Todd Ebert, RPh

Anesthesiology News published a commentary by John G. Brock-Utne, MD, PhD (2018;44[12]:5,7), which maintained that the blame for current drug shortages should go to group purchasing organizations (GPOs). That commentary elicited the following letter in support of GPOs.

Ongoing prescription drug shortages continue to be a public health crisis and jeopardize patient access to essential medications. For anesthesiologists in particular, these impacts are especially acute, with over 98% of American Society of Anesthesiologists (ASA) members noting that they regularly experience drug shortages for commonly used drugs like hydromorphone (Dilaudid), fentanyl, morphine, bupivacaine, and epinephrine.1 Health care GPOs are critical partners helping hospitals and the health care system prevent and mitigate the impact of drug shortages by working collaboratively with hospitals, physicians, manufacturers, distributors and government agencies to ensure that hospitals and patients have access to the lifesaving drugs they need.

As the sourcing and purchasing partners to virtually all of America’s 7,000+ hospitals, GPOs have a unique overview of the conditions that give rise to drug shortages, which—as the FDA has repeatedly identified—are primarily caused by quality-control problems, manufacturing issues and barriers to getting new suppliers online.

The Healthcare Supply Chain Association (HSCA) and its member GPOs have leveraged their unique line of sight over the entire health care supply chain to advocate for policy solutions that increase competition and help avoid shortages. For example, HSCA provided feedback to the DEA regarding a proposed rule on annual opioid production limits.2 HSCA urged the DEA to differentiate between outpatient/oral narcotics and inpatient/injectable opioids, many of which are currently already in shortage and are an essential element of treatment for inpatient post-surgical and medical pain management.

HSCA also recently participated in a drug shortage working group along with the ASA and other leading health care provider organizations to develop recommended policy proposals to help prevent and address drug shortages.

Ongoing drug shortages are a complex problem without an overnight fix. GPOs will continue to work in lockstep with hospitals and anesthesiologists to mitigate the impact of drug shortages and advocate for enduring policy solutions that protect patients and empower health care providers to provide first-class patient care.


Todd Ebert, RPh, is the President and CEO of the Healthcare Supply Chain Association (HSCA).

References

  1. www.asahq.org/ about-asa/ newsroom/ news-releases/ 2018/ 04/ anesthesia-drug-shortages-negatively-affecting-patient-care
  2. www.supplychainassociation.org/ 2018/ 05/ 04/ hsca-comments-on-dea-proposed-rule-on-opioid-production-limits/
  3. www.supplychainassociation.org/ wp-content/ uploads/ 2018/ 05/ hsca_statement_on_president_.pdf
  4. www.supplychainassociation.org/ 2018/ 06/ 07/ hsca-letter-re-the-creates-act-s-974/

The FDA’s Drug Shortages list is regularly updated by the agency, and can be found here: bit.ly/2xtyPG0. As we reported in our May issue (“Opioid Shortages Force Improvisation—and Cancellations”), the reasons for the shortages vary. Shortages of certain drugs affect the availability of other drugs, with cascading shortages being noted as mitigating strategies are put into effect to deal with the problem. Our review of the situation earlier in 2018, suggested that most shortages would be corrected by the first quarter of 2019, but now companies are saying many of the manufacturing delays will continue into the second quarter—at least.

The fault does not necessarily lie with drug manufacturers exclusively, either. As argued in a commentary posted on AnesthesiologyNews.com by John G. Brock-Utne, MD, PhD, a professor of anesthesiology (emeritus) at Stanford University Medical Center, in California, group purchasing organizations have “undermined competition and profitability in the drug/IV fluid market” (bit.ly/2QRDprN). Congress, he argued, needs to repeal the safe harbor law, 42 US Code 1320a-7b(b)(3)(C), that in effect grants “legalized kickbacks and rebates.” Countering that argument is Todd Ebert, RPh, at left, replying for the Healthcare Supply Chain Organization.

The anesthesia drugs that are currently (as of Dec. 4, 2018) in short supply include:

  • Atropine Sulfate Injection (due to increased demand and discontinued manufacturing)
  • Bupivacaine Hydrochloride and Epinephrine Injection, USP (due to increased demand)
  • Bupivacaine Hydrochloride Injection, USP (due to increased demand)
  • Edrophonium Chloride (ENLON) Injection, USP (discontinued manufacturing)
  • Edrophonium Chloride, USP and Atropine Sulfate, USP Injection (ENLON-PLUS) (discontinued manufacturing)
  • Ketamine Injection (Hospira states Q2 2019 recovery; other manufacturers cite increased demand)
  • Lidocaine HCl Topical Jelly (Teva discontinued manufacturing)
  • Lidocaine Hydrochloride (Xylocaine) Injection (due to increased demand and discontinued manufacturing)
  • Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine (Hospira states Q2 recovery; Fresenius cites manufacturing delay due to shortage of a key component)
  • Methadone Hydrochloride Injection (shortage of active ingredient)
  • Ropivacaine Hydrochloride Injection (due to increased demand or manufacturing delay)

Analgesics also are in short supply, including:

  • Diclofenac Sodium (Dyloject) Injection (discontinuation)
  • Diclofenac Sodium Extended Release Tablets (discontinuation)
  • Disulfiram Tablets (discontinuation)
  • Fentanyl Citrate (Sublimaze) Injection
  • Hydromorphone Hydrochloride Injection, USP
  • Indomethacin Capsules (discontinuation)
  • Ketoprofen Capsules (discontinuation)
  • Ketorolac Tromethamine Injection (due to increased demand or manufacturing delay)
  • Meperidine Hydrochloride Injection, USP, CII (discontinuation)
  • Methadone Hydrochloride Injection
  • Methocarbamol Tablets (due to increased demand, shortage of active ingredient and discontinuation)
  • Morphine Sulfate (Avinza) Extended-Release Capsules (discontinuation)
  • Morphine Sulfate Extended-Release Tablets (discontinuation)
  • Morphine Sulfate Injection, USP (due to increased demand or manufacturing delay)
  • Nabumetone Tablets (discontinuation)
  • Orphenadrine Citrate Injection (discontinuation)
  • Promethazine (Phenergan) Injection (due to increased demand)
  • Remifentanil (Ultiva) Lyophilized Powder for Solution Injection (due to increased demand)
  • Talwin (Pentazocine Lactate Injection, USP, CIV) (discontinuation)