schedule 4 (s4) medical cosmetic injectables
TRANSCRIPT
Gold Coast Public Health Unit
Schedule 4 (S4)
Medical Cosmetic Injectables
A pilot compliance survey of service
providers
Lisa Mundy
Environmental Health Officer
Gold Coast Public Health Unit
07 5667 3200
Gold Coast Public Health Unit
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 1996.
2 distinct categories of S4 injectables
• Muscle relaxants
• Dermal fillers
Gold Coast Public Health Unit
Muscle relaxants and fillersS4 Muscle Relaxants S4 Fillers
Botox (onabotulinumtoxin A)
Dysport, (abobotulinum toxin A)
Xeomin (incobotlinum toxin B)
Myobloc (rimabotulinum toxin B)
Restylane, Perlane, Dermalive,
Juvederm, Esthelis, Fortellis,
Princess, Radiess (hyaluronic acid)
Hylaform, Hyalase (hyaluronan,
sodium hyaluronate)
Collagen
Nufill, Sculptra (polylactic acid)
Aquamid (polyacrylamide)
$$$Treatments
are very
expensive!
Gold Coast Public Health Unit
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)
Gold Coast Public Health Unit
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)
Gold Coast Public Health Unit
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)
Gold Coast Public Health Unit
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
Gold Coast Public Health Unit
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)– https://www.legislation.qld.gov.au/view/html/inforce/current/sl-1996-0414#sec.161
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)– https://www.legislation.qld.gov.au/view/html/inforce/current/sl-1996-
0414#sec.175
– https://www.legislation.qld.gov.au/view/html/inforce/current/sl-1996-
0414#sec.162
Gold Coast Public Health Unit
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)
Gold Coast Public Health Unit
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
Gold Coast Public Health Unit
Results - obtaining, purchase and storage
Gold Coast Public Health Unit
Results – storage/reconstitution matters
Gold Coast Public Health Unit
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
Gold Coast Public Health Unit
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 (2-8OC)
– Muscle relaxant S4 storage conditions
– Timeframes and cold chain temperature monitoring for
temperature sensitive S4s
Gold Coast Public Health Unit
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
Gold Coast Public Health Unit
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
Gold Coast Public Health Unit
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
Gold Coast Public Health Unit
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!!
Gold Coast Public Health Unit
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
Gold Coast Public Health Unit
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
Gold Coast Public Health Unit
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.
Gold Coast Public Health Unit
Thanks!
Any questions???