‘Unexplained pharmaceuticals’ found in complementary and alternative medicines

The research found two ‘clear cases’ of pharmaceutical adulteration, including a combination of paracetamol and chlorpheniramine in one product, and trace amounts of buclizine, a drug no longer in use in Australia, in another.
 
Overall, 5% of the samples contained undeclared pharmaceuticals such as caffeine, synephrine or ephedrine that were not included on the label.  
 
The vast majority of these products (85%) were listed on the Australian Register of Therapeutic Goods (ARTG), meaning they should have been assessed for safety and quality, and only allowed to contain approved ingredients.
 
Dr Evan Ackermann, immediate past Chair of the RACGP Expert Committee – Quality Care (REC–QC), told newsGP current regulatory arrangements for complementary and alternative medicines (CAMs) have failed ‘repeatedly’ and post-marketing surveillance is inadequate.
 
‘The current TGA [Therapeutic Goods Administration] approach to these listed medicines is simply a perfunctory policy approach to patient safety, a real abrogation of responsibilities by government and TGA to protect patients,’ he said.
 
‘This report … details a number of instances where product content could cause safety problems, such as nut allergy.’
 
A spokesperson told newsGP the TGA ‘welcomes’ the research and that it will help inform the Government’s ongoing evaluation of the way it regulates complementary medicines.
 
‘The Authority takes a risk-based approach to regulation, with different levels of risks for different products,’ they said.
 
‘The TGA Regulatory Investigation and Enforcement Section investigates alleged contraventions of the [Therapeutic Goods] Act and works closely with counterparts in state and territory health to undertake compliance and enforcement activities.’
 
One quarter of contaminated products contained animal DNA, including from rats, dogs, goats and pigs, while traces of frog and the Asian Highland Shrew were found in a ‘slimming’ and ‘detox’ tea.
 
Neem oil – which, according to the researchers can poison children and cause vomiting, metabolic acidosis and toxic encephalopathy – was also discovered.
 
The researchers suggested contamination from commonly domesticated animals could be inadvertent and due to manufacturing deficiencies or transportation, but others, such as reindeer DNA in a supplement powder for ‘general wellbeing’ were more difficult to explain.
 
The testing results led the authors to call for stronger pre-market evaluation of CAMs, using the toxicological screening and DNA sequencing techniques outlined in the study, a recommendation Dr Ackermann supports.
 
‘More has to be done to ensure the quality of products beforehand and to take action against the companies involved for abusing the system,’ he said.
 
‘This is now a multi-billion dollar market in Australia. It is time to start improving the standards for these “listed” medications to the same standards as “registered” medication.’
 
The TGA responded to questions regarding potential pre-market authorisation by stating CAMs manufacturers have a number of matters for which ‘compliance is expected’ and may be the subject of further assessment. 
 
‘These include pre-approval and inspections for compliance with the requirements for good manufacturing principles, usage of pre-approved low-risk ingredients, and being subject to a program of desktop random and targeted post-market compliance reviews, including laboratory testing of products, as well as reviews activated by safety signals such as adverse event reports,’ the spokesperson said.
 
There are approximately 12,000 medicines listed on the ARTG at any one time, with more than 1000 added each year.
 
In 2017–18, the TGA conducted 243 post-marketing compliance reviews, of which only 42 were found to have no compliance breach.

complementary medicines pharmacy research Therapeutic Goods Administration