Assessing the Impact of FDA's Proposed Changes in Classification of Opiod Derivatives

Will you be affected by the reclassification of Opiods from Schedule III to Schedule II?

[10-24-2013-Janet Woodcock, Director of FDA's Center for Drug Evaluation & Research] Over the past several years, 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, the 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 has 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 comes 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 we received input from a wide range of stakeholders, including patients, health care providers, outside experts, and other government entities.

By early December, FDA plans to submit formal recommendation package to HHS to reclassify 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.

It is anticipated that the National Institute on Drug Abuse (NIDA) will concur with our recommendation. This will begin a process that will lead to a final decision by the DEA on the appropriate scheduling of these products.

Going forward, the agency will continue working 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.

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 would be 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 the policy changes. This is being distributed to selected groups of consumers.

Please review the following anonymous questions. Your best answer to these questions will help us to determine how consumers will be most affected and where our advocacy efforts should be placed. 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.

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

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* 1. Did someone help you complete this survey?

Yes

What is your relationship?

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

YES

Comment

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* 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?

YES

Comment

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

I do not have a physician to prescribe schedule II drugs at this time

Primary care physician

Pain management physician

Physiatrist

Neurologist

Psychiatrist

Orthopedist

Other

Other (please specify)

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

YES

Comment

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* 6. If the proposed changes go into effect in January of 2014, will you have to change your current pharmacy?

YES

Comment

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

Script only

Confirmation call to my prescribing physician

Proof of medical condition (medical records)

Government issued identification (Drivers license or ID card)

Confirmation of prior approval and authorization from insurer

Comment

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

YES

Comment

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

Comment

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* 10. When the proposed changes go into effect, will 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)	Oxycodone (any dose, form) YES	Oxycodone (any dose, form) NO	Oxycodone (any dose, form) NO Physician to Prescribe	Oxycodone (any dose, form) Pharmacy will not fill	Oxycodone (any dose, form) Insurer will not cover	Oxycodone (any dose, form) Cash sale required
Morphine (any dose, form)	Morphine (any dose, form) YES	Morphine (any dose, form) NO	Morphine (any dose, form) NO Physician to Prescribe	Morphine (any dose, form) Pharmacy will not fill	Morphine (any dose, form) Insurer will not cover	Morphine (any dose, form) Cash sale required
Oxymorphone	Oxymorphone YES	Oxymorphone NO	Oxymorphone NO Physician to Prescribe	Oxymorphone Pharmacy will not fill	Oxymorphone Insurer will not cover	Oxymorphone Cash sale required
Methadone	Methadone YES	Methadone NO	Methadone NO Physician to Prescribe	Methadone Pharmacy will not fill	Methadone Insurer will not cover	Methadone Cash sale required
Transdermal fentanyl	Transdermal fentanyl YES	Transdermal fentanyl NO	Transdermal fentanyl NO Physician to Prescribe	Transdermal fentanyl Pharmacy will not fill	Transdermal fentanyl Insurer will not cover	Transdermal fentanyl Cash sale required
Transdermal buprenorphine	Transdermal buprenorphine YES	Transdermal buprenorphine NO	Transdermal buprenorphine NO Physician to Prescribe	Transdermal buprenorphine Pharmacy will not fill	Transdermal buprenorphine Insurer will not cover	Transdermal buprenorphine Cash sale required
Ritalin	Ritalin YES	Ritalin NO	Ritalin NO Physician to Prescribe	Ritalin Pharmacy will not fill	Ritalin Insurer will not cover	Ritalin Cash sale required
Adderall	Adderall YES	Adderall NO	Adderall NO Physician to Prescribe	Adderall Pharmacy will not fill	Adderall Insurer will not cover	Adderall Cash sale required
Urine screening required	Urine screening required YES	Urine screening required NO	Urine screening required NO Physician to Prescribe	Urine screening required Pharmacy will not fill	Urine screening required Insurer will not cover	Urine screening required Cash sale required

What is your pharmacy's policy on cash sales?

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* 11. How do you currently receive your medications?

Walk in

Mail

Home delivery by filling pharmacy

Family or friend fills the prescription for me

I am homebound or disabled and cannot present my script to a pharmacy by myself

Other (please specify)

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* 12. 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	Hydromorphone YES	Hydromorphone NO	Hydromorphone Extended Release	Hydromorphone Brand	Hydromorphone Generic	Hydromorphone Preapproval Required
Oxycodone	Oxycodone YES	Oxycodone NO	Oxycodone Extended Release	Oxycodone Brand	Oxycodone Generic	Oxycodone Preapproval Required
Morphine	Morphine YES	Morphine NO	Morphine Extended Release	Morphine Brand	Morphine Generic	Morphine Preapproval Required
Oxymorphone	Oxymorphone YES	Oxymorphone NO	Oxymorphone Extended Release	Oxymorphone Brand	Oxymorphone Generic	Oxymorphone Preapproval Required
Methadone	Methadone YES	Methadone NO	Methadone Extended Release	Methadone Brand	Methadone Generic	Methadone Preapproval Required
Transdermal fentanyl	Transdermal fentanyl YES	Transdermal fentanyl NO	Transdermal fentanyl Extended Release	Transdermal fentanyl Brand	Transdermal fentanyl Generic	Transdermal fentanyl Preapproval Required
Transdermal buprenorphine	Transdermal buprenorphine YES	Transdermal buprenorphine NO	Transdermal buprenorphine Extended Release	Transdermal buprenorphine Brand	Transdermal buprenorphine Generic	Transdermal buprenorphine Preapproval Required
Ritalin	Ritalin YES	Ritalin NO	Ritalin Extended Release	Ritalin Brand	Ritalin Generic	Ritalin Preapproval Required
Adderall	Adderall YES	Adderall NO	Adderall Extended Release	Adderall Brand	Adderall Generic	Adderall Preapproval Required

Comment

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

	YES	NO	Extended Release	Brand	Generic	Preapproval Required
Hydromorphone	Hydromorphone YES	Hydromorphone NO	Hydromorphone Extended Release	Hydromorphone Brand	Hydromorphone Generic	Hydromorphone Preapproval Required
Oxycodone	Oxycodone YES	Oxycodone NO	Oxycodone Extended Release	Oxycodone Brand	Oxycodone Generic	Oxycodone Preapproval Required
Morphine	Morphine YES	Morphine NO	Morphine Extended Release	Morphine Brand	Morphine Generic	Morphine Preapproval Required
Oxymorphone	Oxymorphone YES	Oxymorphone NO	Oxymorphone Extended Release	Oxymorphone Brand	Oxymorphone Generic	Oxymorphone Preapproval Required
Methadone	Methadone YES	Methadone NO	Methadone Extended Release	Methadone Brand	Methadone Generic	Methadone Preapproval Required
Transdermal fentanyl	Transdermal fentanyl YES	Transdermal fentanyl NO	Transdermal fentanyl Extended Release	Transdermal fentanyl Brand	Transdermal fentanyl Generic	Transdermal fentanyl Preapproval Required
Transdermal buprenorphine	Transdermal buprenorphine YES	Transdermal buprenorphine NO	Transdermal buprenorphine Extended Release	Transdermal buprenorphine Brand	Transdermal buprenorphine Generic	Transdermal buprenorphine Preapproval Required
Ritalin	Ritalin YES	Ritalin NO	Ritalin Extended Release	Ritalin Brand	Ritalin Generic	Ritalin Preapproval Required
Adderall	Adderall YES	Adderall NO	Adderall Extended Release	Adderall Brand	Adderall Generic	Adderall Preapproval Required

Comment

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* 14. How do you travel outside your home?

I drive myself and have a valid driver's license

I no longer drive and rely on friends or family

I no longer drive and rely on public transportation

I no longer drive and rely on hired transportation (e.g. taxi, pay someone's gas and time, etc.)

I am homebound and rely on supplies to be delivered to me

Other (please specify)

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

1. How many miles away from your home is your prescribing physician located?

2. From the time you leave your home until you return, how much time is involved?

3. Average expense including gas, meals, lodging, care partner expenses?

4. How many physician appointments per month on average?

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

YES

Comment

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

Not applicable

YES

Comment

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* 18. What is your approximate average household income?

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* 19. Select all sources for your household income

I have no household income to report

Wages, earned income

VA Disability

Social Security Disability (SSDI)

Social Security Insurance (SSI)

Social Security Retirement (SSA)

Pension

Private Insurance Disability from employer

Savings

Trusts

Other (if other, add source to comments)

Other (please specify)

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

Other (please specify)

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* 21. Demographics

State:

ZIP:

Email Address:

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* 22. Which category below includes your age?

17 or younger

18-20

21-29

30-39

40-49

50-59

60 or older

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* 23. What is your gender?

Female

Male

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

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