Applies to: All Newcastle Cosmetic Doctor (NCD) clinical and administrative staff

1. Purpose

To standardise the creation, review, provision, and documentation of Patient Information Sheets (PIS) and written informed consent for all topical products—prescription and non‑prescription—supplied, prescribed or recommended by Newcastle Cosmetic Doctor (NCD). This SOP ensures patients receive accurate, comprehensible information to support shared decision‑making and meet Australian legal, ethical, and privacy obligations. ^{1 2 3}

2. Scope & Applicability

Applies to all clinicians and staff involved in patient education, dispensing or sale of topical creams, ointments, oils, enzymes, serums, sunscreens, and compounded formulations. It covers appointment‑based care and retail transactions where a clinician recommendation is made under the NCD banner. Injectables and surgical procedures are governed under separate consent policies. ^{1 4 4}

3. Legal & Ethical Framework

Informed consent is a continuous process requiring clear disclosure of indications, benefits, risks, alternatives, and costs, with opportunities for questions and withdrawal. NCD aligns with AHPRA’s cosmetic procedure guidance, NSQHS partnering and governance standards, NSW Health consent policy, and the Australian Privacy Principles for handling patient information. Advertising and claims within PIS must comply with AHPRA and ACCC to avoid misleading statements and non‑evidence‑based promises. ^{1 5 3 4 6 7 8}

4. Definitions

“Patient Information Sheet (PIS)” is a clinic‑approved written resource provided before or at prescribing/dispensing that outlines how to use a topical product, expected benefits, common and serious risks, precautions, and aftercare. “Written consent” is the signed acknowledgement that the patient has received and understood material risks, alternatives and costs and agrees to proceed; consent is valid only if voluntary, informed, and specific to the product and regimen. ^{3 6 9}

5. Developing Patient Information Sheets

PIS content must describe the product’s active ingredients and strengths, indication and expected timeframes for benefit, common side effects (e.g., irritation, peeling), serious risks (e.g., allergic contact dermatitis, chemical burn), contraindications (e.g., pregnancy for retinoids), interactions (e.g., with peels/laser), application instructions, storage, and red‑flag symptoms. Where a product is a therapeutic good, PIS should align with TGA CMI or Product Information where available; for compounded items, align with the prescriber’s instructions and compounding pharmacy documentation. ^{10 11 1 8}

6. Readability, Accessibility & Translations

PIS must use plain language, short sentences, and active voice; avoid jargon and define necessary medical terms. Layout should prioritise headings and sequenced instructions; consider large print upon request. For non‑English speakers, provide translated PIS or certified interpreter support, ensuring the English master remains the reference document and translations are version‑controlled for equivalence. ^{3 12 13 14}

7. The Consent Process

Consent begins with discussion and provision of the PIS, followed by teach‑back to confirm understanding of key points (indication, risks, alternatives, cost). Patients must be given time to consider information and ask questions; for cosmetic indications, apply any relevant cooling‑off expectations in line with AHPRA guidance. Consent is documented via signature (paper or secure digital) and linked to the clinical note; repeat consent is obtained when the regimen or risk profile changes. ^{1 3 6 7}

8. Special Populations & Safeguards

For patients with limited health literacy, language barriers, or cognitive impairment, additional safeguards such as interpreter services, carer involvement, or simplified summaries are used. Pregnancy and breastfeeding require explicit risk counselling for retinoids and other contraindicated actives; minors require parental consent consistent with jurisdictional rules. Document the rationale for capacity assessment and any accommodations provided. ^{3 6 7}

9. Photography, Data & Privacy

Where photographs are used for monitoring, obtain a separate photo consent specifying clinical use, storage, and any de‑identification for teaching. Marketing use requires separate explicit consent and must avoid testimonials per AHPRA rules; store images and consent forms securely with role‑based access and audit trails according to the Australian Privacy Principles. ^{2 5 4}

10. Documentation & Record Retention

Link the signed consent and PIS version to the clinical note, including batch/lot where relevant to traceability. Retention of consent records must meet Australian Privacy Principles and local health record requirements; maintain for at least seven years or longer for minors, consistent with jurisdictional policy. ^{5 6 4}

11. Provision, Version Control & Governance

Each PIS includes a version number, approval date, and next review date. Only the latest approved version is available to clinicians and patients; superseded versions are archived. A governance lead (Responsible Medical Practitioner or delegate) oversees updates for regulatory changes, new evidence, and readability improvements. ^{4 3 1}

12. Managing Adverse Reactions & Escalation Instructions

PIS must clearly state expected transient effects versus warning signs that require cessation and urgent review (e.g., blistering, severe swelling, infection). Patients receive daytime and after‑hours contact details and instructions for care while awaiting assessment. Moderate‑to‑severe reactions are documented and, where indicated, reported to the TGA; this SOP cross‑references the NCD Adverse Reactions and Follow‑Up SOP. ^{1 3 9}

13. Advertising Compliance Within PIS

PIS language must avoid therapeutic claims for cosmetic products and must not include testimonials. Where a product is therapeutic, claims must reflect approved indications and evidence; statements about outcomes must be balanced and not guarantee results. All PIS content is reviewed against AHPRA advertising rules and ACCC consumer law to prevent misleading or deceptive conduct. ^{2 10 1}

14. Training & Competency

All staff involved in consent and patient education complete induction and annual refreshers on shared decision‑making, health literacy principles, interpreter use, and documentation standards. Competency is confirmed by direct observation and periodic audits of records. ^{3 4 7}

15. Audit, Review & Continuous Improvement

Quarterly audits sample consent forms and PIS distribution to verify version control, completeness, and patient understanding (via teach‑back documentation). Findings inform targeted training and content revisions; annual review incorporates regulatory updates and consumer feedback. ^{3 4 1}

Sources

1. Medical Board of Australia / AHPRA, Guidelines for practitioners who perform cosmetic procedures (2025)., viewed 24 October 2025, https://www.medicalboard.gov.au/ ↩
2. AHPRA, Advertising a regulated health service – Guidelines (2024)., viewed 24 October 2025, https://www.ahpra.gov.au/Resources/Advertising-hub/Advertising-guidelines-and-other-guidance/Advertising-guidelines.aspx ↩
3. ACSQHC, NSQHS Standard 2: Partnering with Consumers (shared decision-making, health literacy)., viewed 24 October 2025, https://www.safetyandquality.gov.au/standards/nsqhs-standards/partnering-consumers-standard ↩
4. ACSQHC, NSQHS Standards – Clinical Governance (Std 1) & Medication Safety (Std 4)., viewed 24 October 2025, https://www.safetyandquality.gov.au/ ↩
5. OAIC, Australian Privacy Principles – 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. NSW Health, Consent to Medical and Healthcare Treatment – Policy and Guidelines., viewed 24 October 2025, https://www.health.nsw.gov.au/policies/ ↩
7. RACGP, Informed consent in general practice and documentation guidance., viewed 24 October 2025, https://www.racgp.org.au/ ↩
8. NSW Health, Poisons and Therapeutic Goods – Pharmaceutical Services (prescribing/dispensing records)., viewed 24 October 2025, https://www.health.nsw.gov.au/pharmaceutical/Pages/default.aspx ↩
9. Therapeutic Goods Administration (TGA), Consumer medicine information (CMI) & labelling guidance., viewed 24 October 2025, https://www.tga.gov.au ↩
10. ACCC, Australian Consumer Law – Misleading claims and consumer guarantees for health products., viewed 24 October 2025, https://www.accc.gov.au/ ↩
11. WHO, Ethics and informed consent in health care – patient information standards., viewed 24 October 2025, https://www.who.int/publications ↩
12. EMA, Guideline on the readability of the label and package leaflet of medicinal products for human use., viewed 24 October 2025, https://www.ema.europa.eu/en ↩
13. FDA, Patient labeling and Medication Guides – Guidance for Industry., viewed 24 October 2025, https://www.fda.gov/ ↩
14. NHMRC, National Statement on Ethical Conduct in Human Research (for consent principles reference)., viewed 24 October 2025, https://www.nhmrc.gov.au/ ↩
15. Therapeutic Guidelines / AMH, Dermatology – patient counselling points and precautions., viewed 24 October 2025, https://tgldcdp.tg.org.au/ ↩