Articles Posted in Health Care Technology

As previously discussed on this blog, one of the most common errors made by prescribing doctors, or in those who input values, is accidentally increasing the dosage, such as in the entering of “10.0 mg,” when the person should have input “1.0 mg.” Even though the error is only a matter of a decimal, it could kill or severely injure a patient.

Medication errors such as these occur frequently, at an estimated one million incidents each year, contributing to 7,000 deaths.

According to recent research, the best known way for hospitals to protect patients from errors is by adopting technology called computerized physician order entry (CPOE). The way these systems work, is that when the person who is entering the prescription into the system enters the values, they are checked against the patient’s records, allergies, etc. This information is then cross referenced for safety and other measures before being sent to the pharmacy. In the opening hypothetical, a properly performing system would alert the physician to the misplaced decimal in the order. Some of the best systems may have actually prevented the order from being written in the first place.

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With the advent of new electronic means of managing patient health records, there are now additional ways in which prescription errors can take place.

For example, PCEHR, the Personally Controlled eHealth Record System, was adopted in June 2012 in Australia.It is a health information database designed for use by patients, and according to the National E-Health Transition Authority’s website, “is currently distributed across a wide range of locations including their general practices, hospitals, imaging centres, specialists, and allied health practices.” In essence, the PCEHR is somewhat like an all encompassing electronic health record of a patient. The aim of the program is to make the healthcare system more streamlined and efficient, allowing patients to effectively “share” it with relevant care providers.

A recent article entitled “Pharmacy Error Probable Cause of PCEHR Problem,” which was published appropriately enough in Australia’s eHealth Magazine, details how one woman’s PCEHR somehow received not one but two incorrect prescriptions.

The author reported that she discovered that two prescriptions had been added to her PCEHR. The prescriptions were for drugs that had never been prescribed to her, and were for medical conditions that she did not have.

The drugs were not only written into her record, but apparently were also dispensed by her local pharmacy, even though a notice regarding a consultation at the time they were allegedly dispensed was lacking. The relevant government agency encouraged the woman to inquire with the pharmacy regarding the error, and in doing so the pharmacy cancelled the prescriptions on her patient file. Within a day of the pharmacy’s correction, the woman’s PCEHR was also updated. However, the government told the woman that the same prescription had actually been dispensed on an additional occasion, from a different pharmacy.

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In an ironic finding, considering a recent article indicated that ordering drugs via a computer order entry system actually decreased the risk for error, a new study analyzed by Pharmacy Practice News concluded that Electronic Health Records (EHRs) may lead to an increase in medication and other treatment errors.

The study found that for various reasons, electronic health records may lead to more drug mistakes rather than prevent them.

The study examined the Pennsylvania Patient Safety Reporting System (PA-PSRS) database, and by utilizing specific search terms, found over 8,000 relevant reports during an eight year period. After sifting through the results, a little over 3,000 were found to have some sort of error.

Among these, the results were as follows:

  • 89% of the records were labeled “event, no harm,” meaning that the error did not result in an adverse effect on the patient
  • 10% were labeled as constituting “unsafe conditions,” which also did not result in patient harm
  • 0.48% involved some sort of temporary harm to the patient.

Of these 0.48%, the harm was caused by:

  • entering incorrect medication data
  • administration of incorrect medicine
  • ignoring a documented drug allergy
  • failing to enter lab test results
  • failure to document

One of the incidents in particular involved a failure to document an allergy to penicillin, which resulted in a significant harm to the patient.

Of all of the resultant error, 81% of them dealt with medication errors, including incorrect medication, incorrect dosage, timing, patient or route. Of the remaining errors, around 13% were regarding issues with complications of procedures, tests, or other treatments.

A common recurring problem uncovered by the researchers was the entering of data in the wrongplace, or inputting incorrect information, such as the wrong physician name.

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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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