Fill ADR FORM & perform causality assessment using Naranjo scale and WHO UMC method for following case Mr Sushant A Gupta, 30-years old male with 68 kg weight was diagnosed as a case of bacterial meningitis. He was started empirically with Inj Ceftriaxone 2 g IV OD and Inj Vancomycin 500 mg IV slowly in 30 minutes 6 hrly on 12.10.2015 at 9 AM. After 30 minutes of drug administration, he started developing fever with chills, urticaria, popular rash over face, abdomen and limbs and intense flushing. His blood pressure was 90/60 mm of Hg. Both the antibiotics were stopped and he was treated with Inj. Pheniramine 25 mg IM at 10 AM following which the reaction completely subsided at 2 PM on same day. At 5 PM on same day, the Inj Vancomycin was re-introduced to the patient. Same symptoms developed again within 1 hour and resolved 4 hrs after administration of Inj. Pheniramine 25 mg IM Note: • Inj Vancomycin o Brand Name: Vanzid o Manufacturer: SWACH Healthcare o Batch number: KKIL098 o Expiry date: Mar 2016 • Inj Ceftriaxone o Brand Name: Taximax o Manufacturer: Wedley Labs o Batch number: OPO659 o Expiry date: Dec 2016
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Naranjo scale causality assessment ADR form WHO UMC method vancomycin red man syndrome
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Naranjo ADR probability scale 10 questions scoring table filled example
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ADR Form & Causality Assessment - Mr. Sushant A. Gupta
PART 1: SUSPECTED ADVERSE DRUG REACTION (ADR) REPORTING FORM
| Field | Details |
|---|---|
| Patient Initials | S.A.G. |
| Patient Age | 30 years |
| Sex | Male |
| Weight | 68 kg |
| Date of ADR | 12.10.2015 |
| Time of ADR onset | ~9:30 AM (30 minutes after drug administration) |
| Indication for which drug was given | Bacterial Meningitis |
Suspected Drug(s)
| Drug 1 | Drug 2 | |
|---|---|---|
| Generic Name | Vancomycin | Ceftriaxone |
| Brand Name | Vanzid | Taximax |
| Manufacturer | SWACH Healthcare | Wedley Labs |
| Batch No. | KKIL098 | OPO659 |
| Expiry Date | March 2016 | December 2016 |
| Dose | 500 mg IV | 2 g IV |
| Frequency | 6 hourly | Once daily |
| Route | Intravenous (slow, 30 min) | Intravenous |
| Start Date | 12.10.2015, 9 AM | 12.10.2015, 9 AM |
| Stop Date | 12.10.2015, ~9:30 AM (stopped on ADR) | 12.10.2015, ~9:30 AM (stopped on ADR) |
Description of ADR
Nature of Reaction: Vancomycin Infusion Reaction (formerly "Red Man Syndrome") - Type A (augmented), non-immunological, infusion-rate dependent
Signs & Symptoms observed:
- Fever with chills
- Urticaria
- Papular rash over face, abdomen, and limbs
- Intense flushing
- Hypotension: BP 90/60 mmHg
Time of onset: 30 minutes after start of infusion (09:30 AM)
Dechallenge: Both drugs stopped at ~09:30 AM. Treated with Inj. Pheniramine 25 mg IM at 10 AM. Reaction completely subsided by 2 PM the same day.
Rechallenge: At 5 PM on 12.10.2015, Inj. Vancomycin was re-introduced. Same symptoms reappeared within 1 hour and resolved 4 hours after Inj. Pheniramine 25 mg IM.
Concomitant Medication
| Drug | Dose | Route | Indication |
|---|---|---|---|
| Inj. Pheniramine | 25 mg | IM | Treatment of ADR (antihistamine) |
| Inj. Ceftriaxone | 2 g | IV OD | Bacterial meningitis |
Treatment Given for ADR
| Drug | Dose | Route | Time |
|---|---|---|---|
| Inj. Pheniramine (antihistamine) | 25 mg | IM | 10 AM, 12.10.2015 (1st episode) |
| Inj. Pheniramine (antihistamine) | 25 mg | IM | After rechallenge (2nd episode) |
Outcome of ADR:
- 1st episode: Completely recovered by 2 PM on 12.10.2015
- 2nd episode (after rechallenge): Recovered ~4 hours after Pheniramine administration
Reporter Details
| Field | Details |
|---|---|
| Causality Assessment (Naranjo) | See Part 2 |
| WHO-UMC Category | See Part 3 |
| Suspected Causative Drug | Inj. Vancomycin (Vanzid) |
PART 2: NARANJO CAUSALITY ASSESSMENT SCALE
Applied to Inj. Vancomycin (primary suspect drug - rechallenge confirmed)
| No. | Question | Yes | No | Do Not Know | Score Given | Justification |
|---|---|---|---|---|---|---|
| 1 | Are there previous conclusive reports on this reaction? | +1 | 0 | 0 | +1 | Red Man Syndrome (Vancomycin Infusion Reaction) is well-documented in literature |
| 2 | Did the adverse event appear after the suspected drug was administered? | +2 | -1 | 0 | +2 | Symptoms appeared within 30 min of vancomycin infusion |
| 3 | Did the adverse reaction improve when the drug was discontinued or a specific antagonist was administered? | +1 | 0 | 0 | +1 | Reaction subsided completely after stopping drug + Pheniramine (antihistamine) |
| 4 | Did the adverse event reappear when the drug was re-administered? | +2 | -1 | 0 | +2 | Yes - same symptoms returned within 1 hour of rechallenge at 5 PM |
| 5 | Are there alternative causes (other than the drug) that could on their own have caused the reaction? | -1 | +2 | 0 | -1 | Underlying meningitis could contribute to fever/flushing, so alternative cause cannot be excluded entirely |
| 6 | Did the reaction reappear when a placebo was given? | -1 | +1 | 0 | 0 | Not applicable / Do not know |
| 7 | Was the drug detected in blood (or other fluids) in concentrations known to be toxic? | +1 | 0 | 0 | 0 | Drug levels not measured / Do not know |
| 8 | Was the reaction more severe when the dose was increased or less severe when the dose was decreased? | +1 | 0 | 0 | 0 | Dose was not changed; same dose used on rechallenge / Do not know |
| 9 | Did the patient have a similar reaction to the same or similar drugs in any previous exposure? | +1 | 0 | 0 | 0 | No prior history mentioned / Do not know |
| 10 | Was the adverse event confirmed by any objective evidence? | +1 | 0 | 0 | +1 | Clinically documented: urticaria, rash, hypotension (BP 90/60), flushing - directly observed |
Naranjo Total Score: +6
| Score Range | Category |
|---|---|
| ≥ 9 | Definite |
| 5 - 8 | Probable |
| 1 - 4 | Possible |
| ≤ 0 | Doubtful |
Naranjo Verdict: PROBABLE ADR (Score = 6) The reaction is likely caused by Vancomycin. The positive dechallenge and positive rechallenge with the same drug (Q3, Q4) together with prior literature documentation (Q1) and temporal relationship (Q2) and objective confirmation (Q10) drive this score firmly into the "Probable" category.
PART 3: WHO-UMC CAUSALITY ASSESSMENT
Applied to Inj. Vancomycin (Vanzid)
WHO-UMC Criteria Checklist
| Criterion | Present? | Evidence |
|---|---|---|
| Plausible time relationship between drug administration and adverse event | YES | Symptoms began within 30 minutes of infusion start |
| Improvement on dechallenge (drug stopped / antidote given) | YES | Reaction completely subsided by 2 PM after drug was stopped and Pheniramine given |
| Rechallenge positive (reaction reappeared on re-administration) | YES | Identical symptoms returned within 1 hour of re-introducing Vancomycin at 5 PM |
| Alternative causes reasonably excluded | PARTIAL | Underlying meningitis could account for fever; however, urticaria, rash, and flushing pattern are highly specific for Vancomycin infusion reaction |
| Pharmacologically plausible reaction | YES | Vancomycin infusion reaction is a well-known, rate-dependent histamine-release reaction (MRGPRX2-mediated mast cell degranulation) |
| No alternative explanation better explains the event | YES | Ceftriaxone was also stopped, but reaction recurred specifically on Vancomycin rechallenge - not ceftriaxone rechallenge |
WHO-UMC Category Definitions
| Category | Criteria |
|---|---|
| Certain | Plausible time relationship + improvement on dechallenge + positive rechallenge + no alternative explanation |
| Probable/Likely | Plausible time relationship + improvement on dechallenge + no alternative explanation + rechallenge not required |
| Possible | Plausible time relationship + could also be explained by disease or other drugs |
| Unlikely | Temporal relationship improbable + other explanation more plausible |
| Conditional/Unclassified | More data needed for proper assessment |
| Unassessable | Information insufficient to assess |
WHO-UMC Verdict: CERTAIN
Justification: All four hallmark criteria are met:
- Plausible temporal relationship - symptoms within 30 min of infusion
- Dechallenge positive - complete resolution after stopping drug + antihistamine
- Rechallenge positive - identical reaction confirmed when Vancomycin restarted at 5 PM
- Reaction is pharmacologically plausible (histamine-release mechanism) and specific to Vancomycin (not reproduced by Ceftriaxone alone)
The positive rechallenge (rarely available clinically) is the key feature that elevates this from "Probable" to "Certain" under WHO-UMC, even though the Naranjo scale scores it as "Probable" (score 6) because Naranjo Q5 on alternative causes slightly penalizes the score.
PART 4: SUMMARY & CLINICAL NOTES
| Parameter | Finding |
|---|---|
| ADR Identified | Vancomycin Infusion Reaction (Red Man Syndrome / VFS) |
| Causative Drug | Inj. Vancomycin 500 mg IV infused over 30 minutes |
| Precipitating Factor | Rapid infusion rate (500 mg in 30 min = too fast; recommended minimum 60 min; max rate 10 mg/min for doses >500 mg) |
| Mechanism | Non-immune, non-IgE-mediated histamine release from mast cells via MRGPRX2 receptor activation |
| Naranjo Score | 6 - PROBABLE |
| WHO-UMC Category | CERTAIN |
| ADR Severity | Moderate-Severe (hypotension, systemic symptoms, required treatment) |
| Preventability | Preventable - slower infusion rate (≥60 min) and/or pre-medication with antihistamine would have reduced risk |
| Management | Antihistamine (Pheniramine 25 mg IM) - effective; future doses should be infused over minimum 60-90 min with antihistamine premedication |
Note on discordance between Naranjo (Probable) and WHO-UMC (Certain): This is expected - Naranjo is an algorithmic scoring tool where Q5 (alternative causes) deducted 1 point due to underlying meningitis. WHO-UMC relies on global clinical assessment and weighs the positive rechallenge very heavily, appropriately classifying this as "Certain." Both assessments confirm Vancomycin as the causative agent.
1.Write a suitable PRESCRIPTION for patient suffering from STATUS ASTHMATICUS ? 2.What are different parts of prescription ? 3.What is the full form of Rx in medical term? 4.What is the impotance of AGE? Write prescription according to KD Tripathi Textbook of pharmacology
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KD Tripathi prescription writing parts superscription inscription transcription signatura age importance Rx full form
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Prescription for Status Asthmaticus & Prescription Writing (KD Tripathi)
QUESTION 3: Full Form of Rx
Rx is derived from the Latin word "Recipe" meaning "Take Thou" or "You take please" - it is a directive from the physician to the pharmacist/dispenser to prepare and dispense the prescribed medicines.
Other theories of origin:
- Symbol of the Eye of Horus (Egyptian symbol of health and healing)
- Symbolic appeal to the Roman god Jupiter (god of knowledge and healing) for the prescription's success
- (Ref: KD Tripathi, Essentials of Medical Pharmacology)
QUESTION 2: Different Parts of a Prescription
As per KD Tripathi, an ideal prescription consists of the following 8 parts:
| Part | Content |
|---|---|
| 1. Prescriber's Details | Name, qualifications, designation, institution/clinic address, contact number, registration number |
| 2. Date | Day on which the prescription is written |
| 3. Patient's Details | Name, Age, Sex, Weight, Address |
| 4. Superscription | The symbol Rx (Recipe - "Take Thou") - marks beginning of drug orders |
| 5. Inscription | Body of the prescription - names and amounts of: (a) Basis - chief active ingredient, (b) Adjuvants - secondary drugs assisting basis, (c) Corrigents - correct undesirable qualities, (d) Vehicle/Solvent/Excipient - suitable form of administration |
| 6. Subscription | Directions to the pharmacist for compounding and dispensing (quantity to be dispensed, number of doses, dosage form) |
| 7. Transcription / Signa / Signatura | Directions to the patient - dose, route, frequency, timing, duration of use |
| 8. Signature | Prescriber's signature with date (legal requirement) |
QUESTION 4: Importance of AGE in a Prescription
Age is a critical component of the superscription/patient details section. Its importance includes:
- Dose calculation - Pediatric doses differ markedly from adult doses (e.g., Young's formula, Clark's formula, mg/kg dosing). Elderly patients need dose reduction due to altered pharmacokinetics.
- Drug selection - Certain drugs are contraindicated at specific ages (e.g., tetracyclines in children <8 years, fluoroquinolones in growing children, NSAIDs in neonates).
- Pharmacokinetics - Absorption, distribution, metabolism, and excretion all vary with age. Neonates have immature liver enzymes; elderly have reduced renal clearance.
- Medico-legal significance - Age establishes legal context (consent, capacity, pediatric formulation need).
- Helps pharmacist verify appropriateness of prescribed doses.
- Risk assessment - Identifies age-related contraindications (e.g., aspirin in children - Reye's syndrome risk).
"Age should always be mentioned as drug dosage varies greatly with age" - KD Tripathi
QUESTION 1: Prescription for Status Asthmaticus
Clinical Note: Status asthmaticus is a severe, life-threatening asthma attack that does not respond to conventional bronchodilator therapy. It is a medical emergency requiring immediate hospitalization and IV drug therapy. The prescription below follows the KD Tripathi treatment protocol.
╔══════════════════════════════════════════════════════════════════╗
║ DR. A.K. SHARMA, MBBS, MD (Medicine) ║
║ Department of General Medicine ║
║ City Hospital, Mumbai - 400001 ║
║ Phone: 022-XXXXXXX Reg. No.: MCI/XXXX ║
╠══════════════════════════════════════════════════════════════════╣
║ Date: 21/07/2026 ║
║ Patient Name: Mr. XYZ Age: XX yrs Sex: M ║
║ Weight: XX kg Address: ________________ ║
║ Diagnosis: STATUS ASTHMATICUS ║
╠══════════════════════════════════════════════════════════════════╣
║ Rx ║
║ ║
║ EMERGENCY / IN-HOSPITAL MANAGEMENT ║
║ ║
║ 1. O₂ Inhalation ║
║ Via mask / nasal prongs at 4-6 L/min ║
║ Maintain SpO₂ > 92% ║
║ (Correct hypoxia - first priority) ║
║ ║
║ 2. Inj. Hydrocortisone (Solu-Cortef) 100-200 mg IV stat ║
║ Then 100 mg IV 6 hourly × 24 hours ║
║ (Fast-acting IV glucocorticoid - anti-inflammatory) ║
║ Switch to: Tab. Prednisolone 40-60 mg PO OD ║
║ for 5-7 days (taper and stop) ║
║ ║
║ 3. Salbutamol (Albuterol) Nebulization ║
║ 2.5-5 mg in 3 mL Normal Saline via nebulizer ║
║ Every 20 min × 3 doses (1st hour), then ║
║ Every 1-4 hours as needed ║
║ (Short-acting β₂ agonist - bronchodilator) ║
║ ║
║ 4. Inj. Ipratropium Bromide (Atrovent) 0.5 mg nebulized ║
║ Combined with Salbutamol nebulization ║
║ Every 20 min × 3 doses, then every 4-6 hours ║
║ (Anticholinergic - additive bronchodilation) ║
║ ║
║ 5. Inj. Aminophylline 250 mg in 100 mL NS ║
║ Slow IV infusion over 20-30 min (loading dose) ║
║ Then 500-1000 mg in 500 mL D5W ║
║ IV infusion at 0.5 mg/kg/hr (maintenance) ║
║ Monitor for toxicity (nausea, palpitations, seizures) ║
║ (Methylxanthine - bronchodilator, respiratory stimulant) ║
║ ║
║ [If above measures fail - Refractory Status Asthmaticus:] ║
║ ║
║ 6. Inj. Magnesium Sulfate 2 g IV ║
║ In 50 mL NS over 20 minutes (single dose) ║
║ (Smooth muscle relaxant - bronchodilator) ║
║ ║
║ 7. Consider: Inj. Adrenaline (Epinephrine) ║
║ 0.3-0.5 mL of 1:1000 solution SC / IM ║
║ (For anaphylaxis-like refractory bronchospasm only) ║
║ ║
║ GENERAL MEASURES: ║
║ - IV Fluids: NS / RL to maintain hydration ║
║ - Arterial Blood Gas (ABG) monitoring ║
║ - Peak Expiratory Flow Rate (PEFR) monitoring ║
║ - Avoid sedatives, β-blockers, NSAIDs, aspirin ║
║ - ICU admission if PaCO₂ rising / SpO₂ falling ║
║ - Mechanical ventilation if respiratory failure develops ║
╠══════════════════════════════════════════════════════════════════╣
║ Signature: ________________ Date: 21/07/2026 ║
╚══════════════════════════════════════════════════════════════════╝
Pharmacological Rationale (as per KD Tripathi):
| Drug | Class | Mechanism | Role |
|---|---|---|---|
| O₂ | - | Corrects hypoxia | First priority; target SpO₂ >92% |
| Hydrocortisone IV | Glucocorticoid | Anti-inflammatory; reduces airway edema, mucus, and β₂ receptor downregulation | Cornerstone of status asthmaticus - acts in 6-24 hrs |
| Salbutamol nebulization | SABA (β₂ agonist) | Bronchodilation via β₂ receptor activation → ↑ cAMP → smooth muscle relaxation | First-line bronchodilator; rapid onset |
| Ipratropium bromide | Anticholinergic | Blocks muscarinic M₃ receptors → reduces bronchoconstriction | Additive bronchodilation with β₂ agonists in acute exacerbation |
| Aminophylline IV | Methylxanthine | Inhibits phosphodiesterase → ↑ cAMP; also antagonizes adenosine | Reserved for refractory cases; narrow therapeutic index |
| Magnesium sulfate IV | Mineral | Competes with Ca²⁺ at smooth muscle binding sites → bronchodilation | For β₂-agonist refractory cases |
| Adrenaline SC | Catecholamine | α + β agonist | Only if anaphylaxis component or extreme refractory cases |
Key Point from KD Tripathi: "In status asthmaticus, start with a rapidly acting IV glucocorticoid which generally acts in 6-24 hours - shift to oral therapy for 5-7 days, then discontinue or taper rapidly. Rescue treatment with short-acting inhaled β₂ agonist is essential."
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