Patient Safety

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.”

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.

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:

Veterans Hospital Paves the Way for Computerized Records

October 30, 2009 | Lebowitz & Mzhen

In a post from earlier this year, our attorneys at Lebowitz & Mzhen Personal Injury Lawyers discussed how computerized health records would help Maryland pharmacists and doctors to eliminate Maryland medication mistakes.

According to a recent article in the Wall Street Journal, on how to digitize the health-care industry, Veterans hospitals have proven to have paved the way——showing doctors and pharmacists important lessons on how to effectively make the digital transformation.

The U.S. Department of Veterans Affairs digitized their records years ago, with great results. Independent studies show that the VA outperformed the private sector and Medicare on preventative services and chronic care. VA officials have claimed that the digital technology has helped cut down on patient hospitalizations and has helped patients live longer.

The VA’s digital records system has been a blessing to patients, allowing doctors and nurses at more than 1,400 facilities to share the medical history of the patients—avoiding the unnecessary repetition of costly tests. As well as storing patient data, the system gives screening warnings and keeps an eye on patient levels, like blood pressure and weight—all safeguards for improved quality care.

In a digitized record for a 59-year old Maryland patient at the VA medical center, all of his health problems were listed, like diabetes and hypertension, as well as all of his data since he has been a patient at the center. The screen showed a list of all current medications, including insulin, the drug Furosemide for heart failure, and Oxycodone, the pain medication. The patient’s doctor can reorder a drug through the system, sent directly to the pharmacy—eliminating medication mistakes and pharmacy misfills. If the doctor orders a new prescription that conflicts with a drug the patient is already taking, there is a warning in the system.

Medication Error Injury Prevention—Study Recommends Knowing Your Pharmacist

October 26, 2009 | Lebowitz & Mzhen

A recent American Pharmacists Association (APhA) survey, that our Maryland Pharmacy Error Injury Attorneys have been following, revealed that 1.5 million people are injured by medication-related errors every year. The APhA commissioned the consumer survey, led by Harris Interactive, to investigate how consumers interact with their pharmacists, and how building relationships with pharmacists can avoid patient error and reduce medication mistakes and pharmacy misfills.

The APhA always recommends that people carry an updated list of their current prescription medications, over-the-counter (OTC) drugs, herbal supplements and vitamins. The list should include the name of the medications, the dosage, as well as the conditions that the medications treat. Any patient allergies should also be included in the list.

The study reports that while a large percentage of Americans have an up-to-date list of medications, only 28% of consumers actually carry the list with them at all times—an act that could prevent personal injury and medication mistakes, by providing emergency personnel and pharmacists with lifesaving information regarding drug names, proper dosing, allergy information, and drug interactions and side effects.

According to Kristen Binaso, pharmacist and national APhA spokesperson, until electronic medical records are used as the standard in sharing patient information in the health care industry, consumers should protect themselves by keeping a current medication list with them at all times, to show the doctor and pharmacist—to avoid the risk of improper dosing, medication duplication, pharmacy misfill, and harmful drug side effects and interactions. In a recent post, our Maryland Mistake Attorneys further discussed how these electronic health records will help pharmacists and doctors to eliminate medication errors.

Next to doctors, pharmacists are the second most trusted health care providers and trained medication experts, yet the survey found that 77% of consumers do not know their pharmacists names, and only 40% of consumers have asked their pharmacists valuable questions about their medication needs.

ISMP Medication Error Cases and Prevention Checklist

October 9, 2009 | Lebowitz & Mzhen

In a prior post from this week concerning pharmacy error injury, our Maryland Medication Error Attorneys at Lebowitz & Mzhen Personal Injury Lawyers discussed a recent study published by the Institute of Medication Practices (ISMP), and the ongoing problem with drug naming standards in extended release medications.

In this study, the ISMP revealed a series of cases reported to the institute, in which drug name suffix medication mistakes have frequently occurred. This study showed specific case examples in order to establish clearer naming conventions in the industry, and improve comprehensive pharmacist and patient awareness—to prevent pharmacy error injury and misfills in the future.

The ISMP study reported these specific medication mistake cases:

• Physicians often prescribe extended release products without the correct suffix, or with a suffix that does not exist for that particular product.

• In an analysis of 402 prescribing errors published by Medscape Pharmacists, the most common type of error in the study (280 cases, 69.7%) was failure to specify the controlled release formulation.

• The ISMP received reports of cases in which pharmacists dispensed Metadate ER instead of Metadate CD—two different extended release forms of methylphenidate-UCB, a stimulant medicine commonly used to treat ADHD. In one case, a prescription for Metadate CD 20 mg was misfiled at a pharmacy, where the staff dispensed Metadate ER 20 mg.

• Some products have multiple suffixes for different formulations of the same drug. Diltiazem products for example (calcium channel blockers) are used to slow the heart rate and normalize the heart rhythm in hypertension and arrhythmia. The many suffixes for Diltiazem include SR, CD, XR, XT, and LA.

• Electronic prescribing can also lead to medication errors on behalf of the prescriber. In one case, a prescriber electronically selected metroprolol tartrate instead of metoprolol succinate because of choosing incorrectly on his PDA.

According to this report, pharmacists, practitioners, and patients should take extra care when reviewing the different formulations and medication names, especially if the medication is available in more than one dosage form.

The ISMP recommends the following medication error prevention checklist:

Patient Safety Alert: ISMP Reports Medication Error with Drug Name Suffixes

October 6, 2009 | Lebowitz & Mzhen

As Maryland Medication Error Attorneys, we have been following a recent study published by the Institute of Safe Medication Practices (ISMP), about the lack of prescription drug naming standards in extended release medications that lead to pharmacy error injury.

According to the study, although extended release drug formulations provide multiple benefits for many patients, the titles used for many medications are often confusing, and can cause patient error when the same drug is presented with several different oral dosage forms in the suffix.

Extended release drug formulations play an important role in maintaining consistent prescription therapies, by preventing the need for patients to remember to repeat dosages—delivering a steady dose of the medication throughout a specific period of time. The difficulty with many of these medications comes in the name. According to the study, drug manufacturers add suffixes or modifiers to already well-known medication names, to keep awareness of the brand, yet differentiate between the immediate-release counterparts. For example: Wellbutrin SR is a sustained release anti-depressant, whereas Wellbutrin XL is the extended-release version. Same name, different release rate.

Maryland Law Encourages Maryland Doctors to Computerize Patient Records

May 27, 2009 | Lebowitz & Mzhen

In prior posts concerning Maryland medication mistakes, the attorneys at Lebowitz & Mzhen Personal Injury Lawyers have discussed how computerized health records help doctors and pharmacists eliminate medication errors.

Today, Governor Martin O’Malley, signed a bill that is designed to increase the speed with which Maryland doctors implement electronic patient records. The new law hopes to reduce the high costs that doctors must pay to implement electronic patient records systems by requiring private insurance companies to give physicians financial incentives to implement electronic patient records. Under the law, after a doctor implements a computerized records system, insurance companies may offer the doctor increased reimbursements for procedures they perform, a lump sum payment, or some other monetary advance. Additionally, under the new law, the state will fine physicians who have not adopted a computerized records system by 2015.

Since 2003, Maryland has been on the cutting edge of the movement towards computerized patient records. In that year, The Montgomery County Health Information Exchange Collaborative began a pilot program that linked community hospitals, the county’s health department, and area health clinics. The link allowed participating health care providers to easily access patient records.

The program developers believed that their medical information network would have the greatest impact on the county’s poorer citizens and those without health insurance. These individuals generally receive care in a number of different locations, and often times, the facilities do not share vital patient information. The link allowed the facilities to share patient information and reduce the risk of medication errors.

Maryland medication mistake attorneys will review the impact this law has on patient safety, and the state’s progress towards completely computerized patient records.

Patient Safety Alert: Medication Mistakes with Injected Medicines Are Frequent

April 28, 2009 | Lebowitz & Mzhen

According to researchers, the results of a recent international study demonstrate that patients receiving injected medicines are at a higher risk of medication mistakes. Researchers determined that oral or written miscommunication were the root cause of 24% of all errors, and that health care workers confused drug names in 18% of the cases.

Researchers in the study observed patients in Intensive Care Units in 27 countries, including two in the United States, and found that 20% of patients experienced at least one error and 14% experienced more than one injected medication mistake. Fifteen errors caused either permanent injury or death of the patient involved.

Overall, researchers concluded that patients with more serious illness were at a higher risk for injuries caused by these mistakes. Maryland medication mistake attorneys believe that the results of this research demonstrate the importance of patients having a family member act as their advocate during an extended hospital stay. In addition to questioning doctors, the advocate should pay particular attention to the medications prescribed to the patient and attempt to make sure that health care workers administer the medications at the proper times and in proper dosages.