Hospitals are encouraged to remove propoxyphene
June 1, 2008 5 minutes read
Hospitals are encouraged to remove propoxyphene
Florida hospital did so effortlessly
It's time to take propoxyphene off the hospital's shelves, according to the recent clarion call issued by the American Society of Health-System Pharmacists (ASHP) of Bethesda, MD. ASHP called for the Food and Drug Administration (FDA) to remove the pain drug from the market.
Specifically, ASHP refers to the synthetic opioid propoxyphene, which is marketed as Darvon®, or propoxyphene plus acetaminophen, which is marketed as Darvocet®.
While some hospitals have discouraged use of propoxyphene for years, others might find that physicians resist requests to stop prescribing the drug because of their own and their patients' preferences.
But tradition isn't a good enough reason to keep prescribing a drug that research shows has more adverse effects than acetaminophen and no additional benefit.
There has been evidence for decades that propoxyphene has no place in a hospital pharmacy, says Randy C. Hatton, PharmD, FCCP, BCPS, co-director of the Drug Information and Pharmacy Resource Center at Shands at the University of Florida in Gainesville, FL. Hatton also is a clinical professor at the University of Florida in the college of pharmacy.
Shands in Gainesville removed propoxyphene from its shelves in the early 1980s, Hatton notes.
"For a long, long time we've taken an evidenced-based approach to our formulary," Hatton says. "In the early 1980s we looked at the literature available then, and there was a fair amount of literature that showed that propoxyphene with acetaminophen — or Darvocet — was no more effective than acetaminophen alone."
Also, the literature has shown for decades that propoxyphene increases the risks of adverse events and toxicities.
"So our evidence back in the early 1980s was that there were better therapeutic alternatives," Hatton says.
When Shands first removed propoxyphene from its formulary, there was some resistance.
Most of the pushback came from physicians who had prescribed the drug for years and found that patients liked the red pills, Hatton says.
"With pain medications there is a huge placebo response, and Darvocet in those days was a big red tablet," Hatton says. "People did find relief from it, but you get relief from acetaminophen too."
Since every formulary has options for non-formulary use, some physicians continued to prescribe propoxyphene in the two decades since the hospital made that change.
"Mainly it was prescribed for patients who were admitted on the drug," Hatton explains. "Some patients come in and have had chronic pain, taking pain medicine for years, if not decades, and they might be very insistent on using Darvocet."
The amounts that were prescribed were small and weren't tracked until a couple of years ago when the hospital's drug information center assessed its use, Hatton says.
"We evaluated it and decided we would not use it at all," Hatton says.
"We did a medication use evaluation over a six-month period, collecting data on 30 patients receiving the drug," Hatton says. "We wanted to see the characteristics of the patients getting the drug."
The evaluation found that 43% of the patients were older than 65 years, and about half of the elderly patients were on propoxyphene before their hospital admission.1
Also, the evaluation focused on the prescribers to see if they might have the impression that the drug was a beneficial product, Hatton notes.
It did not appear that any one physician or hospital service had relied heavily on propoxyphene, so a more targeted education effort did not appear necessary, he adds.
If anyone had an issue with propoxyphene being pulled off shelves, Hatton would have gone over the literature and provided justification for the decision.
"We don't always use a medication use evaluation and audit, but if we think there might be some controversy about a decision, or if we think a drug might be used for something we're not considering, then this is an additional tool at our disposal," Hatton says. "An audit might reveal something we haven't thought of."
The data collected include the patient type, indication of use, the drug's typical dosage, issues regarding the drug's use, etc.
"You can go to the patient's chart and talk with the patient to find out specifically why the patient is taking that drug," Hatton says.
Once the hospital's formulary committee heard the data and approved the change, it was time to educate the hospital's prescribers and pharmacists about how the drug would no longer be made available.
A notice was put in the September, 2007, edition of the Drugs & Therapy Bulletin, which is edited by Hatton.
Another key to having a smooth transition to taking the drug off shelves was to offer physicians an alternative to prescribing propoxyphene, Hatton says.
"There's a psychology in the placebo effect with pain medications, and there's also psychology in trying to stop physicians from prescribing a drug," he explains. "It's very difficult to convince people to stop doing something by saying, 'Gee, don't do that.'"
In hospitals where propoxyphene use is high and popular among some physicians, it would be a good idea to meet with them prior to making the decision formal and learn about their concerns and issues, Hatton suggests.
"Providing an alternative is one of the best approaches," he says.
For example, physicians could prescribe tramadol (Ultram®), which is a unique pain medication that affects the neurotransmitter with a different mechanism of action, Hatton says.
"It's not a terribly potent medication, but it's at least as effective as propoxyphene and acetaminophen," he adds. "And it can be combined with acetaminophen (Ultracet®)."
While plain acetaminophen would be a good prescribing choice, its ubiquity makes it a less exciting drug to patients, so tramadol is an alternative that could work with some patients, Hatton says.
Also, there might be withdrawal symptoms among some long-term propoxyphene users, so part of the pharmacy's guidance for physicians was the suggestion that they could treat such symptoms with clonidine, Hatton says.
Since the drug has been removed there has been very little response from providers and patients.
The hospital's decision to remove propoxyphene from its shelves paralleled efforts by a neighboring veteran's administration hospital that was moving in the same direction, Hatton notes.
"The fact that they were doing the same thing helps," he says.
But there was one patient who was very upset when told he couldn't have the drug, and the pharmacy administrator called him to explain the hospital's rationale for the decision, Hatton recalls.
"One of the things we had going for us is that propoxyphene hasn't been in our formulary for 25 years and our use was relatively low," Hatton says. "That makes our situation a little bit easier than in some places that have had it in their formulary for a long time and their use is high."
Reference
- Hatton RC. Nonformulary and not available. Drugs & Therapy Bulletin 2007;21:1-3.
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