Pharmacy Error Injury Lawyer Blog

FDA Pressures Johnson & Johnson for Broad Recall of OTC Drugs

January 25, 2010 | Lebowitz & Mzhen

Johnson & Johnson (J&J) has recently recalled certain lots of Tylenol, Rolaids, Benadryl and Motrin, after consulting with the U.S. Food and Drug Administration (FDA). McNeil Consumer Healthcare, the J&J subsidiary that sells the drugs, is voluntarily recalling the lots of the Over-The-Counter (OTC) products, in an effort to maintain the health and safety of the consumer and to prevent OTC medication errors.

The company has recalled these drugs based on consumer complaints of an unusual, moldy, musty smell that reportedly caused nausea, vomiting, diarrhea and gastrointestinal pain. The smell was found to be caused by trace amounts of the chemical 2, 4, 6-tribromoanisole (TBA)—a chemical often applied to wood pallets that are used in the transportation and storage of the materials used for product packaging.

The FDA has criticized J&J for not reacting quickly enough to customer complaints, and for failing to fix the problem, a problem that has been familiar to J&J. Customers have reportedly been complaining since 2008 about their pills having a mildew-like odor. In December of 2009, Tylenol Arthritis Pain medication was also recalled related this same issue.

According to the FDA, J&J and McNeil did not conduct a quick and comprehensive investigation into the problem, and failed to provide high quality products to consumers—responsibly protecting them from personal injury or illness. Many consumer complaints were received as early as 2008 and 2009, and the test results indicating TBA contamination were not shared with the FDA until after an inspection.

Dangerous Error-Prone Prescription Abbreviations

January 20, 2010 | Lebowitz & Mzhen

As Maryland Pharmacy Error Attorneys, we have been following a recent report by The Institute for Safe Medication Practices (ISMP) about the danger of error-prone abbreviations and when it comes to writing a prescription—the fact that some shortcuts don’t save time, and can result in pharmacy error or injury.

According to the ISMP Error Alert article, nearly everyone in the healthcare industry uses shortcuts, like abbreviations and symbols, in an effort to save time when handwriting specifics for the prescription—including phrases, units of measure and words. Some shortcuts can in the end can be very time consuming, as they need to be checked and verified for accuracy on the receiving end. These verifications could also reportedly cause a greater chance for medication error than if the prescription was written out without abbreviations or symbols. The article claims that it is important to prevent future misunderstandings now, instead of waiting until medical abbreviations, dose designations or symbols lead to a patient injury.

The article lists a few common error-prone abbreviations, symbols and dosage misunderstandings that take more time for the pharmacist to check, and could cause medication mistakes:

• Some abbreviations that indicate the frequency of when to take the drug, can be difficult to understand, and can lead to error. In one prescription for “Penicillin VK 500 mg Q1D X 7D,” the physician accidentally typed “Q1D” (once a day) instead of “QID” (four times a day). The pharmacist realized the mistake, and that the patient was supposed to be taking the penicillin four times a day for seven days (7D). Another example of frequent error comes in the abbreviation for “D” (days), where it can also be mistaken for “doses.”

Local Pharmacy Mistake Kills 21 Polo Horses

December 31, 2009 | Lebowitz & Mzhen

In a widely publicized pharmacy error from earlier this year that our Maryland Pharmacy Error Injury Lawyers followed, 21 elite horses tragically died after a pharmacy incorrectly prepared the medication given to the horses.

According to reports, 21 of the 25 horses of the Venezuelan polo team were allegedly given an a drug mixed to replicate the name-brand supplement Biodyl—a concoction of vitamins and minerals often used to treat muscle fatigue in horses. Biodyl is reportedly used safely around the world, but hasn’t been approved by the U.S. Food and Drug Administration for this country.

The drug concoction was prepared by Franck’s Pharmacy Compounding Lab in Ocala, and the mixture allegedly contained a strength of an ingredient that was incorrect—making the horses sick and causing their tragic death at the International Polo Club of Palm Beach in Wellington, Florida. Only the horses treated with the medication mistake became sick and died within hours of treatment, after collapsing, as they were unloaded from their trailers where they were scheduled to play in the U.S. Polo Open.

Fox News reported that veterinarians commonly turn to compounding pharmacies for medications that aren’t readily available on pharmacy shelves. The Lechuza polo team said in a statement that a Florida-based veterinarian wrote a prescription for the pharmacy to create a compound similar to Biodyl, after using the manufactured version of the drug for many years without problems.

Steps for Preventing Prescription Errors in Pharmacies

December 29, 2009 | Lebowitz & Mzhen

In a related blog from yesterday, our Maryland Pharmacy Misfill Lawyers discussed a recent article from USA Today, where the step-by-step process of how a prescription is filled was followed in two pharmacies—to uncover how pharmacy mistakes are taking place, and how to prevent them in the future.

The article revealed how the possible errors are made and also discussed what steps pharmacies are making to try and prevent these errors, and reduce the number of pharmacy mistakes and patient injuries that could happen in the future.

Pharmacies are trying to prevent errors by:

• Encouraging improved communications between doctors and pharmacies.

• Encouraging doctors to write the prescriptions in full length, instead of using medical codes or abbreviations.

• Trying to transition from prescriptions that are handwritten to electronic prescribing—where a doctor sends the prescription directly from the doctors’ offices to the pharmacy computers.

• Computers are being used to aid the prescribing process, with more alerts for drug interactions, allergies, or patient’s illnesses.

• Other computer safety features include popup boxes when a technician enters or confuses a drug name with similarly named drug. After the popup appears, the technician has to initial the box to show he checked the drug.

Understanding the Prescription Drug’s Path through a Pharmacy can Reduce Error

December 28, 2009 | Lebowitz & Mzhen

In a recent study that our Maryland Pharmacy Error Attorneys have been following, USA Today investigated every step of a prescription’s path in a pharmacy—to uncover the potential for medication mistakes with each step of the filling process, that can lead to patient injury or wrongful death.

In the research, USA Today interviewed pharmacy experts and toured two pharmacies, a CVS and Walgreens, to study the six steps of the prescription filling process, and the potential errors that can happen along the way, as well as real cases that have caused actual injuries or death.

Step 1: Prescription received

When the customer drops off the prescription to the technician, or the doctor’s office calls in the prescription, errors can occur if a technician misunderstands a doctor’s handwriting, prescription codes and abbreviations or misunderstands the oral instructions over the phone. In one case, a doctor’s prescription for methadone read “sig 4 tablet BID for chronic pain,” which means “Please label (sig) this drug to say: take 4 tablets twice per day (BID) for chronic pain. The technician typed, “Take 4 tables by mouth as needed for chronic pain.” The patient allegedly died of an overdose of methadone.

Step 2: Prescription entry
A technician then scans the original prescription into the computer and manually enters the patient’s personal data, like name, address, date of birth and phone number, as well as drug information, strength, dosage instructions and quantity. If a technician incorrectly types the prescribed drug dosage, formulation or the patient’s medical condition, history or allergies into the computer, then serious errors can occur, including personal injury. Also if the wrong drug code is chosen in the computer system, it can be mistaken for a similarly named drug. In one instance, a pharmacy was asked to fill a prescription for compazine, an anti-nausea drug, (COM) and accidentally gave the patient a generic substitute for coumadin, a blood thinner (COU).

Pharmacy Mistake Leads to Wrongful Death—Rite Aid Faces Lawsuit

December 22, 2009 | Lebowitz & Mzhen

Our Maryland Pharmacy Error Injury Lawyers have been following the recent case filed last week on behalf of John Sheridan, a man who died after being prescribed the wrong dosage of a cancer medication.

According to the suit, Sheridan was prescribed Temodar, a powerful drug for brain tumors that was part of his treatment of cancer in September 2007. The prescription was allegedly written incorrectly, and Sheridan was wrongly prescribed 10 times the correct dosage—he reportedly took the medicine daily when it was only to be used every other week. Rite Aid Pharmacy allegedly dispensed the drug to Sheridan, without checking with Sheridan’s oncologist for a second opinion to clarify the prescription mistake.

The lawsuit accuses a Rite Aid pharmacy for contributing in the wrongful death of Sheridan, who reportedly had consumed toxic doses of the cancer medication. According to the Associated Press, the doctor who wrote the incorrect prescription has settled with Sheridan’s estate.

According to a 2006 report from the Institute of Medicine, at least 1.5 million Americans are injured by medication mistakes every year, and nearly 7,000 people die every year from medication errors annually.

Childrens’ Doses of Swine Flu Vaccine Recalled in Maryland

December 17, 2009 | Lebowitz & Mzhen

In Maryland news this week, our medical mistake lawyers have been following the recall announcement by Sanofi-Aventis, the vaccine manufacturer of 800,000 doses of H1N1 vaccine for children under the age of three. According to the Washington Post, the flu vaccine has lost potency after being shipped from the factory, and doses are being recalled in Maryland and nationwide.

The recall dosages are single-dose pre-filled syringes containing the vaccine specifically created for children ages 6 to 35 months. It is a voluntary, nationwide recall by Sanofi Pasteur.

During testing at the time of the vaccine’s manufacture, the doses contained 7.5 micrograms of antigen, the recommended dosage used to stimulate immunity in children. But later testing showed degradation of the vaccine, making it less potent than desired. This proved to be the case with four lots of the vaccine, totaling 800,000 doses.

According to the Centers for Disease Control Prevention (CDC), this recall is part of a routine quality assurance program and is non-safety related. Children who received the vaccine do not need to be re-immunized, but with future immunizations, children should be given the proper vaccination dosage. With children who have only received one vaccine dose, they should get the get their scheduled second dose.

QJM: How to Prevent Medication Errors and Injury with Balanced Prescribing

November 30, 2009 | Lebowitz & Mzhen

As Maryland Medication Mistake Attorneys we have recently read an article published in the QJM, the long-established leading general medical journal, on the topic of medication errors—giving an overview of what medication mistakes are, how they happen, and how to prevent them from happening in the future.

According to the article, published in August 2009, a medication error is a failure in the process of treatment that can lead to the harming or personal injury of a patient. Medication errors can often occur in:

• Prescribing faults: ineffective prescribing, irrational or inappropriate prescribing, under-prescribing and over-prescribing when deciding which treatment and dosage plan to take.

• Prescription writing: illegibility
• Formulation manufacturing: incorrect strength, misleading packaging
• Drug formulation dispensing: incorrect drug, formulation and label
• Administering the medicine: incorrect dosage, wrong directions for frequency, invalid duration of treatment
• Monitoring drug therapy treatment and drug treatment alteration when required

Medication errors can be classified, according to the article, by the use of psychological error classifications—knowledge-errors, rule-errors, action-errors, and memory-based errors. It is important to detect the medication mistakes, that can range from trivial to serious, and to create a working environment that is free of blame, and encourages the reporting of errors.

The article also recommends, “balanced prescribing” to avoid medication errors. In balanced prescribing, the mechanism of action of the drug should complement the pathophysiology of the disease—optimizing the balance of benefit to harm.

Walgreen’s Pharmacy Misfill—Child Given Heart Medication Instead of H1N1 Antiviral Drug

November 27, 2009 | Lebowitz & Mzhen

Our Pharmacy Misfill Attorneys in Maryland have been following the recent news of a dangerous medication mistake made by a Walgreen’s pharmacy, where a child was given heart medication instead of an antiviral drug to treat the H1N1 flu virus.

When Wilma O’Neill picked up the prescription for her daughter earlier this month, she expected to administer an antiviral medication to help her child’s swine flu symptoms. Over the next 24 hours, O’Neill gave her daughter two doses of the Walgreen’s prescription, and only stopped the medication after the drugstore called, claiming that there had been a pharmacy medication mistake, and someone had received the wrong prescription.

O’Neill brought the prescription back to the pharmacy, where they discovered that her daughter had been given the liquid pediatric medication Amiodarone by mistake—a drug used to treat irregular rapid heartbeats. According to Medline Plus, the U.S. National Library of Medicine on-line service, Amiodarone is used to treat and prevent life-threatening abnormal heart rhythms by relaxing overactive heart muscles, and is used only when other medications are not tolerated. The first few doses should reportedly be administered in a hospital setting, as the medication could cause fatal side effects. The child had been given two times the normal dosage of the actual heart medication, which could have resulted in pharmacy error injury.

O’Neill’s daughter was raced to the emergency room, and monitored carefully. Her EKG was initially normal, and then irregular a day later. O’Neill believes that had the mistake not been realized, the outcome could have been much worse, as her daughter was also very sick with the H1N1 virus.

Walgreen’s acknowledged the mistake and apologized for the error. The company didn’t disclose how the error was discovered, but claimed to have numerous safety checks in place in the drugstore to reduce the possibility of human error. In 2007, Walgreen’s was profiled in a the news program “20/20” for making prescription drug errors, after a child was mistakenly given an adult blood-pressure drug by the pharmacy. The child was rushed to the emergency room after weeks of taking the medicine with delirium symptoms and shaking limbs.

Alert for Public Safety—FDA Reports Medication Error with Tamiflu

November 18, 2009 | Lebowitz & Mzhen

The FDA has recently published a patient safety alert, reporting medication dosage errors associated with Tamiflu, (for oral suspension), the top doctor prescribed anti-viral flu medication, administered to both adults and children. Our Maryland Pharmacy Misfill Injury Attorneys have been following this prescriber and pharmacy alert report, and how it could effect patient safety in this current H1N1 influenza pandemic.

According to the agency alert, the FDA has received reports that the Tamiflu (oral suspension) dosing instructions for the patient do not match the dosing dispenser. U.S. health providers often write liquid medicine prescriptions in teaspoons or milliliters (mL), while the dosage of Tamiflu is in milligrams (mg). Prescribers and pharmacists have been warned that Tamiflu’s dosing dispenser included in the package has markings only in mg—30, 45, and 60.

The alert recommends that: