July 23, 2014

New Indian App May Decrease Prescription Errors By Increasing Legibility and Decreasing Translation Errors

by Lebowitz & Mzhen

It seems that there really is an app for everything. In a recent article by DNA India, a new app is on the market targeted towards Indian physicians. The app, called Safe RX, is a way for doctors to put in prescriptions for patients that ensure the prescriptions are legible. In addition, the app automatically can translate the prescription into 14 different languages, further decreasing any chance of confusion.

With the incidents of prescription error at an all-time high, apps like this one aim to fill a gap where oversight is minimal.

In addition to the safety aspects of the app, it will also automatically recommend generic equivalent for brand name prescriptions. This should help to keep medical costs down for people without insurance.

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July 16, 2014

Prescription Error Causes Man to Permanently Lose His Sight

by Lebowitz & Mzhen

Earlier this year in June, a Texas man filed a lawsuit against a CVS Pharmacy alleging that the pharmacy’s error caused him to permanently lose sight in one of his eyes. According to a report by a local news source, the man was given a prescription for eye drops to treat his pink eye back in 2012. When the man took the prescription to his local CVS Pharmacy, the prescription was filled with an ear medication with a similar name.

When the man took the medication home and put it in his eye, as the label on the box instructed, his eye became painful and irritated. Eventually, he completely lost sight in that eye. The box containing the drops clearly labeled the drug as ear medication. However, the pharmacist's label instructed the man to apply three drops of the medication in each eye twice daily.

The man’s caregiver told reporters that the loss of his sight has caused the man’s overall condition to deteriorate rapidly, requiring that he have nearly constant supervision. Texas state law limits the man’s potential recovery amount to $250,000.

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July 9, 2014

Baby Given Adult-Strength Painkillers in Pharmacy Error

by Lebowitz & Mzhen

In a frightening story out of North Houston earlier this month, an eight month old child was given painkillers instead of cold medicine by a local pharmacy. According to a report by a local news source, the child’s parents took her to the doctor complaining of a persistent cough and cold. The prescribing doctor called in a prescription to a local Walgreen’s pharmacy for the infant’s condition.

Upon picking up the prescription from Walgreen’s and giving it to her daughter, the woman’s mother noticed that the infant fell asleep immediately, one time with her eyes rolling back into her head. It wasn’t until about a week later that there was a knock on the door by a Walgreen’s pharmacy technician explaining to the mother that they had accidentally provided her daughter with adult-strength codeine instead of the cold medication prescribed by the girl’s doctor.

Walgreen’s acknowledged the mistake, taking ownership immediately. In fact, the company issued the following statement regarding the error:

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June 25, 2014

Hospitals Beginning to Place Pharmacists in the Emergency Room to Cut Down on Medication Errors

by Lebowitz & Mzhen

At the Children’s Medical Center in Dallas, Texas, 10 full-time pharmacists have been brought on to the staff to help combat medication errors in the emergency room. According to a recent report by NPR, the hospital views the addition of the pharmacists as a vital safety net.

perscription-drug-case-1156714-m.jpgAs one emergency room physician put it, “Every single order I put in is reviewed in real time by a pharmacist in the emergency department prior to dispensing and administering the medication." This is especially necessary in the emergency room, where there is no time to clarify what a doctor meant to prescribe.

The article also notes that medication errors are not necessarily caused by prescribing the wrong drug, although that is a large part of the problem. There are also thousands of cases each year where a patient is given a medication that they are allergic to or that reacts dangerously with another medication they are taking. Due in part to these reasons, medication errors are three times more likely to occur in children than in adults. In fact, one study found that nearly 25% of children’s prescriptions contain at least one error.

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June 18, 2014

New York Hospital Implements Robotic System to Combat Medication Errors

by Lebowitz & Mzhen

In St. Barnabas Hospital in the Bronx, a new robotic system is being used to fill IV medications. The new system, called RIVA, replaced the human element in the filling of medications in hopes that the high number of IV medication errors will drop.

According to a report in the New York Daily News, IV medication error rates rose 52% between the years of 2004 and 2008. These types of medical errors can often have drastic consequences, resulting in serious injury or death. In fact, each year there are 7,000 deaths from IV medication error, and hundreds of thousands get sick from medication-related errors. According to some estimates, the financial cost of medication errors exceeds $3.5 billion annually.

The new RIVA system uses artificial intelligence to fill the IVs and sterilizes the medication at the same time, using UV rays. Dr. Ruth Cassidy, vice president and chief pharmacy officer of St. Barnabas Hospital’s pharmacy department, explains that the new system decreases the chance of any medication error by completely removing the possibility for fatigue or contamination, the two main problems when humans are used to fill the medications.

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June 11, 2014

Blood Pressure Medication Found in Allergy Medicine Bottles, Leads to Recall

by Lebowitz & Mzhen

Earlier in May of this year, an Indian-owned pharmaceutical company announced a voluntary recall of over 10,000 bottles of promethazine hydrochloride, a drug used to treat allergies. According to a report by Medical Daily, the recall was initiated when a 25-mg tablet of atenolol was found mixed in with the allergy medication. Atenolol is a medication used to treat high blood pressure. The recall affects those bottles with a September 2015 expiration date.

Potential side effects for atenolol are listed as constipation, memory loss, impotence, numbness, and diarrhea. There has not been any research done to determine what potential side effects may occur from taking the two medications together. However, out of an abundance of caution, the company decided to recall the bottles.

This recall is a Class-II recall, meaning that it “involves a potential health hazard situation where there is remote probability of adverse health consequences from the use of the product.” Evidently, this is the seventh recall that this particular pharmaceutical company has announced this year. Given their track record, the FDA is beginning to crack down on Indian pharmaceutical companies. In fact, the FDA has already placed a ban on the import of medication from two Indian pharmaceutical companies this year. Given this company’s track record for 2014, it may be next.

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June 4, 2014

Drug Manufacturers Consent to Oversight by Federal Agency Following Increased Scrutiny

by Lebowitz & Mzhen

Following a meningitis outbreak that was linked to a faulty drug, several custom drug manufacturers have recently consented to voluntary oversight by the FDA. According to a report by AZ Central, the manufacturers of custom drugs exist in a bit of a legal loophole. These manufacturers often create specific drug “cocktails” designed to treat very specific conditions.

These “shadow” drug makers, as the article refers to them, came under scrutiny after an outbreak of meningitis was linked to 64 deaths and over 700 illnesses. Under current law, these manufacturers are not regulated by the federal government. However, in 2012, there were two citations issued for unsanitary conditions and a faulty injection.

These specialty drugs, which are prescribed by doctors and filled at regular pharmacies like CVS or Walgreens, are often combinations of other approved drugs. However, since the manufactures operated somewhere between the smaller state-regulated compounding manufacturers and the large-scale drug manufacturers regulated by the FDA, it is unclear who is in charge of making sure these facilities are up to par with the governing safety standards in place.

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May 28, 2014

Drug Recall for a Generic Version of Claratin, 30,000 Packets

by Lebowitz & Mzhen

Earlier this month, Ranbaxy Laboratories initiated a voluntary drug recall of over 30,000 blister packs of one of the drugs it makes. The drug, which is a generic version of the popular allergy medication Claratin, is called loratadin and is a slow release pill with an added decongestant.

The FDA’s official title for the drugs is “Non-Drowsy 24 Hour Formula Allergy Relief and Nasal Decongestant, Pseudoephedrine Sulfate, USP 240 mg, Loratadine, USP, 10 mg, 5, 10, 15 count blister packs, OTC Only.”

According to a report by Business Insider, the recall affects drugs that were sold in the following five states: Rhode Island, Ohio, California, Pennsylvania, and Texas. Evidently, the expiration on the packaging indicates that it expires in September 2015. The defective drug was sold at the following pharmacies: Rite Aid, CVS, Discount Drug Mart, H-E-B, Kroger, Good Neighbor Pharmacy, and Sunmark.

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May 21, 2014

Pharmacy Error Nearly Causes the Death of Another Young Boy

by Lebowitz & Mzhen

Earlier this year in Crystal Lake, Illinois, a five-year-old boy ended up taking a dangerous dose of an anti-psychotic drug when the pharmacy gave the drug to his mother under the auspice of a treatment for his allergies. According to a report by the local NBC affiliate, the young boy, Ali Ahmed, was in need of medication for his allergies, and a prescription was called in for him at the local Walgreen’s pharmacy.

When his mother went to pick up the prescription, she picked up what she thought to be the allergy medication that her son’s doctor had called in. However, the pharmacist gave her Halperidol instead, a dangerous anti-psychotic drug used primarily to treat adults with serious mental health issues.

Luckily, the boy's parents only gave him a small dose of the wrong medication. After young Ali took the medication, he slept for two days straight. After waking, he had a small snack, and his neck began to flare. Emergency personnel were called, and eventually the flare went away. However, as soon as the neck flare went away, he began to act strangely and then fainted. His parents called the boy’s doctor, who told them to take him to the hospital immediately.

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May 14, 2014

Air Force Claims Medication Errors on Base Presented Very Low Risk

by Lebowitz & Mzhen

Earlier this year in April, the Air Force released a report indicating that it had prescribed the wrong medication on an Air Force base in Kitty Hawk, North Carolina. Evidently, on April 29th, someone reported that their prescription was not properly filled; Tylenol was prescribed instead of Robaxin, a muscle relaxer.

perscription-drugs-2-1160103-m.jpgThe Air Force immediately conducted an internal investigation and found that 1273 patients had been provided the incorrect medication at the Kitty Hawk base. Of those, the Air Force was able to contact 926 of the patients by telephone to let them know that they may have been proved the wrong medication. The remaining patients were sent a certified letter in the mail to let them know of the pharmacy’s error. Air Force records indicate that no one actually took the improperly prescribed drugs.

According to a report by the Dayton Daily News, the medication errors were due to a malfunction in an automated system that the Air Force pharmacy uses to fill prescriptions. Once the error was found, pharmacists and pharmacy techs began to fill all prescriptions by hand to ensure that patients received the correct medication.

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May 7, 2014

Colorado Man Recovers Over $10 Million in Pharmaceutical Error Case

by Lebowitz & Mzhen

Physicians and nurses owe a duty to all of their patients to administer the proper medication and provide a certain basic level of medical care. Most of the time, physicians do the best job they can making sure that the sick are well cared for, but on occasion a lapse in judgment can result in serious consequences.

Bethel v. United States of America

In a recent case from Colorado, a man was granted a verdict in excess of $10 million after he suffered severe brain damage as a result of medication error. The facts of the case were as follows:

Bethel, the plaintiff in the lawsuit, was under the care of the Veterans Affairs Medical Center when he underwent general anesthesia. He was to be cared for by a doctor as well as by a first-year resident. The resident prepared Bethel for surgery, but in so doing administered a paralytic drug instead of a sedative drug. At this time, the doctor was away attending to another patient.

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April 29, 2014

Pharmaceutical Company's Failure to Warn Did Not Cause Plaintiff's Injury, Court Rules

by Lebowitz & Mzhen

Pamidronate2DACS.svg.pngA federal district court dismissed a lawsuit against a pharmaceutical company for alleged failure to warn, holding that any defect in the drug’s label did not influence the prescribing doctor’s decision regarding the drug. Parkinson v. Novartis Pharmaceuticals Corp., No. 3:12-cv-02089, opinion (D. Ore., Mar. 20, 2014). In a claim for damages caused by a manufacturer’s failure to warn of a hazardous condition or risk, a plaintiff must prove that the failure to warn was a proximate cause of their injuries. The “learned intermediary doctrine” often applies in cases involving pharmaceutical drugs, meaning that the question is whether the failure to warn influenced the prescribing physician, not the plaintiff. The plaintiff must prove that the physician would not have prescribed the drug, or would have done so in a different manner, had the manufacturer provided adequate warnings.

The plaintiff was diagnosed with stage IIIB breast cancer in January 2003. She underwent chemotherapy for about six months and then voluntarily stopped receiving treatment. In May 2005, she underwent radiation therapy on her pelvis to treat pain caused by the cancer, which by then had spread. She also had surgery on her legs because of bone damage. Her physician began administering monthly infusions of Aredia, a bisphosphonate used to treat bone damage in cancer patients, in June of that year. Bisphosphonates have been associated with an increase risk of osteonecrosis of the jaw (ONJ), a condition in which the jaw bone weakens and, in some cases, dies. Dental surgery may aggravate the condition in cancer patients receiving bisphosphonates.

The plaintiff’s physician testified in his deposition that he was aware of the risks associated with ONJ, but felt that they were outweighed by the benefits of the drug for the plaintiff. He also testified that he continues to prescribe Aredia and other bisphosphonate drugs. After the plaintiff had been receiving monthly Aredia infusions for over a year, the doctor switched her to Zometa, another bisphosphonate, in September 2006. The plaintiff saw a dentist in December 2006, reportedly the first time in five years. She then began experiencing tooth and jaw aches, and was eventually diagnosed with bisphosphonate-related ONJ in January 2008.

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