Saturday, August 30, 2014
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Errors can happen with pharmacy's automatic drug refill service

If you have a prescription filled regularly for a chronic condition like high blood pressure or diabetes, you will likely be asked about signing up for your pharmacy's automatic prescription refill program. This service has some great points, including convenience. But it can lead to errors. Good communication with your pharmacist about therapy changes is essential to avoiding mistakes.

Errors can happen with pharmacy's automatic drug refill service

If you have a prescription filled regularly for a chronic condition like high blood pressure or diabetes, it’s likely you will be asked about signing up for your pharmacy’s automatic prescription refill program. This is most often an option where you have to fill out a form at the store or on the web to request the service, although in some cases the pharmacy may do this without your having to sign up for the service. In either case, based on how many days the original prescription is supposed to last, their computer is set to automatically refill your prescription before it runs out. You can get an e-mail or text message or the system can contact you by telephone to remind you that your prescription refill is due and ready for pick-up.

Once you opt-in for automatic refills, as long as there are remaining refills permitted, every prescription you get in the future will automatically be refilled. If notification has taken place and the prescription is not picked up, another automated contact will happen. About the only complaint I do hear about this service is that it sometimes clogs your voice mail or is it may be a minor annoyance since it’s a computer calling you, and not actually your pharmacist.

This service has some great points. It eliminates the need for the patient to remember to request a refill and thus help patients comply with their doctor’s instructions. It also helps improve safety since staff at the pharmacy can better prioritize their work flow and they won’t feel so rushed. Pharmacists also appreciate it because there’s less urgency to dispense on demand since patients don’t need to stand by in the pharmacy until the prescription is ready. While this also happens to be good for drug companies since the reminders assure they’ll sell more drugs, this is a service provided by your pharmacist, not them. It doesn’t compromise your privacy and I’m not aware of any influence on the part of pharmaceutical manufacturers.

Still, there’s a potential downside. In the past few weeks we heard from a patient utilizing the automatic refill system who picked up three prescriptions but later called the pharmacy to report he had picked up a blood pressure pill called Norvasc, which his doctor had already discontinued. Fortunately, he hadn’t yet taken any. In another case a patient’s Cardizem, a heart medication, was increased from 240 mg to 360 mg. The elderly gentleman purchased the new prescription for diltiazem 360 mg but also received the diltiazem 240 mg prescription that had been filled earlier through the automatic refill program. After receiving a call from the confused patient, the pharmacist contacted the patient’s doctor to determine which strength the patient should be receiving. Had the patient accidentally taken both strengths of Cardizem, it could have caused serious heart or blood pressure complications.

Rarely do patients or their doctors remember to communicate to the pharmacy that changes in medication therapy have taken place. But if the pharmacist doesn’t know about changes the computer is not reset. That increases the risk of a medication being automatically dispensed even after it has actually been discontinued or the dose or dosing frequency was changed. The system just continues to produce labels with instructions that are no longer correct. Sometimes the pill has a new appearance that you may not recognize as being the same drug. This scenario is a set up for inadvertently taking the same medicine twice. Pretty much any pharmacist working in a pharmacy with automatic refills can recall situations where a discontinued medication was inadvertently dispensed.

Patients can also opt out of refill programs either on the Internet or in person, although I am not suggesting that since the convenience of automatic refills is usually a win-win. However, the importance of notifying your pharmacy or having your doctor’s office do so when changes are made, cannot be underestimated. In practice this is often overlooked and the older prescription can remain set for automatic refill. If the medicine stays the same but a change is made only to the strength or dosing frequency, it sets up circumstances where drug duplication can occur. Otherwise, the older discontinued medication may still be used when it shouldn’t. I’m particularly concerned when patients without insurance, or those who take advantage of pharmacy $4 generic programs, pay cash and shop around. This makes it more likely that not all of your drug information will be in one location and that any duplication will not be recognized. This is one reason why I always advise patients to choose a single local pharmacy, even when they get certain prescriptions through mail order.

Automatic refill programs can help patients adhere to their prescribed medication regimens. They’re convenient, you don’t need to remember to call, and your prescription will be ready once you get your pharmacy’s message, so there’s no needless waiting at the pharmacy. But good communication between you and your pharmacist about therapy changes is essential to avoid errors.

 

 

 

 

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.

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Check Up covers major health events in our region and offers everything from personal health advice to an expert look at health reform. Read about some of our bloggers here.

For Inquirer.com. Portions of this blog may also be found in the Inquirer's Sunday Health Section

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