PV Modules

Patient Safety Associates (PSAs) must manage certain high-priority, complex, or sensitive case types, as these situations have greater regulatory importance and require specialized documentation and follow-up.

Below are the key special scenarios, their definitions, required actions, and examples.

1. Pregnancy & Lactation Exposure

Why special?

• Risk to fetus/infant
• Limited data available
• Regulatory requirement for close monitoring

When reported?

• Drug exposure before conception, during pregnancy, or during breastfeeding

PSA Responsibilities

• Capture trimester, maternal health, dose, duration
• Collect pregnancy outcome (live birth, miscarriage, stillbirth)
• Follow-up until outcome is known
• Complete pregnancy follow-up form

Examples

1. Woman takes isotretinoin during early pregnancy → potential teratogenic risk
2. A breastfeeding mother reports infant diarrhea after maternal antibiotic use

2. Paediatric & Geriatric Safety

Paediatrics

• Children have different PK/PD responses
• Higher vulnerability to dosing errors
• Off-label use is common

PSA Actions:

• Capture age in days/years
• Check for weight-based dosing
• Confirm off-label use

Geriatrics

• Polypharmacy
• Organ impairment → greater ADR risk

PSA Actions:

• Capture comorbidities
• Collect concomitant medications

Examples

• Child receives adult dose → excessive sedation
• Elderly patient develops severe bradycardia due to drug interactions

3. Overdose

Definition

Administration of a larger-than-recommended dose, intentional or accidental.

PSA Actions

• Identify dose taken vs. recommended dose
• Capture symptoms, treatment, and outcomes
• Determine if overdose was intentional (suicidal) or unintentional (accidental)

Examples

• Patient accidentally takes double dose of warfarin
• Intentional overdose of antidepressant reported as suicide attempt

4. Medication Errors

Types

• Prescribing error
• Dispensing error
• Administration error
• Monitoring error

PSA Responsibilities

• Identify stage of error
• Capture root cause (look-alike/sound-alike, wrong route, miscalculation)
• Determine whether AE occurred or not (both reportable)

Examples

• Wrong drug dispensed due to look-alike packaging
• Nurse administers IV drug intramuscularly

5. Off-Label Use

Definition

Use of a drug outside approved indication, dose, route, age group.

PSA Responsibilities

• Document indication and reason
• Assess seriousness and outcome
• Identify if off-label contributed to AE

Examples

• Antipsychotic used in children outside approved age
• Higher-than-approved dose leading to hypotension

6. Device-Related Events

Applies to:

• Drug-delivery devices (pens, inhalers, syringes)
• Combination products
• Medical devices included with drug kits

PSA Responsibilities

• Record device type, batch, lot number
• Capture malfunction details
• Determine user error vs. device failure

Examples

• Insulin pen malfunctions and delivers no dose
• Inhaler blocker causes improper drug delivery

7. Lack of Efficacy (LOE)

Definition

Drug does not produce the expected therapeutic effect.

Why special?

For some drugs (e.g., antibiotics, vaccines, antiepileptics), LOE can be life-threatening.

PSA Actions

• Verify indication, compliance, correct use
• Capture clinical condition before and after treatment
• Identify drug resistance (if applicable)

Examples

• Antibiotic fails to control infection → hospitalization
• Asthma inhaler ineffective due to poor technique

Summary Table

Special Scenario	Why Important?	Key Actions
Pregnancy/Lactation	Fetal/infant safety	Follow-up until outcome, detailed maternal history
Paediatric/Geriatric	High vulnerability	Check dosing, comorbidities, weight
Overdose	High risk	Dose comparison, intent, outcome
Medication Errors	Preventable harm	Identify stage + root cause
Off-label Use	Regulatory relevance	Document indication + AE link
Device-related Events	Device malfunction risk	Capture lot/batch + malfunction
Lack of Efficacy	May be life-threatening	Verify adherence, technique, resistance