​Wednesday, June 20, 2012

How the War on Rx-Drugs Victimizes Pain Patients


[In the News] In a battle against prescription drug abuse and diversion, primarily involving opioid pain relievers, the U.S. Drug Enforcement Agency (DEA) has launched attacks on wholesalers and pharmacies within the legitimate supply chain. Questions are being raised about the foresight of such tactics, as healthcare providers are becoming leery of prescribing and severe shortages of these vital analgesics loom over the horizon.In the end, patients with pain may become collateral damage in this “War on Rx-Drugs.”

According to a recent report from Reuters news service [“U.S. War on Drugs Moves to Pharmacy from Jungle”; June 16, 2012], in response to ever-increasing concerns about the diversion of prescription pain relievers to illegitimate use, the DEA has beefed up its efforts at deterrence and is deploying many of the tactics it uses to combat illegal drugs, such as wire taps, undercover operations, and informants.

Such efforts have helped it dismantle many “pill mills” — bogus pain clinics writing thousands of questionable prescriptions — as well as rogue Internet pharmacies. However, the agency is now applying the same tactics to prosecute the legitimate pharmaceutical supply chain, including wholesalers and pharmacies that must follow strict record-keeping and security rules to prevent drug diversion.

Tactical Maneuvering

During the past few years, according to the Reuters report, the DEA has stepped up its inspections and levied millions of dollars in fines against drug wholesalers for what it claimed were breaches of the rules. Last February, the DEA suspended the license of drug wholesaler Cardinal Health Inc. to sell opioid analgesics and other controlled substances from its center in Lakeland, Florida. The DEA said the wholesaler had failed to detect suspicious order volume from several of its pharmacy customers.

Under a settlement, Cardinal agreed not to ship controlled substances from that facility for 2 years. Then, shortly afterward, the DEA raided two CVS pharmacies and issued inspection warrants at a half-dozen Walgreens drugstores and a Walgreens distribution center.

DEA Administrator Michele Leonhart has defended the actions as essential for combating prescription drug abuse and diversion. But critics say that applying the same strong-arm tactics to the legitimate supply chain as to Colombian drug lords is ineffective and is also causing supply shortages that harm patients with pain.

“Going after a pharmaceutical [distributor] is not like going after the Medellin cartel,” said Adam Fein of Pembroke Consulting. “I don’t believe it is appropriate for the DEA to shrink the supply of prescription drugs, because it has unanticipated effects that have nothing to do with the problem.”

However, the DEA has come under increasing pressure from Congress to show it is containing the diversion problem.Leonhart claims that the best benchmarks of the agency’s success should be the disruption and destruction of the organizations and the networks feeding the problems, so the agency is going in that direction. The DEA has expanded its use of tactical squads, combining special agents, diversion investigators, and local law enforcement officers to track down and prosecute prescription drug dealers.

Still, the Reuters report observes, “sending in tactical diversion squads to break up pill mills does not address the leaks occurring from medicine cabinets at home or the drugs passed along from friends and family. That is one reason the DEA is attempting to squeeze supplies at the wholesale level.”

John Coleman, a former DEA chief of operations, comments that “Going after Cardinal has sent shivers up the distributor grapevine.” Along with that, “close a CVS pharmacy in Florida, and I guarantee every pharmacy within 500 miles will be checking their records,” he says.

Fears Running Rampant

Pharmacists confirm that they are indeed fearful, Reuters reports, with some being reluctant to accept new customers requiring prescription analgesics. Others will only accept patients within a certain geographic area or refuse to accept cash.

“We turn away five or six people a day,” said Steven Nelson, owner of a discount drugstore in Okeechobee, Florida, and chairman of governmental affairs for the Florida Pharmacy Association. Even large chains are leery:

Walgreens spokesman Michael Polzin said that after looking into everything going on in Florida, “we’ve decided not to comment on our operations there at this time.”

CVS pharmacies across Florida stopped filling prescriptions written by 22 of the top-prescribing physicians, pending a review of their dispensing practices. The company declined to elaborate on its actions, except to say that it will continue to monitor prescriptions for controlled substances and is “committed to supporting efforts to prevent drug abuse and keep controlled substances out of the wrong hands.”

Physicians are equally fearful, according to Reuters. Many have increased patient monitoring, which means more urine tests, more documentation, and more frequent “pill count” checks, where patients must go to the prescriber’s office with their pill bottles to prove they have not sold or misused their medication.

“Every hour of the day I have concerns I’ll be audited, that my ability to take care of my patients and my family can be taken away, and I’m as legitimate as you can get,” said one prescriber who has a private orthopedic practice in Florida. “You’re constantly watching over your shoulder and it takes a toll,” he told Reuters news.

Slashing Supplies, Raising Questions

During the past 5 years, Cardinal has cut supplies of controlled substances to more than 375 customers nationwide, including 180 pharmacies in Florida, Reuters reports. Other wholesalers are similarly cautious; AmerisourceBergen Corp. now monitors orders for suspicious increases of 20% to 30% in volume.

All of those involved — wholesalers, pharmacists, prescribers — claim they want to help curtail abuse, but DEA rules have not always been clear. Meanwhile, the DEA’s Leonhart rejects that notion, claiming the agency has repeatedly communicated its requirements in meetings and presentations.

But John Burke, president of the nonprofit National Association of Drug Diversion Investigators (NADDI), says the DEA behaves as though those it monitors are the enemy. “The mindset is, these are folks we have to keep at arm’s length,” he told Reuters.

The DEA’s strategy is also prompting new questions from Congress. Reuters reports that Senators Chuck Grassley of Iowa and Sheldon Whitehouse of Rhode Island asked the GAO (Government Accountability Office) to study whether the agency’s actions are contributing to shortages of medications for pain patients.

Others say the DEA should not be in the business of regulating industry at all.Scott Gottlieb, former deputy commissioner of the Food and Drug Administration (FDA), publicly criticized the DEA for attacking prescription drug problems in the same way it pursues criminal drug cartels. “The problem is, the DEA may be the wrong enforcer here. It’s very difficult to separate appropriate use from illicit use with law-enforcement tools alone,” Gottlieb wrote in the Wall Street Journal [“The DEA’s War on Pharmacies—and Pain Patients”; March 22, 2012].

The DEA’s confrontation with wholesalers and pharmacies follows public concerns about who has been responsible for shortages of many critical drugs within the healthcare system nationwide. The Reuters report notes that the DEA strictly controls the amount of an ingredient in a potentially addictive drug that its manufacturer can obtain each year, based on the projected needs of legitimate patients. Manufacturers have claimed that the agency does not always authorize enough material in time for them to amply supply customers with products. The DEA counters that shortages are resulting from unspecified poor business decisions made by the companies.

Meanwhile, the Reuters report observes, patients with pain, unable to access a needed supply of prescribed analgesics, are struggling to function. Substitute pain medications often are inadequate and even those are becoming scarce.

COMMENTARY: An Unintended Public Health Crisis

The above article adapted from Reuters news pretty much tells the tale ofhow the war on illicit drugs in America has shifted to a war on prescription pain-relievers, namely opioid analgesics, in which patients with chronic pain are becoming collateral damage. What has happened in Florida may be only a harbinger of what is to come around the country, and in other countries.

The aggressive tactics being initiated by government regulatory and law enforcement agencies against legitimate operations within the pharmaceutical supply chain — wholesalers, pharmacies, prescribers — seem unprecedented in American history. One can hardly blame these businesses and healthcare providers for their fears, motivating them to drastically curtail product prescribing, dispensing, and distribution rather than risk being shut down entirely.Perhaps, this is exactly what the government intended to happen.

Clearly, the bellwether victims in this “war” are patients with chronic pain whose ongoing access to essential pain-relievers has disintegrated or is increasingly threatened. Next, however, there could be supply shortages of vital opioid analgesics even for treating acute pain conditions — a broken bone, surgical wound, and the like — or severe cancer-related pain; an unimaginable but looming possibility.

Decision-makers and leaders at all levels of government owe it to the public to consider the long-term consequences of actions today that could incur extensive and unnecessary suffering tomorrow.There is no doubt that problems of Rx-drug misuse, abuse, overdose, and diversion are real, of considerable magnitude, and of great significance. However, the government’s shortsighted efforts to quickly stem those problems may end up causing an enduring public health crisis of extraordinary proportions.

​Wednesday, April 10, 2013
Will Pain Patients Be Going “Cold Turkey”?


[Cold Turkey] As noted previously in these UPDATES, voices of the many millions of persons with chronic pain often seem to go unheard when it comes to policies and regulations governing their treatment, particularly when it comes to recent initiatives that threaten to limit access to opioid analgesics. Finally, they have spoken up, largely out of concern and fear that the day might come when they will be forced off of their medications — “cold turkey.”

Supported by a new research survey, with 2,840 participants from 10 patient groups, the International Adhesions Society (IAS; www.adhesions.org) submitted concerns to the U.S. Food and Drug Administration (FDA) regarding a petition from Physicians for Responsible Opioid Prescribing (PROP) to change labeling on opioid analgesic products. The PROP petition, most recently discussed in an UPDATE [here], requests 3 changes: (1) strike the term “moderate” from the indication of opioid analgesics for non-cancer pain (leaving “severe pain” as the only indication); (2) add a maximum daily opioid dose, equivalent to 100 milligrams of morphine for non-cancer pain; and (3) add a maximum duration of 90 days for continuous (daily) opioid use for non-cancer pain.

According to David Wiseman, PhD, MRPharmS, founder of the IAS, their survey data submitted to the FDA represents the voices of more than 25 million Americans with chronic pelvic, abdominal, or spinal pain due in part to adhesions, endometriosis, interstitial cystitis, irritable bowel syndrome, and complications of gynecological surgery. Overall, the group asserts, the opioid requirements of almost all patients would be negatively impacted by proposed limits of the PROP petition and patients’ future access to opioids would be strongly compromised.

“None of our patients want to take pain medications,” Wiseman writes in his recommendations to the FDA. The vast majority, if not all, of the patients we serve are responsible users of these drugs. Opioids are the last resort for many patients unable to find alternative relief. We are concerned that the proposals will precipitate a ‘cold turkey’ [withdrawal] for millions of chronic pain patients.”

In the survey, which had been conducted online, patients responded to a range of questions about their pain and its treatment. Opioid therapy was being prescribed for the majority of respondents (62%, or 1766/2840), and several questions specifically addressed how components of the PROP petition would affect their care.

Limiting indication to “severe” pain only — 46% of all respondents would be excluded from treatment with opioids because their pain is not rated as “severe.” Less than 1% of patients reported having only “mild” pain.

Limiting duration of treatment — 86% of the cohort reporting opioid use would be excluded from further treatment because they have used opioids for more than 3 months; 55% of those patients had been prescribed opioids for more than 2 years.

Limiting dose to 100mg morphine equivalent — 24% of patients taking opioids would be excluded from further treatment on the basis of this dose limit.

Combining opioid dose and duration limits — the combined effect of these 2 restrictions would exclude from further opioid treatment 86% of all patients currently prescribed opioids.

Combining dose, duration, and pain severity limits — applying all 3 restrictions would exclude 92% of the patients in this study from further opioid therapy.

[Pain Words] One of the problematic aspects of the proposed label changes is defining what is meant by words like “severe pain.” Difficulties of ranking pain severity on a numeric rating scale (NRS) were most recently discussed in an UPDATE [here]. The IAS survey asked participants to select the lowest number that means to them pain described as “Mild,” “Moderate,” “Moderate to Severe,” or “Severe.” For the 1,754 respondents to this question, there is a diversity of opinion and significant overlap of categories when words are used to segment an 11 point NRS.

Wiseman observes, this means that attempting to categorize pain and determine qualification for opioid therapy by the use of word descriptors will be imprecise and inequitable. Some patients will be unfairly denied opioids, while others will undeservedly receive them, defeating the objectives of the proposed label changes.

A number of questions asked respondents their opinions about current opioid prescribing practices and how label changes might alter those. Overall, when considering each of the 3 proposed restrictions — relating to pain level, dose, and treatment duration — 57%, 43%, and 68% of patients, respectively, believed that their healthcare providers would be less willing or not willing to prescribe opioids for their pain. Furthermore, 53% believed that their health insurance carriers would be very likely or almost certain to deny coverage for opioid analgesics.

Overall, either because of prescribers’ reticence or lack of insurance coverage, respondents felt their access to pain medication and control would be greatly (62%) or somewhat (26%) reduced, with only 12% believing that their access would not change. In another question on this topic, 82% of respondents agreed somewhat or strongly with the statement: “Too many label restrictions will reduce my ability to get pain relief.”

In a question assessing patients’ perceptions about the use of opioids, 76% agreed somewhat or strongly with the statement: “We need opioid drugs, but I wish there were alternatives that were safer and with fewer side effects.” In this regard, survey respondents also were allowed to add personal comments, and here are several:

  • “Chronic pain patients are responsible users of opioids, please do not treat us like criminals. Keep the government out of the practice of medicine.”
  • “If you understood better how pain affects my life, you will understand why I need medication. Opioids help us live our lives.”

  • “Punish those who are abusing opioids – find other ways to address abuse, you may not succeed but don’t hurt us in the meantime.”

  • “Restrictions on opioids would increase suicide rates among chronic patients and drive patients to obtain drugs illegally.”

  • “Educate doctors better on the treatment of pain — opioids can be used safely.”

Finally, proponents of the label-change petition have argued that the restrictions would not limit pain management practices, since “off label” prescribing of opioid medications still would be permitted. However, echoing the opinions of others in the field, Wiseman observes that such sentiments are “untenable and disingenuous,” and further asserts:

“In an environment of ever-more aggressive malpractice litigation and cost containment by hospitals and insurance providers, physicians will be reluctant to prescribe ‘off-label’ for fear of legal or professional reprisals, and payors may deny coverage for treatments that are ‘off-label’ and ‘experimental.’ Legitimate patients will have reduced access to opioid analgesia. This fear was expressed by more than 80% of patients in our survey of chronic pain patients, which also showed that the use of opioids would be considered off-label in 92.4% of the patients we surveyed, if all three limitations were implemented.”

Participants in this survey of patients in the USA were >18 years old, with chronic, non-cancer pain, and 93% were female. Average age was about 47 years (range 18-83), and 5% of respondents were uninsured, 22% were covered by Medicare/Medicaid, and the remaining 73% were insured through their employers or otherwise. Patients reported an average of nearly 8 types of pain, including interstitial cystitis (71%), pain during or after intercourse (57%), back pain (53%), vulvodynia or vaginal pain (40%), irritable bowel syndrome (38%), other bladder pain or pain related to urination (35%), migraine (33%), arthritis or other joint pain (32%), hip pain (31%), pain due to adhesions (29%).

Almost all patients (97%) reported some pain lasting more than 2 years. Respondents reported using (at any time) an average of 2.68 different opioid analgesics (range 1-15, mode 1). The 5 most commonly used opioids in this population were hydrocodone (27%), oxycodone (20%), tramadol (15%), codeine (7%), and morphine (6%).

COMMENTARY: This was an important study and the only one that we know of to directly assess and reflect patients’ perceptions of the potential impact that label changes requested in the PROP petition would have on their treatment for chronic non-cancer pain. Yet, it must be conceded that surveys of this sort have strong limitations.

Most significantly, the 2,840 total participants in this survey represent a relatively tiny and select sampling of all patients with chronic pain who might benefit from opioid therapy. Respondents were overwhelmingly female and comprised a subgroup that is not representative of all types of pain conditions. Also, since respondents volunteered online for the survey, there was likely a selection bias in that patients with strong interests or opinions regarding the issues may have more eagerly participated. Furthermore, some of the questions were speculative, asking respondents to imagine what would happen if the label changes were imposed in the future.

The survey was organized by the International Adhesions Society (IAS), which is funded by Synechion, Inc., a company owned by Wiseman that focuses on adhesions and non-pharmacologic therapies for related pain conditions. However, a commercial vested interest in outcomes of the survey seems unlikely. Other organizations, which encouraged participation by their audiences, included: Endometriosis Association, Interstitial Cystitis Association, Interstitial Cystitis Network, Endometriosis Research Center, Arachnoiditis Society for Awareness and Prevention, EaseNervePain.com, HysterSisters.com, LivinginPain.org, and DrugWatch.com.

Despite the limitations, if results of this survey are valid and can be reliably extrapolated to the much larger and broader population of persons with chronic pain, it seems clear that the proposed opioid label changes could have a devastating and enduring impact on the well-being of the majority of those patients who benefit from opioid analgesic therapy.This also is consistent with the many apprehensive comments from patients received in the past at various UPDATES articles addressing this topic, and it is in opposition to the claims of some professionals that the label changes would not negatively affect optimal patient care. Meanwhile, as of this writing, the FDA is pondering a decision on the PROP proposal.

Victimizing Pain Sufferers