Errors in local pharmacies

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.

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.

CVS to Pay $650,000 and Establish Safety Procedures Following Prescription Errors in New Jersey

March 12, 2013 | Lebowitz & Mzhen

The New Jersey Division of Consumer Affairs has announced that it has reached a deal with CVS-Caremark regarding several incidents involving commingled prescription medications.

Under the agreement, CVS will contribute $650,000 to go toward establishing programs regarding prescription drug safety and abuse. The incidents took place over a four month period, from December 2011 to March 24, 2012, in five different New Jersey CVS pharmacies.

The first incident involved a CVS in Chatham, where on at least 15 separate occasions a breast cancer treatment drug was mixed in with prescriptions for children’s chewable fluoride. Apparently, both the medications looked similar, in that they were both small white pills, but were stamped with different identification information.

You read that right, a breast cancer treatment drug, was mixed up with children’s chewable flouride. In other words, what amounts to something comparable to a vitamin was confused with a potentially dangerous substance. Tamoxifen is a cancer-fighting drug that interferes with estrogen. It is used in the treatment for both patients fighting metastatic breast cancer, and those believed to be at risk for developing breast cancer.

Following the investigation of the initial mix ups, authorities eventually discovered several similar incidents involving the co-mingling of prescription pills at other CVS locations. These included:

metoprolol, used to treat high blood pressure, was commingled with risperidone, a schizophrenia medication
pravastatin, a cholesterol drug, was incorrectly given instead of metformin, a diabetes medication
Coreg, a blood pressure drug, was prescribed at 20 milligrams per tablet, but the patient received 80 milligram tablets of Coreg four times the correct dosage as well as the correct concentration
approximately 30 prescriptions from an automated filling machine were filled incorrectly when cholesterol pills were mixed with blood pressure pills

In response to these incidents, it is reported that CVS contacted all of the potentially affected patients, and informed them what measures to take. It also took measures to correct the manner in which the mistakes were made, and notified the Division of Consumer Affairs and the State Board of Pharmacy.

As part of the settlement, in addition to the payment, CVS will take other preventative measures, which include producing pamphlets for public information, providing information regarding pills on its website, and various training programs for its pharmacy staff.

Check Your Pills Twice: Pharmacist Gives Woman Incorrect Pills

February 19, 2013 | Lebowitz & Mzhen

A Seattle woman suffering from multiple sclerosis, who also recently underwent hip surgery, went to her local pharmacy to have her prescriptions filled.

When the woman went to take her pills, she noticed that something was a bit off. She knew that thecapsule was supposed to be white and green and have the numbers “293” imprinted on it, with a 250 milligram dose of her medication. Instead,however, she saw that the pill was light green and dark green, and had the number “294,” indicating that it was in fact a 500 milligram pill. It was then that she realized she had been ingesting doublethe prescribed dose for at least two days.

While it turns out that the printing and information on the label for her prescription pill bottle was correct, apparently the pharmacist at the Rite Aid where her prescription was filled gave her the incorrect dose. In a statement the woman reiterated that her doctor prescribed her medications in order to accommodate her MS, and that the potential impact on her health due to the double dosing is currently unknown.

In a statement regarding the incident, a Rite Aid spokesman stated that their company has a seven point check for accuracy for each prescription before it leaves the pharmacy. The company is now investigating to see if that procedure was followed, and will potentially require retraining for its employees.

Appellate Court Denies State Access to Pharmacy’s Medication Error Data, Citing Federal Privacy Laws: Department of Financial and Professional Regulation v. Walgreen Company

October 9, 2012 | Lebowitz & Mzhen

A pharmacy resisted a subpoena from Illinois regulators seeking information on medication errors, citing a federal law that encourages pharmacies to track medication errors, but protects the confidentiality of those records. The trial court agreed with the pharmacy’s position in Department of Financial and Professional Regulation v. Walgreen Company, 970 N.E.2d 552 (Ill. App. 2nd Dist. 2012), and granted its motion to dismiss the subpoenas. The Illinois Court of Appeals affirmed the ruling, finding that federal law privileged the medication error records from disclosure to the state government. Although federal law encourages pharmacies to track medication errors, it limits the uses to which the government may put the resulting records.

The Illinois Department of Financial and Professional Regulation (DFPR) issued three subpoenas to Walgreens in July 2010, seeking reports of medication errors involving three specific pharmacists in Walgreens’ employ. It petitioned the circuit court to enforce the subpoenas in October 2010. Walgreens quickly moved to dismiss the petition, claiming that the records sought by the DFPR were privileged under the Patient Safety and Quality Improvement Act of 2005 (PSQIA).

The PSQIA provides mechanisms for reporting and analyzing a wide array of medication error data. The law provided for the establishment of Patient Safety Organizations (PSOs) under the Agency for Healthcare Research and Quality (AHRQ). PSOs are independent organizations that gather and analyze medication error reports from doctors, pharmacies, hospitals, and other health care facilities within a designated geographic area. They cooperate and collaborate with the AHRQ and other PSOs with the goal of developing improvements in patient safety and reductions in the number of medication errors. The PSQIA provides that all reports made by pharmacies and other organizations to their local PSO are “patient work product,” and therefore are privileged from disclosure.

Woman Injured by Medication Error During Eye Surgery Gets New Trial

September 13, 2012 | Lebowitz & Mzhen

A woman who lost one of her eyes after eye surgery got a new trial after her case went before the Iowa Court of Appeals. After a trial in Whitley v. C.R. Pharmacy Service, Inc., a jury originally returned a verdict in favor of the defendant pharmacy. The plaintiff appealed, arguing that the trial court erred in allowing the pharmacy to introduce never-before disclosed evidence at trial. The appeals court agreed that this prejudiced the plaintiff, and granted the new trial.

Whitley was a member of the Iowa Army National Guard who needed to improve her eyesight in order to apply for an officer commission in the armed forces. An ophthalmologist, Dr. Lee Birchansky, performed Epi-LASIK on both of her eyes in November 2005. Whitley later developed corneal scarring, a known side effect of the procedure. At Birchansky’s recommendation, she underwent a procedure called corneal scraping on March 9, 2006. A medication called mitomycin is used during this procedure. Birchansky’s office ordered a 0.02% mitomycin solution from C.R. Pharmacy.

Whitley reported a stinging sensation when Birchansky applied the mitomycin, which continued long after the procedure. After several weeks, she could only see colors and shapes, and she had persistent headaches. Birchansky referred her to a glaucoma specialist, who suspected Whitley had received the wrong concentration of Mitomycin. Birchansky sent the remaining mitomycin, which he found in a container with a C.R. Pharmacy label dated March 9, for testing at the University of Iowa. The tests revealed that the solution contained no mitomycin. Whitley’s condition deteriorated further. She underwent corneal transplant surgery in both eyes, but still lost her left eye.

Drug Shortages Shown to Contribute to Pharmacy Errors, While DEA Prescription Drug Crackdowns Shown to Contribute to Shortages

June 21, 2012 | Lebowitz & Mzhen

Drug shortages are affecting hospitals and pharmacies around the country. The reasons range from supply problems preventing the production of drugs, to business decisions made by pharmaceutical companies that reduce or discontinue production of certain drugs. Some critically important medications, like drugs used to treat cancer, are often in short supply.

On top of this situation, efforts by the federal Drug Enforcement Administration (DEA) to crack down on prescription drug abuse may also be contributing to drug shortages. In addition to basic problems of availability of needed medications, research suggests that drug shortages may increase the likelihood of medication errors.

Pharmacists report that they often first learn about a drug shortage when they try to order a drug from a distributor, only to learn it is backordered. This can put patients in a dangerous position, depending on the urgency of their need for the medication. In addition to cancer drugs, shortages are reportedly affecting painkillers and medications needed for emergencies, like epinephrine. These are drugs that patients need in ready supply. In the absence of a commonly-used medication, doctors may resort to a substitute medication that is less effective, or perhaps less familiar to a pharmacist.

Court Rejects State Effort to Obtain Patient Data In Pharmacy Error Investigation

June 14, 2012 | Lebowitz & Mzhen

An appellate court in Illinois has rejected an effort by the state’s Department of Financial and Professional Regulation (DFPR) to obtain quality control reports from a pharmacy. Walgreens Pharmacy refused to comply with a subpoena from DFPR seeking information on several pharmacists under investigation. Walgreens argued that producing the reports would violate patient privacy rules. Under 2005’s federal Patient Safety and Quality Improvement Act (PSQIA), pharmacies are encouraged to report information on prescription misfills and other medication errors to groups known as patient safety organizations (PSO). The law provides that these reports, intended for use in promoting patient safety, are protected from discovery or disclosure. The court ruled that Walgreens’ quality control reports fall under the PSQIA’s protection.

DFPR was conducting an investigation of three pharmacists employed by Walgreens. On July 1, 2010, it served a subpoena on the company, requesting “incident reports of medication error involving” the three pharmacists. Walgreens objected in writing and refused to comply with the subpoena. DFPR filed a petition in circuit court seeking judicial enforcement of its subpoena on October 8, 2010.

DEA Suspends Licenses of Drug Distributor and Two Pharmacies for Selling Excessive Amounts of Painkillers

May 22, 2012 | Lebowitz & Mzhen

The U.S. Drug Enforcement Agency (DEA) has suspended a major pharmaceutical distributor from shipping or selling certain painkillers and other medications from a Florida facility as part of a settlement with the company. Two Florida pharmacies have also had their controlled substance licenses suspended. The DEA’s investigation centered on large shipments of painkillers from the distributor to the pharmacies. The painkillers were then sold to the public.

The DEA pursued these companies as part of a broader crackdown on prescription drug abuse, particularly the abuse of painkillers. The issue is of particular concern because of the risk of medication errors in pharmacies that might illicitly distribute prescription drugs.

Two CVS pharmacies were the focus of the DEA’s investigation. The two stores, both located in Sanford, Florida, reportedly ranked 23rd and 37th in the nation for highest number of oxycodone pills sold.

Oxycodone, also known as ‘Oxy,’ is an opiate painkiller with a high potential for addiction and abuse, and therefore it is strictly regulated by the DEA. A pharmacist employed at one of the stores allegedly told DEA investigators last year that they would sometimes run out of oxycodone less than an hour after the store opened, and that they nearly always ran out before noon. The DEA suspected both stores of inappropriately dispensing oxycodone and other controlled substances, alleging that the pharmacies’ sales of the drugs were unusually high.

Child Overdoses on Painkiller Due to Virginia Pharmacy Error

May 7, 2012 | Lebowitz & Mzhen

A child in Henrico County, Virginia suffered a serious overdose after a mixup of two drugs with similar names caused him to receive a powerful painkiller instead of his intended medication. The child reportedly recovered fully, but required hospitalization and gave his family and doctors quite a scare. Although there is no indication that the child’s family is pursuing legal action against the pharmacy, the pharmacist who filled the prescription received a reprimand from Virginia’s Board of Pharmacy.

On July 7, 2010, the child’s parents picked up his prescription at a local pharmacy. They thought that it was Methylin, which the child’s doctor had prescribed to treat attention deficit disorder (ADHD) with autistic tendencies. Methylin, also marketed as Ritalin or the generic methylphenidate, is a psychostimulant used to treat ADHD and other psychiatric conditions. Because the drug can be habit-forming, its use and distribution is tightly controlled. Furthermore, its effects vary greatly depending on the individual patient’s diagnosis, the size of the dosage, and the length of time it is taken. It requires the close monitoring of a doctor.