Добавил:
Sekretar
kiopkiopkiop18@yandex.ru
t.me/Prokururor I Вовсе не секретарь, но почту проверяю
Опубликованный материал нарушает ваши авторские права? Сообщите нам.
Вуз:
Предмет:
Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_5739_Библиотеки_им_академика_М_И_Перельмана.pdf
Pharmacy Practice188
• “Protected from light” the product is to be stored either in a
container made of material that absorbs light sufficiently to
protect the contents from change induced by sunlight. The
various temperature conditions for storage of drugs as
specified in various schedules are:
i. Room temperature 15°C–25°C
ii. Cold or cool 8°C–15°C
iii. In a refrigerator 2°C–8°C
iv. In a deep freeze (–15°C)
• Inventory means all the raw materials, spare parts, tools,
maintenance consumables, fuels, lubricants, semi-processed
materials, finished goods, etc.
• “Inventory is a detailed list of those movable items which
are necessary to manufacture a product and to maintain the
equipment and machinery in good working order. The
quantity and value of every item is also mentioned in the list”.
• Importance of inventory control:
i. Major part of finance of an industry is spent on inven-
tories. If inventory is controlled then the industry can
earn more profits.
ii. Wastage of materials and theft of materials can be
checked.
iii. If inventory control is maintained then there are no
changes of overstocking.
iv. Men, machines and materials are properly utilized.
v. The products can be supplied to the consumers at a short
notice.
• Economic order quantity is a technique by which the orders
of goods to be purchased are placed in such a way that it
gives maximum economy in purchasing of any material.
• The economic order quantity may be determined by using
the following formula:
EOQ =
2A.O
C
where EOQ = Economic order quantity
A = Annual consumption
O = Ordering cost per unit
C = Carrying cost per unit
Drug Store Management and Inventory Control 189
PRAPRA
PRAPRA
PRA
CTICE QUESTIONSCTICE QUESTIONS
CTICE QUESTIONSCTICE QUESTIONS
CTICE QUESTIONS
VV
VV
V
erer
erer
er
y Shory Shor
y Shory Shor
y Shor
t Answer Tt Answer T
t Answer Tt Answer T
t Answer T
ype Questionsype Questions
ype Questionsype Questions
ype Questions
1. Define inventory control.
2. What are the objectives of inventory control?
3. With suitable examples mention what is cold storage?
4. Give 4 drugs to be stored at cold temperature.
5. Define drug store.
6. Enlist the factors affecting inventory control.
7. What is the formula to calculate EOQ?
ShorShor
ShorShor
Shor
t Answer Tt Answer T
t Answer Tt Answer T
t Answer T
ype Questionsype Questions
ype Questionsype Questions
ype Questions
1. Classify various techniques of inventory control. Explain
any one.
2. Write a note on periodic and perpetual method of inventory.
3. List out the various inventory control methods and its
application in drug store management.
4. Write a note on the legal aspects involved in the storage of
drugs.
5. What is buffer stock and safety stock?
LL
LL
L
ong Answer Tong Answer T
ong Answer Tong Answer T
ong Answer T
ype Questionsype Questions
ype Questionsype Questions
ype Questions
1. Define inventory control. Classify it and explain in detail
about any one method.
2. Enlist the factors affecting inventory control. Draw a layout
of drug store.
3. Write a detailed note on storage conditions for a drug store.
4. Write a short note on types of materials stocked in drug
store.
Objective TObjective T
Objective TObjective T
Objective T
ype Questionsype Questions
ype Questionsype Questions
ype Questions
1. Minimum area of ___ sq. metre is required for running a
retail or wholesale drug store.
A. 15 B. 10
C. 20 D. 25
2. “Protected from moisture” means product is to be stored
in a:
A. Well closed container
B. Air tight container
Pharmacy Practice190
C. Amber colored container
D. None of these
3. Match the following:
A. Room temperature i. 2–8°C
B. Cold or cool ii. 15°C
C. In a refrigerator iii. 8–15°C
D. In a deep freeze iv. 15–25°C
4. Requirements specified in ___________ of D&C Act should
be fulfilled for organization of drug store.
AnswersAnswers
AnswersAnswers
Answers
1. B 2. B 3. A-iv B-iii C-i D-ii 4. Schedule M
“Investigational drugs are those drugs which are under
consideration but not yet approved by the Food and Drug
Administration (FDA) or legal authority of the respective
country for human use”.
PPPRRRIIINNNCCCIIIPPPLLLEEE IIINNNVVVOOOLLLVVVEEEDDD
Hospitals are the primary centers for clinical studies on
investigational drugs. Basic principles and procedures involved
in the use of investigational drugs are:
i. An institution where investigational drug studies are
done should contain adequate safety measures for its
staff, patient and the scientific integrity of the study.
ii. All investigational drug studies must meet the criteria of
ethical, legal and scientific standards and must be
conducted by qualified investigators.
iii. All patients who participate in investigational drug
studies must freely give their consent in writing to treat
with the drugs. This consent must be obtained from the
patient or his legally authorized representative before
treatment is begun, and the patient has been fully
informed about the study objectives and the risks and
benefits associated with the drug.
The principal investigator is responsible for the proper
maintenance of the case report forms and all other records
required in the study by the drug sponsor as per FDA also
ensure proper packaging and labeling, storage condition, dose
preparation and administration.
Investigational
use of Drugs
20
Pharmacy Practice192
CLCL
CLCL
CL
ASSIFICAASSIFICA
ASSIFICAASSIFICA
ASSIFICA
TION OF DRUGSTION OF DRUGS
TION OF DRUGSTION OF DRUGS
TION OF DRUGS
The various classifications of drugs used for investigational
drugs in hospitals are given below.
CategorizationCategorization
CategorizationCategorization
Categorization
Class A: Should contain all investigational drugs that are in a
preliminary experimental stage. The use of drug in this category
is usually restricted to the principal investigator.
Class B: Should consist of investigational drugs which have
passed through the preliminary research stage. Usually, drugs
in this category are supplied to the department of pharmacy
by the principal investigator and are dispensed only upon his
written prescription.
Class C: It is limited to drugs approved by the USP, NF or
passed by the Federal FDA for commercial distribution. Drugs
in this category may be used within the hospital and clinics.
Class D: Drugs are preparations which have been accepted
for use in the hospital and are listed in the hospital formulary.
OperationalOperational
OperationalOperational
Operational
a. General: An FDA approved drug which as recommended as
essential for good patient care with a well established usage.
b. Conditional: Certain drugs may be approved for a condi-
tional period of trial. A drug approved by the FDA for
general use, but which the committee wishes to evaluate for
given period before final consideration.
c. Investigational: Drugs which are not approved by the FDA
for use other than under controlled clinical settings must be
approved by the research advisory committee.
Control of Investigational DrugsControl of Investigational Drugs
Control of Investigational DrugsControl of Investigational Drugs
Control of Investigational Drugs
All investigational drugs should be registered with the phar-
macy and therapeutics committee. This may be accomplished
by a letter from the principal investigator, which provides the
following information:
i. New drug number
ii. Generic name of drug
iii. Manufacturer of drug
iv. Chemical name of drug
Investigational use of Drugs 193
v. Proprietary name of drug
vi. General chemistry
vii. Pharmacology of drug
viii. Toxicology of drug
ix. Dose range
x. Method of administration of drug
xi. Antidote of drug
xii. Therapeutic use of drug
Pharmacists have developed various forms which may be
used to disseminate the above information on an investigational
use drug to the various staff doctors and nurses. These forms
are usually as follows:
a. Physician’s data sheet on investigational drugs
b. Nurse’s data sheet on investigational drugs
c. Pharmacist’s data sheet on investigational drug
PhysicianPhysician
PhysicianPhysician
Physician
’s Data Sheet’s Data Sheet
’s Data Sheet’s Data Sheet
’s Data Sheet
i. Name of the investigational drugs
ii. Manufacturer of drug
iii. Strength and form of investigational drug
iv. Amount received, date received and batch number.
v. Pharmacologic and therapeutic properties, dosage and
precautions
vi. Mode of administration by investigator.
Nurse’s Data SheetNurse’s Data Sheet
Nurse’s Data SheetNurse’s Data Sheet
Nurse’s Data Sheet
i. Name of the investigational drugs
ii. Manufacturer of drug
iii. Strength and form of investigational drug
iv. Pharmacologic and therapeutic properties, dosage and
precautions.
v. Arrangements which have made for its administration by
chief pharmacist.
Pharmacist’s Data SheetPharmacist’s Data Sheet
Pharmacist’s Data SheetPharmacist’s Data Sheet
Pharmacist’s Data Sheet
i. Investigational drug
ii. Manufacture
iii. Chief investigator
Pharmacy Practice194
iv. Date
v. Physician
vi. Patient
Identification of Investigational DrugsIdentification of Investigational Drugs
Identification of Investigational DrugsIdentification of Investigational Drugs
Identification of Investigational Drugs
Whenever class A or class B drugs are dispensed from the
pharmacy, they should be labeled in such a manner as to
differentiate them from routine prescription drugs. In some
hospitals, investigational use drug labels are printed in red ink
on white paper stock having following information:
i. Patient’s name
ii. Data
iii. Prescription number
iv. Doctor’s name, and
v. Directions for use
PHARMAPHARMA
PHARMAPHARMA
PHARMA
CIST ROLECIST ROLE
CIST ROLECIST ROLE
CIST ROLE
The pharmacist is responsible to the organization as well as
the principal investigator for seeing that procedures for the
control of investigational drug are followed and consist of
following steps.
1. A copy of the approved research protocol should be kept in
the pharmacy. Using the protocol and additional information
supplied by the principal investigator, the pharmacist should
prepare an investigational drug data sheet, which concisely
summarizes for the medical, nursing and pharmacy staff
regarding use of the drug. This form should contain:
a. Drug designation and common synonym
b. Dosage form and strength
c. Usual dosage range including route of administration
d. Indication
e. Expected therapeutic effect
f. Toxicities, their treatment, etc.
2. Investigational drug supplies must be kept in the pharmacy.
The pharmacy should maintain an investigational drug
inventory record.
3. The dispensing of investigational drugs should be done
with the rest of the drug distribution system with respect of
Investigational use of Drugs 195
packaging, labeling, profile maintenance, delivery and so
forth.
4. Patient education and monitoring of therapy is very
important. These functions should be done in a coordinated
manner by the pharmacist and nursing staff.
5. At the end of the study, the pharmacist should return all
unused drugs to the principal investigator or sponsor.
6. Drug costs and other expenses associated with investi-
gational drug studies should be properly allocated and
reimbursed.
RR
RR
R
ole of the Pharmacist in the Clinical Evaluation of a Drugole of the Pharmacist in the Clinical Evaluation of a Drug
ole of the Pharmacist in the Clinical Evaluation of a Drugole of the Pharmacist in the Clinical Evaluation of a Drug
ole of the Pharmacist in the Clinical Evaluation of a Drug
Once the pharmacologist has demonstrated a new compound
to be effective and safe in animal test, clinical trials are done.
These trials usually proceed in two steps—preliminary and
extended. During the preliminary stage, the principal
investigator cautiously administers the drug to a limited
number of selected patients and closely follows the results.
After having gained experience and confidence in its use, the
investigator is generally ready to conduct an extended
comprehensive evaluation of its efficacy. During this stage, the
pharmacist can play an important role by assisting in the
development of the protocol and the control of a double blind
test/study having the experimental drug and placebo prepared
exactly the same dosage form and presentation. Neither the
patient nor the doctor informed as to whether the placebo and
the potent article.
RR
RR
R
ole of the Pharmacist in the Clinical Investigationole of the Pharmacist in the Clinical Investigation
ole of the Pharmacist in the Clinical Investigationole of the Pharmacist in the Clinical Investigation
ole of the Pharmacist in the Clinical Investigation
This study is very important to produce the substantial
scientific evidence of safety and effectiveness needed to
approve the drug for marketing. It is divided in four phases.
Phase I: To determine toxicities, metabolism, absorption,
elimination.
Phase II: Initial trial on limited patients for treatment (specific
disease).
Phase III: Involve extensive clinical trial, information obtained
from above.
Phase IV: Post-marketing surveillance.
Pharmacy Practice196
ISOLISOL
ISOLISOL
ISOL
AA
AA
A
TED KEY POINTSTED KEY POINTS
TED KEY POINTSTED KEY POINTS
TED KEY POINTS
• “Investigational drugs are those drugs which are under
consideration but not yet approved by the Federal Food and
Drug Administration (FDA) or legal authority of the
respective country for human use”.
• Basic principles and procedures in the use of investigational
drugs should involved are:
i. An institution where investigational drug studies done
should contain adequate safety measures for its staff,
patient.
ii. All investigational drug studies must meet the criteria of
ethical, legal and scientific standards.
iii. All patients who participate in investigational drug
studies must freely give their consent in writing to treat
with the drugs.
• The various classifications of drugs used for investigational
drugs in hospitals are:
1. Categorization
i. Class A: Should contain all investigational drugs that
are in a preliminary experimental stage.
ii. Class B: Should consist of investigational drugs
which have passed through the preliminary research
stage.
iii. Class C: It is limited to drugs approved by the USP, NF
or passed by the Federal FDA for commercial
distribution.
iv. Class D: Drugs are preparations which have been
accepted for use in the hospital and are listed in the
hospital formulary.
2. Operational
i. General: An FDA approved drug which as recommen-
ded as essential for good patient care with a well
established usage.
ii. Conditional: A drug approved by the FDA for general
use, but which the committee wishes to evaluate for
given period before final consideration.
Investigational use of Drugs 197
iii. Investigational: Drugs which are not approved by the
FDA for use other than under controlled clinical
settings must be approved by the research advisory
committee.
• Pharmacists have developed various forms which may be
used to disseminate the above information on an investiga-
tional drug to the various staff doctors and nurses. These
forms are usually as follows:
i. Physician’s data sheet on investigational drugs
ii. Nurse’s data sheet on investigational drugs
iii. Pharmacist’s data sheet on investigational drugs
• Identification of investigational drugs are printed in red ink
on white paper stock having following information:
i. Patient’s name
ii. Data
iii. Prescription number
iv. Doctor’s name, and
v. Directions for use
• Role of the pharmacist in the clinical evaluation of a drug:
During the preliminary stage, the principal investigator
cautiously administers the drug to a limited number of
selected patients and closely follows the results.
• Role of the pharmacist in the clinical investigation: It is
divided in four phases.
i. Phase I: To determine toxicities, metabolism, absorption,
elimination.
ii. Phase II: Initial trial on limited patients for treatment
(specific disease).
iii. Phase III: Involve extensive clinical trial, information
obtained from above.
iv. Phase IV: Post-marketing surveillance.
PRAPRA
PRAPRA
PRA
CTICE QUESTIONSCTICE QUESTIONS
CTICE QUESTIONSCTICE QUESTIONS
CTICE QUESTIONS
VV
VV
V
erer
erer
er
y Shory Shor
y Shory Shor
y Shor
t Answer Tt Answer T
t Answer Tt Answer T
t Answer T
ype Questionsype Questions
ype Questionsype Questions
ype Questions
1. What is an investigational drug?
2. What is the role of pharmacist in investigational drug use?
3. What is the principle behind investigational use of drugs?