A Pained Life: ER Protocols

By Carol Levy, Columnist

When I read about people going to the emergency room to be treated for breakthrough pain, it is rare for anyone to say they felt they were well-treated. They tend to say they were disbelieved, looked at as a drug seeker, or the ER doctor did not give them enough meds to last until they could see their pain management doctor.

I have almost always replied, “Ask your doctor to send a protocol letter to the ER. Then if you have to go they will know what you have and how your doctor wants it treated.”

It occurred to me that it would be a good idea for me to query some ER's and see if this was in fact good advice.

After talking with one nurse, I did not feel it necessary to talk with any others.

She told me too often patients come in who are known to be drug addicts or drug seekers. Often they come in complaining about chronic pain.

This can make it hard to distinguish who is truly in pain vs. someone feigning pain merely to get narcotics. 

I asked if a letter from a doctor explaining what the patient has and what could be done for them would help.

"That won't work," she said.  I asked why not.

"Very simply, the doctor would have to constantly be updating the letter,” she explained. “A letter written 6 months ago would be ignored. Things change, the patient may change, and we could not rely on something written that long ago. If a doctor sent us a protocol letter it would have to be updated every month or so and no doctor is going to go to the trouble to do that."

That made a lot of sense. Both that a doctor would not be willing to take the time and that the protocol letter would have to be a recent one.

“What if a patient called their doctor's office and then the doctor called the ER with instructions about what to do for the patient?” I asked.

“That would work. And is probably the best thing for someone to do,” the nurse told me.

I know it is hard to wait when you are in pain. I know the idea of giving the doctor time to call back -- say in an hour -- would seem like the longest hour in the world, especially when the pain feels insurmountable.

Most ER physicians don’t know us when we come in. We are just another stranger, saying we are in pain and often asking for narcotics. If we give our doctors the time to call them, the chances are much greater that an ER visit will have a better outcome – instead of leaving us feeling disrespected, mistreated, or not treated at all.

Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 30 years. She is the author of “A Pained Life, A Chronic Pain Journey.”  Carol is the moderator of the Facebook support group “Women in Pain Awareness.” Her blog “The Pained Life” can be found here.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Study Finds Acupuncture Has Placebo Effect

By Pat Anson, Editor

When it comes to acupuncture, perception apparently does matter.

British researchers found in a new study that people with back pain who believe acupuncture will not help or do little to relieve their symptoms will gain less benefit from treatment than people who believe it works.

And people who feel they can manage their back pain have less disability as a result of acupuncture treatment.

“They experienced less disability over the course of treatment when they came to see their back pain as more controllable, when they felt they had better understanding of their back pain, when they felt better able to cope with it, were less emotional about it, and when they felt their back pain was going to have less of an impact on their lives," said Felicity Bishop, PhD, an Arthritis Research UK career development fellow.

Bishop and her colleagues at the University of Southampton wanted to find out why some people with back pain gain more benefit from acupuncture than others. They recruited 485 people with back pain and asked them to complete questionnaires before they saw an acupuncturist; as well as two weeks, three months and six months after starting treatment. The questions measured psychological factors, clinical and demographic characteristics, and back-related disability.

The study, which was funded by Arthritis Research UK, is being published in The Journal of Clinical Pain.

"The analysis showed that psychological factors were consistently associated with back-related disability," said Bishop, who believes acupuncturists should consider helping patients think more positively about their back pain as part of their treatment.

"People who started out with very low expectations of acupuncture -- who thought it probably would not help them -- were more likely to report less benefit as treatment went on,” she said.

Previous research has shown that many factors -- other than the insertion of needles – can play a role in the effectiveness of acupuncture, such as the relationship that the patient develops with the acupuncturist and the patient's belief about acupuncture.

"This study emphasises the influence of the placebo effect on pain. The process whereby the brain's processing of different emotions in relation to their treatment can influence outcome is a really important area for research,” said Dr. Stephen Simpson, director of research at Arthritis Research UK.

Acupuncture, which was originally developed as part of traditional Chinese medicine, is one of the most widely practiced forms of alternative medicine. As many as 3 million Americans receive acupuncture treatments, most often for relief of chronic pain.

While there is little consensus in the medical community about acupuncture’s value, a study in the Archives of Internal Medicine found that relief offered by acupuncture is real and should be considered a viable form of treatment .

Focusing on patients who reported chronic back and neck pain, osteoarthritis, chronic headache and shoulder pain, researchers at Memorial Sloan-Kettering Cancer Center in New York conducted a meta-analysis (a study of studies) of 29 studies involving nearly 18,000 adults.

“Acupuncture is effective for the treatment of chronic pain and is therefore a reasonable referral option. Significant differences between true and sham acupuncture indicate that acupuncture is more than a placebo,” the study concluded. “However, these differences are relatively modest, suggesting that factors in addition to the specific effects of needling are important contributors to the therapeutic effects of acupuncture.

Hysingla & Zohydro: Same Church, Different Pew?

By Dr. Jeffrey Fudin

Same church different pew you ponder?  It’s not that simple. 

Almost a year to the day since the availability of Zohydro ER (hydrocodone extended release, manufactured by Zogenix), there is now another kid on the block; Hysingla ER (hydrocodone extended release, manufactured by Purdue). Nobody can deny that Zogenix paved a pretty hefty path to bring and keep this on the market.

Along the way was a pretty disheartening road.  But no matter how many unearthed faults were found in the path, they were minuscule compared to the faulted rhetoric among media sensationalists and politicians. With one road block after another, it became clear that politicians were more interested in saying something (anything) for the attention than they were about the truth. In fact, their futility and sensationalistic journalism promulgated numerous blogs here.  

On the one hand I suppose that was cultivating for this site and our readers, but unfortunately it was on the backs (perhaps literally) of legitimate pain sufferers that might otherwise benefit from an extended release formulation of hydrocodone.  Rehb.com provides some interesting infographics that break down nationally and by state, various permutations of how “Admissions to treatment facilities has been steady or rising for the past 20 years, yet it seems elected officials spend less and less of their time on the floor of the House and Senate talking about it.”

The indisputable facts are that since Zohydro ER release in March 2014, there have been over 50,000 prescriptions filled (almost 3 million capsules dispensed) yet an extremely low incidence of abuse, misuse, and diversion reported in the surveillance databases. 

Do note however that because schedule II drugs are not allowed automatic refills, each Rx is considered an initial fill, so the 50,000 prescriptions does not equate to 50,000 patients. I imagine we will see similar safety and surveillance data for Hysingla ER in the months ahead.

So, you ask, what are the differences?  On the surface it seems simple; 1 ) Hysingla ER is once daily dosing and Zohydro ER is twice daily dosing; 2 ) Hysingla ER has an FDA label as “abuse deterrent” and Zohydro ER does not (yet); and 3 ) Hysingla ER is a tablet and Zohydro ER is a capsule.

Let’s break this down, because ultimately it really should be about the patient.

History tells us that once daily or twice daily intended dosage forms sometimes require twice or three times daily dosing respectively.  Third party payers have notoriously used this as an excuse not to pay. By way of example, OxyContin (oxycodone extended release) is indicated for every 12 hour dosing, but it is not uncommon to see it appropriately prescribed every 8 hours instead of every 12 hours. The same is true for Avinza (morphine extended release).  Avinza is indicated for every 24 hour dosing, but it is not uncommon to see it prescribed every 12 hours instead of once daily. The best example where reality, practicality, and just plain good medicine flew in the face of the original package insert is brand name Duragesic, fentanyl transdermal (TD).   

The original package insert required every 72 hour changes of the patch.  Some patients didn’t receive adequate analgesia for that period of time – the manufacturer recommendation therefore was to raise the patch dosage to the next highest strength.  Sure, this would therefore raise the overall serum levels thus extending the therapeutic blood levels perhaps into the third day, but was it clinically the best thing for the patients and did it adhere to basic therapeutic principals?  The answer is no!  We always want to give the lowest effective dose.  If that could be achieved by remaining on the same fentanyl dose and changing it more frequently, then that is the proper approach.  See Medscape, Can Fentanyl Patches Be Replaced Sooner to Improve Pain Control?

To address point #1 above, the once daily practicality and convenience of Hysingla ER is of course a wonderful thing.  For a caregiver that can only get to the home once daily, it is a Godsend.  But, although it is a nice option for many, some patients might be better off on a lower overall 24 hour dose by using the every 12 hour dosage form of Zohydro ER.

To address point #2, abuse deterrent technology (ADT) is a wonderful thing too (kudos to Purdue), but ADT is not the be all and end all of substance abuse; it is simply another option.  To read more about that, see the Pharmacy Times article Abuse-Deterrent Opioid Formulations: Purpose, Practicality, and Paradigms. For the record, Zogenix ER has received FDA approval for their new abuse deterrent formulation.

And finally to address point #3, Hysingla ER is a tablet and Zohydro ER is a capsule.  From experience, it is clear that some patients are better able to swallow one compared to the other.  For some, the fear of swallowing a tablet (a form of phagophobia) is insurmountable.  For those that cannot swallow a tablet, I do prefer a capsule and the patient is told to sit or stand straight, place the capsule in their mouth, sip a mouthful of water, and look down towards the table or floor.  The capsule floats to the back of the throat – now swallow.  Although this often works, some might do better with a small tablet.

Hysingla ER is available by tablet in milligram strengths of 20, 30, 40, 60, 80, 100, and 120.

Zohydro ER is available by capsule in milligram strengths of 10, 15, 20, 30, 40, and 50.

For the benefit of media sensationalists and political mouthpieces, let me save you the trouble and embarrassment this time around, because if tempted, I will call you out publically again.  Hysingla ER 120mg is not 3 times more potent than Zohydro ER 40mg. They are equipotent because hydrocodone is hydrocodone is hydrocodone as explained in the previous post here, ZOHYDRO: What weighs more – A pound of feathers or a pound of hydrocodone?

Kudos to the two companies that fought to bring these new options to market for patients that can truly benefit from a single entity extended release dosage form of hydrocodone. 

Jeffrey Fudin, PharmD, is a Diplomate to the American Academy of Pain Management. 

Dr. Fudin practices as a Clinical Pharmacy Specialist and Director at the Stratton Veterans Administration Medical Center in Albany, NY.  

This column is republished with permission from Dr. Fudin’s blog.