Have you been affected by the reclassification of Opioids from Schedule III to Schedule II?

Since 2009, the U.S. Food and Drug Administration (FDA) has been carefully evaluating and weighing the appropriate use of opioid analgesic drug products. 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.

In recent years, FDA has 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 would increase the controls on these products.

Due to the unique history of this issue and the tremendous amount of public interest, the FDA announced the agency’s intent to recommend to HHS that hydrocodone combination products should be reclassified to a different and more restrictive schedule. This determination came after a thorough and careful analysis of extensive scientific literature, review of hundreds of public comments on the issue, and several public meetings, during which input was received from a wide range of stakeholders, including patients, health care providers, outside experts, and other government entities.

HHS reclassified hydrocodone combination products into Schedule II. Schedule II drugs are a category of drugs considered to have a strong potential for abuse or addiction but that also have legitimate medical use. Included are opium, morphine, and cocaine. Schedule III. drugs are a category of drugs that have less potential for abuse or addiction than Schedule I or II drugs and have a useful medical purpose. Included are short-acting barbiturates and amphetamines.

The National Institute on Drug Abuse (NIDA) concurred with this recommended action, beginning a process that led to a final decision by the DEA on the appropriate scheduling of these products.

The ensuing months have yielded a variety of patient experiences. Public agencies have committed publicly to continue 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. By some reports, this has been an uneven process and patients have reported a variety of experiences.

The drugs at issue contain a combination of hydrocodone and an over-the-counter painkiller like acetaminophen or aspirin and are sold either as generics or under brand names like Vicodin or Lortab. Doctors use the medications to treat pain from injuries, arthritis, dental extractions and other problems. The change would reduce the number of refills patients could get before going back to see their doctor and impose new restrictions on access to and use of these medications.

The following drugs are now all reclassified from Schedule III to Schedule II:
• Hydromorphone (any brand, any dose)
• Oxycodone (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

FDA has 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 non cancer pain to be represented in understanding the impact of these policy changes. This is being distributed to selected groups of consumers who have gathered together in social media because of their shared experience in dealing with significant pain related health conditions.

Please review the following anonymous questions. Your best answer to these questions will help us to determine how consumers have been most affected and where our advocacy efforts should be placed in so far as advocating for a National Pain Strategy. Your 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 as a factor in your response.

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. Your response is purely voluntary and your responses will remain confidential.

The contact person for this survey is: Terri Lewis PhD tal7291@yahoo.com

* 1. Did someone help you complete this survey?

* 2. Do you have one or more medical conditions that require you to take schedule III or schedule II drugs?

* 3. Do you have chronic or intractable pain condition that has lasted or is expected to last more than 90 days and is currently being treated?

* 4. Do you have access to a physician who is registered to prescribe schedule II narcotics? Select all that apply.

* 5. As a result of these changes, did you have to make a major change to your pain control strategy?

* 6. Does your current pharmacy have a policy that prohibits the filling of scripts for schedule II narcotics?

* 7. When the changes went into effect in January of 2014, did you have to change your current pharmacy?

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

* 9. Will your pharmacy issue you a partial prescription or a 'raincheck' if you present a valid prescription but they cannot confirm the script at the time you present?

* 10. Do you currently receive a prescription for any of these medications?

  YES NO Generic Brand Name Prior Approval Required Refill monthly Refill 3 mos Refill 6 mos Refill Other interval
Oxycodone (any dose, form)
Morphine (any dose, form)
Hydrocodone (any dose, form)
Oxymorphone
Methadone
Transdermal fentanyl
Transdermal buprenorphine
Ritalin
Adderall
Urine screening required

* 11. When the proposed changes went into effect, did you have to stop taking any of these medications due to lack of an available physician to prescribe, pharmacy rules, or insurer prohibitions in coverage?

  YES NO NO Physician to Prescribe Pharmacy will not fill Insurer will not cover Cash sale required
Oxycodone (any dose, form)
Morphine (any dose, form)
Hydrocodone (any dose, form)
Oxymorphone
Methadone
Transdermal fentanyl
Transdermal buprenorphine
Ritalin
Adderall
Urine screening required

* 12. How do you currently receive your medications?

* 13. Did you 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
Oxycodone
Morphine
Hydrocodone
Oxymorphone
Methadone
Transdermal fentanyl
Transdermal buprenorphine
Ritalin
Adderall

* 14. Do you expect to continue to need these and similar medications as the direct result of your current medical diagnosis ?

  YES NO Discontinued, Withheld Discontinued, Substituted Extended Release Brand Generic Preapproval Required
Hydromorphone
Oxycodone
Morphine
Hydrocodone
Oxymorphone
Methadone
Transdermal fentanyl
Transdermal buprenorphine
Ritalin
Adderall

* 15. How do you travel outside your home?

* 16. Use the comment field to answer questions about your current physician appointment travel related expenses.

* 17. Can you drive to your pharmacy to fill a prescription without assistance?

* 18. Do you expect to recover to the point that you can complete the activities of attending doctor's appointments or filling prescriptions without assistance?

* 19. Identify any extra burden of costs absorbed by your household as the result of changes to prescribing schedules.

* 20. Select all sources for your household income

* 21. Do you have an Insurance Source? Select all sources and indicate whether you insurer covers schedule II narcotics.

  Selected Covers Schedule III drugs Covers Schedule II drugs
No insurance coverage to report
Private insurance (myself or family member)
Medicaid
Medicare Part A
Medicare Part B
Medicare supplemental insurance
Workman's compensation covered injury
Tricare (VA health care coverage)
VA Dependent spouse coverage
Other
My Insurer requires prior authorization for schedule II narcotics
My insurer will not provide coverage for shedule II narcotics
I will lose my coverage for these medications when this policy goes into effect
Changes to this policy will not affect my current coverage

* 22. Has your working relationship to your primary care provider experienced a significant change as a result of changes to prescribing policies at the federal and state level?

* 23. Has your working relationship to your pharmacist or pharmacy experienced a significant change as a result of changes to prescribing policies at the federal and state level?

* 24. Demographics

* 25. We have learned that the experience of persons may be different because of their age. Would you like to identify the category that includes your age?

* 26. We have learned that men and women may have a different experience. Would you like to share your gender?

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