January 19, 2012

Online Pharmacies Offer Savings, but Also Present Risks

987822_95717228_01242012.jpgOnline pharmacies have become increasingly common as an alternative to brick and mortar drugstores, offering possible cost savings and saving consumers one or more errands. Many major drugstore chains now offer online ordering in addition to their in-store services. A number of companies have set up exclusively web-based services as well. Some misconceptions exist regarding businesses that sell prescription medications online. Reputable and legitimate online pharmacies invariably require valid prescriptions, and they operate under the same rules as any pharmacy with a physical location.

A minimum amount of diligence can assist a consumer in finding a good online pharmacy. They will either need to receive a paper prescription slip from the consumer by mail, or they may call the doctor to confirm the prescription. Generally speaking, reputable online pharmacies do not solicit business through e-mail marketing. Most people by now have received more than one piece of “spam” e-mail offering discounted medications over the internet. These are not part of the legitimate online pharmacy business, but some scam services mimic legitimate services very effectively.

State pharmacy boards sometimes have information pertaining to illegitimate online operations. When in doubt, the Maryland Board of Pharmacy or the National Association of Boards of Pharmacy may have helpful information. The federal Department of Justice also investigates and prosecutes illegitimate and illegal websites. In September 2011, it reached an agreement with Google in which Google agreed to forfeit $500 million for taking advertisements from and offering support to online pharmacies based in Canada. These Canadian pharmacies target U.S. consumers, although importation of prescription medications violates federal drug laws.

Congress is also weighing in on the safety of online pharmacies. Senators Dianne Feinstein (D-CA) and Jeff Sessions (R-AL) introduced a bill in December called the Online Pharmacy Consumer Protection Act. The bill would enable the government to crack down on online services that dispense medications without a valid prescription. The bill, which the two senators have previously introduced, was originally inspired by a California teen who died of an overdose of Vicodin he purchased online.

Even legitimate online pharmacies can still present risks for consumers. CBS Sacramento reports the case of a woman who repeatedly received the wrong medication from an online service. Instead of Lipitor, the company kept sending her Zocor. Her only means of addressing the problem with the pharmacy was through an 800 telephone number. They finally determined that the woman’s doctor had phoned in the wrong prescription. The virtual nature of the pharmacy proved to be a disadvantage in this situation, since the woman had only a limited ability to address the issue with an actual person by telephone.

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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 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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August 3, 2011

Safety of Electronic Medical Records Questioned After Pharmacy Error Leads to Death of Infant

A recent Chicago Tribune article, that our Baltimore pharmacy misfill injury attorneys have been following, looks closely at electronic medical record safety, after a tragic medication error occurred, stemming from a computer mistake made at the Chicago-area Advocate Lutheran General Hospital, that caused the death of a newborn infant.

According to the article, Genesis Burkett, an infant born 16-weeks premature, was given a fatal overdose of sodium chloride last year, receiving over 60 times the dosage ordered by the physician. The hospital pharmacy error was reportedly made after a technician from the hospital pharmacy misread and inaccurately typed the doctor's handwritten prescription orders into a hospital computer—a common source of pharmacy misfills and errors, as attorneys have discussed recently in a Baltimore pharmacy error injury blog.

The data entry mistake then caused a pharmacy misfill, as the automated machine prepared an intravenous solution containing a lethal overdose of sodium chloride that caused the infant’s heart to stop. Advocate Health Care’s chief medical officer, Dr. Lee Sacks stated that the pharmacy error could have been prevented by the automated alerts on the IV compounding machine, but at the time that the customized bag was prepared for the infant, the alerts were not activated and connected to the main pharmacy information systems at the hospital. The family’s attorney reportedly blamed the pharmacy error and wrongful death on a mislabeled IV bag.

After the medication error led to the infant’s tragic death, Advocate has since added electronic alerts to the IV compounders and initiated other medication safety measures to prevent this kind of pharmacy error from happening in the future.

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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 15, 2011

Study Shows Transition to Electronic Medical Record Systems May Cause Potential Errors

According to a recent study published in the Journal of General Internal Medicine, although doctors and hospitals are in a mad dash to update to new electronic medical record systems (EMR)--after last year’s stimulus package promised a $27 million pay out to providers that meet the new EMR use--that transition can be risky and lead to an increase in certain types of medication errors in the months after the switch.

In the study, that our Hartford County, Maryland pharmacy error attorneys have been following, researchers found that although the change to a more streamlined system for entering prescription drug orders led to a general decrease in prescribing errors, other types of errors surfaced in the first few months after the changes were made.

Researchers reportedly followed 17 doctors who switched to new EMR systems, and found that improvements were immediately found in prescribing errors, where abbreviations that have a high potential to cause patient injury or harm dropped significantly. But rates of other prescription errors, such as medication direction mistakes were higher three months after the EMR switch over, and some rates of errors were even higher after an entire year using the system.

Rainu Kaushal, the chief of the division of quality and medical informatics at New York-Presbyterian Hospital/Weill Cornell Medical College, and the author of the study, claims that although the overall drop in prescribing errors is good, the results of the study show that there is a need for constant reassessments of the new systems—especially to prevent prescribing and medication errors in the future.

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May 9, 2011

FDA Redesigns Pharmacy Packet Inserts to Avoid Medication Error Injury

According to a recent article in the Wall Street Journal, a new national initiative is underway to make prescription medications clearer, and to decrease the rise of medication error that lead to hospitalizations and emergency room visits from patients who take their medication incorrectly—which according to the National Community Pharmacists Association happens to three out of every four Americans.

The U.S. Food and Drug Administration (FDA) is reportedly planning to test a new one-page information sheet to replace the many leaflet inserts and medication guides that are widely used in retail pharmacy chains across the country. And the U.S. Pharmacopeial Convention, the organization responsible for setting quality standards that are enforced by the FDA for the strength, purity and quality of medicines, has also developed a new program to create national standards for prescription labels, which currently vary greatly from pharmacy to pharmacy. The national label standard would require clearer instructions on the medication dosage, the medication timing and clearly state the purpose of the medication—to reduce medication and pharmacy error injury.

Currently, in pharmacies across the country, consumers may receive three different forms of drug information and pamphlets with their prescription medication—drug package inserts that are written by the drug manufacturer with FDA approval, drug guides for specific classes of drugs and products that are required by the FDA, and third-party consumer medical information. And according to the WSJ, recent FDA studies have shown that the drug information offered to consumers does not provide reliable understanding with the people taking the drugs, and is often conflicting in instruction, or even inaccurate, which could lead to patient harm or injury.

According to a recent FDA risk-communication advisory panel, more than half of adults misread or misunderstand one or more of common drug prescription precautions or warnings. In one study, patients were found to better understand language on warning labels that was simple and specific, like “use only on your skin” as opposed to “for external use only.” For consumers with lower English literacy skills, picture icons were provided, like a sun with a black bar, with the phrase, “limit your time in the sun.”

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April 1, 2011

Benefits of Robo Pharmacy Technology in Reducing Prescription Errors

In a recent Maryland pharmacy error injury lawyer blog entry, our attorneys discussed automated hospital pharmacies the use robots instead of people for tasks that are traditionally manual—in an effort to eliminate medication errors that could cause patient harm or personal injury.

According to the Medical Center of the University of California, San Francisco (UCSF), a hospital that recently implemented an automated hospital pharmacy--the benefits of using an robots instead of people are:

• Robots will help take over the manual medication dispensing tasks traditionally performed by pharmacists and nurses, who will in turn have more time to work with physicians to decide what the best patient drug therapy is, and will have more time to monitor each patient for any clinical responses or adverse reactions to medicine.
• The new pharmacy will provide pharmacy students with a strong training ground in the safe medication distribution systems of the future.
• The pharmacy will also enable the center to study new forms of medication delivery in order to share this groundbreaking information with other hospitals all over the country.
• Out of the 350,000 doses prepared by the robo-pharmacy since 2010, there has not been a single medication error or pharmacy misfill.

According to UCSF, the automated medication dispensing system will allow pharmacists to use their expertise in pharmaceutical care to make sure that each patients receives medication therapy that is catered to their individual needs, in a safe and effective way.

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March 28, 2011

UCSF Employs New Automated Pharmacy to Prevent Pharmacy Error

In an effort to reduce pharmacy misfills and medication error, the Medical Center of the University of California, San Francisco (UCSF), has recently employed a series of pharmacy robots, according to recent technology news that our Baltimore-based pharmacy misfill attorneys have been following.

In the newly automated hospital pharmacy, UCSF has employed what they consider to be the most comprehensive robots on the market, to prepare and track medications and improve the safety of patients. According to UCSF, since the automated system took over in October 2010, there has not been a single error in the 350,000 medication doses prepared.

This newly automated pharmacy reportedly streamlines the delivery of medication from the prescription directly to the patient, making every step in the medication therapy process safe and effective--from deciding the best drug treatment to patient administration—in order to reduce medication error injury.

How the Robo-Pharmacy Technology works:

• The automated system reportedly prepares medications that are oral and injectable, including chemotherapy drugs that are toxic. The robots are also able to fill IV bags or syringes with medications.
• Once the computers receive a new electronic medication order from an UCSF physician and pharmacist, the robots pick the medication, package the drugs, and dispense doses of the pills that are individualized for each patient.
• The robots assemble medication doses into a thin plastic ring that contains a bar code with all of patients' medications for a period of 12 hours.
• In the fall of this year, all UCSF Medical Center nurses will start using bar code scanners that read patients’ medication data at their bedsides--a topic our attorneys have discussed in a recent Maryland pharmacy error injury blog--to verify that the patient is being treated with the correct medication.
• A robotic inventory management system also maintains all medication products, with pharmacy warehouses that provide both refrigerated and non-refrigerated drug and supply storage and retrieval.

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February 9, 2011

Study Finds Frequency of Pain Relieving Medication Errors in Hospitals

According to a recent study in The Journal of Pain, that our prescription error attorneys based in Rockland, Maryland have been following, medication errors involving pain relievers, or analgesics, including errors made in prescribing, are a substantial contributor to adverse patient events in pain therapy that are preventable.

The study was performed in a hospital facility with 631 beds, and found that the frequency of pain medication errors in hospitals to be 3 per 1,000 prescriptions.

Researchers at the Albany Medical Center in the state of New York reportedly found in previous research that a major number of prescription analgesic errors are preventable, occurring in all stages of the prescription medication usage process, with the primary cause being prescribing errors. The researchers then combed through a large database containing prescribing errors that had been previously prevented by pharmacists in order to pinpoint the main characteristics associated with an increased risk for medication errors.

The overall drug error rate in the study was found to be 2.87 errors per 1,000 orders with a drug prescribing error rate of .63 per 1000 that was potentially serious. Error rates with analgesics were reportedly found to be higher in pediatric orders, a topic discussed in our pharmacy error injury blog from last week.

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January 7, 2011

Pharmacy, Nursing Home Sued After Pharmacy Misfill Leads to Resident’s Death

In recent news that our Washington D.C. pharmacy error attorneys have been following, a nursing home was fined $12,000 last month, after a pharmacy misfill caused a nursing home resident to receive the incorrect medication for 18 days, leading to her wrongful death.

The Auburn Citizen reports that according to an investigation by the New York State Health Department in March and April of 2009, Geraldine Burke, a 94-year-old resident, was given tablets of a blood pressure medicine and diuretic by three different nurses in the Cayuga County Nursing Home, instead of the thyroid medication she had been prescribed.

The tragic medication error reportedly happened as a result of a pharmacy misfill, where a technician at HealthDirect, a separate division of Kinney Drugs that provides pharmacy services for more than 100 facilities, had filled and shipped the wrong medication for Burke. The two medications reportedly had similar looking names—methimazole and metolazone—a common medication mistake that plagues pharmacies in this country, as our lawyers have reported in a recent blog.

Neither the pharmacy or the nursing home recognized the mistake, and Burke was given 11 doses of Metolazone, the diuretic. The autopsy reportedly found that Burke died from heart issues, that were a result of kidney failure, worsened by the diuretic, along with other conditions. When the facility discovered the medication error after her death, they reported it to the Health Department, where they were fined $12,000. Burke’s family sued Cayuga County for negligence, and in turn Cayuga sued HealthDirect for their pharmacy misfill.

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November 18, 2010

Maryland Hospitals Decrease Medication Error with New Technology

According to a study that our Baltimore, Maryland attorneys reported on in a recent blog, thirty-five Maryland hospitals increased their median safety over the past ten years, reducing medication error and patient injury with new technology.

In Maryland’s Peninsula Regional Medical Center, the hospital is reportedly improving the tracking of patient records and the prevention of complications with drugs that can lead to medication errors, when medication is improperly administered, through technology. The hospital is reportedly using a barcode system that our Maryland medication error attorneys also discussed in a recent blog, that removes the chance for medication errors by using barcode scanners to ensure that the barcodes on the prescription match the patient’s bracelet wrist-band and the medication, as well as the dosage.

The hospital also uses “Rosie” the Pharmacy Robot, who joined the pharmacy in 1999 and fills 2,500 doses daily from the pharmacy with 100% accuracy. By using barcode technology, Rosie finds a patient's drug that has been ordered by the physician and then entered by the pharmacist, and prepares the medication with a special barcode for patient delivery. The robot reportedly even notes when the medication stocks are running low and creates new orders electronically.

Other Maryland patient safety initiatives include the use of electronic medical records, Acudose Medication Storage Cabinets, where security codes are used and any drug taken from the cabinet is recorded, and Online Point of Care Wireless Patient Charting. The hospital is reportedly working on eliminating all human error, and continues to invest in new strategies and procedures as well as technology to reach “zero errors” to protect the health and safety of patients.

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November 17, 2010

Study Finds Maryland Hospitals Improve Safety and Health Standards

A recent study, published in the medical journal, Quality & Safety in Health Care, reportedly found that thirty-five Maryland hospitals showed notable improvements in the safe delivery and administration of drugs to patients in hospitals.

The study was performed on behalf of the Maryland Patient Safety Center, whose aim is to create health care in Maryland that is safer than any other state in the country by reducing adverse medication events, improving patient safety, and by focusing on improving the care systems in Maryland hospitals.

Released in October of last year, the study concluded that when measuring the delivery of medication, the combined Maryland safety scores for these hospitals dealing with acute care rose by almost 10 percent in over two years, reducing occurrences of medication errors.

By comparing safety data on medication and drug use between the years of 2005 and 2007, the authors of the study reported that Maryland hospitals received the highest scores in the packaging of drugs, the standardized distribution of drugs and safe labeling, safe storage of drugs, and keeping chemicals that are hazardous away from drug-preparation and patient areas, to reduce patient injury or harm.

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November 3, 2010

Study Shows Barcode eMAR Technology Can Help Reduce Medication Errors

In a recent blog, our Maryland pharmacy error injury attorneys discussed reducing medication error and patient injury with barcode electronic systems, that link barcodes on the patient’s wrist bracelet with the patient’s electronic records and prescriptions, to ensure that the medication and dosage match the prescription for the patient.

According to a recent study that the Agency of Healthcare Research and Quality (AHRQ) in Rockville, Maryland, has funded, barcode technology, working together with eMAR, the electronic medication administration system, can help reduce medication errors by over 50%. The study was published earlier this year, in the May issue of the New England Journal of Medicine.

Barcode eMAR combines technology to ensure that each patient is given the proper medication with the correct dosage at the right time, in order to prevent medication errors or patient injury. When this combination of technology is used, before administering the medication, the nurses must scan the barcode on the patient’s wrist bracelet, and then scan the medication. If both barcodes don’t match the approved medication, or the timing is not correct for the patient’s next dose, an alert is issued by the system. If the patient’s medication is overdue, warnings are also sent out to the nurses.

In the study, researchers at Boston’s Brigham and Women’s Hospital compared 6,723 medication administrations given on hospital units before the barcode eMAR was introduced with the 7,318 administrations of medication given after the barcode system was introduced.

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November 1, 2010

Children’s Hospital Launches Initiative to Prevent Medication Error

After two children died from medication errors at Seattle Children’s Hospital over a period of 18 months, as our Baltimore, Maryland medication error injury lawyers recently discussed in a blog, the staff of the hospital held a special 'Zero Errors Initiative' Patient Safety Day on Saturday, to prevent tragic medication errors like these from happening to children in the future.

According to the Seattle Post Intelligencer, over 550 physicians, staff, pharmacists, and nurses convened at the hospital for special patient safety sessions, focusing on training designed to prevent future incidents of medication and pharmacy errors.

Pat Hagan, the president of Children’s Hospital reportedly stated that these tragedies and the harm that was done to these children by the hospital will never be forgotten. Hagan said this has been a profound tragedy for the families, and for the hospital staff, and that this feeling will propel the hospital to continue to find ways to prevent life-threatening medication errors from happening.

The sessions during the safety training day included topics such as strengthening the safety of verbal orders, standardizing children's medications located on care units, prescribing, dispensing and administering medications that are high-risk, improving communication between providers when handing off patients, and patient safety training with the use of simulation.

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October 28, 2010

Medication Error Reduced By “Scanning” Patients for Electronic Records

In a related blog, our Baltimore, Maryland medical error attorneys discussed a recent study showing that implementing electronic health records significantly reduces medical and medication error, by integrating various systems across the country with hospitals and medical groups, to create a common platform for sharing patients’ medical records.

Health-care providers at the Tucson Medical Center (TMC) are reportedly achieving great success with a new electronic system using computerized scanning to verify their work. The electronic system is part of a new protocol at the medical center that was launched on June 1, 2010, after a $30 million upgrade to its electronic medical records system. Under the new system, each patient receives a bar code that is printed on a hospital bracelet. In an effort to reduce medication error and patient injury, before health-care providers can administer any medication, or perform any lab tests, the patient’s bracelet must be scanned, similar to a grocery checkout scanner. The medication must then also be scanned, to make sure that both the dosage and medication match the prescription for the patient.

In the preliminary three months of the new protocol, the system reportedly sent out around 1,500 medication error alerts that the health-care providers immediately corrected. Common medication errors like confusing continuous release and sustained release were also remedied, as the computer caught the medication errors after the patient’s bracelet was scanned.

According to Frank Marini, the CEO and vice president at TMC, the medical center implemented the electronic medical records in 2002, but still had paper charts for patients up until this year. Under the new federal health-reform law electronic medical records are a requirement.

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August 26, 2010

Study Reviews Risk Levels Associated with Pharmacy Drug Dispensing

As Washington D.C. pharmacy error injury lawyers, we have been following recent study results released by the company Centice, that discuss the risk levels associated with drug dispensing processes, and the occurrence of pharmacy errors or misfills.

Centice is a company focused on the chemical verification of dispensed prescription drugs, and has recently published findings from that investigate levels of risk in the dispensing process for prescription drugs from Pharmacy Quality Assurance and Rx Verification Study.

According to the study’s research, after a single pharmacy error in the dispensing process, pharmacists can spend up to fifty hours correcting the dispensing error, or Quality Related Event (QRE).

Centice claimed that when looking at the total prescriptions filled, pharmacy error rates are very small, but when factored into dispensing many prescriptions over a period of time, given average pharmacy filling volumes, any prescription error that leaves the pharmacy can impact customer retention and the financial stability of the pharmacy, and could also lead to potential patient injury or even wrongful death.

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August 2, 2010

E-prescribing Usage Increases with Doctors, but Not Without Problems

As our Washington D.C. Pharmacy Error Injury Attorneys reported in a recent blog, physicians who are not prescribing medications electronically, or e-prescribing, by 2012 will be financially penalized by the federal government.

Although the use of electronic prescribing has increased in years, and evidence shows that e-prescribing can reduce pharmacy misfills that can lead to patient injury or even wrongful death, many local doctors reportedly clam that overall acceptance of this important technology is lagging.

According to a study published last week by the Washington-based think tank, the Center for Studying Health System Change, less than one-third of this country’s physicians in office settings, are e-prescribing. The study also revealed that even fewer physicians that were e-prescribing were using the beneficial aspects of the system, like searching for serious drug interactions and using the system to cross reference patient insurance for prescription drug verifications to ensure health plan payment coverage. The study also found that even fewer doctors who used the electronic system would actually prescribe medications electronically, opting to use the fax machine instead for prescription submittal.

The Institute of Medicine (IOM) claims 1.5 million people in this country are injured by preventable medication errors, with nearly 7,000 deaths every year.

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July 29, 2010

USP Advisory Panel Pushes for Prescription Label Standardization

According to the Institute of Medicine (IOM), the misuse of medication results in over one million adverse drug events every year. In a recent blog, our attorneys discussed the current efforts made by the U.S. Pharmacopeial Convention (USP) to establish a universal standard for prescription drug labels and instructions, by issuing a series of recommendations in order to add more consistency to prescription labeling—to reduce medication errors that can result in personal injury or wrongful death.

The USP is a Maryland-based nonprofit organization that issues standards that are legally enforceable for the quality, strength, and purity of medicines in this country. In 2007, the USP developed the Health Literacy and Prescription Container Labeling Advisory Panel to examine the different ways prescription drug labeling could be improved.

The IOM claims that health literacy affects ninety million adults, who are unable to benefit properly from the health care due to a lack of understanding of drug instructions and information about medication interactions. After the IOM called for new drug label standards, the USP panel recently released recommendations that are based on patient well being, and health literacy—as bad health literacy can cause medication errors, and increase the potential for heath risks and personal injury.

According to Joanne G. Schwartzberg, co-chair of the panel, standardizing the medication labels can markedly improve the health and safety of patients, by providing reliable, simple and straightforward information. The USP panel recommendations cover the appearance, content, format and languages on prescription labels, in an effort to optimize patient understanding, and eliminate medication error and misuse.

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July 26, 2010

Forum Guidance Leads FDA to Help Reduce Medication Errors

According to recent news that our Washington D.C. pharmacy error injury attorneys have been following, the U.S. Food and Drug Administration (FDA) has committed to reduce medication mistakes by publishing a draft guidance by the end of this fiscal year. The FDA states that one third of medication errors, including 30% of errors ending in deaths that are reported to the Institute of Safe Medication Practices (ISMP), may occur as a result of drug labeling and packaging.

The FDA reportedly claimed that medication errors often happen as a result of names that look alike or sound alike, encoded numerals, failure to recognize active ingredients, dangerous medical abbreviations, and name length.

In a FDA workshop last month, Carol Holquist, RPh and director of FDA’s Division of Medication Error Prevention and Analysis reportedly claimed that guidance on these medication mistake issues is an important first step to developing a consensus to form new FDA regulations, which can take around 10-15 years.

The American Society of Health-System Pharmacists (ASHP)’s director of Medication Use Quality Improvement, Bona Benjamin, also reportedly told the workshop group that the ASHP’s 2007 recommendations for the FDA are still current—that human factoring should be applied scientifically to drug packaging and labeling, and barcode verification should be encouraged, as nearly 20% of hospitals are using barcode medication verification.

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