Patient Safety

Proposed Laws Increasing Ratio of Pharmacy Technicians to Pharmacists Could Adversely Impact Patient Safety

March 5, 2014 | Lebowitz & Mzhen

Pharmacies often rely on a team of medical professionals to meet the demands of customers. These teams consist of pharmacists, who must meet educational and licensing requirements in all U.S. states and the District of Columbia; and pharmacy technicians, who are not always subject to such strict credentialing requirements. Some states set a maximum ratio of pharmacists to pharmacy technicians, while others simply require that the pharmacist have adequate support from staff and technology to perform their professional duties. Pending legislation that would increase the number of technicians that can work under a pharmacist has raised concerns about patient safety.

To obtain a pharmacy license, an individual must obtain a degree from an accredited pharmacy school, pass several examinations, and maintain continuing education requirements. Many states do not require as many credentials to work as a pharmacy technician. Maryland requires a person to have a high school diploma or equivalent, complete a 160-hour training program or obtain certification from a national pharmacy organization, and complete annual continuing education. Supervision of pharmacy technicians by licensed pharmacists is critically important to patient safety.

According to a report by Tampa’s WFTS on pending legislation in Florida, errors occur in an estimated 0.09 percent of all prescriptions filled in the United States. While this seems like a small number, the Kaiser Family Foundation estimates, based on data from 2011, that doctors write more than 59 million prescriptions per year in Maryland alone. That means that more than 53,100 pharmacy errors may occur per year in this state. Most of these errors do not cause any harm, but injuries from pharmacy misfills can be severe.

Washington DC News Investigation Finds Multiple Medication Errors at National Pharmacy Chain

February 27, 2014 | Lebowitz & Mzhen

In a report on its investigation of the national pharmacy chain CVS/pharmacy, Washington DC’s NBC affiliate, News 4, claims to have found numerous alleged medication errors and other problems. Consumers reported receiving the wrong prescription and, in at least one case, meeting with indifference from employees. A former CVS pharmacist with more than thirty years at the company filed a whistleblower lawsuit last year, alleging in part that the company fired him in retaliation for reporting his concerns about an increasing rate of medication errors due to staff reductions. CVS has denied the allegations against it and publicly stated its commitment to protecting patients’ health and safety.

Washington’s News 4 reported a woman’s claim that CVS made a mistake when refilling her prescription for potassium citrate, which she took for her kidneys. She noticed that the pills did not look familiar, and saw that the pharmacy had given her a bottle of potassium chloride instead of citrate. The pills look similar and have similar names, but they have very different uses. Potassium chloride is used to treat hypokalemia, or low blood potassium, and can cause serious, even fatal, complications for some kidney patients. The woman claimed that when she notified the pharmacy manager of the mistake, he responded “Well, potassium is potassium.”
The report also looked at automatic refills, a service offered by CVS and other pharmacies. This allows the pharmacy to refill a prescription at regular intervals, so that the patient does not have to call and request a refill. Problems may occur, however, if the pharmacy refills prescriptions that the patient does not want or need. An elderly patient told the news team that he ended up with more Lidoderm patches, which contain an extremely strong painkiller, than he wanted, based on the auto refill system. This could lead to confusion for some patients, who might not realize that they are receiving medications they did not request.

Hospital Uses “Storytelling” Approach to Prevent Medication Errors

February 13, 2014 | Lebowitz & Mzhen

A hospital in Houston, Texas has adopted a “narrative-based approach” of communicating the details of medication errors to hospital staff (login required). A medication safety consultant employed by the hospital found that the prior approach, which relied on unit managers to pass along information to their teams, was not leading to greater institutional knowledge about how to avoid medication errors. The new approach involves the production of short videos detailing the issues that led to a specific medication error. The success of the program is difficult to measure, as it is based solely on self-reporting by hospital leaders who seemed to perceive a substantial reduction in medication errors during the eight-month pilot program. The program bears some similarities to how many attorneys approach claims for pharmacy and medication errors, as a narrative story told to the judge and the jury.

MD Anderson Cancer Center ran a pilot program from October 2012 to June 2013. Every month, a team consisting of a nurse, a pharmacist, and a patient safety specialist would review recent medication errors to identify important concerns. They would decide on three events or issues, and another multidisciplinary team would pick one to use in a video. The hospital’s communications department would handle the actual production, including writing a script, shooting and editing the video, and formatting it into a PowerPoint presentation.

Once the hospital administration approved the final video, it would be uploaded to the hospital’s intranet. The hospital’s various department heads and team leaders would be notified of the new video. The leaders would then be responsible for showing the video to their teams. The hospital produced one video a month for eight months. Hospital leaders reportedly accessed the videos more than 3,500 times during that period, and eighty-three percent of them showed the videos during staff meetings. A majority of leaders said in survey responses that the videos were a “very” or “extremely” successful means of communication. The hospital permanently adopted the program, and has expanded it to share other information besides medication errors.

Similar Drug Names Can Cause Confusion, Catastrophe if Pharmacy Makes an Error

January 15, 2014 | Lebowitz & Mzhen

Confusion between two similarly-named drugs can be harmful or even fatal if the error is not detected quickly. An error could result from any number of circumstances, such as a pharmacist who misreads a doctor’s handwriting or a nurse who accidentally administers the wrong drug. The U.S. Food and Drug Administration has procedures for comparing new drug applications to existing drugs, but this does not guard against confusion regarding drugs that are already on the market. A pharmacy journal published an account last year of one such medication error at an oncology clinic, which fortunately did not result in any complications for the patient who received the wrong medication. A version of the drug she received, however, has been implicated in numerous injuries and lawsuits.

The journal Hospital Pharmacy included an account in its June 2013 issue of a fourteen year-old girl diagnosed with acute promyelotic leukemia (APL) who received the wrong medication for about four months. APL, according to the authors, can quickly turn fatal and requires immediate treatment. Her doctors prescribed an oral dose of trentinoin, a vitamin A derivative commonly prescribed in a topical form under the name Retin-A to treat and prevent acne. It is administered orally in 10-miligram capsules to treat APL. The same basic effect that treats acne can also fight cancer cells.

After completing a course of treatment, the patient returned to the hospital about a month later. Her doctors decided to do several rounds of outpatient intravenous chemotherapy and continue the oral trentinoin. A nurse in the oncology clinic, possibly unfamiliar with the drug, instead called in a prescription for isotrentinoin under the brand name Claravis. While similar to trentinoin, isotrentinoin is primarily used to treat severe acne. It was formerly marketed as Accutane, but the manufacturer discontinued the brand in 2009, allegedly in part because of lawsuits claiming harmful side effects.

Court Finds Failure to Warn and Design Defect Claims Preempted in Lawsuit Against Generic Antibiotic Manufacturer

January 8, 2014 | Lebowitz & Mzhen

A federal court dismissed most of the causes of action in a lawsuit alleging that a generic antibiotic caused a dangerous, potentially-fatal reaction. Wilson v. Amneal Pharmaceuticals, LLC, No. 1:13-cv-00333, order (D. Id., Dec. 31, 2013). The lawsuit asserted claims under Idaho state law, but the decision is similar to federal court decisions in other states involving generic drug manufacturers. Federal laws and regulations make recovery of damages difficult for injuries caused by generic drugs.

The plaintiff’s doctor prescribed Bactrim, a generic antibiotic manufactured by the defendant, Amneal Pharmaceuticals. After taking the medication for one week, the plaintiff reportedly developed Stevens-Johnson syndrome, a reaction to a medication or infection that causes painful rashes and blisters. It can be very difficult to treat, and in severe cases, can cause permanent injury or death. The plaintiff sued Amneal in state court, asserting seven causes of action including defective design, negligent manufacture, and failure to warn. Amneal removed the case to federal district court based on diversity jurisdiction. It attached various FDA documents to its answer, including formal approvals of changes to the drug label.

Amneal moved the court to take judicial notice of the documents it produced with its answer, and to dismiss the plaintiff’s complaint for failure to state a claim on which the court could grant relief. The plaintiff opposed the motion for judicial notice and moved the court to allow discovery to proceed. The court denied the plaintiff’s motion and granted the motion to take judicial notice. Judicial notice is proper, it held, when the evidence in question is widely available or a matter of public record. It found that all of the documents in question were easily obtainable online, and that no one disputed their authenticity. The court proceeded to decide the motion to dismiss without the introduction of any further evidence besides the pleadings.

Massachusetts Senate Passes Bill Regulating Compounding Pharmacies

November 13, 2013 | Lebowitz & Mzhen

The Massachusetts Senate voted late last month unanimously to increase regulatory oversight within the state of drug compounding pharmacies, in order to help protect patient safety.

The potential issues regarding the largely unregulated compounding pharmacies such as the one in Massachusetts, which was believed to be the source of a deadly fungal meningitis outbreak, have been discussed at length on this blog.

Following the contamination of compound medications affecting hundreds of patients, which was eventually traced back to a Massachusetts lab, one of the most important regulations of the bill is that it establishes sterile compounding and complex non-sterile compounding specialty licenses, which will be issued by the Board of Registration of Pharmacy.

Makers of Tylenol Announce New Label Warnings in Attempt to Reduce Overdoses

September 13, 2013 | Lebowitz & Mzhen

Johnson & Johnson recently made the decision to make some changes in the way it labels Tylenol, specifically in regards to adding additional warnings of the potential dangers the drug may pose.

The warning will make it explicitly clear that the over-the-counter drug contains acetaminophen, a pain-relieving ingredient that’s the nation’s leading cause of sudden liver failure.

These preventative measures are believed to be related to the fact that the company is reportedly currently facing more than 85 personal injury lawsuits in federal court blaming Tylenol for various liver injuries and deaths.

Defective Blood Glucose Monitor Test Strips Pose Major Potential Risk to Diabetics

August 29, 2013 | Lebowitz & Mzhen

Individuals in Ireland with diabetes may be at a serious risk of injecting themselves with dangerously high levels of insulin, due to an error in glucose monitoring kits recently discovered.

According to the authorities, some 4,100 boxes of test strips, which are directly used to measure glucose levels in the blood of diabetics, are being recalled due to a manufacturing error which could give a false reading. The strips were part of a faulty batch of GlucoMen LX Sensor test strips.

The strips, which are used as home kits, may result in an overestimation of the diabetic’s blood glucose level, which could potentially result in them injecting themselves with too much insulin.

Pennsylvania Patient Safety Organization Releases Staggering Report of Prescription Errors

June 17, 2013 | Lebowitz & Mzhen

According to a report released earlier this month by the Pennsylvania Patient Safety Authority, more than 800 patient medication errors were reported to the agency over a six-month period. According to the report, errors were most likely to occur during the transcribing and administration phases, and occurred the least often during the dispensing and prescribing phases.

Of the 813 reported events, these errors occurred within the following time periods:

353 (43%) administration phase

311 (38%) transcribing phase

98 (12%) prescribing phase

42 (5%) dispensing phase

The three most common medication errors involved: Insulin, Heparin, and Vancomycin (an antibiotic). For those incidents involving a single known medication, almost a third of them were associated with such high-alert medications.

There were many factors involved in the errors. For example, in one case, two separate patients had been prescribed the same medication, but in different doses. The error occurred when the doses were switched.

Another contributing factor was identified as inadequate procedures for verifying the identity of the correct patient, such as with identification bracelets.

Among the reported errors submitted, these were associated with the following:

26% (214) medical-surgical units

22% (180) pharmacy

10% (80) emergency department

3% (25) involved pediatric patients

Despite the various errors, the report stated that none of the incidents resulted in patient harm. While three incidents required temporary intervention, none resulted in prolonged harm or injury.

Birth Control Pill Error May Cause Unintended Pregnancy

April 15, 2013 | Lebowitz & Mzhen

Canadian officials have recently announced the recall of a particular lot of birth control pills called Alysena 28. The recall affects a small number of packages which contained 14 placebo and 14 active pills rather than 21 active pills and 7 placebo.

Women who are taking the pill in order to prevent pregnancy could face the possibility of an unintended pregnancy should they take the pills subject to the recall. The particular brand of birth control pill subject to this error, Alysena 28, is sold in British Columbia, New Brunswick, Newfoundland and Labrador, Nova Scotia, Ontario, P.E.I. and Quebec. Many pharmacies are reporting that they did not receive or distribute the affected pills.

Although this error occurred in Canada, there have been many similar birth control pill packaging errors in the U.S. recently. Last February alone, Glenmark Generics and Pfizer, Inc. issued individual recalls for birth control pills which were packaged in the incorrect order. Speculation regarding wrongful pregnancy cases abounded on the internet. Several of the sources regarding these recalls point out the fact that the affected pills are different colors, so patients who have been taking the medications for a period of time may have avoided taking the pills incorrectly.