The 15th case of the novel coronavirus (COVID-19) was confirmed in the United States on Thursday,1 and experts are expressing concerns that the outbreak in China could result in drug shortages in the US.

According to the World Health Organization (WHO), there are now over 63,500 cases globally.2 There have been 1381 deaths in China, including 100 reported on Friday. Outside of China, there have been 2 deaths.2 Chinese officials have also released data on infections among health workers, with 1716 reported cases, and 6 deaths.2

“This is a critical piece of information because health workers are the glue that holds the health system and outbreak response together,” said Tedros Adhanom, PhD, director general of WHO, during a Friday press conference.2
 

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Michael Ryan, MA, executive director of the WHO Health Emergencies Program, noted in a press conference on Thursday that the large increase reported by China in the last several days is partially due to a change in reporting procedures. Many cases in China are being reported retroactively as testing procedures improve, causing the large spike.3

In addition to 15 confirmed cases, the US has 81 cases pending test results.4 In a CDC press conference on Wednesday, Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases, said Americans should prepare to see increased spread.5

“The goal of the measures we have taken to date are to slow the introduction and impact of this disease in the United States but at some point, we are likely to see community spread in the US,” Messonnier said.5

Although the number of US cases is still low, experts are raising concerns that the US reliance on China for pharmaceutical ingredients could result in drug shortages as Chinese officials battle the outbreak.

According to Politico, approximately 60% of factories manufacturing drug ingredients and finished medications for US markets are located overseas, including 40% in China and India. China provides the raw material used in 13% of US drugs.6

According to Ron Piervincenzi, PhD, CEO of US Pharmacopeia (USP), the only confirmed shortages as a result of the virus outbreak are for masks and protective gear.7 However, he did note several weaknesses that are already being seen. Quality inspections in China may have stopped or slowed due to travel restrictions, Piervincenzi said. In addition, transportation systems have been shut down, and manufacturing capacity is reduced.7

While the FDA has temporarily halted travel to China, Piervincenzi emphasized that there is currently no threat to the quality of ingredients as a result.

“FDA and [the] industry can still continue to ensure the quality of ingredients and finished formulations by testing them against USP standards upon receipt at manufacturing plants or at ports of entry,” Piervincenzi said, in an email to Pharmacy Times.7

Past crises such as Ebola and Swine Flu have resulted in a rise of poor quality and falsified products, Piervincenzi added,7 but he had several recommendations for companies concerned about the COVID-19 crisis and its impact.

“It is early days, but now is the time for companies to assess their quality control systems in order to get ahead of any threats,” he said in the email.7


REFERENCES
  1. CDC Confirms 15th Case of Coronavirus Disease (COVID-19) [news release]. CDC website; February 13, 2020. https://www.cdc.gov/media/releases/2020/s0213-15th-coronavirus-case.html. Accessed February 14, 2020.
  2. Daily media briefing on COVID19. World Health Organization. February 14, 2020. https://twitter.com/WHO/status/1228334921401323520. Accessed February 14, 2020.
  3. Media Briefing on COVID-19 Outbreak [audio file, 2.08]; World Health Organization. February 13, 2020. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/media-resources/press-briefings#. Accessed February 14, 2020.
  4. Coronavirus Disease 2019 (COVID-19) in the US. CDC website; Updated February 14, 2020. https://www.cdc.gov/coronavirus/2019-ncov/cases-in-us.html. Accessed February 14, 2020.
  5. Transcript for CDC Telebriefing: CDC Update on Novel Coronavirus. CDC website; February 12, 2020. https://www.cdc.gov/media/releases/2020/t0212-cdc-telebriefing-transcript.html. Accessed February 14, 2020.
  6. Karlin-Smith, S. FDA: No drug shortages reported because of coronavirus but situation ‘fluid’. Politico; February 7, 2020. https://www.politico.com/news/2020/02/07/chinese-drugs-shortage-coronavirus-112049. Accessed February 14, 2020.
  7. RE: Coronavirus Impact on Global Supply Chain [email]. From Daniella Gutierrez; February 13, 2020.