Mental health facilities providing certain substance use disorder treatment or services should report any adverse event associated with the use of a drug that occurred in connection with that service.
Examples of adverse events are deaths or transfers to medical facilities or medical units (including emergency departments) that are related to detoxification or opiate maintenance complications, instances of delirium tremens, and seizures.
In this context, an “adverse event” is an undesirable effect, reasonably associated with use of a drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. There should be some basis to believe there is a causal relationship between the drug and the occurrence of the adverse event.
This requirement applies to mental health facilities that offer substance use disorder treatment services as provided in 104 CMR § 27.03(10). These may include separate, identifiable substance abuse treatment programs, as well as medically assisted treatment and medically monitored detoxification services.
Reference: 104 CMR §27.03(10)
