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Pharmacy Law CE Column

By Shari L. Miller, MA, CPhT, JD, attorney at Shari L. Miller, Attorney, PLL

Recent FDA Activities to Curb Abuse, Misuse and Diversion of Opioids: Part Two


On July 9, 2012, the FDA took two actions to further address the ongoing problems of opioid abuse and diversion. As noted in last month's article, the first action was the announcement of a crack-down on unapproved oxycodone makers of single-ingredient, immediate-release products, giving them 45 days to stop producing the pain meds and 90 days to cease shipping or risk ramped up FDA enforcement.13 The second recent action was the approval of a risk management program, known as a Risk Evaluation and Mitigation Strategy (REMS) for extended-release and long-acting (ER/LA) opioid analgesics.

This REMS affects more than 20 companies and more than 30 products. The Food and Drug Administration Amendments Act of 2007 (FDAAA) gave the FDA the authority to require REMS for pharmaceutical products deemed high-risk to address the prescription drug abuse, misuse, and overdose epidemic. The REMS program introduces new safety measures designed to reduce risks and improve the safe use of ER/LA opioids, while ensuring access to needed medications for patients in pain.14

REMS are legal tools to protect the public health and do not replace existing state and federal regulations. The elements of REMS are enforceable, with civil monetary penalties ranging from $250,000 per violation, not to exceed $1 million in a single proceeding. Failure to comply can result in a drug being deemed misbranded.15

The key components of the ER/LA opioid analgesics REMS include training for prescribers, an updated Medication Guide and patient counseling document, and assessment/auditing. The central focus is education for all DEA registered prescribers, even though it is not mandatory. The manufacturer is responsible for making these programs available and will probably do so by providing educational grants to accredited CE providers to offer training to prescribers at no or minimal cost, expected to begin in March 2013. Patient education is also important, and the REMS will include a patient-counseling document for the prescribers to give to patients. An updated one-page Medication Guide will be provided by the pharmacy dispensing the opioids. The guide will include instructions for patients to consult their healthcare professional before changing doses, signs of potential overdose and emergency contact instructions, and advice on safe storage to prevent accidental exposure to family members.16

What is the role of the pharmacist regarding opioid dispensing?

Pharmacists have an important role to play in reducing prescription drug misuse and abuse, as discussed above. Key roles for the pharmacist include:17

  • Obtaining education on signs of addiction, abuse/misuse of opioids and sharing such information with pharmacy staff
  • Having a protocol in place when opioid abuse/misuse is suspected, being mindful of privacy laws such as HIPAA
  • Distributing the updated Medication Guide as required by the REMS
  • Educating patients by actively engaging them in discussions about safe use of their opioid therapy, including:
    • Reminding patients/caregivers to take their medication only as prescribed
    • Protecting their prescriptions against accidental use, theft, and misuse by using safe storage/security measures such as keeping out of reach of children
    • Discussing dosing, warning signs of toxicity and caution driving with new fills or dose escalations
    • Role of immediate-release versus extended release
    • Discussion of drug interactions
    • Information about not sharing opioid prescriptions
    • Placement of patches outside view
    • Discussing the importance of compliance
      • The risks of abuse, misuse and overdose
      • Specific requirements such as monitoring
    • Safe disposal during therapy and after the medication is no longer needed
      • Remind the patient of the next National Take-Back Initiative event scheduled for September 29, 2012
  • Following a patient care plan, pain contract or medication agreement that may establish ground rules for opioid prescriptions such as
    • No early refills
    • No pain medications from other clinics or Emergency Rooms
    • Dispensing by one pharmacy only
  • Collaborating and communicating with prescribers about patient selection, on-going monitoring, aberrant behavior and dosing
  • Obtaining and providing addiction treatment-related resources and information to patients
  • Ensuring that the pharmacist understands the federal and state regulations on dispensing opioids
  • Assessing the pharmacy's current opioid dispensing patterns and likely future requirements
  • Engaging with prescribers to ensure seamless integration of each REMS into the pharmacy practice
  • Raising awareness of the dangers of prescription drug abuse in the community
  • Awareness that some insurers are limiting new prescriptions for some opioids to a 30-day supply

Be aware of street slang regarding opioid abuse:

  • OxyContin® terms: OC, OX, Oxy, Oxycet, Oxy 80's, Oxycotton, Hillbilly Heroin, Killers and kicker
  • Percocet and Percodan terms: Percodoms, Percs
  • Use of OxyContin®: "Jammed" is under the influence of OxyContin®

Watch for possible signs of a drug-seeking patient:

  • Impatience or obsessive behavior, repeated calling demanding refills
  • Negative mood changes, intoxicated or unkempt appearance, frequent requests for early refills, increased dosing without authorization, doctor-shopping, using pain medication in response to situational stressors, hoarding pills, frequent claims of lost or stolen medication.

Note: Pain relief-seeking patients may also have similar behaviors to drug-seeking patients.18


Pharmacists in dispensing opioids have a critical function and opportunity to assist in reducing prescription drug misuse and abuse. Education of the pharmacist, the pharmacy staff and most importantly, the patient, is the first step. Some practical pharmacist best practices for preventing opioid abuse, misuse and diversion include:

  • Continue to exercise professional judgment and follow best practice
  • Identify the patient picking up the medication
  • Validate the prescription with the prescriber
  • Use a Prescription Drug Monitoring Program (in states that have one)
  • Comply with the medication agreement
  • Be alert for aberrant behaviors
  • Report concerns to prescriber
  • Inform patients of the necessity of safe storage/security measures17


For CE Credit Click Here

1. Epidemic: Responding to America's Prescription Drug Abuse Crisis, at Accessed August 15, 2012.

2. Oxycodone, DEA, Office of Diversion Control, Drug & Chemical Evaluation Section, August 2011, at Accessed August 15, 2012.

3. FDA Acts to Reduce Harm from Opioid Drugs, July 2011, Accessed August 14, 2012.

4. Questions and Answers: FDA approves a Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release and Long-Acting (ER/LA) Opioid Analgesics, at Accessed August 14, 2012.

5. Drugs and Chemicals of Concern, Answers to Frequently asked Questions Regarding OxyContin®, at: Accessed August 21, 2012.

6. Hall AJ, et al. JAMA 2008;300:261320, as quoted in Marsha K. Millonig, BSPharm, MBA, President & CEO Catalyst Enterprises, LLC, Associate Fellow, Center for Leading Healthcare Change, University of Minnesota College of Pharmacy, 2012 educational expo, University of Minnesota.

7. OxyContin Abuse and Diversion and Efforts to Address the Problem, Prescription Drugs, GAO-04-110, at Accessed August 16, 2012.

8. Carise, Legget Dugosh, McLellan, Camilleri, Woody, Lynch, Prescription OxyContin Abuse Among Patients Entering Addiction Treatment, Am J Psychiatry 2007; 164:1750-1756. doi: 10.1176/appi.ajp.2007.07050252, at Accessed August 21, 2012.

9. History of OxyContin®: Labeling and Risk Management Program, Anjelina Pokrovnichka, M.D., at
. Accessed August 15, 2012.

10. FDA Approves New Formulation for OxyContin®, April 5, 2010, at Accessed August 17, 2012.

11. Cicero TJ, Ellis MS, Surrat HL. Effect of abuse-deterrent formulation of OxyContin®. The New England Journal of Medicine, July 12, 2012, as quoted in Drug Topics, August 9, 2012, OxyContin® users are switching to heroin, at Accessed August 17, 2012.

12. Opana® Abuse in USA Overtakes OxyContin®, July 10, 2012, at Accessed August 17, 2012.

13. Federal Register Volume 77, Number 130 (Friday, July 6, 2012), Notices, Pages 40069-40072, FR Doc No: 2012-16475, at Accessed August 16, 2012.

14. FDA NEWS events, at Accessed August 16, 2012.

15. Draft Guidance. Guidance for Industry: Format and content of proposed Risk Evaluation and Mitigation Strategies (REMS), REMS assessments, and proposed REMS modifications. US Department of Health and Human Services. Food and Drug Administration, September 2009, at Accessed August 17, 2012.

16. Questions and Answers: FDA approves a Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release and Long-Acting (ER/LA) Opioid Analgesics, at Accessed August 14, 2012.

17. Many of the roles are suggested in the presentation by Marsha K. Millonig, BSPharm, MBA, President & CEO Catalyst Enterprises, LLC, Associate Fellow, Center for Leading Healthcare Change, University of Minnesota College of Pharmacy, 2012 educational expo, University of Minnesota.

18. Yasgur, "My Parrot Ate my Pain Pills": Dealing with Drug-Seeking Patients, Medscape Business of Medicine, posted August, 10, 2012, at Accessed August 21, 2012.

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