Request for Consumer Feedback due June 17, 2018

For the millions of American patients experiencing multiple, complex, chronic illnessesses or living with chronic pain, opioids in various forms and strengths, when prescribed appropriately, can allow patients to manage their pain as well as significantly improve their quality of life when combined with a program of effective integrated health management.

In recent years, federal agencies (FDA, CDC, DEA and more) have become increasingly concerned about the abuse and misuse of opioid products, which have been described as an epidemic of major proportions in certain parts of the United States.  We know that the failure to properly account for legal, therapeutic uses and consequences versus the consequences of illicit use has created an enormous backlash for patients who rely on these medications and who have used them safely and properly to good effect. 

FDA is challenged with determining how to balance the need to ensure continued access to persons who rely on opioids for continuous pain relief while addressing the ongoing concerns about safe use, abuse and misuse.  Determining where to place the focus on alternatives and new drug development is the focus of a meeting in Washington DC on July 9, 2018. Many of you will not be able to attend this so we are taking your voices to Washington DC with us.  You can register to attend or view this hearing.

The registration link is located here :

FDA and CDC have publicly stated that they want to work with patient groups to determine the impact of this change. We believe that it is important for consumers with chronic and intractable pain (for any reason) to be represented in the policy changes. This collection tool is being distributed to consumer groups through social media platforms.  Results will be summarized and shared with FDA and respondents for the July 9 2018 meeting and in the after meeting comments forwarded into the Federal Register by September 10, 2018.  FDA is particularly interested in hearing from patients who experience chronic pain that is managed with analgesic medications such as opioids, acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), antidepressants; other medications; and non-pharmacologic interventions or therapies.

Do not try to take this survey with a smart phone unless you have installed survey monkey on your phone.  This survey requires  javascript to be enabled. To download javascript go to this link, download the free software, and install-

We have captured the questions that FDA has invited a response to and we have added questions that will help you to clarify your personal experience. Please review them. Your best answer to these questions will help us to determine how consumers are most affected and where our advocacy efforts should be placed. Your personal identifying information will not be shared under ANY circumstances but your email and state/zip are necessary to confirm that (1) we can follow up with you if we have questions and (2) we can examine geographic location patterns as a factor in your response. Each submission will be assigned a code for reference in order to assure anonymity.  During the data analysis process your personal name will be separated from the information and separately and securely store with a record number.

If you are a care partner to a friend or family member who cannot complete this on their own, please indicate that you have provided assistance on behalf of another.

The contact person for this survey is: Terri Lewis PhD

* 1. My role is (select your primary role)-

* 2. I am the family member, of a loved one who is now deceased since the inception of changes to his or her prescribing routine for pain management. (If this question does not apply, skip and go to 3.)

* 3. Do you or the person you are assisting have one or more medical conditions that require you to take medications (schedule II-controlled substances or schedule III-uncontrolled substances) or over the counter drugs? For each, list the symptoms that cause you the most concern.

* 4. Characterize your disease and pain symptoms in terms of the length of time that you have been dealing with it.  Select the answer that best applies to you.

* 5. Do you or the person you are assisting currently have access to a team of physicians who are board certified and registered with DEA to prescribe all your medications including schedule II narcotics? Select all that apply.

  Not available to me I need it but I don't have access (denied, lost, discharged) Available to me when I need it
Primary care physician
Pain management physician
Rehabilitation medicine doctor or Physiatrist
Psychiatrist, Psychologist, Licensed counselor
Internal medicine specialist
Physical therapist or Occupational therapist
In home care giver support

* 6. If you or the person you are assisting have been discharged by a physician or clinic, please share alternative forms of pain management you are using or have considered using? Select all that apply.

  No Yes See my comments
I have been discharged from primary care because of my need for pain support and I am concerned about my level of functioning or independence.
I have been discharged from pain management care and I am concerned about the current levels of care on my functioning and independence.
I am using over the counter medications (OTCs) to help reduce pain.
The reduction in pain care has increased my use of alcohol or tobacco to control pain levels.
The loss of pain care has resulted in feelings of hoplessness and/or increased my consideration of suicide.
I have borrowed or considered borrowing medications from friends or family to address my pain levels.
I have used or are considered the use of street drugs to address my untreated pain levels.
The discharge from pain care resulted in a decline in my health status.
The discharge from pain care has added extra stress or burden to my daily life
My family life is negatively affected by my loss of access to pain care.
I have refused some services that I felt were not appropriate for my needs (comments)
I have been told that I must accept services I do not want in order to get services that I need
My refusal of unwanted services resulted in my discharge from primary care, pain management, or other services.
Discharge from primary or pain care has resulted in long lapses in the care of my disease(s) and/or pain support

* 7. Describe your pharmacy relationships

  Yes No See Comments
My insurance plan 'locks' me into the use of a specific or a single pharmacy for my medications.
My pharmacy treats me like a valued customer.
My pharmacy has your prescriptions in stock when you present your script?
My pharmacy provides adequate counseling from my pharmacist when I fill my scripts
My pharmacist teaches me about common drug interactions (drug-drug; drug-food, drug-OTCs; drug-alcohol)
If my pharmacy is out of medications, they help ,e locate a pharmacy that can fill my prescription?
Is your pharmacy a preferred provider to your insurance plan?
My pharmacist understands my medical needs and history.
My pharmacy consistently fills my prescriptions.
My pharmacy has a drug 'take back program' and allows me to return unused medications.
My pharmacy offers medications in packaging appropriate for my use.

* 8. What does your pharmacy require from you ? Select all that apply.

* 9. Have you or the person you are assisting changed your pharmacy one or more times in the last 24 months? Select all that apply.

* 10. Do you or the person you are assisting currently receive a prescription for any of these medications?

  YES NO Generic Brand Name Prior Approval Required Dose or unit count limits Refill requires personal visit to pharmacy Insurance coverage Cash purchase, no insurance
Oxycodone (any dose, form)
Hydrocodone (any dose, any form)
Morphine (any dose, form)
Any other form of opiate (dilaudid, Zohydro, other)
Transdermal fentanyl
Transdermal or sublingual Buprenorphine or Suboxone (generic or other)
Ritalin or Adderall
Urine toxicology screening required

* 11. Did you or the person you are assisting have to stop taking any of these medications due to lack of an available physician to prescribe, changes to pharmacy rules, or insurer prohibitions in coverage? Select all that applies.

  YES NO NO Physician to Prescribe Pharmacy will not fill Insurer will not cover Cash purchases not accepted
Oxycodone (any dose, any form)
Hydrocodone (any dose, any form)
Morphine (any dose, any form)
Transdermal fentanyl
Transdermal Buprenorphine or Suboxone (generic or branded)
Ritalin or Adderall
Urine screening required

* 12. Did a change of physician or prescriber result in a change of medications or substitutions of nonopiates, injections, pain pumps, or electrical stimulation devices?

  Gabapentin, Lyrica, Antidepressants or similar Buprenorphine, Suboxone, Naloxone, or Methadone Required as a condition of treatment Various* (describe in comments)
Substitution with alternative medications
Reduction of opiate doses to comply to a guideline or changes to state law
Injections (Epidural steroid (ESI), trigger point, joint)
Pain pump 
Electrical stimulation device (Spinal cord stimulator or TENS unit, other)
Other adjunctive or complementary methods (e.g. pain education, biofeedback, CBT/mindfulness)
Surgical recommendations 
Chiropractic or like therapy

* 13. How I access my medications:

* 14. Do you or the person you are assisting expect to continue to need these or similar medications as the direct result of your current medical diagnosis for the balance of your life? Select all that apply.

  YES NO Extended Release Brand Generic Preapproval Required
Other form of opiate (Dilaudid, Zohydro, other)
Transdermal fentanyl
Transdermal buprenorphine

* 15. Factors that I account for in choosing a course of treatment:

* 16. Barriers that affect my care (briefly describe):

* 17. Is there something out there that would constitute an improvement to your treatment regimen? Please describe.

* 18. Are there activities or tools that could help you do that help you to manage your pain levels if they were available or affordable? Please share?

* 19. Estimate the amount of household income (out of pocket expense) consumed by pain management and support for health care (Select all that apply. Describe) ?

* 20. Select all sources for your household income or the household income available to the  person you are assisting.

* 21. Insurance Source. Select all sources and indicate whether you insurer covers your needs (schedule II narcotics, physician services, adjunctive care).

  Available to me Not available to me My plan has physicians, clinics, hospitals appropriate for my needs My plan covers Schedule II drugs My plan covers Schedule III drugs My plan covers adjunctive services (home care, OT/PT, chronic care, hospice, alternative methods)
No insurance coverage to report
Private insurance (myself or family member)
Medicare Part A
Medicare Part B
Medicare Advantage (C [covers parts B&D)
Medicare Part D (Drug coverage)
VA sponsored health care (VAMC, CBOT, other)
VA Dependent spouse coverage
Workman's Compensation
My Insurer requires prior authorization for schedule II narcotics
My insurer will not provide coverage for schedule II narcotics
I have lost my coverage for these medications as a result of changes to my insurance plan
Changes to policies or physicians have not been affected my current coverage

* 22. In the last 24 months, my support for pain management has -

* 23. Rate your satisfaction with the following supports

  Not available Not satisfied Satisfied Very satisfied Comments
Primary care
Pain management
Specialty medical care (neurology, orthopedic, rheumatology, etc.)
Integrated pain supports (counseling, psychiatriatry, mental health)
Pharmacy services
Education about my health management
Addiction services
Palliative or chronic care
Insurance plan
Assistive technology or equipment providers
Hospital, skilled nursing, or emergency room services
Communication between members of my health care team

* 24. Demographics (REQUIRED)

* 25. Which category below includes your age?

* 26. What is the sex or gender orientation you declare?

* 27. Racial  or ethnic group with which you identify for census purposes

* 28. Highest level of education (Select one).

Thank you for taking the time to complete this survey. We will send results to you through the email address you have provided.

* 29. By selecting YES at this step, I agree to share my information with the survey manager with the understanding that results will be used to represent my information to FDA for their July 9 2018 meeting, and that I may withdraw my authorization at any time by contacting the survey manager.  My NAME and personally identifiable information will never be publicly released but my choices will be analyzed for the purpose of understanding the status of persons who currently need support for chronic pain in any form.  My authorization expires 12 months from the date I complete this survey and submit my results.

* 30. I would like to be contacted to participate in research opportunities regarding my personal experiences regarding the management of pain and/or interaction with pain management services, supports.