KVV E-Modules - Introduction to Adverse Drug Reaction Reporting

Quadrant -I (Video)

Quadrant 1: Introduction to Adverse Drug Reaction Reporting- Dr. Anjali Ravindra Shinde

Quadrant 1: Introduction to adverse drug reaction reporting- Dr. Sujata Abhay Jadhav

Quadrant 1: Drug abuse- Ajish Gopinath Mangot

Quadrant 1: Drug abuse- Siddhant Mahapatra

Quadrant 1: Legal ethical professional implications of drug abuse- Dr. Hemanth Kumar R G

Quadrant - II (Study Material)

1. Quadrant 2: Introduction to Adverse Drug Reaction Reporting- Dr. Anjali Ravindra Shinde

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2. Quadrant 2: Introduction to adverse drug reaction reporting- Dr. Sujata Abhay Jadhav

Additional study material Book reference- S.K.Srivastava: 'Pharmacology for MBBS' ; Avichal Publishing Company. Title - 'Commonly Abused Drugs.

3. Quadrant 2: Drug abuse- Ajish Gopinath Mangot

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4. Quadrant 2: Drug abuse- Ajish Gopinath Mangot

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5. Quadrant 2: Drug abuse- Ajish Gopinath Mangot

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6. Quadrant 2: Drug abuse- Ajish Gopinath Mangot

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7. Quadrant 2: Drug abuse- Ajish Gopinath Mangot

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8. Quadrant 2: Drug abuse- Ajish Gopinath Mangot

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9. Quadrant 2: Drug abuse- Ajish Gopinath Mangot

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10. Quadrant 2: Drug abuse- Ajish Gopinath Mangot

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11. Quadrant 2: Drug abuse- Ajish Gopinath Mangot

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12. Quadrant 2: Drug abuse- Ajish Gopinath Mangot

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13. Quadrant 2: Drug abuse- Ajish Gopinath Mangot

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14. Quadrant 2: Drug abuse- Ajish Gopinath Mangot

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15. Quadrant 2: Drug abuse- Siddhant Mahapatra

16. Quadrant 2: Drug abuse- Siddhant Mahapatra

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17. Quadrant 2: Drug abuse- Siddhant Mahapatra

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18. Quadrant 2: Legal ethical professional implications of drug abuse- Dr. Hemanth Kumar R G

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Quadrant - III (Assignments)

1. Quadrant 3: Introduction to Adverse Drug Reaction Reporting- Dr. Anjali Ravindra Shinde

Assignments- ADR

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2. Quadrant 3: Introduction to adverse drug reaction reporting- Dr. Sujata Abhay Jadhav

Assignments

3. Quadrant 3: Drug abuse- Dr. Ajish Gopinath Mangot

Drug abuse

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4. Quadrant 3: Drug abuse- Siddhant Mahapatra

Drug abuse

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5. Quadrant 3: Legal ethical professional implications of drug abuse- Dr. Hemanth Kumar R G

Additional study material- . ICMR National Ethical Guidelines (Relevant Sections) (PDF) For research ethics involving vulnerable populations. https://ethics.ncdirindia.org/asset/pdf/ICMR_National_Ethical_Guidelines.pdf

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Quadrant - IV (MCQs)

What does ADR stand for in the context of drug safety?

A: Adverse Drug Reaction B: Advanced Drug Report C: Applied Drug Research D: Active Drug Review

What should be done if an ADR is suspected?

A: Ignore it if it seems minor B: Report it to a pharmacovigilance authority C: Wait for further symptoms to develop D: Discontinue the medication without reporting

Which of the following is a common example of an ADR?

A: Imroved health after medication B: A decrease in blood pressure C: Rash or itching after taking a medication D: Increased energy levels

What does a 'black box warning' on a drug label indicate?

A: The drug is approved for over-the-counter use B: The drug has been recalled C: There are serious or life-threatening ADRs associated with the drug D: The drug is safe for use during pregnancy

What is the primary method used to collect data on ADRs from the general public?

A: Randomized controlled trials B: Post-marketing surveillance C: Laboratory tests D: Clinical case studies

What is a 'Signal' in pharmacovigilance?

A: A known ADR B: An indication that a new drug is effective C: Information suggesting a new or previously unrecognized safety issue D: A routine safety check

Which term describes ADRs that occur due to a drug’s long-term use?

A: Acute ADRs B: Chronic ADRs C: Idiosyncratic ADRs D: Immediate ADRs

Which of the following is a key objective of pharmacovigilance?

A: To maximize profits from drug sales B: To ensure all drugs are completely free of risks C: To detect and assess risks associated with drug use to improve patient safety D: To reduce drug approval times

What is addiction primarily categorized as?

A: A psychological disorder B: A neurological disorder affecting the brain's reward system C: A physical illness D: A behavioral problem

A 45-year-old man is brought to the emergency department with slurred speech, unsteady gait, and vomiting after heavy alcohol intake. …

A: Emotional lability B: Hyperglycaemia C: Airway compromise D: Poor coordination

A chronic alcohol user presents with withdrawal and confusion. Which intervention is specifically intended to prevent a serious neurological complication?

A: IV fluids alone B: Low-dose antipsychotics C: Thiamine administration D: Activated charcoal

A patient undergoing alcohol withdrawal requires the closest monitoring during which period due to risk of seizures and delirium tremens?

A: Within 6–8 hours B: Within 2–3 days C: Day 5–7 D: After 2 weeks

A patient with hepatic dysfunction is admitted for alcohol withdrawal. Which medication is to be preferred for management?

A: Lorazepam B: Diazepam C: Chlordiazepoxide D: Any of the above

A 28-year-old man is found unconscious with shallow breathing and pinpoint pupils. Which substance intoxication is most likely?

A: Alcohol B: Cannabis C: Nicotine D: Opioids

A known opioid-dependent patient presents with overdose. How should naloxone be initiated in this patient?

A: 0.04–0.1 mg IV B: 10 mg IV bolus B: 2 mg IM immediately D: Oral naloxone

Which medication is most preferred for treating opioid withdrawal?

A: Methadone B: Buprenorphine C: Naloxone D: Naltrexone

A patient reports recurrent episodes of severe vomiting relieved temporarily by hot showers. This presentation could be suggestive of:

A: Acute gastroenteritis B: Alcohol withdrawal C: Opioid withdrawal D: Cannabinoid hyperemesis syndrome

A patient planning smoking cessation is started on varenicline. According to recommended practice, it should be initiated:

A: At least 1 week before the quit date B: On the quit date C: After stopping nicotine completely D: Only after nicotine patch failure

A 45-year-old man is brought to the emergency department with slurred speech, unsteady gait, and vomiting after heavy alcohol intake. …

A: Emotional lability B: Hyperglycaemia C: Airway compromise D: Poor coordination

A chronic alcohol user presents with withdrawal and confusion. Which intervention is specifically intended to prevent a serious neurological complication?

A: IV fluids alone B: Low-dose antipsychotics C: Thiamine administration D: Activated charcoal

A patient undergoing alcohol withdrawal requires the closest monitoring during which period due to risk of seizures and delirium tremens?

A: Within 6–8 hours B: Within 2–3 days C: Day 5–7 D: After 2 weeks

A patient with hepatic dysfunction is admitted for alcohol withdrawal. Which medication is to be preferred for management?

A: Lorazepam B: Diazepam B: Chlordiazepoxide D: Any of the above

A 28-year-old man is found unconscious with shallow breathing and pinpoint pupils. Which substance intoxication is most likely?

B: Alcohol B: Cannabis C: Nicotine D: Opioids

A known opioid-dependent patient presents with overdose. How should naloxone be initiated in this patient?

A: 0.04–0.1 mg IV B: 10 mg IV bolus 2 mg IM immediately Oral naloxone C: 2 mg IM immediately C: Oral naloxone

Which medication is most preferred for treating opioid withdrawal?

A: Methadone B: Buprenorphine C: Naloxone D: Naltrexone

A 24-year-old man reports irritability, anxiety, insomnia, vivid dreams, and tremors starting 36 hours after stopping chronic use of cannabis. …

A: It is usually severe with medical complications B: It is typically mild with no medical complications C: Antipsychotics are preferred D: Long-term sedatives are recommended

A patient reports recurrent episodes of severe vomiting relieved temporarily by hot showers. This presentation could be suggestive of:

A: Acute gastroenteritis B: Alcohol withdrawal C: Opioid withdrawal D: Cannabinoid hyperemesis syndrome

A patient planning smoking cessation is started on varenicline. According to recommended practice, it should be initiated:

A: At least 1 week before the quit date B: On the quit date C: After stopping nicotine completely D: Only after nicotine patch failure

The backbone of India’s legal framework for drug control is:

A: Drugs and Cosmetics Act B: Indian Penal Code D: NDPS Act, 1985 D: Mental Healthcare Act

Under the NDPS Act, possession of drugs is punished based on:

A: Age of the offender B: Intention C: Quantity involved D: Type of institution

Which ethical principle is violated when a doctor under influence harms a patient?

A: Autonomy B: Beneficence C: Non-maleficence D: Justice

Reporting an intoxicated colleague is ethically justified primarily to protect:

A: Hospital reputation B: Legal safety C: Patient safety D: Personal image

Abuse of professional privilege leading to enhanced punishment under NDPS Act is covered under:

A: Section 8 B: Section 21 C: Section 32B D: Section 64A

Which of the following is a professional consequence of drug abuse in medical students?

A: Promotion B: Expulsion or suspension C: Increased confidence D: Improved academic performance

Ethical concern in research involving drug abusers mainly relates to:

A: Sample size B: Randomization C: Informed consent D: Publication bias

Doctors abusing drugs are ethically unacceptable mainly because they:

A: Break hospital rules B: Violate ethical principles C: Damage infrastructure D: Reduce workload

Which ethical pillar ensures fairness and equality in patient care?

A: Autonomy B: Beneficence C: Justice D: Confidentiality

Personal consumption of narcotic drugs is punishable under NDPS Act section:

A: Section 8 B: Section 21 C: Section 25 D: Section 27

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