What should consumers expect when a dispensing error occurs?

By Michael R. Cohen, President, Institute for safe medication Practices

Most patients are enlightened enough to know that human error can creep in just about anywhere, including when getting a prescription filled at the pharmacy. Fortunately, considering the billions of prescriptions filled each year by pharmacies in the US, and thanks to adoption of new technologies and improvements in pharmaceutical product naming, packaging and labeling, we’re beginning to see evidence that many of the errors we’ve seen in the past have begun to wane. Even when pharmacy dispensing errors they do happen, it’s usually something that gets by that’s unlikely to cause harm. Still, that’s little consolation for patients at the receiving end of a dispensing error, since they also recognize that harm does sometimes result, and a very serious error could just have easily have happened.

This attitude is reflected in the comments patients or caregivers express when they report a medication error to ISMP. Patients are usually more upset about the response they get when they contact the pharmacist or pharmacy manager than they are about the actual error itself. All too often consumers tell us that pharmacists, technicians, and pharmacy management (including corporate) respond poorly when confronted about the possibility of a dispensing error. It shows that some in pharmacy have not been educated or properly prepared to respond when a patient identifies that an error has been made.

A consumer error report we got this past week provides a perfect example. A woman picked up a prescription for alprazolam (Xanax) that her doctor has prescribed for anxiety. The container label did say “alprazolam” and it had the proper directions. When she went to take the first pill, she noticed it was white instead of blue like she got before, but she figured the pharmacy must have used a generic. She took the first tablet at 4 pm. By 6 pm she expected to feel better but she did not. By 8 pm she still wasn’t getting any relief. So, with her doctor’s approval, she took 2 more pills. All of a sudden, at 10 pm, the woman started shaking, her mind began to race, and she felt cold and jittery. She just knew something was wrong.

Since the woman’s pharmacy was still open, she called them. The pharmacist asked about the color of the pills, and the markings and then blurted out, “Oh, that’s thyroid medication. You’ll need to speak to the store manager tomorrow to get it exchanged. That was it. No apology, no, I’m sorry, no sympathizing for the woman’s adverse reaction, nothing! The next day the pharmacy supervisor offered no apology either. She just exchanged the pills and said, “Here you go, hope you feel better.” The woman hadn’t slept all night and was still feeling sick. But that was it - the total pharmacy response.

Sadly, pharmacy policies usually address legal considerations that often prevent pharmacy staff from offering an explanation of how the error happened and future steps that will be taken to avoid similar events. But patients are looking for open and honest communication from their healthcare providers. They want honest disclosure and knowledge that there’s an action plan to assure it won’t happen again to them or anyone else. They also want to know exactly HOW the error happened and what the pharmacy’s plan is to plug holes in the system that let the error get by.

My August 9, 2010 blog noted that if there’s a mistake, many pharmacies ask the customer to return the erroneous drug to the pharmacy. If you suspect an injury, before doing so you’ll want to discuss that with your attorney. Some pharmacies offer a discount coupon or refund for the erroneous Rx. I guess they figure that providing a discount coupon and/or refunding the cost of the prescription may be enough to make the problem go away. It’s up to you whether you’re satisfied with that and want to accept, but for everyone’s sake I hope that people are most interested in assuring that the causes of the error are identified and acted upon to avoid similar mistakes that might affect themselves or others in the future.

Every pharmacy should have written policies and procedures for handling medication errors, and more importantly, these procedures need to be seen, read, understood, and even practiced in various mock situations by every member of the pharmacy team. Dispensing errors must be responded to immediately and with concern. Part of the plan of course must define when others (e.g., prescriber) should be notified. Staff needs guidance about what to say and do as well as what not to say or do. Here’s something consumers want to hear from pharmacists: “Please let me explain what we believe happened and how we plan to fix it” or “At this point I cannot answer how this happened but I promise you I will look into it and get back to you and tell you about the actions we will take.” Then they need to know when the actions arrived at have been accomplished.

Many of the issues that cause dispensing errors are related to look-alike/sound-alike drug names, unsafe prescription drug packaging, and other medication system flaws. These events should also be reported confidentially to the national Medication Error Reporting Program operated by ISMP. Our organization, in turn, warns of system flaws that could lead to errors at other pharmacies. All pharmacies need to be more proactive to lessen the chance that an error will be repeated. Rather than having to tell a patient, “We’ll make sure it doesn’t happen again,” it would be far better for pharmacists to say to themselves, “We’ll make sure it doesn’t happen in the first place.” Part of every pharmacy’s risk management plan should include a process for learning about these errors and addressing those that apply. Amazingly, no state pharmacy board requires that this be done by their regulated pharmacies. That needs to change.

This blog was written as much for my pharmacy colleagues to read as it was for consumers. As patients are continually encouraged to be more active in their care and serve as a final check at the pharmacy, it’s critical that pharmacy staff prepare for the inevitable occurrence of a medication error. Based on what patients tell us, the attention and concern demonstrated to the patient and family in the aftermath of an error may even be enough for a patient to remain a customer and also not seek legal advice.





ISMP QuarterWatch highlights safety issues with Chantix, Seroquel and Victoza
Since 2008, the Institute for Safe Medication Practices (ISMP) has published QuarterWatch, a program that allows us to look at medication errors and serious side effects reported to the US Food and Drug Administration (FDA) during specific 3-month periods each year. The primary goal of the program is to improve patient safety through the identification of signals that may represent serious safety issues with medications. The term signal means evidence that, in our judgment, is substantial enough to warrant further investigation to determine frequency of occurrence and establish a causal relationship to the suspect drug. We report these potential safety problems to FDA and the companies that make the medicines and we also let your doctors, nurses, and pharmacists know about them by getting the word out to the public through professional media and news reports.
Last week we published QuarterWatch for the third quarter of 2010. Of note, one of the drugs that stood out was Chantix (varenicline), the stop-smoking drug which is heavily advertised on TV. Since 2009, Chantix has carried a boxed warning in its labeling about a possible association of Chantix with suicidal thoughts and aggressive behavior. Prior to the third quarter last year, FDA's adverse-event database had shown 37 suicides reported to the agency by the manufacturer, Pfizer, and an additional 85 reported by consumers and doctors. During third quarter 2010, we found that hundreds of older serious psychiatric adverse event reports regarding Chantix were not initially entered into the FDA Adverse Event Reporting System (AERS) by Pfizer per usual procedure. Most notable were 150 cases of completed suicides, some dating back to 2007.  
In brief, when a drug company learns of a patient’s death, an “expedited” report is normally submitted to FDA within 15 days and flows automatically into AERS. But for unknown reasons, Pfizer classified these suicides among less serious injuries and submitted them amid hundreds of other less serious reports as an appendix to a quarterly text report intended for page-by-page reading. So the reports were not entered into the FDA Adverse Event Reporting System (AERS) as FDA expected.
Thus, until July 2010, when FDA asked the manufacturer to resubmit "thousands" of reports that were reported in periodic summary reports to the agency's AERS system (http://online.wsj.com/article/BT-CO-20110519-713714.html), safety analysts were not aware of more than half of the reported suicide cases in which Chantix was the primary suspect drug, and did not have available hundreds of other reported cases of serious psychiatric side effects. So much missing data could have led to an underestimation of the risks of Chantix.
In response to our QuarterWatch publication last Thursday, FDA posted a statement (http://www.fda.gov/Drugs/DrugSafety/ucm255918.htm) acknowledging that the reports were initially sent to the Agency in a way that did not allow for comprehensive evaluation. They also noted that a few other manufacturers were also submitting some adverse-event reports through "improper" channels.
FDA said that the reports about Chantix confirmed what they already knew about Chantix and would not have changed the Agency's position on the drug's risks and benefits, given that the data in these reports were consistent with those that led to the 2009 labeling change. They are continuing to monitor the drug’s safety. FDA said they also initiated additional post-market safety activities such as requiring Pfizer to conduct a large, comparative, post-market clinical trial assessing the safety of Chantix among other smoking cessation aids. FDA has also initiated two observational safety studies on Chantix, one with the Veterans Administration and one with the Department of Defense.
When we first examined varenicline data in 2008, reports for this drug outnumbered reports for all other US prescription drugs, although dispensed prescriptions and reported events later declined. Now, with a spike of 1,055 serious ADEs reported in the third quarter of 2010, varenicline again surpassed all other drugs we regularly monitor and also ranked first in reported deaths—more than twice as many as any other drug.

Two other drugs also presented safety signals during Q3 2010. One of these was the new diabetes drug Victoza which was associated with reports of pancreatitis.  FDA approval of this drug was controversial because of uncertainty about its cardiovascular risks, and because animal studies showed an increased risk of thyroid cancer. Early adverse event reporting did not speak to these still unresolved issues, but did reveal a marked signal for pancreatitis. Evidence accumulates that similar drugs like Januvia and Byetta may all share an elevated risk of pancreatitis, although possibly to differing degrees.

Signals were also seen with Seroquel (quetiapine). The drug shares with other antipsychotic drugs the risk that some of its most common side effects can be irreversible, notably some cases of diabetes and certain movement disorders. In the third quarter of 2010 we noted hundreds of new reported cases of diabetes associated with QUEtiapine, together with a smaller number of reports of dyskinesia (involuntary muscle movements), dystonia (spasms or prolonged contractions), and parkinsonism (tremors or muscle rigidity). You can find our full report here (http://www.ismp.org/Newsletters/acutecare/articles/20110519.asp).

Most of the time medicines provide much needed benefits to consumers when used safely. However, there is a great need for better communication and management of risks associated with medicines. The best recommendation we can give to consumers is to be informed. Discuss all your options with your doctors and pharmacist, and ask about the serious side effects of medicines. I highly recommend that you sign up for customized safety alerts for the medications you take (https://www.consumermedsafety.org/medsafetyalert.asp). In this way you can help make the most informed decisions about your healthcare.