Applies to: All Newcastle Cosmetic Doctor clinical and administrative staff

1. Purpose

This policy establishes the procedures for identifying, assessing, documenting, and reporting adverse reactions related to topical products prescribed, dispensed, or recommended by Newcastle Cosmetic Doctor (NCD). It ensures timely clinical response, protects patient safety, and aligns with Australian pharmacovigilance, privacy, and clinical governance standards, as well as global safety monitoring systems such as WHO and FDA frameworks. ^{1 2 3 4}

2. Scope & Applicability

This SOP applies to all NCD staff involved in the prescribing, dispensing, recommendation, or follow-up of topical preparations — including prescription creams, compounded ointments, cosmeceuticals, and non-prescription skincare. It encompasses both minor irritation and severe hypersensitivity events, regardless of where the product was applied or purchased, when the brand or formula was recommended under NCD care. ^{2 3 5}

3. Definitions

An “adverse reaction” is any unexpected, unintended, or harmful response temporally associated with the use of a topical product, whether prescription or over-the-counter. Reactions are categorised by clinical severity as follows: • Mild: transient erythema, dryness, tingling, or peeling; self-limiting and expected. • Moderate: allergic contact dermatitis, persistent erythema, burning, pruritus, or swelling requiring medical review. • Severe: vesiculation, ulceration, chemical burns, secondary infection, or systemic involvement. All suspected product-related reactions must be documented and escalated according to this procedure. ^{6 7 9}

4. Clinical Recognition & Immediate Response

Clinicians must promptly recognise potential topical adverse reactions during consultations, telehealth reviews, or patient reports. For mild irritation, recommend cessation of the product, barrier repair measures, and review after 48–72 hours. Moderate reactions require in-person examination to assess for allergic or irritant dermatitis and may involve topical corticosteroids or antihistamines. Severe reactions necessitate immediate medical attention, wound care, and, if systemic symptoms occur, transfer to an acute facility. ^{3 6 8}

5. Documentation Requirements

All adverse reactions must be recorded in the patient’s clinical record, including product details (name, batch, expiry), time of onset, symptoms, severity, management provided, and photographic evidence where appropriate. Records are maintained under the patient’s file with reference to relevant progress notes and consent forms. Data privacy and retention follow the Australian Privacy Principles (APPs). ^{9 6 10}

6. Escalation & Reporting Pathway

For all moderate or severe reactions, notify the Responsible Medical Practitioner immediately. The RMP determines the requirement for TGA adverse event reporting and, if necessary, alerts the supplier or compounding pharmacy. All serious events (e.g., hospitalisation, infection, scarring) are documented in the NCD incident register and reviewed under NSQHS governance standards. ^{1 3 4 13}

7. Reporting to TGA & External Agencies

Suspected serious adverse reactions to prescription topical medicines or compounded products are reported through the TGA “Report a Problem” portal within 10 business days of identification. If the product is compounded, the compounding pharmacist must also be notified. Global reporting awareness includes WHO’s International Drug Monitoring Program, FDA MedWatch, and EMA EudraVigilance systems, which support international signal detection. ^{1 9 11 12}

8. Patient Follow-Up

Follow-up occurs within 2–7 days depending on reaction severity. Mild irritant responses are reviewed by phone or telehealth, while moderate or severe reactions require in-person assessment, wound evaluation, and photographic monitoring. Patients are counselled on future product avoidance and given written instructions; medical certificates and referrals are provided when required. ^{2 3 6}

9. Root Cause Analysis & Continuous Improvement

Each adverse reaction triggers an internal review to identify root causes such as incorrect product selection, labelling, compounding errors, or patient non-adherence. Lessons learned inform updates to protocols, patient education materials, and supplier vetting. Quarterly review meetings evaluate trends in adverse events and implement risk mitigation strategies. ^{13 3 13}

10. Privacy, Data Protection & Record Retention

All adverse event reports and follow-up records are securely stored for at least seven years in compliance with OAIC and NSW Health requirements. Access is limited to authorised clinicians and auditors; any use of de-identified data for education or quality improvement requires explicit patient consent. ^{5 4 14}

11. Staff Training & Competency

All clinical and administrative staff receive annual training on recognising dermatologic adverse reactions, documenting clinical findings, and completing TGA and internal reporting forms. Training incorporates case simulations and updates from relevant NSQHS and TGA advisories. ^{1 3 8}

12. Review & Audit

This SOP is reviewed annually or following major legislative updates or serious adverse incidents. Audit results, staff feedback, and TGA safety bulletins guide revisions to ensure continual alignment with best-practice pharmacovigilance standards. ^{1 3 9}

Sources

1. Therapeutic Goods Administration (TGA), Reporting adverse events – Therapeutic goods., viewed 24 October 2025, https://www.tga.gov.au/reporting-problems ↩
2. AHPRA / Medical Board of Australia, Guidelines for practitioners who perform cosmetic procedures (2025)., viewed 24 October 2025, https://www.medicalboard.gov.au/ ↩
3. NSQHS Standards – Recognising and Responding to Acute Deterioration (Standard 8)., NSQHS Standards – Recognising and Responding to Acute Deterioration (Standard 8)., viewed 24 October 2025, https://www.safetyandquality.gov.au/ ↩
4. NSW Health, Adverse Event Reporting and Management Policy., viewed 24 October 2025, https://www.health.nsw.gov.au/ ↩
5. Office of the Australian Information Commissioner (OAIC), Guide to health privacy for health service providers., viewed 24 October 2025, https://www.oaic.gov.au/privacy/your-privacy-rights/health-and-medical-research/guide-to-health-privacy ↩
6. Therapeutic Guidelines: Dermatology – Management of cutaneous drug reactions., Therapeutic Guidelines: Dermatology – Management of cutaneous drug reactions., viewed 24 October 2025, https://tgldcdp.tg.org.au/ ↩
7. Australian Medicines Handbook (AMH), Dermatology: topical agents, adverse effects, and interactions., viewed 24 October 2025, https://amhonline-amh-net-au/ ↩
8. RACGP, Clinical governance and incident management in general practice., viewed 24 October 2025, https://www.racgp.org.au/ ↩
9. WHO, Safety Monitoring of Medicinal Products – Guidelines for Setting Up a Pharmacovigilance Centre., viewed 24 October 2025, https://www.who.int/publications ↩
10. FDA, MedWatch: The FDA Safety Information and Adverse Event Reporting Program., viewed 24 October 2025, https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program ↩
11. EMA, EudraVigilance – European adverse drug reaction reporting system., viewed 24 October 2025, https://www.ema.europa.eu/en/human-regulatory/research-development/pharmacovigilance/eudravigilance ↩
12. NSW Health, Poisons and Therapeutic Goods Regulation – Pharmaceutical Services., viewed 24 October 2025, https://www.health.nsw.gov.au/pharmaceutical/Pages/default.aspx ↩
13. ACSQHC, Standard 4: Medication Safety and adverse event management., viewed 24 October 2025, https://www.safetyandquality.gov.au/standards/nsqhs-standards/medication-safety-standard ↩
14. WHO, Global Manual on Adverse Event Detection and Management (2022)., viewed 24 October 2025, https://www.who.int/publications ↩
15. CDC, Clinical guidance on management of allergic and dermatologic reactions., viewed 24 October 2025, https://www.cdc.gov/ ↩