There Is Another Drug Reform Bill the Senate Must Pass

By Michael C. Barnes, Guest Columnist

After last month’s midterm elections, the U.S. Senate passed the Medical Marijuana and Cannabidiol Expansion Research Act. The House had passed the bill in April, and President Biden signed it into law on December 2. The new law has been described as “modest” because it mostly facilitates research on marijuana and cannabidiol to support the development of medications for approval by the Food and Drug Administration (FDA).

The law also eliminates a longstanding regulatory roadblock that has prevented marijuana research; hindered the development of marijuana-derived, FDA-approved medications; and led to 37 state-regulated markets for marijuana products that do not meet federal consistency, purity, and potency standards. New research can be expected to yield marijuana-derived medications that the FDA can approve.

There is another regulatory burden that the Senate must eliminate before the end of this year. This change in federal law would also be modest, but it would facilitate access to treatment for opioid use disorder (OUD), which is essential amid the nationwide fentanyl poisoning crisis. S. 3257 would expand the time health care providers can hold long-acting, injectable buprenorphine (an FDA-approved medication for OUD) from 14 days to 60 days. It’s that simple. But like the new marijuana research law, the modest change will make a significant difference.

In the 12 months that ended June 30, 2022, 102,842 people died of a drug poisoning. Of those, 69,150 involved synthetic opioids, predominantly illegal fentanyl. Facilitating access to evidence-based treatment for OUD is more important now than ever. Changing the law cannot wait until the next Congress gets up and running.

S.3257 would amend the Controlled Substances Act, which currently requires that a health care provider administer injectable buprenorphine OUD medication to the patient named on the prescription within 14 days after the medication was delivered to the provider. The supposed purpose of the 14-day limit is to prevent the diversion of the medication to the illicit market.

But in 2020, the Government Accountability Office (GAO) reported that “all of the provider groups GAO spoke with said that diversion of injectable … buprenorphine is unlikely, and representatives from three of the six provider groups said that the design of these formulations reduce opportunities for diversion due to how they are administered.”

For patients and providers, the 14-day limit is too short considering the coordination required to facilitate injectable buprenorphine prescribing, insurance coverage and payment, delivery and receipt, and appointment scheduling and attendance. Sixty days are necessary to ensure that medication administration may take place at a time when the patient, provider, and medication are available.

Additionally, the 14-day limit wastes valuable health care resources and places patients’ recovery and lives at risk. For example, if an insured patient is not able to attend a medical appointment on or before the 14th day after the injectable buprenorphine was delivered to his or her provider, the medication must be disposed of.

It is unlikely that an insurer would pay for a replacement product, and it is common for patients not to be able to pay for medications out of pocket. As a result, a patient may be forced to go without a week or months’ worth of medication for OUD. This situation can put the patient at risk for a recurrence of OUD symptoms, active substance use, poisoning by illicit substance, and death.

In June, the House of Representatives passed H.R. 7666 with broad bipartisan support. Section 264 of H.R. 7666 contains a provision expanding the 14-day limit to 60 days.

In passing the marijuana research act, the Senate proved itself willing and capable of enacting modest yet meaningful drug reforms during its lame-duck session. To prevent drug poisonings and avoid wasting lifesaving medications, the Senate must do so again by expanding the 14-day limit to 60 days.

Michael C. Barnes is the managing attorney for Sequel Health Law. He serves as counsel to Aimed Alliance, a not-for-profit health policy organization.

The goal of Aimed Alliance is to create a society in which consumers can make informed and individually appropriate decisions about their health care, without those decisions being overridden by third parties.

Now Is the Time to Advocate

By Barby Ingle, PNN Columnist

I have written many articles on patient advocacy and it is still one of the topics I am most asked about. Now through the first week of September is the perfect time to visit with your state legislators and congressional representatives. I have appointments with three coming up in the next few weeks myself.

They need to hear from their constituents. The need to learn about issues facing people who vote in their districts and state. They need to know who makes up the pain community so that they can better represent and REMEMBER us when it is time to vote on legislation that may help or hurt our access to proper and timely pain care.

How do you get an appointment? Look up the website for your legislator or congressman and request a meeting. Sometimes you can make an appointment directly through the website, but I believe the best way is to call and set it up, followed by a written request or confirmation of the appointment.

You may be scheduled with the lawmaker themselves or a staff member who assists them with a particular issue. In our case, it is usually the staffer who handles health or insurance issues.

These appointments can take place in Washington, DC or in your home state. The U.S. House (but not the Senate) is in recess until after Labor Day, so most representatives are in their districts campaigning for the midterm elections. Many are taking meetings and doing town halls.

When you call for a meeting, you may get voicemail. Leave a message! If you don’t get a return call in a few days, call again. If someone answers, call and ask to speak with the scheduler.

It’s impressive to friends, family and other pain community members when you actually follow through with a meeting. It is something that anyone can do, but few actually try. Most rely on others to make it to these meetings.

You need to focus on what you'll talk about before the meeting. If you get an appointment, dig in and study. Do your homework and research legislation so you can explain why you support or oppose it. Share your personal story in a highlight reel fashion. You might have a 20+ year story of living with chronic pain and illness, but you should get it down to no more than 2 minutes. Highlight the challenges you faced and where you are now in the chronic care process.

Make an Ask

The main purpose of your first meeting will be to familiarize yourself with your senator, representative or legislator and make a memorable connection. Stay on topic, stay timely and “make an ask” – ask them to do something specific for you.

These meetings typically last 15 to 20 minutes. Don’t bring a truck load of supporting materials. Discuss no more than 3 topics at the meeting and leave a one-page fact sheet for each topic. You want them to know that they can use you as a resource, so include a calling card with your contact information.

If you are asked about a fact that you don’t know the answer to, just say, “I don’t know.” It is better to be truthful than to make something up and risk losing credibility. You can always follow-up later with the information they seek.

You are there to make an ask, so set a reasonable deadline for them to respond to you with the answer. They may say right away they won’t support or oppose a bill and why. Don’t argue with them if they do. Use it as a teachable moment as to why you hope they will reconsider and how their decision will affect you and others like you in the pain community. If they haven’t taken a position on the issue in the past, it is not likely that they will commit to one in this meeting.

When you get home, always send a short thank you letter to the representative or staffer who was there. Also include any follow-up answers you promised. Remember, if you met with a staffer, they are there to filter out the messaging and bring back the best info they can to the representative.

our 2017 MEETING WITH WITH REP. ANDY BIGGS

If you do get an actual face-to-face chat with your senator or representative, you are lucky. In 2017, we were fortunate to get a meeting with Arizona Rep. Andy Biggs (pictured above).  A personal meeting like that demonstrates to lawmakers there is a constituency for chronic pain and illness that is active in their district and needs to be listened to.

After your first meeting, get ready for the next one. Stay in touch with the staffers and representatives, and when it comes time for them to act or vote, there is a better chance they will remember you and your story and do something that helps the pain community in a positive way.

Hearing directly from patients and caregivers goes a long way in helping us get access to proper and timely pain care. They need to know that we care, so they should care too.

Barby Ingle lives with reflex sympathetic dystrophy (RSD), migralepsy and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the International Pain Foundation. She is also a motivational speaker and best-selling author on pain topics. More information about Barby can be found at her website. 

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

16 Senators Urge DEA to Lower Opioid Supply Again

By Pat Anson, Editor

Sixteen U.S. senators have sent a letter to the head of the Drug Enforcement Administration asking the agency to consider further cuts in the supply of hydrocodone, oxycodone and other opioid pain medication in 2018.

The DEA, which regulates that amount of controlled substances that can be manufactured each year, reduced the quota for Schedule II opioids by 25 percent or more in 2017 after receiving a similar letter last summer.  The supply of hydrocodone, one of the most widely used painkillers, was cut by 34 percent.

“We commend DEA on taking initial steps last year to lower production quotas for the first time in a generation,” the senators wrote to DEA acting administrator Chuck Rosenberg.

“However, the 2017 production quota levels for numerous schedule II opioids remain dramatically higher than they were a decade ago.  Further reductions, through DEA’s existing quota-setting authority, are necessary to rein in this epidemic.”

The letter, which was drafted by Illinois Democrat Dick Durbin, was signed by 15 other Democrats and one Independent: Senators Sherrod Brown (D-Ohio), Amy Klobuchar (D-Minn.), Edward J. Markey (D-Mass.), Joe Manchin (D-W.Va.), Dianne Feinstein (D-Calif.), Claire McCaskill (D-Mo.), Patrick Leahy (D-Vt.), Tammy Baldwin (D-Wisc.), Jeanne Shaheen (D-N.H.), Kirsten Gillibrand (D-N.Y.), Catherine Cortez Masto (D-Nev.), Maggie Hassan (D-N.H.), Richard Blumenthal (D-Conn.), Al Franken (D-Minn.) and Angus King (I-Maine).

Between 1993 and 2015, the senators say the DEA allowed production quotas for oxycodone to increase 39-fold, hydrocodone to increase 12-fold, hydromorphone to increase 23-fold, and fentanyl to increase 25-fold.

Production quotas may have been rising, but opioid prescriptions have actually been falling for several years.  Last week the CDC released a report acknowledging that opioid prescribing in the U.S. has fallen by 18 percent since 2010.  

Many PNN readers have complained that since the 2017 quotas were adopted they now have trouble getting legitimate prescriptions filled because pharmacies do not keep enough pain medication in stock.

“My pharmacy has been trying to fill my pain medication for 6 days now,” wrote Karen. “So I call my pain management office and (they) don't know there is a shortage! Help us get our medication!”

“I am horrified by the absolute stupidity of these lawmakers who have no business making any decisions about my pain management!” wrote Tracey, who has been taking pain medication for 5 years. “All of the lawmakers said this would not affect those with already established chronic pain! Well guess what they lied!”

“I am writing to each one of these senators and letting them know how I feel on this issue. We need to vote these people OUT of office come election time, send them a powerful message. Although at this point the damage is already done. People like myself shouldn't have to consider suicide to end their constant pain,” wrote Jenny.

While many patients complain of shortages, the senators who signed the letter talk about states being “flooded” with opioids.

“Pharmaceutical companies have irresponsibly flooded states with millions and millions of opioids pills – enough, in fact, for every adult in America to have their own bottle,” Sen. King said in a statement. “And the consequences are both clear and dire: As the number of pills has grown, so has the drug epidemic. By scaling back the overabundance of these opioids, the DEA can help directly stem the tide of addiction while still also ensuring that those who suffer from chronic pain have the medication they need.”