key: cord-0967087-uskjhaxw
authors: Liu, Sam Chi-Hao; Huang, Mei-Chen; Horng, Shiow-Shiun
title: TFDA takes actions to help mitigate supply disruptions or shortages of drug
date: 2020-05-30
journal: J Formos Med Assoc
DOI: 10.1016/j.jfma.2020.05.014
sha: 6a1576a652e8034fa1b40184633768eaa86c75eb
doc_id: 967087
cord_uid: uskjhaxw

nan

During the COVID-19 pandemic, governments around the globe impose quarantines, lockdowns and transportation reductions to slow the spread of the disease. These control measures disrupt normal business operations which includes the pharmaceutical industries. Potential supply chain disruption are foreseen when the two world's largest active pharmaceutical ingredient (API) producers and suppliers, China and India, shut down the manufactures and restrict the pharmaceuticals exportation. Taiwan Food and Drug Administration (TFDA) has thus taken several preventive and proactive actions to fight the disease and to protect public health during the supply disruption scares.

Monitoring and evaluating the risks of supply disruptions or drug shortages At the early stage of the outbreak of COVID-19, 1 TFDA has been actively monitoring drug shortage information released by other countries and proactively reached out to the pharmaceutical companies to monitor the stock of commonly used drugs for the treatment of pneumonia to ensure stable supply of them.

To prevent the impact of APIs shortage from China, TFDA has actively worked with industrial associations and organizations to identify the potential drugs (including antibiotics, steroids, antipyretic analgesics, gastrointestinal medication, etc.) which may be impacted by the COVID-19 outbreak and discussed about the prevention and mitigation strategies. TFDA asked pharmaceutical companies to take inventory, evaluate the risks of supply disruptions or shortages of drugs, and report to TFDA as early as possible once drug shortage situation was detected. In addition, TFDA provided expedited reviews for adding new registered API manufacturers and API import permits to help pharmaceutical companies find alternate supply.

Moreover, in order to stimulate the importation of APIs, the agency has stipulated guidance to provide subsidies and necessary supports to the pharmaceutical companies who suffer from operational difficulty due to the COVID-19.

Meanwhile, as the supply is limited, an adequate and balanced distribution of drugs is also one of the important risk mitigation strategies. In order to prevent the uneven distribution or stockpiling of some commonly used drugs, TFDA has notified medical institutes not to stockpile drugs and issued two guidelines, which limits the maximum amount of purchases to 1.1 times of last year's monthly average in each purchase. The Ministry of Health and Welfare (MOHW) also asked medical institutes to remove the phrase "all the prescribed medicines cannot be replaced by other brands" on the prescription, thus to increase the interchangeability of the drugs. The medical institutes should also return the exceeding amount of drugs to the pharmaceutical companies.

In order to ensure sufficient and stable supply of alcoholbased sanitizer products during the pandemic, TFDA has been working with medical institutes, Taiwan Tobacco & Liquor Corporation (TTL), Taiwan Sugar Corporation (TSC), community pharmacies, manufacturers and government partners. TFDA has coordinated with multiple stakeholders to ensure the supplies of medicinal alcohol (including hygiene hand gel) and "hygiene alcohol (not for medical use)" to medical institutes and the public.

TFDA has asked for the assistance from TTL and TSC to manufacture hygiene alcohol and distributed them to TTL and TSC retail stores, community pharmacies, cosmetic stores, supermarkets and convenient stores. The agency has also been in touch with the manufacturers to closely monitor the amounts of the medicinal alcohol and assisting the manufacturing by rearranging the sources of alcohol ingredients, providing expediting reviews, asking Ministry of Economic Affairs to increase the import allowance of alcohol ingredients, and asking Customs Administration, Ministry of Finance, to lower the tariff. The medicinal alcohol was primarily delivered to medical institutes. Once the needs of medical institutes have been satisfied, other products can be open to the public.

Furthermore, TFDA also restricted the exportation of the alcohol-based sanitizer products according to Pharmaceutical Affair Act (PAA) Article 56, and regulated the prices of it based on "Special Statute for COVID-19 Prevention, Relief and Restoration".

TFDA also took actions to ensure adequate supply of the therapeutics for patients. Take hydroxychloroquine (HCQ) for example. According to"Interim Guidelines for Clinical Management of SARS-CoV-2 Infection" announced by Taiwan Centers for Disease Control, 2 HCQ may have therapeutic effects against SARS-CoV-2, so TFDA has been in touch with the manufacturers for contract manufacturing. The agency also restricted the exportation of HCQ according to PAA Article 56 and issued an official letter to the manufacturers on 7th April and stated that the manufacturers should report to, and receive prior approval from, TFDA before the exportation of HCQ.

TFDA has been working collaboratively with industries, academics, medical institutes and government partners to mitigate supply disruptions, shortages of drug and protect the public. We sincerely hope that our experiences can be helpful to the international community.

(Data collection ends: April 14 2020)

Initial rapid and proactive response for the COVID-19 outbreak e Taiwan's experience

Taiwan Centers for Disease Control, Ministry of Health and Welfare. Interim guidelines for clinical management of SARS-CoV-2 infection. 5th ed. Taiwan Centers for Disease Control

All authors are currently employed by Taiwan Food and Drug Administration (TFDA). The study design, analysis and interpretation of data, writing of the report, and decision to submit the perespective had been approved by TFDA.