Setting the Record Straight on Our Anti-Diversion Programs

Purdue’s strong record of coordination with law enforcement has been acknowledged by the DEA and other law enforcement stakeholders who’ve used the information we’ve provided.

Beginning in 2007, Purdue provided Los Angeles-area law enforcement information that helped lead to the convictions of the criminal prescribers and pharmacists referenced by the LA Times.

The LA Times wildly distorts the role that Purdue, a company representing two percent of opioid prescriptions, plays in policing the pharmaceutical supply chain.

Contrary to the paper’s implications, we cannot simply order a wholesaler to stop shipping a product. However, we can and have reduced products shipped to a wholesaler if we have concerns about the pharmacy customer.

When Purdue learned that the original formulation of OxyContin® was being abused, the company spent more than a decade developing an abuse-deterrent formulation, which received FDA approval in 2010. This innovation is intended to make opioids less attractive on the black market, a point the LA Times acknowledges in its article.

Read the complete responses we provided to the Los Angeles Times below:

Comments Attributable to Philip C. Strassburger, General Counsel

Abuse & Diversion Detection

Purdue’s industry-leading Abuse & Diversion Detection (ADD) program, launched in 2002 and publicly disclosed in 2003, is one of several Purdue initiatives designed to help address our nation’s opioid epidemic.

Purdue’s programs to combat opioid abuse and diversion have been reviewed by law enforcement agencies and government officials. In fact, after reviewing our program, an attorney general required another opioid maker to implement a similar ADD program.

Our procedures help ensure that whenever we observe potential abuse or diversion activity, we discontinue our company’s interaction with the prescriber or pharmacist and initiate an investigation.
While we make information in our ADD program available to law enforcement and state medical boards, it would be inappropriate to direct every single anecdotal and often unconfirmed claim of potential misprescribing to these organizations.

Lake Medical Group

In 2007 Purdue began sharing information with state and federal law enforcement regarding potential criminal drug diversion in California. In the matter of Lake Medical Group, Purdue was proud to assist federal authorities in their prosecution of that criminal drug ring, which led to several convictions. Federal prosecutors in that case employed information obtained through Purdue’s ADD and OMS programs.

Lam’s Pharmacy

Purdue informed local and federal law enforcement about our concerns regarding Lam’s Pharmacy and potential drug diversion in Nevada. We also met with multiple wholesalers to discuss these concerns. As a result of this coordination, several wholesalers discontinued shipping product to the pharmacy, and Purdue significantly reduced its product flows to a third wholesaler. This episode demonstrates that no one drug company can control the entire supply chain, and it’s why the Controlled Substances Act relies on the coordination of all players.

Importantly, Lam’s was also apparently serving many legitimate patients, which is why steps to reduce product flows need to be carefully implemented, to avoid hurting appropriate patients.

Controlled Substances Act

We have robust programs designed to ensure that Purdue is compliant with the Controlled Substances Act and have at all times complied with the law. Furthermore, we have a long record of close coordination with the DEA and other law enforcement stakeholders to detect and reduce drug diversion. The Agency is familiar with our programs, as well as our record of providing them with valuable information.

When in 2001 Purdue learned that two employees had stolen controlled substances from a manufacturing facility, we alerted and cooperated with law enforcement to bring an immediate halt to the illegal conduct and assist the prosecution of those employees. Since that time, we’ve continuously refined our programs.

Order Monitoring System

All DEA registrants, including pharmaceutical manufacturers and wholesalers, are required to monitor and report suspicious orders to the DEA. This information can be used to alert DEA and other law enforcement agencies about potential diversion. Purdue does not ship prescription products directly to retail pharmacies; it sells only to authorized wholesalers, who maintain their own order monitoring programs.

Supply Chain Responsibility

The CSA is designed to form a network of supply chain participants monitoring and acting on available market information, and Purdue has fully participated in that process in compliance with the law.

Each registrant in the supply chain is responsible for monitoring and reporting suspicious orders to DEA. Once Purdue identifies the potential suspicious activity of a wholesaler’s customer, Purdue informs the wholesaler, so they can perform their due diligence based on their broad access to all the pharmacy’s products, not just Purdue products.

While Purdue cannot compel a wholesaler to discontinue shipping to one of its customers, we can and have reduced the product we ship to a wholesaler if we have concerns about the customer at the end of the supply chain.

Need for Confidentiality

A degree of confidentiality regarding the details of these programs is essential to their effectiveness. Improperly disclosing the workings of these programs is irresponsible and only aids those seeking to divert and abuse prescription opioids, potentially worsening a national health crisis.

ADD & OMS Program Limitations

With the benefit of hindsight, it’s easy to criticize private sector programs for failing to detect every instance of sophisticated and covert criminal activity, but law enforcement considers these programs important tools in helping identify inappropriate opioid prescribing and diversion.



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Important Safety Information

WARNING: ADDICTION, ABUSE AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and CYTOCHROME P450 3A4 INTERACTION

Addiction, Abuse, and Misuse

OXYCONTIN® 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 OXYCONTIN and monitor all patients regularly for the development of these behaviors or conditions [see Warnings and Precautions (5.1)].

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of OXYCONTIN. Monitor for respiratory depression, especially during initiation of OXYCONTIN or following a dose increase. Instruct patients to swallow OXYCONTIN tablets whole; crushing, chewing, or dissolving OXYCONTIN tablets can cause rapid release and absorption of a potentially fatal dose of oxycodone [see Warnings and Precautions (5.1)].

Accidental Ingestion

Accidental ingestion of even one dose of OXYCONTIN, especially by children, can result in a fatal overdose of oxycodone [see Warnings and Precautions (5.2)].

Neonatal Opioid Withdrawal Syndrome

Prolonged use of OXYCONTIN 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)].

Cytochrome P450 3A4 Interaction

The concomitant use of OXYCONTIN with all cytochrome P450 3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in oxycodone plasma concentration. Monitor patients receiving OXYCONTIN and any CYP3A4 inhibitor or inducer [see Warnings and Precautions (5.14) and Clinical Pharmacology (12.3)].

  • OxyContin 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 and gastrointestinal obstruction, hypersensitivity (e.g., anaphylaxis) to oxycodone.
  • OxyContin contains oxycodone, a Schedule II controlled substance. OxyContin exposes users to the risks of opioid addiction, abuse, and misuse. As modified-release products such as OxyContin deliver the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount of oxycodone 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 OxyContin and monitor all patients during therapy for the development of these behaviors or conditions.
  • Instruct patients to swallow the OxyContin tablets intact. Crushing, chewing, snorting, or injecting the dissolved product could result in overdose and death.
  • Serious, 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 initiation of therapy or following a dose increase; therefore, closely monitor patients for respiratory depression. Proper dosing and titration of OxyContin are essential. Overestimating the OxyContin dose when converting patients from another opioid product can result in fatal overdose with the first dose.
  • Accidental ingestion of even one dose of OxyContin, especially by children, can result in respiratory depression and death due to an overdose of oxycodone.
  • Prolonged use of OxyContin 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.
  • Hypotension, profound sedation, coma, respiratory depression, or death may result if OxyContin is used concomitantly with other CNS depressants, including alcohol or illicit drugs that can cause CNS depression. Start with 1/3 to 1/2 the usual dose of OxyContin, monitor patients for signs of sedation and respiratory depression, and consider using a lower dose of the concomitant CNS depressant.
  • Closely monitor elderly, cachectic, and debilitated patients, and patients with chronic obstructive pulmonary disease because of increased risk of life-threatening respiratory depression. Consider the use of alternative non-opioid analgesics in patients with chronic pulmonary disease if possible.
  • OxyContin may cause severe hypotension, including orthostatic hypotension and syncope in ambulatory patients. Monitor patients during dose initiation and titration. Avoid use of OxyContin in patients with circulatory shock.
  • Monitor patients taking OxyContin who may be susceptible to the intracranial effects of CO2 retention for signs of sedation and respiratory depression. Avoid the use of OxyContin in patients with impaired consciousness or coma.
  • OxyContin is contraindicated in patients with GI obstruction, including paralytic ileus. Use caution when prescribing OxyContin for patients who have difficulty swallowing, or have underlying GI disorders that may predispose them to obstruction. Consider use of an alternative analgesic in these patients.
  • OxyContin may cause spasm of the sphincter of Oddi. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms.
  • OxyContin may aggravate convulsions in patients with convulsive disorders and may induce or aggravate seizures in some clinical settings. Monitor patients with a history of seizure disorders for worsened seizure control.
  • Avoid the use of mixed agonist/antagonist or partial agonist analgesics in patients who have received or are receiving OxyContin, as they may reduce the analgesic effect and/or precipitate withdrawal. Do not abruptly discontinue OxyContin.
  • OxyContin may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery.
  • Concomitant use of CYP3A4 inhibitors may prolong opioid effects. Use with CYP3A4 inducers may cause lack of efficacy or development of withdrawal symptoms. If co-administration is necessary, evaluate patients frequently and consider dose adjustments until stable drug effects are achieved.

Please read the Full Prescribing Information, including Boxed Warning, for information about OxyContin.

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