Feature: Prescription Drug "Fatal Medical Errors" Rising Dramatically -- What Does It Mean?

A study released this week charted a startling increase in deaths from "fatal medical errors," particularly those associated with people mixing street drugs and alcohol with prescription medications at home. In this context, "fatal medical error" refers to people dying from taking prescribed medications, usually opioids, but also including other drugs, such as benzodiazepines (Valium, for example).

But while the numbers have some in the medical community calling for tighter restrictions on prescribing, they have some in the pain relief community worrying about just that possibility. And they're leaving other interested observers wondering just how accurate they are, what they mean, and just who is dying.

According to the study by University of California at San Diego sociologist David Phillips, which examined all US death certificates from the beginning of 1983 to the end of 2004, the overall death rate from fatal medical errors increased more than three-fold over that period, but the death rate from fatal medical errors when the drugs are taken at home and combined with alcohol and/or street drugs has increased a whopping 30-fold.

That means that accidental overdoses at home with alcohol or street drugs involved accounted for 17% of fatal medical error deaths in 2004. That's a seven-fold increase over the 2.3% reported in 1983.

In real numbers, the study found 22,770 fatalities from medication errors in 2004, with 3,792 of them attributed to mixing meds with alcohol or other drugs. In 1983, by contrast, only 92 people died from mixing drugs.

The increase in fatal medical errors involving prescription drugs is larger than the increase in the use of prescription drugs themselves, which has increased about 70% in the last decade.

Fatal medical errors involving prescription drugs dispensed in a hospital or doctor's office setting increased only 5%, while such errors involving home use but no street drug or alcohol use and such errors involving medical settings and alcohol and/or street drug use both increased five-fold.

Phillips and his coauthors pointed their finger at the ongoing migration of prescription drug dispensing from medical professionals at hospitals and doctors' office to patients at home. The decades-long shift in the location of medication consumption from clinical to domestic settings, they said, "is linked to a dramatic increase in fatal medication errors."

It is not just people swallowing prescription pills at home, but the involvement of other drugs in the overdoses that is disturbing, they said. "Domestic fatal medication errors, combined with alcohol and/or street drugs, have become an increasingly important health problem."

The study recommended increased screening for patient abuse of prescription drugs, alcohol, or street drugs, as well as increased vigilance toward prescribing medicines with known dangerous interactions with alcohol or street drugs.

But others in the medical profession are taking the study's findings and running with them. One medical blogger looking to restrict access to pain meds put it like this: "What is going on here is a direct result of politicizing medicine by the pain rights movement and the organizations that have mandated liberal pain management into guidelines and enforcement standards. More recently the push to promote patient satisfaction in healthcare organizations has resulted in liberalizing of prescribing opioid medications to make patients happy. Whatever happened to do no harm? Medicine has lost its way. These numbers should serve as a wake up call and re-examination of pain management practices."

And that is, unsurprisingly, raising hackles in the embattled pain relief movement. Pain relief advocates have long argued that access to effective opioid pain medications is too restricted, pointing to numerous cases of doctors prosecuted and imprisoned for their prescribing practices -- and the patients being left in the lurch.

"The pain relief movement had made only modest gains when it was faced with a government-wide crackdown, led by the Justice Department," said Siobhan Reynolds of the Pain Relief Network. "Now, those who know that they could find help in the form of opioids, find themselves shut out of care and stigmatized by the entire system. I don't think I have ever seen a more destructive phenomenon sweep this country... all in the name of a drug free America, an America which could never exist."

It's not pain patients who are dying of opioid overdoses, said California pain management physician Dr. Frank Fisher. "I've analyzed dozens of these deaths now, and the field of forensic pathology is in such disarray that any time they find an opioid post-mortem, they label the death an overdose," he said. "But pain patients almost never overdose because of the phenomenon of tolerance -- unless it's a massive deliberate overdose, and then they have to take the benzos, barbiturates, or alcohol."

"It's true that it's very hard for an opioid tolerant person to overdose -- if they know what they're doing," said Dr. Matt Das Gupta, an epidemiologist working with North Carolina's Project Lazarus, a program that distributes the opioid antagonist naloxone (Narcan) to drug users to prevent overdoses. But mixing opioids with other drugs or alcohol can fell even the hardiest opioid tolerant patient, he warned.

Most pain patients are dying of cardiac disease, said Fisher. "Heart disease kills pain patients because they're sedentary because of their conditions and they're under stress from chronic pain. What I'm seeing is an epidemic of cardiac disease brought on or exacerbated by chronic pain. Medical examiners are calling them overdoses because they have opioids in their systems, but the medical examiners are wrong when it comes to chronic pain patients."

Suicides among pain patients are no surprise, said Fisher, but they tend to be undercounted. "Unless they leave a note, the medical examiner never calls it suicide, they will call it undetermined or accidental overdose. The medical examiners are giving us terrible data," he complained.

"Medical examiners not coding properly is a perennial problem," said Das Gupta. But that could go both ways. "There are people who died who probably should be included, but were not coded as ODs. For example, one code is chronic use of opioids. If you include that, the numbers go up by 10% or 15%."

(For more on the controversies surrounding drug-related deaths, cause of death coding issues, and associated topics, check out this page at Brian C. Bennett's web site, Truth: The Anti-Drug War.)

While pain relief advocates such as Reynolds and Fisher are concerned primarily with protecting patients' access to effective opioid pain relievers, harm reductionists such as Das Gupta are concerned primarily with preventing overdoses and other deaths related to drug use. While the harm reduction movement has traditionally focused on the use of street drugs, like cocaine and heroin, the rapid increase in prescription drug deaths may be a sign that it needs to broaden its focus.

"When you look at deaths at the state level and start to pull actual medical examiner case files, you find that the people dying are really a mix of pain patients, non-medical opioid users, and heroin users," said Das Gupta. "Here in North Carolina, we found that 80% of prescription overdose deaths were people with prescriptions. That doesn't mean they were chronic pain patients, though; they could have been people scamming docs. What we have is a really heterogenous mix, and the way things are coded doesn't offer enough nuance."

Project Lazarus is trying to adjust, he said. "We've been tweaking traditional programs to a different setting. Instead of using needle exchange programs, we're doing it through doctors' offices," explained Das Gupta. "Anyone who prescribes opioids for pain in North Carolina should be considering naloxone for specific populations," he said. "There is an ethical responsibility for physicians not to endanger their patients' lives."

"We're working on overdose prevention here in New York, but the people we have had access to are the heroin users," said Dr. Sharon Stancliff, medical director for the Harm Reduction Coalition, for whom she oversees drug overdose prevention projects in New York and San Francisco. "But the bigger problem is people misusing or abusing opioids. We need to be getting information out to the general practitioners who are prescribing these drugs. They need to be prescribing Narcan with all those meds," she suggested.

"We need to change the national agenda about overdose prevention," said Stancliff. "Naloxone is an answer, but it's not the only answer. We need naloxone, we need education, we need more research."

And, Stancliff added, the federal government needs to quit being an obstacle and start helping to solve the problem. "We don't have an early alert system, we have really bad surveillance, we're not getting the research done," Stancliff complained. "We don't know who is dying -- is it the people being prescribed the drugs? Is it people they're giving them to? Is it illicit drug users? We don't know enough. The Centers for Disease Control don't quite cover this, and it should be a Substance Abuse and Mental Health Services Administration (SAMHSA) issue, too. Maybe in the next administration, when harm reduction isn't a dirty word."