Articles Posted in Health Care Technology

A bill introduced late in the most recent session of the U.S. Congress would have enhanced federal regulation of compounding pharmacies. The bill never made it out of its committee, but the representative who introduced it says he plans to try again in the new session. At least one state governor has also proposed a state-level bill, and a nationwide organization is conducting its own pharmacy inspections. The nationwide outbreak of fungal meningitis in late 2012, traced to a compounding pharmacy in Massachusetts, was a major factor in bringing about these actions.

Congressman Edward J. Markie, the Democratic representative for Massachusetts’ Fifth District, introduced H.R. 6584, The Verifying Authority and Legality in Drug (VALID) Compounding Act on November 2, 2012, not long before the end of the Congressional session and only a few days before the 2012 Presidential Election. It gained eight cosponsors, and was referred to the House Subcommittee on Health, where it remained, and died, at the end of the 112th Congressional Session. Given the turbulent political atmosphere in Washington DC at the time, it is perhaps not surprising that the bill gained little support or attention. Markey has stated that he intends to reintroduce the bill in the 113th Congress.

The VALID Compounding Act would give the U.S. Food and Drug Administration (FDA) authority over large compounding pharmacies, particularly those that act as drug manufacturers. Smaller “traditional” compounding pharmacies would be exempt from FDA regulation, provided that only licensed pharmacists or physicians personally compound drugs for individual patients with valid prescriptions, the pharmacy uses best manufacturing practices and approved ingredients, and it does not copy commercial drugs. Compounding pharmacies could request waivers of the three restrictions from the FDA in cases of drug shortages or if it is deemed necessary for public health. The law would also create a public list of drugs that should not be compounded, and would require labeling of compounded drugs to indicate that the FDA has not tested or approved the drug.

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

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

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Handwritten prescription slips have always presented risks to patients. The risk of a pharmacist or pharmacy technician misreading a doctor’s handwriting, sometimes known as “chicken scratch” among pharmacists, leads to the risk of a misfilled prescription. This could involve the wrong dosage of a drug, or the wrong medicine entirely, with the consequences ranging from adverse side effects, worsening of a patient’s condition, or even death. New computerized systems for doctors and other medical professionals, however, join the ever-increasing number of electronic solutions to common human errors. These systems can help combat not only pharmacy errors, but also prescription fraud and prescription drug abuse.

Electronic prescriptions, or e-prescriptions (e-Rx), allow a doctor to write a prescription by submitting a request to a pharmacy online, rather than writing out the prescription on a prescription pad. A 2010 study mentioned by the New York Times, which examined handwritten prescriptions from doctors, physician assistants, and nurse practitioners in New York, found a thirty-seven percent error rate for handwritten prescriptions, not including legibility errors. The study found legibility errors in eighty-eight percent of the handwritten prescriptions. These errors can result in a patient receiving the wrong dosage or the wrong medication. They may also result in the pharmacy needing extra time to consult with the prescribing doctor or professional to sort the matter out, which could cause harm to a patient in urgent need of a particular medication.

Congress promoted the use of e-Rx in the 2009 Health Information Technology for Economic and Clinical Health Act (HITECH Act), passed as part of that year’s economic stimulus bill. The HITECH Act establishes certain acceptable uses for electronic medical records, giving regard to issues of patient privacy and the security of patients’ personally identifying information. It specifically names e-Rx as an approved use.

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Online 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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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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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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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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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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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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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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