By Marcelo E. Bigal, MD, PhD, Chief Medical Officer, Purdue Pharma
As a researcher with a specialty in headaches and other forms of pain and the chief medical officer of a company that manufactures prescription opioids, I recognize that we must balance the need to treat chronic pain severe enough to require opioids with ongoing efforts to address the deeply concerning opioid crisis and the impact it is having on families and communities across the country.
While reading the recent data brief from the US Department of Health & Human Services Office of Inspector General (OIG) detailing continued concerns regarding opioid use in Medicare Part D, I reflected on the “call to action” in the report, which states: “The high level of opioid use continues to call for the public and private sectors to work together to address this crisis.”
Collectively, we could quickly make a great deal of progress through three practically achievable solutions:
- Increasing utilization of state prescription drug monitoring programs (PDMP) — electronic databases that track controlled substance prescriptions in a state — network,
- Moving toward electronic prescribing, and
- Ensuring wider distribution of FDA-approved Medication Guides.
The OIG data brief focused on identifying patients who receive high amounts of opioids (an average morphine equivalent dose of greater than 120 mg a day for at least three months), and on the importance of reducing “doctor shopping” as important areas for addressing prescription opioid misuse and abuse among anyone who receives prescription opioids.1
Per the brief, doctor shopping is defined as having received high quantities of opioids, having consulted with multiple prescribers, and having filled opioid prescriptions in multiple pharmacies (at least four prescribers and four pharmacies). These findings are consistent with those found in an FDA-mandated study by opioid manufacturers.2 The report emphasizes that prescribers play a key role in combating opioid misuse, and that state PDMPs can provide invaluable information to prescribers about a patient’s opioid prescription story.
We strongly agree that healthcare professionals can make a difference in addressing opioid misuse and that PDMPs are an important part of the equation. Although PDMP systems have been available for many years, until more recently, their utility was somewhat limited. States have made progress in improving PDMPs, and checking these databases has become a more routine part of the clinical workflow for many prescribers.3 Purdue supports efforts to improve PDMP utility for clinicians, including the ability to access data across state lines. To aid in this effort, we provided funding to enable states to connect at no cost to the National Association of Boards of Pharmacy platform to share PDMP data with other states.
Electronic prescribing for controlled substances is another tool that can improve efficiency, promote patient safety, and reduce diversion.4,5 A benefit of e-prescribing is that its software can be mapped to electronic health records and to regulatory databases, offering an enhanced tool for research and epidemiological surveillance. Connecting these technologies enables healthcare professionals to access data on a specific patient in real time — as they are making prescribing decisions — and aligns with recommendations in the OIG data brief.
In addition to using tools such as PDMPs and e-prescribing, there are other ways the healthcare community can proactively support safer use of prescription opioids. One useful and potentially underutilized tool to consider is FDA-approved Medication Guides. Medication Guides are handouts that pharmacists are required to distribute to patients at the time a prescription is received. Federal regulation requires Medication Guides to be issued with certain drugs, including opioid analgesics.6
Medication Guides contain FDA-approved information that can help patients avoid serious adverse events.7 For opioids, they highlight serious and common risks, including misuse, abuse, addiction, overdose, and death. These Medication Guides also include information about safe storage and what to do with any remaining or unused pills after someone stops taking them. This information is particularly important because more than 50 percent of people who report that they have misused prescription opioids say they have gotten them from friends or relatives – in other words, the medicine they misused was not prescribed for them.8
To help reduce the risks associated with opioid analgesics, everyone who receives a prescription opioid should be given information about the risks of misuse, abuse, and addiction; how to handle the medicine safely; when and how to take the medication; where to store the medication; and how to properly dispose of any unused pills.
Unfortunately, Medication Guides are of little value to patients if patients do not receive them, read them, and understand the important information contained in them. The FDA recognizes that there are shortcomings in the current distribution system for Medication Guides. Experts who have advised the agency on improving the Medication Guides suggested that patients receive them at the time the medication is prescribed — before they go to the pharmacy to fill the prescription.9
We believe Medication Guides could have greater value if they are reviewed and discussed between the physician and the patient at the time the drug is prescribed so the patient can learn about the drug before they proceed to the pharmacy. Pharmacies should also distribute them to help ensure patient understanding about the medication they are receiving. A list of medicines with available Medication Guides is available at FDA.gov.
Healthcare professionals can be agents of positive social change by actively reminding patients and caregivers of the importance of reading the Medication Guide and ensuring that they understand the content before they begin taking the medication. Furthermore, the Centers for Disease Control and Prevention recommends that clinicians discuss with household members and caregivers the risks if opioids are intentionally or unintentionally shared with others for whom they are not prescribed, including the possibility that others might experience overdose at the same or at lower dosage than prescribed for the patient.10
Ensuring patients have access to information about safe use and proper disposal of prescription opioids is one aspect of a comprehensive approach needed to help address the opioid crisis. Additional policies including supporting clinicians to obtain informed consent prior to initiating treatment with an opioid analgesic, encouraging prescribers to routinely check the PDMP, and facilitating the use of electronic prescribing for controlled substances are important as well. When all stakeholders work cohesively, we will be able to treat pain properly and address the opioid crisis from multiple angles.
1US Department of Health & Human Services. Office of the Inspector General. Opioid Use in Medicare Part D Remains Concerning. Retrieved from https://oig.hhs.gov/oei/reports/oei-02-18-00220.pdf. Accessed July 3, 2018.
2Walker A, Weatherby, L. Possible Opioid Shopping and its Correlates. Clin J Pain. 2017;33:976–982.
3American Medical Association. American Medical Association Opioid Task Force 2018 Progress Report. Retrieved from https://www.end-opioid-epidemic.org/wp-content/uploads/2018/05/AMA2018-OpioidReport-FINAL-updated.pdf. Accessed August 1, 2018.
4Porterfield A, Engelbert K. Electronic Prescribing: Improving the Efficiency and Accuracy of Prescribing in the Ambulatory Care Setting. Perspectives in Health Information Management, Spring 2014.
5Drug Enforcement Administration. Economic Impact Analysis of the Interim Final Prescription Rule. March 2010. Retrieved from https://www.deadiversion.usdoj.gov/ecomm/e_rx/eia_dea_218.pdf. Accessed August 20, 2018.
6US Food & Drug Administration. CFR – Code of Federal Regulations Title 21. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=208&showFR=1. Accessed August 1, 2018.
7US Food & Drug Administration. Medication Guides for Certain Prescription Products. Retrieved from https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm107825.htm. Accessed July 3, 2018.
8Substance Abuse and Mental Health Services Administration. Key Substance Use and Mental Health Indicators in the United States: Results from the 2016 National Survey on Drug Use and Health. Figure 34. Retrieved from https://www.samhsa.gov/data/sites/default/files/NSDUH-FFR1-2016/NSDUH-FFR1-2016.pdf. Accessed August 1, 2018.
9US Food and Drug Administration. Summary of Public Hearing on FDA’s Use of Medication Guides to Distribute Drug Risk Information to Patients June 12-13, 2007. Retrieved from https://www.fda.gov/Drugs/DrugSafety/ucm173480.htm. Accessed July 5, 2018.
10Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016. MMWR Recomm Rep 2016;65(No. RR-1):1–49. DOI: http://dx.doi.org/10.15585/mmwr.rr6501e1.