Pharmacy Error Injury Lawyer Blog

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.

Florida Considers Bill Potentially Impacting Patient Safety

May 13, 2013 | Lebowitz & Mzhen

Last month, the Florida House of Representatives passed a bill, by a vote of 101 to 16, that would double the number of pharmacy technicians each pharmacist can supervise from three to six.

The pharmacists remain responsible for signing off on all of the medication orders, regardless of whether they fill them personally or a trained pharmacy technician fills them under supervision.

Opponents of the bill argue that it puts corporate profits at more of a priority than patient safety.

Under current law, pharmacies have to petition the State Board of Pharmacy in order to have each pharmacist supervise more than one, up to three, technicians. But the bill would allow up to six techs per pharmacist without any prior board approval. Thus, the bill is essentially eliminating the current oversight, and creating the opportunity for a six fold increase in the number of techs without requiring any special application process.

Critics further point to the incidences of pharmacy error that are occurring with the 1:3 ratio, and imply that this would only become more prominent with less oversight.

Major pharmacy retailers, such as Walgreen’s, CVS and Publix, support the bill, claiming that they operate in several states which do not have any mandated ratios, and according to their statistics do not have a difference in quality across these different states. If pharmacies are able to hire more pharmacy technicians, who are paid much less than pharmacists, their potential profits could rise because they could sell more medicine in the same amount of time.

Young Girl Narrowly Survives Morphine Overmedication in Hospital

May 6, 2013 | Lebowitz & Mzhen

The U.S. Food and Drug Administration recently updated one of its website pages regarding medication error and consumer awareness. One of the stories included is a cautionary tale for all hospitalized individuals receiving medication intravenously.

When a 9 year old girl shattered her elbow on the soccer field, her M.D. parents took great care in selecting a hospital for her treatment. Following a successful three hour surgery to repair her injury, the girl was prescribed morphine through a pump, and was also hooked up to a heart rate monitor, breathing monitor, and blood oxygen monitor. She responded so well, that doctors decided to turn the morphine pump off, and discontinue regular vital sign checks.

The girl’s mother slept in her daughter’s hospital room that night. When she woke up in the midde of the night to check on her, the girl was barely breathing, and was verbally non-responsive. Apparently, the morphine pump was not only still turned on, but in fact had been turned up to high. The narcotic flooded the girl’s body, but thankfully she survived the ordeal. It is disturbing to consider what may have happened if the mother hadn’t woken up when she did.

The parents in this case were satisfied with the manner in which the hospital handled the error, which included acknowledging the error, addressing future treatment for their daughter, and a plan for how to avoid such errors in the future. The mother believes that short staffing and a holiday weekend may have been contributing factors.

Improperly Mixed Nutritional Supplements Given to 186 Babies & Children in Compounding Error

April 29, 2013 | Lebowitz & Mzhen

Authorities for Alberta Health Services (AHS), located in Edmonton, recently announced another major pharmaceutical error, which this time may have impacted some 186 sick children. This is the third major pharmaceutical/compounding error that has been announced within the Canadian healthcare system within the past month.

According to a statement from AHS, the error in this case, which is said to have affected children, many of whom are premature babies, was the result of an improperly compounded nutritional supplement, called Total Parenteral Nutrition. The result was a concoction which contained double the prescribed dose for zinc, copper, selinium, and chromium. The formula was fed intravenously to children within three Edmonton hospitals for a period of time in December 2012 through April 2013. The health authority apologized for the error, and has stated that it will launch a complete investigation into how the matter occurred in the first place.

Fortunately, according to authorities, the mistake has not resulted in any injuries or deaths, and the risk of any such complications developing is low. They stated further that none of the doses were above recommended maximum levels for the patients, even though the individual doses were higher than prescribed.

Most of the affected families have been contacted, although authorities report they do not need to do anything now. They are offering blood tests for the children if the parents would like, in order to allay any potential concerns.

Total Parenteral Nutrition, the supplement involved in these cases, is purportedly used for sick children and premature babies, who are unable to receive adequate nutrition through normal methods.

Electronic Health Records May Increase Risk of Medication Errors

April 19, 2013 | Lebowitz & Mzhen

In an ironic finding, considering a recent article indicated that ordering drugs via a computer order entry system actually decreased the risk for error, a new study analyzed by Pharmacy Practice News concluded that Electronic Health Records (EHRs) may lead to an increase in medication and other treatment errors.

The study found that for various reasons, electronic health records may lead to more drug mistakes rather than prevent them.

The study examined the Pennsylvania Patient Safety Reporting System (PA-PSRS) database, and by utilizing specific search terms, found over 8,000 relevant reports during an eight year period. After sifting through the results, a little over 3,000 were found to have some sort of error.

Among these, the results were as follows:

89% of the records were labeled “event, no harm,” meaning that the error did not result in an adverse effect on the patient
10% were labeled as constituting “unsafe conditions,” which also did not result in patient harm
0.48% involved some sort of temporary harm to the patient.

Of these 0.48%, the harm was caused by:

entering incorrect medication data
administration of incorrect medicine
ignoring a documented drug allergy
failing to enter lab test results
failure to document

One of the incidents in particular involved a failure to document an allergy to penicillin, which resulted in a significant harm to the patient.

Of all of the resultant error, 81% of them dealt with medication errors, including incorrect medication, incorrect dosage, timing, patient or route. Of the remaining errors, around 13% were regarding issues with complications of procedures, tests, or other treatments.

A common recurring problem uncovered by the researchers was the entering of data in the wrongplace, or inputting incorrect information, such as the wrong physician name.

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.

Watered Down Chemo Given to Thousands of Patients in Compounding Error

April 8, 2013 | Lebowitz & Mzhen

Canadian officials recently announced their discovery that over 1,000 patients undergoing chemotherapy over the past year have received diluted versions of their medications. Affected patients were receiving treatment for breast, lung and bladder cancers. Seventeen patients at one hospital alone have died since beginning treatment. One center reported more than 600 affected patients, making it the most impacted so far.

The problem was discovered by a pharmacy technician at a hospital late last month. The premixed drug cocktail, which contained too high a percentage of saline solution, was shipped out to at least four hospitals in Ontario and one in New Brunswick. Apparently the overfilling of bags that already contain saline is not that uncommon of a practice.

Among the answers sought by Canadian health ministry officials are the following:

How did the dilution of the drugs impact patients’ treatments and longevity? Was the product properly labelled? How did it pass through so many hands for nearly a year before one pharmacist technician in Peterborough noticed there was a problem? Who’s watching the medication that so many rely on to make them better?

One administrator in charge of a facility that administered some of the defective chemo drugs stated that they rely on the manufacturer to provide drugs consistent with what they are contracted to provide, and that they therefore do not perform random testing to confirm concentration of the products.