classes:
a.
Long-lasting Benzodiazepine drugs;
b. Benzodiazepine or other anxiolytic
sedative drugs;
c. Drugs for sleep
induction;
d. Antipsychotic
drugs;
e. Antidepressant
drugs.
17.B.3.
Unnecessary Drug - is any drug that is used in excessive
doses, for excessive periods of time, without adequate monitoring, without an
appropriate diagnosis or reason for the drug, used in the presence of adverse
reactions which indicate that the drug should be reduced or discontinued
entirely, and any combination of the above reasons.
17.C.
Supervision of Drugs and
Biologicals
17.C.1. Each facility
shall have a State licensed Pharmacist as a consultant.
17.C.2. Responsibilities of the Pharmacist
Consultant:
a. Assists with the development of
written policies and procedures for pharmaceutical services.
b. Reviews medication storage areas for, but
not limited to, labeling, storage, ventilation, humidity and temperature
control, expired medications, security, sanitation and completeness of
emergency medications box. (See Section 17. I.4.)
c. Determines that drug records are in order
and that an account of controlled drugs is maintained and reconciled.
d. Monitors adherence to stop order and
standing order policies.
e.
Evaluates staff performance in carrying out pharmaceutical policies and
procedures.
f. Reviews the drug
regimen of each resident monthly and as needed, including monitoring for
unnecessary drugs.
g. Provides the
professional staff with in-service education and on-going communication
regarding drugs and biologicals, including information on drug
incompatibilities, new drugs, drug sensitivities, and drug
interactions.
h. Participates in
resident care conference as appropriate.
i. Participates in the Professional Policy
Committee and Quality Assurance Committee meetings to review and make
recommendations relating to pharmaceutical services.
17. C.3. Reports of the Pharmacist Consultant
shall contain:
a. Documentation in the
resident's record that review of the medication regimen has been performed and
that issues and irregularities identified have been reported to the Director of
Nursing and the attending physician.
b. A description of all activities, findings
and recommendations contained in a report submitted to the Director of Nursing
and the Administrator.
17.D.
Handling of Drugs and
Biologicals
17.D.1. All medications
shall be kept in their original containers unless transfer of the medication is
done to another storage container by or under the supervision of a pharmacist
or a physician. All pharmaceutical containers having soiled, damaged,
incomplete, illegible or makeshift labels shall be returned to the issuing
pharmacy for relabeling or shall be destroyed in accordance with 17.D.8. of
this section.
17.D.2. Each
resident's medication container shall be clearly labeled in accordance with
State and Federal law and shall include:
a.
Prescription number;
b. Resident's
full name;
c. The name, strength
and dosage form of the drug;
d.
Current directions for use;
e. Name
of prescribing physician;
f. Name,
address and telephone number of the pharmacy issuing the drug;
g. Date of issue (latest refill);
h. Expiration date, not to exceed one (1)
year from the date of repackaging or dispensing or the manufacturer's original
date, whichever is earlier;
i.
Appropriate accessory and cautionary instructions.
17.D.3. There shall be a physical barrier
between medications marked "for external use only" and any medication to be
taken internally. There shall also be a physical barrier separating eye
medications, ear medications and topical medications.
17.D.4. The telephone number of the Poison
Control Center shall be conspicuously posted near the telephone at each nurses
station.
17.D.5. All drugs and
biologicals shall be stored in locked rooms or compartments, separate from food
and laboratory specimens, and under proper temperature control in accordance
with United States Pharmacopeia standards:
a.
Refrigeration: 36-46 degrees Fahrenheit
b. Cool 46-59 degrees Fahrenheit
c. Controlled Room Temperature 59-86 degrees
Fahrenheit
17.D.6.
Medications which have an expiration date that has been exceeded shall be
removed from use and properly disposed of, according to requirements
(17.D.8.).
17.D.7. All prescribed
medicines are the property of the resident. Upon discharge of a living resident
from a licensed facility, the prescribed medicine, including controlled drugs
or substances may be released with the resident, but only upon written
authorization of the resident's physician. Each drug release will be documented
in the resident's record. Subsequent to discharge, unclaimed medications shall
be retained no longer than ninety (90) days.
17.D.8.
Disposition of
Medicationsa. All prescribed
medications, other than Schedule II controlled substances, shall be destroyed
by the Director of Nursing Service or a designee, and shall be witnessed by a
licensed member of the nursing staff.
b. The destruction shall be conducted in such
a manner as to prevent any persons from being able to use, administer, sell or
give away the medication.
c.
Individual unit doses, other than Schedule II through V controlled substances
must be returned to the pharmacist and any credit or rebate made to person(s)
who originally paid for the medication.
d. Amounts destroyed or returned to the
pharmacy shall be recorded on the resident's record with the signature of two
(2) witnesses.
e. Following the
death of the resident, medications shall be removed from circulation within
seventy-two (72) hours.
f. Schedule
II controlled substances shall be disposed of as outlined in Section 17.F.2. of
this Chapter.
17.D.9.
Licensed facilities may stock in bulk supply those items and drugs regularly
available at a pharmacy without prescription.
17.D.10.
Reporting of Tampered With or
Stolen Drugs
The Department and the Attorney General shall be notified
verbally within seventy-two (72) hours when there is suspicion that a
medication has been tampered with or stolen. A written report shall also be
submitted by the facility to both agencies.
17.D.11. A record shall be maintained, in
which the following information shall be available for all prescription
medications received in the facility:
a. Name
of resident for whom received;
b.
Name of pharmacy;
c. Prescription
number;
d. Name of drug and
strength;
e. Amount of medication
received;
f. Date
received;
g. Signature of licensed
person receiving the medication.
17.D.12. All resident Schedule II controlled
substances received in the facility shall be listed as received in a bound book
from which no pages shall be removed
17.D.13. A separate emergency supply inventory, which is the
property of the provider pharmacy, shall also be maintained with the following
record requirements:
Receiving:
a. Date
received
b. Name of the nurse
receiving
c. Name, strength and
dosage form of the medication
d.
Amount received
Utilization:
a.
Date used
b. Nurse
administering
c. Patient's
name
d. Amount used
e. Amount remaining
These records shall be duplicated and kept as a permanent
part of the facility records. The originals remain the property of the
pharmacy, as does the medication.
17.D.14. A medication supply shall not be
maintained by a resident, unless requested by the resident and specifically
authorized by the resident's physician and the multidisciplinary
team.
17.E.
Administration
17.E.1.
Medications shall be administered as prescribed and according to a clearly
defined procedural system and reconciled with the physician's orders on a
regular basis.
17.E.2.
Orders
for Medication
a. All medications
administered to residents shall be ordered in writing by the resident's
physician or authorized designee. Oral orders for medications shall be accepted
only by a licensed nurse or pharmacist, immediately reduced to writing, signed
by the person accepting the order and countersigned by the attending physician
within five (5) business days.
b.
Medications not specifically limited as to time or number of doses, when
ordered, shall be automatically stopped in accordance with written stop order
policy approved by the physician or physicians responsible for advising the
facility on its written policies. The resident's physician shall be notified
prior to any discontinuance of medication.
c. Orders concerning medications and
treatments shall be in writing, signed and dated by a physician and shall be in
effect for the time specified by the physician, but not to exceed a period of
sixty (60) days. A grace period of ten (10) days may be allowed for the
resident whose condition during this period of time did not require a
physician's visit.
d. Orders for
Schedule II controlled substances shall be in effect for no longer than one (1)
week, unless there are specific written orders to the contrary, but in no case
shall the order be in effect for a period of more than thirty (30) days without
a reorder.
17.E.3.
Personnel Administering Medication
a. All medications shall be administered by
medical and nursing personnel in accordance with the Nurse Practice Act of
Maine and applicable law.
b. All
medications shall be administered by licensed medical or nursing personnel,
Certified Nursing Assistant/Medications, or other individuals authorized by law
who have been issued a certificate indicating completion of an advanced
training program including the administration of oral medications as approved
by the Maine State Board of Nursing.
c. Medications which are prescribed to be
given as needed must only be administered after an evaluation of the resident
by a licensed nurse or physician.
d. Medications shall be administered as soon
as possible after doses are prepared by the same person who prepared the
medication for administration.
17.E.4.
Medication
Identification
The facility must have an organized system for drug
administration that identifies each drug up to the point of
administration.
17.E.5.
Resident Identification
There shall be provision for assuring proper identification
of residents by all personnel administering medications.
17.E.6.
Self-Administration of
Medications
An individual may self-administer medications if the
multidisciplinary team has determined that the practice is safe, and with the
written permission of the resident's attending physician.
17.F.
Control of Narcotics,
Barbiturates and Other Controlled Substances
17.F.1
Policies and Procedures
a. All facilities shall comply with State and
Federal regulations governing narcotics and those drugs subject to the
Comprehensive Drug Abuse Prevention and Control Act of 1970, and any amendments
thereto.
b. For purposes of this
section, narcotics, barbiturates and other controlled substances shall include
any substance listed under the Federal Uniform Controlled Substance Act,
Sections 1 through 5.
c. All
Schedule II controlled substances, including the emergency supply, received in
the facility shall be recorded in a bound drug book as specified in this
Chapter. Whenever a container of Schedule II controlled substances has been
used up, as evidenced by the record required in this Chapter, it shall be noted
in the bound drug order book by signature and date that the supply is
depleted.
d. For all substances
listed in Schedule II as above, there shall be an individual narcotic sheet on
which shall be recorded the name of the resident receiving the substance,
prescription number, the name, date, strength, dosage, and method of
administration, the name of the prescribing physician, the signature of the
nurse administering it and the balance on hand. This record shall be filed in
the individual resident's record upon completion.
e. The emergency supply inventory shall name
the resident for whom the controlled substance was issued, the name of the
physician, and the date issued, signed by the nurse issuing the medication and
the nurse receiving the medication.
f. The count of Schedule II controlled
substances, to include the emergency supply, shall be recorded and signed at
the change of each shift by two people qualified to administer medications, one
of whom shall be a licensed nurse.
g. All Schedule II controlled substances,
including the emergency supply, shall be stored under double lock, in a locked
box attached to the wall or shelf or locked cabinet within the medication
cabinet or cart, or an approved double locked cabinet attached to the
wall.
h. Policies shall be
developed relative to the accounting of controlled substances other than
Schedule II.
17. F.2.
Handling of Unused Schedule II Controlled Substances
a. The Director of Nursing Services, or a
designee, shall list all such unused substances, tape the cap or cover with
tamper evident seals and keep the same in a secure, double-locked area, apart
from all other drugs. The drugs shall be accessible only to the Director of
Nursing or designee.
b. A current
inventory of these substances shall be maintained and recorded in a monthly
inventory recorded by the Director of Nursing and one other licensed nurse.
These inventories must be maintained for a period of at least five (5) years or
as required under Federal/State statutes.
c. Prior to the destruction of these
substances by the authorized person, the inventory shall be verified by that
person. Notation shall be made of the destruction, date and signed by all
authorized individuals.
d. Disposal
of such substances shall occur by incineration or by flushing into the sewage
system and shall be made in the presence of a representative from the
Department, a Maine licensed pharmacist, a member of the Board of Pharmacy who
is a licensed pharmacist, or Federal Drug Enforcement Agency agent. At least
one party must be a disinterested party. For the purposes of this section, a
disinterested party shall be considered to be either a nurse who was not the
last nurse to inventory the discarded item or a pharmacist who is not
affiliated with the provider who dispensed the drug.
e. For Schedule II controlled substances,
notation of such destruction shall be made on the inventory list required in
17.F.2.b. For Schedule II substances, notation of such destruction shall also
be made on the residents individual Schedule II controlled drug sheet, signed
and dated by the person who disposed of the drug and the authorized person
witnessing the disposition. For Schedule II substances, notation of such
destruction shall be made in the bound book required in Section
17.F.1.c.
17.G.
Recording of Medications
17.G.1.
Records of
Administration
A record shall be kept of all drugs and medications
administered, including name of drug, dose form, dosage, and time given. This
shall be promptly recorded on the record of medications and treatment,
initialed by the administering individual, with the full name of the individual
written somewhere on such record. The need for and response to medications
administered which were prescribed to be given as needed shall be documented on
the medication or clinical record.
17.G.2.
Record of Time Started, Given
or Discontinued
Entries shall be made on the medication records to indicate
whenever medications are started, given, or discontinued.
17.H.
Reporting of
Medication Errors and Adverse Reactions
17.H.1.
Reports to Physician
Medication errors and adverse reactions shall be immediately
reported to the resident's physician. Medication errors include omissions, as
well as errors of commission. Adverse reactions shall also be reported to the
pharmacist consultant and pharmacy.
17.H.2.
Clinical Records
An entry of the error and/or adverse reaction shall be made
in the resident clinical record.
17.H.3.
Incident Reports
There shall be an incident report made out for each
medication error and/or adverse reaction. These reports shall be kept together
on the premises of the facility, reviewed by the Quality Assurance Committee
and be made available for review by representatives of the Department.
17.I.
Equipment
and Supplies
17.I.1.
Medicine
Cabinet
A cabinet or medication cart shall be provided for individual
prescriptions. The cabinet/cart shall be of sufficient size, properly lighted,
and located where easily accessible and locked when not in use. The medicine
cabinet/cart shall be equipped with separate cubicles, plainly labeled, or
provided with other physical separation for the storage of each resident's
prescriptions.
17.I.2.
Medicine Measuring Devices
Appropriate measuring devices for the accurate measure of
liquid medications shall be provided. If not disposable, these medicine
containers shall be returned to the institution's dishwashing unit for
processing after each use.
17.I.3.
Cabinets for Cleaning Supplies
and Poisons
There shall be a separate secure cabinet apart from medicine,
drugs, and food, for the storage of all bleaches, detergents, disinfectants,
insecticide, and poisons. These shall be clearly labeled.
17.I.4.
Emergency Medication Box
There shall be readily available in a secure area, an
emergency medication box approved by the facility's group of professional
personnel. All medication shall be in single dose form, if available, and any
drug removed from the kit shall be replaced within 24 hours and have a drug
prescription to cover replacement of same within 5-7 days. An adequate
inventory level shall be maintained to assure that a supply is
available.
17.I.5.
Reference Material
There shall be, readily available to all staff, current
(within two [2] years) medication reference material and up-to-date information
for all medications in use in the facility.
17.I.6.
First Aid Kit
There shall be a first aid kit which is OSHA approved and
equipped as facility policy dictates, readily available at each nurses
station.
