January 5, 2012

FDA Weighs in on Marketing Pharmaceuticals via Social Media

1260785_84481055_01052012.jpgThe U.S. Food and Drug Administration (FDA) released a memorandum in late December laying out guidelines for the use of social media, such as Facebook and Twitter, by pharmaceutical companies in marketing their products. The memo’s release came more than two years after the FDA held hearings on the matter in November 2009. Although the memo provides useful guidance, it is not nearly as comprehensive as industry insiders expected. The guidelines only deal with online discussions of off-label drug uses, those which lack explicit FDA approval.

Social media, the FDA felt, poses different challenges and risks than previous technological advances in marketing, such as television advertising, because social media allows much faster access to information and more direct contact between manufacturers and consumers. It convened hearings in November 2009 to examine these concerns. According to the New England Journal of Medicine, the FDA issued warnings to fourteen drug companies in April 2009 after it found sponsored ads for prescription drugs in search engines that lacked a clear statement of risks.

A major question for the FDA was that of “balance,” making sure consumers had access to all relevant information about a particular drug. This includes not only information about known side effects, but also, when claims are made about a drug, about the financial interests of the person or company making the claim. Among social media services, it is also increasingly difficult to determine whether a pharmaceutical company is responsible for a claim about a medication. Google and sites like Wikipedia make it increasingly easy for the general public to make claims about prescription drugs. The FDA has a responsibility to police the accuracy of claims made by the manufacturers. A major challenge for the FDA is therefore how to deal with inaccurate information widely disseminated by people other than the manufacturers.

The FDA’s guidelines address unsolicited requests from consumers for information about “off-label” uses. Generally, companies should not directly answer questions posted online about off-label uses, but should refer people to their websites or hotlines for more information. Answering such questions, the FDA says, is not unlawful per se, but could count as “evidence of a new intended use.”

Major pharmaceutical companies, or “Big Pharma,” spent $1 billion on online marketing in 2011, according to Ad Age. This number is expected to keep increasing, but it still represents a small percentage of pharmaceutical marketing. The industry expected clear, definitive guidelines on social media use, but got something more vague. The FDA has stated that, because of the ever-evolving nature of social media, it will not issue platform-specific guidelines for each social media service. It says it plans to issue further guidelines in the future.

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December 20, 2011

State Revokes Three Professionals' Licenses to Prescribe Medication

1157469_84791438_12202011.jpgThe Delaware Secretary of State’s Office has suspended the Controlled Substance Registrations of two medical doctors and a nurse practitioner because of allegations that they overprescribed a number of controlled substances in unreasonable and excessive amounts. Complaints filed against the the three, who all worked in the pain management field, further allege that they disregarded evidence that some of the prescribed medications were being abused or even diverted. The suspension immediately halted their legal authority to write prescriptions. One physician and the nurse practitioner reportedly also surrendered their Drug Enforcement Agency (DEA) registrations to federal authorities. The doctors may face further disciplinary action beyond the Secretary of State’s investigation.

One of the physicians, Dr. Mohammed Niaz, worked with the nurse practitioner, Jean Binkley, as her supervisor. The Secretary of State alleges that Dr. Niaz wrote prescriptions for over 57,000 tablets of various controlled substances during the first seven months of 2011. This amount included 42,000 tablets of the Schedule II narcotic Oxycodone. Binkley is alleged to have separately written prescriptions for over 89,000 Oxycodone tablets.

The state further alleges that one patient, using prescriptions obtained from Niaz and Binkley, obtained 360 Oxycodone tablets and 90 tablets of Alprazolam within a two-week period earlier this year. This is considered an unreasonable amount for one person for such a brief period of time. Alprazolam is the generic name for the drug Xanax, a Schedule IV controlled substance used to treat anxiety, but also highly prone to abuse. Both types of drug can be highly addictive and dangerous if abused, and their distribution is strictly controlled. The state alleges that many of the drugs obtained through prescriptions written by Niaz and Binkley ended up in the hands of people who did not have a prescription and did not have guidance on how to use the drugs safely.

Dr. Patrick Titus allegedly wrote an even greater number of irregular prescriptions. One pharmacy’s records reportedly showed 3,941 prescriptions written by Dr. Titus between January and November 2011, accounting for almost 750,000 pills of seventeen Schedule II narcotic pain medications such as Oxycodone, Oxycontin, and Morphine.

The Secretary of State launched an investigation with the assistance of the Delaware Attorney General’s office and the Division of Professional Regulation. Delaware law empowers the Secretary of State to revoke a medical professional’s license to prescribe medicine if “continued registration would be inconsistent with the public interest.” The Secretary of State’s reasoning in this case seems to be that these three medical professionals have established a sufficiently questionable prescription history, and that they would constitute a threat to the public interest if allowed to continue writing prescriptions.

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December 14, 2011

Doctors Offer Five Steps to Help Seniors Reduce Their Risk of Drug Side Effects

For people over the age of 65, two-thirds of emergency room visits result from side effects of medications in two broad categories, according to the Boston Globe and the New England Journal of Medicine. The categories are medications used to treat heart disease and those taken for diabetes. The study specifically lists blood thinners and anti-platelet drugs in the heart disease category, and blood-sugar-lowering drugs and insulin in the other. Numerous emergency room visits happen because of dangerous, and preventable, interactions between these drugs and other common medications.

The Globe goes on to list a series of tips to help seniors educate themselves about their medical conditions, their treatments, and the most common dangers inherent in their prescribed medications. Many medications require frequent, often constant, adjustments in dosage, so close communication with your doctor is essential. Long-term use of some medications can often cause their own medical complications and side effects, such as hypoglycemia with blood-sugar-lowering medications. The author quotes five tips from the American Association of Family Practitioners:

1. Obtain both written and verbal instructions from your doctor about the proper use of your medication. Ask your doctor to repeat the instructions as many times as it takes until you understand them. Understanding exactly how and when to take your medication is perhaps the most important step in avoiding injury.

2. Read your prescription, then read the label of the drug once you get it from the pharmacy. Read both the label on the bag and on the bottle itself. Make sure your name appears on all labels, and make sure the name and dosage of the drug match the prescription. Incorrectly-filled prescriptions are a frequent cause of medication-related injuries.

3. Talk to the pharmacist about possible side effects. You have an opportunity to do this whenever you pick up a prescription. The pharmacist can explain possible side effects and common drug interactions to you. That is part of why the pharmacist is there.

4. Stay in contact with your doctor and show up when requested for further testing. Notify the doctor of any side effects you are experiencing, no matter how minor they may seem to you. Failure to follow up once a medication is prescribed can lead to negative side effects down the road if the doctor cannot make adjustments to your treatment based on new information or changing circumstances. The doctor may also need to adjust medication based on unforeseen side effects, drug allergies, or other drug interactions.

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November 3, 2011

Hospitals and Pharmacies Hit by Nationwide Drug Shortages

A shortage of commonly-used drugs is impacting care in hospitals nationwide. Reports released by the American Hospital Association and the American Journal of Health-System Pharmacists indicate a chronic shortage of crucial medications, with over 800 AHA-member hospitals reporting shortages. Shortages can appear quite suddenly in a hospital environment, with the need for a specific drug suddenly spiking to an amount greater than the supply. Hospitals and pharmacies struggle to compensate for these shortages, sometimes by prescribing alternative drugs, and sometimes by turning to less-than-scrupulous vendors with uncertain records of quality. The possibility for errors, both in prescribing and dispensing medications, is great in such situations.

In a report published by the Patriot-News, one Pennsylvania hospital stated that, out of around three thousand prescription medications commonly used, it experienced shortages of 211 drugs in 2010, up from 70 in 2006. This mirrors conditions in hospitals all over the country. Healthcare administrators around Pennsylvania have reported shortages of fifty or more medications in their facilities, often stating that the shortages are the worst in at least twenty years. This puts significant pressure on doctors, nurses, and pharmacists to identify and locate acceptable substitute medications, often with very little time to spare.

The Food and Drug Administration reported shortages of 178 drugs in 2010. The majority of the shortages are of older drugs administered in hospitals by injection or intravenously. Shortages can result from problems with raw materials and problems arising in the process of producing and distributing drugs. Some drugs may be held up by new regulations, but many drugs fall by the wayside if manufacturers find them not to be profitable.

When a particular drug is unavailable due to a shortage, medical professionals must locate another treatment. This often involves an alternative medication that may not be as effective, that may not be recommended for a particular use, or that may not have equally good quality control. Nine patients died at Alabama hospitals earlier this year, allegedly due to a substitute drug contaminated with bacteria commonly found in tap water and bathrooms.

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August 30, 2011

Reducing Medication Error Injury by Keeping Health Record Journals

Our Prince George’s County, Maryland pharmacy error lawyer blog recently reported on the important role communication plays between patients and their healthcare providers—in order to reduce the risk of medication errors or pharmacy misfills, and to promote the safe and effective use of drug therapy.

Every year, 1.5 million Americans experience medication-related injuries, according to a study by the Institute of Medicine. In order to prevent medication errors, the American Pharmacists Association (APhA) reports that it is important for patients to keep accurate health records with them when visiting the doctor and pharmacist, including current prescription medication lists detailing the dosage information along with all health conditions that the medication is treating.

Patient medication lists can reduce the risk of pharmacy misfills, incorrect dosages, medication duplication, allergy interaction, and any harmful side effects from potential dangerous drug interactions. The APhA also states that by keeping drug lists with them at all times, patients can prevent medical error by providing emergency staff and hospital pharmacists with important information that could saves lives in an emergency.

According to a recent Chicago Tribune article, doctors are now recommending that individuals turn the medication lists into a comprehensive health journal, to keep healthcare providers informed and to prevent medication error injury.

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August 29, 2011

Report Finds Medication Errors in Chronic Drug Therapy After Seniors Leave Hospitals

According to a recent study discussed in the Journal of the American Medical Association (JAMA), that our Baltimore medication error lawyers have been following, hospitalized patients are more likely to have medication errors than non-hospitalized patients—when drugs used to treat chronic conditions are unintentionally discontinued in hospitals, especially if the patients are in a hospital’s intensive care unit.

The study reportedly showed that transitions in healthcare can increase a patient’s chances for medical errors that stem from inaccurate or incomplete communication between the hospital staff, the primary care physician, and the patient—causing an interruption or discontinuation of medications that aim to help treat patients’ chronic diseases on a long term basis.

According to the authors, the problem of medication errors and the unintentional discontinuation of drugs can happen during hospital stays, transfers and discharge. Treatment in intensive care units can also increase the risk of medication errors of omission as the healthcare providers are focused on emergency care and may engage in the practice of discontinuing a medication used for chronic illnesses during a time of critical illness.

The medication error study followed nearly 400,000 patients who were older than 65, and who had over one year of experience continuously taking one of the following five drug classes: respiratory inhalers, gastric acid suppressors, statins, anticoagulant or antiplatelet agents, and levothyroxine, used to treat the thyroid gland.

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August 25, 2011

Medical Error Leaves Judge with Surgical Sponge in Body

Our Baltimore medication error injury blog recently reported that according to the Institute of Medicine, 1.5 million medication error injuries occur every year around the country that are preventable, and as many as 98,000 deaths due to medical errors.

When Nelson Bailey decided to have elective surgery for diverticulitis, a condition causing him abdominal discomfort, he was told that he would be out of the Good Samaritan Medical Center in around four days. What Bailey didn’t expect, according to a recent article in the Sun Sentinel, was that he would suffer from two different and equally serious medical errors at the hospital that would change his live completely.

Bailey, a Palm Beach County judge, underwent the intestinal surgery in October 2009, where the surgeon made a medical error by mistakenly leaving a surgical sponge inside Bailey’s body—that was reportedly as big as a washcloth, and was left to fester for five months.

When Bailey was recovering from surgery he then experienced a hospital pharmacy error, after the pharmacy prepared the incorrect medication. The doctor had reportedly ordered blood pressure lowering medication, but when the wrong medication was sent from the pharmacy, the nurse gave him the drug without double checking the drug label.

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August 22, 2011

New Palm-Vein Scanning Technology Introduced to Reduce Medical Errors in Hospitals

Our Hartford County, Maryland pharmacy error injury attorneys have been following the latest healthcare technology introduced by New York University’s Langone Medical Center, in an effort to reduce the amount of time it takes to check patients in to the hospital, and to eliminate medical errors.

As our lawyers have discussed in a previous Maryland medication error injury blog, according the Institute of Medicine, there are 1.5 million medication error injuries every year that are preventable, and as many as 98,000 deaths due to medical errors.

The new biometric technology aimed to improve patient safety is made by Fujitsu, the technology services company, and works with the concept that like fingerprints, every patient has an individual and unique palm-vein configuration. The technology uses near-infrared waves to take an image of a patient’s palm veins, which the software then links to that patient’s medical records in about a minute. Other reported benefits of the technology is that a patient does not have to be conscious during the check-in process, and the system eliminates the need for a patient to fill out any forms, unless the patient's insurance has changed since the last palm scan.

The hospital reportedly experiences around 1.7 million patient visits per year, and is in the process of converting as many patients as possible to the new palm scanning system, to prevent medical errors and patient injury. Since 250 scanners were installed in June, over 25,000 patients have received palm-vein scans that have been registered in the system. The palm scan does not appear in the patient’s medical records, and it is not stored as an image. After the palm is scanned, the image is converted into special numeric code.

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August 18, 2011

WHO Claims Hospitals Are More Dangerous Than Airline Travel

According to a recent report in Medical News Today that our Baltimore medical error injury attorneys have been following, Professor Sir Liam Donaldson has been appointed as the new Envoy for Patient Safety for the World Health Organization (WHO). Donaldson recently stated, in an effort to highlight the fact that healthcare safety around the world needs to be improved, that going to the hospital is far more dangerous than flying on an airplane, as the WHO reports that millions of people die annually from medical errors associated with healthcare—far more, according to Donaldson, than accidents on planes.

In his striking comparison, Donaldson claimed that if a patient entered the hospital he would have a 1 in 10 chance of experiencing a medical error, with the chances of wrongful death due to medical error being 1 in 300. Donaldson then stated that in comparison, the risk of dying in a plane crash is far less—approximately 1 in 10 million.

Donaldson reportedly stated that in an effort to reduce the growing number of hospital related infections resulting in patient injury or harm that happen every year, patients need to ask questions and make sure that hospitals maintain the basic hygiene standards and conform to the WHO’s healthcare checklist to prevent medical error or patient illness or injury during surgical procedures.

According to the WHO statistics, 7 in 100 patients in the hospitals throughout developed countries experience infections linked to healthcare, whereas in developing countries this number increases to 10 patients in every 100. The risk of infection is directly tied to the length of time a patient stays in the hospital's intensive care unit. The WHO figures show that risk of infection is lower in the United States than in Europe, but the death from hospital-acquired infection is higher. In the United States, 1.7 million hospital acquired infections reportedly happen every year, resulting in 100,000 deaths, and in Europe, 4.5 million hospital acquired infections happen every year, resulting in around 37,000 deaths.

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August 10, 2011

The Benefits and Problems of Electronic Medical Records Systems

In a recent Baltimore County pharmacy misfill injury blog, our attorneys discussed a tragic medical error that caused the death of an premature infant, after a pharmacy technician accidentally entered the wrong information into the computer, causing the intravenous solution prepared buy an automated machine to contain a lethal dose of sodium chloride. This pharmacy error has reportedly brought the issue of electronic medical health records safety concerns back into the forefront of patient safety.

As our attorneys have reported in a related Hartford County medication error injury blog, the medical industry is shifting toward electronic medical records and computerized systems that make medical processes and prescription orders automatic, in an effort to reduce pharmacy error injury or wrongful death.

The Chicago Tribune reports that the federal government is also currently helping the digital shift by giving $23 billion in incentives to healthcare providers who purchase the electronic systems, with the hopes that these medical technologies will help increase access to patients' medical information, help healthcare providers communicate better with each other, help doctors to see test results more quickly, and implement electronic safeguards to remind doctors about recommended medical practices, or to alert them about harmful drug interactions before prescribing.

With all of the benefits that come with electronic medical records and computerized systems, potential problems are also taking place, like crashing of hospital computers, or software bugs that interfere with important data, or even delete information from computerized records. Computerized systems also reportedly can produce data about patients that is disorganized or difficult to read, especially when a doctor is quickly looking for critical patient information.

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July 29, 2011

Risperdal Recalled by Manufacturer Due to Drug Contamination

Our Talbot County, Maryland pharmacy error injury lawyer blog recently discussed a series of recalls drug maker Johnson & Johnson made last year, in an effort to maintain the health and safety of consumers—after complaints of an unusual smell causing nausea, vomiting, diarrhea and gastrointestinal pain were reported, due to trace amounts of 2, 4, and 6-tribomoanisole (TBA), a chemical used to preserve wood necessary in the construction of pallets used for transportation and shipping of the product packaging materials.

In related news, Ortho-McNeil-Janssen Pharmaceutical, the drug manufactures of Risperdal (risperidone), an antipsychotic drug used for the treatment of schizophrenia, bipolar disorder, and irritability associated with autistic disorder in adolescents and children, recently voluntarily recalled 16,000 bottles of the brand name drug and 24,000 bottles of the generic drug—also because of an unusual odor.

The Risperdal drug manufacturers found that the unusual smell was also caused by trace amounts of TBA, used to preserve wood pallets for the transportation and storage of product materials. While not considered to be toxic, a small group of patients have reported gastrointestinal symptoms when taking products with this offensive odor. The drug maker claims that the presence of TBA has not caused any reported serious adverse events, but the company has instituted a series of actions to reduce the potential of TBA contamination in the future, to avoid personal injury or harm to any consumers.

This is the second medication error warning surrounding Risperdal this year. Last month our attorneys discussed another warning involving Risperdal in a Baltimore pharmacy error injury blog, issued by the U.S. Food and Drug Administration, discussing potentially dangerous medication errors associated with Risperdal and Requip, a drug used for the treatment of Parkinson’s disease and Restless Legs Syndrome, with 226 reports of patients receiving the incorrect medication.

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July 25, 2011

Report Warns Consumers to Take Precautions With Drug Labels and Instructions

In a previous Baltimore medication error injury blog post, our attorneys discussed a recent investigation by Consumer Reports Health that found evidence of inconsistency among prescription drug labels for warfarin, a blood thinner. The report found that important safety warnings and medication guides that are required by the federal government in order to prevent medication errors, were often omitted or left out of patient’s warfarin prescriptions.

As our Maryland pharmacy mistake lawyer blog has reported previously, every year, according to research by the Institute of Medicine, there are 1.5 million preventable medication error injuries, one third of which take place outside of hospitals, where consumers must make their own decisions about following medication instructions. Consumer Reports Health suggests that these medication errors happen because consumers are confused by the material that is included with prescriptions, and that they rely heavily on the medication bottle label—a problem if there are omissions or inconsistencies with the drug label.

The report found the following discrepancies:

• Four out of five pharmacies neglected to provide the medication guides that are required by the FDA for certain drugs, including warfarin.
• All of the pharmacies provided their own materials for the patients, but these conflicted with the guides for warfarin approved by the FDA. The FDA recommended that patients abstain from alcohol while taking the drug, while two pharmacies warned patients that they should just limit or avoid alcohol usage.

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July 8, 2011

Medication Errors Linked to Death of Patient in Nursing Home

In a recent Baltimore pharmacy error injury blog, our attorneys discussed a pharmacy misfill and medication error that lead to a 94-year-old nursing home resident's wrongful death in New York, after she received the incorrect medication for nearly twenty days as a result of a pharmacy misfill.

In a related news report, a patient in a nursing home, also in the State of New York, has recently died, after medication errors allegedly led to her wrongful death.

The patient reportedly entered the Lake Ridge Care Center on the 10th of January in 2010, due to congestive heart failure and low potassium. Her doctor reportedly ordered that the she receive three doses (two-tablets) of potassium every day. According to the New York State investigation, the staff of the home failed to properly administer twenty-six of the medication doses to the patient over a period of eight days.

On January 23, 2011, the patient was reportedly sent to the hospital emergency room, where she suffered a severely abnormal heart rhythm and died the same day, from cardiac arrest. Her potassium levels were found to be extremely low, due to medication errors that led her to miss her prescribed potassium doses to help blood pump through the heart.

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July 1, 2011

New Study Finds Electronic Medication Error Rates Consistent with Handwritten Prescriptions

In recent news that our Pharmacy error injury attorneys have been following, a new study from the Journal of the American Medical Informatics Association found that prescriptions sent electronically to pharmacies by doctors are almost as likely to have errors as the prescription medication orders handwritten by doctors.

The study examined 3,850 electronic prescriptions that a commercial pharmacy retain chain received over a period of four weeks in 2008. Out of the 3,850 e-prescriptions studied, researches found that 12%, almost 500, contained a total of 466 prescribing errors.

The researchers noted that their findings on e-prescribing error rates are consistent with their earlier study and research for error rates on handwritten prescriptions. Out of the 466 electronic prescribing errors discovered, only one-third of them could have caused patient harm or personal injury.

According to Bloomberg, the results undermine the safety benefits expected from e-prescribing, especially as the federal government paid over $158.3 million to doctors and hospitals in the beginning of 2011 to encourage doctors to switch over to electronic health records, as a way to reduce healthcare costs and eliminate medical and medication errors. The report found that although many providers are rapidly adopting electronic health records and e-prescribing, many of the expected benefits of the electronic computerized prescribing will not take effect if the electronic prescribing applications are not able to catch medication errors, or in fact cause medication errors.

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June 27, 2011

FDA Warns of Confusion between Risperdal and Requip, Leading to Medication Error

The Food and Drug Administration recently issued a warning about the potentially dangerous medication errors occurring with the drugs Risperdal (risperidone) and Requip (ropinrole)—with 226 reports of patients accidentally receiving the wrong drug, causing sickness and at least one death.

Risperdal (risperidone) is an antipsychotic used for the treatment of schizophrenia, autism side effects and bipolar disorder, and is reportedly being confused with Requip (ropinirole), a drug used for the treatment of Parkinson’s disease and Restless Legs Syndrome, that acts in place of dopamine.

According to the Food and Drug Administration report, the medication errors are happening as a result of the drug name similarity as well as the similarity in generic drug labels and packaging, with overlapping drug characteristics such as the drug strengths, and dosing intervals. Other errors have reportedly stemmed from illegible handwriting on prescriptions.

Patients who were victims of the medication errors have reportedly experienced confusion, tiredness, hallucinations, and an altered or changed mental status, among others health problems.

The FDA warns patients who are taking the generic versions of Requip or Risperdal to notice the name and appearance of their medication, to know exactly why they are taking the drug, and to ask any questions and to report any difference in medication appearance to their pharmacists—to avoid pharmacy misfills or medication errors.

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June 6, 2011

FDA Tips for Administering OTC Medication to Children—to Reduce Medication Error Injury

In a previous Washington D.C. medication error injury lawyer blog, we covered the recent guidelines announced by the U.S. Food and Drug Administration (FDA) aimed to prevent medication errors and overdoses with children’s over-the-counter (OTC) medications.

According to the FDA, accidental medication errors and overdoses in young children are a common health problem, but a problem that is entirely preventable. The new guidelines are aimed to reduce frequent medication administration errors that happen as a result of confusing label instructions, inconsistency with the drug measuring devices, and confusion over the exact units of medication measurement—to prevent harm or injury.

Along with the new medication error prevention guidelines, the FDA also outlined tips for parents and caregivers, to reduce administration error when giving medicine to a child or infant.

According to the FDA, always:

• Know the active ingredients in the medicine that you are giving to your child.
• Read and follow the drug facts label on all medicines that are OTC.
• Use the tools for dosage administration that come with the medicine. Never use tools from other medication.
• Be aware of the difference between a teaspoon and a tablespoon.
• Know your child’s weight exactly.
• Check the medicine three times.
• Make sure to give the right medicine in the exact amount that is directed.
• Ask your doctor, nurse or pharmacist to make sure which medicines can be used at the same time.
• Store your medicines in a safe place that is out of reach for children.
• Make sure to use caps on all medicines that are child-resistant.

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June 3, 2011

Hospital Fined $50K in Medication Mistake

In recent news that our Rockville, Maryland medication error injury attorneys have been following, twelve Los Angeles-area hospitals were hit with administrative penalties this week by the California Department of Public Health, ranging from $25,000 up to $75,000, after the facilities were found to be non-compliant with requirements that were likely to cause serious injury or death to patients.

One medical center, Promises Hospital, was reportedly fined $50,000 for a medication mix-up that caused a patient with a heart condition to require emergency response.

According to the Los Angeles Times, a medication error was reported in 2010 that led to the inspection of Promises Hospital. The inspectors reportedly found that a patient was given a dose of Cardizem, the drug used to treat irregular heart rhythms, that was 10 times the ordered dose—causing the patient’s heart rate to drop so quickly that the nurse was unable to get a blood reading for almost 10 minutes.

According to the department, when problems are found in facilities, hospitals must take corrective actions to prevent any similar medication errors or other problems from happening in the future, and causing injury or death to patients.

Promises Hospital reportedly claimed that it has initiated an investigation into the drug error, and has taken the necessary steps to prevent this medication mix-up for happening again in the future.

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June 1, 2011

New FDA Guidelines to Prevent Children’s OTC Medication Errors

In a recent Baltimore, Maryland pharmacy error injury lawyer blog, our attorneys discussed an FDA panel’s recent recommendation that dosing instructions be based primarily on children’s weight, and not age—as studies found that many parents administer the wrong drug dosage to their children because of confusing medication label instructions.

The FDA has recently released new guidelines that are expected to reduce the prevalence of medication error and overdoses with Children's liquid over-the-counter (OTC) medication, which is administered and dispensed with cups, spoons and droppers.

The guidance was reportedly developed after past reports of medication errors revealed that labels often cause confusion with administration, the measuring devices provided in drug packages are often inconsistent with the labels, and parents often used devices from other drug products to dispense the medication that do not match the label instructions—leading to medication error.

According to the FDA recommendations:

• Dosage dispensing devices (cups, spoons, droppers) should be included with all OTC medications that are liquid and taken orally.
• Over-the-counter (OTC) drugs will reportedly now come with dispensing devices that are calibrated to match the exact units of measurement specified on the drug label—to avoid drug error or injury.
• Companies should make sure that the liquid dispensing devices are used only to measure the intended drug products.
• The markings on the dispensing devices should be visible when the liquid medication is added for measurement.

And as our Maryland medication mistake attorneys discussed previously, the FDA is also advising that liquid acetaminophen products will be changed to one concentration only, with age-appropriate dosages, to reduce medication dosing errors.

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May 27, 2011

FDA Panel Looks to Prevent Drug Error by Changing Children’s Acetaminophen Product Labels

In recent pharmacy error injury news that our Hartford County, Maryland attorneys have been following, a panel advising the U.S. Food and Drug Administration (FDA) has recommended that dosing instructions for children’s acetaminophen be based primarily on a child’s weight and not age, and be changed to include children under two years—to reduce the risk of medication error.

According to the Wall Street Journal (WSJ), a majority of dosing information for over-the-counter (OTC) children’s medicine containing acetaminophen have instructions based on age, with only some information on dosing by weight, causing confusion in dosing that could lead to error or injury. Acetaminophen is the most commonly used OTC medication to lower fevers in children and relieve pain, with the best-known brand being Children’s Tylenol.

The federal advisory panel has recently recommended that all acetaminophen products should contain a standard label with updated weight tables to reflect average weight increase among children over the past 20 years.

According to the FDA reports from 2000 to 2010, there were 14 fatalities and 74 non-fatal adverse events that were related to acetaminophen drug errors in infants and children from the age of 13 and younger. Some of the medication error fatalities were due to incorrect usage of the more-concentrated infant drops that were meant for older children, but used on infants.

The FDA panel reportedly recommended a single infant and children’s medication formula in 2009 that is slated for release this summer. The panel also recommends that the FDA should consider a single concentration of acetaminophen in solid forms, to avoid possible drug errors or overdoses with children.. The panel also voted to add dosage instructions for children from six months to two years onto liquid products. Currently on acetaminophen formulations for children, the dosing information is for children from 2-12 years old, with instructions to contact your doctor for children under 2 years.

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May 19, 2011

Prescription Error Overdose Leads to Paralysis, Victim Hopeful for Recovery

Our Maryland pharmacy misfill injury attorneys have been following the recent developments in the tragic Walmart prescription error incident from 2008 that caused a teenager to suffer a pain medication overdose that led to paralysis.

When Jessie Scott was 18, and suffering from strep throat pain, his doctor prescribed a low-dose of the pain reliever, oxycodone hydrochloride. After receiving the prescription from Walmart, Jessie’s mother administered one dose to her son.

In a grave prescription drug error, the Walmart pharmacist reportedly failed to dilute the drug, and the prescribed dosage of 5 milligrams was actually around 100 milligrams, causing a prescription drug overdose. Jessie went into a coma, suffered organ failure and paralysis.

Scott, who is now 20 years old, has reportedly experienced some remarkable changes physically and psychologically, making incredible strides since the horrific incident that caused his disabilities. Thanks to a court prescription error lawsuit settlement with Walmart, Jessie’s parents were able to build an area in their house with special accommodations that allow him to be transported from room to room. He can now raise his arms, hold his head upright, wiggle his toes, and even kick. Although the odds seem to be against him, Jessie holds out hope that he will walk again.

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