The Obama administration announced on Tuesday a new initiative to reduce prescription painkiller misuse and overdose, a problem that has become the leading cause of accidental death in 17 states, surpassing car accidents — and killing more than 28,000 people annually. The new plan includes increased funding for state prescription drug monitoring programs (PDMPs) as well as an FDA-led program to educate doctors about risks related to opioid painkillers.
The state of Florida, whose population includes many elderly patients requiring pain treatment, has long resisted using a PDMP. But Florida agreed to do so last week despite privacy objections from its governor. The country’s drug czar, along with several other states, have long blamed Florida for being the source of many diverted and misused medications used in the South, noting that 98 of the nation’s 100 top prescribers of oxycodone (the generic form of Oxycontin) are located in Florida. Forty-three states currently use PDMPs.
The question is, do drug monitoring programs work? If they are effective at reducing misuse and deaths, do they also reduce appropriate pain care? Not mentioned in the announcement of the White House plan was a relevant new study led by researchers at the Centers for Disease Control and Prevention (CDC), which compared rates of overdose deaths and prescribing in states with and without PDMPs between 1999 and 2005.
PDMPs collect information about patients’ prescriptions in a database and make the data accessible to doctors, pharmacists and sometimes law enforcement. The new study, published recently in the journal Pain Medicine, found that such prescription monitoring had no effect on either overdose deaths or rates of prescribing. “In a national study, we compared states that had PDMPs and those that didn’t, and found that states with PDMPs overall did not have lower rates of drug overdose or opioid-related deaths and did not have overall less consumption of opioid analgesics,” says lead author Leonard Paulozzi, a medical epidemiologist at the CDC.
“I think what it underscores is that utilization of a PDMP is probably not enough,” says Dr. Lynn Webster, a board member of the American Academy of Pain Medicine and medical director of Lifetree Clinical Research in Utah.
Paulozzi agrees that the study, whose data only goes up to 2005, doesn’t necessarily mean that PDMPs don’t work. It may have more to do with how the PDMP works. Another study in which Paulozzi compared New York State’s prescription-monitoring program to that of Pennsylvania did find an effect. From 1999 to 2004, overdose deaths in Pennsylvania increased, while the rate in New York did not; during that period, the risk of overdose in Pennsylvania was 1.6 times higher than in New York. And the opioid prescribing rate in New York dropped to two-thirds lower per capita than that of Pennsylvania.
So what did the two states do differently? New York required doctors to use special tamper-proof prescription forms and provided much better funding for its program than Pennsylvania did, according to the study. New York also tracked all opioid prescriptions, while Pennsylvania tracked only those involving the highest risk category of drugs, Schedule 2.
Advocates for pain patients worry, however, when they see large reductions in prescribing associated with monitoring programs. “The states where there are PDMPs indicate that fewer Schedule 2s are prescribed,” says Siobhan Reynolds, a long time activist for pain treatment. “That means that the people with the most severe pain are bearing the burden of all these supposed safety measures.”
She adds, “Without pain control, people in severe pain develop all kinds of other, expensive medical conditions that taxpayers and those who carry medical insurance ultimately shoulder. So the real cost of these programs is hidden from public view.”
Paulozzi says the key is to figure out exactly which individual components of PDMPs are contributing to success in certain states: “Is it proactive use by doctors? Is it proactive reporting of ‘doctor shopping’ to law enforcement, as opposed to reporting it to doctors? Is it the extent to which staff [at doctor's offices and pharmacies] can make use of data?” He notes that we still don’t know which elements matter most and which might unfairly affect pain patients.
Another difference between New York and Pennsylvania may involve the availability of naloxone, the overdose antidote that can be used to revive victims. Most people who overdose are not legitimate pain patients who mistakenly take the wrong amount, but people who misuse opioids with other drugs, in most cases mixing them with alcohol or other depressants like Xanax. Fully 70% of those who report misusing painkillers do not have their own prescription for them, but obtain the drugs from a relative or friend.
In the mid 2000s, New York State began a major initiative to provide naloxone to addicts at programs like needle exchanges, and to train them on how to save overdose victims. By contrast, Pennsylvania has only a few naloxone programs.
In Illinois, the Chicago Recovery Alliance has distributed more than 11,000 naloxone kits since 2001 — and more than 1,000 overdose reversals have been reported since then, along with a reduction in heroin overdoses. (More on TIME.com: Distributing An Overdose Antidote )
But naloxone distribution to addicts doesn’t reach first-time users who are at high risk of overdose; nor does it include pain patients who may mistakenly overdose or have their medications stolen by relatives. That’s why Wilkes County in North Carolina, which has been hard hit by prescription drug misuse and overdose, runs a pilot program called Project Lazarus that provides naloxone to all high-risk patients when they receive a prescription for strong painkillers, just in case. (More on TIME.com: Should Overdose Antidote Be Made More Accessible?)
“We don’t yet know how many overdoses have been reversed but it’s going well,” says Rev. Fred Brason, the project director for Project Lazarus. At least nine studies have been published evaluating naloxone programs — all of which had positive findings — and they are now available in at least 17 states.
Naloxone has not been reported to cause harm if it is used unnecessarily. Its worst side effects tend to be withdrawal symptoms caused by reversing the overdose and therefore blocking the opioid’s action on the brain.
But although Food and Drug Administration commissioner Margaret Hamburg acknowledged at a press conference Tuesday that naloxone might be part of the solution to reduce overdose deaths, use of the treatment does not appear in the strategy released by the administration.
Other elements outlined in the new plan [PDF] include increased Drug Enforcement Agency (DEA) attention to opioid prescribers, take-back plans to reduce problems associated with leftover pills, and a proposal to introduce new legislation requiring doctors and dentists to be educated about opioids before they can receive a DEA registration number to prescribe them.
Will these measures prove effective? Research has not linked law enforcement crackdowns with reductions in overdose death, and physician education requirements and take-back programs have not been extensively studied.