Opioid Shortages Force Improvisation and Cancellations – May 7, 2018 —Michael Vlessides
The proliferation of opioid abuse and its alarming death toll have become major issues in both medical care and politics, but while many have spent the last several months decrying opioids, alarm has been slowly building over shortages of these same drugs.
Shortages of many injectable forms of opioids have reminded patients, federal agencies and clinicians alike of the vital role they play in a variety of health care settings, and left institutions nationwide scrambling to find alternative medications and analgesic routes.
Although these efforts may ultimately somewhat slake our thirst for opioids and promote multimodal analgesia, the immediate fallout of the shortage
- has left patients in pain,
- caused the cancellation of elective procedures, and
- raised the specter of serious medication errors.
Every day, clinicians of all stripes begin their workdays by trying to juggle an ever-changing supply of injectable opioids. “It consumes me on a daily basis,” said Anthony Laurent, RPh, MBA , the director of pharmacy at the University Medical Center New Orleans, in Baton Rouge. “Every day, I have to ration our limited supplies to the areas that are most in need. What’s worse is that by the time we get notified of a medication shortage, it’s already affected our resources.”
A Nationwide Phenomenon
The shortage—which is primarily affecting injectable formulations of morphine, hydromorphone and fentanyl, including prefilled syringes, small ampules and vials for IV delivery—started last summer but has intensified in recent weeks.
It is a nationwide phenomenon affecting academic institutions, community hospitals and surgical centers alike; regional variations seem to be the product of storage and inventory differences, not differential distribution patterns.
a bipartisan group of senators introduced a bill in March that would strengthen the DEA’s ability to lower manufacturers’ quotas on controlled substances such as opioids, based on, among other things, national overdose statistics.
The DEA doesn’t seem to need the added power:
It cut opioid production by 25% in 2017, and has proposed another 20% reduction for this year.
Importing opioids isn’t an option in such a heavily regulated arena, either.
In the meantime, the shortage of the three primary opioids has created a run on other drugs, subsequently causing them to fall into shortage as well, placing further strains on already stretched institutions.
In light of the bad news, relevant medical associations have not been content to stand by and watch their members—and the patients they serve—suffer. In late February 2017, the American Hospital Association, ASA, American Society of Health-System Pharmacists (ASHP) and American Society of Clinical Oncology all cosigned a letter to Robert W. Patterson, the acting administrator of the DEA. In that letter, the organizations urged the agency to use its discretionary authority to adjust aggregate production quotas for injectable opioids “in order to mitigate ongoing drug shortages” by allowing other manufacturers to supply product until the shortages resolve.
So they requested that the DEA allow more production over a year ago, but instead, the DEA announced further cuts.
It is really medical care we are getting when politics is so intimately involved now?
The signatories also stressed that injectable opioid shortages may threaten patient care. “Rather than selecting a product that might be most clinically efficacious for patients, during shortages prescribers are forced to order whichever IV opioid is available,” they wrote. “Furthermore, dosing equivalency between the IV opioids differs significantly, which can lead to dosing errors.”
Amidst the Chaos, Opportunity?
Among the many strategies being employed in U.S. institutions are:
- supplementing oral opioids for injectables where appropriate;
- using alternative injectable products, such as morphine or fentanyl, when hydromorphone is unavailable;
- revising high-volume order sets that incorporate routine orders for hydromorphone to include alternative agents;
- stressing nursing education regarding use of oral opioids, where appropriate;
- employing multimodal analgesia with agents such as nonsteroidal anti-inflammatory drugs, acetaminophen and GABAnergic agents to reduce the need for opioids; and
- using local anesthetics and regional anesthesia where appropriate.
“If you’re optimistic, you can look at this situation and say it’s offering us an opportunity to use non-narcotics for pain control,” said Allen J. Vaida, PharmD, the executive vice president of the Institute for Safe Medication Practices (ISMP). “And to tell the truth, I think a lot of people are taking advantage of that. But from the OR [operating room] and anesthesia standpoint, you still need your morphine, hydromorphone or fentanyl.”
However, all is not rosy when it comes to alternative analgesic strategies. Almost every clinician and organization recognizes that these shortages—and the mitigation strategies they promote—have the potential to increase the possibility of medication errors and adverse events.
For one thing, clinicians now find themselves turning to second-line drugs that they turned away from years ago, mostly due to their side effect profiles.
“For example,” said Dr. Philip, “we commonly use hydromorphone for surgical analgesia due to its fast onset time and outstanding side effect profile. Now we have to switch to morphine, which causes a host of known side effects. Yes, these side effects are manageable and safe, but the drug just isn’t as good.
The other problem with using these less common drugs is that they have different potencies than their more common brethren, and require different formulas and dosages.
And let’s not forget that every person metabolizes different opioids differently, so using different drugs during surgery when the patient is already unconscious is very risky.
“As we know, the doses of these medications are vastly different,” Vaida said. “So if you get one drug on Monday and a different drug on Tuesday, it could lead to serious implications.”
At the same time, some patients are not getting the drugs—or pain relief—they need.
Although multimodal analgesia may be the wave of the future, not all clinicians are literate in its use.
Less potent medications like acetaminophen clearly do not provide as much analgesia as opioids.
Then why have there been numerous studies making exactly these claims? Probably because research has become politicized. (see Opioids Blamed for Side-Effects of Chronic Pain)
Cancer patients also have found it challenging to fill opioid prescriptions at community pharmacies—a direct result of the government’s efforts to curb oral opioid misuse.
When government policies start going after cancer patients they will encounter a formidable foe in the “pink ribbon campaign”.
Our country considers cancer pain “special” and immune to all the nonsense going on about opioids, but even cancer pain relief is being infringed upon now with the DEA lowering quotas for opioid manufacturing.
“Many pharmacies are not stocking supplies like they used to, for multiple reasons,” Craig explained. “They either don’t want to serve those kinds of patients, or they’re fearful of litigation by dispensing too much.
I can tell you that every new law and every new proposal affects our patients here.
It’s not supposed to affect cancer patients, but it actually does.”
Medical Associations Propose Action
The good news is that national associations are not taking the situation lightly, and are urging legislators to take steps to ensure such shortages do not recur.
More recently, the five signatory agencies of the July 2017 letter to the DEA—plus an additional two: the American Society for Parenteral and Enteral Nutrition and the Children’s Hospital Association—followed up with a series of recommendations to Congress on what should be done to minimize patient effects from drug shortages in the future.
These strategies include:
- requiring manufacturers to provide the FDA with more information on the causes of the shortages and their expected duration;
- requiring manufacturers to establish contingency plans and/or redundancies;
- requiring more transparency from manufacturers;
- examining drug shortages as a national security initiative; and
- asking the Federal Trade Commission to include in its review of drug company merger proposals the potential risk for drug shortages.
Clearly, these agencies are concerned with the effect of market consolidation on manufacturers’ abilities to consistently meet demand.
Neither the FDA nor DEA replied to requests for interviews.
ASHP (courtesy of data from Erin Fox and the University of Utah) publishes a list of drugs currently in shortage at www.ashp.org/?Drug-Shortages/?Current-Shortages/?Drug-Shortages-List?page=CurrentShortages.