Pharmacy Error Injury Lawyer Blog

Doctor Groups Advocate for Limits on the Use of Painkillers for Anything Less than Severe Pain

August 16, 2012 | Lebowitz & Mzhen

Several groups of doctors and health care officials are calling on the U.S. Food and Drug Administration (FDA) to modify its guidelines for opioid painkiller prescriptions. The proposed changes would include restrictions on “off-label” uses, meaning uses not explicitly approved by the FDA, and limits on the amount of time a doctor may prescribe a painkiller for a patient. The purpose of the changes would be to counter a growing rate of abuse and addiction to the powerful drugs, which has recently resulted in multiple adverse reactions and medication errors.

Abuse of prescription drugs is now the “fastest growing drug problem” in the U.S., according to the Centers for Disease Control and Prevention (CDC). The CDC says that about 27,000 people died from accidental drug overdoses in the U.S. in 2007, and an increased use, and abuse, of prescription opioid painkillers is responsible for much of that total. The government has already attempted crackdowns on “pill mills” and pharmacies that, they allege, sell painkillers to addicts without medical necessity. This includes widespread investigations of drug wholesalers that move large volumes of painkillers and other controlled medications. The latest recommendations would impact how pharmaceutical companies label and market their drugs, in addition to how doctors prescribe them.

Johns Hopkins Study Recommends Training of Nurse-Pharmacist Teams to Review Patient Drug Regimens, as a Way to Prevent Medication Errors

August 8, 2012 | Lebowitz & Mzhen

Serious complications and injuries can result from discrepancies between the medications patients take at home, the medications they receive in the hospital, and the medications they take home with them. To prevent such medication errors, a recent study out of Johns Hopkins recommends that hospitals train teams of nurses and pharmacists to reconcile patients’ medication lists. Such teams could better ensure that patients receive consistent medications and dosages, at a lower cost to both the hospital and the patient, thus improving overall health and safety for hospital patients.

The Journal of Hospital Medicine published the study, entitled “Nurse-pharmacist collaboration on medication reconciliation prevents potential harm,” in its May/June 2012 issue. The purpose of the study was to test how “medication reconciliation” could help prevent “adverse drug effects” (ADEs). The study involved over five hundred patients at a “1000 bed urban, tertiary care hospital” from January 2008 through March 2009. Nurses would conduct an interview with patients to obtain a home medication list (HML), outlining all medications regularly taken by the patients. Patients often forgot or otherwise omitted some medications during this process, or were unable to remember the name or dosage of a drug. Some patients could only provide a description of the drug’s appearance, and many were not certain what condition a particular drug treated. Discrepancies between the medications a patient was actually taking and those they received during treatment and upon discharge occurred in forty percent of hospital visits, according to the researchers.

Hospital Uses RFID Tags to Keep Track of Emergency Room Drugs

July 26, 2012 | Lebowitz & Mzhen

Hospitals must regularly contend with medical emergencies, such as heart attacks or allergic drug reactions, that require an immediate response. Hospitals maintain supplies for such emergencies, known as “crash carts,” that contain equipment and medications for diagnosing and, if necessary, reviving patients. Monitoring and maintaining the crash carts requires the careful attention of hospital staff. New technologies, however, allow hospitals to track crash cart inventories more efficiently. One Baltimore hospital is using radio-frequency identification (RFID) tags to ensure that crash carts are fully stocked with necessary drugs, and that all of the drugs are up-to-date.

A typical crash cart includes multiple shelves and trays, all of which must be carefully and consistently organized. Each crash cart has a cardiac monitor and defibrillator, equipment for intubating a patient, and other associated materials. The nine trays in each cart at the University of Maryland Medical Center in Baltimore contain a variety of drugs for emergency use. One tray could have anywhere between twenty-five and seventy-five items. Maintaining a supply of available equipment and drugs, and making sure the drugs are not expired, is critically important for patient safety.

Pharmaceutical Company Pleads Guilty to Health Care Fraud, Agrees to Pay Record $3 Billion Penalty

July 19, 2012 | Lebowitz & Mzhen

GlaxoSmithKline (GSK), one of the world’s largest pharmaceutical companies, has entered into a plea agreement with the U.S. Department of Justice (DOJ) over allegations of fraud in marketing certain drugs and of failure to report safety data, according to a DOJ press release. The DOJ had filed a three-count criminal information against GSK for alleged violations of the federal Food, Drug and Cosmetic Act, including alleged promotion of certain drugs for uses not approved by the U.S. Food and Drug Administration (FDA). This is commonly known as “off-label promotion.” As part of its guilty plea, GSK has reportedly agreed to pay a total of $3 billion in penalties and civil settlements, the largest settlement by a pharmaceutical company in history.

According to the DOJ, GSK promoted off-label uses for at least five of its drugs: Advair, Lamictal, Paxil, Wellbutrin, and Zofran. In the case of the antidepressant Paxil, GSK allegedly promoted its use to treat depression in pediatric patients despite a lack of FDA approval for such a use. GSK also allegedly paid kickbacks to doctors for prescribing these five drugs and at least four more: Flovent, Imitrex, Lotroniex, and Valtrex. In regards to the diabetes drug Avandia, the DOJ accused GSK of making false or misleading statements to doctors and the FDA, in part by omitting mention of studies investigating concerns from European officials regarding possible complications certain cardiovascular patients. The DOJ further claimed that GSK reported false “best drug prices,” the lowest price charged to customers. As a result, the company allegedly underpaid rebates that it was required to pay to state Medicaid programs.

Third Circuit Addresses Issue of Standing in “Off-Label” Pharmaceutical Marketing Litigation

July 12, 2012 | Lebowitz & Mzhen

The Third Circuit Court of Appeals affirmed the dismissal of a consolidated putative class action lawsuit against pharmaceutical company and its affiliated marketing companies. A trial court had ruled that plaintiffs lacked standing to sue the defendants over alleged off-label marketing of certain drugs. The plaintiffs were consumers, whose doctors allegedly prescribed the medications for off-label uses; and third-party payors (TPPs), including an insurance company and several unions. In In re: Schering Plough Corp. Intron/Temodar Consumer Class Action, the Court of Appeals ruled that the plaintiffs had not shown a sufficient connection between the defendants’ marketing and the actual prescriptions or the alleged injuries. The case demonstrates not only an aggressive posture by the defendant, but also the difficulty of asserting a class action in drug-related injury cases.

The U.S. Food and Drug Administration (FDA) regulates prescription medications, approving drugs for certain uses and prohibiting advertising for unapproved, or “off-label,” uses. It does not, however, regulate doctors, and therefore has no jurisdiction over how doctors prescribe approved drugs. The defendant, Schering-Plough Corporation (Schering) manufactured several oncology and hepatitis drugs approved by the FDA. A 2001 FDA investigation found that Schering had promoted off-label uses of these drugs. Schering eventually pleaded guilty to one count of conspiracy to make false statements to the government and entered into a settlement agreement, paying a $180 million fine in 2007. It also paid $255 million to settle civil fraud claims with Medicare, Medicaid, and the Veteran’s Administration.

Lawsuits against Schering by consumers and TPPs soon appeared all over the country, claiming that Schering’s misconduct caused doctors to prescribe their drug for off-label, and therefore ineffective, uses. The Judicial Panel on Multi-District Litigation consolidated the cases and moved them to the District of New Jersey. The named plaintiffs filed a consolidated class action in December 2007 alleging violations of federal and state Racketeer Influenced and Corrupt Organizations (RICO) acts, state consumer fraud laws, and various common law claims. The TPPs claimed that they had to pay for both the ineffective prescription and a subsequent effective one, while the consumers claimed injuries and medical expenses. The District Court dismissed the entire suit in July 2009 for lack of standing and failure to state a claim, holding that the complaint did not include enough facts connecting the alleged injuries to the alleged misconduct.

Study Suggests that Electronic Medical Records Can Reduce Error Rates

July 5, 2012 | Lebowitz & Mzhen

Electronic health records (EHRs), used in place of voluminous paper records, may significantly reduce the risk of errors, and therefore medical malpractice claims. This finding is from a study published in the June 25 online edition of the Annals of Internal Medicine. Doctors have been very slow to adopt many newer technologies, including EHRs. Much of the hesitance is driven by concerns over the cost of switching to electronic systems, but also over concerns about how doctors’ ethical duties to their patients. In particular, effectively protecting patients’ privacy while using newer computer technologies remains difficult. The study, while limited in scope, offers support to the idea that use of EHRs may help prevent medication errors and other types of malpractice.

EHRs are a digital version of personal health records. In addition to personal identifying information like date of birth, they may include dates of treatment, results of tests, dates and descriptions of surgeries and illnesses, prescription medication history, and family medical history. Under state and federal privacy laws, this information is highly confidential, with severe penalties for medical professionals who breach privacy. EHRs offer the benefit of making comprehensive information easily accessible to a treating physician. Sophisticated systems may even alert a doctor or pharmacist of potential drug interactions with a new prescription. The downside, of course, is that a patient’s entire medical profile may be vulnerable to theft, or may be compromised by data or equipment failures.

Study Finds Use of Interpreters in Hospital Emergency Departments Reduces Medication Errors Almost by Half

June 28, 2012 | Lebowitz & Mzhen

A study published recently in the Annals of Emergency Medicine looked at whether the use of a trained, professional interpreter with limited-English or non-English-speaking patients in hospital emergency departments (ED’s) reduced the incidence of medication errors and other mistakes. The study compared situations in which a trained interpreter was present with situations with an amateur translator and situations with no interpreter. Patients who had the assistance of professional interpreters suffered a far lower rate of risky translation errors, particularly errors related to medication dosages. The findings could provide a helpful model for hospitals seeking to reduce pharmacy misfills due to language barriers, and also for other communication barriers like hearing impairment.

The researchers conducted a “cross-sectional error analysis” of ED visits captured on audiotape over the course of thirty months. The visits occurred at two Massachusetts pediatric ED’s. They reviewed fifty-seven meetings between doctors or other medical professionals and Spanish-speaking patients and caregivers with limited English proficiency. Twenty of the visits utilized professional interpreters, and twenty-seven had “ad hoc interpreters.” The remaining ten visits occurred with no interpreters.

In reviewing the fifty-seven meetings, the researchers counted nearly two thousand translation errors. Eighteen percent of those errors had the potential to affect the patient’s treatment. The percentage of potentially harmful errors, when broken down among the three types of meetings, revealed that meetings with professional interpreters had just over half the rate of errors as the other meetings. While twelve percent of the translation errors in visits with professional interpreters were potentially harmful, the rate for visits with amateur translators was twenty-two percent. The rate for visits with no interpreter was twenty percent. Interestingly, the visits with no interpreter at all had a lower error rate than those with an ad hoc translator.

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.