Survey: Two-Thirds of Patients Unable to Get Hydrocodone

By Pat Anson, Editor

About two-thirds of pain patients say they were no longer able to obtain hydrocodone after the opioid painkiller was reclassified by the U.S. government from a Schedule III medication to a more restrictive Schedule II drug, according to the results of a new survey.

Many patients who had been taking hydrocodone at the same dose for years said their doctor would no longer prescribe the painkiller. Over a quarter (27%) said they had suicidal thoughts after being denied a prescription for hydrocodone.

The survey of over 3,000 patients was conducted online by the National Fibromyalgia & Chronic Pain Association (NFMCPA) and the findings presented this week at the annual meeting of the American Academy of Pain Medicine. An abstract of “Hydrocodone Rescheduling: The First 100 Days” can be found here.

Hydrocodone was rescheduled by the Drug Enforcement Administration in October of last year to combat an “epidemic” of prescription drug abuse. The rescheduling limits patients to an initial 90-day supply and requires them to see a doctor for a new prescription each time they need a refill. Prescriptions for Schedule II drugs also cannot be phoned or faxed in by physicians.

The reclassification quickly made a drug that was once the most widely prescribed pain medication in the country – at nearly 130 million prescriptions each year – to one of the hardest to get.

Other key findings of the survey:

  • 88% of respondents believe the change to Schedule II denies pain patients the right to adequate pain care.
  • 75% believe the change will not prevent prescription drug abuse.
  • 72% believe the change is harmful to pain patients.
  • 18% said it led to a "worsened relationship" with their doctor.
  • 30% reported "issues" with their pharmacy filling prescriptions.

Patients also reported higher expenses due to increased doctor’s visits, higher co-pays, greater transportation costs to visit the doctor and multiple pharmacies, and lost income due to inability to work because of pain.

The survey is believed to be the first to report on the experiences of pain patients treated with hydrocodone since the rescheduling took effect. The respondents were overwhelmingly female, which reflects the demographics of fibromyalgia and many other chronic pain conditions.

Hydrocodone isn’t the first pain medication to be in short supply. A report released last month by the Government Accountability Office (GAO) faults the DEA for poor management and “weak internal controls” of the quota system under which controlled substances are produced and distributed.

Between 2001 and 2013, the GAO said there were 87 “critical” shortages of drugs containing controlled substances, over half of them pain relievers. The vast majority of drug shortages lasted over a month and some dragged on for years. An oral solution of oxycodone was difficult to obtain for eight and a half years.

“The shortcomings we have identified prevent DEA from having reasonable assurance that it is prepared to help ensure an adequate and uninterrupted supply of these drugs for legitimate medical need, and to avert or address future shortages. This approach to the management of an important process is untenable and poses a risk to public health,” the report states.

Lyrica Fails in Study of Juveniles with Fibromyalgia

By Pat Anson, Editor

Lyrica, a blockbuster drug widely prescribed to treat chronic pain in adults, works no better than a placebo in treating juveniles with fibromyalgia, according to the results of a new study released by Pfizer (PFE). Lyrica is Pfizer’s top selling drug with annual worldwide sales of over $5 billion.

The double-blind Phase IV trial was conducted to fulfill a post-marketing study required by the Food and Drug Administration after Lyrica was approved for the management of fibromyalgia in adults in 2007. The generic name of Lyrica is pregabalin, which was originally developed as an anti-epileptic drug.

“The primary endpoint of the study was not achieved as there was not a statistically significant difference between pregabalin and placebo in mean pain score,” Pfizer said in a statement.

A total of 107 adolescents (ages 12-17 years) were enrolled in the 15-week study at multiple centers across the U.S., Europe and Asia. It was the first large study on the efficacy and safety of Lyrica in juveniles with fibromyalgia.

The National Institutes of Health estimates that about 5 million Americans suffer from fibromyalgia, a poorly understood disorder characterized by deep tissue pain, fatigue, headaches, mood swings and insomnia.

In the study, Lyrica was administered twice daily, starting at 75 mg/day and then increasing to up to 450 mg/day, depending on the tolerability and response of the patient. The most common side effects in the study were dizziness, nausea, headache, increased weight and fatigue. Many other patients who take Lyrica complain of similar symptoms.

"Pfizer is committed to better understanding the full clinical profile of our approved medicines in pediatric and adolescent patients. This study advances the understanding of this patient population," said Steve Romano, MD, senior vice president of Global Medicines Development for Pfizer. "These results do not change the established benefit of Lyrica for its approved indications, including fibromyalgia in adults."

In addition to fibromyalgia, Lyrica is approved by the FDA to treat chronic pain associated with epilepsy, shingles, diabetic peripheral neuropathy, and spinal cord injury. The drug is also prescribed “off label” to treat lumbar spinal stenosis, the most common type of lower back pain in older adults.