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:
(4) optimizing
patient therapy outcomes. It is recognized that the patient might be best
served if medication is not provided.
(a)
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 pharmacy technicians and
designed forms, etc.
(1) Name,
address, telephone number;
(2) Date
of birth (age);
(3)
Gender;
(4) Medical history
(A) Significant patient health problems known
to the pharmacist;
(B) Prescription
drug reactions/prescription drug allergies;
(C) List of prescription medications and
legend drug administration devices known to the pharmacist.
(5) 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 one-time situation, the pharmacist may forego the above
requirement to record and maintain the information.
(6) Pharmacist comments
(b) Drug use evaluation for new and refill
prescriptions Drug use evaluation or drug utilization review includes the
following activities:
(1) The pharmacist shall
evaluate the prescription or medication order for:
(A) Reasonable dose and route of
administration;
(B) Reasonable
directions for use.
(2)
The pharmacist shall evaluate medication orders and patient information for:
(A) Duplication of therapy - is the patient
taking the same or similar medication(s)?;
(B) Prescription drug-prescription drug
interactions;
(C) Proper
utilization (over or underutilization);
(D) Known drug allergies.
(3) Drug-drug contraindications as
defined by the Board. (Is this medication contraindicated with another
medication the patient is taking?)
(4) 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.
(5) If a problem is
suspected and the physician is informed, the pharmacist shall document the
process.
(c) Patient
counseling.
(1) 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;
(2)
Alternative forms of patient information may be used to supplement, but not
replace face-to-face patient counseling;
(3) 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.
(4) 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 it is when professionally
deemed to be appropriate and when medications are provided by the pharmacy, and
when a pharmacist is on duty and a patient is discharged from the hospital or
institution.
(5) 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 publication as determined by the
Board.
(6) 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.
(d) "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) Explanation
of 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 over-the-counter 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
judgment of the pharmacist.
(d) Drug interactions - 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 do 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. (2/12/91, 2/10/98, 07/15/2004)