Ensuring access to chronic pain medications

NEW YORK — News stories about doctor shopping and prescription pad pilfering in pursuit of a pain-pill induced high have become commonplace, prompting many legislators and regulators to consider further restrictions on pain medicines like hydrocodone compounds.

But there may be a story that’s not being told — that the patients who suffer from chronic pain and need that hydrocodone to reclaim their lives are being stigmatized. The prevalence of pain pill abuse has left in its wake as many as 116 million legitimate pain sufferers who are finding it more difficult to access their therapies.

It’s a stigmatized population, but not unfamiliar. The disease states in which patients may need chronic pain relief include such well-known conditions as fibromyalgia, diabetes neuropathy, post-surgical, osteoarthritis and lupus. Cancer patients going through chemotherapy are also chronic pain sufferers.

The reality is there is a significant population suffering from chronic pain. The perception is that anyone seeking relief from that chronic pain likely is an addict.

“A pain patient is not the same as an abuser — they’re two different people,” Paul Gileno, president of the U.S. Pain Foundation, told DSN. “A person with pain is not the person that’s robbing the pharmacies in search of pain meds. They’re two different people, but they seem to be lumped in together.”

“People feel so stigmatized when they’re a person with [chronic] pain,” Gileno, said. “They feel like they’re doing something wrong because they need pain meds. [And] the doctors are getting so nervous about prescribing [the controlled substances] that they underprescribe.”

According to a study of physicians’ attitudes about pain drugs published in 2013 in The Journal of Pain, negative physician attitudes about opioid medications are closely associated with lower rates of prescribing, and more favorable attitudes are linked with higher prescribing levels.

And while that stigma represents its own barrier to appropriate access, both regulators and legislators are seeking to further restrict access to these medicines in an effort to crack down on the problem of controlled substance abusers.

The Food and Drug Administration currently is pushing to reclassify hydrocodone compounds by a more restrictive schedule — moving these medicines from Schedule III, where they are now, to Schedule II.

“Each day that passes means rising abuse, and even death, at the hands of hydrocodone-based drugs,” stated Sen. Charles Schumer, R-N.Y. “I’m very pleased that the FDA … will tighten up control of one of the most highly prescribed — and abused — drugs on the market.” Schumer has lobbied hard for the rescheduling of hydrocodone compounds. His home state of New York has already moved in that direction by reclassifying these pain relievers to Schedule II in February 2013.

For patients, reclassifying hydrocodone compounds as a Schedule II substance would require them to make a doctor’s visit every time they need a prescription. Refills of Schedule II drugs are not permissible; and the prescriptions have to be original copies. That represents a significant cost barrier that for many pain sufferers may further restrict access to much-needed medicines.

“We see it as an access issue,” Gileno said. “It means more doctor visits for patients, more travel, more co-pays. It means more cost to a person with pain,” he said. “These are people who are on a regimen of medicine that has been working for them. … It raises costs for the patient. People who are already struggling to work now have the additional co-pays and time [commitments].”

The rescheduling of hydrocodone compounds will have repercussions up and down the supply chain, in large part because of the sheer volume of prescriptions that would be reclassified. In 2012, pain was the No. 2 most-prescribed therapeutic class of medicines, with 472 million prescriptions written, according to IMS Health. The most-prescribed medicine for the year was hydrocodone/acetaminophen, with 135.3 million prescriptions written for the pain-relieving compound.

Proponents of rescheduling point to the large volume of pain pill prescriptions written each year and suggest that that’s the problem — doctors are writing too many prescriptions for products like hydrocodone/acetaminophen. Pain patient advocates can identify with that volume of prescriptions as well, because behind the majority of those prescriptions is a pain sufferer. Restricting access doesn’t help them.

At the wholesale level, Schedule II substances have to be stored in a locked vault vs. being restricted to a caged area, meaning drug distributors would need to make wholesale capital investments in expanding their vault space to accommodate that additional 135.3 million in hydrocodone/acetaminophen prescriptions alone.

And retailers would likewise need to invest in larger, security storage units in an effort to be compliant with the new restrictions. That is, if they want to stock enough supply to meet demand.

That increase in investment could force many pharmacy operators, especially smaller community pharmacies serving rural patients, to reconsider carrying hydrocodone compounds at all.

On the state level, many legislators are debating how to best regulate controlled substances like hydrocodone compounds. But in place of rescheduling, some states are imposing restrictions on refills of Schedule III medicines. For example, New Mexico recently placed limitations on the time period within which a prescription for hydrocodone and APAP, for example, can be filled. The restriction encourages prescribers to see patients more frequently vs. just calling in refills.

In Alabama, Gov. Robert Bentley in August signed three bills in an effort to curb prescription drug abuse and diversion. One beefed up the state’s prescription drug monitoring program; another increased regulation of pain management clinics, a regulatory trend that stretches from Ohio down to Florida; and a third made “doctor shopping” a criminal offense. None of these measures restrict access of pain medicines from legitimate patients, necessarily.

“There are many good physicians treating patients who have legitimate issues with pain, and we want to encourage the continued treatment of those patients,” stated Buddy Smith, chairman of the Medical Association of the State of Alabama Board of Censors.  “Some states that have tried to combat prescription drug abuse have passed legislation that had disastrous effects on patient care and placed tremendous burdens on physicians. This package presents a workable solution. It comprehensively tackles this growing problem in our state.”

Presently, 49 states and the District of Columbia have prescription monitoring programs in place that help reduce the ability to doctor shop — only Missouri doesn’t have a monitoring program in place. When seeing a patient, a doctor can access the program and make sure their patient hasn’t recently filled a pain medicine prescription. And many of the states are sharing that information with bordering states to prevent someone from doctor shopping across state lines.

“It makes a lot of sense because it protects legitimate patients who have been going to the same pharmacy, getting their prescriptions filled,” Gileno said. “We don’t want people scared of appropriate therapies. We want them to be aware of it and educated. There are millions of people with positive stories who are taking