Pharmacy Dispensing Standards of Practice (and Reality)
Whether you represent a client injured by a dispensing error or a pharmacist accused of violating the standards of practice, here is a quick rundown of what often happens in the real-world pharmacy.
As a pharmacist and as one very familiar with pharmacy (and pharmacist) standards of practice, I am frequently asked exactly what safeguards do pharmacies usually have in place to prevent dispensing errors? The next follow-up question is, how (and why) do pharmacists and technicians regularly skip those safeguards? This article is a general answer to those questions and will hopefully give you some insight into the common safeguards pharmacy chains employ and the common circumventions employees make, usually to meet corporate metrics or to avoid a customer complaint.
The pharmacy dispensing process can be broken down into four parts: data entry of the prescription, filling of the prescription, verification by a pharmacist of the filled prescription compared to the written prescription, and finally, release of the prescription to the customer. There are opportunities for error at each step, as well as some generally accepted standards of practice to prevent such errors.
A customer walks up to the counter with a written prescription. A staff member (usually a technician with some experience) will accept the prescription and check that basic information is present, such as patient name, birthdate, doctor name, medication name, directions, quantity, refills, and doctor signature. The prescription may also come in electronically, over fax, or via a voicemail. The data entry staff member will scan in the prescription to preserve an electronic image and then proceed to type in the relevant information, including the drug name. Many pharmacy computer systems are set up to allow some form of a shorthand search, such as the first few letters of the drug name followed by its strength, eg, ‘met50’ for metoprolol tartrate 50 mg (a short-acting blood pressure medication). However, these same systems will also return metformin 500 mg (a diabetes medication), metoprolol succinate 50 mg (a long-acting blood pressure medication), metaxalone 500 mg (a muscle relaxer), and metronidazole 500 mg (an antibiotic), among others, as potential choices. If the data entry staff member is a bit careless and leaves off the zero, the system could potentially return methadone 5 mg (an opiate pain medication) and methotrexate 2.5 mg (a rheumatoid arthritis medication with several potentially severe drug interactions). If the staff member thinks it is faster to search by what they think is the brand name (who wants to type in a 13-letter generic name when you could just search a catchy brand name?), the opportunities for error open up even further. The data entry staff member then selects the medication and uses a similar process for the directions field (pharmacy staff are encouraged to type in shorthand commands such as ‘qd’ for every day, ‘qid’ for four times a day, ‘qod’ for every other day, etc. to avoid grammatical or spelling errors from freehand text entry).
Here, the pharmacy systems diverge. Some pharmacies require the pharmacist to compare the entered prescription information with the electronic prescription image before the prescription can proceed further. Others send the prescription automatically to the filling stage. This can be a crucial element that requires an expert familiar with the particular pharmacy chain and its practices involved in your suit. Seeking out an expert knowledgeable about the pharmacy chain involved can be worth the time and effort involved.
In our example, let’s assume the prescription makes it to the filling stage. All medications are required to be labeled with a unique 11-digit number, called the NDC. The NDC gives the manufacturer, medication, strength, and even stock package size based on its 11 digits. Therefore, nearly all pharmacy systems require that the NDC scanned during the filling process match the NDC chosen during data entry. Sounds easy, right? Just scan the barcode on the medication stock bottle and the system will tell you if it matches the expected medication, right? Right or wrong, the system will require that the medication filled match the medication chosen in data entry. Unfortunately, most pharmacy systems allow a user to override an NDC mismatch flag. For instance, since the NDC is specific down to package size; a 500-count bottle of medication that is equivalent to the 100-count version of the same medication is still flagged as a mismatch. So for the sake of time, pharmacy staff often override the NDC match if the bottle size in the pharmacy does not match up. However- as in the previous example looking for metoprolol tartrate 50 mg- if a staff member grabs a bottle of metformin 500 mg and the system flags an NDC mismatch and the staff member thinks it’s simply because the system wants a 500 count bottle and the metformin comes in a 100 count bottle, they can override the flag and the wrong medication proceeds down the line.
Additionally, many pharmacy staff are pressed for time and instead of following a corporate directive to scan out a single medication and then count it out and give it directly to the pharmacist, they will pull several medications for several different prescriptions and scan them all out and then count out each medication. This opens up the chance for counting out a medication and accidentally putting it in the wrong prescription basket despite the accuracy scan showing that the correct medication was scanned. Furthermore, all too often staff will pull a medication that they think is an equivalent medication but the pharmacy computer system makes it time-consuming to check if the new medication’s NDC is equivalent to the original medication. Therefore, staff may bypass the accuracy scanning and count out what they think is an equivalent medication and send it to the pharmacist labeled under the original medication’s NDC.
So what can the pharmacist do? In every pharmacy, the standard is for the pharmacist to open the medication vial and compare the medication in the vial to the expected medication (usually a pharmacist is provided a visual picture of the medication and an NDC). Most pharmacies require that the pharmacist pour out some (or all) of the medication to verify that there are not any stray pills that somehow found their way into the vial. Unfortunately, more than a few pharmacists skip this step (presumably in the interest of time). This is the primary way that incorrect medications find their way to consumers. There is not much else clearer than ‘does the pill in the bottle match the expected image on the screen?’ In my experience, I have found several instances where medications of different sizes/shapes/colors were intermingled with the correct medication or where a medication totally different in appearance was dispensed to a patient because a pharmacist did not perform the basic rudimentary step of taking off the vial lid and looking at the medication. Most of these omissions were either due to lack of care by the pharmacist or time pressures from corporate. Many pharmacy chains make pharmacists eligible for bonuses (or to be written up) based on the speed with which they verify medications. If a pharmacist is looking at 50 baskets of unverified medications they may well take shortcuts including not visually verifying a medication.
Let’s assume the correct prescription has made it through pharmacist verification and is ready to be sold to a customer. Most pharmacy chains put prescriptions in bags and sort those bags alphabetically. A customer calls the pharmacy saying they’ve been given the wrong medication. Where does the error lie? The staff member who pulled the wrong prescription? The pharmacist who switched up two patients’ medications and then bagged them? The patient who didn’t check the name on the prescription before taking it home? The cashier a pharmacy had to pull spur of the moment from the front store who didn’t know the correct pharmacy procedures? The pharmacy chain’s outdated register systems that didn’t recognize the wrong patient’s medication was going to the wrong customer? Retail pharmacy is set up for errors and unfortunately, the current staffing crisis makes it worse. That’s why a pharmacy administration expert witness could make the difference for your client.
By The Legal RXpertABOUT THE AUTHOR: Renay Green
Pharmacy Expert Witness, Expert Testimony, Case Review
Pharmacy Expert Witness, Expert Testimony, Case Review
Pharmacy expert witness with over a decade's experience at major chain pharmacies coupled with a legal background.
Copyright The Legal RXpert
Disclaimer: While every effort has been made to ensure the accuracy of this publication, it is not intended to provide legal advice as individual situations will differ and should be discussed with an expert and/or lawyer.For specific technical or legal advice on the information provided and related topics, please contact the author.