The October 19, 2017 report from the Department of Veterans Affairs Office of Inspector General, Office of Healthcare Inspections, entitled, “Healthcare Inspection Opioid Agonist Treatment Program Concerns VA Maryland Health Care System Baltimore, Maryland” (Report No. 16-01091-06) stated that the Opioid Agonist Treatment Program (“OATP”) at the Baltimore VA Medical Center, one of three VA Maryland Health Care System campuses, lacked effective quality controls necessary to ensure patients consistently received required treatment planning and monthly counseling. The findings were the result of an investigation that began after the VA received a confidential complainant in 2015 regarding the Baltimore OATP.
The investigation found that the Baltimore OATP lacked a clear policy on cardiac risk management and quality controls to ensure recommended cardiac monitoring, and that the OATP Medical Director’s responsibilities did not include ensuring compliance with all applicable Federal, State, and local laws as required.
However, the investigation did not substantiate that Baltimore OATP patients died as a result of the shortcomings (39 patients were identified whose death occurred during or after receiving OATP treatment in Fiscal Years 2014 and 2015 and the first quarter of Fiscal Year 2016, but in none of those cases could the investigators establish a link between deficient individual counseling and the patient’s death).
What Are Opioids?
Opioids are a class of drugs that include prescription pain relievers such as oxycodone, hydrocodone, morphine, codeine, and fentanyl, as well as the illegal drug heroin. In addition to relief of pain, opioids can produce feelings of extreme well being (euphoria). Common side effects of opioid use include drowsiness, constipation, nausea/vomiting, and dizziness. At high doses, opioids can cause respiratory depression and other physiological actions that can lead to death. With prolonged use, physical and/or psychological dependence can occur.
What Is Opioid Use Disorder?
Opioid use disorder is a problematic pattern of opioid use leading to clinically significant impairment or distress. Opioid use disorder symptoms include a strong desire for opioids, inability to control or reduce use, continued use despite interference with major obligations or social functioning, use of larger amounts over time, development of tolerance, spending a great deal of time to obtain and use opioids, and withdrawal symptoms that occur after stopping or reducing use, such as negative mood, nausea or vomiting, muscle aches, diarrhea, fever, and insomnia.
How Is Opioid Abuse Treated?
Opioid treatment programs may include opioid agonists such as methadone and buprenorphine. Opioid agonists bind to the body’s opioid receptors and assist with reducing opioid withdrawal symptoms and cravings.
The Baltimore VA Medical Center’s OATP
The Baltimore VA Medical Center requires OATP patients new to the program (0 to 3 months) to report to the OATP pharmacy for daily observed dosing Monday through Saturday (daily reporting), and pharmacists provide one dose to be taken Sunday. As patients progress through the program, the status may expand and can range from reporting 5 days per week with take-home doses for Saturday and Sunday, to reporting biweekly for take-home doses to last 2 weeks (biweekly reporting). In all cases, patients must report to the OATP in person at least biweekly to receive methadone or buprenorphine.
The Department of Veterans Affairs Office of Inspector General, Office of Healthcare Inspections, conducted a site visit to the Baltimore OATP on April 26–27, 2016, and reviewed the electronic health records (EHRs) of those patients for treatment planning/updating and documentation of monthly counseling sessions that occurred during the interval from April 1, 2015 to March 30, 2016.
Patients receiving methadone comprised 89% of the study population (241 of 272). Of the 272 EHRs reviewed, 64 (24% ) did not contain evidence of compliance with 42 CFR § 8.12 (f)(4) and OATP policy. Nine of these EHRs did not contain a documented initial treatment plan. Eight of the patients without a documented initial treatment plan had been OATP patients for the entire study period and the remaining patient entered the program in October 2015. The remaining 55 EHRs did not contain evidence that the treatment plan had been updated within 6 months (180 days) of the OATP’s most current opportunity during the study period. Days overdue for the delinquent treatment plan updates ranged from 7 to 647 days with a median of 157 days.
Were Deaths Related To The OATP Deficiencies?
The review of the records of 39 patients who had a recorded date of death during or after receiving OATP treatment in the study period (i.e., between January 3, 2014 and March 5, 2016) revealed that 18 of these cases (46%) either lacked cause of death documentation or had evidence that suggested the cause of death could possibly be related to substance use or OATP treatment. Of the 18 reviewed patient deaths, four patients were either discharged from OATP more than one year before they died, or were referred but not enrolled in OATP during the year before they died, and therefore treatment deficiencies were excluded as potentially contributing to their deaths. Another eight patients were treated with office-based buprenorphine, and therefore OATP treatment practices would not pertain to their situations. Of the remaining six patients, all of whom were treated in OATP during the year before they died, two died from reasons judged to be unrelated to misuse of opioids. The remaining four patient deaths were either likely or definitely due to opioid misuse, and deficiencies were found in the OATP-provided treatment for three of these four patients with respect to the frequency of individual counseling sessions; however, these patients were actively engaged in other elements of OATP treatment. In none of these cases could the investigators establish a link between deficient individual counseling and the patient’s death.
The report concluded, in part: “We substantiated that the OATP lacked effective quality controls necessary to ensure patients consistently received required treatment planning and monthly counseling. We determined the failure to provide consistent treatment planning and monthly counseling was due, in part, to lack of counseling staff supervision. We did not substantiate that OATP patients died as a result. We also determined the OATP lacked a clear policy on cardiac risk management and quality controls to ensure appropriate cardiac monitoring.”
If you or a loved one suffered injuries (or worse) as a result of opioids or other prescription drugs in Baltimore, in Maryland, or in another U.S. state, you should promptly seek the legal advice of a drug claim lawyer (opioid claim lawyer) in your state who may investigate your drug claim for you and represent you in a drug case, if appropriate.
Visit our website or call us toll-free in the United States at 800-295-3959 to be connected with medical malpractice attorneys in your state who may assist you with your opioid claim.
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