A New Age for Tramadol

Big news has once again hit the world of pharmacy recently: Tramadol is now scheduled as a schedule IV controlled substance in all states according to the Drug Enforcement Agency (DEA).1 On July 2, 2014 the DEA announced this update in the Federal Register.2 Tramadol and any product containing the substance will require a “C-IV” notification on all its labels as of August 18, 2014.1 Schedule IV is “defined as drugs with a low potential for abuse and low risk of dependence” according to the DEA.3

In 1995, tramadol was approved as an opioid analgesic with monoamine reuptake inhibition used for the treatment of moderate to severe pain in adults.2 A typical dose of tramadol is one to two tablets (comes as 50 or 100 mg tablets) every four to six hours as needed for pain, with a maximum dose of 400 mg/day.2 Withdrawal symptoms, tolerance, dependence, and addiction to tramadol have all been reported before.2 Since tramadol is an opioid, immediately we would be concern with abuse or misuse. Tramadol is most often abused in these specific populations of narcotic addicts, chronic pain patients, and health professionals.2 According to the DEA, a report by IMS Health National Prescription Audit Plus, tramadol was dispensed 43.8 million times in the United States in just the year 2013.2 American Association of Poison Control Centers reported 13,067 contacts with tramadol with 6,589 contacts being single substance exposures, and nine reported deaths in 2012.2 Another report completed in 2012 by the National Survey on Drug Use and Health stated “3.2 million people in the U.S. aged 12 or older used tramadol for nonmedical purposes in their lifetime.”2

While several states had previously scheduled tramadol as a controlled substance1, Missouri has no state law scheduling tramadol as a controlled substance. Therefore, Missouri pharmacists need to know and take action on several things in order to be compliant with the August 18, 2014 effective date. Some of these actions required include:

  • All pharmacies and providers stocking tramadol or products containing tramadol must take inventory on or before August 18, 2014 and these substances must remain a part of all controlled substances inventories. 1, 4
  • All prescriptions for tramadol and products containing tramadol must follow the federal and state controlled substance prescription rules and regulations starting on August 18, 2014.1
  • Tramadol and products containing tramadol shall be marked as Schedule IV Controlled Substance in the pharmacy’s computer.
  • All prescriptions for tramadol must be changed over to reflect the specific pharmacy’s controlled numbering format for filing and record purposes.4
  • No electronic prescriptions shall be accepted for products containing tramadol, unless the pharmacy follows specific requirements in 21 C.F.R. §1311 set by the DEA.4
  • All prescriptions written for tramadol and products containing tramadol may only be refilled five times within a six month time period.4
  • All prescriptions written for tramadol and products containing tramadol will only be valid for 6 months.4
  • All prescriptions written for tramadol and products containing tramadol can only be transferred between pharmacies once.4 If pharmacies share an electronically, online, real-time database, then they may transfer the prescription as many times as allowed by the number of refills or expiration date.5

Some of these changes will cause confusion for patients and pharmacists will need to make sure their patients understand these changes in order to prevent misunderstandings in the future. For example, a prescription written for tramadol used to be valid for 12 months, with no restriction on the number of refills, and it could be transferred between pharmacies as many times as necessary.5 If you have any questions regarding the rescheduling of tramadol and products containing tramadol, contact the Missouri Board of Pharmacy. Overall, the addition of tramadol to a schedule IV will help prevent abuse and misuse, which will further protect our patients.

Ashley Buehler

UMKC School of Pharmacy at MU

PharmD Candidate 2015

MPA Rotation Student, July 2014

Resources

1DEA classifies tramadol a controlled substance. (2014, July 9). Retrieved from http://www.nabp.net/news/dea-classifies-tramadol-a-controlled-substance

2Tramadol (trade names: ultram®, ultracet®). (2014, July). Retrieved from http://www.deadiversion.usdoj.gov/drug_chem_info/tramadol.pdf

3Drug scheduling. (n.d.). Retrieved from http://www.justice.gov/dea/druginfo/ds.shtml

4Pharmacist’s manual an informational outline of the controlled substances act. (2010). Retrieved from http://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/pharm_manual.pdf

5Rules of department of insurance, financial institutions and professional registration. (n.d.). Retrieved from http://www.sos.mo.gov/adrules/csr/current/20csr/20c2220-2.pdf

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