How have you been affected by the reclassification of opiate medications or changes to state laws?

INSTRUCTIONS TO RESPONDENTS-
 
For the millions of American patients experiencing an acute medical need or living with chronic pain, opioids, 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, the FDA and CDC have become increasingly concerned about the abuse and misuse of opioid products, which have sadly reached epidemic proportions in certain parts of the United States. While the value of and access to these drugs has been a consistent source of public debate, the FDA has been challenged with determining how to balance the need to ensure continued access to those patients who rely on continuous pain relief while addressing the ongoing concerns about abuse and misuse.

In 2009, the U.S. Drug Enforcement Administration (DEA) asked the U.S. Department of Health and Human Services (HHS) for a recommendation regarding whether to change the schedule for hydrocodone combination products, such as Vicodin. The proposed change was from Schedule III to Schedule II, which increased the controls on these products.
 
In 2015, the CDC contracted with a panel of experts to make recommendations for the development of guidelines designed to address perceived problems with increasing overdose deaths associated with the use of prescription medications and illicit, illegally obtained opiates. These Guidelines for prescribing opiates for persons with chronic pain were issued in March of 2016.
 
Throughout the period from 2012 to 2016, states began to pass legislation which changed prescribing practices for persons with chronic pain who utilize opiates and other schedule II medications for pain management.
 
States have devised and install prescription drug management programs (PDMPs), initiated drug take back programs and limited access by making changes to prescribing practices.
 
Both CDC and FDA have professed their desire to work with professional organizations, consumer and patient groups, and industry to ensure that prescriber and patient education tools are readily available so that these products are properly prescribed and appropriately used by the patients who need them most.

Nevertheless, reports from consumers indicate that their access to appropriate pain management has been disrupted by changes to scheduling, the adoption of CDC's Guidelines for Chronic Pain Prescribing, and changes to state prescribing laws.

The following drugs have been reclassified from Schedule III to Schedule II:
  • Hydromorphone (any brand, any dose)
  • Oxycodone (any brand, any dose)
  • Hydrocodone (any brand, any dose)
  • Morphine (any brand, any dose)
  • Oxymorphone (any brand, any dose)
  • Methadone (any brand, any dose)
  • Transdermal fentanyl (any brand, any dose)
  • Transdermal buprenorphine (any brand, any dose)
  • Ritalin (any brand, any dose)
  • Adderall (any brand, any dose)
 
Reports of difficulties in access to support have emerged from the patient community. These reports include-
  • Different restrictions on opiate prescribing levels have emerged from state to state. 
  • Different physician qualifications for prescribing and training have appeared as a function of differing state laws. 
  • Refill practices are now variable from pharmacy to pharmacy and state to state.
  • Forced substitutions with less effective prescription medications.
  • Forced acceptance of interventional procedures (injections, pumps, or stimulators) as a condition for prescribing oral forms of opiates.
  • Physician discharge of patients wit
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 selected groups of consumers through social media platforms.

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Please review the following questions. 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 tal7291@yahoo.com

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

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* 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.)

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* 3. Do you or the person you are assisting have one or more medical conditions that require you to take medications (schedule III or schedule II) or over the counter drugs?

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* 4. Do you or the person you are assisting have a chronic or intractable pain condition that has lasted or is expected to last more than 90 days for which you receive continuous treatment ?

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* 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
Neurologist
Psychiatrist, Psychologist, Licensed counselor
Orthopedist
Rheumatologist
Internal medicine specialist
Endocrinologist
Physical therapist or Occupational therapist
In home care giver support

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* 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?

  No Yes See my comments
I have been discharged from primary or pain care and I am concerned about my level of functioning or independence.
I have NOT been discharged from primary or pain care but I am concerned about the current levels of care on my functioning and independence.
Are you using or considering the use of over the counter medications (OTCs) to help reduce pain?
Has reduction in pain care increased your use of alcohol or tobacco to control pain?
Has the loss of pain care resulted in feelings of hoplessness or increased your consideration of suicide?
Have you borrowed or considered borrowing medications from friends or family to address your untreated pain levels?
Have you used or are considering the use of street drugs to address your 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

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* 7. Describe your pharmacy relationships

  Yes No See Comments
Does your pharmacy treat you like a valued customer?
Does your pharmacy have your prescriptions in stock when you present your script?
Do you receive adequate counseling from your pharmacist when you fill your scripts?
Does your pharmacist teach you about common drug interactions (drug-drug; drug-food, drug-OTCs; drug-alcohol)
If your pharmacy is out of medications do they help you locate a pharmacy that can fill your prescription?
Is your pharmacy a preferred provider to your insurance plan?
Is your pharmacist informed about your medical needs?
Has this pharmacy ever refused to fill your prescriptions?
Does your pharmacy have a drug 'take back program' if you find that you need to return unused medications?
Does your pharmacy offer your medications in packaging appropriate for your use?

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

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* 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.

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* 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)
Oxymorphone
Any other form of opiate (dilaudid, Zohydro, other)
Methadone
Transdermal fentanyl
Transdermal or sublingual buprenorphine
Ritalin
Adderall
Urine screening required

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* 11. When these changes went into effect, 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)
Oxymorphone
Methadone
Transdermal fentanyl
Transdermal buprenorphine
Ritalin
Adderall
Urine screening required

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* 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 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

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* 13. How do you or the person you are assisting currently receive your medications? Select all that applies.

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* 14. Did you or the person you are assisting require these or other schedule II medications before the injury or disability that resulted in the onset of chronic or intractable pain syndrome?

  YES NO Extended Release Brand Generic Preapproval Required
Hydromorphone
Hydrocodone
Oxycodone
Morphine
Oxymorphone
Other form of opiate (Dilaudid, Zohydro, other)
Methadone
Transdermal fentanyl
Transdermal buprenorphine
Ritalin
Adderall

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* 15. 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
Hydromorphone
Hydrocodone
Oxycodone
Morphine
Oxymorphone
Other form of opiate (Dilaudid, Zohydro, other)
Methadone
Transdermal fentanyl
Transdermal buprenorphine
Ritalin
Adderall

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* 16. How do you or the person you are assisting travel outside your home?

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* 17. Use the comment field to answer questions about physician appointment travel related expenses.

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* 18. Can you drive to your doctor's office or pharmacy to fill a prescription without assistance?

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* 19. Do you expect to your health to recover to the point that you will no longer require continuous care that includes pain management?

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

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

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* 22. Do you have an 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 III drugs My plan covers Schedule II drugs My plan covers adjunctive services (counseling, home care, OT/PT, alternative methods)
No insurance coverage to report
Private insurance (myself or family member)
Medicaid
Medicare Part A
Medicare Part B
Medicare Advantage (C [covers parts B&D)
Medicare Part D (Drug coverage)
Tricare
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 policy
Changes to policies or physicians have not been affected my current coverage

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

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* 24. 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 care
Insurance plan
Assistive technology or equipment providers
Hospital, skilled nursing, or emergency room services
Communication between members of my health care team

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* 25. Demographics (REQUIRED)

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* 26. Which category below includes your age?

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

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* 28. Racial group with which you identify for census purposes