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Do pharmacists share any liability for failure to warn of side effects?

Discussion in 'Pharmacy' started by Socrates25, 03.20.12.

  1. Socrates25

    Socrates25

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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?
  2. spacecowgirl

    spacecowgirl brr

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  3. Ackj

    Ackj

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    It kind of sucks, because there's realistically no way to counsel on every single ADR for a drug, since there's at least 20-30 in the PI of every drug. I usually counsel on the most common, and maybe signs/symptoms of the rare/serious, but I mean I'm not talking about SJS with every single rx that goes out.
  4. genesis09

    genesis09 Senior Member

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    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.
  5. pinipig523

    pinipig523 I like my job!

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    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.
  6. flyerschickxox

    flyerschickxox

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    I got SJS from Lamictal and even had lawyers contact me wanting to sue people for it. And they even said theres no point to going after pharmacists for things like that cause there is no way to win. They said pharmacist do not have fault unless they knew I was allergic to something similar and didn't warn me.
  7. genesis09

    genesis09 Senior Member

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    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.
  8. pinipig523

    pinipig523 I like my job!

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    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.
    Last edited: 03.21.12
  9. KUMoose

    KUMoose Grumpy old man

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    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. ;)
  10. pinipig523

    pinipig523 I like my job!

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    The medico legal system is stupid and full of flaws.

    For me to look over every single drug that the patient is using - that's not something routinely possible. And a lot of these ADR are not common side effects either.
  11. KUMoose

    KUMoose Grumpy old man

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    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.
    Last edited: 03.21.12
  12. Carboxide

    Carboxide

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    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.
  13. KUMoose

    KUMoose Grumpy old man

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    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. ;)
  14. Praziquantel86

    Praziquantel86 Moderator Emeritus

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    In an ED? They see 10 - 15 (maybe more, maybe less - depends on the day/place) patients an hour and have to do an awful lot more than counsel on ADRs. You're comparing apples and oranges, here.

    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?
  15. whatbout2morrow

    whatbout2morrow Is there anything you would not do for your family Bronze Donor

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    I agree with what the article tries to say in the end, especially because the pharmacist is the drug expert, but yeah, you're right, it's simply not practical at this point.

    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?
  16. KUMoose

    KUMoose Grumpy old man

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    First our duty is actually to inform people HOW to take medicine under the law and t(ORBA90), not what happens when you take the medicine. Dooley, says that pharmacists
    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.

    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).

    Unfortunately that comes down to "that's for the jury to decide". If I were trying this I would trot out people that would lay a foundation of repitious behavior, to hopefully create the "if he/she's done it all these other times why wouldn't he do it this time." Additionally I'd hope that the ADR is something obscure and/or not related to concomenent drug use, because I don't want a largely ignorant jury to try and weight risk-vs-reward.

    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.
    Last edited: 03.21.12
  17. pinipig523

    pinipig523 I like my job!

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    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.

    If docs and pharmacists can't counsel patients appropriately of all the ADRs, then there has to be a system in place that allows a lower paid worker to go through the minutias of these ADRs - one who can spend more time per patient and only go through ADRs with the patient.

    Patients should sign a RELEASE FORM - everyone else seems to do this. You can't go biking down a mountain in Maui without signing a release form, you can't go climbing up a wall without signing a release form.
    Last edited: 03.21.12
  18. pinipig523

    pinipig523 I like my job!

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    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?
  19. KUMoose

    KUMoose Grumpy old man

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    We all have multitasking requirements Pin. Come spend the day when I'm pushing out 500-600 prescriptions, taking 20-40 calls an hour, dealing with a jammed vaccum tube, giving vaccinations on a walk-up basis and making sure people get called so I don't have to restock that control medication they are too lazy to pick up (which may send them to see you.)

    In a nutshell, we all have our "crosses" to carry. It's impossible to directly compare the two, but lets just agree that the business model we live in makes it extremely difficult to provide the kind of care I think we'd all agree we'd like to hit.

    Take it with a grain of salt, what I post is my interuptation of what I've read thus far. While OBRA 90 was step forward, it's not as big as it could (should) have been. And while we may have more knowledge of the drug, we can not with great certainty be assured we have all the information.

    Working at the VA was the only place that I really felt an obligation AND had comfort knowing I had the majority of the facts when it came to counseling. I can't tell you the number of times in my clinical, non-VA rotations where I'd go into counsel a patient only to find out additional information not in their charts that impacted my spiel. It was, on average, twice a site. Which given only about 15 - 20 consults per site, that's a chunk.

    Remember retail doesn't get to take med hx, see lab results or always have a current medication list, even though we're suppose to try. We're completely dependent on the consumer/patient to provide the information and when they use (willingly or through coercion) multiple routes for obtaining medicines. The stance generally isn't that pharmacists don't know more about drugs, rather that they have a more narrow picture (even post-OBRA90) than physicians. Think about all those companies that give away free ABX prescriptions. Think those histories are complete? Half complete?

    Further, it's unlikely that the AMA will willing part with any control that would likely be required to give pharmacists equal care knowledge under the current system. Many physicians still refuse to send me a medication list, they print it out to the patient and have the patient bring it in, if they so choose.

    As for tort reform it's one of the Republican's planks to control rising costs. Does it need to happen, yes. Does there need to be caps? Not sure, this isn't the place for that discussion. Is Texas looking to do tort reform? No clue, I don't live there and the crazy crap going on here is keeping me politically busy enough.
  20. pezdispenser

    pezdispenser

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    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.
  21. rxlea

    rxlea Unicorn in training Moderator Emeritus

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    Not all patients can read or understand those leaflets. Most of the time, they go into the trash. The reality is that there is not enough time/labor to provide thorough counseling to every patient. I spent 20 minutes once going over the ten new medications a patient received upon discharge. After explaining everything and answering all of her questions, I couldn't believe the time went by like that. There has to be a better way for all of us. I think we can all agree that continuity of care is a good thing. The problem is resources and access to all relevant medical information. It seems like the integrated medical systems are addressing this and operate more efficiently but that technology is expensive and requires ongoing maintenance.
  22. sfwusc

    sfwusc Pre Med Student

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    According to the NP/PA that I know in South Carolina, they work under a MD license. The MD might not have to be on site for the NP, but they are responsible for them. That is likely why they are not liable...they aren't the top of the food chain.
  23. sfwusc

    sfwusc Pre Med Student

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    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.
  24. pinipig523

    pinipig523 I like my job!

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    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.
  25. Ackj

    Ackj

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    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."
  26. pinipig523

    pinipig523 I like my job!

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    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.
  27. Carboxide

    Carboxide

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    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.
  28. pinipig523

    pinipig523 I like my job!

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    And...

    1. You fill so you should also feel that all your years studying pharmacology should give you the knowledge to also warn the patient and not just fill. You're a doctor.
    2. I go by limited patient information since I am not the patient's primary care doctor - you do the same. You only know a part of the patient's history and you should be able to warn them of ADR of THAT particular drug that you're filling. I'm not saying that you should warn them of ALL possible ADR - but you should be "capable" of warning them of ADRs of the particular drug you are filling.

    It's not difficult and outside the realm of possibility to just say, "I don't know your entire medical history, I don't know all the other drugs you're taking but the physician prescribed you Bactrim, but as your pharmacist - these are the known ADR of this particular drug... etc."

    So don't give me that BS that you need to know the entire history and all the other drugs that the patient is taking. Re-read the title of the thread, it asks if you should "SHARE" the liability. And although the legal system does not say that you have any liability - I agree that you SHOULD SHARE with the liability. There is nothing outside the scope of your knowledge that suggests that you cannot advise the patient on a drug's particular ADR.

    You know more pharmacology than I do, you study pharmacokinetics, etc... - you should feel the need to use it.

    You're a doctor.

    That's why.
    Last edited: 03.31.12
  29. All4MyDaughter

    All4MyDaughter SDN Mommystrator Staff Member Administrator SDN Senior Moderator Lifetime Donor Partner Organization

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    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.
  30. pinipig523

    pinipig523 I like my job!

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    Exactly.

    Now keep in mind that everything I said in my posts on this thread are only my opinions so take it for what it is.

    But my opinion is that we (pharmacist and physicians) are trained well enough that if it truly was for the patient's best interest in mind (legalities aside), we should both be involved in warning the patient of every drug ADRs. Now, as many have mentioned, it is near impossible to do, but we should still try. Given the difficulty of doing so, it would be in the patient's best interest if both the physician prescribing and the pharmacist filling should both be involved in the warning of ADR - and not just leave it to a single practitioner.

    I don't think anyone here can argue that a pharmacist is any less capable of discussing ADRs of a particular drug being filled than the physician prescribing said drug. Yes, the physician may have access to more medical info/history, but given the drug at hand, the pharmacist should be able to warn of that specific drug and its adverse drug reactions at the very least. You guys are pharmacists, not techs.

    I agree with the post above.
  31. Pharmavixen

    Pharmavixen foxy pharmacist

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    In school long ago, the professor said, "You tell them the common side effects, and the rare ones that can get you sued." It works for practising reality-based medicine, but litigation has nothing to do with reality.

    I married into a hyper-neurotic family, where people fret inordinately over their health, some of them running to the dr for every tiny little thing (a drawback to the single-payor system we enjoy in Canada. But I digress...) The problem of these litigation-based leaflets warning of every possible AE is people like my inlaws, who obsess over unlikely events to the point of causing themselves real harm. Like my father-in-law, who wouldn't take his Lipitor out of fear of rhabdo, and his cholesterol was 15 mmol/L (almost 600 mg/dL). He eventually had to have stents installed, and his cardiologist had a pointed conversation with him about relative risks. So now he takes the Lipitor. But still he frets.

    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.
  32. pinipig523

    pinipig523 I like my job!

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    A double edged sword. You warn them they fret, you don't and the lawyers find a way to sue. :thumbdown:
  33. Angryrooster

    Angryrooster

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    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!)
  34. rx2010

    rx2010

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    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).
  35. PharmDstudent

    PharmDstudent

    Joined:
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    Messages:
    4,346
    Status:
    Pharmacist
    SDN 7+ Year Member
    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". :thumbdown:
  36. Pharmavixen

    Pharmavixen foxy pharmacist

    Joined:
    01.20.08
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    1,036
    Location:
    Canada
    Status:
    Pharmacist
    SDN 5+ Year Member
    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?
  37. pinipig523

    pinipig523 I like my job!

    Joined:
    01.06.04
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    1,307
    Location:
    Missing Chicago
    Status:
    Attending Physician
    SDN 10+ Year Member
    I was thinking the same thing... in the ER - I document that I told the patient this or I counseled the patient on that. But, I don't exactly know how this plays out in court.

    I know pharmacists can document, but I doubt you guys document on every single encounter.

    This!

    I agree 100%, you guys are the experts - help a brother out! :D

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