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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_5739_Библиотеки_им_академика_М_И_Перельмана.pdf
Pharmacy Practice198
4. What do you understand by control of investigational
drugs?
ShorShor
ShorShor
Shor
t Answer Tt Answer T
t Answer Tt Answer T
t Answer T
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1. Write a note on investigational use of drugs.
2. What is the role of pharmacist in the clinical evaluation of
drug?
3. Classify the investigational drugs in a hospital.
4. Discuss the various classes for the investigational drugs.
5. Write a note on label used for investigational drugs.
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 investigational drugs. Classify the investigational
drugs. Also discuss the principle involved behind these
drugs.
2. What is the role of a pharmacist in clinical evaluation of a
drug.
3. What is control of investigational drugs? Write a note on:
A. Label for investigational drugs
B. Operational classification of these drugs
C. Identification of investigational drugs
Objective TObjective T
Objective TObjective T
Objective T
ype Questionsype Questions
ype Questionsype Questions
ype Questions
1. _____drugs are those which are under consideration but not
yet approved by FDA or legal authority of the respective
country for human use.
A. New drugs
B. Placebo drugs
C. Investigational drugs
D. None of these
2. _________are primary centres for clinical studies on
investigational drugs.
A. Hospitals
B. Research labs
C. Industries
D. Research institutions
3. All the investigational drugs should be registered with:
A. P&T committee B. FDA
C. HIS D. None of these
Investigational use of Drugs 199
4. Clinical investigation is done in ____ phases.
A. 3 B. 5
C. 4 D. 6
5. All investigational drugs must meet the criteria of____, ____
and _____ standards.
AnswersAnswers
AnswersAnswers
Answers
1. C 2. A 3. A 4. C 5. Ethical, legal and scientific
LABORALABORA
LABORALABORA
LABORA
TORTOR
TORTOR
TOR
Y TESTSY TESTS
Y TESTSY TESTS
Y TESTS
Laboratory test results may be positive, negative, or
inconclusive. Positive test results mean that the amount of a
substance being tested for is higher or lower than normal.
Negative results mean that the substance being tested for was
present in a normal amount. Inconclusive test results are those
that are not clearly positive or negative.
FF
FF
F
alse Palse P
alse Palse P
alse P
ositive and Fositive and F
ositive and Fositive and F
ositive and F
alse Negative Talse Negative T
alse Negative Talse Negative T
alse Negative T
estsests
estsests
ests
A false-positive test result is one that shows a disease or
condition is present while in actuality it is not present. A false-
positive test result may suggest that a person has the disease
or condition when he or she does not have it. For example, a
false-positive pregnancy test confirms pregnancy, when in
reality the woman is not pregnant.
A false-negative test result may suggest that a person does
not have a disease or condition while in actuality if the disease
is present. For example, a false-negative pregnancy test does
not confirm pregnancy while in actuality the woman is
pregnant. The various factors affecting test results are:
i. Pregnancy
ii. Medicine taken
iii. Eating habits
iv. Smoking
v. Stressed conditions
Interpretation of Clinical
Laboratory Tests
21
Interpretation of Clinical Laboratory Tests 201
BLBL
BLBL
BL
OOD CHEMISTROOD CHEMISTR
OOD CHEMISTROOD CHEMISTR
OOD CHEMISTR
YY
YY
Y
Blood chemistry tests are blood tests that measure amounts of
certain chemicals in a sample of blood. They show how well
certain organs are working and can help find abnormalities.
There are many types of blood chemistry tests. They measure
chemicals including enzymes, electrolytes, fats (also called
lipids), hormones, sugars, proteins, vitamins and minerals. The
following some common blood chemistry tests are:
a. An electrolyte panel measures sodium, potassium, chloride,
magnesium, phosphate and bicarbonate.
b. Kidney function tests (also called a renal panel) measure
blood urea nitrogen (BUN) and creatinine.
c. Liver function tests measure alanine aminotransferase
(ALT), alkaline phosphatase (ALP), aspartate transaminase
(AST), bilirubin, albumin and total protein.
d. A basic metabolic panel (BMP) includes an electrolyte panel
and kidney function tests and also measures glucose and
calcium.
Blood chemistry tests are common blood tests. They are often
done as part of a routine checkup, but can be done at any time.
Blood chemistry tests are done to:
i. Check general health
ii. Check organs working like kidneys, liver and thyroid
iii. Check the body’s electrolyte balance
iv. Help diagnose diseases
v. Check how a treatment is affecting certain organs
vi. Monitor cancer
Procedure for blood chemistry tests are to be followed special
instructions before having blood chemistry tests like not to eat
or drink anything (except water) for several hours before
having blood chemistry tests. This is called fasting. Some
medicines may also affect blood chemistry test results hence
they must be stopped.
Blood chemistry tests are usually done in a community lab
or hospital.
Blood is usually taken from a vein in the arm. An elastic
band (a tourniquet) is wrapped around the upper arm to apply
Pharmacy Practice202
pressure to the area and make the veins easier to see. The
patient is asked to make a fist so the veins stand out more. The
skin is cleaned and disinfected. A needle is inserted into the
vein and a small amount of blood is removed. The blood is
collected in a tube and labeled with the name of the patient
and other identifying information.
The blood collected is then examined by a specialist at the
laboratory (a laboratory technologist) using microscopes and
other special equipment. Here is a list and explanation of
several blood tests (Table 21.1).
Table 21.1: List of common blood chemistry tests
Test name Function Value
Blood urea For renal disease, check Normal range: 7–25 mg/dl
nitrogen (BUN) glomerular function
Calcium (Ca) Check parathyroid Normal range: 8.5–10.8 mg/dl
functioning and calcium
metabolism
Chloride (Cl) Check water and Normal range: 96–109 mmol/L
electrolyte balance
Cholesterol High total cholesterol may Total normal range: Less than
(Chol) indicate atherosclerosis 200 mg/dl
related to coronary heart Low-density lipoprotein (LDL)
disease; indicates thyroid Normal range: Less than
and liver function 100 mg/dl
High-density lipoprotein (HDL)
Normal range: 60 mg/dl
or greater
Creatinine Check creatinine levels Normal range: 0.6–1.5 mg/dl
(Creat) which may be due to
renal damage
Fasting blood Fasting blood sugar is Normal range: 70–110 mg/dl
sugar (FBS) measured to assess
glucose metabolism
2-hour post- Used to assess glucose Normal range: Less than
prandial blood metabolism 140 mg/dl
sugar (2-hr
PPBS)
Glucose Use to assess glucose 30 min: 150–160 mg/dl
tolerance metabolism 1 hour: 160–170 mg/dl
test (GTT) 2 hours: 120 mg/dl
3 hours: 70–110 mg/dl
Contd.
Interpretation of Clinical Laboratory Tests 203
HEMAHEMA
HEMAHEMA
HEMA
TOLTOL
TOLTOL
TOL
OGOG
OGOG
OG
YY
YY
Y
Hematology involves the study of the blood, in particular how
blood can affect overall health or disease. Hematology tests
include tests on the blood, blood proteins and blood-producing
organs.
These tests can evaluate a variety of blood conditions
including infection, anemia, inflammation, hemophilia, blood-
clotting disorders, leukemia and the body’s response to
chemotherapy treatments. Tests may be routine and regular,
or they may be called upon to diagnose serious conditions in
urgent situations. In many cases, the results of a blood test can
give an accurate assessment of body conditions and how internal
or external influences may affect a patient’s health. Beside
chemical tests some other routine blood tests are given below.
Complete Blood Count (CBC)Complete Blood Count (CBC)
Complete Blood Count (CBC)Complete Blood Count (CBC)
Complete Blood Count (CBC)
The CBC is one of the most common blood tests. It is an assay
of the ratio of red to white blood cells, types of white cells, and
the number of platelets in blood. It can be used as an initial
screening test for an infection and a general measure of health.
Table 21.1: List of common blood chemistry tests (Contd.)
Test name Function Value
Potassium (K) Assess water and Normal range: 3.5–5.3 mmol/L
electrolyte balance.
High potassium levels
can cause cardiac
arrhythmia, while low
levels may cause cramps
and muscle weakness
Sodium (Na) Used to assess salt 135–147 mmol/L
balance and hydration
levels 135–147 mmol/L
Thyroid- Measured to diagnose Normal range: 0.3–4.0 g/L
stimulating thyroid function
hormone disorders
(TSH)
Urea Urea is a product of Normal range: 3.5–8.8 mmol/L
amino acid metabolism.
It is measured to check
kidney function
Pharmacy Practice204
HematocritHematocrit
HematocritHematocrit
Hematocrit
A hematocrit is a measure of the blood volume consisting of
red blood cells. A high hematocrit level can indicate
dehydration, while a low hematocrit level may indicate anemia.
An abnormal hematocrit may signal a blood disorder or bone
marrow disease.
RR
RR
R
ed Blood Cellsed Blood Cells
ed Blood Cellsed Blood Cells
ed Blood Cells
Red blood cells carry oxygen from the lungs to the rest of the
body. Abnormal red blood cell levels might be a sign of anemia,
dehydration, bleeding, or another disorder.
White Blood CellsWhite Blood Cells
White Blood CellsWhite Blood Cells
White Blood Cells
White blood cells fight infection, so a high white cell count
may indicate infection, blood disease, or cancer.
PlateletsPlatelets
PlateletsPlatelets
Platelets
Platelets are fragments that stick together to help blood clot
when a blood vessel is broken. Abnormal platelet levels may
signal a bleeding disorder (insufficient clotting) or a thrombotic
disorder (too much clotting).
HemoglobinHemoglobin
HemoglobinHemoglobin
Hemoglobin
Hemoglobin is the iron-containing protein in red blood cells
that carries oxygen to cells. Abnormal hemoglobin levels might
be a sign of anemia, sickle cell, or other blood disorders.
Diabetes can raise levels of hemoglobin in blood.
Mean Corpuscular VMean Corpuscular V
Mean Corpuscular VMean Corpuscular V
Mean Corpuscular V
olumeolume
olumeolume
olume
Mean corpuscular (MCV) is a measure of the average size of
the red blood cells. Abnormal MCV may indicate anemia or
thalassemia.
Mono ScreeningMono Screening
Mono ScreeningMono Screening
Mono Screening
Infectious mononucleosis, also known as mono, is caused by
the Epstein-Barr virus. It can be a serious condition and is highly
contagious. Mononucleosis testing involves looking for the
antibodies the immune system makes as it works to fight the
infection.
Interpretation of Clinical Laboratory Tests 205
Vitamin BVitamin B
Vitamin BVitamin B
Vitamin B
1212
1212
12
Deficiency T Deficiency T
Deficiency T Deficiency T
Deficiency T
estingesting
estingesting
esting
A lack of vitamin B
12
can make the patient feel tired, run down
and without energy. A simple blood test can detect whether
vitamin B
12
levels have decreased. This vitamin is essential for
healthy blood cells, healthy nerves and stable DNA. If a
deficiency is detected, this condition is easy to manage with
supplements, changes to the diet and vitamin shots.
RR
RR
R
enal Penal P
enal Penal P
enal P
rofilingrofiling
rofilingrofiling
rofiling
The kidneys are responsible for a lot of waste management
and cleansing in the body. Renal profiling can provide a unique
and valuable snapshot of how the kidneys are functioning. The
blood test will include testing the levels of creatinine and blood
urea nitrogen, both responsible for healthy kidney function.
Cholesterol TCholesterol T
Cholesterol TCholesterol T
Cholesterol T
estingesting
estingesting
esting
High levels of cholesterol have been linked to heart disease
and other potentially fatal conditions for some time. Cholesterol
testing can alert a doctor as to whether a patient needs to take
action to lower blood cholesterol and whether further treatment
is required. The blood test itself involves testing the total
cholesterol, LDL cholesterol (the bad), HDL cholesterol (the
good), triglycerides and the patient’s risk ratio.
Blood Glucose TBlood Glucose T
Blood Glucose TBlood Glucose T
Blood Glucose T
estingesting
estingesting
esting
Blood glucose testing is used to show how well the patient has
been able to control his or her diabetes over the past few
months. It is a non-fasting test that shows the level of glucose
values in the blood. It is also known as A1c, glycohemoglobin
or HbA1c testing. While it is a very accurate test, it should
never be used in place of routine daily glucose testing.
URINALURINAL
URINALURINAL
URINAL
YSISYSIS
YSISYSIS
YSIS
A urinalysis is a quick, noninvasive test that requires no special
preparation. In most cases, it is easy to perform.
A doctor may use the test as part of a routine check or for a
more specific reason, such as to look for underlying conditions
or infections, to confirm a pregnancy, or to check for drug use.
A person should follow their doctor’s instructions when taking
Pharmacy Practice206
the test to get a valid sample. A urinalysis is a test of the urine.
A urinalysis is used to detect and manage a wide range of
disorders such as urinary tract infections, kidney disease and
diabetes.
A urinalysis involves checking the appearance, concentration
and content of urine. Abnormal urinalysis results may point
to a disease or illness. For example, a urinary tract infection
can make urine look cloudy instead of clear. Increased levels
of protein in urine can be a sign of kidney disease.
A urinalysis is a common test that is done for several reasons:
i. To check the overall health: Urinalysis may be done as a
routine medical examination, pregnancy checkup, pre-
surgery preparation, or on hospital admission to screen
for a variety of disorders such as diabetes, kidney disease
and liver disease.
ii. To diagnose a medical condition: Urinalysis may be
done to check abdominal pain, back pain, frequent or
painful urination, blood in urine, or other urinary
problems.
iii. To monitor a medical condition: In case of kidney
disease or a urinary tract disease the doctor may
recommend a urinalysis on a regular basis to monitor the
condition and treatment of kidney.
Other tests, such as pregnancy testing and drug screenings,
also may rely on a urine sample. For example, pregnancy testing
measures a hormone called human chorionic gonadotropin
(hCG). Drug screenings detect specific drugs or their metabolic
products, depending on the purpose of the testing.
PP
PP
P
rocedure for Urinalysisrocedure for Urinalysis
rocedure for Urinalysisrocedure for Urinalysis
rocedure for Urinalysis
To get the most accurate results, the sample may need to be
collected midstream, using a clean-catch method. This method
involves the following steps:
i. Cleanse the urinary opening. Women should spread their
labia and clean from front to back. Men should wipe the
tip of the penis.
ii. Begin to urinate into the toilet.
iii. Pass the collection container into the urine stream.
Interpretation of Clinical Laboratory Tests 207
iv. Urinate at least 1 to 2 ounces (30 to 59 ml) into the
collection container.
v. Finish urinating into the toilet.
vi. Deliver the sample to the designated area within
60 minutes of collection or refrigerate the sample.
In some cases the doctor may insert a thin, flexible tube
(catheter) through the urinary tract opening and into the
bladder to collect the urine sample. The urine sample is sent to
a laboratory for analysis.
RR
RR
R
esultsesults
esultsesults
esults
For a urinalysis, the urine sample is evaluated in three ways:
(i) Visual examination, (ii) dipstick test, and (iii) microscopic
examination.
Visual ExaminationVisual Examination
Visual ExaminationVisual Examination
Visual Examination
A laboratory technician examines the urine’s appearance. Urine
is typically clear. Cloudiness or an unusual odor may indicate
a problem such as an infection.
Blood in the urine may make it look red or brown. Urine
color can be influenced by diet, e.g. beets or rhubarb may add
a red tint to the urine.
Dipstick TDipstick T
Dipstick TDipstick T
Dipstick T
estest
estest
est
A dipstick test uses a thin, plastic stick with strips of chemicals
on it, is placed in the urine to detect abnormalities. The chemical
strips change color if certain substances are present or if their
levels are above normal. A dipstick test checks for:
i. Acidity (pH): The pH level indicates the amount of acid
in urine. Abnormal pH levels may indicate a kidney or
urinary tract disorder.
ii. Concentration: A measure of concentration, or specific
gravity, shows how concentrated particles are in the
urine. A higher than normal concentration often is a
result of not drinking enough fluids.
iii. Protein: Low levels of protein in urine are normal but
larger amounts may indicate a kidney problem.
iv. Sugar: Normally, the amount of sugar (glucose) in urine
is too low to be detected. Any detection of sugar on this
test usually calls for follow-up testing for diabetes.