ADVERSE DRUG REACTIONS(ADR)

PREPARED BY,
DR.ARCHA MANOJ
CLINICAL PHARMACIST
 DEFENITION
Any noxious, unintended and undesired effect of a drug which occurs at a dose used in humans
for prophylactic, diagnostic or therapeutic purpose..

❑TYPE OF ADVERSE DRUG REACTIONS

TYPE OF REACTION DESCRIPTION
TYPE A (Augmented) Dose dependent
TYPE B (Bizarre) Non-dose dependent
TYPE C (Chronic) Dose-related and time- related
TYPE D (Delayed) Time- related
TYPE E (End of Use) Withdrawal
❑TYPE A (AUGMENTED):
• Reactions which can be predicted from the known pharmacology of the drug.
• Eg: NSAIDS and Peptic ulcer disease.
• Nitrates- Headache
• Beta blockers- Bradycardia
• Prazosin- Postural hypotension
• Anticoagulants- Bleeding

❑TYPE B (BIZARRE):
• Unpredictable, causing an allergic response.
• Eg: Penicillin and anaphylaxis
• Anticonvulsant- Hypersensitivity.

❑TYPE C (CHRONIC):
• Associated with long term use and involves dose accumulation.
• Eg: Antimalarials and ocular toxicity.
❑TYPE D (DELAYED):
•Occur some time after treatment has started,
•Eg: Leukopenia 6 weeks after lomustine.
• Antipsychotics- Tardive dyskinesia
• Analgesics- Nephropathy
• Chemotherapy- Secondary Tumors

❑TYPE E (END OF USE):

•Occur on withdrawal especially when drug is stopped abruptly.
•Eg: Phenytoin withdrawal– Seizures
• Steroid withdrawal– Adrenocortical insufficiency.
TYPES OF SCALES
•WHO-UMC CAUSALITY ASSESSMENT SCALE
•ADVERSE DRUG REACTION PROBABILITY SCALE (NARANJO)
•HARTWIG et al. SCALE
•PREVENTABILITY ASSESSMENT SCALE
•PREDICTABILITY SCALE
PREDICTIBILITY SCALE
•TYPE A (PREDICTABLE):
✓Often predictable and dose dependent
✓Responsible for at least 30% of ADRs.
✓Eg: Anticholinergics and dry mouth

•TYPE B (UNPREDICTABLE):
✓Rare and unpredictable
✓Eg: Chloramphenicol and aplastic anemia,
Penicillin induced anaphylactic shock.
PREVENTABILITY ASSESSMENT SCALE
Preventability of ADRs is assessed by using Schumock and Thornton scale.
•DEFINITELY PREVENTABLE:
1. Was there a history of allergy/ previous reactions to the drug?
2. Was the drug involved inappropriate for the patients clinical conditions?
3. Was the dose, route or frequency of administration inappropriate for the patients age,
weight or disease state?
4. Was a toxic serum drug concentration( or laboratory monitoring test) documented?
5. Was there a known treatment for the adverse drug reaction?
•PROBABLY PREVENTABLE:
1. Was required therapeutic drug monitoring/ other necessary laboratory test not performed?
2. Was a drug interaction involved in the ADR?
3. Was poor compliance involved in the ADR?
4. Were preventative measures not prescribed or administered to the patient?

•NOT PREVENTABLE:
If all above criteria not fulfilled.
COMMON CAUSES OF ADR
•Failing to take the correct dosage at the correct time.
•Overdosing
•Allergies to the chemical components of the medicine
•Combining the medicine with alcohol
•Taking other drugs or preparations that interact with the medicine
•Taking a medicine that was prescribed for others.
FACTORS AFFECTING ADR
PATIENT RELATED FACTORS:
•Age
•Sex
•Genetic factors
•Concurrent disease
•Compliance with dosing regimen
•Total number of medications
•Diet, smoking, environmental factors.
PREVENTION OF ADR
•Avoid all unappropriate use of drug.
•Appropriate use of dose, route and frequency of drug administration.
•Rule out possibility of drug interactions
•Adopt correct drug administration technique
•Carry out appropriate laboratory investigations
•Be aware about interactions with certain foods, alcohol.
COMMON ADVERSE DRUG REACTIONS IN HOSPITAL:
IDENTIFIED DRUGS/ CLASS IDENTIFIED ADRs
Amlodipine Peripheral edema
ACE Inhibitors Dry cough
Gabapentin Drowsiness
Ferrous supplement Constipation
Warfarin, Aspirin Bleeding
Beta blockers Bradycardia
Amitryptline Blurred vision and dryness of mouth
NSAIDS Gastritis
Atorvastatin Myopathy
Isosorbide mononitrate Headache
Theophylline Tachycardia, dyskinesia
Vancomycin Red man syndrome
Sulphonamide Steven Johnson’s syndrome
Rifampin Oranfe-red urine
Glucocorticoid Horseness of voice, osteoporosis

Valproate Thinning and curling of hair

Tetracycline Discoloration of teeth

Clofazemine Reddish black discoloration of skin

Aspirin Reye’s syndrome

Paracetamol, Isoniazid Hepatotoxicity

Amphotericin B Nephrotoxicity

Ceftriaxone, Ciprofloxacin, Fluconazole, Cefotaxime Itching

Ceftriaxone, Ringer lactate, paracetamol, cefixime Rashes

Timolol eye drops Redness of eye

Rhabdomyolysis Daptomycin
ADR REPORTED IN HOSPITAL
•INJ. CIPROFLOXACIN 400MG- ITCHING AT THE INJECTION SITE
•INJ. AMOXICILLIN 500MG- HIVES AND REDNESS
•INJ. LEVOFLOXACIN 500MG - REDNESS
•INJ. ACUCLAV 1.2GM - REDNESS
•TAB. GLYCIPHAGE G2- NEUROGLYCOPENIA
•TAB LEFRA 20MG - LEUKOPENIA
•TAB. ISODRIL 5MG -HEADACHE
•INJ. GLANCLAV 1.2GM - BLISTERS ON SITE OF INFECTION
•TAB.GLIMI 2MG AND TAB. GEMER 2MG- OHA INDUCED NEUROGLYCOPENIA
•INJ.VANLID 1GM - ITCHING AT THE SITE OF INFECTION
•INJ. CEFTRIAXONE 1GM- ITCHING
•INJ PANTOCID 40MG- ITCHING OVER THE BODY AND BREATHING DIFFICULTY
•TAB. LOSAR- HYPERKALEMIA
•TAB. THIAZIDE (AQUAZIDE)- HYPOKALEMIA
WHAT TO REPORT
•PvPI encourage all types of suspected ADRs
reporting whether they are known, unknown,
serious, or non- serious, frequent, or rare
regardless of an established causal relationship
between a drug and the reaction.
•ADRs related with the use of allopathic
medicines, vaccines, traditional medicines,
medical devices, contast media, etc. can be
reported.
WHO CAN REPORT ADR
•All healthcare professionals (physicians,
pharmacists, nurses) and patient/consumers can
report ADRs to NCC or AMCs.
•The pharmaceutical companies can also send
individual case safety reports for their product to
NCC.
WHOM TO REPORT
•A reporter can send filled ADR reporting form directly to NCC or their nearest AMC. In case of
AMC, these reports are confirmed by healthcare professionals and entered into vigiflow and
sent to NCC for further assessment. These reports are then finally reviewed at NCC and
committed to WHO-Uppasala Monitoring Centre. The obtained information is entered in the
drug safety databases, analysed and assessed by the experts to identify new signals.
•The submitted ADR report does not have any legal implication on the reporters. The patients
identity are held in strict confidencial and protected to the fullest extent.
•Therefore, healthcare providers are encouraged to report ADRs for better understanding of the
risk associated with the use of medicines and to safeguard the health of Indian population.
HOW TO REPORT
•Suspected ADR reporting forms for healthcare
professionals and consumers are available on
the website of IPC to report ADR.
•To remove language barrier in ADR reporting the
consumer reporting form made available in 10
vernacular languages (Hindi, Tamil, Telugu,
Kannada, Bengali, Gujarati, Assamese, Marathi,
Oriya, and Malayalam). ADRs can be also
reported via PvPI helpline number
(18001803024) on weekdays from 9.00am to
5.30 pm. The mobile android application for ADR
reporting also been made available to the public.
MANAGEMENT OF ADR:
•Discontinue the offending agent if:
•It can be safely stopped
•The event is life threatening/ intolerable
•There is a reasonable alternative
•Continuing the medication will further exacerbate the patients condition
•Administer appropriate treatments
•Provide supportive care.
PROCEDURES
•Monitor the patient closely for any adverse reactions.
•If any adverse reactions happened, discontinue the drug
immediately and inform the doctor.
•According to the condition drug may be discontinued,
stopped, decreased, dose along with anti- allergic drugs
administration.
•When suspected drug administration restarted and
adverse reaction occurs, stop the drug and consider the
ADR caused by the suspected drug.
•Suspected drug should be given in slow rate of infusion
and with proper monitoring.
THANK YOU