Asia-Pacific Roundup: TGA seeks feedback to reduce paracetamol poisoning

Australia’s Therapeutic Goods Administration (TGA) is holding a consultation into ways to reduce the risk of paracetamol poisoning, based on and independent review that found “a concerning increase of misuse in the community.”
 
TGA commissioned the report in response to the rising prevalence of intentional paracetamol poisoning, especially among young people, involving paracetamol purchased without the oversight of a pharmacist in supermarkets and convenience stores.
 
Recommendations based on the expert panel’s findings include reducing the size of packs of paracetamol sold in supermarkets and convenience stores, limiting purchases to one or two packs at a time,  and making modified-release paracetamol prescription-only.
 
“In Australia, unlimited numbers of packs of paracetamol can be purchased without a prescription at pharmacies or supermarkets, with 96 or 100 tablet packs and 20 tablet packs, respectively, being the most commonly purchased through these channels. Many countries, including the EU, UK, and New Zealand have introduced some restrictions to target the problem. Our literature review noted that reduction in pack size has been found to reduce deaths from poisonings by about a third, although effects may be less for non-lethal outcomes,” the experts wrote.
 
TGA and the delegate of the Secretary of the Department of Health and Aged Care are seeking feedback on those recommendations, as well as limiting paracetamol packaging to blister or strip packs, thereby preventing the impulsive attempts to self-poison, and on placing the products behind the counter.
 
The consultation notes that at this stage, neither TGA nor the delegate have formed a view on which options to implement. They will decide on a path forward after the public consultation, which ends on 14 October, and a meeting of the Advisory Committees on Medicines Scheduling that is set to take place in November.
 
TGA Consultation, Review Recommendations
 
India updates National List of Essential Medicines, adding 34 drugs while deleting 26 others
 
India has updated its National List of Essential Medicines (NLEM) for the first time since 2015. The latest round of revisions saw officials remove 26 medicines while adding another 34, causing the number of products on the list to increase slightly to 384.
 
Building on the World Health Organization's development of an essential medicine template, India previously created a list tailored to its priority healthcare needs to promote the rational use of medicines, support safe and effective treatment and serve as a guiding document for state governments that prepare their own lists.
 
Officials made significant changes when creating the 2015 NLEM, adding 106 medicines and removing another 70. The new list features fewer changes to the list of products. As was the case in 2015, officials made the most changes to the list of anti-infective medicines, deleting nine products and adding 18. The changes mean the anti-infective section has grown from 69 medicines in 2011 to 109 in the latest NLEM.
 
Officials can remove anti-infective medicines from the list for all the same reasons as they remove other products, such as reports of serious safety concerns and reduced disease burden, and because the emergence of drug-resistant pathogens has rendered them ineffective. However, officials were advised to shy away from using that power in favor of other strategies to counter drug resistance.
 
“[The] majority of the experts opined that making such antimicrobial agents less available by removing them from the NLEM may in fact deprive the patients having serious bacterial infections of the beneficial effects of these drugs,” the report states. “Therefore, the committee opined that a strong antimicrobial stewardship program and continuous education to the prescribers/doctors would be a better and effective strategy rather than restricting their availability.”
 
The new list also includes structural changes, with officials merging four categories covering epilepsy, Parkinson’s disease, migraine and dementia into a single category called medicines for neurological disorders. There are now 27 categories, down from 30 in the 2015 edition.
 
NLEM 2022, CDSCO Report
 
TGA investigating potential contamination of sitagliptin with nitrosamine
 
TGA is investigating the potential contamination of sitagliptin medicines with “very low levels” of the nitrosamine impurity NTTP. To prevent a shortage, TGA is allowing the supply of products that exceed the acceptable intake limit of 37 ng per day.
 
Sitagliptin was originally sold in Australia by Merck under the brand name Januvia. However, the Australian Register of Therapeutic Goods now lists 106 entries featuring the ingredient from companies including Apotex, Sandoz, Sun Pharma and Teva Pharmaceutical. Australian sponsors have reported that some sitagliptin products exceed the intake limit.
 
In response, TGA, which calculates short-term exposure to NTTP levels of up to 246 ng per day does not pose a health concern, has temporarily removed the intake limit in the belief a shortage of the diabetes drug would be more damaging than the impurity. TGA has found exposure to up to 246 ng per day of NTTP until 31 May 2023 poses minimal additional cancer risk over lifetime exposure to the usual limit.
 
The agency is requiring sponsors to investigate the issue and to monitor and report NTTP levels while they address the presence of the impurity. TGA is also working with sponsors to improve manufacturing and testing processes with a view to ensuring sitagliptin medicines meet its quality standards.
 
TGA Notice
 
Months after posting version one, Malaysia’s MDA updates guide to re-registering medical devices
 
Malaysia’s Medical Device Authority (MDA) has published the second edition of its guideline for the re-registration of registered medical devices. MDA released the first edition of the text in June.
 
Most of the changes in the second edition are editorial in nature, altering the wording of the document without revising its messaging. However, MDA has also added some new content to the latest version, all of which relates to the second stage of the process in which companies apply to re-register medical devices via the online application system MeDC@St.
 
The authority has added a new line to a list of bullet points about stage two to clarify that the “applicant is not allowed to submit re-registration application concurrently with change notification application.”
 
The other addition affects a table about the re-registration requirements, which now features a section on pre-market clearance or approval. MDA states that “all application shall undergo conformity assessment via verification route for registered medical devices,” adding that companies need to notify it if a CE mark is removed.
 
MDA Guidance