Pharmacy Error Injury Lawyer Blog

New Heparin Labels Intended to Reduce Fatal Overdoses

July 25, 2013 | Lebowitz & Mzhen

A recent article in Pharmacy Practice News discussed ways in which updated labeling standards for Heparin Sodium Injection and Heparin Lock Flush Solution may not eradicate the problems associated with overdose completely. One major reason being that some of the older problematic versions of the label remain in pharmacy stocks.

According to information on the relevant organization’s website, the new labeling requirements, which took effect this May, require that the new heparin products clearly indicate the concentration of the medication, followed by how much medication is in each milliliter (mL).

Prior labels stated the per mL amount, with the total container volume appearing elsewhere, thus leading to errors when practitioners mistook the per mL amount as the total volume in the vial. This sort of mistake led to dangerous heparin overdoses.

For example, in one case a patient died due to bleeding in the brain, which occurred as a result of two practitioners mistakenly thinking that a 10-mL vial of heparin held a total of 1,000 units, when each vial actually contained 10,000 units (1,000 units/mL). As a result, they administered 30,000 units to the patient instead of 3,000.

Lawmakers Reverse Decision to Shut Down Pharmacy Blamed for Causing Heart Attack

July 18, 2013 | Lebowitz & Mzhen

Massachusetts lawmakers, and specifically the state’s Board of Registration in Pharmacy, have been under increased scrutiny following the deadly meningitis outbreak that occurred last year.

Prior to the outbreak, the regulators changed course regarding a decision to shut down a Massachusetts pharmacy whose medication error sent a teenager to the emergency room with a heart attack. While they claim to still be investigating, they have yet to take disciplinary action against the responsible pharmacy.

According to state records, in July of 2011 Royal Palm Specialty Pharmacy reportedly accidentally gave a patient thyroid medication that was 1,000 times too concentrated. This devastating error required hospitalization for serious heart complications. The board reportedly only found out about the error after the boy’s mother called to complain, four months later.

According to state documents, instead of supplying 10 microgram capsules of the relevant thyroid medication, the pharmacy apparently provided capsules containing 10,000 micrograms.

After taking the drug, the teenager had to be taken to an emergency room four times and hospitalized twice in August 2011 for heart problems. The symptoms still plague the young man, as he reportedly continues to experience generalized weakness and heart palpitations.

Investigators found that the pharmacy did not report the overdose to the state board, even though they are required to report any errors that lead to death or serious injury within 15 days. A pharmacist for the company says that she did not report the error, because she did not know the extent of the harm to the young man, as she could not get in touch with his mother. The pharmacist has since been reprimanded by the state for the error.

Dangerous Drug Disaster Narrowly Avoided When Vitamin Substituted with Resuscitation Medication

July 11, 2013 | Lebowitz & Mzhen

A Washington woman narrowly avoided a potentially tragic prescription error, when she picked up her usual prescription for the vitamin B12. The label on both the bag and the container even contained the correct name: Cyanocobalamin.

The woman noticed that the color of the actual liquid was different, in addition to the cap on the bottle, but she dismissed her concerns as a potential change in manufacturer.

Then, as usual, the woman’s son came over to help her with the injections. After inspecting the bottle, he asked the woman about it. Fortunately, due to his prior medical training, her son realized that what the woman had was actually not the usual B12 vitamin injection, but rather the dangerous drug atropine, which is used to resuscitate patients in cardiac arrest, among other uses.

The woman had gotten the medication from the military base near her home in Virginia, which sends its prescriptions out to a national center to be filled. It was apparently the national pharmacy that made the error.

The medicine the woman was given could have killed her instantly, or at least led to a heart attack or stroke, among other side effects.

Man Given Opposite of Intended Medication Sues Pharmacy

July 2, 2013 | Lebowitz & Mzhen

A man who went into a pharmacy in order to get pills to keep him awake throughout the day allegedly ended up suffering serious consequences when he was instead given sleeping pills.

The 61 year old man alleges that the mistake caused him to get into minor car accidents, and led to his arrest for driving under the influence of a controlled substance. Luckily for the man, prosecutors later dropped the misdemeanor charges when they decided that he probably was not aware of what he had been taking.

The pharmacy reportedly told police that they had given the man someone else’s prescription. However, the pharmacist also claimed that he told the man that they were sleeping pills, and were only to be taken before bed.

However, the victim in the case maintains that he was given no such warnings, and that he had in fact been instructed to take the medication in the morning. His suit claims that after taking the first pill, that afternoon he began to run some errands, and became drowsy and incoherent. He then pulled his vehicle onto a sidewalk, then backed into another vehicle, before driving to a family member’s home and crashing into their garage door.

Pharmacist’s License Revoked Following Dangerous Drug Mistakes

June 24, 2013 | Lebowitz & Mzhen

A Rhode Island pharmacist, and former state senator, has had his license revoked from the state earlier this month (registration required), following the accidental administration of morphine to two children who received medicine from the pharmacy where he worked.

The Health Director, Michael Fine, ordered the pharmacist’s license to practice revoked, stating the seriousness of the errors, and that a third serious dispensing error of this nature could lead to the potential death of a patient. This was reportedly the second time since 1999 that a pharmacy under the man’s control had made a major labeling error.

According to the order, the man’s license was initially suspended in March 2012, when he acknowledged being the pharmacist in charge of a location where the two mistakes were made. According to the report, two children, aged 11 months and 2 years, were mistakenly dispensed a medicine containing morphine and other serious pain reliever medications, instead of the drug they were supposed to receive in order to treat acid reflux and related conditions. The Health Director stated that this pharmacist has now had three disciplinary proceedings since 1999, and that the similarity and severity of the two incidents “demonstrate an indifference to proper pharmaceutical practice.”

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.

Electronic Health Records Create New Opportunities for Prescription Errors

June 10, 2013 | Lebowitz & Mzhen

With the advent of new electronic means of managing patient health records, there are now additional ways in which prescription errors can take place.

For example, PCEHR, the Personally Controlled eHealth Record System, was adopted in June 2012 in Australia.It is a health information database designed for use by patients, and according to the National E-Health Transition Authority’s website, “is currently distributed across a wide range of locations including their general practices, hospitals, imaging centres, specialists, and allied health practices.” In essence, the PCEHR is somewhat like an all encompassing electronic health record of a patient. The aim of the program is to make the healthcare system more streamlined and efficient, allowing patients to effectively “share” it with relevant care providers.

A recent article entitled “Pharmacy Error Probable Cause of PCEHR Problem,” which was published appropriately enough in Australia’s eHealth Magazine, details how one woman’s PCEHR somehow received not one but two incorrect prescriptions.

The author reported that she discovered that two prescriptions had been added to her PCEHR. The prescriptions were for drugs that had never been prescribed to her, and were for medical conditions that she did not have.

The drugs were not only written into her record, but apparently were also dispensed by her local pharmacy, even though a notice regarding a consultation at the time they were allegedly dispensed was lacking. The relevant government agency encouraged the woman to inquire with the pharmacy regarding the error, and in doing so the pharmacy cancelled the prescriptions on her patient file. Within a day of the pharmacy’s correction, the woman’s PCEHR was also updated. However, the government told the woman that the same prescription had actually been dispensed on an additional occasion, from a different pharmacy.

“Check Your Pills” Essay Tells of Woman’s Personal Debilitating Pharmacy Error Injury

June 3, 2013 | Lebowitz & Mzhen

An essay contest sponsored by the Daughters of the American Revolution spurred an entry by a woman left severely disabled by her life threatening pharmacy error injury.

A pharmacy error led to the woman accidentally being given a blood thinner, instead of her diabetes medication (subscription required to view).

The error led to intense pain, and eventually prevented her from being able to walk. She was barely able to even talk on the night she called for help. After spending four days in the Intensive Care Unit, and a further two weeks in the hospital, it took months of physical therapy and other treatment to recover from her physical injuries, including brain damage.

The woman’s essay stresses the need for individuals to check their medications and trust their instincts when it comes to prescriptions.

“I knew my pills were different, had a different shape. I should have questioned them,” she said. The reason she didn’t was because when she asked on a prior occasion, she was told by a different pharmacy that they changed manufacturers often, in order to get the lowest medication cost. Therefore, she assumed that this was the case in this instance.

The takeaway message is that even a small and accidental error can have long-lasting, and in some cases deadly, results. It is because of individuals like this woman who share their stories, that the message to check your medications is getting increased publicity.

Asthmatic Nearly Dies After Dangerous Drug Administration

May 24, 2013 | Lebowitz & Mzhen

An 87 year old woman suffering an asthma attack was taken to a local hospital in Winnipeg by her granddaughter. The woman’s granddaughter, who brought her to the hospital, thought that the treatment would be routine. What followed, however, was far from it.

The woman reportedly ended up on life support, for then unknown reasons. In fact, the patient ended up on a respirator in the ICU for several days. She was apparently in such grave condition that the hospital recommended removing her from life support. Luckily for the emotionally distraught family, after four days in the ICU, the woman’s condition began to improve.

Two weeks following the incident, an individual from the hospital contacted the woman’s family, and admitted that the hospital had made a mistake in the patient’s medicine.

One of the pills that was administered was a “beta blocker,” which is relevant because these types of drugs are known for potentially causing issues for individuals with asthma or other respiratory conditions. As such, they are typically avoided altogether for use in these patients. The hospital claimed that the medication error was not responsible for the woman’s worsened condition, with one doctor writing in her file that the drug, “may or may not have contributed…” to the woman’s need for life support.

A pharmaceutical expert made a statement regarding the physiological impact of these types of drugs, stating that, “If people have either COPD or asthma, and part of the pathology of these diseases is that the airways are already tight, …use it with extreme caution.”

Robots May be the Answer to Decreasing Contamination and Error in IV Compounding

May 20, 2013 | Lebowitz & Mzhen

Following the widespread contamination problems at several compounding facilities, hospitals and pharmacies have begun to reevaluate the potential options for improving sterility and quality of compounded IV fluids and related products.

One potential option is the use of robots in lieu of pharmacists or technicians. One such robot is called RIVA, a fully automated IV compounding robot. The vice president of marketing at the company which sells RIVA stated that hospitals were already expressing an interest in their product prior to the contamination issues, but that interest had piqued following the incidents.

The primary draw of such automated systems is the fact that it minimizes the potential for human error, given the fact that there is very little human manipulation involved in the process. In essence, an individual inputs the stock drug vials, the bags to be filled, empty syringes, and whatever other components may be required, sets the parameters for production, presses the start button, and then takes the finished and labeled mixed bags or syringes from the output chutes. Thus, in addition to lowering the chance for human error in actually compounding the drugs, there is also a considerably lower chance of contamination, since the robots contain an aseptic environment, and the only touching happens before and after the mixing has occurred.

Additionally, the RIVA machine in particular has multiple accuracy checks in place. These include:

weighing of drug vials before and after use
weighing of syringes prior to and following filling
comparison of photos of drug labels with file photos, and
bar code scanning

Preparations failing any of these tests are automatically rejected by the machine. Additionally, pulsed ultraviolet light flashes at vials throughout various sanitation points. Throughout periodic testing for contamination following installation of a RIVA unit has failed to produce a single positive culture thus far.

The unit operates 18 to 22 hours daily, during which time it can fill approximately 400 to 500 syringes. The robot can be programmed to produce batches of individualized patient specific doses, or larger batches of the same drug and dose. According to IHS, the company who sells RIVA, preparing 350 syringes for the machine requires approximately three hours of a technician’s time.