Arkansas Administrative Code › Agency 070 - Board of Pharmacy › Rule 070.00.98-003 - Regulation 48 - Patient Information, Drug Use Evaluation, and Patient Counseling

Current through Register Vol. 49, No. 6, June, 2024
48. PATIENT
		  INFORMATION, DRUG USE EVALUATION, AND PATIENT COUNSELING.
The intent of this regulation is to improve pharmaceutical care
			 by defining basic standards of care. Pharmacy care/ pharmaceutical care is
			 defined as the responsible provision of drug therapy for the purpose of
			 achieving definite outcomes that improve a patient's quality of life. These
			 outcomes are:
(1) cure of disease;
(2) elimination or reduction of a
		  patient's symptomatology;
(3)
		  arresting or slowing a disease process; or
(4) preventing a disease or symptomatology.
Pharmaceutical care (clinical pharmacy) involves four major
			 functions on behalf of the patient;
(1)
		  identifying potential and actual drug-related problems;
(2) resolving actual drug-related
		  problems;
(3) preventing potential
		  drug-related problems; and
(4)
		  optimizing patient therapy outcomes. It is recognized that the patient might be
		  best served if medication is not provided.
Section I: PATIENT INFORMATION (PROFILE)
In order to effectively counsel patients, the pharmacist must,
			 through communication with the patient or caregiver, make a reasonable effort
			 to obtain, record, and maintain the following information for each patient. It
			 is recognized that most of this can be obtained using qualified pharmacy
			 employees and designed forms, etc.
A)
		  Name, Address, Telephone Number;
B)
		  Date of Birth (Age), Gender;
C)
		  Medical History
1. Significant patient health
		  problems known to the pharmacist.
2. Prescription drug reactions/prescription
		  drug allergies
3. List of
		  prescription medications and legend drug 7; . administration devices known to
		  the pharmacist.
D)
		  Transitory patients or situations where the pharmacy will only provide
		  medication one time-In obtaining patient information, if the pharmacist knows
		  or is informed by the patient that this is a onetime situation, the pharmacist
		  may forego the above requirement to record and maintain the
		  information.
E) Pharmacist
		  comments
Section II:
		  DRUG USE EVALUATION-For New and Refill Prescriptions
Drug use evaluation or drug utilization review includes the
			 following activities:
A) The
		  pharmacist shall evaluate the prescription or medication order for:
1. Reasonable dose and route of
		  administration,
2. Reasonable
		  directions for use.
B)
		  The pharmacist shall evaluate medication orders and patient information for:
1. Duplication of therapy - is the patient
		  taking same or similar medication(s).
2. Prescription drug-prescription drug
		  interactions
3. Proper utilization
		  (over or under utilization).
4.
		  Known drug allergies.
5. Drug-Drug
		  Contraindications as defined by the Board. (Is this medication contraindicated
		  with another medication the patient is taking?)
It is recognized that the ultimate decision to use the medication
			 or not use the medication rests with the physician who has more complete
			 patient information. It is the pharmacist's responsibility to monitor the
			 patient's medication therapy in the areas addressed in this regulation and
			 inform the physician of the suspected problem.
If a problem is suspected and the physician is informed, the
			 pharmacist shall document the process.
Section III : PATIENT COUNSELING
* A pharmacist shall counsel the patient or caregiver "face to
			 face" if the patient or caregiver is in the pharmacy. If not, a pharmacist
			 shall make a reasonable effort to counsel the patient or caregiver;
* Alternative forms of patient information may be used to
			 supplement, but not replace face to face patient counseling;
* Patient counseling, as described herein, shall also be required
			 for outpatients of hospitals and institutions when medications are dispensed on
			 discharge from the hospital or institution.
* Patient counseling as described in this Regulation shall not be
			 required for inpatients of a hospital or institution where a nurse or other
			 licensed health care professional is authorized to administer the medication.
			 However, the pharmacist shall provide drug therapy counseling when
			 professionally deemed to be appropriate and when medications are provided by
			 the pharmacy, when a pharmacist is on duty and a patient is discharged from the
			 hospital or institution.
* The pharmacist shall maintain and make available to all
			 patients appropriate patient-oriented reference materials USP-DI or Facts and
			 Comparisons Patient Drug Facts or an equivalent or better as determined by the
			 Board.
* It is recognized that the ultimate decision to not provide
			 patient counseling rests with the physician. If the physician in specific
			 instances (blanket requests not accepted) requests that information NOT be
			 provided to the patient and gives reason, the pharmacist should honor that
			 request in almost all instances.
PATIENT COUNSELING shall mean the effective communication by the
			 pharmacist of information, as defined in this act to the patient or caregiver,
			 in order to improve therapeutic outcome by encouraging proper use of
			 prescription medications and drug delivery devices.
1) For original prescription medication
		  orders, (excluding renewed or updated prescriptions the patient has been
		  recently taking) and orders for legend devices specific areas of counseling
		  shall include:
a) Name and general
		  description of the medication dispensed, i.e. antibiotic, antihistamine, blood
		  pressure medicine, etc.
b) Name,
		  general description and directions for use of drug delivery devices, i.e.,
		  insulin syringes, morphine pump, etc.
c) Explain route of administration, dosage,
		  times of administration, and continuity of therapy;
d) Special directions for storage as deemed
		  necessary by the pharmacist;
e) If
		  the drug has been determined to have a significant side effect by the Board of
		  Pharmacy, the patient shall be properly counseled to the extent deemed
		  necessary by the pharmacist.
f)
		  When the prescription drug dispensed has a significant side effect, if taken
		  with OTC drugs, the pharmacist should counsel the patient about that
		  interaction. (Example: Coumadin with Aspirin)
g) If the prescription medication is
		  significantly affected by food or diet the pharmacist should so advise the
		  patient. (Example: Tetracycline with milk or food)
h) The pharmacist shall inform the patient or
		  caregiver that he/she is available to answer questions about medications or
		  general health information.
2) Refills-On refills the pharmacist shall
		  present the opportunity for the patient or caregiver to ask questions. However,
		  counseling on refills is not required except when needed in the professional
		  judgement of the pharmacist.
Section
		  IV: DRUG
		  I
		  NTERACTIONS-SIGNIFICANT SIDE EFFECTS
Recognizing that a pharmacist cannot be expected to recognize all
			 possible drug interactions and also recognizing that the pharmacist and the
			 patient does not have time to explain the numerous side effects of drugs, the
			 pharmacy shall maintain a computer program which will identify Significant Drug
			 Interactions (These are drugs with side effects which may be managed most
			 effectively if the patient is aware of the specific side effect and what to do
			 if it occurs.) The pharmacist in charge will be responsible for assuring that
			 the computer system adequately flags and warns the pharmacist of any occurrence
			 of significant drug interactions or significant side effects. (If a pharmacy
			 was in business before September 1,1997, and at that time, did not have a
			 computer system, said pharmacy may substitute Patient Drug Facts or other drug
			 interaction manuals to reference drug interactions and side effects for
			 effective patient counseling. This method should only be used until such time
			 as the pharmacy acquires an adequate computer program as described in this
			 section.)
The pharmacist will be responsible for counseling the patient on
			 these interactions with verbal and, where appropriate , written information.
			 (Amended 10/10/98)