Addressing the Epidemic: What Can Be Done?
Medscape: This brings up the big question: What can be done? Is the answer a combination approach of physician and patient education along with prescription monitoring programs and/or the FDA's risk evaluation and mitigation strategies (REMS)? What do you believe is the next step on the part of the physicians?
Dr. Paulozzi: The CDC has made some recommendations in terms of opioid analgesics, in an issue brief that you can find at the National Center for Injury Prevention Website.[19] We talk about general recommendations to use opioids for pain only after determining that they are really necessary, while also using the lowest effective dose. We recommend something that is not done commonly enough -- random urine drug testing for opioids and other drugs, particularly patients under 65 years of age; we're talking about that middle-aged group and people in their 20s -- if they're being treated long term with opioids.
We recommend being aware of, and concerned, if a patient gets up to a high daily dose of opioids without improvement. We talk about 120 morphine milligram equivalents per day as a point at which it's advisable to seek consultation with a pain specialist to determine what's really going on with a patient. We also recommend that providers -- as mentioned earlier by Rick -- take advantage of the state prescription drug monitoring programs, which are now the law in over 40 states. Such programs can tell you what other providers are also prescribing to your patients. I think these have been an indispensable tool.
All of those things have to happen. I think we have to have better surveillance using the state prescription monitoring program to identify people who are clearly using drugs inappropriately, and get them into special programs; get them into substance abuse treatment. The state prescription monitoring programs need to identify the providers who are not pain specialists, but are writing hundreds of prescriptions a day, and identify the so-called pill mills that seem to exist in every state, and take appropriate action. In some cases this will require enabling legislation to define what a pill mill is in a given state. Therefore, there are some enforcement strategies and legal changes that may be necessary to get a handle on the distribution through black market channels of these potent drugs.
Dr. Weisler: Returning to a point that Len made earlier, the perception among some people seems to be that because these opiates are FDA-approved prescription drugs, they must be safe. We have to convey to the general public that this isn't necessarily the case when these powerful pain drugs are not used as directed. This includes educating all adults as well as parents, grandparents, and teenagers -- all ages -- that these drugs carry a significant amount of risk unless they're used appropriately. People, I would hope, will also take advantage of other potentially beneficial programs, such as drop-off programs where old or unused prescription drugs are dropped off or picked up, much like efforts to reduce the availability of firearms in some communities.
Medscape: Perhaps, Dr. Paulozzi, can you speak to the role of industry in the FDA's new REMS initiative? What responsibility will the pharmaceutical companies have in all of this?
Dr. Paulozzi: The FDA is working currently on a risk evaluation and management strategy, or REMS, for the long-acting forms of opioids and hopes to release it in some version this summer. It will describe approaches that the pharmaceutical industry should use to manage the risk. It's unclear what the contents will be exactly of that REMS. I think that clearly someone -- and I would prefer it be a federal agency -- needs to monitor, in the mode of postmarketing surveillance, what's happening with the distribution of drugs, the kinds of prescriptions being written, and the health outcomes.
We really need to be on top of this issue in a much more timely way in the future, and that may require improvement in our surveillance mechanisms, maybe using prescription drug monitoring program data as a public health surveillance tool to see, for example, what the average daily dose is among patients, or how many people are seeing 6 or more physicians in 6 months for an opioid prescription. There are a lot of ways to use these data, and I think that the FDA and the pharmaceutical industry need to work together with public health partners to try to develop the best method to track outcomes so that we can really see what effect the laws are having on the problem, rather than simply waiting for a couple of years for the statistics to come out. We need to see in real time what the impact is of the measures that we're increasingly taken to address the problem.
Dr. Weisler: One more thing -- which you mentioned earlier, Len -- is that roughly 1 in 5 people who are dying from these unintentional drug poisonings are doing things like doctor shopping and have seen 5 or more doctors for controlled substances in the past year, and I don't think there's a provider out there who hasn't been fooled by patients. A lot of times when you get the data from the prescription drug monitoring program, you will find that patients will have 2, 3, 4, 5, and 6 providers, none of whom know about the other provider and what's being given. Pharmacies don't necessarily know about other pharmacies, so being able to improve that communication between providers about compounds, like potent pain medications and even benzodiazepines, would also be very helpful clinically. Having a national prescription drug monitoring program, or at the very least coverage in each of the 50 states, would also be very helpful.
Dr. Paulozzi: Yes; I think that addressing this problem has to include more than 1 agency, the physicians, the regulatory agencies, the industry, and the public. However, the prescription monitoring programs are very useful in terms of looking at patterns of users, and not just their opioid use. You can certainly look at what's happening with the other drugs, such as benzodiazepines.
Dr. Patkar: One point I would like to make is that about a quarter to a third of patients in pain clinics have a history of substance abuse, according to studies at University of North Carolina at Chapel Hill and other places. There needs to be a coordination between pain programs and addiction treatment programs to treat these patients. I think unless that is coordinated care, these patients are going to be a real problem, and these are the patients who eventually end up with problems of abuse, diversion, or overdose.
Medscape: Dr. Paulozzi, can you speak to what you and the CDC are doing to address the issue of unintentional overdoses? What sorts of initiatives and research are you conducting?
Dr. Paulozzi: We're working on a variety of things in the realm of education, enforcement, and economic strategies. In terms of education, we think that we need guidelines on the proper use of opioids in EDs. There are guidelines for opioids in chronic use, chronic pain, but 40% of opioid prescriptions are written in the ED. There is a lot of doctor shopping going on in the ED, so we think that that's a priority.
In terms of enforcement, we'd like to evaluate laws in states in regard to doctor shopping and pill mills, to see whether they're having an impact on the problem. In terms of economic strategies, we think that the Medicaid programs and the insurers will want to do a better job identifying this problem because it's costing them a lot of money, so we are working to try to get some evaluations done, such as of the Medicaid lock-in programs, and other measures taken by insurance companies, like prior authorization, to see whether they can identify at-risk individuals, not enable their substance abuse, and get them into substance abuse treatment -- and have better outcomes.
I'd say that we're trying to bring some real evidence base to the policy decisions that we're making, both federally and on the state level.
Dr. Patkar: I agree that the efforts have to involve better education, monitoring, regulation, and policies along with development of opiate analgesics with less abuse potential. A simple strategy that clinicians could follow is to advise patients who are prescribed opiates to secure the bottles in a locked cabinet and perform random pill counts. I have had several patients with opioid addiction who were obtaining their tablets from their parents' medicine cabinets without their knowledge. It is worth knowing about sensible strategies that clinicians can adopt for better opioid risk management, risk minimization, and compliance monitoring. Dr. Weisler has already referred to the Controlled Substances Monitoring System adopted by several states that prescribers can access. Other examples include evaluation of risk for addiction in patients who are being prescribed opiates, having a risk management plan for such patients that includes initial use of nonnarcotic medications for pain, urine drug screens, pickup from a single pharmacy, and treatment for comorbid psychiatric and substance abuse conditions. Clinical guidelines for safer opioid prescribing have been published by the American Academy of Pain Medicine and medical boards, such as North Carolina Medical Board and Pennsylvania Medical Board. I would encourage clinicians to implement these guidelines for prescribing opiates for chronic pain.
I would comment that the Controlled Substances Monitoring System (CSMS) in North Carolina is, as far as I know, the same as the prescription drug monitoring programs. I think about 35 states have operating prescription drug monitoring programs, and about 5-7 others have authorized them for future startup. They might not all have as good access to the data as the CSMS but I think we should be clear that we are talking about something that is present in some form in almost all states.
Dr. Weisler: I would echo what both Len and Ashwin have said, that is the importance of both evaluating and effectively treating people with mental and substance use conditions, while hopefully also preventing or reducing the frequency of episodes of illness or substance use. We also have to consider the huge economic losses to society, families, and individuals associated with medication misuse, and patients dying way too young, which happens all too often. A lot of times you'll see drug abuse and mental health related problems translate into legal issues, such as diversion, drug distribution, and other crimes.
There was a very nice study[20] a few years back in JAMA that looked at about 25,000 prisoners in different state, county, and federal systems. Thirty-five percent to 54% of the people who they interviewed had some mania; between 16% and 30% reported symptoms of major depression; and 10%-24% reported symptoms of a psychotic disorder, such as delusions or hallucinations. Like Ashwin talked about earlier, if you have these serious mental illnesses, the likelihood of also having comorbid substance abuse or dependence problem goes up enormously, and so does the risk for crime and legal problems. The problems of reducing unintentional poisoning and suicides are also at times made more difficult by the fact that we now have the same number of mental health beds in the United States per capita (1 for every 3000 now vs 1 for every 300 residents in 1955) as we did in the 1840s when Dorthea Dix was alive.[21]
One last question, Len: I was looking at some data and shared on the Winnipeg, Canada, area; they have also had a significant increase in unintentional drug overdose deaths. Many, many people died who were actually on a waiting list for methadone treatment. Do you think this is a North American problem? Is this a world problem?
Dr. Paulozzi: My understanding is that they are seeing an increase in both the use of opioids and the adverse consequences in Canada, but their rates are still behind ours. There has also been an increase in prescription drug-related deaths in Australia. However, by far and away, most of the reports, most of the literature, is coming from the United States.
Medscape: Dr. Paulozzi, do you have any final thoughts?
Dr. Paulozzi: I would summarize by saying that basically what we intended was more compassionate management of pain in the United States, but we embarked upon this path without a full understanding of how to do it well or how to manage the problems. We probably underestimated the risks from a dramatic increase in the use of opioid analgesics.
On the whole, this topic deserves all the attention that it can get. Thank you to everyone for participating in this call.
Medscape: Thank you, everyone.
Helpful resources: For information in regard to state prescription drug monitoring programs, visit the Drug Enforcement Administration's Office of Diversion Control Website. For more on governmental efforts to prevent suicide and prescription drug misuse, visit The National Strategy for Suicide Prevention Website.
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Cite this: Unintentional Drug Poisoning Deaths: A National Epidemic - Medscape - Jun 28, 2010.
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