Amar Shaheed Baba Ajit Singh Jujhar Singh Memorial

ASBASJSM
COLLEGECOLLEGEOF
OF PHARMACY
PHARMACY(AN AUTONOMOUS COLLEGE) BELA
(An Autonomous College)
BELA (Ropar) Punjab

Program : B. Pharmacy
Name of Unit : Drug Store management
Subject /Course name : Pharmacy Practice
Subject/Course ID : BP 703T
Class: B.Pharm. Semester : VII
Module : V
Course coordinator : Ms. Amanpreet Kaur
Mobile No. : 9056661610
Email id : [email protected]

Learning Outcome of Unit

LO Learning Outcome (LO) Course

Outcome Code
LO1 Students able to understand Ideal Drug Store Requirements, BP703.5
Importance and Types of Inventory Control
LO2 Students learn about record maintenance for dispensing of BP703.5
investigational drugs
LO3 Student able to understand role of principle investigator for use, BP703.5
control and supervision of investigation drugs in hospital.
LO4 Students learn about various biochemical tests and their clinical BP703.6
significance
LO5 Student learn about importance Of clinical laboratory testing. BP703.6

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MODULE CONTENT TOPIC

NO. TOPIC
1 Drug store management and inventory control:- Organisation of drug store, types of
materials stocked and storage conditions, Purchase and inventory control: principles,
purchase procedure, purchase order, procurements and stocking, Economic order
quantity, Reorder quantity level, and methods used for the analysis of the drug
expenditure.
2 Investigational use of drugs:- Description, Principles involved, classification, control,
identification,role of hospital pharmacist, advisory committee.
3 Interpretation of Clinical Laboratory Tests:- Blood chemistry, hematology and
urinalysis.

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A. DRUG STORE MANAGEMENT

Drug store management is one of the important aspects in pharmaceutical business. It is also
called as retail pharmacy, which consists of final activity and is a place where drugs will be in
the hands of the patients/consumers or to provide services to the patients/consumers. The word
retail is derived from the French word Retailer, meaning to cut a piece off or to break bulk. For
successful of any retail firm, some important factors are taken into consideration. As pharmacy is
specialized field, some of factors are different compared to other retail outlets. Ideal drug store
requirements are mentioned below:

Location of Drug Stores:

Developing 'Business areas,

Near Hospitals/Clinics

Other Requirements
for Drug Store:
Expansion Programme
for Future Need,
Credit System,
Pharmaceutical care
like Patient
Counselling and book
and Reading
Materials

Legal Requirement for Drug Store:

Registered Pharmacists/ Retail Sale

License/ Minimum Sq.ft. Area Refrigerator/

Air Cooler/Proper Storage Facilities/ Disaster Plan

Ideal Drug Store Requirements

Purchasing of Materials
Purchasing or procurement is an important aspect of material management in pharmaceutical
field. Purchasing of any materials/equipments related to pharmacy should be a genuine activity.
A well planned and sound purchasing policy ensures sufficient purchases to meet all anticipated
needs but avoids either over stocking or under stocking. Economical, efficient and timely
purchases should be an objective of a sound purchasing policy.

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Right
Quality

Right
Quantity

Right
Time

Right
Place

Right
Price

Right
Source
Six R's of Scientific Purchasing of Pharmaceuticals Purchasing Procedure:
Once the selection of suppliers is done, then purchasing of drugs is done based on drug store
requirements. Orders can be placed from single supplier or multiple suppliers. For continuity of
supply of drugs most reputed, trusted supplier need to be selected. Mode of payment for
purchase depends on supplier and buyer. It may be through credit, online or cash transactions.
Purchase Order: An order may be defined has as an offer to buy specific drug product from
suppliers. Order should be clear and free from any errors. It is one of the important written
documents for future references. The particulars mentioned in purchase orders are:

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Drug stores are used to store all kind of products/materials like; capsules, tablets, liquid
dosage forms, injections, antibiotics, narcotics and psychotropic substances, biologicals, medical
devices, etc.
Storage/Store keeping is directly concerned with physical storage of goods. Proper storage
offer protection against fire, damage, deterioration, theft, losses, etc. It helps in identifying and
locating drugs through indexing, labels and identification marks. Another important aspect of
storage is; it helps in effective inventory control. Storage conditions of pharmaceuticals should
possess the following:
• Adequate temperature.
• Sufficient lightning.
• Clean conditions.
• Humidity control.
• Cold storage facilities.
• Adequate shelving to ensure integrity of the stored drugs.
Storage Conditions as per Indian Pharmacopoeia

Stora e Conditions Indian Standards as er IP-1996

Cold Temperature not exceedin 8 0C (between 2 0 C-8 0 C).
Cool A temperature between 80C — 25 0C.
Warm A temperature between 300C — 400C.
Excessive Heat A temperature above 400 C.
Temperature between -25 0 C to -IOOC.

Room Temperature Temperature revailin at workin area.

D Place Average relative humidity not exceeding 40%.

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Vaccines and Sera: Products to be stored at a certain temperature.

Insulin: Products sensitive to heat & requiring

refrigeration
Special
Elixirs and alcohol based products: Flammable
Storage
products
Requirements

Expensive & habit forrning drugs: Products

prone to theft Or misuse
Nitroglycerine and Expensive and habit forming drugs are t
exchanged places

Special Storage Requirements Inventories in Drug Store

Inventory means stock. To stay ahead in the market, drug stores need to take into consideration
about demand and supply. Buying the right quantity is important to the success of the business in
a number of ways. Inventory is required to satisfy future demands and plans of the drug store.
One of the most important aspects of inventory is to have the items in stock at the moment they
are needed. Inventory is the availability of goods or materials at any given time. Inventory
system controls and monitors levels of inventory and regulates what levels should be maintained,
when stock should be refilled, and how large orders should be placed. Inventories are affected by
fluctuations in demand and manufacturing lead times which are covered by reserve stock or
safety stock. Inventory is in the form of money and asset for organization. The purchase and
holding of minimum supply of item will give better return on investment and inventory turnover.
Many active ingredients like antibiotics and vitamins deteriorate very fast if they are not properly
stored. Hence, these materials should be produced as and when required. A well-managed
inventory can help in cost reduction of the organization. Thus, the savings can be invested by the
organization for other profitable ventures. The various types of materials which are kept as
inventories are all types of drugs, over the counter drugs and medical devices as per schedules
mentioned in Drugs and Cosmetic Act, 1945.

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Purpose of Inventory Management:

The main objectives of Inventory management are:

1. Satisfy customers demands without delay: The main objective of inventory management is
to satisfy customers' demands by supplying drugs/medicines without endless delay.
2. To minimize carrying cost of inventory: Another important objective Of inventory
management is to reduce investment in inventory at minimum level to maximize
productivity.
3. Competition: To stay ahead in competitive market, drug store needs to dispense drugs as
per requirement in the market.
4. To reduce the losses: There may be unexpected loss of goods due to theft, obsolescence
and wastage, etc.
Uncertainty in Business: In rapidly changing environment, market (business) is facing multiple
challenges in all means. To standardize the market, drug store has to go for inventory
management

Intuitive Method: The in-built method is aided by the well-known want book. This is the
most common method in practice today and surely the least effective. Items are recorded in the
book when the number of units in stock reaches one to three, and the amount ordered is the best
estimate of the person in charge of inventory.
ABC Analysis of Materials: It enables the management to plan efforts to get. It is a powerful
approach in the direction of cost reduction, as it helps to control items required for production

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with a selective approach. Proper color codification may be adopted for ABC categories of
items.ABC analysis is called as always better control.
Class Cost Percentage Quantity Procurement order
(%)
High 75 10 Frequent order

B Medium 15 15 Once in three months

c Low 10 75 Once in six months (Bulk
Order)

What are Class ABC Items?

Class A: These are fundamental items. They are bulk drugs which are costly. The cost of
procurement of these items is high. In terms of quantity, they are only 10%. Class A items are
antibiotics and costly drugs. Searching for many sources of supplier for class A item will be
more economical. As the Class A items are very costly accurate forecast is needed for these
items.
Class B: These are not so costly items as compared to Class A items. Class B items constitute
for 15% in terms of quantity. They are usually excipients used for drugs. These are not
fundamental items compared to Class A items.
Class C: These are also not fundamental items. These are economical items. They are
excipients used for drugs. Class C items constitute for 75% in terms of quantity. The
procurement order id made once in Six months. ABC analysis helps in reducing clerical costs
and rationalizes the number of orders and reduce overall inventory.
ECONOMIC ORDER QUANTITY

The EOQ is one of important method of inventory management. In pharmaceutical industry,

high cost is invested on materials with longer procurement time. EOQ is represented is by the
formula:

EOQ =

Where, A =Annual usage in rupees

S= Ordering cost in rupees
I=Inventory
EOQ is based on inter-relationship of costs which shows carrying costs. As order quantities
go up, so do carrying cost, but ordering costs go down. Conversely, as order quantities go down,
so do carrying costs, but carrying costs go up. EOQ analysis determines whether these costs are
in balance. The EOQ equation shows that the most economic lot size is the function of the square
root of the annual usage of items expressed in rupees. Material manager should decide how
much to buy and when exactly to buy. Excess of inventory will increase chances of

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obsolescence. Purchasing of materials should be done in right time, using efficient forecasting
methods carefully. Ordering to nearest trade quantity or quality may be essential, as low demand
and supply will be uneconomic to produce and quote. The order quantity could be altered to get
certain benefits of transportation and discounts offered for bulk purchase of materials. In case of
perishable goods, the quantity has to be adjusted to shelf life of the item. When price fluctuate,
dynamic programming technique has to be used to determine the quantity of purchase.
VED Analysis:
VED is one of important type of inventory management. VED analysis is done to control
critical inventory situation. VED analysis is called Vital Essential Desirable.
V-Vital: Item without which production will completely stop.
E-Essential: These items are also called as alternative items.
Desirable: These items can be endured for a long period.
SDE Analysis:
SDE analysis is based spares availability of an item:
S-Scarce items: These items are especially imported and those which are very much in short
supply. Due to scarcity of these items, they are procured on yearly interval.
D-Difficult items: These are difficult for availability.
E-Easy items: These items are easily available. They are produced locally. Due to their easy
availability, firms may not require to hold these items in large volume in their stock.
SOS Analysis: SOS Analysis is done, keeping in view the seasonality or non-seasonality of
the item.
• S - Seasonal Items
• OS - Non-seasonal Items
Depends on seasonality and non-seasonality of the items, procurement actions vary.
Example: Sales of certain commodities, such as; cough and cold products, increase between
rainy and winter season due to the cold and flu season whose procurement is seasonal, these
companies need to procure their requirement for a longer duration so as to adjust their
production plans. Non-seasonal items are available throughout the year without any major price
variation. Since seasonal items, which are available for a limited period, are procured in bulk to
manage the production process throughout the year.
Recent Trend in Inventory Management:
Use of computers in inventory control. As computerization of inventory control will provide
effective control and increase profitability. Computerization has reformed inventory
management with the help of technology company can trace their goods till it reaches in the
hands of a customer. Reports which can be generated by computer like:
• Forecasting: Reports can be generated for sales history, sales forecast and forecasting
techniques.
• Material planning reports can be maintained for material requirement and bills of material.
• Inventory management: Reports regarding Maximum inventory level, Minimum inventory
level and ABC analysis can be maintained.

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B. INVESTIGATIONAL USE OF DRUGS

Investigational dugs are those drugs or mixture or chemical which are not released and
certified by the food and drug administration (FDA) for the general use and sale for the
commercial concern. These drugs usually stand the statement on their labels as "Caution: New
Drug — Limited by Federal Law to Investigational use". They are released only to the principle
investigator who is the member of medical staff of hospital after obtaining consent by duly sign
the food and drug release form for the manufacture of respective investigational drugs.
CLASSIFICATION OF INVESTIGATIONAL NEW DRUGS
Class A This class should contain all investigational use drugs which are under the
preliminary experimental stage.
These drugs are restricted to used only by principle investigator.

Class B This class of investigational drugs has passed through preliminary

experimental research stage. In this class, the investigational drugs are
supplied to pharmacy department by principle investigator and are only
dispensed after obtaining of his written prescription which is duly sign.

Class C This class of investigational drugs are approved by the USP, NF or passed by
the Federal FDA for use and sale as commercial concern. These drugs may be
used only in hospital setup for their patients under the supervision of medical
staff after fulfillments of specific procedure

Class D These classes of the drugs have been accepted for use in hospital and are listed in the
hospital formulary.

PRINCIPLES INVOLVED
Investigational drug should be used only in hospital setup, which is the primary center for the
clinical investigations. As per the definition, these are not the general-purpose use and these are
not yet to release or certified by FDA for general use or for sale in commercial interest. It is
responsibilities of hospital and medical staff to check and establish the proper procedure for the
use of investigational drugs for their patient's benefits. The procedure and the control on the use
of investigational drugs are based on the following principles:
1. The investigational drugs should be used under strict medical supervision, mainly under
the supervision of principal investigator who is supposed to be a member of medical staff
and having responsibilities of obtaining of necessary consent.
2. Hospital should do these procedures for short term research purpose in most critical cases
such as; advanced stage of cancer with aim at beneficial and protection for their patients.
3. When the nurse is called for drug administration and is a part of the procedure, then nurse
should have detailed information of investigational drug such as; dosage form, available
strength, action of drug, its uses, side effects and toxicities, etc.

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4. It is responsibility of hospital to establish a central unit with the help of pharmacy and
therapeutic committee for the maintenance and availability of essential information on the
investigation drugs to authorized personnel.
5. Pharmacy department should find appropriate place for the storage of such investigation
drugs. The department will also responsible for provision of proper labelling and
dispensing in accordance to written order of the principle investigator.
Advisory Committee and their Responsibilities:
In the view of drugs which are used in the investigational purpose in the hospital are
subjected to review by advisory committees which are nothing but the committee on the human
use in research; and Pharmacy and Therapeutics Committee (PTC). In which the principle
investigator should provide all the information related to investigational drugs to the PTC and
should letter for intention to use of investigation drugs in patients. It is the responsibilities of
hospital and members of PTC to develop procedures and policies for the handling of
investigational drugs in the hospital for the patient's benefits.
The committee on the human use in the clinical research is the standing committee of hospital
and is responsible for the providing the guiding principles and policies issues in association with
the use of human/patients for the clinical research investigations.
Following are some important policies which are need to be implemented in hospital where
enforcing the use of investigational drugs for the safeguard the rights and welfare of human
subjects.
• The use of investigational drug in patient must be approved from the human subject
committee, pharmacy and therapeutic committee and if applicable isotope committee
before the use for the patients in the hospital.
• The principle investigator shall be informed in the written that, neither the hospital nor
other hospital staff will be responsible for any legal liabilities which may occur during the
use of investigational drugs.
• Investigator should not proceed to use the investigational drug before obtaining of the
consent form from the patient or legally responsible person.
• The principle investigator is responsible for to register each investigational drug in
pharmacy department and provide all the related information to prepare investigational
drug data sheet and drug formulary.
CONTROL AND SUPERVISION OF INVESTIGATIONAL USE OF DRUGS
All investigational drugs which are in use, are under the strict supervision of principle
investigator and are registered with the Pharmacy and Therapeutics Committee (PTC). The
following information must be given by principle investigator to PTC with letter indicating the
intension to use such investigational drug in patient in his supervision.
1. New drug number 2. Generic name
3. Manufacturer 4. Chemical name
5. Proprietary name 6. General chemistry
7. Pharmacology 8. Toxicology

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9. Dose range 10. Method of
administration
11. Antidote 12. Therapeutic use
The above information on each investigational drug usually found in the brochure which is
provided by the manufacturer and supplier to the principle investigator after fulfilment of official
procedure.
Pharmacy department may use this information in the form of Physician Data Sheet on the
Investigation drugs for circulation various medical staff and nurses dealing with use of particular
investigational drugs.
Hospital can design drug report form for use of investigational drugs. Such form may provide all
information required for the handling and dispensing procedure for the investigational drug by
the medical staff, nurse and pharmacist. This form must be kept in such place where it can easily
accessible to staff associated with handling of investigational drugs. Each staff dealing with the
procedure of investigation drug use must comply with the guidelines frame by the hospital and
maintain the record in duplicate entries. Similarly, pharmacist should maintain records (separate
file) for the dispensing of each investigational drug along with receipt of written prescription of
principle investigators.

IDENTIFICATION OF INVESTIGATIONAL USE OF DRUGS

Pharmacist must ensure to label each class of investigational drugs before they are going to
dispense. Labelling of class A and class B drugs in such a manner that, these class drugs should
be differentiate from routine prescription drugs. In some hospital, for proper differentiating with
other class, hospital use printed label in red ink on the white paper stock. In addition to this label
information, hospital also provide the above printed layout format for the dispensing record of
the investigational drugs.
ROLE OF HOSPITAL PHARMACIST IN HANDLING OF
INVESTIGATIONAL DRUGS

1. Assisting in the Development of the Study Design:

Pharmacists provide his support in the development of the new protocol and control on the
use of investigational drugs in the hospital. The investigational drugs are assigned to pharmacist
for dispensing purpose according to written order from principle investigator in predetermined
pattern.
2. Acting as Independent Collaborator:
Pharmacist act as an independent collaborator by maintaining all the records and codes in the
handling of investigational drugs in the hospital. This would give the investigators the
advantages of having code information available for 24 hours a day and 7 days a week and the
ability to break the code for an individual patient without exposing the rest of the study.
Collecting, Storing and Distributing Essential Information Concerning the Investigational
Drug Being Studied: As per the brochure provided by the manufacturer, the pharmacist
should prepare data sheet on the investigational drug which provide the all information about

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the investigational drugs. This drug data sheets gives information to the medical, pharmacy
and nursing staff. This form should contain:
(a)Drug designation and common symptoms.
(b) Dosage form and strengths available.
(c) Dosage schedule and route of administration.
(d) Indicators.
(e) Expected therapeutic effects.
(f) Expected and potential untoward effects.
(g) Contraindications.
(h) Storage requirements.
(i)Instructions for dosage preparation and administration.
(j)Instructions for disposition of unused doses.
(k)Names and Telephone numbers of principal and authorized co-investigators.
The data sheet on the investigational drug is reviewed by the principal investigator and then
the copies are distributed to the appropriate pharmacy staff and all the patient care units
whenever the drug will be used.
3. Packaging and Labelling of Investigational Dugs for Multiple or Unit Dose Containers:
Investigational drugs must be properly packaged in accordance with all applicable regulatory
standards for example: F. D. A, C.P. Packaging act.
4. Preparing Dosage Forms:
The pharmacist can provide a valuable service to the new drug researcher by formulating new
dosage form from the pure chemical.
5. Dispensing of Investigational Drugs to both Inpatients and Outpatients:
Dispensing of investigational drugs should be incorporated with the rest of the drug
distribution system. The pharmacist should maintain the inventory record for the dispensing of
investigational drug. This form should contain name of drug, dosage form, and strength, batch
number and name of manufacturer along with complete address. In this form there is need to
maintain the record of other information which are essential for the drug order. It is essential to
provide the sufficient information on proper dosage, route of administration, possible toxic
reactions and side effects, precautions and proper labelling is available to them.

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C. INTERPRETATION OF CLINICAL LABORATORY TESTS

INTRODUCTION: The importance of the clinical laboratory tests is in detection of

abnormal biochemical constituents present. In biological fluid and organ specimen, there are
several biochemical constituents available and they contribute to perform important
physiological and biochemical functions. An abnormal value of these constituents indicates
when the people are suffered from any medical conditions. Several diagnostic testings are
essential to performed for recognition of the abnormal biochemical and hematological
constituents in the management of patient care, monitoring of the effects of prescribed therapy
and allowing detecting of abnormal condition of patient earlier. Below are describing the basic
principles of the reactions relating to the most widely used qualitative tests.
Importance of Laboratory Testing:
Following are the importance of laboratory testing in detection and solving of several issues
of the patients:
• Laboratory testing helps in finding of basic information of health of patients.
• Ability to provide the information of normal or abnormal functioning of the health.
• Provides the information about the medical condition before showing any kind of
symptoms.
• Helps in the identification of cause of the abnormal function of health or symptoms.
Helps in decision making process in working of medicine and accordingly provide the
direction to choose correct medications.

HEAMATOLOGY AND BLOOD CHEMISTRY : Hematological testing is related with

blood only. The test includes blood and its components such as blood cells, haemoglobin,
protein, bone marrow, platelets, etc. The conditions such as; hemophilia, thrombus formation,
bleeding disorders, leukemia, multiple myeloma etc. affects the process of blood formation and
functions of each components reflected by abnormal laboratory values. Following are describing
various hematological parameters used in laboratory investigation.
Hematological Test:
1. WBC:
It is a test to count the number of white blood cell (WBC) in body and it is a part of complete
blood count. High or low number of counts indicates underlying medical condition. Laboratory
testing for WBC count helps to detect hidden infection within body and it will help for doctors to
diagnose the medical condition such as; immune deficiency, UTI infections, blood disorders, etc.
It will also help to monitor the effectiveness of medications such as effectiveness of
chemotherapy in cancer patients, effectiveness of antibiotics in UTI infections.
2. Hematocrit:
The hematocrit is also known by other name i.e. percentage of red blood cells. Estimation of
RBC level helps to diagnose or monitor the response of treatment. Lower number of hematocrit

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value indicates anemia while higher than normal indicates dehydration, polycythemia, etc.
Generally, a normal range of RBC is considered to be 38.3 to 48.6 percent for men while 35.5 to
44.9 percent for women.
3. Erythrocyte Sedimentation Rate (ESR):
It is a type of blood cells and used to measure how fast erythrocyte get settle at the bottom of
test tube of blood sample. Generally, erythrocytes are settling slowly but, in some conditions,
there is faster rate of sedimentation than normal indicates the underlying condition associated
with inflammation. There is clump/stick formation of RBC due to inflammation results into cells
become heavier and get settle earlier compared to normal condition. This test does not indicate
the cause of inflammation or where is inflammation. The results of ESR are estimated by
measuring the volume of clear plasma in tube containing heparinized blood sample. In which,
low value indicates a smaller number of cells are settle while large values indicate a greater
number of cells are settle.
Generally, the results of this test are used along with other test results. The higher ESR rates
indicate joint pain, pain in neck and shoulder, headache, abnormal weight, digestive problems,
fever etc.
4. Haemoglobin:
It is protein in red blood cells associated with carries of oxygen to organ and tissue of the
body. It also transports carbon dioxide from the organ and tissue to lungs. If the laboratory test
results reveal low concentration of haemoglobin than normal indicates there is low level of red
blood cell and high chances of anaemia. There are so many reasons for anaemia including;
deficiency of vitamin, chronic disease or bleeding. Similarly, if the laboratory test results reveal
high concentration of haemoglobin indicates blood disorders such as; polycythemia vera, may be
living in high altitude, dehydration. Generally, the normal level of haemoglobin is 13.5 to 17.5
gm/dl in men while in female the range is 12.0 to 15.5 mg/dl.
Types of Blood Chemistry (Biochemical Test):
1. Blood Glucose Estimation:
It is also called blood sugar test and mostly the test is performed after patient have fasted or
randomly (called random glucose test). The test is generally used to monitor the glucose level in
diabetes patients. The test detects conditions of hypoglycemia as well as hyperglycemia. Most of
the diabetic patients do this test by their own by using rapid test kit with special machine for
reading of glucose concentration in blood by simple finger-prick test. The normal range of
fasting (10-16 hours) blood glucose is below 100 mg/dl. Range of 100-109 mg/dl indicates
prediabetes and such individual may be at higher risk of diabetes so in such cases, OGTT (oral
glucose tolerance test) should be performed for continuous monitoring of blood glucose level.
2. Folate Test:
It is nothing but the folic acid (vitamin B-9) test and it is measured the amount of folic acid in
the blood. Folic acid is essential for the production of RBC and repairing of the nerve tissue in
the body. These cells are associated with carrying of the oxygen to entire body so this test is
important for maintaining the overall health of person.
Generally, folate is found in green vegetables, dry beans, peas, cereals and in fruits. It is very

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essential in normal growth, particularly for development of babies in pregnancy.

Several reported literatures indicate that deficiency of folic acid associated indicates the
condition of anemia, neural tube defects in new babies, etc.
3. hAb1c:
It is also name as glycated or glycosylated haemoglobin. HbA1c indicates the haemoglobin is
joined together with glucose. The main function of haemoglobin is carrying of oxygen. The
amount of HbA1c in blood directly reflects how much amount of glucose available in blood. The
life of RBC is 4 months. So, this test results reflect how much amount of sugar is present since 4
months in the blood. This test is different than blood sugar test which indicates presence of sugar
at that moment only.
Other biochemical analyses are given in below separate liver and kidney functions test.

LIVER FUNCTION TEST

Determination of Bilirubin:
Bilirubin is the byproduct of the heme. In the liver bilirubin is conjugated with diglucoronide
and is excreted in bile. There is specific reaction by which identification for increased in the
level of bilirubin can done. This reaction called Van den Bergh reaction and it is mixture of
sulfanilic acid and sodium nitrite in equal concentration. The principle of the reaction is based on
diazotization reaction. In which diazotized sulfanilic acid get reacts with bilirubin to produce
azobilirubin which is in purple color form and that can be measured by colorimeter or Spectro-
photometrically. High laboratory test values represented for the various form of bilirubin such
as; conjugated, unconjugated and mixture of both indicates the medical condition of obstructive
form of jaundice, hemolytic jaundice and hepatic jaundice respectively.
Determination of SGPT and SGOT:
Another name of SGPT is alanine transaminase (ALT) and it is specifically increased in the
hepatic disease such as liver damage, hepatic jaundice, liver cirrhosis, metastatic carcinoma,
drug induced liver diseases, etc. SCOT is gold/direct marker for the identification of
hepatocellular damage or injury. While SGOP, name by aspartate transaminase (AST) which is
useful and count as indirect marker for the identification of liver injury.
The basic principle or reaction associated with estimation is SGPT produces pyruvate and
SGOT produces oxaloacetate and this get reacts with 2, 4-dinitrophenyl hydrazine to produced
dinitrophenyl hydroazone which shows brown in colour in alkaline medium and that can be
measured at colorimeter or spectrophotometer at 505 nm. Higher laboratory test results for SGPT
compared to SGOT indicates chronic liver disease while higher test results for SGOT represents
chances of cirrhosis and acute alcoholic hepatitis.
Alkaline Phosphatase:
Alkaline phosphatase (ALP) is an enzyme and mainly it is obtained from bone and liver cells.
The normal level of ALP is 3 -13 KA units/dl. Increased in the level of ALP indicates the bone
resorption process which may leads to osteoporosis. Elevated level of ALP is also another
indicator of high level of bilirubin due to biliary obstruction which is observed in hepatic

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jaundice, liver cirrhosis and hepatic tumor.
Gamma Glutamyl Transpeptidase (GCT):
GGT is a microsomal enzyme and it is widely distributed in body tissues, including liver. The
normal level of GGT is 5-40 IU/D. Elevated level of GGT indicated in condition of biliary
obstruction and alcoholism.
Galactose Tolerance:
Galactose is a monosaccharide and exclusively metabolized by the liver. Thus, the liver
function can be assessed by estimating the utilization of galactose. In this high level of galactose
indicates poor functioning of liver and vice-versa. Generally, the test of galactose is performed
by blood withdrawal at the interval of 10 minutes for next 2 hours of food ingestion. The half-
life of galactose in normal individual is around 10-15 minutes. The elevated level of galactose is
also an indicator of hepatocellular damage, liver cirrhosis and infective jaundice.
Serum Albumin:
It is a protein and it is an important indicator for testing of live function. A low value of
protein indicates the damaging of liver while high level of albumin indicates impairment of liver
functions.
Prothrombin Time:
Clotting factors are essential for blood clot process and these factors are synthesized in the
liver. Impairment of liver function demonstrated by increased in bleeding tendency which is
associated with decreased in the concentration of clotting factors. So, this can be assessing by
estimating of prothrombin time. The test is generally performed on the non-heparinized blood
sample. Prolong in prothrombin time indicates impairment in the liver function or liver damage
compared to normal. Hippuric Acid Synthesis:
Synthesis of hippuric acid take place in liver and it is product of benzoic acid and glycine.
Liver is the major source of organ for the detoxification and estimation of hippuric acid synthesis
is an ideal method the assessing the function of liver. Increased in the concentration of hippuric
acid indicates the hepatic damage. Normally around 60% of sodium benzoate which is
equivalent to 4.5 gm of hippuric acid is eliminated in urine. The normal concentration of
hippuric is less than 3 gm.
KIDNEY FUNCTION TEST: Kidney function test are normally performed to assess the
renal function. These are simply estimated by using blood sample or/and urine analysis. In
several medical conditions such as diabetes as well as in elderly person there is need to estimate
or monitor the renal function test. Following are describing the various type of kidney functions
test.
Clearance Tests:
Estimation of rate of clearance for the substance which is already present in the blood is
mostly preferred for the assessment of kidney function. There are two compounds namely urea
and creatinine that are present in blood as well as in urine and can be used for assessment of
kidney function. Decreased in the concentration of these compound in urine reflected high
concentration of these compound indicates renal problem.
Rate of creatinine clearance is 145 ml/min which is marginally higher than glomerular

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filtration rate (125 ml/min) because creatinine is secreted by the renal tubule. While the
clearance rate for the urea is 75 ml/min while is comparatively lower than GFR due to partially
reabsorbed by the renal tubules. The rate of creatinine production and elimination is equal i.e. 1
1 ratio, so any fluctuation/difference in the reading can be used for interpretation and conclusion
of results Creatinine estimation is widely used laboratory test for assessment or detection of renal
impairment. This test is useful for an early detection of impairment before the clinical
manifestation likely to produce.
Urea Clearance Test/Blood Urea Nitrogen:
Urea Nitrogen is the end product of protein metabolism and its rate of clearance is lesser than
GFR due to its partial reabsorbed by renal tubules. Further urea clearance is also influenced by
protein contents of the diet. Due to this reason, urea clearance is not much sensitive than
creatinine clearance for assessing of kidney function. The normal range of urea clearance is 12 to
20 gm/24 hours in urine. Lower values of urea clearance indicate insufficient concentration of
protein in diet or renal problem. As such the urea clearance fall below the level of 50% of
normal then only the blood urea level found to detect thus the creatinine clearance is a better
indicator for the assessment of renal function.
URINE ANALYSIS
It is analysis or test of urine used for diagnosis of various kinds of disorders, such as renal
disease, diabetes and urinary tract infection. In urine analysis, there is checking of appearance of
urine, concentration (pH), and content of urine. An abnormal result of urine analysis indicates
the disease or some kind of illness. For example, in urinary tract infection, the color of urine
looks cloudy instead of clear. Increased in the concentration of protein of in urine also indicates
the sign of kidney disease. There requires more testing of urine analysis to reveal the source of
the problem.
Visual Examination:
Typically, the urine is clear and laboratory technician examine the appearance of urine. If the
appearance of urine is looks cloudy and unusual odor indicates infections and may other
problems. Blood in urine make the red or brown color of urine. Urine color influenced by type
and varieties of food eaten for example- beet root make urine red tint to urine.
Dipstick Test:
Dipstick test is used to identify the abnormality or the bacterial infections. In this test there is
use of thin plastic stick with impregnated chemical or strip of chemical on the stick. If the certain
substance or abnormality is available in urine or available at above normal range then their
results into change in the color of strip. The test is used to detect or evaluate the following
indices.
 It is used to detect the acidity (pH) in urine. Abnormal pH levels may see in a kidney or
urinary tract disorder.
 The test is used to estimate the concentrated (higher molarity) or diluted urine or specific
gravity of urine. The result of higher than normal concentration indicated the dehydration
or not drinking enough of fluid.

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This test is also used to estimate the protein in urine sample. In the urine low level of
protein is normal. Even though small increased in the concentration of protein is not so
much concerned while larger quantity of protein in urine indicates the major renal
problem,
This test is also used for bilirubin determination which is a byproduct of RBC after its
breakdown. After formation of bilirubin it get transported to liver for its removal and
become a part of bile. Detection of bilirubin indicates the liver damage or diseases.
Sugar estimation. Normally there is presence of sugar in urine in very small quantity,
which is very low to detectable range. While observance of sugar in urine in detectable
range indicates the chances of diabetes and there is need of follow up of testing for
diabetes.
Ketones determination. Similar with the glucose, any detectable concentration found in
urine may call for diabetes and there require follow-up of testing.
Presence of blood in urine may need of some additional testing because it may be sign of
infection, blood disorders, kidney damage, bladder/kidney stone, and cancer of
kidney/bladder.
Evidence of infection can be detected by this test by simple observance of WBC and it indicates
the sign of urinary tract infection
Microscopic Examination:
In this test, some drops of urine are observed under microscope. If following are observed at
above average range, then additional testing may require for detail diagnosis and confirmation of
laboratory analysis and medical conditions.
1. Presence of white blood cells may indicate the sign of an infection.
2. Presence of red blood cells may indicate the sign of renal disease, hemolytic
condition/blood disorder or any another underlying medical condition, such as bladder
cancer.
3. Presence of bacteria or yeasts indicates the probability of infection Presence of tube-
shaped proteins in urine may indicate the kidney disorders.
4. Presence of crystals in the urine sample may be a sign of kidney stones.

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QUESTION BANK
A. 2 MARKS QUESTIONS
1. Define inventory and inventory control?
2. Enlist methods to determine EOQ.
3. Enlist factors affecting inventory control.
4. Give formula of EOQ Analysis.
5. Give the purpose of investigational use of drugs (IUD) in hospitals.
6. Enlist different classes of drugs used in hospitals research program.
7. Give the four phases used in clinical investigation of drugs.
8. What is blood?
9. Enlist physical characteristics of blood.
10. Give the characteristics of plasma.
11. What is urinalysis?
12. What is hematology?
B. 5 MARKS QUESTIONS
1. Describe dipstick urinalysis.
2. Write a note on interpretation of urinalysis.
3. Describe IUD and its principle involved in hospital.
4. Describe documents used to amend in IND.
5. Write a short note on lead time, safety stock method, re-order level.
6. Write a short note on organization of drug store.
7. Write about VED analysis.
C. 10 MARKS QUESTIONS
1. What are the features of good layout design? Write objective of inventory control.
2. Define purchasing, its principle and procedure for purchasing of materials.
3. Write role of hospital pharmacist in the clinical evaluation of a drug and give
classification of drugs according to the adoption in hospital.
4. What is hematology? Write a note on interpretation of laboratory tests in hematology.
5. Write in detail about liver and kidney function test.

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