Pharmacy Error Injury Lawyer Blog

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.

National Patient Safety Board Would Reduce Medication Errors, Say Celebrity Supporters

June 7, 2012 | Lebowitz & Mzhen

The National Transportation Safety Board (NTSB), the federal agency that reviews highway and aviation accidents and makes recommendations for safety regulations, could serve as a model for an entity to monitor patient safety, according to a number of celebrities and other advocates. A medical journal article co-authored by actor Dennis Quaid and airline pilot Chesley B. “Sully” Sullenberg III argues for the creation of such an entity to apply lessons of previous medication errors and other mistakes towards the prevention of future problems. They cite the NTSB’s success at recommending effective revisions to airline safety regulations.

In an article published in the March 2012 issue of the Journal of Patient Safety, Quaid and Capt. Sullenberg join a medical doctor and an attorney in calling for creation of a safety board for patients. All four authors have experience as jet pilots, and all four have experience in aviation safety. Quaid additionally has endured a medical “near-death experience” with his twin children. They describe a “healthcare financing crisis” due in part to inefficient healthcare spending and waste, based on decisions made by corporate boards and administrators rather than doctors. They recommend adoption of “best practices” based on past experience, similar to the way the aviation industry has improved safety with the assistance of the NTSB.

Electronic Prescriptions Help Doctors and Pharmacies Avoid Medication Errors, Prevent Fraud and Abuse

May 31, 2012 | Lebowitz & Mzhen

Handwritten prescription slips have always presented risks to patients. The risk of a pharmacist or pharmacy technician misreading a doctor’s handwriting, sometimes known as “chicken scratch” among pharmacists, leads to the risk of a misfilled prescription. This could involve the wrong dosage of a drug, or the wrong medicine entirely, with the consequences ranging from adverse side effects, worsening of a patient’s condition, or even death. New computerized systems for doctors and other medical professionals, however, join the ever-increasing number of electronic solutions to common human errors. These systems can help combat not only pharmacy errors, but also prescription fraud and prescription drug abuse.

Electronic prescriptions, or e-prescriptions (e-Rx), allow a doctor to write a prescription by submitting a request to a pharmacy online, rather than writing out the prescription on a prescription pad. A 2010 study mentioned by the New York Times, which examined handwritten prescriptions from doctors, physician assistants, and nurse practitioners in New York, found a thirty-seven percent error rate for handwritten prescriptions, not including legibility errors. The study found legibility errors in eighty-eight percent of the handwritten prescriptions. These errors can result in a patient receiving the wrong dosage or the wrong medication. They may also result in the pharmacy needing extra time to consult with the prescribing doctor or professional to sort the matter out, which could cause harm to a patient in urgent need of a particular medication.

Congress promoted the use of e-Rx in the 2009 Health Information Technology for Economic and Clinical Health Act (HITECH Act), passed as part of that year’s economic stimulus bill. The HITECH Act establishes certain acceptable uses for electronic medical records, giving regard to issues of patient privacy and the security of patients’ personally identifying information. It specifically names e-Rx as an approved use.

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.

Pain Patches Pose a Serious Risk to Children, FDA Warns

May 15, 2012 | Lebowitz & Mzhen

The U.S. Food and Drug Administration (FDA) has issued a reminder to the public of the danger posed to young children by patches containing the painkiller fentanyl. Young children, largely because of their curiosity, are at high risk of exposure to fentanyl if patches are within their reach. The patches contain a high concentration of a powerful narcotic, and even used patches can retain as much as fifty percent of the drug’s original potency. Improper use of the patch could result in a serious medication error or injury. The FDA’s notice also contains advice for proper storage and disposal of the patches.

Doctors prescribe fentanyl patches to treat chronic pain, of a moderate to severe level, that requires a more regular application of medication than painkillers in pill form would allow. They are available under the brand name Duragesic, or as a generic. The patch, when applied directly to the skin, provides a steady dosage of fentanyl, a very potent opioid narcotic. It is only recommended for patients who have already taken another narcotic pain medication, and therefore have a tolerance to its effects. Patients should only use the patches on their skin, and they are specifically cautioned not to chew on or swallow any part of a patch. Fentanyl patches pose such a great danger to young children in part because children are more likely to put them in their mouths, and because they have not built up any tolerance to narcotic medications.

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.

CEO of Fitness Website Pleads Guilty to Labeling “Drugs” as “Nutritional Supplements”

April 27, 2012 | Lebowitz & Mzhen

The founder and chief executive officer of a popular fitness website, Bodybuilding.com, has pleaded guilty in a federal court in Idaho to five misdemeanor counts arising from products sold through the website that the government alleged were “misbranded drugs.” The products allegedly contained various forms of steroids classified as “drugs” under federal law. Prosecutors sought to hold him liable for allegedly misleading the public about the products’ components.

Ryan DeLuca served as the CEO of Bodybuilder.com between 2007 and 2009. During that time, according to federal prosecutors, the company sold at least five products labeled and marketed as “dietary supplements” that the federal Food, Drug and Cosmetic Act classified as “drugs.” The products, which had names like “I Force Methadrol” and “Rage RV5,” allegedly contained synthetic anabolic steroids or synthetic steroid “clones.” The U.S. Food and Drug Administration (FDA) began investigating the company as early as 2002. It executed a search warrant in September 2009 on the company’s headquarters in Idaho. In November 2009, the company issued a voluntary recall of sixty-five “dietary supplement” products the FDA said should be classified as steroid-containing drugs.

Federal prosecutors charged DeLuca with at least five misdemeanor counts of “introduction of misbranded drugs into interstate commerce.” They alleged that Bodybuilding.com had gross receipts of nearly $1.8 million from the sale of mislabeled product between January and July of 2009. They further alleged that the company’s FDA compliance officer told DeLuca and others in 2009 that certain products violated FDA labeling regulations. Each misdemeanor charge could result in a one-year prison sentence.

DeLuca pleaded guilty to the five counts on April 9, 2012 in a federal court in Boise. He agreed to pay a fine of $500,000, and the government recommended that he receive probation, but no jail time.

Pharmacy Errors and Injuries Can Result From Similar-Sounding Drug Names

April 19, 2012 | Lebowitz & Mzhen

Three medications with similar-sounding names have caused some confusion, and almost caused some serious injuries, in recent months, according to the Philadelphia Inquirer. Two heart medications, Pradaxa and Ranexa, have names that resemble each other and PreNexa, a prenatal vitamin available only by prescription. Medication errors with heart patients or people who are pregnant can have serious short- and long-term consequences, so caution and vigilance are crucial to help patients avoid mix-ups.

Since two of these medications treat heart conditions, mix-ups in pharmacies could be common. Fortunately, that does not currently appear to be the case, but the potential remains for dangerous errors. Any mix-up of these three drugs has the potential for catastrophe, but patients can take a few simple steps to protect themselves. The U.S. Food and Drug Administration generally does not allow drugs used to treat the same or related conditions to have substantially similar or confusing names, but it does happen on occasion. A patient could ask the doctor to include a notation explaining the purpose of the prescription, in order to guide a pharmacist in dispensing the proper medication.

A person filling a prescription also has the ability to discuss the medication with the pharmacist on duty, which is an excellent way to get additional information on the medication and possibly correct errors. If the pharmacist has more information from the patient, the pharmacists can better understand and assist the patient’s needs. A quick conversation with a pharmacist can even reveal, and give an opportunity to correct, errors made in filling the prescription.

A quick review of these three medications can illuminate the risks patients face from drug mix-ups. Pradaxa is an anticoagulant used in patients suffering from atrial fibrillation, a heartbeat irregularity that increases the risk of blood clots. Blood clots can cause stroke and other serious, even life-threatening conditions. Taking the wrong medication leaves the patient at an elevated risk for blood clots. Giving Pradaxa to a patient who does not have atrial fibrillation puts that patient at risk for excessive bleeding and other complications, particularly in people who are pregnant.

Ranexa is an anti-anginal medication that treats chest pain occurring when the heart is not getting sufficient oxygen. Angina sufferers must take the drug on a regular basis for it to have effect, although it cannot cure angina. A person who should be taking Ranexa faces a higher risk of hemorrhaging and bruising if they take Pradexa by mistake.

Pharmaceutical Company Fined $1.1 Billion Over Deceptive Drug Marketing

April 12, 2012 | Lebowitz & Mzhen

An Arkansas judge imposed a $1.1 billion fine on Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals, after a jury found the companies liable for deceptive trade practices and false claims. The state of Arkansas sued the companies, alleging that they presented false and misleading information to doctors and patients about the antipsychotic drug Risperdal. The state attorney general’s office accused the companies of downplaying, hiding, or omitting mention of the risk of certain side effects in off-label uses of the drug. This is one of several verdicts against Janssen and Johnson & Johnson in suits brought by state governments, and more lawsuits are pending in other states.

This case is important to advocates for victims of pharmacy and medication errors because doctors and pharmacists rely on accurate information to perform their professional duties. Incorrect or misleading information endangers patients’ health, and even their lives, particularly when such information may have been deliberately put forth by a drug’s manufacturer.

Risperdal first entered the market in 1994 as a “second-generation” antipsychotic. Johnson & Johnson has earned billions of dollars from sales of the drug, which became available in generic form under the name Risperidone in 2004. The U.S. Food and Drug Administration (FDA) first approved Risperdal for the treatment of schizophrenia in adults. It later approved the drug for use in schizophrenia patients ages 13 to 17, and for bipolar disorder. The drug is sometimes used “off-label” for anxiety disorders and other mental health conditions.

The controversy in the Arkansas lawsuit began in 2003, when Janssen sent a letter to over 6,000 doctors in the state regarding use of Risperdal in elderly dementia patients. The letter allegedly minimized or concealed information regarding the elevated risk of stroke and diabetes for elderly dementia patients using the drug.

The state of Arkansas sued Johnson & Johnson and Janssen in 2007 for violations of state deceptive trade practice laws. It asked the judge to impose the statutory fine of $5,000 for each prescription issued under the marketing campaign, estimating the total number of prescriptions to be more than 250,000.

The judge penalized the companies for almost 239,000 prescriptions that violated the state’s False Claims Act, and for 4,600 letters to doctors violating the Deceptive Trade Practices Act. He imposed fines of $5,000 and $2,500, respectively, for these violations, totalling $1.1 billion.