Study: One in Five Opioid Prescriptions for Low Back Pain

By Pat Anson, Editor

Doctors continue to prescribe opioids for low back pain, headaches and fibromyalgia – even though some medical guidelines recommend against their use for such common conditions, according to a large new study.

In an analysis of prescriptions filled for 12 million of its members between July 2013 and September 2014, pharmacy benefit manager Prime Therapeutics found that about one in five opioid prescriptions were written to treat low back pain.

"Our analysis found low back pain was the most common diagnosis among all members taking an opioid, even though medical guidelines suggest the risks are likely greater than the benefits for these individuals," said Catherine Starner, PharmD, lead health researcher for Prime Therapeutics.

Over 22% of those receiving long-acting opioids had been diagnosed with low back pain, nearly 5% had headache and about 2% were diagnosed with fibromyalgia.

In a position paper adopted last year, the American Academy of Neurology found there was “no substantial evidence” for long term use of opioids to treat low back pain, fibromyalgia and headache.

Collectively, the data suggest that opioids do not improve function in low back pain and therefore should be avoided. While I am an advocate of minimizing opioids to every extent possible, I also believe that absolutes can be damaging," said Beth Darnall, PhD, a pain psychologist, clinical associate professor at Stanford University and author of Less Pain, Fewer Pills.

“In select individual cases, opioids may be one part of an effective pain management plan.  Even then, patients should be monitored closely and opioids used at the lowest dose for the shortest amount of time possible.  The opioid studies are based on large samples and there are always outliers; we must find ways of minimizing risks, protecting patients, and still leaving room for the reality that the medications may be effective for a minority of individuals.”

Nearly 9% of Prime Therapeutics’ members were prescribed at least one opioid during the study period. On average, the cost for those taking short-acting opioids was $72 per member, compared to $907 per member taking only long-acting opioids.

The company said a clinical program that assesses the appropriateness of long-acting opioids could help improve safety and reduce costs. A screening program could also identify members with a significant number of opioid claims in a short period, or those with diagnosed conditions that may not benefit from prolonged opioid use.

"Identifying these members and helping them find the most appropriate pain treatment for their condition could help reduce safety concerns," said Starner.

Darnall says an education program would also help – one that includes non-drug treatments.

“To reduce opioid prescriptions, patients must be given access to effective alternatives,” Darnall said in an email to Pain News Network. “Additionally, by providing patients with education regarding the limitations of opioids and associated risks clinicians may engage patients in their own care and motivate them to seek and try alternatives.  Such alternatives include psycho-behavioral interventions, self-management programs, graded exercise programs, rehabilitation approaches, and the like.”

Prime Therapeutics manages pharmacy claims for health insurers, employers, and government programs including Medicare and Medicaid. It is collectively owned by 13 Blue Cross and Blue Shield Plans, subsidiaries or affiliates.

Nerve Stimulation Effective in Treating Cluster Headache (VIDEO)

By Pat Anson, Editor

A neuromodulation device that stimulates a nerve in the neck substantially reduced the number and frequency of attacks in patients suffering from cluster headache, according to small study published in the journal Neurology

Image courtesy of electrocore

Image courtesy of electrocore

Seventy-nine percent of patients who completed the study (15 out of 19) reported an overall improvement in their condition after using gammaCore, a nerve stimulator that sends electrical signals along the vagus nerve, which runs through the neck to the brain. Eleven of the patients had chronic cluster headaches, and eight were classified as episodic.

“Cluster headache is a dreadful, extremely painful and disabling condition that can be very complex to manage. Given the unmet need for effective and safe treatments, we were excited to see the outcomes in these patients of an approach offering very considerable promise for future development.” said Peter Goadsby, PhD, who led the research at the Royal Free Hospital in London and the Beaumont Hospital in Dublin.

Cluster headache is a neurological disorder characterized by recurring, severe headaches on one side of the head, often around the eye. Attacks occur suddenly and can range from 15 minutes to three hours. Recommended treatments for cluster headaches include oxygen or triptan. 

Nearly half (47%) of the acute attacks treated with gammaCore ended in an average of 11 minutes.  Ten patients reduced their use of oxygen by 55% and nine patients reduced their triptan use by 48%. Preventative use of the gammaCore device resulted in a substantial reduction in the frequency of attacks, from 4.5 attacks every 24 hours to 2.6 after treatment. 

The treatment, which is self-administered by the patient for two minutes, involves placing the hand-held gammaCore device on the skin of the neck over the vagus nerve. In the study, patients administered two to three rounds of neurostimulation twice per day. Acute attacks were treated with up to six doses at the onset of the attack. Patients reported no serious side events.

GammaCore, which is manufactured by New Jersey based electroCore, is not currently approved by the Food and Drug Administration and is not available in the United States. 

The company is seeking FDA approval for gammaCore in the treatment and prevention of cluster headache. The device currently has regulatory approval for the acute and/or prophylactic treatment of cluster headache, migraine and medication overuse headache in the European Union, South Africa, India, New Zealand, Australia, Colombia, Brazil, Malaysia, and Canada. 

“It is not certain how vagus nerve stimulation treats and prevents migraines and cluster headaches, but data suggest that it may work by sending signals into the brain that reduce the amount of a substance, called glutamate, that has been associated with headache symptoms,” the company says in a statement on its website.

ElectroCore is developing Vagus Nerve Stimulation (nVNS) therapies for the treatment of multiple conditions in neurology, psychiatry, gastroenterology and respiratory fields. The company’s initial focus is on the treatment of primary headaches (migraine and cluster headache), and the associated chronic co-morbidities of gastric motility, psychiatric, sleep, and pain disorders.

ElectroCore has raised more than $80 million from investors including Merck’s Global Healthcare Innovation fund.