Inventory Control

Drug Store Management &

Pharmacy Practlce
7. Which of the following
(a) Dried plasma
drugs are stored below 20' CT
(b) Human fibrinogen
(d) All
Chapter ..20
() Human thrombin
AnswerKey
5-(d)6-(0)7-()
-)2- (a)3- (b)4-(d) INVESTIGATIONAL USE OF
Short Answer Questions:
1. Define drug stores
sub-organization in any hospital where materials
DRUGS
Ans.: Drug stores are defined as atill inspected, approved and stocked. 20.1 INTRODUCTION
obtained are held in abevance
2. Give the functions of inventory control. market conditions Developing a chemical from the status of an interesting or unique
low as possible consistent with Inthe crash
Ans.: 1. To keep the inventoriesof asstock" purchase at to that of a useful pharmaccologic entity
2. To minimize "out danger, which result therapeutic tool involves the efforts of many individuals. Those
uneconomical rates. participating in the research process may incude the chemist, the pharmacologist. the
product to meet the reasonable
3 To maintain a sufficient stock of finished
expectations of customers for prompt delivery of goods
and regular material reoort
ohatma the statistician and the pharmacist.
practitioner,
ical chemist, the toxicologist., the clinical pharmacologist and the medical

4A antain proper records so as to supply accurate 20.2 DESCRIPTION OF INVESTIGATIONAL DRUG USE
5. To forecast market and economic conditions of supply as regards availability of An investigational drug can also be called an experimental drug and is being studied to
materials. see if your disease or medical condition improves while taking it Scientists are trying to
3. Give the objectives of inventory control. prove in clinical trials
Ans: 1 To supply the drug in time.
2. To reduce investment in inventories and made effective use of capital . f the drug is safe and effective.
investments. How the drug might be used in that disease.
3. Efforts are made to procure goods at minimum price without bargaining the How much of the drug is needed.
oid stock out and . Information about the potential benefits and risks of taking the drug.
4 shortage.
5. Wastages are avoided. Not every person's disease or medical condition responds the same way to approved
Long Answer Questions: drugs Your healthcare provider might have talked to you about using an investigational drug
1. Add a note on Organization of Drug Store. if you have:
Ans: Refer Point 19.2
2. Add a note on Storage Conditions. Experienced side etfects that are too severe to continue taking
Ans: Refer Point 194, Limited treatment options available.
3. Add a note on Purchasing and inventory control. Heard about promising early study results for a specifc investigational dug.
Ans.: Refer Point 19.5 disease or medical condition
Very Long Answer Questions: No approved drugs available to treat your
INVESTIGATIONAL DRUGS
1. bplain in detail Purchase Procedure. 20.3 PRINCIPLE INVOLVED IN
or mixtures which have not
Ans: Refer Point 19.6. "Research or investigational drugs are those compoundsgeneral distribution and use
2. Explain in detail Techniques of by the Food and Drug Administration for
Inventory Control or Inventory Analysis. been released
Ans: Refer Point 19.8. on their labels as
The drugs usually bear the following statementinvestigational
New Drug - Limited by Law to use'.
"Caution:
20.1
10.15
 Investigational Use of Druos Pharmacy Practice
Pharmacy Practice Investigational Use ot Drugs
Released Fom
They are released only to physicians who sign the proper Food and Drugparticipate in an 20.4 CLASSIFICATION OF
INVESTIGATIONAL DRUGs
pharmacist is in a strategic position to One simple classification, which can be adapted to any
Tor the manufacturer. The clinical drugs because such drugs must be tried in hospital research program, is to
evaluation programme on investigational are available. It is categorize:
medical facilities
hospital setting where the necessary ylaboratory and other 1. Class A: Should contain all investigational use drugs that are in a
Therapeutic Committee to establish policies and preliminary
thus, a prime responsibility of Pharmacy and drugs in hospital.
experimental stage. The use of drug in this category is usually restricted to the
procedures relative to handling and control of investigational principal investigator.
of investigational drugs in the hospital
There are many problems associated with the use 2. Class B: Should consist of investigational use drugs which have passed through the
and some of which are as follows:
due care in the proper
preliminary research stage. Usualy, drugs in this category are supplied to the
1. Legal problem may result if a hospital does not exercise department of pharmacy by the principal investigator and are dispensed only upon
his written prescription.
handling of investigational drug in the overall care of the patient.
to the patient. It
2. Nurses usually are responsible for administering investigational drug administration, 3. Class Cs limited to drugs approved or passed by the FDA for commercial
is essential that sufficient information on proper dosage, route of distribution, Drugs in this category may be used within the hospital ar its clinics if the
possible toxic reactions and side effects precaution and proper labeling is available physician complies with some specific procedures.
to them. 4. Class D: Drugs are preparations which have been accepted for use in the hospital
3. Investigational drugs made available from the manufacturer to the principal and are listed in the hospital formulary.
investigator are not labeled sufficiently in many instances to prevent the possibility of Another simple classification which can be adapted to any hospital pharmacy operation:
error in their administration to patient. 1. General: An FDA-approved drug which as recommended as essential for good
patient care with a well-established usage, once accepted may be prescribed by all
4. The written consent of the patient is necessary for using the investigational drugs. members of the attending and house staff.
5. Institutions in which cinical research is conducted must have an Institutional Review
Committee (RC) or Clinical Research Committee. No cinical study may be initiated 2. Conditional: Certain drugs may be approved for a conditional period of trial. A drug
to evaluate
approved by the FDA for general use, but which the Committee wishes
unless approved in writing by the committee. The Director of Hospital Pharmacy period before final consideration, may be prescribed by all members of the
should member of LR.C. or be consulted by the committee whenever drug studies gven nd
are involved. attending dhouse staff.
3. Investigational: Drugs which are not approved by the FDA for use other than under
A
6. Investigational drugs must be used only under the supervision of principal
controalled clinical ings must be approved by the Research Advisory Committee.
investigator or authorized company investigators. study involving drugs must be submitted to the pharmacy
7. The principal investigator is responsible for the proper maintenance of the case protocol of any study
INVESTIGATIONAL DRUGS
report form and all other records required in the study by the manufacturer or F.DA. 20.5 CONTROL, IDENTIFICATION OF
the principal investigator for seeing
There must be mechanism to assure that sufficient supplies of the drugs are always The pharmacist is responsible to the institutien and should be developed
control of the investigational drugs
available in the institution for the duration of studies. that procedures for guidelines in case of investigational
implemented. Pharmacist should follow the following
9. Bulk supplies of the investigational drugs must be properly stored.
drugs: from
10. Investigational drugs must be completely and correctly labeled. be kept in pharmacy after its approval
11. The records of the amount of drug received from the manufacturer and amount 1 The copy of Research Protocol should
Institutional Review Committe.
dispensed to patient must be maintained. Investigational Drug Data Sheet" which gives the
12. If the patient is to receive the drug at another facility suitable arrangement for 2. The pharmacist should prepare thedrugs The drug d heet gives information to the
information about investigational should contain:
transfer must be made. Sufficient information for the safe use of drugs and copy of staf. The form
Medical, Pharmacy and Nursing
the patients signed consent form must accompany the drug. synonyms.
13. Investigational drugs must be properly packaged in accordance with all applicable .Drug designation and common
Dosage forms and strengths available.
standards and "
and regulations for example, F.DA, LP. and Packaging Act. 205
20.2
 Investlgational0S8 Ot
Pharmacy Practlce
Pharmacy Practice
Investigatlonal Use of Drugs
Dosage schedule and route of administration. double-blind studies The double-blind studies are devised by having the
Indication. experimental drug and the placebo prepared in exactly
Expected therapeutic effects. oenuie products are then entrusted to the pharmacist to dispense according to a
Expected and potential untoward effects. P d paten and to maintain exact record of, which patient received the
g and which received the placebo? The patient as well as
Contraindications. having idea physician will not be
about the placebo or potent drug distribution. The results of these
Storage requirement. are collected. trials
Instructions for dosage preparation and administration. pharmacy. f the
information for breaking the double-blind codes must be kept in
Instruction for disposition of unused doses. nharmacegency arises for breaking the double-blind code then
co-investigators. or on call is authorized to provide necessary information.
" Names and telephone ne numbers of principal and authorized Pharmacist with m
the e n o roiopharmaceutics pharmacokinetics and analvtical
The drug aa sheet viewed by the principal investigator and along with chemistry can
hould be should be submitted to the LRC. Copies should be excretion rater D h o 0and tissue levels of the new drugs as well as their
submitted, distributed to the aporopriate pharmacy staff and all patient care units ymonitoring
about dosage adjustment, mode above factor can advise the investigators
of administration of new drug and about product
where the drug will be used. formulation.
3. The dispensing of investigational drugs should beinvestigational
integrated withdrugs
the rest of drug
should be
2. Acting as an impartial collaborator: Pharmacist can act as an impartial
collaborator
distribution system. The prescription labels for by maintaining all records a oes in the double-blind studies, This wedd ak
distinguishable from other labels by an appropriate legend for example, the investioaters th
a dav
ng code intormation available 24 hourseatent
"Investigational Drugs". and seven davs a wl oreak the code far an indvidual
4. Investigational drug supplied must be kept only at the pharmacy. The pharmacy m t e t o
without exposing the er of sucy. Pharmacist can compile all information
should maintain an Investigational Drug Inventory Record. This form should contain concerning study drugs and maintain within pharmacy.
drugs name, dosage form and strength, lot number and the name, address and 3. Collecting, storing and disseminating essential information concerning the
telephone number of manufacturer and other information needed for ordering drug.
5. The pharmacy should return ll unused drug to the principal investigator or drugs being studied: The pharmacy can effectively serve as the central areas for the
manufacturer at the conclusion of the study. collection, storage and disseminating of essential information concerning
6. The pharmacy shuld give the institutions administrator an annual or semi-annual investigational drugs. The pharmacist should prepare the "investigational drug data
statistical summary of investigational drugs use, including the information as: sheet" vhich gives the infomation to the medical, pharmacy and nursing staf. This
. Number of drugs studied in progress. forn should contain:
" Listing of all drugs studied during the previous year. Drug designation and common synonyms.
7. Drug costs and other expenses associated with investigational drug studies should be Dosage forms and strengths available.
properly allocated and reimbursed. " Dosage schedule and route of administration.
8. Monitoring of therapy and patient education are two clinical functions which are
Indication.
particularly important and applicable to investigational drugs. These functions should Expected therapeutic effects.
be provided by the pharmacy and nursing staff and the authorized
20.6 ROLE OF HoSPITAL
investigators. Expected and potential untoward effects.
PHARMACIST IN INVESTIGATIONAL
DRUGS Contraindications.
Following are the areas where the phamacist assists the Storage requirement.
clinical research team in investigational drug studies: physician and patients and his Instructions for dosage preparation and administration.
1. Assisting in the development of the . Instruction for disposition of unused doses.
study design: Pharmacist can play an
important role by assisting in the development of the protocol and control of Names and telephone numbers of principal and authorized co-investigators,
204 20.5
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levestlgational Use of Drugs

Pharmacy Practice
Pharmacy Practlce investigator. The coniee Investlgatlonal Use of Drugs
should by the principal all the patient care unite
be reviewed harmacy 20.7 ROLE OF
The drug data sheet staff and
should be distributed to the appropa dclinical study. All personal involved in
ADVISORY COMMITTEE IN INVESTIGATIONAL
USE OF DRUGS
where the drug
prescription, will be administering
dispensing effectivey evd obsening the actions of the drug are wel The Generic Drugs A
gs Advisony Committee is to advise on the safety and
as members of the
research team. human generic irug products for use in treating "a broad spectrum humaneffectiveness of
informed and can truly function
Investigational drugs in multiple or unit de Drug Abuse Advison Commitee, with a broad charge. advises theofFDA diseases. The
and labeling
4. Packaging Investigational packaged properly in accordance with all "the scientific and m
Commissioner on
containerns: drugs must be Packaging Act.
evaluation of all information The Food and Drug Administration
eg. FDA, LP and requlates more thanan 150,000
15000
marketed drugs and medical devices. At any time, nearly 3,000
applicable standards and regulations of the
should be integrated with the rest investigational new drugs are being developed. More dietary supplements than ever before
The dispensing of investigational drugs for investigational drugs should be are on the market, and Americans today have a much broader range of food
choices. Then
drug distribution system. Prescription labels there are the scores of blood products and veterinary medicines for which the
Investigational
distinguishable from other labels by an appropriate legend, eg. responsible
FDA is

a valuable service to the new Institutional Review Board (Independent review).

5. Preparing dosage forms: The pharmacist can render Withdrawals.
drug researcne formulating
Tomo new dosage forms from the pure chemical. The
in End point justification of dinical trial phases.
epare the new dosage form by taking all factors
pharmacist should prepare
tests for Phase repetition.
considerations regarding stability of drug and carry all bacteriological
of research project. so
potency and sterility of new dosage form. Time is the essence Data Integrity and archival.
many investigators will attempt to speed uup for formulation of new dosage form by Other types of committees in Hospital
not carrying the control tests but the pharmacist should not agree on this matter. 1 Infection Control Committee.
6. Dispensing of investigational drugs to both inpatients and outpatients: The 2 Central sterile supply Committee.
dispensing of investigational dugs should be integrated with the rest of the drug 3. Biodegradable waste committee.
distribution system. Investigational drug supplies must be kept only in the pharmacy. 4. Medical Record committee.
The pharmacy should maintain an investigational drug inventory record. This form
should contain drugs name, dosage form and strength, ot number and the name, REVIEW QUESTIONS
address and telephone number of manufacturer and other information needed for Multiple Choice Questions:
ordering drug. Nurses are usually responsible for administering investigational drugs 1 Investigational drugs are released only to who sign the proper Food and Drug
to the inpatients It is essential that sutficient information on proper dosage, route of Released Form for the manufacturer,
administration, possible toxic reactions and side effects, precautions and proper (b) Physicians
(a) Pharmacists
labeling is avallable to them. If the patient is to receive the investigational drug at (c) Patients (9 None of these
another facility then suitable arrangement for transfer must be made. Sufficient
information for safe use of investigational drugs and cooy of the drug. These drugs 2. Which class of investigational drugs contains all investiçational use drugs that are in
must be completely and correctly labeled. Bulk supplies of the investigational drugs a preliminary experimental stage?
(a) ClassA (b) ClassB
must be properly stored. There must be mechanism to assure that sufficient supplies (d) None of these
of the drugs are always available in the institution for the duration of ( Class C
record of the amount of drug received from the manufacturer and amountstudies. The 3. The is responsible to the institution and the principal investigator for seeing
to patients must be maintained. The dispensed that procedures for control of the investigational drugs.
pharmacy should return all unuseo (b) PI
investigational drugs to the principal investigator ormanufacturer at theconcuso
(a) Pharmacist
(d) None of these
of the study. (c) Physician
20.2
206