Liability With OTCs

Carl Customer comes into your pharmacy and purchases some OTC naproxen sodium.  He is injured from using the product and files a lawsuit.  Does he file it against Pam Pharmacist?  Do pharmacists face liability for the OTC products in their stores?

  1. Carl buys the naproxen without ever speaking to Pam or her even knowing Carl was in the store.
  2. Carl buys the naproxen after receiving counseling from Pam but the harm is a result of a defect in the product unknown to Pam
  3. Carl buys the naproxen after receiving counseling from Pam but the harm is a joint result from a defect unknown to Pam and inadequate counseling
  4. Carl buys the naproxen and the harm is a result of inadequate counseling from Pam.

Pharmacists CAN face liability from the sale of OTC products when the sale results in harm to the buyer/patient.  The probability of liability increases many fold when the pharmacist, who may be just an employee of a chain and has no voice in the purchase of the OTC drugs, has an interaction with the patient that the patient relies on in making the decision to buy.  Bad advice can create the same liability as a prescription dispensing or counseling error.

The two main cornerstones for lawsuits regarding OTC drugs are the same as for prescription medications: errors and failure to counsel.  What kind of errors?  An example would be suggesting aspirin for arthritis for a patient taking blood thinners, ibuprofen for a patient with a history of bleeding ulcers.  Take note: here, the patient has a duty to inform you of health issues or ask you to look over their profile in your computer, though you do need to ask questions.

Let’s look at the examples above.  Liability is least likely to occur in # 1 as there is no pharmacist interaction.  However, lawsuits have been won against pharmacists and pharmacies that a) did not pull recalled products, b) did not pull expired products, or c) did not pull products with recent bad publicity.  The importance of a and b you already know.  With c, these cases can be hard to win for the patient; bad publicity is not often enough reason to pull a product but it has been sufficient in some cases.

In # 2, liability is also not likely to attach to the pharmacist.  Packages are sealed so we cannot look at the tablets inside.  Even if we could, there is no likelihood that we could know naproxen tablets had 3 times the active ingredient as listed on the label just from a visual inspection.  A manufacturing error will be a problem for the manufacturer, not the pharmacist.  Liability attaches when the pharmacist becomes aware of the manufacturing issue and does not immediately act to remove the OTC from where the public can get to it.

With # 3, liability attaches to Pam.  Even if she was unaware of the manufacturing issue, her inadequate counseling caused Carl to buy a product he should not be using.  EG, Pam failed to counsel Carl to avoid other NSAIDs while taking the naproxen.  The extra high dose in the naproxen plus the other NSAIDs causes GI bleeding.  Pam and the manufacturer share fault.

Finally, liability almost attaches for sure.  Bad, wrong, or inadequate counseling that results in harm is a serious matter, as we all know.  Time to call me and/or your malpractice carrier.

In counseling for an OTC product, always refer the patient to the package information.  This may save you, or help somewhat, if your counseling fails to cover every aspect of the patient’s concerns.  Also, point out the lack of FDA approval is there is none.  Your liability falls when the government has such disclaimers on the packaging.  Make the patient verbally acknowledge this.  Finally, like prescription counseling, always end your spiel with “Do you have any more questions?”  You are tossing the ball, and a lot of the responsibility, back onto the patient.

What should be covered in counseling?  The same points that are required by state law in prescription medication counseling.  Follow those points and the liability possibility shrinks substantially.

The majority of the buying public first purchases an OTC product at a location that has a pharmacy, thus showing an implicit reliance on the presence of the pharmacist that the product is good, safe, and effective.  Pharmacists, even if they are employees of a chain and have no say in front end purchasing and stocking, still have the possibility of liability from the public’s purchase of these products, all the more so when the pharmacist is consulted prior to buying.   Approach an OTC consultation with the same professionalism as with a prescription.

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