Informed Consent Bill On Psychotropics Back In NJ
29 CommentsBy Ed Silverman // February 29th, 2008 // 11:22 am
Three years ago, the FDA required makers of antidepressants to supply Med Guides along with their pills. That wasn’t good enough for a couple of New Jersey moms, who have been pushing their state legislature to go even further - a bill requiring a doctor or nurse to obtain informed consent from a minor’s parent before writing a prescription for any psychotropic that already carries a Black Box warning.
Last November, however, it looked like the bill, which had been kicking around a year, was dead after making it to the New Jersey assembly and senate. The state senator who heads the health committee, Joe Vitale, failed to schedule the bill for a vote, citing procedural issues and the need for further study. At the time, he told us the bill would still move forward, but it never did. He hasn’t returned calls seeking comment.
As a result, the legislation had to be introduced from scratch. Those two moms, however, have succeeded in finding five new sponsors in the assembly, where the bill has been introduced and will be heard this coming Monday morning before the consumer affairs committee. “This fight isn’t over,” says Lisa Van Syckel, a self-styled parental advocate. (This is the bill).
“Informed consent is the only way to make sure information is passed from physcians to patients,” says Laurie Yorke, a registered nurse and the other mom who pushed for legislation. “And with these drugs, there are a lot of varying opinions among physicians, as well as misconceptions in general. Unfortunately, the adverse reactions can be misconstrued as part of the illness, when it may be due to the drug. And parents need to know that, but if they’re not given sufficient information, they’re not going to know what to look for.”
Meanwhile, the moms and their supporters are seeking sponsors in the state senate for a companion bill. A spokeswoman for one senator, Shirley Turner, says Turner is interested in the bill and is considering introducing legislation.
It remains unclear whether the bill will again be opposed by the New Jersey chapter of the National Alliance on Mental Illness, a non-profit advocacy group. Phil Lubitz, the advocacy director for the local chapter, which has accepted funding from drugmakers that sell antidepressants and antipsychotics, including Abbott Labs, Bristol-Myers Squibb, Eli Lilly, Glaxo, Pfizer, AstraZeneca, Wyeth and Johnson & Johnson, didn’t respond to a request for comment.
nipsey russell
pharmalot’s own Lisa Van S????
Jack2
Yes. Pharmalot’s LVS.
Is this for SSRIs only? SSRIs and SNRIs (I don’t even know if SNRIs carry the BBW)? What’s the penalty for not asking for consent (I’m inclined to believe not all docs know which drugs carry a bbw, especially when some members of a class carry the warning and some don’t). Also, what if something is prescribed off-label for depression - it might not have a bbw, so then it doesn’t require consent?
Lisa Van S
HMMMM,… not sure what you mean, care to elaborate?…
Ed Silverman
Hi Nipsey,
Yes. As you seem to know, she is quite vocal and, as I’ve learned, quite active. And some of those activities bear watching. Not everyone gets their legislature to introduce and reintroduce legislation. Interesting, yes?
Thanks for stopping by,
ed
Lisa Van S
Jack2
“All” antidepressants carry a Black Box Warning including SNRI’s. Seroquel and Abilify, which are antipsychotcs carry a Black Box Warning for increased risk of Violence/Suicide. Not to Mention boys will lactate, and possibly rcve mastectomies due to side effects. Not Informing parents is downright “cruel”
Lisa Van S
Hey Guys,
Any comments to what Laurie has said here, she’s a nurse you know?
or, is it just more fun to poke at me?
Nathan
This is great — seriously. Good job Lisa (and Laurie). All drugs should require informed consent — not just antidepressants and not just for minors. Obviously exceptions would have to be made for emergencies and for unconscious patients.
Seriously – It should be MANDITORY for the doctor to go over the expected benefits of the medication and the potential side effects of the medication for EVERY prescription written. Moreover, the patient should sign a statement that they have received such training from the doctor. This would presumably do two things:
1) Avoid misunderstandings (or nonunderstanding) of side effects.
2) Cut down on frivolous lawsuits. How can somebody sue for a side effect that they were well aware was a possibility?
Who is opposed to this sort of legislation? It’s hard for me to imagine that doctors, patients, or pharmaceutical companies would be opposed to it.
Lisa Van S
Nathan,
Well we can start with Assemblyman Herb Conaway(he’s a physician) and his wfe has rcved approx $30,000 from GSK according to financial Disclosures.
American Academy of Pediatrics
New Jersey Counsel of Child an Adolescent Psychology,Psychiatry
American Psychiatric Association
Phil Lubitz- NJ Nami http://www.namipharma.org/en-sponsors.html
Senator Vitale- He received an Award from Nmi on June 2,2007. And according to NJ Citizen, the Senator has rcved
some pretty “Hefty” campaign contributions from the pharmaceuitical industr
Industry doesnt have to oppose,.. their apologists are doing it for them.
Im anticipating a very crwded Assembly Hearing Room on Monday.
The safety of our Children’s Medicines should be a priority,.. unfortunately its not.
Nathan
First off, money from GSK doesn’t necessarily mean that they are opposed to the legislation — has GSK specifically stated their opposition to it?
Why are these groups opposed to this legislation? Are they concerned about those crazy parents who refuse to give their kids any medication? (including vaccines)
There doesn’t appear to be a significant “down side” to this legislation. Any money that companies loose in prescription sales are likely to be gained by lower lawsuit payouts.
Dave M
Just as a point of interest.
There are 180,000 NPs and PAs who can prescribe in all 50 states.
Can we stop saying “the doctor” when we mean prescriber? I have been prescribing since 1976.
Please.
Dave Mittman, PA
Secty
American College of Clinicians
http://www.amcollege.org
Doug Bremner
Maybe Lisa can summarize for us what argument these groups are making against the bill, if any
Lisa Van S
Doug Bremner,
You can listen to their argument here Click on May 17,. 10 am:
http://www.njleg.state.nj.us/media/archive_audio2.asp?KEY=ACO&session=2006
Lisa Van S
Dave M
The NJ Bill,.. Covers you also!!
Lisa Van S
Dave,
Im curious,..Do you oppose this Bill? and if so , why?
Lisa Van S
Nathan,
One would think so.
Lisa Van S
Nathan,
No Dead Children!!,.. No Lawsuits!!.. Works for me.
Jack2
I don’t have a problem with it, but mostly cause I don’t work as a pharmacist anymore. I just think prescribers might oppose it because it could increase their liability (I would think it actually decreases a drug companies liability), and will increase their workload.
I’m also a rules/numbers/details guy. I want to know what happens to the doc who forgets to get the consent. Does the pharmacist have to verify the consent before filling the script. I know pharmacists dislike anything that takes up their time (controlled substances, med guides, insurance claims), so I don’t think they will receive this warmly. Okay, Seroquel carries the suicide bbw because it’s indicated in adjunctive therapy for depression. Zyprexa doesn’t carry the warning, probably because it doesn’t carry this indication. But it does carry a bbw for increased mortality in the elderly. Is that relevant? If it isn’t relevant, but is still a bbw, does the doc still need to mention it according to the law as written? So if a doc gives on-label Seroquel they need to get special consent but if they give off-label Zyprexa they might not?
I think most med professionals will oppose anything that requires intimate knowledge of the labels. I think most docs/pharmacists/nurses/phys. assistants/therapists lump all the drugs in a given class together. Only pharm companies really care about the subtle differentiation. So I don’t think many HCPs, off the top of their head, can tell you what exactly is written in the PI.
I can’t listen to their arguments through the link though, because I’m at work so that’s just my guess.
I don’t oppose it. I think it can be beneficial, although if that benefit exceeds the extra effort, I just don’t know (sorry for being insensitive Lisa-I’m sure in your mind it’s worth the effort). I also care, or would care if I still worked out “there” as an HCP about the details of how it’s implimented. I’m sure you already considered this much more closely than I have Lisa. Those are just the details, snags, and contingencies I thought of.
Matt
Lisa, you’re doing a great job, don’t bother to acknowledge your detractors.
Keep up the great work!
Laurie
Jack2, Pharmacists are solidly behind this bill. The bill outlines what the penalty is for those who don’t comply.
“I think most med professionals will oppose anything that requires intimate knowledge of the labels.”
And this is exactly why this bill is necessary. If a medical professional is going to prescribe it, they better know what the warnings are and inform their patients. If they had been doing this all along this bill wouldn’t be necessary.
This bill, at the current time, would not include Zyprexa, since the black box warning isn’t in place for kids. There’s still more work to be done.
Laurie
“There doesn’t appear to be a significant “down side” to this legislation. Any money that companies loose in prescription sales are likely to be gained by lower lawsuit payouts.”
Nathan you are absolutely right. If parent are fully informed about the risks, there is no basis for a lawsuit. This was never about money, this is about informing parents. I afree….there is NO downside to this.
Bob
This is why I have a problem with it:
It removes all personal responsibility from the patient.
If something goes wrong, the patient will have more “ammo” to go after the drug companies, doctors, pharmacists, etc…
We live in a country of morons, and this is just going to make people dumber.
Great.
Lisa Van S
Bob,
How so?.. Your comment sure has me stumped!!
Bob
Lisa-This isn’t a knock.
This is just for arguments sake…
What happens to the Dr’s who only have ass it? Or, the Dr’s who have patients sign without reading? How about if the patient does read and sign, but says they never received any info?
Whatever happened to a person spending ten minutes on the internet and looking it up themselves? I know I do.
Pommawolf
As a former patient who was given Paxil in early 2000, I was on the drug at an outrageous dosage. The doctor wasn’t even aware of the side effects, let alone the withdrawl. Let me tell you, being on those drugs affect your thinking, how can you think its a matter of patient responsibility when it changes the thought process?
When I stopped takingit, the doctor had no idea of side affects, and I became seriously ill. Knocked me off my feet for a week. The side effects are terible. How can anyone hold a patient responsibility when the doctors and the drugs companies were not open about anything about the drugs? Let me tell you, thedoctors are ill informed about 90% of the drugs on the marlet…and you espect the patient to be all knowledgeabe? I hardly think so. I’m 49 years old, and I will never take another of those SSR, and inform everyone of their danger.
Jack2
I still don’t know the penalty docs could suffer for not telling the warning, but good luck guys. Bob makes a good point. You may want to make an effort to insure that this doesn’t become another piece of paper in a long stack of papers that people are given to sign - which discourages them from reading it.
For example, every time you pick up a prescription at a pharmacy and sign, you’re not signing that you picked up the script, you’re signing that you waived counseling from the pharmacist - the pharmacist must offer to counsel you. But many people just sign it without thinking twice about it.
I could see your piece of paper becoming something like the pharmacy-counseling piece of paper.
Dellianan of the Sea
They killed my Dear Brother.
Laurie
” Or, the Dr’s who have patients sign without reading? How about if the patient does read and sign, but says they never received any info?”
As I said at the hearing on this Bill..as it stands now you are handed a prescription and off you go. Being asked to sign something will trigger the “why am I being asked to sign for this?”. Yes, this now places some responsibility with the patient, as it should be, and it points the patient in the direction of looking for further information. What they do with that information is up to them, as with any medical information.
Lisa Van S
Bob,
I agree with you…
Kat
Woohoo! Way to go NJ moms! :-D
I once took both Zoloft and Paxil. They made me feel worse and made me skip classes more than the depression did. I said, “no more! I’ve got to do something else other than take these things.” Looking back, I know I did the right thing.
I think doctors *should* give info, but it is also the patient’s responsibility to take their health into their own hands–take a specific interest in their own well-being, even if it means reading things they might not think they understand. And if it means grabbing a dictionary, so be it.
But I especially support this need for informed consent in relation to medications given to a minor.
BB,
Kat ^.^