Takeda Pharmaceuticals Approve Actos Settlement Agreement

Takeda Pharmaceuticals executives have reached agreement with a committee of negotiating plaintiffs’ counsel on an approximately $2.4 billion settlement to resolve well over 8,000 lawsuits filed against the company for failing to disclose bladder cancer risks present in the diabetes drug Actos. Many of the lawsuits are part of the Louisiana Multi-District Litigation (MDL).

The “Actos Resolution Program” will pay an average of $287,000 per bladder cancer case where the plaintiff first used Actos prior to December 1, 2011. Actos clients can also opt to forgo the settlement and take their case to court seeking larger damages.

In order for the Actos Settlement to take effect, at least 95% of the current plaintiffs must accept the settlement terms. This would result in Takeka paying $2.37 billion as the total settlement payment. However, if the percent increases to 97% then Takeda’s payment obligation will increase to $2.4 billion. Additional costs could raise Tadeka’s settlement expenses to $2.7 billion.

In April 2014, a Louisiana jury awarded $9 billion in punitive damages and $1.5 million in compensatory damages from Takeda Pharmaceuticals and Eli Lilly & Co., their marketing partner, in a single case. That award was later reduced to $36.8 million by the judge.

Tadeka’s Actos settlement was first reported on April 1, 2015 by Bloomberg in the amount of $2.2 billion. However, plaintiffs’ lawyers rebuked that offer and felt their clients were entitled to more compensation from the drug manufacturer.

Documentation for the Actos settlement agreement including the Master Settlement Agreement dated April 28, 2015 is available at the official Actos settlement website.

Source: Louisiana MDL Website

Medication Errors Common after Hospital Discharge

A new study indicates that over half of heart patients made medication errors or misunderstood instructions given to them about their medications after being discharged from hospital stays. The study highlighted the importance of medical professionals giving clear, easy-to-understand instructions. It also indicated that “health literacy” in general decreased the likelihood of risky medication errors.

This study is another indication that a person’s ability to interpret and act on health information strongly determines if a patient will correctly follow medication and care instructions. According to the CDC, a large percentage of the population does not have this health literacy. Around 20-30% of prescriptions are never filled, and over 50% of prescriptions are not finished or taken as prescribed. This indicates that medication errors by the heart patients in the study may be part of a greater trend of medication errors after hospital stays.

Factors That Influence Whether or Not a Patient Follows Care Instructions

Dr. Amanda Mixon and her team assessed 471 people hospitalized for heart failure, heart attacks, and related heart conditions in this study to determine which factors may influence a person’s likelihood of making a medication error. The study participants had an average age of 59 and almost half were women. The participants were given a health literacy test to gauge their understanding of health information and a numeracy test to measure basic math skills. Then doctors followed up with patients after discharging them from the hospital to see how well the patients followed medication instructions.

Over half the patients in the study made medication errors or misunderstood instructions given by doctors. One-fourth of patients left out one or more prescribed medications and more than a third were taking something that they were not supposed to take. Fifty-nine percent of the patients in the study misunderstood the purpose, dosage, or frequency of their medications.

The results did reveal some patterns in which patients were more likely to make errors. Patients scoring highest on the math skills test were 23% less likely to add or omit medications than low-scoring patients. Patients with the highest health literacy scores were about 16% less likely to make any medication errors. In general, people with lower cognitive function were more prone to medication errors.

Demographics had an influence on the study as well. Women were about 40% less likely to make a mistake than men were. Interestingly, single people of all ages were about 70% more likely to make a medication error than married people were. However, older people were increasingly more prone to medication errors.

The doctors involved in the study suggest that a screening tool could be helpful to determine which patients may be more likely to make medication errors. This would allow doctors to give added care to those who need it. Until something like a screening test can be comprehensively administered, doctors need to make sure to keep in mind patients that may need more information about medications, in order to fulfill their duty of care.



Inconsistency of Prescription Labels Risks Medication Errors

Medication errors cause thousands of deaths in the United States every year. A recent study by the University of Waterloo and the Canadian National Institute for the Blind determined that many of these errors are caused by illegible labeling.

Many factors can affect the legibility of a drug label from a pharmacy. Fonts that are too small, overly crowded instructions, and inconsistencies in the location of information on prescription drug labels can all cause confusion for patients. Elderly adults, who are already susceptible to medication errors, have the most trouble with these details.

According to the study, very few labels actually followed the professionally recommended guidelines for legibility of prescription labels recommended by the following:

  • The US Pharmacopeia
  • The American Society for Consultant Pharmacists
  • The National Patient Safety Agency in the UK
  • The American Foundation for the Blind
  • The Canadian National Institute for the Blind
  • The Royal National Institute of Blind People in the UK
  • The American Council of the Blind

The following discrepancies affected the legibility of the labels in the study:

  • Only 44% of the medication instructions used 12-point font size, the minimum accepted print size for optimal legibility.
  • Not a single drug or patient name on labels in the study met the minimum 12-point font standard.
  • 95% of the labels were judged to have overly crowded information, making it difficult to read important information, especially for those with diminished eyesight.
  • Just 51% of the labels used left alignment, which is recommended for legibility.
  • The instructions were given in complete sentences, making it difficult for patients to interpret.
  • There was a lack of consistency of the location of different types of information.
  • Every label in the study fell short of legibility recommendations in some way.

Improving Prescription Legibility

In order to study the legibility of labels currently used by pharmacies, researchers in the Waterloo study had 45 Canadian pharmacies in Kitchener, Waterloo, and Cambridge print a sample prescription label with the patient’s name, drug name, and instructions. They then compared the labels to each other and to label printing recommendations from pharmaceutical and health organizations and non-governmental organizations for ideal readability.

The researchers determined not only that recommendations were being ignored, but also that there were very few requirements for legibility and readability being handed down to individual pharmacies. In order to rectify this problem, researchers have proposed new guidelines and regulations for label size, font size and color, sentence alignment, and highlighting.

The researchers next plan to create a prototype for a uniform label and test it on both patients and pharmacists to try to improve legibility standards. “We expect that addressing these factors together will improve the accessibility of prescription labels. We need to move from a pharmacy-centered labeling standard, to a patient-centered one,” said Carlos H. Rojas-Fernandez, Professor at Waterloo’s School of Pharmacy and researcher on this study. In the meantime, patients need to be aware of this lack of clarity and make sure to read prescription bottles especially carefully.




FedEx Indicted for Delivering Illegal Drugs to Addicts

A federal grand jury in San Francisco has indicted FedEx Corporation, FedEx Express, Inc., and FedEx Corporate Services, Inc. with conspiracies to traffic controlled substances and misbranded prescription drugs for its role in delivering prescription pain pills, sedatives, anti-anxiety drugs, and other controlled substances from illegal Internet pharmacies. The 15-count indictment from the U.S. Department of Justice (DOJ) essentially charges the company as a drug dealer who facilitates procurement of illegal drugs without proper prescriptions by addicts.

If FedEx is convicted, the company could face penalties of $1.6 billion. FedEx has denied any culpability and has vowed not only to plead not guilty, but also to refuse to settle with the regulators. It further states that any investigation into these accusations before the indictment would have violated the company’s policy of not opening any packages it handles, thus giving FedEx deniability. However, the company did state in an SEC filing that if it is found guilty, the penalties could be “material” to its finances.

Regulators Accuse FedEx of Conspiring with Illegal Drug Companies

According to the indictment, FedEx delivered illegal drugs for over five years, even after being informed that the company may be in violation of the Controlled Substances Act, the Food, Drug and Cosmetic Act, and numerous state laws by both the Food and Drug Administration and the DOJ. Despite this knowledge, FedEx allegedly continued business as usual, even making it easier for illegal pharmacies to evade prosecution by the Drug Enforcement Agency (DEA).

Documentation indicates that in order to avoid losing shipping business as pharmacies constantly changed shipping companies and locations to avoid detection by the DEA, FedEx created a sales policy under which all online pharmacies were assigned to a catchall goods classification. This gave the companies more privacy and hid the identities of the drug providers.

Furthermore, FedEx is accused of willfully ignoring signs that deliveries were being made to addicts and dealers trying to conceal their identities. Many drivers of the company reported concerns that delivery addresses for these companies were sometimes parking lots and other abandoned locations. Moreover, some drivers reported being stopped on delivery routes by customers desperately demanding packages of pills. Senior management dismissed these concerns.

Even when a major customer of Fedex was indicted for selling illegal drugs, the company continued to deliver packages for its successor. The indictment further alleges that FedEx’s accounts from online pharmacies tripled to more than 600 during the five-year period, majorly contributing to the growing problem of counterfeit drugs entering the United States.

Although it remains to be seen if these charges will stick, the implications of such an aggressive lawsuit could be serious for other actors in the industry. Its competitor UPS has already settled similar charges, and it is possible that similar indictments will be handed down to other companies. What is clear, however, is that United States regulators will be investigating illegal Internet pharmacies more aggressively in the future. Perhaps some of the next targets of these probes will be buyers of the illegal drugs. In this case, consumers using these websites should be even more aware of the risks.



Changes in the Appearances of Pills Can Cause Lapses

Over the last ten years, generic drugs have become increasingly popular due to the savings to consumers and insurance companies. These efforts to keep healthcare costs low have saved people in the United States $1.2 trillion in that time.

Many doctors, insurance companies, and even patients switch to the cheapest generic version of a drug as soon as it becomes available. After all, the medicine is essentially the same, only perhaps with a new appearance. When patients go to pick up a refill of a prescription, they may be surprised to find that the pills are a different shape or color than they received before.

According to a recent study by prescription drug researchers from Boston’s Brigham and Women’s Hospital, this may be a problem. Research suggests that changes in a particular medication’s color or shape can cause many patients to discontinue necessary medication without notice.

Why Changes in the Appearances of Pills Can Cause Problems

Because of the way that pharmacies negotiate with drug manufacturers in order to get the best price, they may dispense one generic manufacturer’s drug one month and refill it later with the same drug made by a different manufacturer. These pills will be effective for patients even though the medication may have a different size, shape, color, and formulation. These changes should not affect the treatment of any patient or disrupt recovery in any way.

However, patients are often not told what to expect from these new pills. Even if a pharmacist may mention that the pill looks different, some patients do not trust the medication because it looks different. These patients may lose confidence in the medicine’s safety or effectiveness. Often patients suspect that there is a problem. Some patients will stop taking the pills until they can ask their doctor about the change. Others stop taking the drug entirely.

Some patients may not intend to make medication errors, but are confused by the new look of the medication. Many patients who take multiple pills daily have a difficult time keeping a medication schedule straight. Any change can disrupt a patient’s habits. These patients may forget the new pill, confuse it with another pill, or even accidentally double up on one medication.

These are serious problems, since many of the patients who are the most easily confused by the new look of a pill are those who most require the medication to live. The authors of the study have encouraged the FDA to rethink its hands-off policy on regulating the appearance of generic drugs and to require similar appearances for equivalent medications. Medication errors cause thousands of death in the U.S. every year. This change in regulations can help patients avoid errors.