A project on Adverse Drug Reaction under the guidance & supervision of Consumer Education & Research Centre (CERC), Ahmedabad.

1. Project on
Adverse drug reaction
Submitted to:
Consumer education & research centre
1st
December 2015
BY:

2. NISHU P. VORA
DARSHAN R. KABRA
HARSHUL N. VAGHELA

3. * AMBULATORY PATIENTS – Patientswhoare not bedriddenORthose whocanwalk.

4. ADVERSE DRUG REACTION
 INTRODUCTION
Adverse Drug Reaction is the harm caused due to use of given
medicines OR unwanted or harmful reaction experienced after the
administration of a drug or combination of drugs under normal
conditions of use.
Thus, simply speaking ADRs are inevitable consequences of
pharmacotherapy (Pharmaceutical Drugs). It is well known that all
drugs carry the potential to produce desirable and undesirable
effects. No drug is absolutely safe under all circumstances of use
or in all patients except Ayurvedic & Homeopathic drugs and
ADRs may occur even if a drug is correctly selected and dosed.
The Adverse Drug Reaction classified on the basis of Edward and
Aronson classification system were found to be of 6 types –
1. Type A (Augmented Pharmacologic Effects) -
a) Related to pharmacological action of drug
b) Predictable
c) Dose dependent
d) Common
Different classes: 1) Toxicity of overdose (Drug overdose)
2) Side Effects
3) Secondary Effects
4) Drug Interactions

5. 2. Type B (Bizarre Effects) –
a) Unrelated to pharmacological actions
b) Unpredictable
c) Unrelated to dose
Different Classes: 1) Drug Intolerance
2) Hypersensitivity
3) Pseudo allergic reactions
4) Idio syncratic reactions
3. Type C (Chronic Effects) –
a) Associated with long term drug therapy
b) Well known and can be anticipated
c) Eg : Opoids , Alcohol , Barbiturates
4. Type D (Delayed Effects) –
a) Carcinogenic (Medication lead to cancer; take >20 y to develop)
& teratogenic (Drug- induced birth defects) effects
b) Very Rare
5. Type E (End of Treatment Effects)
6. Type F (Failure of Therapy)

6.  ITEMS THAT COULD CAUSE ADVERSE DRUG
REACTION:
1) Drugs prescribed by a doctor
2) Drugs bought over the counter
3) Pain medications
4) Antibiotics
5) Vitamins
6) Some food and drink such as alcohol and caffeine

7.  SIGNS AND SYMPTOMS OF ADVERSE DRUG REACTION
The symptoms involved in an Adverse Drug Reaction will depend
upon the age of an individual and dosage taken. Some of the most
common symptoms are:
1) Mild , Moderate , Severe or Lethal
2) Sign & symptoms manifest soon after 1st dose or only after
chronic use
E.g., Allergic reactions occur soon after drug is taken usually
2nd time (itching, rash, eruption, upper or lower airwayedema with
dyspnea & hypotension).
3) Irritation to the skin
4) Bleeding
5) Nausea
6) Vomiting
7) Diarrhea
8) Breathing Problems
 RESULTS AND FINDINGS
Adverse Drug Reaction is most common in:
1) Women
2) Elders (above 60 years)
3) Very young (1-4 years)
4) Patients taking more than 1 drug

8. Also as per the surveys and findings it has been found that there is a
correlation between increasing age and adverse drug reaction (ADR)
rate, at least for some medical conditions. More than 80% of ADRs
causing admission or occurring in hospital are type A (dose-related) in
nature, and thus predictable from the known pharmacology of the drug
and therefore potentially avoidable. Antibiotics, anticoagulants, digoxin,
diuretics, hypoglycaemic agents, antineoplastic agents and nonsteroidal
anti-inflammatory drugs (NSAIDs) are responsible for 60% of ADRs
leading to hospital admission and 70% of ADRs occurring in hospital.
These are generally drugs with a low therapeutic ratio (ratio between the
average therapeutic and toxic dose). In addition, they all figure highly in
lists of medicines most likely to be used in the elderly, and likely to be

9. associated with adverse drug interactions. It has been suggested that type
A ADRs are more common in the elderly and the unpredictable type B
(‘bizarre’ or idiosyncratic reactions) less common. However, some
important and occasionally serious examples of type B toxicity (e.g.
hepatotoxicity in association with the antibiotic flucloxacillin or the
antibiotic combination, coamoxiclav) appear to be commoner in elderly
than younger individuals.
MEDICINES REACTIONS
Amidopyrine (for inflammation) white blood cell disorder
Clioquinol (for skin infections) visual impairment
Erythromycin-estolate
(antibacterial)
hepatitis (liver disorder)
Oral contraceptives thromboembolism (blood clots)
Statins (for controlling cholesterol) muscle degeneration
Thalidomide (for managing
morning sickness)
phocomelia (disfigured infants)
9 REASONS WHY OLDER ADULTS ARE MORE LIKELY
THAN YOUNGER ADULTS TO SUFFER ADRs –
1. Smaller bodies and different body composition
2. Decreased ability of the liver to process drugs
3. Decreased ability of the drugs to clear drugs out of the body
4. Increased sensitivity to drugs
5. Decreased Blood-Pressure maintain ability
6. Decreased Temperature compensation
7. More diseases that affect the response to drugs
8. More drugs, and therefore more ADRs
9. Inadequate testing of drugs on older adults before approval

10.  SOME FACTS ON ADVERSE DRUG REACTIONS
1. Patients who experienced Adverse Drug Events (ADEs) were
hospitalized an average of 8-12 days longer than the patients
who didn’t suffer ADEs and their hospitalization costs $16000
to $24000 more.
2. Anywhere from 28%-95% of ADEs can be prevented by
reducing medication errors through computerized monitoring
systems. (Medication Error - It is any preventable event that may cause
or lead to inappropriate medication use or patient harm while the
medication is in the control of the health care professional, patient, or
consumer; Computerized Monitoring System - The system integrates
computerized data on each hospital patient (medications, clinical
laboratory, blood gas, ECG, allergies, diagnosis, etc.) and returns to the
pharmacist warning messages and suggestions regarding patient drug
therapy).
3. Computerized medication order entry has the potential to
prevent an estimated 84 percent of dose, frequency and route
errors.
4. Hospitals can save as much as $500000 annually in direct costs
(Stationary Costs) by using computerized systems.
5. Over 770000 people are injured or die each year in hospitals
from ADEs which may cost upto $5.6 million each year per
hospital depending on hospital size.
6. National hospital expenses to treat patients who suffer ADEs
during hospitalization are estimated at between $1.56 and $5.6
billion annually.
7. Medication errors associated with ADRs are as follows:
 Missed dose - 7% (medicine to be taken but not taken)
 Wrong technique – 6% (taken inappropriately)

11.  Illegible order – 6% (Unreadable prescription which led to
giving of different drug by pharmacist)
 Duplicate therapy – 5% (Wrong treatment by doctor due to
unclear history of the patient OR patient’s lack of knowledge)
 Drug-Drug interaction – 3-5% (Risk increases as many drugs
are administered at the same time to the patient)
 Equipment failure - 1%
 Inadequate monitoring – 1% (Inappropriate follow-up)
 Preparation error – 1%
8. Studies indicate that anywhere from 28-95% of ADEs can be
prevented.
 MECHANISM AFTER ADVERSE DRUG REACTION
(Authorities, Reporting and future course of action)
The Central Drugs Standard Control Organisation (CDSCO), New
Delhi, under the aegis of Ministry of Health & Family Welfare,
Government of India has initiated a nation-wide
pharmacovigilance programme in July, 2010, with the All India
Institute of Medical Sciences (AIIMS), New Delhi as the National
Coordinating Centre (NCC) for monitoring Adverse Drug
Reactions (ADR) in the country to safe-guard Public Health. In
year 2010, 22 ADR monitoring centres (AMCs) including AIIMS,
New Delhi had been set up under this Programme. To ensure
implementation of this programme in a more effective way, the
National Coordinating Centre was then shifted from the All India
Institute of Medical Sciences (AIIMS), New Delhi to the Indian
Pharmacopoeia Commission (IPC), Ghaziabad, (U.P.) in April,
2011.

12. Thus, the Pharmacovigilance Program of India (PvPI) was
launched with a broad objective to safe guard the health of people
of India. Adverse drug Reactions (ADRs) are reported from all
over the country to NCC-PvPI, which also work in collaboration
with the global ADR monitoring centre (WHO-UMC), Sweden to
contribute in the global ADRs data base. NCC-PvPI monitors the
ADRs among Indian population and helps the regulatory authority
of India (CDSCO) in taking decision for safe use of medicines.
PURPOSE
The purpose of the PvPI is to collate data, analyze it and use the
inferences to recommend informed regulatory interventions,
besides communicating risks to healthcare professionals and the
public. The broadened patient safety scope of pharmacovigilance
includes the detection of medicines of substandard quality as well
as prescribing, dispensing and administration errors.
Counterfeiting, antimicrobial resistance, and the need for real time
surveillance in mass vaccinations are other pharmacovigilance
challenges which need to be addressed.
REPORTING
To report suspected ADRs, filled ADR form can be sent to the
nearest monitoring centre.
The form for ADR reporting is available on the site of PvPI
( http://www.ipc.gov.in/PvPI/pv_adr.html ).

13. Adverse drug reaction Type of drug Examples
Anemia (resulting from
decreased production or
increased destruction of red
blood cells)
Certain antibiotics Chloramphenicol
Angioedema (swelling of the
lips, tongue, and throat causing
difficulty breathing)
ACE inhibitors Captopril , Enalapril
Bone fractures Bone fractures Esomeprazole,Lansoprazole
Confusion and drowsiness Sedatives, including many
antihistamines
Diphenhydramine
Decreased production of white
blood cells, with increased risk
of infection
Certain antipsychotic drugs Clozapine
Kidney damage NSAIDs (repeated use of
excessive doses)
Ibuprofen,Ketoprofen
Liver damage Some analgesics Acetaminophen (use of
excessive doses)
Muscle tissue destruction
(rhabdomyolysis)
Statins Atorvastatin
Stomach or intestinal ulcers
(with or without bleeding)
NSAIDs Aspirin
Toxic epidermal necrolysis
(see Stevens-Johnson
Syndrome (SJS) and Toxic
Epidermal Necrolysis)
Some antibiotics Penicillins
Blood clots Birth control drugs (all forms
including patches and pills)
Drospirenone/ethinyl
estradiol

14. CONCLUSION
The above detailed report is on the topic – Adverse Drug Reaction
which is basically the bad reactions caused due to consumption of drugs
(mostly allopathy). Also, we have understood that Ayurvedic &
Homeopathic medicines are far better than Allopathic because the earlier
medicines have no side effects and it is so because Ayurvedic and
homeopathic medicines are left sided medicines which our human body
also accepts. However, Allopathic medicines are right sided and thus
cause ADR.
At this juncture it would be necessary to refer to thoughts of Dr B. M
Hegde penned by him in his book titled " Douglas C Wallace, a noted
American professor of genetics, in his classic, Mitochondria as Chi, in
the journal, Genetics (2008; 179: 727-735) has shown that all
reductionist chemical molecules used in our therapeutics being
dextrorotatory, while the body molecules are levorotatory, destroy body
cells. Whereas all the Eastern herbal drugs are accepted by the body as
food (they are also levorotatory) and help the system!"

15. SUMMARY
This report contains definitions, causes, facts, cures and reporting
procedures after ADEs. Also, Adverse Drug Reaction depends upon the
individual’s age and dosage taken. Some of the eye opening facts are
also mentioned. Many of us believe that there is a pill for every ill. This
concept is not only naïve but dangerous. While certainly there is no pill
for every ill, there is an illness following every pill. This concept can
easily be understood after reading this project/report. After completing
the report, we have understood that one of the leading causes of deaths
in the world is due to Adverse Drug Reaction.
“The Jem cannot be polished without friction, nor medicines
perfected without trials”.
- Chinese Proverb

16. BIBLIOGRAPHY
1. http://www.ipc.gov.in/PvPI/pv_home.html
2. http://www.wiredhealthresources.net/resources/NA/WHO-
FS_MedicinesSafetyAdverseReactions.pdf
3. http://icmr.nic.in/ijmr/2012/september/0907.pdf
4. http://www.msdmanuals.com/home/drugs/adverse-drug-
reactions/overview-of-adverse-drug-reactions
5. http://pubmedinfo.com/pdf/Full%20Book_Final.pdf
6. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1884428/
7. http://archive.ahrq.gov/research/findings/factsheets/errors-
safety/aderia/ade.html#Introduction
8. “Prophetic thoughts and articles on health & disease – body and
mind” by Dr. B. M. Hegde.