HEALTHCARE PROFESSIONALS NEED TO PREPARE FOR A SHORTAGE OF PENICILLIN! This week, Pfizer sent a warning to the U.S. Food and Drug Administration (FDA) that the ongoing drug shortages impacting the U.S. are now threatening to exhaust two commonly used forms of penicillin.

In a letter to doctors this week, Pfizer said it's facing a shortage of various injectable penicillin products it manufacturers, including prefilled syringes. The letter stated:

"The supply interruption is the result of a complex combination of factors including significant increases in demand, due to an increase in syphilis infection rates as well as competitive shortages."

According to the Centers for Disease Control (CDC), there were more than 175,000 cases of syphilis reported in 2021. The agency says that's a 74% increase since 2017.

A major concern is pregnant women passing on syphilis to their newborns. The CDC says there were nearly 2,900 cases of newborns with syphilis in 2021, a 203% increase since 2017.

Health officials state that a single injection of penicillin can cure the early stages of syphilis.

Pfizer said it's prioritizing the manufacturing of the products to treat the sexually transmitted disease, but it doesn't expect to be fully recovered from the shortage until the second quarter of 2024.

In a report released this month about drug shortages, the FDA said it's working with manufacturers and other partners to "mitigate the impact of shortages that cannot be prevented".

Pfizer alerted the FDA that there is "a limited supply and impending stock out" of Bicillin L-A and Bicillin C-R, two of its injectable penicillin products.

Bicillin L-A is used to treat strep infections in the throat, nose or skin; syphilis or syphilis-like infections; and to prevent problems stemming from strep. Bicillin C-R is also used to treat strep infections in the throat, nose, skin, or soft tissues, as well as scarlet fever, pneumonia, and ear infections.

Bicillin injections are colloquially referred to as the "peanut butter shot" in the military due to the color of the drug. The injection is widely known as being particularly painful. Neither of these drugs is available in lower-cost generic forms.

Pfizer cited a "complex combination of factors" for the shortage, including an increase in demand and a rise in syphilis rates.

"We are continuing to work with Pfizer and offer any assistance needed to help with supply," an FDA spokesperson told The Hill. "Pfizer is prioritizing the manufacturing of Bicillin L-A, and additional releases for the adult formulation are expected this month. We are also in close communication with the CDC and sharing information as it becomes available."

"The FDA continues to encourage companies to notify the agency when there is a spike in demand so that they can work with them early on to mitigate or prevent any impacts on availability," the FDA added.

The company estimated that supplies of Bicillin C-R would be depleted around the third quarter of this year, while pediatric pre-filled syringes of Bicillin L-A would be depleted even earlier.

This warning comes amid shortages of several other crucial medications. Cancer centers in the U.S. are reporting shortages of two key chemotherapy drugs, while the Adderall shortage announced late last year persists. The FDA says over a dozen cancer-treatment drugs are under shortage.

(The Hill June 13, 2023)

RESOURCES

To keep up with shortages see the following websites:

• ASHP WEBSITE
  https://www.ashp.org/​drug-shortages/​current-shortages
• UNIVERSITY OF UTAH WEBSITE
  https://pharmacy​services.​utah.edu/​rx-web-links/​drug-shortages
• DRUGS.COM WEBSITE
  https://www.drugs.com/​drug-shortages/
• USP WEBSITE

  The USP's Medicine Supply Map is an early-warning system for possible drug shortages, whether due to global health crises, natural disasters, geopolitical events, or quality-related issues in manufacturing. It enhances visibility into the upstream medicines supply chain to help governments, manufacturers, distributors, and providers identify and address vulnerabilities, lessen quality risks, reduce the frequency and duration of potential drug shortages, and protect patients.

  The USP's Medicine Supply Map leverages insights derived from the use of USP quality standards in more than 22 thousand locations around the world, spanning 92 percent of generic medicines approved in the U.S. It aggregates more than 40 external datasets and 250 million data points to quantify risk and resilience in the upstream pharmaceutical supply chain.

  Insights on Supply Chain Vulnerability

  Read original analysis about the global distribution of APIs and risks associated with specific drug classes, from broadly used medicines to those that are critically needed in small populations.

  Pinpoint Supply Chain Risks

  Leveraging multiple data sources, the Medicine Supply Map helps identify, characterize, and quantify risk factors to help guard against over-reliance on over-concentrated sources, reduce disruptions, and build resilience.

  Make Better Product Decisions with USP's Medicine Supply Map Insights for Manufacturers
  Medicine Supply Map (usp.org)

  Give Yourself Time to Plan with USP's Medicine Supply Map Insights for Hospitals

  Supply Resilience Scores to Address Risks
  Data analytics shed light on factors that help drive resilience in the pharmaceutical supply chain. Vulnerable populations can be particularly at risk when shortages occur, as with pediatric oncology medicines.

• FDA WEBSITE WWW.FDA.GOV
  Reports Sent to Congress on Drug Shortages
  • Tenth Annual Report on Drug Shortages for Calendar Year 2022 (PDF - 677 KB)
  • Ninth Annual Report on Drug Shortages for Calendar Year 2021 (PDF - 462 KB)
  • Eighth Annual Report on Drug Shortages for Calendar Year 2020 (PDF - 204 KB)
  • Seventh Annual Report on Drug Shortages for Calendar Year 2019 (PDF - 279 KB)
  • Sixth Annual Report on Drug Shortages for Calendar Year 2018 (PDF - 400 KB)
  • Fifth Annual Report on Drug Shortages for Calendar Year 2017 (PDF - 7 MB)
  • Fourth Annual Report on Drug Shortages for Calendar Year 2016 (PDF - 5 MB)
  • Third Annual Report on Drug Shortages for Calendar Year 2015 (PDF - 268 KB)
  • Second Annual Report on Drug Shortages for Calendar Year 2014 (FDA Archive) External Link Disclaimer
• Other Resources
  • Drug Shortages Infographic
  • Graphic - A Drug Supply Chain Example
  • General Drug Shortages Questions and Answers
  • Managing Drug Shortages

Did You Know (On Drugs/Medicines) ...The following?

"The best of all medicines are resting and fasting." (Franklin)

Over the door of a library in Thebes is the inscription: "Medicine for the soul" (Diodorus Siculus)

"God heals and the doctor takes the fee." (Franklin)

"He who has health has hope; and he who has hope has everything." (Arabic Proverb)

Thoughts for the Week!

"Nothing in the world is more haughty than a man of moderate capacity when once raised to power." (Wessenburg)

"Good health and good sense are two of life's greatest blessings." (Publilius Syrus)

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From Out of the Past

If Crusoe'd
Kept his chin
More tidy,
He might have found
A Lady Friday!
     Burma-Shave