Schedule 4 (S4) Medical Cosmetic Injectables

Transcription

1 Schedule 4 (S4) Medical Cosmetic Injectables A pilot compliance survey of service providers Lisa Mundy Environmental Health Officer Gold Coast Public Health Unit lisa.mundy@health.qld.gov.au

2 What are S4 cosmetic injectables? Cosmetic injectables contain Schedule 4 (S4) medicines or restricted drugs and can only be supplied or administered on written prescription. Queensland Health currently regulates activity relating to S4/restricted drugs under the provisions of the Health (Drugs & Poisons) Regulation distinct categories of S4 injectables Muscle relaxants Dermal fillers

3 Muscle relaxants and fillers S4 Muscle Relaxants S4 Fillers Restylane, Perlane, Dermalive, Botox (onabotulinumtoxin A) Dysport, (abobotulinum toxin A) Xeomin (incobotlinum toxin B) Myobloc (rimabotulinum toxin B) Juvederm, Esthelis, Fortellis, Princess, Radiess (hyaluronic acid) Hylaform, Hyalase (hyaluronan, sodium hyaluronate) Collagen Nufill, Sculptra (polylactic acid) Aquamid (polyacrylamide) $$$ Treatments are very expensive!

4 Why do consumers seek these services? Muscle relaxants - to relax existing frown lines and prevent formation of expression lines (e.g. forehead, eyes, nose, between eyebrows) Dermal Fillers - to plump or replace volume lost with age; to fill existing lines (e.g. lips, chin, cheeks, nasal folds, neck)

5 What can go wrong Reduced viability and effectiveness Infections Nerve damage Paralysis (e.g. part of face such as eyelid) Difficulty swallowing and speaking Disfigurement (temporary or permanent) Death (rare, often confounding factors)

6 What were we aiming to achieve? 1. Intelligence gathering Pilot project - Identifying any emerging public health risks associated with the industry practices around S4 cosmetic injectables Endorsements for S4/restricted drugs General S4/restricted drugs provisions Counterfeit S4/False description Infection control provisions Poisons/Scheduled Substances (general)

7 What were we aiming to achieve? 2. Enforcement Action for any non-compliance with QH legislation: Health (Drugs and Poisons) Regulation 1996; Health Act 1937 and also Chapter 4 of the Public Health Act 2005 Obtaining Possession Storage Administration Disposal

8 Endorsements for S4s in Queensland Doctors Obtain an S4 Possess an S4 at a place occupied by the Dr Dispense or prescribe the S4 to/for the person Supply or obtain the S4 for the person Administer an S4 OR Give someone who may administer (endorsed person) an oral or written instruction to administer (e.g. an RN under a standing order) Registered Nurses Cannot independently purchase, administer, store or prescribe S4s Can possess S4s at the place of nursing Can administer a dispensed S4 medicine OR under oral or written instruction of a Dr/authorised prescriber. Cosmetic nursing is not recognised under the Act and Regulation. Additional controls on endorsements for Ens (direct supervision)

9 Methodology Compiled a list of all service providers in Gold Coast jurisdiction Web searches/gumtree/facebook and covert calling (to determine if a Dr is onsite/dr or RN is administering) Developed an audit tool, enforcement guide and guidance note Risk assessment of businesses based on type (e.g. mobile, home, beauty salon, cosmetician/aesthetician clinics) Audits plus relevant seizure and enforcement action Referral of issues/trends to QH policy units or other agencies (e.g. TGA, AHPRA, OHO, interstate regulatory agencies) Exclusions Dentists; Medical practitioners (GP clinic)

10 Results 18 Service Providers audited late 2014/ early 2015 All S4 stock was imprest No dispensed medicines were being administered Some good news All legitimate suppliers, TGA approved S4s All temp sensitive S4s received under cold chain

11 Results - obtaining, purchase and storage

12 Results storage/reconstitution matters

13 Results - Administration Clients from 11% (2) were not physically assessed by a Dr 22% of assessments by Drs were Tech based (e.g. skype/videoconference) All persons administering were endorsed 50% were RNs/50% were doctors One RN was administering S4 without the oral/written instruction of a DR Most were under standing orders No enrolled nurses were found administering

14 Main issues identified Administration Lack of physical/clinical assessment by doctors prior to prescribing S4s (contrary to Medical Board Code of Conduct) RNs administering S4s in the absence of an oral or written instruction (without a standing order) Reconstitution and cold chain (2-8 O C) Muscle relaxant S4 storage conditions Timeframes and cold chain temperature monitoring for temperature sensitive S4s

15 Main issues identified (cont.) Prescribing, obtaining and purchase orders Unauthorised persons obtaining S4s Suppliers/wholesalers not checking that the person ordering is endorsed to obtain S4s (inadequate CAVP) Accessibility Access to S4s by non-endorsed persons (e.g. beauticians) Mobile/independent businesses Exponential growth in the industry of mobile businesses or service providers with Dr/RN working independently High use of technology based consults for cosmetic injectables Poses a plethora of issues around storage, reconstitution, infection control

16 Enforcement actions Warning letters or compliance notices issued to all 18 surveyed service providers 1 subsequent interview and investigation with an RN and the prescribing Dr No seizures of S4 medicines or other scheduled drugs and poisons were necessitated

17 General findings No national governance over cosmetic medical services Expanding industry with widening demographic audiences (online, social media, coupon websites) Cosmetic nursing claimed as a quality benchmark PBS medical use of muscle relaxants is expanding Advertising of Schedule 4 medicines No unlawful sale of S4 medicines uncovered

18 General Findings Infection control 7 practices required to have ICMP, only 6 had one. Unregulated practices (not covered by ICPAS) Contemporary practices have arisen requiring further attention e.g. vampire facials (above) Various other potential HRPAS were noted (dermal rolling/skin needling) No concerns regarding scheduled poisons (e.g. S2/S3/S4 topical anaesthesia) The cosmetic/beauty industry is extremely complex!!

19 Project outcomes Potential policy amendments Advocacy for the results to potentially inform new and existing legislative amendments including: consider incorporating minimum standards or a system of registration for administering RNs to ensure ethical outcomes provisions relating to temperature control of drugs and poisons outside of dispensaries Recommend alignment of national and state legislation, practice standards and frameworks Review and streamline referral pathways between agencies

20 Project Outcomes cont. Industry/Regulator/Stakeholder communication Increased industry awareness of legislative obligations Increased enquiries from service providers to GCPHU Fact sheet/communique - prepared for industry to field the growing number of enquiries from new and existing cosmetic injectable businesses - Prepared for future publication as a public health alert in association with media/social media release

21 Key project successes Audit documents developed to cover the Regulation, Act, Public Health Act 2005 and other relevant state/national legislation(tga/ahpra) Educating EHOs in contemporary application of legislation Uncovered key trends/systemic non-compliances in the medical cosmetic injectable industry Developed educational material to inform consumers /industry Identified recommended amendments to legislation Identified lack of national legislative governance or accreditation for the cosmetic industry.

22 Thanks! Any questions???