In response to the new Indiana opioid prescribing rule for chronic pain, the American Civil Liberties Union (ACLU) filed a lawsuit Jan. 8 against members of the Medical Licensing Board (MLB) of Indiana, in their official capacities. The suit, filed in the U.S. District Court for the Southern District of Indiana, argues that patients prescribed opioids for chronic pain management should not be forced to consent or be subject to annual drug testing as a condition of treatment.
Wierciak, et al. v. Individual Members of the Medical Licensing Board of Indiana alleges this required testing constitutes an unreasonable search and, therefore, violates the Fourth Amendment. The lawsuit seeks a court order prohibiting the MLB from requiring patients to consent to and undergo drug testing when not medically indicated.
The complaint also seeks certification of the suit as a class action. Currently, no timeline exists for a decision; the ISMA will provide updates on the case.
Pharmacies presenting challenges
“The ISMA is receiving many reports from all across the state that pharmacies and pharmacists are increasingly placing barriers between doctors and their patients who have been issued controlled substance prescriptions,” said Julie Reed, ISMA general counsel.
Some pharmacists are requiring that the prescriber provide documentation before the prescription will be filled. This may include a care plan, progress notes, full medical records and/or a copy of the patient treatment agreement.
Other pharmacists are running through a checklist before dispensing or are reportedly forcing primary care doctors to change their prescriptions to lower dosages or durations – rationing medications. Some pharmacy chains are also sending letters notifying prescribers that their prescribing practices match with the pharmacy’s red flags list, and the prescriber should call immediately for a consultation.
“Most of these pharmacy issues are pretty new,” said Reed, “and they may be getting worse.” Pharmacists have always had a legal duty to ensure prescriptions they fill were issued for a legitimate medical purpose.
But in April, the ISMA reported that pharmacies were rolling out new national Good Faith Dispensing policies in response to DEA enforcement actions, stemming primarily from opioid dispensing practices in Florida. (See ISMA e-Reports)
“Now, pharmacies seem to be taking further action based on the new Indiana pain management rules,” Reed added. “Some communities may be under greater scrutiny than others.”
The ISMA is in communication with the Indiana Board of Pharmacy, whose members are looking into this matter. The Indiana Office of the Attorney General and the MLB are aware, and the ISMA continues to work on the issue. In the meantime, doctors and patients who are affected should report their experiences directly to the Indiana Board of Pharmacy at (317) 234-2067.
More about the new rule
The 2013 Indiana General Assembly unanimously passed SB 246 mandating, among other things, the MLB to create emergency standards and procedures for prescribing opioids for chronic pain management by Nov. 1, 2013. The new rules, which became enforceable Dec. 15, 2013, require doctors who prescribe opioids to patients at certain levels for more than three consecutive months to take additional evaluation and compliance steps.
Specifically, the rule specifies what has to be included in the initial evaluation and risk stratification of the patient, as well as informed consent. It requires the patient and doctor to enter into a written treatment agreement, ensures the patients are seen at least every four months, if not more often, and requires the prescriber to run and review INSPECT reports and drug tests, both initially and annually.
Exemptions exist in the rule for patients with a terminal medical condition, residents of an Indiana-licensed health facility, patients enrolled in an Indiana-licensed hospice program, and patients enrolled in an inpatient or outpatient palliative care program of an Indiana-licensed hospital or hospice.
The drug testing requirement being challenged in the courts does not go into effect until Jan. 1, 2015. The MLB is tasked with adopting final rules this year; the ISMA will be involved in that process.
Find the rules here. The ISMA has a summary of the rules, resources to help you comply and educational webinars on the ISMA website.