Asia-Pacific Roundup: New Zealand eyes removing pholcodine cough medicines from market

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is seeking feedback on whether pholcodine-containing medicines should be withdrawn from the market after regulators in Australia, the EU and UK have already done so over safety concerns.

New Zealand’s Medicines Adverse Reactions Committee (MARC) reviewed the safety and efficacy of pholcodine-containing medicines in December 2019. At that time, MARC concluded that there was too little evidence to indicate that the medicines should be withdrawn but recommended restrictions. New Zealand made pholcodine a pharmacist-only drug late last year.

Now, Medsafe is questioning whether tougher actions are needed in light of a study published in the British Journal of Anaesthesia in March. The study found patients exposed to pholcodine in the year before receiving neuromuscular blocking anesthesia agents were more likely to experience anaphylaxis.

The European Medicines Agency requested the postmarketing study during a 2011 review of pholcodine and was the first to act in response to the data, recommending the withdrawal of the medicines from the European market late last year. Australia’s Therapeutic Goods Administration (TGA) and the UK’s Medicines and Healthcare products Regulatory Agency both withdrew pholcodine-containing medicines in March.

The New Zealand regulatory agency has requested expert advice from MARC and is seeking input from other stakeholders as part of a public consultation that will run until 8 May.

The withdrawal of pholcodine-containing medicines would affect 15 products, most of which are sold by iNova Pharmaceuticals.

Medsafe Notice

WHO issues alert after contaminated, India-made medicines found in Pacific islands

The World Health Organization (WHO) has published an alert after discovering cough syrups containing a potentially deadly contaminant in the Marshall Islands and Micronesia. Tests by Australia’s TGA showed that syrups contained unacceptable levels of diethylene glycol (DEG) and ethylene glycol (EG).

From October 2022 to January 2023, WHO issued three medical product alerts related to the discovery of contaminated cough syrups linked to more than 300 deaths across the Gambia, Indonesia and Uzbekistan. WHO responded to the incidents by calling on manufacturers to only buy pharmaceutical grade excipients from “qualified and bona fide suppliers” and to comprehensively test their supplies.

As was the case in two of the three previous alerts, WHO linked the contaminated products to India. The stated manufacturer is QP Pharmachem, and the stated marketer is Trillium Pharma. Neither company had given guarantees to WHO on the safety and quality of the products as of the time of the publication of the alert last week.

QP Pharmachem’s managing director Sudhir Pathak told Reuters it tested a sample from the exported batch in response to a query from the local state drug regulator. “We found it satisfactory, and the regulator found it satisfactory, too,” Pathak said.

The WHO alert makes no mention of whether the contaminated cough syrups have caused adverse events. WHO’s alert covers the Marshall Islands and Micronesia, but the product may have marketing authorizations in other parts of the region or have been distributed in other countries through informal channels.

WHO Alert, Reuters

TGA acts to ensure supply of antibiotics in Australia as shortage situation drags on

TGA has made a Serious Scarcity Substitution Instrument (SSSI) for cefaclor oral liquid. The SSSI declares 125mg/5mL and 250mg/5mL cefaclor oral liquid strengths as scarce medicines and allows pharmacists to substitute one dose for the other without first checking with the prescribing physician, in order to mitigate the impact of ongoing disruption to the supply of antibiotics in Australia.

Antibiotics including amoxicillin and cefaclor are in short supply in Australia because of manufacturing problems and unexpected increases in demand. TGA expects most of the shortages to end in the coming months but warns “ongoing global constraints” on the availability of some products will make it hard to access certain products in Australia until the end of the year.

The SSSI is scheduled to stay in force until the end of September. TGA expects Alphapharm and Viatris, the sponsors of cefaclor oral liquids, to resolve the shortages between 31 July and 30 September.

TGA Notice

Philippine FDA shares guidelines on training sessions as face-to-face events resume

The Philippine Food and Drug Administration (FDA) has shared guidelines on the conduct of training sessions and seminars as it starts resuming face-to-face education after going online in the pandemic.

The Philippine regulatory agency will announce events on its website and Facebook page. Registration for all events will be on a first-come, first-served basis and interested parties are required to register prior to the event. FDA will close registration once it has the desired number of applicants.

After receiving a registration request, FDA will send a course assessment slip with payment instructions via email. The applicant has five working days to pay FDA. Failure to pay the agency by the deadline will result in the automatic cancellation of the application.

FDA Notice

Japan’s PMDA adds video on sharing safety risk information to e-learning platform

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has added a video about disseminating safety risk information to its e-learning platform.

The Japanese regulatory agency set up the PMDA-ATC E-learning system at the start of 2020 and has continued to update the content since the launch. The latest edition is a five-minute, English-language video that introduces the risk communication tools that Japanese officials use to provide timely safety information to healthcare professionals and the public.

In the video, PMDA explains how it immediately publishes safety measures adopted by the Japanese Ministry of Health, Labour and Welfare on its website. Healthcare professionals can receive the information via PMDA medi-navi, an email service that provides essential safety information. The video explains what medi-navi is and how healthcare professionals can register to use the service.

The video also covers how PMDA makes safety information available to patients.

PMDA Report

Asia-Pacific Roundup: New Zealand eyes removing pholcodine cough medicines from market

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