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BEYOND-USE DATE IN

DISPENSING
Prof. Dr. Suwaldi Martodihardjo, M.Sc., Apt
Faculty of Pharmacy
Gadjah Mada University
Jogjakarta

DEFINITIONS/DESCRIPTIONS
Compounding (USP):
The preparation, mixing, assembling, packaging,
or labeling of a drug or device:
(i). as the result of a practitioners Prescription
Drug Order or initiative based on the
pharmacist/patient/prescriber relationship in the
course of professional practice, or
(ii). For the purpose of, as an incident to research,
teaching, or chemical analysis and not for sale or
dispensing. Compounding also includes the
preparation of drugs and devices in anticipation of
Prescription Drug Orders based on routine,
regularly observed patterns.
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Dispensing:
Reviewing the order for correctness of dosing and
indication for use; processing the order;
compounding/ preparing the drug; and dispensing
the drug in a timely manner.

Prescribing:
Assessing the need for/selecting the correct drug;
individualizing the therapeutic regimen; and
designing the desired therapeutic response.

Administering:
Administering the right medication to the right
patient; administering the medication when
indicated; and informing the patient about the
medication

Monitoring:
Monitoring and documenting the patients
response; identifying and reporting ADR;
reevaluating the drug selection, drug regimen,
frequency, and duration.
The prescription dispensing is likely to be the
major activity occupying pharmacists time.
There are steps involved in preparing and
distributing medications to patients.

In a pharmaceutical care practice, the role of


pharmacist must be focused on professional
activities that address patients drug therapy
needs. Daily operations management by the
pharmacist should be minimized to allow for
uninterrupted patient interaction.

FUNCTIONS OF PRACTICING
PHARMACISTS

Types of Functions:
1. professional functions;
2. technical functions essential to practice;
3. administrative, supervisory, and
managerial functions;
4. Entrepreneurial functions related to the
investment of capital and ownership of
pharmacies.

PROFESSIONAL FUNCTIONS
The commission to Implement Change in
Pharmaceutical Education of the American
Association of Colleges of Pharmacy (AACP)
identified 10 (ten) functions of professional
pharmacy practice.

These functions are:


1. participating in the process of drug use
decisions;
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2. selecting the drug product dosage form;


3. Selecting drug product source of supply;
4. determining the dose and dosage schedule;
5. preparing the drug product for patient use;
6. providing the drug product to the patient;
7. providing drug information to the patient;
8. monitoring the patient to maximize
compliance;
9. monitoring the patient to detect adverse
drug reactions and drug interactions;
10. Monitoring the patient to enhance the
outcomes of drug therapy.

TECHNICAL FUNCTIONS ESSENTIAL TO


PRACTICE
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Some of the technical functions are:


1. functions indirectly related to dispensing;
2. functions carried out as a prerequisite to
dispensing;
3. Functions directly involved with dispensing.

The Practice of Pharmacy (The NABPs Model


State Pharmacy Practice Act (MSPPA)) means:
1. The interpretation, evaluation, and
implementation of Medical Orders;
2. The Dispensing of Prescription Drug Orders;
3. Participation in Drug and Device selection,
Drug Administration, Drug Regimen Reviews,
and drug or drug-related research;
4. Provision of Patient Counseling and the
provision of those acts or services necessary to
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provide Pharmaceutical Care in all areas of


patient care including Primary Care; and
5. The responsibility for:
a. Compounding and Labeling of Drugs
and Devices (except Labeling by a
Manufacturer, re-packager, or
distributor of Non-Prescription Drugs
and commercially packaged Legend
Drugs and Devices),
b.Proper and safe storage of Drugs and
Devices, and
c. Maintenance of proper records for them.
In 1990, the Board of Trustees of the American
Pharmaceutical Association (APhA) adopted the
following mission statement for pharmacy:
The mission of pharmacy is to serve society as the
profession responsible for the appropriate use of
medications, devices, and services to achieve
optimal therapeutic outcomes.

Today, the primary role of the pharmacist in


contemporary practice is the delivery of
pharmaceutical care.

The American Pharmaceutical Association, in


1996, issued Principles of Practice for
Pharmaceutical care:
Pharmaceutical care is a patient-centered,
outcomes oriented pharmacy practice that
requires the pharmacist to work in concert with
the patient and the patients other healthcare
providers to promote health, to prevent disease,
and to assess, monitor, initiate, and modify
medication use to assure that drug therapy
regimens are safe and effective.
The goal of pharmaceutical care is to optimize
the patients health-related quality of life
(HRQOL) and achieve positive clinical outcomes,
within realistic economic expenditures.
Domains of Quality of Life (QOL)
The four major domains of QOL:
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1. Physical status and functional abilities


2. Psychological status and well-being
3. Social interactions
4. Economic and/or vocational status and
factors.

Pharmaceutical care requires:


1. an expert knowledge of therapeutics,
2. a good understanding of disease processes,
3. knowledge of drug products,
4. strong communication skills,
5. drug monitoring, drug information, and
therapeutic planning skills,
6. The ability to assess and interpret physical
assessment findings.

LABELING PRESCRIPTIONS
Required and recommended elements on labels
for prescriptions:
a. Name and address of pharmacy that dispensed
the drug
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b.Name of patient; if the patient is an animal,


label with the species of animal and the
owners name
c. Name of prescriber
d.Direction for use
e. Date dispensed
f. Cautionary statements, if any
g. Serial number of prescription
h.Name or initial of the dispensing pharmacist
i. Name (proprietary or generic) and strength of
drug product dispensed
j. Name of the manufacturer or distributor of
the product dispensed
k. Beyond-use date of the product

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The examples of prescription label


Practical Pharmacy
13 Kartoiboro Street
Sleman, Jogjakarta
Rx 123
Su Gih Utang.

Pharmacist: SMRT

Date: 27/11/04
Dr. Mujarab

Take one capsule three times daily for ten days


Amoxicillin 250 mg. capsules
Mfg: Rugby Labs
Quantity: 30
Refills: 0
Discard after: 00/00/00

Practical Pharmacy
13 Kartoiboro Street
Sleman, Jogjakarta
Rx 123
Pharmacist: SMRT
Ba Yar Utang

Date: 27/11/04
Dr. Baik Hati

Take one tablet every four to six hours as needed for


severe pain
Tylenol w/ Codeine no.3 tablets Quantity: 30
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Mfg: Punyaku Labs
Refills: 1
Discard after: 00/00/00

Auxiliary Labels: May cause drowsiness;


Alcohol and operating car or machine
warning;
Do not transfer label

EXPIRATION AND BEYOND-USE


DATING
Expiration Date
USP 27 (2004) defines:
The expiration date identifies the time during
which the article may be expected to meet the
requirements of the Pharmacopeial monograph,
provided it is kept under the prescribed storage
conditions.

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The expiration date limits the time during which


the article may be dispensed or used.
Where an expiration date is stated only in terms of
the month and the year, it is a representation that
the intended expiration date is the last day of the
stated month

Beyond-Use Date
This is the date put on the dispensing container by
the pharmacist.
USP 27 (2004) states:
1. The dispenser shall place on the label of the
prescription container a suitable beyond-use
date to limit the patients use of the article
based on any information supplied by the
manufacturer and the General Notices and
Requirements of this Pharmacopeia. The
beyond-use date placed on the label shall not
be later than the expiration date on the
manufacturers container.
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2. The beyond-use date is the date after which


an article must not be used.

Drug products labeled, packed, and dispensed by


the pharmacist on prescription orders:
1. The National Association of Board of
Pharmacy (NABP) Model Rules for
Pharmaceutical Care recommends that
beyond-use date be included on the
prescription label.
2. The General Notices of the USP states that the
dispenser (the pharmacists) shall label a
prescription container with a beyond-use
date.
3. The pharmacists feel it is their professional
responsibility to provide their patients with a
date after which a medication may no longer
have its labeled potency.

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Difficulties in Assigning Beyond-Use


Dates
The General Notices of the USP 27 states:
Pharmacists are reminded to use professional
judgment when using the available information
for determining beyond-use dates.

Assigning Beyond-Use Dates to Manufactured


Drug Products Dispensed By the Pharmacist
Multi-dose containers
1. The USP allows use of the manufacturers
expiration date or 1 year from the date the
drug product is dispensed, whichever is
earlier.
This is the maximum length allowed, and the
factors such as the drug, the container, and

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the storage conditions (e.g., temperature,


humidity and light) must be considered.
The exception to this would be a volatile drug
like nitroglycerine.
2. The USP specifies that the facility in which
drug products are packed and stored has a
temperature that is maintained so as not to
exceed a mean kinetic temperature of 25oC.
3. To protect the product from humidity or
moisture permeation, any plastic packaging
material must provide protection better than
that given by PVC.

Single-unit and unit-dose containers for nonsterile dosage forms


1. The USP (27) allows use of the
manufacturers expiration date or 1 (one)
year from the date the drug product is
packaged in the unit container, whichever is
earlier.
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2. The plastic packaging materials give better


moisture permeation protection than PVC.
3. The non-sterile solid and liquid dosage forms
are to be repackaged and stored under
conditions specified in the product
monograph; otherwise, the conditions should
be controlled room temperature and relative
humidity should not exceed 75% at 23oC.
4. The USP also prohibits reprocessing of
repackaged unit-dose containers, i.e., the
pharmacist may not remove dosage units
from one unit-dose container and dispense it
in another unit-dose container.

Assigning Beyond-Use Dates to Compounded


Drug Preparations
1. The General Notices of the USP state that
compounded drug preparations shall be
labeled with a beyond-use date.

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2. The general rules for assigning beyond-use


dates state that pharmacist must take into
account the nature of the drug or drugs
involved; the characteristics of the
preparation container, and the expected
storage conditions.
3. Before compounding any drug product,
consult the available literature for stability
information.
4. When assigning a beyond-use date to a
compounded preparation, the pharmacist
must take into consideration the expiration
dates of all the ingredients used in
formulating the preparation.
5. The USP Chapter on pharmacy compounding
has established some basic guidelines that are
useful in assigning beyond-use dates for nonsterile compounded preparations.
a. the guidelines are quoted as follows.
In the absence of stability information
that is applicable to a specific drug and
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preparation, the following maximum


beyond-use dates are recommended for
non-sterile compounded drug
preparations that are packed in tight,
light-resistant containers and stored at
controlled room temperature unless
otherwise indicated.
For Non-aqueous Liquids and Solid
Formulations:
where the manufactured drug product is
the source of active ingredients:
The beyond-use date is not later than
25% of the
time remaining until the products
expiration
Date or 6 months, whichever is earlier.
-where a USP or NF substance is the
source of active ingredient:
The beyond-use date is not later than 6
months.
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For Water-Containing Formulations


(prepared from ingredients in solid
form):
The beyond-use date is not later than 14
days when stored at cold temperatures.
For All Other Formulations:
The beyond-use date is not later than the
intended duration of therapy or 30 days,
whichever is earlier.

b.The application of the above maximum


default beyond-use dates:
1. The pharmacist is crushing Diazepam
tablets for incorporation into
compounded capsules.
If the bulk package of tablets has a labeled
E.D. of 1 year from the date of
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compounding, the maximum possible


beyond-use date would be 3 months (25% of
1 year).
It assumes that the capsules will be
dispensed in a tight, light-resistant
container and stored at controlled room
temperature.
2. If the same situations were to occur but
the capsules were made using pure
Diazepam USP powder, the maximum
beyond-use date would be 6 months.
This assumes that the E.D. of Diazepam
powder is longer than 6 months.
If the E.D of Diazepam is less than 6
months, the beyond-use date on the capsules
would have to be shortened appropriately.
For example:
The E.D. of Diazepam is 4 months, and then
the assigned beyond-use date for the
capsules might be 1 or 2 months.

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3. If either crushed manufactured tablets or


pure powder were used to make a
Diazepam aqueous oral suspension, the
maximum default beyond-use date would
be 14 days.
This assumes that the suspension will be
stored in a cold place such as refrigerator
4. If either crushed manufactured tablets or
pure Diazepam were used to make
suppositories, the pharmacist would have
the option to select 3 months (if using the
crushed tablets above) or 6 months (if
using pure drug powder) because this is a
non-aqueous formulation or the 30 days
or intended length of therapy.

In this case, the pharmacist would have to use


professional judgment in selecting an
appropriate date.
Because heat is used in the compounding
procedure for making suppositories, a
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conservative beyond-use date would be


recommended.

When the pharmacist makes compounded


formulations, he/she usually mixes the drugs and
the excipients, the new preparation should have a
shorter expiration date than that assigned to any
of the single original ingredients.

How much should the pharmacist reduce the


beyond-use date?
There are six key factors to consider:
1. The nature of each ingredient.
For example: KCl, penicillin, and aspirin.
2. The combination of ingredients.
For example: an isoniazid suspension
formulated with 50% sorbitol solution is
stable for ~ 3 weeks, whereas an isoniazid
suspension made with sugar-base syrups is
not nearly that stable.
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3. The final pharmaceutical dosage form.


4. Procedures.
Variation in compounding procedures and
equipment used for making a formulation can
affect the stability of the final preparation.
5. Packaging used for the preparation.
For example: some drugs need tight container
due to its sensitivity to moisture.
6. Possible storage conditions.

CONCLUDING REMARK FOR BEYOND-USE


DATE
1. The subject of assigning scientifically based
beyond-use dates is one that continues to be
debated, it is important to be knowledgeable
about the latest published standards.
2. As professionals charged with protecting the
health of their patients, pharmacists want to
be sufficiently conservative in assigning
beyond-use dates so that the label adequately
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reflects the actual potency of the product or


preparation.
At the same time, the dates should not be so
conservative that patients are unnecessarily
inconvenienced with frequent visits to the
pharmacy, and drug products or preparations
are not wasted by discarding items that are still
within labeled limits.
3. Although there are only few reported cases in
which degraded drugs have caused human
toxicity, it must be remembered that
therapeutic failure, (especially in the case of a
critical drug, a critical disease, or a critical
patient), caused by a sub-potent drug product
or preparation may be just as serious as a
case of toxicity caused by a degraded drug.
This should always be kept in mind when
assigning beyond-use dates and the patient
should be instructed to monitor the results of
the therapy.

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DRUG UTILIZATION REVIEW


(DUR)

US GOVERNMENT REGULATIONS
CONCERNING DUR
Federal Law
DUR is addressed in OBRA 90.
OBRA 90 is the Omnibus Budget Reconciliation
Act of 90 which mandated the formation of state
DUR boards for use in state Medicaid programs
providing outpatient prescription services.
The intent of OBRA 90 was to increase patient
education and to promote the appropriate use of
medication through prescribing practices and
therefore to control health care cost funded by the
government.
The United States Pharmacopoeia (USP) develops
and published standards of care to be
incorporated by these DUR boards.

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Standards are set by regulation and enforced by


the Health Care Finance Administration (HCFA).
The focus of these standards was to prevent:
a. Over/underutilization of drug
b.Duplication of therapy
c. Drug-drug, drug-food, drug-disease, and
drug allergy interactions
d.Incorrect dosage or duration
e. Clinical abuse or misuse.
The OBRA 90 states that the state plan shall
provide for a review of drug therapy before each
prescription is filled or delivered to an individual
receiving benefit under this subchapter, typically
at the point-of-sale or point of distribution.
The review shall include screening for potential
drug therapy problems due to:
1. therapeutic duplication,
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2. drug-disease contraindication,
3. drug-drug interactions (including serious
interaction with non-prescription or over-thecounter drugs),
4. incorrect dosage or duration of drug
treatment,
5. drug-allergy interactions, and
6. Clinical abuse/misuse.
State Law
1. DUR is required in all states, as described in
OBRA 90 federal regulations.
2. The NABP (National Association of Board of
Pharmacy) states in Model Rules for
Pharmaceutical Care:
A Pharmacist shall review the patient record
and each Prescription Drug Order presented
for Dispensing for purposes of promoting
therapeutic appropriateness by identifying:
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a. Over-utilization;
b.Under-utilization;
c. Therapeutic duplication;
d.Drug-disease contraindications
e. Drug-drug interactions;
f. Incorrect Drug dosage or duration of
drug treatment;
g. Drug-allergy interactions; and
h.Clinical abuse/misuse.

There are two distinct types of DUR:


1. Prospective DUR (ProDUR), and
2. Retrospective DUR (RDUR).
ProDUR:
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The review that a pharmacist conducts before


dispensing a new prescription order is ProDUR.
The new prescription order is reviewed with the
intent of maximizing therapy and detecting
problems caused by:
1. Incorrect dosage,
2. route of administration,
3. duration of therapy,
4. therapeutic duplication,
5. drug-allergy contraindications
6. drug-disease contraindications
7. undesirable drug-drug interactions,
8. inappropriate therapeutic use,
9. over utilization of medication,
10.

Under utilization of medication.


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To perform ProDUR well, the pharmacist should


have access to information about the patients:
1. lifestyle,
2. medical history,
3. current diagnosis,
4. past and present medication use, and
5. Laboratory values.
Some of this information can be found on the
patients medication profile record, which is
available in the pharmacy.

RDUR:
A review (often involving comparative statistics)
of a large number of prescription orders that have
already been dispensed.

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This large database is examined for potential


problems, such as fraud, abuse, gross-overuse,
inappropriate or medically unnecessary care
among physicians, pharmacists, and patients.

The goal of RDUR is to maximize cost-effective


rational therapy.

In most cases, identified problems are handled by


educating those involved with the intent of
avoiding the problems in the future.

In cases of fraud or abuse by practitioners or


patients, legal action may be taken.

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PATIENT MEDICATION PROFILE


RECORDS
1. Comprehensive and accurate patient
medication profile records are necessary tools
in performing any form of medication
evaluation.

2. The NABP (USA) recommends that these


patient records be kept for not less than 5
years from the date of the last profile entry.

3. Reviewing the prescription order

The following list identifies information that


should be available and reviewed on patient
medication profile records.

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a. Patient identification information: name,


address, telephone number, date of birth,
gender.

b.Patient medical history: allergies, ADR,


idiosyncrasies, history of chronic
conditions and medical and surgical
events, use of drug products or devices
(either prescription or over-the-counter)
that are not in the dispensing record, and
pharmacists comments or interventions.
If there are none, this should be indicated.

c. Other useful patient information: height,


weight, occupation, any additional helpful
information such as inability to use safety
closures or swallow tablets or capsules.

d.If applicable, information on third-party


payers (insurance, medical assistance).

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e. Information for each prescription order


dispensed:
1. Drug product information name
(generic and/or brand), strength, and
dosage form.
2. Quantity dispensed.
3. Direction for use should identify dose,
frequency and route of administration,
and, if not treating a chronic lifetime
condition, duration of use.
4. Therapeutic indication or when known
the diagnosis related to the prescription
order.
5. Supplemental information and warnings
(i.e., administration instructions).
6. Prescriber identification and contact
information.
7. Retrieval designation assigned to the
prescription order.
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8. Date of dispensing, initial and all


renewals.
9. Identification of dispensing pharmacist.

PROSTECTIVE DUR ELEMENTS


When a new or renewal prescription order is
presented to the pharmacist, the following
elements should be considered when evaluating
the medication management:
1. Accuracy and completeness of the
prescription order.
2. Appropriateness of dose, route of
administration, dosage schedule and dosage
form in relation to disease, patient- and
medication specific characteristics.

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3. Previous allergic reaction or adverse events


with the prescribed drug or with a drug that
is similar structurally or therapeutically. Be
sure to ask the patient or caregiver about both
allergies and adverse events.
4. Unexpected changes in dose and/or schedule
when presented with a new prescription order
for a currently used medication.
5. Quantitative misuse of current medications by
the patient, which could indicate adherence
problems or therapeutic failures of the
medication management:
a. Over-utilization
b.Under-utilization.
6. Undesired medication management due to :
a. Contraindications
b.Drug-drug interactions
c. Drug-disease interactions
d.Drug-laboratory interactions
e. Therapeutic duplication, including
specific ingredients, therapeutic class, or
possible additive effects of dissimilar drug
entities (e.g., sedating antihistamines and
narcotic analgesics).
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7. Check prescription and non-prescription


product usage as well as self-management
with alternative therapies.
8. Drugs that have:
a. a high risk profile due to narrow
therapeutic window,
b.interaction potential,
c. unknown reactions due to new drug
entity,
d.Interaction with specific patient
populations (chronic illness, lifethreatening illness, multiple medication
regimens, greater than or equal to 9 doses
per day, 65 years of age or older, etc.).
9. Specific medications as well as disease and
medication combinations that could be
inappropriate.

WHAT TO DO WHEN A PROBLEM


IS
IDENTIFIED

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General rules for dealing with patients and


other health professionals concerning a problem
with drug therapy:
a. Always be tactful.
b.No matter what the problem (including
over-utilization, failure to adhere to
prescribed therapy, illogical prescribing,
etc.), approach patients, care givers, and
health care providers with the assumption
that there is a good reason or a logical
explanation for the prescribed therapy or
the present course of action.
Considerations
a. Severity of the problem. This must be
considered because it affects your course
of action.
b.A potential problem with a new
prescription or medication order.

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The problem is manageable:


1. Dispense the order as written.
For example:
a. There may be an interaction, but no
special precautions are necessary.
b.There may be an interaction, but it
can be accommodated with
appropriate patient consultation on
use of the medication and/or therapy
monitoring.

2. A change in therapy is possibly needed.


Contact the prescriber first:
Briefly describe the problem
If possible, give a reference source for your
information
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Have suggestions ready for alternatives.

The problem is non-manageable :


1. If the problem cannot be resolved to your
satisfaction, you may decide not to
dispense the medication.
2. You should fully inform the patient of
your concerns and actions on his or her
behalf.
3. Document your intervention.

c. A potential problem with current existing


therapy.
1. There is a problem with overuse or
adherence in the use of a current
medication.
a. Talk with the patient. Remember to
be tactful and assume there is a
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logical reason for the suspected


overuse or non-adherence.
b.If a problem exists, alert the
patients physician so that together
you can work with the patient to
solve the problem.
c. Document the intervention.

2. There is a new adverse event as result


of current therapy.
a. Get the detailed information
from the patient about the
adverse reaction: for example,
what happens, when, specific
circumstances, and medications
being used concurrently.
b.Discuss the problem with the
patients physician:
1. Briefly describe the problem.
2. Have suggestions ready for
alternatives.
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c. Document the intervention.


d.If this is a serious adverse event,
report it to regulatory agency.

PATIENT CONSULTATION
PROFESSIONAL STANDARDS OF
PRACTICE
1. It may seem to you that talking with patients
about their medications is a normal function
of pharmacists, and this has not always been
true.
2. Patient education is promoted as primary
professional responsibility of pharmacists.
a. The APhA Code of Ethics addresses the
issues of patient consultation and
pharmacist-patient communication (Code
of Ethics for Pharmacists, 1994).
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These include:
1. Pharmacists are health professionals
who assist individuals in making the
best use of medications.
2. A Pharmacist promotes the right of
self-determination and recognizes
individual self-worth by encouraging
patients to participate in decisions
about their health.
A pharmacist communicates with patients
in terms that are understandable. In all
cases, a pharmacist respects personal and
cultural differences among patients.
3. A Pharmacist promises to help
individuals achieve optimum benefit
from their medications, to be
committed to their welfare, and to
maintain their trust.

b.The ASHP Guidelines on PharmacistConducted Patient Education and


Counseling on the first paragraph in the
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introductory Purpose section states the


following (Am. J. Health-Syst Pharm,
1997):
Providing pharmaceutical care entails
accepting responsibility for patients
pharmacotherapeutic outcomes.

GENERAL GUIDELINES FOR PATIENT


COUNSELING
The principles for patient counseling which can be
easily applied to any practice setting.
1.

Appropriate physical environment


a. Discussion with patients or care givers
about health, pharmacotherapy, and
other medical issues is a very private
activity. In conducting this activity in a
confidential area is essential.

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b.To perform this service well, the


pharmacist should also provide an
environment that feels comfortable and
unrushed.
2.

Before preparing the prescription:


The consultation process begins not when the
pharmacist transfers the prescription to the
patient, but as the pharmacist receives the
prescription order from the patient or agent
of the patient.
a.

Input from the patient:


1. Ask the patient or caregiver if there is
any information the pharmacist
should have before preparing the
prescription.
For example, has the physician given the
patient any special instructions? Can the
patient open child-resistant safety
closures? Can the patient read the label?
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2. An issue of increasing relevance is


that of third-party coverage for
prescription medications. Some plans
have formulary restrictions
concerning what medications will be
covered.

3. If the prescription order is for a


branded product, check if a generic
equivalent can legally be dispensed.
If so, does the patient want a generic
product? What are the implications with
respect to both therapy and cost to the
patient and third-party coverage and copayments?

b.Review of the patients medication record

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1. Perform the normal prospective DUR


assessments. Are there any
contraindications to the new therapy,
any drug-drug interactions, etc.?
2. Look for problems with the new
prescription, and also review the
patients total drug therapy.
(i) Do there appear to be
problems with adherence
to or over-utilization of
existing therapy?
(ii) Does this patient need a
pep talk or advice on
strategies concerning
adherence issues?
(iii) Are there possible helpful
hints the pharmacist may
give the patient?
For example, if the patient is taking
other medications, he or she would
be probably like to know about
taking more than one drug product
at the same time.
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(iv) Would a dosing aid, such


as pill remainder box, a
tablet crusher, or a pocket
pill box, be helpful?
3. When delivering the prescription to the
patient:
1. It is helpful to give the patient an estimate
of the length of time the consultation
requires.
Recognize the patients right to refuse
counseling.
Most patients are appreciative of your
professional advice and counsel; however,
circumstances may exist that interfere with
a complete counseling encounter.

2. Maintain a professional, sincere attitude.

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Use a professional but friendly, relaxed, and


sincere demeanor.
This attitude should help put the patient at
ease and foster an atmosphere that
encourages the patient to ask questions.

3. Use language appropriate to the needs


and level of understanding of the patient.

4. It is essential that pharmacist inform


patients about both positive and negative
aspects of their therapy.
Precautions in a tactful way should be taken
in disclosing those aspects.

5. Notice the patients body language.


Watch the patients face for feedback.

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6. Be aware of cultural differences among


patients.

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PATIENT CONSULTATION
I. INTRODUCTION
1. Establish relationship with patient
2. Patient Assessment
3. Name of medication and therapeutic
indication
4. Intent and duration of consult
II. ADMINISTRATION
1. Label directions
2. Special instructions
3. What to do about a missed dose
4. How long to continue taking
5. Status of refill
III. PRECAUTIONS/ SIDE EFFECTS/
MONITORING OF THERAPY
1. Precautions and untoward effects
2. Monitoring of therapy
IV. STORAGE INSTRUCTIONS
V. CHECK FOR PATIENT
UNDERSTANDING OF INFORMATION
52

BARRIERS TO PHARMACEUTICAL CARE


A variety of factors have impeded pharmacist
ability to implement pharmaceutical care and can
be grouped into some general categories:
1. Individual pharmacist characteristics:
a. Pharmacists attitudes (lack of
comprehension, misconceptions, fear of
change, and lack of motivation).
b. Lack of advanced practice skill
(therapeutics, clinical problem solving,
communication skill, documentation, drug
information).
2. Practice-setting constraints.
3. Intra-professional barriers.
4. System impediments.
5. Resource-related constraints.

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CONCLUSION
1. The patient-oriented pharmacy profession is
extremely healthy for patient, the
pharmacist, and other members of the
health-care team.
However, this will present pharmacists with a
number of new challenges.

2. The pharmacists must make the acquisition


of contemporary practice knowledge and
skills a high priority, to render the level of
service embodied in the concept of
pharmaceutical care.

3. Pharmacy educators organizations and


regulatory bodies must all work together to
support pharmacists.

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4. Pharmacists should view themselves as


dispensers of therapy and drug-effect
interpretations.

5. Service components of pharmacy should be


identified clearly to be visible to consumers,
so that they know what is available at what
cost and how it may be accessed.

6. The future, pharmacy services must be


evaluated on patient outcome (i.e.,
pharmaceutical care) rather than the
number of prescriptions dispensed, and
pharmacy must evolve toward interpretation
and patient consultation, related to the use of
medications.
Prof. Dr. Suwaldi Martodihardjo, M.Sc.,
Apt
Faculty of Pharmacy Gadjah Mada
University
55

Jogjakarta
REFERENCES
1. Anonym, 2004, USP 27/NF 22, the USP
Convention, Inc, Rockville.
2. Cramer, J.A. and Spilker, B., 1998, Quality of
Life and Pharmacoeconomics, An Introduction,
Lippincott-Raven, Philadelphia.
3. Popovich, N.G., 2000, Pharmacy Practice, in
Remington: The Science and Practice of
Pharmacy, Gennaro, A.R., Ed., 20th Ed.,
Lippincott Williams & Wilkins, Baltimore.
4. Rovers, J.P., Currie, J.D., Hagel, H.P.,
McDonough, R.P., Sobotka, J.L., Eds., 2003,
A Practical Guide to Pharmaceutical Care, 2nd
Ed., , APhA, Washington, D.C.
5. Thompson, J.E., 2004, A Practical Guide to
Contemporary Pharmacy Practice, 2nd Ed.,
Lippincott Williams & Wilkins, Baltimore.
===Prof. Dr. Suwaldi Martodihardjo, M.Sc.,
Apt=====

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