May 2012 Pain Research Updates
DEA Turns Focus on Drugstores and Distributors
In February, the US Drug Enforcement Administration (DEA) took the unusual step of ordering Cardinal Health’s wholesale facility in Lakeland, Florida, to stop dispensing controlled substances, such as oxycodone (OxyContin) and hydrocodone/acetaminophen (Vicodin), to its 2,500 customers in Florida, Georgia, and South Carolina.1
The agency also ordered two CVS pharmacies in Sanford, Florida, to stop distributing these medications. The agency said it took these actions because Cardinal Health failed to maintain effective controls against diversion and the CVS pharmacies were filling prescriptions far beyond the legitimate needs of their customers.
In these cases, the DEA was clearly targeting abusive pharmacies—according to the agency, the two CVS pharmacies filled more than 3 million doses of oxycodone in 2011 versus 69,000 doses per year filled by the average US pharmacy. “They should have known that a large proportion of these pills were not being dispensed for legitimate medical purposes,” said the agency.
According to the Florida Department of Law Enforcement, “on average, seven people die every day in Florida due to prescription drug abuse.” The DEA efforts to reduce drug diversion and abuse have also included arrests and criminal actions against Florida doctors (pill mills) and individually owned pharmacies that operated outside the scope of legitimate medical purposes.
The current action, however, raised concerns among pain management clinicians that legitimate pain patients may be harmed. Addressing this concern, DEA spokesperson Mia Ro told MedPage Today that “the organization isn’t making a special push against retailers or distributors; rather, the orders were brought on by red flags raised by the DEA’s routine monitoring of registrants.”2
Both Cardinal Health and CVS won their federal appeals to continue distributing opioids until another hearing, which was scheduled to be held in April. (As of press time, no action has been taken.) But a Cardinal Health spokesperson said that the distributor has contingency plans in place to ramp up distribution from other facilities around the country if their appeal is not upheld.
Special Web-only Pain Research Updates
Prescribers Experience Frustration Managing EMR Alerts
Medication alerts are frustrating for prescribers using electronic medical records (EMRs), leading some physicians to ignore the alarms, investigators in the US Department of Veterans Affairs (VA) determined in a recent study.3
During the investigation of prescribing practices at a major VA medical center, 120 hours of observations and interviews were logged, with 320 medication alerts being observed among 30 prescribers treating 146 patients.
The sheer number and types of alerts contributed to prescribers overlooking important alerts due to the following factors identified by investigators: The alert does not apply to the patient, the alert provides too much additional information, and the EMR system generated too many alerts. Medication alerts frequently appeared in situations where the alert would contradict common medical practice. Another criticism providers had about the alerts was that the alerts seemed to be written for pharmacists rather than physicians or nurses who did the prescribing.
Suggestions to improve the medication alert system included a need for a more universal design and more support for all prescriber types. Investigators pointed out that this study was conducted at one VA medical center using one type of alert system, and results may vary depending on the EMR system used.
Long-term Opioid Use Seen in Patients Prescribed Opioids for Minor Surgery
Researchers at St. Michael’s Hospital in Toronto recently determined that the prescription of analgesics immediately following minor, low-risk surgery occurs frequently in older adults and is associated with long-term use.4
In a retrospective cohort study, Ontario residents who were 66 years old or older were dispensed an opioid following a minor surgery (cataract surgery, laparoscopic cholecystectomy, transurethral resection of the prostate, or varicose vein stripping). Among the opioid-naïve patients undergoing the surgery, 7.1% were prescribed opioids within 7 days of being discharged, and 7.7% were prescribed opioids 1 year after the surgery.
In the investigators’ primary analysis, patients who received an opioid prescription within 7 days of a minor surgery were 44% more likely to become long-term opioid users within 1 year when compared to patients who received no opioid prescriptions following the surgery.
A secondary analysis conducted to evaluate the prescription of non-steroidal anti-inflammatory drugs (NSAIDs) in patients who underwent ambulatory surgery was much more telling—with 0.3% of patients being prescribed NSAIDs within 7 days of discharge increasing to 7.8% of patients being prescribed NSAIDs 1 year after surgery. This analysis revealed that patients who were prescribed NSAIDs were four times more likely to be taking NSAIDs long term than patients who did not receive an NSAID prescription following minor surgery.
Classification Criteria Released for Polymyalgia Rheumatica
The American College of Rheumatology, in conjunction with the European League Against Rheumatism, recently released provisional classification criteria for polymyalgia rheumatica (PMR)—an inflammatory disorder that is a common cause of widespread pain and stiffness of the shoulders and hips in adults who are 50 years of age or older.
Classification criteria for this rheumatic disease are needed because symptoms of PMR are commonly caused by other illnesses in the same patient cohort, and there are currently no well-established guidelines or tests available to recognize the disease, leading some clinicians to evaluate a patient’s corticosteroid response as a “test of treatment” to establish the diagnosis, according to investigators.5 However, these proposed classification criteria are provisional, and though useful when defining patient groups for epidemiologic or clinical studies, are not diagnostic criteria. Confirmation of these criteria in additional prospective validation cohorts is needed.6
In a 6-month prospective cohort study, Dasgupta et al evaluated 125 patients with new-onset PMR and 169 non-PMR patients with conditions mimicking PMR. An algorithm was developed based on morning stiffness for more than 45 minutes, hip pain/limited range of motion, absence of anti-citrullinated protein antibody and/or rheumatoid factor, and absence of peripheral joint pain. Investigators concluded that a patient could be classified as having PMR if the following parameters are present5: