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I've heard of lots of doctors being sued for failure to warn of a side effect, but I've never heard of a pharmacist being sued as well. Anybody aware of any cases?
The courts have mostly ruled pharmacists do not have a duty to warn. The physician/prescriber is considered to be the learned intermediary. The only successful case involved a pharmacist dispensing a drug in which a patient had a known allergy to a similar drug. The pharmacist did not consult the patient about this. There were two pharmacists involved. The first one put a hold on it to contact the physician, and the second one, override it.
Someone did sue a pharmacy over getting Steven Johnson's rxn on bactrim. The pharmacist did not warn on it. It made it to federal court of appeals and they ruled pharmacists have no duty to warn.
Realistically, I cannot counsel on every single ADR out there. I counsel on the common and the important odd ones. You'll end up scaring people if you tell them about every single side effect.
The courts have mostly ruled pharmacists do not have a duty to warn. The physician/prescriber is considered to be the learned intermediary. The only successful case involved a pharmacist dispensing a drug in which a patient had a known allergy to a similar drug. The pharmacist did not consult the patient about this. There were two pharmacists involved. The first one put a hold on it to contact the physician, and the second one, override it.
Someone did sue a pharmacy over getting Steven Johnson's rxn on bactrim. The pharmacist did not warn on it. It made it to federal court of appeals and they ruled pharmacists have no duty to warn.
Realistically, I cannot counsel on every single ADR out there. I counsel on the common and the important odd ones. You'll end up scaring people if you tell them about every single side effect.
So how am I supposed to warn everyone on every single ADR on a drug when even the pharmacists can't?
My ER would crawl to a halt.
I'm telling you the legal answer to that question. It is much harder to prove pharmacist's liability for dispensing a drug which caused an ADR than the prescriber's liability.
Well then the legal system has some flaws with regards to this. If the pharmacist can't physically give every ADR to a patient, then the physician should not be expected to. I'm not saying that you should be liable - I'm saying that I should not be liable either.
I believe the actual liability would be on information you have and thus could reasonably assume to happen, in addition to blackbox warnings. The theory is that you, as a physician have the (a more) complete picture and thus can change prescribing patterns accordingly.
There are a lot of fatal flaws in the system, especially from your end, as an ED MD. I don't know about your ED service but where I rotated the ED attendings were absolutely vicious if sub-i's/interns failed to get a good hx. I believe you are covered if you make a reasonable effort to obtain the information (med Hx), PCP's have the lion's share of duty to warn. Unfortunately our medical system doesn't really make this universally easy, since patients can and do see multiple docs without a coordinating paper trail for the professionals.
I'd be more than happy to share in that liability, just fax over the complete medical history and allow me access to the patient to verify before you d/c.
So how am I supposed to warn everyone on every single ADR on a drug when even the pharmacists can't?
My ER would crawl to a halt.
What do you mean, "when even the pharmacists can't"? We see WAY more patients q hour than you do and with a hell of a lot less information.
This is an interesting read.
I agree that the system is full of holes, but you can't fix tort reform, without increasing manufacture liability or fixing the insurance system, the medical model and the business model of dispensaries. Neither of those are going to happen in the US, especially in the age of special interests.
Although the author assumes actual contact with the patient and a business model that affords the pharmacists the time and relevant information to go over these things, neither of these are realities at most community pharmacies.
His point is well taken - our duty as pharmacists is to counsel patients on any new medications (this isn't to say that the prescriber doesn't have that duty, but it really is what our main function in the outpatient setting should be), yet we really don't have the time to do that. If we don't, then how can a prescriber?
but is constantly being corrupted/adjusted/revised through the legal system to still keep physicians as the primary duty to warn subject. The legal prescendence is clear, the legal duty of what happens when you take the drug is solely on the physician-prescriber or in the case of a knowledgable patient, the patient themselves.(1) maintaining a patient profile system; (2) reviewing the profile to determine, among other things, if any drugs would interact with patients' current medications; (3) warning patients of any possible interactions; and (4) advising patients of symptoms of toxicity.
Question:
Suppose a patient is counselled by a physician/pharmacist on a rare side effect that has a very minute chance of occuring, and decides to take the drug anyway. What if the said side effect is experienced, later lies/forgets about being counselled about it and proceeds with sues the physician/pharmacy? How can the physician/pharmacist prove that they did indeed counsel the patient on the side effect?
What do you mean, "when even the pharmacists can't"? We see WAY more patients q hour than you do and with a hell of a lot less information.
First our duty is actually to inform people HOW to take medicine under the law (ORBA90), not what happens when you take the medicine. The legal prescendence is clear, the legal duty of what happens when you take the drug is solely on the physician-prescriber or in the case of a knowledgable patient, the patient themselves.
There really isn't an exception universally accepted in the eyes of the law that we're required to inform patients of side effects; we are expected to notify the prescriber in instances where we see concurrent drug issues or *potentially* a personal habit that would cause a problem with a specific drug (e.g. alcohol consumption).
It's why I keep saying for tort reform the first then that has to happen for professionals (malpractice) is to put it before a randomly selected group of peers to determine if the course of actions made sense in their estimation. In the race to the lowest common demoninator, the jury is an educated person's worst nightmare.
Your number per hour and my number per hour are completely different. You do not take a history, do a physical exam, order the appropriate tests, call the appropriate consults, perform the appropriate procedures - then deciding on a dispo whether in-house or discharge home. All the while, I'm ordering meds and prescribing meds.
You're busy because you have a lot of throughput, I'm busy because I'm juggling not just throughput but also a multitude of other tasks.
You seem to have quite a bit on insight on this topic.
1. It doesn't make sense to me that pharmacists are not legally required to aide the physician/prescriber with informing the patient of possible ADR. The pharmacist technically has more intimate knowledge of drugs than we do.
2. What tort reform do you speak of? Does this apply to TX as well?
We provide a written information leaflet with every prescription that includes a list of side effects. As far as I'm concerned, that satisfies our duty to warn; it is now the patient's responsibility to read it.
What's really great is I haven't found a single case where a NP/PA has a duty to disclose either. Now, that's a quick 30 or 35 cases on Lexis, and it's certainly not the end-all-be-all of the subjuct, just my availability for wasting time.
Welcome to why you make the big buck.
If you want a pharmd to share in the risk, then give them the power to prescribe w/o MD oversight. Until then, everyone (NP/PA) is working under the MD or with Tx/information (PharmD) given to them by the MD.
That power is money, so I doubt the MD want to give it up/share it.
The most common adverse effects are gastrointestinal disturbances (nausea, vomiting, anorexia)Sure, you can prescribe. I don't care. But be sure you know why you're prescribing the med (i.e. make the correct diagnosis).
I'm saying - pharmacists are paid a good amount. You guys aren't paid 60K to fill drugs. You guys are paid upwards from 100-150. You should have some liability in dispensing the drug. Although you don't have knowledge of all the drugs the patient takes nor do you have the full history - but you should be liable for the drug you are filling. If it's bactrim - let them know about SJS and the possibility that it may interfere with coumadin if they are taking that.
Nothing too major, but something that helps out the patient.
I know it's not legally mandated, but I just don't see how someone who has a doctorate in pharmacy can't do that. I have a doctorate in medicine and I'm legally mandated to advise the patient on all ADR. You have a doctorate in pharmacology and you should also shoulder some of the burden. You act like you're not one of the big boys - but you are. You're getting paid 6 figures.
The most common adverse effects are gastrointestinal disturbances (nausea, vomiting, anorexia)
and allergic skin reactions (such as rash and urticaria). FATALITIES ASSOCIATED WITH THE
ADMINISTRATION OF SULFONAMIDES, ALTHOUGH RARE, HAVE OCCURRED DUE TO SEVERE
REACTIONS, INCLUDING STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS,
FULMINANT HEPATIC NECROSIS, AGRANULOCYTOSIS, APLASTIC ANEMIA AND OTHER BLOOD
DYSCRASIAS (SEE WARNINGS SECTION).
Hematologic: Agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, neutropenia, hemolytic
anemia, megaloblastic anemia, hypoprothrombinemia, methemoglobinemia, eosinophilia.
Allergic Reactions: Stevens-Johnson syndrome, toxic epidermal necrolysis, anaphylaxis, allergic
myocarditis, erythema multiforme, exfoliative dermatitis, angioedema, drug fever, chills, Henoch-
Schoenlein purpura, serum sickness-like syndrome, generalized allergic reactions, generalized skin
eruptions, photosensitivity, conjunctival and scleral injection, pruritus, urticaria and rash. In addition,
periarteritis nodosa and systemic lupus erythematosus have been reported.
Gastrointestinal: Hepatitis (including cholestatic jaundice and hepatic necrosis), elevation of serum
transaminase and bilirubin, pseudomembranous enterocolitis, pancreatitis, stomatitis, glossitis,
nausea, emesis, abdominal pain, diarrhea, anorexia.
Genitourinary: Renal failure, interstitial nephritis, BUN and serum creatinine elevation, toxic nephrosis
with oliguria and anuria, crystalluria and nephrotoxicity in association with cyclosporine.
Metabolic and Nutritional: Hyperkalemia (see PRECAUTIONS: Use in the Treatment of and Prophylaxis for Pneumocystis Carinii Pneumonia in Patients with Acquired Immunodeficiency Syndrome (AIDS).
Neurologic: Aseptic meningitis, convulsions, peripheral neuritis, ataxia, vertigo, tinnitus, headache.
Psychiatric: Hallucinations, depression, apathy, nervousness.
Endocrine: The sulfonamides bear certain chemical similarities to some goitrogens, diuretics (acetazolamide
and the thiazides) and oral hypoglycemic agents. Cross-sensitivity may exist with these
agents. Diuresis and hypoglycemia have occurred rarely in patients receiving sulfonamides.
Musculoskeletal: Arthralgia and myalgia. Isolated cases of rhabdomyolysis have been reported
with BACTRIM, mainly in AIDS patients.
Respiratory: Cough, shortness of breath and pulmonary infiltrates (see WARNINGS).
Miscellaneous: Weakness, fatigue, insomnia.
That's the problem. Nobody can counsel on all of that. "Watch out for a rash that could become serious" and "be extra careful when looking for signs of bleeding" are simple points that I'm sure most pharmacists cover. But it's all that other junk that no one can possibly mention. Not doctors, not pharmacists, it's just way too much for a patient to know. They wouldn't understand it all, and they'd be afraid to take a medicine that could theoretically do any of those things. My grandfather had a course of Avelox and he was hesitant to take it because he was told "It can stop my heart or rip the muscles in my leg."
Exactly.... that's the problem. This is an impossible task to do on each and every drug. Everything would come to a halt in the ER or the pharmacy. You're right, it's near impossible for the doctor or the pharmacist to discuss every ADR with every patient.. and you scare the crap out of everybody this way as well.
But why just pin it on the doc? I don't get it.
Because:
1. You prescribed the drug. You made the active choice.
2. You have the full patient information, including reasons why a patient may be at higher risk for serious AEs.
That's why.
Legalities aside, I feel that I share the liability. I always try to warn of relevant side effects. It is impossible to get them all. We counsel on all new RXS at my pharmacy as a matter of policy. Not "do you have any questions?" And the pharmacist personally speaks to every waiter at the time of dispensing, whether it's a new RX or a refill.
So we warn someone receiving bactrim of the possibility of SJS, they're horrified by the possibility of all their skin peeling off, and in the meantime their run of the mill UTI becomes full-blown pyelonephritis with septicemia.
As I read through CE law, this is what I gathered:A double edged sword. You warn them they fret, you don't and the lawyers find a way to sue.
Hah! As much as I like to counsel, unfortunately, the members of the general public have the attention span of a gnat. I can barely get a chance to tell them to "shake well", "take it with meals", and "watch for drowsiness".I agree that both the physician and pharmacist should share the responsibility of warning the patient of ADR's. When I counsel patients, I ask them what did their Dr. prescribe the medication for to confirm they are getting the correct medication and possibly catch misfills, and a lot of patients say I have no idea, he just gave me the prescriptions and didn't tell me anything. I think all physicians should at least tell their patient what their medication is being prescribed for. Also, we all agree we can't counsel on ALL possible ADR's, however, we should counsel on most common and the severe ones that needs to be watched out for. In the cases of severe reactions such as SJS, I would let the patient know that it is rare, but be aware it may occur so watch out for it; this usually doesn't scare them from taking the medication at all. Additionally, since we don't have time to mention all the ADR's, I also ask the patients to please do me a favor and to read the drug leaflet before taking their medication and if they have any questions, contact me or their physician. This should cover most of the other ADR's we can't cover with them (if they read it).
Legal-ish sort of question: how can a litigant prove what you did or didn't say in a verbal counselling session. Unless somebody taped it, isn't it just hearsay?
I agree that both the physician and pharmacist should share the responsibility of warning the patient of ADR's. When I counsel patients, I ask them what did their Dr. prescribe the medication for to confirm they are getting the correct medication and possibly catch misfills, and a lot of patients say I have no idea, he just gave me the prescriptions and didn't tell me anything. I think all physicians should at least tell their patient what their medication is being prescribed for. Also, we all agree we can't counsel on ALL possible ADR's, however, we should counsel on most common and the severe ones that needs to be watched out for. In the cases of severe reactions such as SJS, I would let the patient know that it is rare, but be aware it may occur so watch out for it; this usually doesn't scare them from taking the medication at all. Additionally, since we don't have time to mention all the ADR's, I also ask the patients to please do me a favor and to read the drug leaflet before taking their medication and if they have any questions, contact me or their physician. This should cover most of the other ADR's we can't cover with them (if they read it).
As I read through CE law, this is what I gathered:
1- Pharmacists have no duty to warn (generally) due to lack of information about patient hx; however, pharmacists ARE REQUIRED to warn if pharmacists have SUPERIOR information that physicians and patients don't have. Eg, case of Happel vs. Walmart Stores, both patient and physician knew that patient was allergic to Aspirin, but when Toradol was prescribed, they both did not know that Toradol contraindicated/should be avoided in ASA-allergic patients. This case, pharmacists should be held liable for not counseling patients or alerting physicians.
2-Eventhough LEGALLY pharmacists are not tighted to GENERALIZED duty to warn, the Professional duty is A LOT higher. Pharmacists are expected to not only fill medications accurately but also warn/counsel patients on what you think necessary.
And as I know, medical students at my school only have 2 semesters learning about drugs, and that's it. Everything else they learn as they go (i.e, rotations, residency). So, I believe pharmacist are the true experts of medicine and we should practice our knowledge whenever possible.
Note to Pin: BUT I DO SEE a lot of physicians act like jerks and they just do not even want to hear anything from pharmacists. (from what i read in this thread, you sound like a very good resident, so thumb up!)