By Ken Baker, R.Ph., J.D.
Consultant for Pharmacists Mutual Insurance Co.
Every pharmacist knows they can and do make mistakes. If we have a good prescription system, we can usually catch the mistake before it reaches the patient. Eventually, if we practice long enough, one of these near misses reaches a patient and it becomes every pharmacists’ worst nightmare. What happens at that point is often a question of luck.
The patient may notice the mistake and return the prescription to the pharmacy before any of the drug is taken.
The patient may take the medication, but no harm results. For example, a prescription for an otic is mistakenly filled with an ophthalmic form of the drug. A medication error was made, but no one was injured, the patient probably got well and neither the pharmacist nor the patient ever knows a mistake was made.
Too often, however, the patient takes the incorrect medication and notices the mistake only afterwards. How does the pharmacist handle the situation when a patient returns to the pharmacy alleging that the pharmacy made an error? What evidence does the pharmacist need to preserve? What can be said and what should not be said?
A conversation may seem very cordial and end on a good note. Most times the feeling that “everything went well” proves to be correct and the matter is over. Occasionally, however, the patient receives advice from other parties and the friendly exchange escalates into a claim and/or a lawsuit. The problem is you can never be certain what the future will hold, so you should document as if there will be a reason to be able to recall exactly what was said and done. Consider a few sample procedures to follow whenever an incident happens that could lead to a professional liability claim.
Protect your patient.
The first rule is take care of the patient. Whether your pharmacy made a mistake – or someone else did – your patient has a potential problem. They are probably concerned and anxious. There could be worse injuries if treatment is delayed. Find out if the patient took any of the wrong medication or if they missed any prescribed medication. Make certain they get any necessary medical help. Not only may this mitigate damages caused by the error, more importantly, your patient may need to receive treatment. Whether or not they need care is probably not your decision, but the patient’s and the prescriber’s. Even if there is no apparent injury, you need to call the prescriber so the information can be placed in the patient’s file. In McClure v. WALGREEN, the Iowa Supreme Court criticized the pharmacy for failing to warn the patient of the potential effects of the error when its employees discovered the mistake and used this failure as one of the bases of additional damages.
Once all emergencies have been handled, try to find the extent of any potential problems by asking questions. Did the patient take any of the erroneous prescription medication? If so, how much did they take? When did they take it? Document the conversations with the patient or caregiver. If what was said is ever needed, any trial or deposition may be 2-3 years or later in the future. Under court rules, you can use your notes to refresh your recollection. All documentation must be truthful and accurate as your credibility will be on trial as well as the case. If possible, have a witness to the conversation initial the notes. In addition, you should retrieve any incorrect prescription to prevent any additional harm – but do not destroy it. Count the tablets and save the bottle. Treat this as evidence by placing it in an envelope and sealing it with your initials on the closure. The best place to document is on the back of the prescription, on paper stapled to the prescription or in a file folder, as long it’s easy to find later. Notes in the computer can be lost and hand written notes are more easily authenticated. Pharmacists Mutual has a documentation journal available for this purpose. You can get one or more from your Pharmacists Mutual representative or by calling the company and asking for the Pharmacists Journal.
Do not admit liability.
If you make an obvious error, you may say, “I made a mistake, I am sorry.” You may not, however, admit liability or offer to pay money or to settle the case using your own money, as one pharmacist did under pressure from an angry customer. Admitting liability is more than saying “I made a mistake.” A mistake, such as putting the wrong drug in the bottle, is a fact question. Admitting liability, such as saying “I caused your injuries,” is a legal statement. Not only would admitting liability be a possible violation of the conditions in your insurance policy, but would also probably be beyond your knowledge. The patient may have other conditions or other incidents of which you are not aware.
If the error is not obvious to you or if you think you are not responsible for the mistake, you should not argue the point with the patient, but you can express sympathy for the patient. You can always say, “I’m sorry you feel bad.”
When any mistake is made that could result in a claim, immediately report it to your insurance company. Your policy may have penalties for not reporting promptly.
Train your staff.
Finally, train your staff how to react if the “unthinkable” happens. A question like “Why is this tablet a different color?” should be a pharmacist only question. The pharmacist should treat every such question as an error unless and until the opposite is PROVED.
This article discusses general principles of law and risk management. It is not intended as legal advice. Pharmacists should consult their own attorney and insurance company for specific advice. Pharmacists should be familiar with policies and procedures of their employers and insurance companies, and act accordingly. Names used in this article have been changed and any similarity to real persons is purely coincidental.
 In a study at Pharmacists Mutual over a three-year study, 2% of all claims filed against pharmacists involved a prescription for an ophthalmic filled with the otic form. Never in the past 15 years, however has Pharmacist Mutual received a claim for an ophthalmic drop mistakenly given for a prescribed otic.