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Pharmacy Practice28
drug–disease relationship. “Spontaneous reporting agencies”
are set up to collect and gather such case reports. Although
the resulting information collected gives no idea of the
frequency with which a given event is caused by a drug, it
indicates that a number of prescribers feel that the event is
possibly drug-related.
In recent years, national registers have been established in
several countries with the main aim of providing an early
warning that a dug is capable of causing a serious adverse
effect. There registers in general depend upon the voluntary
spontaneous reporting of suspected adverse drug reactions by
doctors. The British registrar of Adverse Drug Reactions was
established in 1964.
The most physicians fail to report many adverse drug
reactions which may be due to the following reasons:
• The misconception that ADR reflects poor therapeutic agent
selection.
• Lack of interest.
• Lack of understanding of what to report.
2. Vital Statistics and Record Linkage Studies
The details of cause of death (as recorded on death certificate)
or of hospitalization (as recorded on the discharge letter) are
routinely collected and analyzed. It gives early warning of an
epidemic of drug-related disease. Record linkage studies may
be used to great effect in the search for drug-induced disease.
3. Cohort Studies
The ‘Cohort’ means identifying a group of recipients of drug
of interest and observing these patients for varying lengths of
time for what happens to them. This type of study is used for
short term clinical trial of new drug. Cohort studies involving
long-term clinical trials are more difficult to organize. Thus,
this method is of great value for detecting predictable adverse
effects due to excessive pharmacological effects arising during
or immediately after short-term treatment.
4. Case Control Studies
It involves the comparison of group of patients with a disease
which is thought to be due to a drug (the ‘cases’) with a group
of patients who do not have the disease (the ‘control’). The
Adverse Drug Reactions 29
drug histories of the cases and controls are obtained and
compared. If a drug is causing the disease then its use amongst
the cases will be far in excess of that found in the controls.
Case control studies can be conducted rapidly and efficiently
at relatively low cost. However, it must be conducted correctly
and resulting data must be interpreted correctly. Following
precautions should be taken while conducting case control
studies:
The cases must be selected carefully. The disease must be
defined clearly, precisely and accurately. The disease under
study must have reasonable risk of being drug- induced.
The controls obtained should be from similar population of
cases with the exception that controls do not have the disease
of interest. Controls are usually hospitalized patients. They
should not include patients admitted for conditions which are
indications of drug of interest or which are caused or prevented
by the drug of interest.
The method used to describe drug use must be identical in
cases and controls. Interpretation of results must be accurate.
ADAD
ADAD
AD
VERSE DRUG REAVERSE DRUG REA
VERSE DRUG REAVERSE DRUG REA
VERSE DRUG REA
CTION REPORTING AND MANACTION REPORTING AND MANA
CTION REPORTING AND MANACTION REPORTING AND MANA
CTION REPORTING AND MANA
GEMENTGEMENT
GEMENTGEMENT
GEMENT
Adverse drug reaction reporting means reporting in the form
of a report when there is some unwanted association between
drug and other things which may lead to adverse reactions.
Any undesirable adverse event suspected to be associated
with use of drug, biological (including blood products), herbal
drugs, cosmetics or medical devices should be reported. They
should include:
• All ADRs as a result of prescription and non-prescription.
• All suspected adverse drug reactions.
• Unexpected reaction, regardless of their nature or severity,
whether not consistent with product information or
labeling.
• An observed increase in frequency of a given reaction.
• A serious reaction, whether expected or not.
• All suspected ADRs associated with drug–drug, drug–food
or drug–food supplements interactions.
Pharmacy Practice30
• ADRs in special field of interest such as drug abuse and
drug use in pregnancy and during lactation.
• ADRs occurring from overdose or medication error.
• Unusual lack of efficacy or when suspected pharmaceutical
defects are observed.
The minimal standard information to be provided for proper
assessment of the ADR case report are:
• Patient information
• Adverse reactions description (include laboratory results if
available)
• Information related to the suspected drug(s)
• Information on management of the adverse reactions
• Information about the reporter
Reporters are advised to study carefully and adhere to the
guides on how to complete an ADR reporting form for proper
interpretation.
Basic PBasic P
Basic PBasic P
Basic P
rinciples of Efficient Rrinciples of Efficient R
rinciples of Efficient Rrinciples of Efficient R
rinciples of Efficient R
eporepor
eporepor
epor
tingting
tingting
ting
• Report the adverse reaction immediately after it occurs.
• Factors contributing in causing the event such as other
prescribed drugs, self-medication, herbal products, food,
chemicals, ask the patient particularly about other medi-
cines taken.
• All reports must have the following four data elements:
i. An identifiable patient
ii. A suspected adverse effect
iii. A named suspected drug (s)
iv. An identifiable reporter
Management of the Adverse Drug RManagement of the Adverse Drug R
Management of the Adverse Drug RManagement of the Adverse Drug R
Management of the Adverse Drug R
eactioneaction
eactioneaction
eaction
Successful management of adverse drug reactions requires
early identification and prompt treatment of anaphylaxis,
whether due to immunoglobulin (Ig)E- or non-Ig E-mediated
mechanisms of mast cell mediator release. Acute therapy is
directed toward enhancement of oxygenation. Requisite
measures include the use of epinephrine, oxygen, and adequate
fluid replacement, in some instances, vasopressors or
corticosteroid drug therapy may be given.
Adverse Drug Reactions 31
Emergency measures may be needed to maintain the airway.
Although the offending drug is discontinued, a necessary drug
for which there is no satisfactory alternative occasionally may
be continued without danger of further anaphylaxis. Good
management can be minimized through use of established
protocols for premedication.
ISOLISOL
ISOLISOL
ISOL
AA
AA
A
TED KEY POINTSTED KEY POINTS
TED KEY POINTSTED KEY POINTS
TED KEY POINTS
• An adverse drug reaction (ADR) is an injury caused by
taking a medication.
• Dose-related adverse drug reactions represent an increase
of the drug’s therapeutic effects. For example, a person
taking a drug to reduce high blood pressure may feel dizzy
or light-headed if the drug reduces blood pressure too
much.
• Idiosyncratic reaction is abnormal in nature and is therefore
not possible to predict who may develop one, when, or what
specific form it will take ahead of time. They are not
common, but sometimes when occur may be life-
threatening in nature.
• Drug allergy (hypersensitivity) develops when the body’s
immune system develops an inappropriate reaction to a
drug.
• Result of excessive pharmacological action may be due to
the drug dosage or prolonged use of a particular drug
• Secondary pharmacological effects due to indirect conse-
quences of a primary action of the drug, e.g. tetracyclines
causing suppression of bacterial flora which may lead to
superinfections.
• Drug withdrawal is the occurrence of symptoms that occur
upon the abrupt discontinuation or decrease in intake of
medications or recreational drugs.
• Drug interaction is defined as the pharmacological activity
of one drug altered by the simultaneous use of another drug
or by the presence of some other substances.
• The drug whose activity is affected by such an interaction is
called a “Object drug”the agent which causes such an
interaction is called the “Precipitant”.
Pharmacy Practice32
• Pharmaceutical interactions occur when drugs are mixed in
IV infusions causing precipitation or inactivation of active
principles. For example, ampicillin, chlorpromazine and
barbiturates interact with dextran in solutions and are
broken down.
• Pharmacokinetic interactions are those in which ADME
properties of the object drug get changed.
• Adverse drug reaction reporting means reporting in the form
of a report when there is some unwanted association between
drug and other things which may lead to adverse reactions.
• Management of adverse drug reactions requires early
identification and prompt treatment of anaphylaxis,
whether due to immunoglobulin (Ig)E- or non-IgE-medi-
ated mechanisms of mast cell mediator release.
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 ADRs.
2. How to manage ADR?
3. What is idiosyncrasy?
4. Enlist various types of drug interactions.
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. Define ADR. Write the factors influencing ADR.
2. Write the classification of ADR with examples.
3. Discuss various drug interactions with examples.
4. Write a note on ADR reporting.
5. What are drug–drug and drug–food interactions?
6. Discuss in brief about dose-related ADR.
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 and classify adverse drug reaction. Explain in detail
the mechanism of type A ADR with example.
2. Define ADR. Write the various causality assessment scales
used in ADR monitoring.
3. What is idiosyncracy. Write about idiosyncratic reactions
with suitable examples.
Adverse Drug Reactions 33
4. Give a overview of adverse drug reaction reporting. What
are the basic principles associated with efficient reporting?
5. Explain the methods used for detection of adverse drug
reactions.
Objective TObjective T
Objective TObjective T
Objective T
ype Questionsype Questions
ype Questionsype Questions
ype Questions
1. Study of adverse drug reactions is called________.
A. Pharmacokinetics
B. Pharmacodynamics
C. Toxicology
D. Pharmacovigilance
2. ADR may be due to:
A. Dose-related B. Idiosyncracy
C. Allergy D. All of these
3. ________ is the occurrence of symptoms that occurs upon
the abrupt discontinuation or decrease in intake of
medications or recreational drugs.
4. The regular use of aspirin and NSAIDs may cause:
A. Stomach irritation and bleeding
B. Swelling of lips, tongue or face
C. Rashes
D. Fever
5. Most common affected organs by an idiosyncratic reaction
are:
A. Skin B. Blood cells
C. Liver D. All of these
6. Match the following:
Drug Withdrawal symptoms
a. Opiates i. Irritability, fatigue, shaking,
sweating, nausea
b. Alcohol ii. Irritability, insomnia, headache,
difficulty in concentration
c. Nicotine iii. Anxiety, sweating, vomiting,
diarrhea
AnswersAnswers
AnswersAnswers
Answers
1. D 2. D 3. Drug withdrawal 4. A 5. D
6. a-iii b-i c-ii
DEFINITION?DEFINITION?
DEFINITION?DEFINITION?
DEFINITION?
A community pharmacy is a pharmacy that deals directly with
people in the local area. The work done includes compounding,
counseling, checking and dispensing of prescription drugs to
the patients with care, accuracy, and legality. Community
pharmacy is also involve in procurement, storage, dispensing
and documentation of medicines. It is an important branch of
the pharmacy having registered pharmacist who has the
education, skills and competence to deliver the professional
service to the community.
A community pharmacist should have:
i. Adequate knowledge of pharmaceutical care, dispensing
and compounding of drugs.
ii. Good communication skills.
iii. Maintain all records.
In short community pharmacy is the drug use, control and
effective application of knowledge of ethics, that assures
optimal drug safety in the distribution and use of medicines
and hence, it ensures maximum well-being of patients while
they are on drug therapy.
Working with doctors and other healthcare professionals,
community pharmacists are helping patients to get the most
from their medicines so that they suffer fewer symptoms,
experience less side effects and understand their treatment
better and all things that are needed for happier healthier
patients.
Community Pharmacy
4
Community Pharmacy 35
STRUCTURE OF RETSTRUCTURE OF RET
STRUCTURE OF RETSTRUCTURE OF RET
STRUCTURE OF RET
AIL AND WHOLESALE DRUG STOREAIL AND WHOLESALE DRUG STORE
AIL AND WHOLESALE DRUG STOREAIL AND WHOLESALE DRUG STORE
AIL AND WHOLESALE DRUG STORE
Retail drug stores fall into several different categories. Most
retail drug stores combine a dedicated pharmacy section with
a general retail store, dealing in over-the-counter medication,
personal care and beauty products, food items and assorted
merchandise, ranging from games and toys to electronics and
clothing.
In India, the minimum area of 10 sq.m is required to start a
medical shop for retail or wholesale. In case, the pharmacy
business combines retail and wholesale, a minimum of 15 sq.m
is required. The store must have refrigerator and air conditioner
in the premises. According to the labeling specifications certain
drugs like vaccines, sera, insulin injections, etc. are required to
be stored in the refrigerator.
For wholesale: The sale of drug by wholesale shall be made
either in the presence of registered pharmacist or in the presence
of a competent person who shall be a graduate with 1 year
experience in dealing in drugs or a person who has passed
SSLC with 4 years experience in dealing in drugs, specially
approved by the department of drug control for the purpose.
For retail: The sale of drug by retail must be made in the
presence of registered pharmacist approved by the pharmacy
council of concerned state (Figs 4.1 and 4.2).
LEGAL REQUIREMENTSLEGAL REQUIREMENTS
LEGAL REQUIREMENTSLEGAL REQUIREMENTS
LEGAL REQUIREMENTS
The sale of drugs is quite different from the sale of other things.
In case of ordinary things the consumers can select the goods
according to there choice but in case of drugs there is the need
of a physician.
Before opening a drug store (whether retail or wholesale),
specific laws are imposed such as:
1. Drugs and Cosmetics Act and Rules (1940 and 1945)
2. Poison Act, 1919
3. Dangerous Drug Act
4. Prohibition and Excise Rules
5. Pharmacy Act, 1948
6. Shops and Establishment Act
Pharmacy Practice36
Fig 4.2: Wholesale drug store
Fig 4.1: Retail drug store
Community Pharmacy 37
Following are certain legal requirements which must be
fulfilled:
1. Minimum qualification: A person who wishes to start a
retailer drug should either be a registered pharmacist. In
order to become a registered pharmacist a person should
fulfilled the requirements laid in Pharmacy Act which
includes the following:
i. The person should have attained at least 18 years of age.
ii. He should be a resident of the state or should be carrying
out his business or profession of pharmacy in the state.
iii. Should possess a degree or diploma in pharmacy or any
other approved qualification, from a institute recognized
by PCI.
A person who wishes to start a wholesale drug store may
not be a registered pharmacist but must have passed at least
matriculation examination and must possess at least 4 years
experience in handling of drugs.
2. Minimum space: A minimum area of ‘10 sq.m is required
for running a retail or wholesale drug store. The area should
be equipped with proper storage facility for preserving
the properties of drugs for which the license applied. For
the storage of thermolabile substances such as vaccines,
sera, enzymatic preparations, antibiotics, vitamins, etc., a
refrigerator is required in order to store these drugs at
temperature between 2°C and 8°C. There should be
sufficient number of storage racks for storing the drugs and
pharmaceuticals. In case of a pharmacy, the requirements as
specified in schedule M, to the Drugs and Cosmetics Act
should be fulfilled.
3. Application for grant of license: For the purpose of
granting sale license, the drugs have been divided into the
following categories:
i. Drugs specified in schedules C and C1 of the Drugs and
Cosmetics Act.
ii. Drugs specified in schedule X of the Drugs and
Cosmetics Act.
iii. Drugs other than those specified in schedules C, and C1
and X