PRESCRIPTION PAIN MEDICATION; LEGAL CONCERNS GROW
The problem of prescription drug overdoses has reached “epidemic proportions” according to the Centers for Disease Control and Prevention (CDC) (Click here for a link to the CDC report). An apparent side effect of the movement for physicians to be more aggressive about treating pain in the late 1990s, such as the “Pain is the 5th Vital Sign,” has been the proliferation of opioid analgesics. Drug distribution of opioids through the pharmaceutical supply chain has gone from the equivalent to 96 mg/per person in 1997 to 700mg/per person in 2007. According to CDC statistics, in 2007 there were 27,000 unintentional drug overdose deaths in the United States, and since 2003 there have been more overdose deaths from opioids than from heroin and cocaine combined.
FIGURE 1. Rate of unintentional drug overdose deaths — United States, 1970–2007
FIGURE 2. Number of unintentional drug overdose deaths involving opioid analgesics, cocaine, and heroin — United States, 1999–2007
It used to be that the most-discussed pain management liability risk to physicians was undertreating patients’ pain, which could lead to licensure board complaints and in rare instances to civil liability. For example, in 2001 a California physician was found liable to the tune of $1.5 Million for failing to adequately manage the pain of an 85 year old man with lung cancer. However, such cases were rare and there is little evidence that many such suits are being brought.
The pendulum has now clearly swung in the other direction, and prescribers are much more likely to face legal action for overtreating patients’ pain by overprescribing pain medications. These cases are being brought in both the criminal and civil courts. Civil lawsuits often follow on the heels of criminal cases and are generally easier to prove. In criminal cases, the proof required for conviction is “beyond a reasonable doubt,” whereas in a civil suit, a plaintiff’s attorney only has to prove a breach of standard of care by a “preponderance of the evidence.”
- In 2012 a Chicago doctor was given four life sentences after having been convicted of causing the deaths of four of his patients of pain management center who overdosed on pain pills.
- Currently, a California doc who wrote 27,000 prescriptions over three years is facing criminal prosecution for the murders of three of the patients.
- A physician in Florida was recently convicted for unlawful dispensing of controlled substances without any physical examination and without determining necessity.
- A physician in New Mexico was convicted of involuntary manslaughter in deaths of three patients due to the quantities and combinations of drugs he prescribed.
- In Illinois the father of a 39-year-old man filed a lawsuit against a doctor alleging gross medical negligence. The man’s father contends the doctor prescribed an excessive amount of oxycodone and then failed to monitor and establish an ongoing treatment plan for his son. The 39-year-old subsequently overdosed on the prescribed pain medication and died.
- A Maryland pain-medicine doctor is being sued by an overdose victim’s family . The lawsuit states the victim died of an overdose of Oxycontin. The doctor is accused of being grossly negligent in prescribing the dangerous narcotic without diligently assessing the victim’s need for it and without putting in place a proper monitoring plan to track his use of the pills. The 39-year-old is one of eight patients who have died as a result of overdosing on drugs prescribed by the doctor in question. Additionally, the same doctor has been named in three other medical negligence and wrongful death lawsuits by family members of patients who overdosed and died.
- An Iowa physician was recently sued by the family of a patient who died from an overdose of oxycodone. Echoing the above suits, the claim is that the physician was “grossly negligent” in prescribing the narcotic painkiller without properly assessing the patient’s need for it or setting up a proper monitoring plan to oversee his use of the pills.
- In a companion criminal case, this patient’s death was one of eight cited by prosecutors who filed criminal charges of involuntary manslaughter against the doctor for allegedly recklessly prescribing large amounts of narcotic painkillers to patients. The Iowa Board of Medicine, which licenses physicians, also has filed administrative charges against the physician, saying he failed to take precautions against abuse of the drugs.
Administrative Investigations (DEA)
In additional to standard criminal prosecutions, physicians who prescribe controlled substances are potential targets of Drug Enforcement Agency (DEA) investigations. If the DEA concludes that a physician is improperly prescribing opioid pain medications, then it can institute administrative proceedings, which can result in the practitioner’s loss of his DEA number and the ability to prescribe controlled substances. In addition to these administrative consequences, the DEA may also refer the matter to federal or state law enforcement officials for prosecution, and to state medical boards for investigation of the practitioner’s medical license. The DEA maintains a listing on its website of investigations of physician registrants that resulted in the arrest and prosecution of the physician from 2003 to the present. (http://www.deadiversion.usdoj.gov/index.html)
What can you do?
A. Document! The most important initial step is to thoroughly document your assessment of the patient, justification for prescribing opioid medications, and plan. Continue to reassess the need for the opioid medications at subsequent visits and document your reasoning behind continuing, tapering, or discontinuing the medications.
B. You should also utilize the two primary tools at your disposal to manage patients for whom you prescribe opioid pain relievers: (1) the “Ambulatory Controlled Substance and Medication Management Agreement,” and (2) participate in the Virginia Department of Health Professions’ Prescription Monitoring Program (PMP).
i. “Ambulatory Controlled Substance and Medication Management Agreement”
- This agreement (click here for a pdf copy), also known as a “contract,” sets out all of the relevant cautions the patient needs to know about taking prescription pain medication, and it also sets out strict compliance guidelines with consequences. The most severe consequence is termination of care. Although these documents are not legally binding if there is a breach by the patient, they serve the dual purposes of (a) reinforcing to the patient the seriousness of these medications, and (b) providing a justifiable foundation for you to terminate care if the patient does not comply. This latter point will prevent any repercussions from the Board of Medicine, should a terminated patient complain that you inappropriately ended your relationship.
- Of course these agreements are only useful if you enforce them, so if you do have one in place, but do not follow it, then you are less likely to be able to justify using it in the future to end a patient relationship. Also, if there is an adverse outcome, you could face an allegation that had you enforced the contract the patient would not have had the opioids and thus would not have been harmed.
ii. DHP Prescription Monitoring Program (PMP)
This program allows you to obtain patient- specific history of prescriptions for all controlled substance use. It will tell you whether a patient is receiving prescriptions for controlled substances from someone other than yourself.
How it Works
- Pharmacies, non-resident pharmacies, permitted physicians, and physicians holding a permit to sell controlled substances are required to report all dispensing of any Schedule II, III, and IV controlled substances to the PMP. The program also requires non-resident pharmacies to report dispensing of controlled substances to Virginia residents. As a registered user, you can access this database of information.
- The regulations do require that you post a sign notifying your patients that you may access information from the PMP files on all Schedule II, III or IV prescriptions. The sign should be posted in your waiting or reception area where you are sure that all patients will be able to see it. You are not required to obtain specific written consent of the patient prior to requesting data.
How to Access
- Prescribers may designate up to two licensed healthcare professionals or delegates under their direct supervision to submit requests for patient histories on their behalf.
- Prescribers who are registered users can either enter a request online or fill out a request form and return it via fax to 804-527-4470. A report containing the patient’s prescription history of controlled substances is made available online or sent back to the user via fax. For patients without any prescription records, a “no data was found” statement is sent to the requester. According to DHP data, 97% of requests are processed within one minute.
- DHP’s PMP is now live twenty-four hours a day, seven days a week
At this time of heightened legal scrutiny of prescriber practices for opioid pain medication, physicians must exercise the utmost prudence and caution when utilizing these therapies. Utilize your best documentation practices and be sure to avail yourself of the narcotic contract and the PMP in order to minimize your risk, and please contact the Trust at any time if you have questions or concerns.