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COMPOUNDING and DISPENSING

Nailis Syifa
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.
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;
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

Some of the technical functions are:


1. functions indirectly related to dispensing;
2. functions carried out as a prerequisite (persyaratan) 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 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:
1. Physical status and functional abilities
2. Psychological status and well-being
3. Social interactions
4. Economic and/or vocational (kejuruan) 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
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 paten 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
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
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.
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.
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.
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 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 non-sterile 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.
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.
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 non-sterile compounded
preparations.
a. the guidelines are quoted as follows.
In the absence of stability information that is applicable to a specific drug
and 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.
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
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.
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
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.

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