About legal requirements to establish a drug store & Adverse drug reaction monitoring & reporting

1. 1
A Presentation on Hospital Pharmacy
By Group B

2. 2
TEAM MEMBERS
1. Ila Mahjabin (23-2321)
2. Maria Rahman(25-2322)
3. Khadija Akter(26-2323)
4. Md. Sohan(28-2325)
5. Fariha Basher Jerin(29-2326)
6. Afsana Akter(30-2327)
7. Sadia Siraj Ritu(31-2328)
8. Shirin Sultana Diba(32-2329)
9. Katha Saha(33-2330)
10. Monalicha(35-2332)
11. Md. Shariful Islam(38-2334)
12. Shazedul Islam(39-2335)
13. Afroza Islam(40-2336)

3. “
Legal Requirements to
Establish a drug store
3

4. A drug store(also called a pharmacy)is a retail shop which provides
pharmaceutical drugs, among other products. At the pharmacy, a
pharmacist oversees the fulfilment of medical prescriptions
The specific laws imposed to run a pharmacy are:
• The Drugs & Cosmetics rules (1940 & 1945)
• The Poisons Act,1919
• The Pharmacy Act,1948
• Shops and Establishments Act,1952
• Dangerous drugs Act,1930
• Prohibition and excise rules
4

5. 5
The legal
requirements to be
fulfilled for opening
a retail drug or
wholesale drug store
are:
Minimum
qualifications
Minimum
space
Store
arrangements
Minimum qualifications:
 Should be a registered pharmacist
 Must be minimum 18 years of age
 Should possess a degree/diploma in pharmacy
 Completed training in a medical store or hospital pharmacy

6. ● Let’s start with Minimum Space
 Minimum area of 10 square meter for
running a retail store
 Equipped with proper storage facility for
preserving properties of drug
 Sufficient number of storage racks
 Areas of the dispensing department shall
be not less than 6 square meters for one
pharmacist working therein with additional
2 square meters for each additional
pharmacist.
Drug Store

7. Application for grant of License
License for running a shop according to shop &
establishment act from labor office situated at district place.
For the purpose of sale
• General License
• Restricted License
7

8. Condition of License
Shall be
displayed at
prominent place
in part of
premises open
to public
Licensee should
comply with
provisions of D
& Cact.
No Physician's
sample or
expired drugs
will be stocked
on sale premises
Compounding of
prescription
would be done
under personal
supervision of
registered
pharmacist
Drugs should be
purchased only
from a duly
licensed dealer/
manufacturer
8

9. Duration of license- An original license or a
renewed license to sell drugs, unless sooner
suspended or cancelled, shall be valid for a
period of five years on and from the date on
which it is granted or renewed.
Renewal of license- application for renewal
may be put up before the expiry or within 6
months of expiry
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10. “
Adverse Drug Reaction
Monitoring & Reporting
10

11. A response to a drug which is Noxious and
Unintended occurs at doses normally used in man for
the prophylaxis, diagnosis, or therapy of disease, or
the modifications of physiological function.
Adverse Drug Effect
Adverse drug reporting helps the drug monitoring
system to detect the unwanted effects of those drugs
which are already in the market. About 0.16% to
15.7% of hospital admissions occur due to ADR. It is
well known that both physicians and pharmacist play
an important role in monitoring and reporting of
ADH.
11
Adverse drug reporting?

12. It caters information
about quality and safety
of pharmaceuticals
products.
It initiates risk
management plans.
It prevent the predictable
adverse effects and
helps in measuring ADR
incidence.
It instructs health care
team, patients,
pharmacists,
and nurses about
adverse drug effects and
creates awareness
regarding ADRs.
12
Benefits of ADR
monitoring

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Who Can
Report?
√All healthcare
professionals (Clinicians,
Dentist, Pharmacist,
Nurses, Physician,
Physiotherapist) etc.
√ All non-healthcare
professionals including
consumers/ patients, etc
can report ADRs
What to
Report?
✓All types of suspected
adverse reactions
• Known or unknown.
•Serious or non series
and
•Frequent or rare
>Reactions from all types
of pharmaceutical
products
•Allopathy
•Vaccines
•Ayurvedic
•Medical devine etc

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How & Whom To
Report?
Use the Spected Adv Drug
Reaction Reporting Form
Modemed side effect.
Reporting form from the
official web site of IPC to
report any ADR link .Fille
AD od to a ADR Monitoring
Cinti (AMC) ducally the
NCC P-PLApoter can benul
the Suspected ADR.

15. 1. Onset of event
Acute (<60 minutes), Sub-
acute (1-24 hrs) and Latent
(>2 days)
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2. Severity
Minor
Moderate
Severe
Lethal ADRs
Classification of ADRs Depending on

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3. Type of reaction
Type A (Augmented),
B (Bizarre),
C (Chemical),
D (Delayed).
E (Exit),
F (Familial),
G (Genotoxicity)
H (Hypersensitivity).
U (Un classified)
4. Other
Side effect, secondary effect, toxic
effects, intolerance, Idiosyncrasy,
Drug allergy, Photosensitivity, drug
dependence, drug withdrawal
reactions, teratogenicity, mutagenicity,
carcinogenicity, drug induced disease.

17. Type A (Augmented) reactions:
Reactions which can be predicted from the known
pharmacology of the drug. Dose dependent, Can
be alleviated by a dose reduction.
E.g.
Anticoagulants -Bleeding
Beta blockers - Bradycardia
Nitrates- Headache
Prazosin - Postural hypotension
17

18. Type B ( Bizarre) reactions
Cannot be predicted from the pharmacology of
the drug. No dose dependent. Host dependent
factors important in predisposition. E.g. Penicillin -
Anaphylaxis Anticonvulsant - Hypersensitivity
Type C (chemical) reactions
Biological characteristics can be predicted from
the chemical structure of the drug/metabolite. E.g.
Paracetamol - Hepatoxicity
18

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TYPE D (DELAYED) REACTIONS
Occur after many years of treatment
Can be due to accumulation.
E.g.
Chemotherapy → Secondary tumors
Phenytoin during pregnancy – Teratogenic effects
Antipsychotics → Tardive dyskinesia
• Analgesics → Nephropathy

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TYPE E (END OF TREATMENT )
REACTIONS
Occur on withdrawal especially when drug is
stopped
abruptly
E.g.
Phenytoin withdrawal → Seizures.
• Steroid withdrawal → Adrenocortical
insufficiency

21. PREDISPOSING FACTORS
POLYPHARMACY
Polypharmacy describes the use of multiple drugs by a single
patient to treat one or more conditions. It is most common among
elderly patients, ages 65 and over. It is estimated to cause
100,000 deaths per year. Alternate names Multiple medications.
 Patients on multiple drug therapy are more prone to develop
an ADR.
 Alteration of drug effect through interaction mechanism or by
synergism.
 Risk increases with increase in the no: of drugs administered
21

22. Multimorbidity:
● Multimorbidity was commonly defined as the presence of
multiple diseases or conditions, often with a cut-off of two or
more. One review developed a holistic definition including
biopsychosocial and somatic factors as well as disease.
Multiple and Intercurrent Diseases:
 Increased risk due to multiple drugs use for their diseases.
 Impaired hepatic and renal status are also at high risk of
developing an ADR.
● Patient with decreased renal function treated with
aminoglycosides increased risk of nephrotoxicity
22

23. Age
1. Elderly and pediatric patients
are more vulnerable to ADRs.
2. In elderly patients
physiological changes.
3. E.g.: nitrate or ACE inhibitor
induce postural hypotension.
4. In neonates drug handling
capacity differ compared to
adult.
5. Eg: gray baby syndrome
with chloramphenicol.
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DRUG
CHARACTERISTICS
1. Some drugs are highly
toxic in nature.
2. E.g.: cytotoxic drugs result
in nausea and vomiting.
3. Narrow therapeutic range
drugs like digoxin and
gentamicin slight increase in
concentration may result in
toxicity.

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GENDER:
1. Women are more susceptible
to ADRs than males, Reasons
are physiological,
pharmacokinetic,
pharmacodynamic and
hormonal.
2. E.g.: Chloramphenicol
induced aplastic anemia and
phenylbutazone induced
agranulocytosis are twice and
thrice as common in woman as
in man respectively.

25. 25
DETECTION OF ADRS
1.pre-marketing studies
2.post-marketing studies
3.Under reporting
4.Communicating ADRs

26. 26
PREMARKETING STUDIES
During the development of new medicines,
their safety is tested in animal models.
Specific animal studies for carcinogenicity,
teratogenicity, and mutagenicity are also
available,
Clinical trials are carried out in 3 different
phases prior to the submission of a
marketing authorization application.
Clinical trials normally identify ARDs of
frequency greater that 0.5-1.0%
POST MARKETING STUDIES
Pharm vigilance methodologies are used for
detection of risk and for the collection of risk
information
Powerful and cost-effective system for the
identification of unknown drug-related risk is
spontaneous adverse drug reactions reporting
Health care practitioner should see it as a part
of professional duty report ADR result in a
patient under his care
Concerned identifying product defect,
intoxicants and abuse and unexpected lack of
therapeutic effect.

27. 27
1.Reporting higher for new
drugs than for old
2.Serious reactions are
reported to a higher degree
3 .Type B reaction is reported
more commonly than their
share of events in practice
4. Reporting is affected by
promotional claims of the drug
sponsor
5.Reporting is affected by
general publicity around the
ADR reporting scheme
Under reporting
The reason more often by health
professionals for not reporting are: 1.Lack
of time
2.Lack of knowledge on what how or
where to report
3.The drug reaction association
is uncertain
4.The reaction is already well-known
5.Guilt or fear of litigation 6.Belief that
all registered medicines are safe
7.Non- availability of reporting forms

28. 28
Communicating ADRs
1.During basic
training of health
professionals
2. Through continuous
education programmes
to health professionals
3. By specially
designated drug
information centres
4.Through packaged
inserts and patient
counselling

29. 29
Two epidemiological methods are most commonly used are
1. Cohort studies
2. Control studies
Cohort studies : Patient exposed to a particular drug are
followed up actively and systematically and ADR frequencies
are compared to an unexposed control population.
Control studies : Individuals affected by the adverse event
being studied are identified. Each case is matched with several
disease -- free control patients randomly recruited from the
study base.

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Role of Healthcare professionals
 The health care professionals should be very vigilant in detecting ADRs.
 ADR may be detected during ward rounds with medical team.
 ADRs detected during review of patient chart, patient counselling, medication
history review, communicating with other health professionals.
To assist ADR health care professionals should closely monitor patients who are
at high risk include.
 Patients with renal or hepatic impairment .
 Patients taking drugs which have potential to cause ADR, E.g., DIGITOXIN
 Patient who have had previous allergic reactions.
 Patient taking multiple drugs.
 Pregnant and breast feeding women.

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