Bill Targets Consent for Psychotropic Drugs
THE ISSUE: Some patient advocates say current informed written consent regulations for prescribing psychotropic drugs don’t go far enough.
THE DETAILS: A House bill would require that consent forms also list alternative treatments, a plan for stopping medication and a review to monitor side effects.
While Massachusetts implemented new regulations governing the use of mind-altering psychotropic medications in 2014, some patient advocates say the three-year old policies don’t do enough.
Current state law requires informed written consent before a patient can be given psychotropic drugs at a nursing home or long-term care facility. That means patients, their healthcare proxies or guardians must agree in writing before a prescriber can administer antidepressants, antipsychotics, anti-anxiety drugs, sedatives or stimulants. The prescriber must provide information about the purpose of the medication, dosage, risks and benefits.
“The kind of information that’s missing is how the resident will be monitored for the side effects, and is there a plan for gradual dose reduction, which is important to do with these serious drugs,” said Arlene Germain, president of Massachusetts Advocates for Nursing Home Reform. “Also, they should be making a statement on the form about the person’s right to stop the medication if they choose to stop it.”
State Rep. Shaunna O’Connell, R-Taunton, said she is concerned about a “national epidemic” of over-prescribing psychotropic drugs for off-label uses.
“It’s like a dirty little secret,” she said.
O’Connell filed a bill, H.3250, that would require informed written consent forms to also include a plan to monitor patients for side effects and to regularly review the prescription. Prescribers would also be required to list alternatives to medication.
“These could be things like talk therapy or music therapy. There are a lot of non-pharmacological alternatives that could be used,” O’Connell said.
The bill is currently in the hands of the Committee on Public Health, where it has yet to receive a hearing. The Massachusetts Senior Care Association did not respond to requests for comment on the legislation.
O’Connell credits a constituent, Nancy Sylvester of Taunton, for bringing the issue to her attention.
Sylvester said she became very concerned about medical consent when she began accompanying an elderly family friend on trips to hospitals and rehabilitation centers in 2011, before the current regulations took effect. The friend, a dialysis patient in his 80s, died in 2011 after getting bedsores that became infected.
Sylvester said she first became alarmed after discovering a doctor said her friend verbally consented to a “do-not-resuscitate” order, just one day after she saw the patient adamantly declare he didn’t want a DNR.
After resolving the DNR issue, the patient moved to a rehabilitation facility, where Sylvester said she discovered her friend was given psychotropic drugs against his will.
“He was completely out of it, then he couldn’t swallow and he got bedsores,” Sylvester said. “Come to find out, they put him on an antipsychotic drug for transport without telling anyone. This went on for three weeks.”
At another rehab facility, staff continued to give the patient psychotropic drugs without informing him or his family, Sylvester said.
“They said, ’He’s agitated; he’s not sleeping,” Sylvester recalled. “They woke him up and pricked him, and he said, ‘You can’t do that to me. You have to ask.’”
The bedsores, Sylvester recalled, later became infected, ultimately killing her friend.
While the state has since put written consent regulations in place, O’Connell said more needs to be done to help patients understand the long-term plan for the medication, whether the drugs are being used for off-label uses and whether there are alternative treatments.
“There are many caregivers, nursing homes and long-term care facilities that do a great job,” O’Connell said. “But for those who are prescribing these heavy drugs without proper consent and with the uses not being indicated, it is a very dangerous practice, and we need to do everything in our power to protect vulnerable senior citizens from this kind of treatment.”