Last night, one of my colleagues brought up the story of an Indiana daycare director who was recently sentenced to 6 months for dosing melatonin to children in her care without the knowledge or consent of the children’s parents. He and another of my coworkers then proceeded to voice the opinion that jail time for this admittedly unwise decision was ridiculous and a gross overreaction. This conclusion was unexpected coming from two pharmacists, one of whom is in a supervisory position. I would have thought that two people who have devoted so much time and resources into the field of pharmacy would have applauded such a sentence for someone taking it upon themselves to give medication (even a mostly benign supplement like melatonin) to anyone, especially children.

While they both acknowledged that the decision was not a good one, they seemed to be of the mind that melatonin was not ‘strong’ enough or ‘worrisome’ enough to warrant criminal action. Because the woman gave the children “pediatric-strength melatonin” and because the intention was to help the children nap, she should not have been criminally charged. Lost her job? Yes. Otherwise censured? Absolutely. But somehow, the idea that a caregiver (presumably unqualified and certainly unauthorized) was held criminally responsible for giving children a sleep supplement without parental permission is another example of how weak American society has become and how cancel-culture has turned us all into milquetoast crybabies who don’t know what discipline is.

I challenged this view by asking, if giving melatonin was acceptable to them, what would the threshold for criminality be? Would any over-the-counter medication or supplement be acceptable? If a child in her care had been sneezing a lot, would it be acceptable for her to have unilaterally administered cetirizine (Zyrtec) to her charges? What if another child was having loose stool? Would they be okay with her giving them loperamide (Imodium) without telling anyone or reaching out to anyone? Personally, I would be okay with a caregiver deciding on their own whether a dose of acetaminophen (Tylenol) was appropriate for a minor injury or if a bit of bacitracin might be useful for a cut. I would, however, expect a notice of such first-aid medicine being administered. Melatonin, however, has no such first-aid applications. Furthermore, even products that might be labeled as ‘pediatric-strength’ or ‘for kids’ are typically not intended for children of pre-school age. Indeed, a quick search of such products clearly shows the cut off to be about 4 years old.

In healthcare, we talk a lot about consent. Patients and/or legal representatives have to sign all manner of forms consenting to disclosures, insurance billing and treatments. Hospitals employ entire departments to set policy and enforce rules about informed consent because violating a patient’s rights can be ethically and financially expensive. Even if the regulatory and legal environment seems to put ridiculous constraints on practitioners viz-a-viz informed consent, the vast majority of medical professionals would recoil at coercing patients into doing things they did not and could not understand. What this Indiana woman did, however, was bypass that important part about informed consent and went straight to action. While it’s true the action was fairly harmless and seemed to be well-intentioned, the fact cannot be avoided that giving toddlers any kind of medicinal product without the knowledge or input of family is and should be a criminal action.

I asked if we would be equally forgiving if a nurse gave an adult patient melatonin without consulting anyone. More to the point, what if a nurse technician (someone unauthorized to administer or even access medications) decided to dose a patient without consulting the care team or even the patient themself? My coworkers seemed to feel that such action would and should result in professional disciplinary action, but not legal action. I feel that the fulcrum upon which this entire dilemma balances is that the product administered was melatonin, a relatively safe and widely used supplement available in a variety of formulations without a prescription or any medical input at all. If this woman had been giving children diazepam (Valium) or microdosing them with ketamine, this would be a completely different story. I feel their opinion would be different even if the children were being given hydroxyzine (Atarax), a prescription medication often used as a mild sedative or anti-anxiety drug. Those are ‘real’ medicines (diazepam and ketamine are actually DEA scheduled controlled substances) and giving those medications to people for whom they were not prescribed is definitely a crime. However, melatonin isn’t even classified as a medication – it’s a supplement and so doesn’t get taken as seriously, even by people in the field. This is in spite of pharmacists always cautioning patients that OTC supplements don’t get the same FDA regulation as medication so you can’t always rely on the packaging to reflect the quality or specifications of the product inside.

Despite the surprise I felt from their reaction, I was glad we had the conversation. These are the kind of things one is constantly facing in healthcare and in childcare. Both are so heavily politicized that it’s difficult to disentangle oneself from the world of social media diatribes and hot-takes and really give a moment of thought to the situation. Did the daycare director cause harm to any of the children? At this time it seems the answer is no. Did she take action in an inappropriate way? Clearly she did. Is it criminal to give young children supplements, regardless of how well-meaning, without seeking any consent from family? As it should be, the answer is yes.