October 2008

News from Attorneys General Offices

  1. At the end of September, California Attorney General Edmund G. Brown Jr. announced a crackdown on prescription drug fraud in California. The campaign, launched in June, has already led to the arrest of dozens of suspects, including one woman who had visited 183 doctors, dozens of emergency rooms, and 47 pharmacies to obtain opioids such as hydrocodone and oxycodone tablets and OxyContin.
  2. Florida Attorney General Bill McCollum announced that a Broward County man has been sentenced to 10 years in prison after his conviction on multiple criminal charges involving a massive drug diversion scheme. Wilber Bherviz operated Houston Rx, a Texas wholesale drug company, that bought pharmaceuticals worth nearly $40 million from unlicensed suppliers in Miami, who diverted the prescriptions from Medicaid patients they recruited.
  3. Indiana Attorney General Steve Carter announced that a former licensed practical nurse has pled guilty to felony and misdemeanor charges for stealing nursing home patients’ pain medicine. To cover up the theft of OxyContin from two nursing home patients, she falsified the medication record to make it seem as though the patients had received their medication.
  4. Attorneys in the office of Montana Attorney General Mike McGrath are arguing a case before a state district court in a lawsuit brought by a terminally ill Billings Montana man and others who are seeking to legalize doctor-assisted suicide. The state’s position is that the issue of assisted suicide is the legislature’s responsibility, not the courts.
  5. Oklahoma Attorney General Drew Edmondson announced the arrest this month of a Tulsa doctor after a three-year undercover investigation. Dr. David Crass has been charged on 34 counts of distributing a controlled and dangerous substance, including Xanax, Valium, Adderall, and Lortab, outside the course of professional practice. He is also charged with one count of Medicaid fraud.

Judicial Developments

  1. In Nguyen v. United States, No. 07-12874 (Oct. 21, 2008), the Eleventh Circuit Court of Appeals held that Dr. Andrew Nguyen, whose arrest, according to the court, was based on no evidence of wrongdoing, could pursue a claim against the federal government for false arrest, false imprisonment, and malicious prosecution. The court held that the 1974 amendment to the Federal Tort Claims Act, passed in response to public outrage over the drug raids of the homes of two innocent families in Illinois, waived sovereign immunity to claims “arising ... out of assault, battery, false imprisonment, false arrest, abuse of process, or malicious prosecution.” Dr. Nguyen was arrested on suspicion of unauthorized delivery of controlled substances.
  2. A probate court in Florida has ordered a new hearing date regarding guardianship of a 38-year old woman who has been unconscious since suffering a cardiac arrest six weeks ago. Her husband, Robert Lavers, filed a motion to oppose a medical guardianship claim by his sister-in-law, Heidi Kaczala. Ms. Kaczala already has the right to make basic medical decisions regarding her sister’s care, but the hearing will determine whether she may make end-of-life decisions.

Legislative Developments

  1. H.R. 6353, the Ryan Haight Online Pharmacy Consumer Protection Act of 2008, has been signed by the President. This law amends the Controlled Substances Act to prohibit the dispensing of controlled substances over the Internet without a valid prescription. A “valid prescription” is defined as one that is issued for a legitimate medical purpose by a licensed practitioner who has conducted at least one in-person medical evaluation of the patient. Telemedicine practitioners are exempt. Online pharmacies must comply with state pharmacy licensing laws in each state in which they sell controlled substances. The law imposes reporting requirements and the display of specific information by the online pharmacy on its home page. The law also authorizes states to apply for injunctions and obtain damages and other civil remedies against online pharmacies that are deemed a threat to its residents.
  2. S. 2162, Veterans' Mental Health and Other Care Improvements Act of 2008, the Veterans Mental Health and Other Care Improvements Act of 2008, incorporates S. 2160, the Veterans Pain Care Policy Act. President Bush signed it on October 10. It requires the Secretary of Veterans Affairs to develop and implement a comprehensive policy on the management of pain experienced by veterans enrolled in the VA healthcare system.
  3. The Military Pain Care Policy Act, H.R. 5465, has been incorporated into the National Defense Authorization Act of 2009, S. 3001, which was signed by President Bush on October 14. The act requires the Department of Defense to implement a pain care initiative in all military health care facilities.
  4. The House of Representatives has passed H.R. 2994, the National Pain Care Policy Act of 2008.
  5. California Governor Arnold Schwarzenegger signed into law AB 2747, the “California Right to Know End-of-Life Act of 2008.” Among other measures, the law requires California medical schools to provide instruction in end-of-life care and requires physicians to advise patients on end-of-life care options, including palliative sedation accompanied by the withholding of food and liquid.
  6. Sarasota County, Florida, is considering adopting an ordinance that would require anyone seeking prescription painkillers to show photo identification in county pharmacies.

Pain Management

  1. The October issue of Experimental and Clinical Psychopharmacology is devoted to articles discussing various aspects of opioid use in pain management. One article, “The Interface Between Pain and Drug Abuse and the Evolution of Strategies to Optimize Pain Management While Minimizing Drug Abuse,”contains a review of pain management efforts, focusing on two particular areas: the emergence of prescreening tools for identifying appropriate candidates for opioid therapy and the concept of “in and out of the box” prescribing whereby practitioners can measure whether one’s prescribing patterns are matching peer prescribing patterns. The authors stress that good pain management should lead to some decreases in pain perception with a corresponding increase in ability to function. Other articles that might be of interest include “Opioids and the Treatment of Chronic Pain: Controversies, Current Status, and Future Directions,” “Addressing the Intersecting Problems of Opioid Misuse and Chronic Pain Treatment,” and “Addiction to Prescription Opioids: Characteristics of the Emerging Epidemic and Treatment with Buprenorphine.”
  2. A neurologist in Virginia who specializes in chronic pain wrote an article for the Hampton Roads Daily Press detailing the frustrations of trying to practice good medicine with third-party payers, whose primary concern is cutting costs, questioning his prescriptions, the therapies he has ordered, and the amount of time he spends with a patient.
  3. A study presented at the American Society of Anesthesiologists’ meeting in October found that women seem to respond better then men to chronic pain treatment and men who smoke receive even less benefit.
  4. The October issue of the Journal of Palliative Medicine reported that hospitals nationwide are falling behind in providing palliative care. Only Vermont, Montana, and new Hampshire earned an “A,” according to America’s Care of Serious Illness: A State-by-State Report Card on Access to Palliative Care in Our Nation’s Hospitals.” Hospitals, however, are increasing the number of palliative care programs. In California, for instance, a survey released in September found that about 43% of hospitals in the state offer some type of palliative care program and that there has been a 90% increase in such programs since 2000.
  5. A survey published in the New England Journal of Medicine found that many patients gave low scores to hospitals on pain management and discharge instructions. The study found that hospitals with higher nurse-to-patient ratios had more satisfied patients.

Prescription Drug Diversion

  1. Cardinal Health, one of the country’s largest distributors of pharmaceutical drugs, has settled allegations that it violated reporting requirements in its handling of some controlled substances. Under the agreement, Cardinal Health will pay $34,000,000 in civil penalties. DEA has alleged that Cardinal’s conduct allowed the diversion of millions of dosage units of hydrocodone from legitimate to non-legitimate channels.
  2. Army officials are concerned about the sharp rise in outpatient narcotic pain relief prescriptions given to soldiers since the beginning of the war in Iraq. One doctor has suggested that doctors may be relying too heavily on narcotics for active duty soldiers. According to court testimony at least 20 soldiers in one engineer company shared and abused painkillers prescribed for their injuries.
  3. A one-hour webcast, sponsored by Cephalon, Inc., was broadcast on October 21. Moderated by Gen. Barry R. McCaffrey, former director of the Office of National Drug Control Policy, the program, titled “When Good Medicines Become Bad Drugs,” focused on helping consumers understand their responsibility in ensuring that opioids are appropriately used and safeguarded.
  4. In October, the National Family Partnership sponsored Red Ribbon Week, a week devoted to educating young people about the dangers of drugs, including prescription drugs. The Partnership also sponsored National Lock Your Meds Day which encourages consumers with prescription medications to safeguard them against diversion.
  5. Dr. Monique Williams of Arcadia, California, has agreed to plead guilty to illegally distributing OxyContin. According to prosecutors, she wrote prescriptions for people she never examined in exchange for cash, sometimes as much as $25 a pill. Both her DEA registration and her California medical license have been suspended.

Other News of Interest

  1. The October 8 issue of the Journal of the American Medical Association included an article reporting a study to evaluate whether patients whose clinicians engaged in end-of-life discussions with them opted for less aggressive interventions. The study authors concluded that end-of-life discussions are associated with less aggressive medical care near death and earlier hospice referrals. More aggressive treatment is associated with worse quality of life for the patient and more difficult bereavement adjustment for loved ones. The article engendered wide-spread media interest, including an article in ScienceDaily and in Medscape.
  2. The October issue of Archives of Internal Medicine included an article that looked at the stability of preferences for end-of-life treatment. The study found that end-of-life preferences appear to remain stable as health declines. However, the most change was seen in those who did not have advanced directives and in those had desired the most aggressive treatment.
  3. The September 1 issue of the Journal of Clinical Oncology reported that terminally ill black and Hispanic adults are less likely than their white counterparts to have a plan in place, such as an advanced directive or a medical power of attorney, for end-of-life care. Eighty percent of white patients who had fewer than six months to live had discussed end-of-life care with their doctors or had a documented plan. In contrast, this was true for only 47 percent of the black and Hispanic patients. An article in the Journal of the American Geriatric Society reported the results of a study in which researchers attempted to discern why there are racial differences regarding advanced care planning and hospice utilization. The authors argued that the medical community must find more culturally appropriate ways to deliver good end-of-life care to African Americans.
  4. A paper in the October 15 issue of the American Journal of Respiratory and Critical Care Medicine reports that sequential withdrawal of life support in the ICU ─ withdrawing life support measures one at a time over a period of days ─ led to greater family satisfaction with care. This was particularly true with the loved ones of trauma patients.
  5. In the discussion among medical practitioners and health policy ethicists concerning care at the end of life, much has been written about treatment that some conclude is painful and even cruel, including resuscitation for cardiac arrest. An interesting article in the Los Angeles Times by a doctor tells the other side of the story. In “How a Cardiac Arrest Made Me a Better Doctor,” the author recounts his feelings of sadness at the necessity to resuscitate and intubate an 89-year old, frail woman in the hospital. “Cracked ribs, broken teeth, electrical skin burns ─ all on a frail old lady at the end of her life. We had kept her alive, but for what? Aren’t we supposed to ‘First, do no harm?’” His surprise at seeing her a few days later, alert, ready to leave the hospital, talking about her great-grandchildren and her plans for the future gave him a different perspective. He wrote, “From that point on, I no longer considered a patient’s age as a determinant of the care they should receive.”

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