Purdue Pharma Launches Awareness Campaign to Inform Pharmacists of a CIII Extended-Release Opioid

Triggered by low awareness revealed by Harris Poll, webcast, printed downloadable materials aim to improve pharmacists’ knowledge and ability to counsel patients on Butrans® (buprenorphine) Transdermal System1

Stamford, Conn. – Oct. 15, 2014 – A recent survey indicates that pharmacists in the U.S. wish they had better resource materials to help them counsel patients about prescription opioid medications.1 To help meet this need, Purdue Pharma L.P. has launched an awareness campaign to address specific knowledge gaps among pharmacists, including: dose initiation, dose titration, and application related to its Schedule III extended-release transdermal opioid, Butrans®.

According to the online poll, conducted by Harris Poll on behalf of Purdue Pharma in February 2014, among 503 pharmacists, 95 percent of pharmacists said counseling patients about prescription opioid medications is an important part of their role as a pharmacist.1 However, 72 percent wish they had better resource materials to help them counsel patients about prescription opioid medications.1

When it comes to Butrans, while 95 percent of the pharmacists polled have heard of the product, 28 percent said they were extremely or very familiar with it.1 Overall, 44 percent of pharmacists are only somewhat familiar with Butrans.1

The survey also revealed that 46 percent of pharmacists who have heard of Butrans demonstrated a lack of knowledge around the proper starting dose for opioid-naïve or opioid-experienced patients.1 Additional details of the survey findings are available at http://bit.ly/1vQMLC1.

“As pharmacists, we take to heart our responsibility in helping to manage our patients and counsel them on safely using any prescription medications,” said American Pharmacists Association member, Michele Matthews, PharmD, CPE, BCACP. “These materials should help reinforce pharmacists’ confidence in their knowledge of Butrans, allowing them to provide their patients proper guidance.”

Purdue is working with the American Pharmacists Association (APhA) to distribute a series of pharmacist resources, including a Pharmacist Brochure and Initiation & Titration Guide, which will reach over 20,000 pharmacists, including APhA members, to help encourage productive pharmacist-patient interactions about Butrans including proper dosing, application, rotation and disposal, and safety. The Pharmacist Brochure can be found at http://bit.ly/1EuIWXh, and the Initiation & Titration Guide can be found at http://bit.ly/1nd2hGW. Purdue will also present a webcast about Butrans in the coming weeks that will be housed at http://bit.ly/1w6SV14.

“Pharmacists are often the last healthcare professional with whom a patient interacts with before using a medication, so they have the potential to make an impact on patients’ quality of care, if given the necessary information on prescription medications and treatments,” said Lisa Miller, PharmD, Executive Director of Healthcare Education and Liaison Programs at Purdue. “Purdue strongly believes it is imperative that we provide pharmacists with essential information about opioid therapies to improve their understanding and encourage appropriate use for their patients.”

Butrans is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Butrans also has the following Limitations of Use: Because of the risks of addiction, abuse and misuse with opioids, even at recommended doses, and because of the greater risk of overdose and death with extended-release opioid formulations, reserve Butrans for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Butrans is not indicated as an as-needed (prn) analgesic.

The Full Prescribing Information for Butrans contains the following Boxed Warning:

WARNING: ADDICTION, ABUSE and MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; and NEONATAL OPIOID WITHDRAWAL SYNDROME

Addiction, Abuse, and Misuse

BUTRANS® exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing BUTRANS, and monitor all patients regularly for the development of these behaviors or conditions [see Warnings and Precautions (5.1) and Overdosage (10)].

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of BUTRANS. Monitor for respiratory depression, especially during initiation of BUTRANS or following a dose increase. Misuse or abuse of BUTRANS by chewing, swallowing, snorting or injecting buprenorphine extracted from the transdermal system will result in the uncontrolled delivery of buprenorphine and pose a significant risk of overdose and death [see Warnings and Precautions (5.2)].

Accidental Exposure

Accidental exposure to even one dose of BUTRANS, especially by children, can result in a fatal overdose of buprenorphine [see Warnings and Precautions (5.2)].

Neonatal Opioid Withdrawal Syndrome

Prolonged use of BUTRANS during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see Warnings and Precautions (5.3)].

Parentheses refer to sections in the Full Prescribing Information.

CONTRAINDICATIONS
Butrans is contraindicated in patients with:

  • Significant respiratory depression
  • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
  • Known or suspected paralytic ileus
  • Hypersensitivity (e.g., anaphylaxis) to buprenorphine

WARNINGS AND PRECAUTIONS

  • Addiction, Abuse, and MisuseButrans contains buprenorphine, a Schedule III controlled substance. Butrans exposes users to the risks of opioid addiction, abuse, and misuse. As modified-release products such as Butrans deliver the opioid over an extended period of time, there is a greater risk for overdose and death, due to the larger amount of buprenorphine present. Addiction can occur at recommended doses and if the drug is misused or abused. Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing Butrans, and monitor all patients during therapy for the development of these behaviors or conditions. Abuse or misuse of Butrans by placing it in the mouth, chewing it, swallowing it, or using it in ways other than indicated may cause choking, overdose and death.
  • Life‐Threatening Respiratory DepressionSerious, life-threatening, or fatal respiratory depression has been reported with modified-release opioids, even when used as recommended, and if not immediately recognized and treated, may lead to respiratory arrest and death. The risk of respiratory depression is greatest during the initiation of therapy or following a dose increase; therefore, closely monitor patients for respiratory depression. Proper dosing and titration of Butrans are essential. Overestimating the Butrans dose when converting patients from another opioid product can result in fatal overdose with the first dose. Accidental exposure to Butrans, especially in children, can result in respiratory depression and death due to an overdose of buprenorphine.
  • Neonatal Opioid Withdrawal SyndromeProlonged use of Butrans during pregnancy can result in neonatal opioid withdrawal syndrome which may be life-threatening to the neonate if not recognized and treated, and requires management according to protocols developed by neonatology experts.
  • Interactions with Central Nervous System DepressantsHypotension, profound sedation, coma, respiratory depression, or death may result if Butrans is used concomitantly with other CNS depressants, including alcohol or illicit drugs that can cause CNS depression. Start with Butrans 5 mcg/hour patch, monitor patients for signs of sedation and respiratory depression, and consider using a lower dose of the concomitant CNS depressant.
  • Use in Elderly, Cachectic, and Debilitated Patients and Patients with Chronic Pulmonary DiseaseClosely monitor elderly, cachectic, and debilitated patients, and patients with chronic obstructive pulmonary disease because of the increased risk of life-threatening respiratory depression. Consider the use of alternative non-opioid analgesics in patients with chronic obstructive pulmonary disease if possible.
  • QTc ProlongationAvoid in patients with Long QT Syndrome, family history of Long QT Syndrome, or those taking Class IA or Class III antiarrhythmic medications.
  • Hypotensive EffectsButrans may cause severe hypotension, including orthostatic hypotension and syncope in ambulatory patients. Monitor patients during dose initiation or titration.
  • Use in Patients with Head Injury or Increased Intracranial PressureMonitor patients taking Butrans who may be susceptible to the intracranial effects of CO2 retention for signs of sedation and respiratory depression. Avoid the use of Butrans in patients with impaired consciousness or coma.
  • Application Site Skin ReactionsIn rare cases, severe application site skin reactions with signs of marked inflammation including “burn,” “discharge,” and “vesicles” have occurred.
  • Anaphylactic/Allergic ReactionsCases of acute and chronic hypersensitivity to buprenorphine have been reported both in clinical trials and in the post‐marketing experience.
  • Application of External HeatAvoid exposing the Butrans application site and surrounding area to direct external heat sources. There is a potential for temperature‐dependent increases in buprenorphine released from the system resulting in possible overdose and death.
  • Use in Patients with Gastrointestinal ConditionsAvoid the use of Butrans in patients with paralytic ileus and other GI obstructions. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms

ADVERSE REACTIONS

  • Most common adverse reactions (≥5%) reported by patients treated with Butrans in the clinical trials were nausea, headache, application site pruritus, dizziness, constipation, somnolence, vomiting, application site erythema, dry mouth, and application site rash.

The Full Prescribing Information for Butrans, including the Medication Guide and Boxed Warning is available at www.purduepharma.com/butranspi and at www.butrans.com.

Butrans can be abused in a manner similar to other opioid agonists, legal or illicit. Purdue supports prescriber and patient education as part of a comprehensive approach to address misuse, abuse and diversion of opioid pain medicines, while ensuring that these medications remain accessible for appropriate patients with chronic pain. Information on the shared REMS is available at www.ER-LA-opioidREMS.com.

About the Survey
This survey was conducted online within the United States by Harris Poll on behalf of Purdue Pharma between February 14 and February 24, 2014 among 503 U.S. adults ages 18+ who are currently employed full-time and/or part-time as pharmacists. For additional information on this survey, please contact Jennifer Soares at jennifer.soares@pharma.com.

About Purdue Pharma L.P.
Purdue Pharma L.P. and its associated U.S. companies are privately-held pharmaceutical companies known for pioneering research on chronic pain. Headquartered in Stamford, CT, Purdue is engaged in the research, development, production, and distribution of both prescription and over-the-counter medicines and hospital products. Additional information about Purdue can be found at www.purduepharma.com.

Media Contact:

Jennifer Soares
Senior Manager, Corporate Affairs & Communications
(203) 588-7623
jennifer.soares@pharma.com
Jim Heins
Senior Director, Public Affairs
(203) 588-8069
james.heins@pharma.com

1Data on File. Purdue Pharma survey by Harris Poll. Field Date: February 2014.

The prescription and illicit opioid abuse crisis is a multifaceted public health challenge, and as a manufacturer of prescription opioids, we have a responsibility to join the fight. At Purdue we are committed to lead our industry in helping address our nation's prescription and illicit opioid abuse crisis.

There is more to come – as we continue to work with partners and experts to deliver solutions. Below you will find additional information about our efforts.

Read our open letter about the opioid crisis.