April 15, 2014

FDA Approves Prescription-Based Antidote for Overdose of Heroin, Other Opioids

by Lebowitz & Mzhen

Naloxone_%281%29.JPGThe U.S. Food and Drug Administration (FDA) approved a “hand-held auto-injector” device for use with known or suspected opioid overdoses. Abuse of opioids, a group of drugs that includes many prescription painkillers, is becoming a serious problem in the U.S., and the FDA claims that opioid overdose has surpassed automobile accidents as the nation’s leading cause of injury deaths. The device, marketed under the brand name Evzio, delivers an injection of naloxone hydrochloride to counter or reverse the effects of opioid overdose. The FDA has stated that it hopes the availability of the device with a prescription will help prevent overdose deaths in emergency situations.

Opioid analgesics are a family of opiate-based drugs commonly used in prescription painkillers. They are derived from the same source as heroin and several other illegal narcotics. Common opioids include codeine, hydrocodone, morphine, and oxycodone. Opioids can be very addictive, so they are tightly controlled by the government. According to the Centers for Disease Control and Prevention (CDC), 16,651 people died of drug overdoses involving opioids in 2010, the most recent year for which statistics are available. This number accounts for about seventy-five percent of all drug overdose deaths that year. Many overdoses involve legally-obtained prescription painkillers. The total number presumably includes intentional and accidental overdoses, as well as dosage errors by a physician or pharmacist.

Evzio, as approved by the FDA, is a handheld device that injects naloxone hydrochloride, an “opioid antagonist” that is a common treatment for opioid overdose. Emergency responders often carry naloxone-containing products for use with suspected overdose victims. Since Evzio is only available with a prescription, it must be obtained in advance of any emergency situation. It is recommended for family members and caregivers of people using opioid painkillers in case of overdose. The device provides verbal instructions for use once it is turned on. A single dose of naloxone, according to the FDA, does not last as long as a typical opioid, so it cautions that the device is not a substitute for medical attention. What the device can do is delay further injury or death due to an overdose until medical attention is available.

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April 8, 2014

FDA Proposes New Guidelines Regarding Off-Label Promotion of Drugs

by Lebowitz & Mzhen

Vaseline_Drug_Facts.jpgThe U.S. Food and Drug Administration (FDA) recently issued draft revisions of pharmaceutical industry guidelines regarding “off-label” promotion of drugs. “Off-label” refers to information about uses of a drug that have not been formally approved by the FDA and are not included in its approved labeling. The agency has treated off-label promotion as “misbranding,” which can carry both civil and criminal penalties under the Food, Drug, and Cosmetics Act (FDCA). The Second Circuit Court of Appeals struck down the conviction of a pharmaceutical sales representative for conspiring to introduce a misbranded drug into interstate commerce, finding that the off-label promotion rule violated his First Amendment right to free speech. United States v. Caronia, 703 F.3d 149 (2nd Cir. 2012). The FDA’s proposed revisions, published in the Federal Register at 79 FR 11793 (Mar. 3, 2014), seek to apply a narrower set of restrictions on off-label promotion.

The FDCA generally prohibits “misbranding” of an approved drug. In a “Guidance for Industry” document published in January 2009, the FDA addressed the distribution of medical literature and other scientific publications regarding off-label uses of approved drugs. The FDA has strict labeling requirements for all approved drugs, including risks of side effects and complications and instructions for use. Off-label marketing of a drug, the FDA stated in the guidance document, constitutes unlawful misbranding of a drug because the drug’s label does not include “adequate directions for use,” as required by the FDCA. 21 U.S.C. § 352(f), 21 C.F.R. § 201.100(c)(1).

The defendant in Caronia was charged with conspiracy to introduce a misbranded drug, and introducing a misbranded drug, into interstate commerce. 21 U.S.C. § 331(a). If a defendant had the “intent to defraud or mislead,” the offense carries a maximum penalty of three years in prison, a $10,000 fine, or both. 21 U.S.C. § 333(a)(2). The case involved Xyrem, a central nervous system depressant with only two FDA-approved uses. The drug contains GHB, a powerful depressant commonly known as the “date rape drug,” making it one that the FDA closely watches.

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March 26, 2014

Public University Collaborates with Private Drugstore Chain on New Model of Patient Care

by Lebowitz & Mzhen

UCSF_Medical_Center_and_Sutro_Tower_in_2008.jpgA national pharmacy chain has partnered with a medical school and a pharmacy school to open a store that will explore a new model for patient care. The “Walgreens at UCSF” store, located on the University of California, San Francisco campus, is reportedly designed to enable extensive communication between pharmacists and patients. Substantial numbers of people in the U.S. take prescription and over-the-counter medications on a daily basis, and medication errors are a significant cause of injuries and deaths. Various hospitals and other medical facilities are trying out different models of care in an effort to reduce the number of medication errors, and the severity of the injuries they may cause, as much as possible.

The central idea behind Walgreens at UCSF, like many other experimental programs, is the importance of communication between patients, physicians, and pharmacists. Few pharmacies are designed with one-on-one pharmaceutical counseling in mind, and pharmacists tend to remain in the back of the store. The store includes a 1,200-square-foot area with numerous private consultation areas, which pharmacists can use to meet with patients. UCSF describes a concierge desk where patients can check prescriptions and set up pharmacist consultations. Pharmacists employed by both the university and Walgreens will work side-by-side. Rather than simply dispensing medications, pharmacists would work with patients to help them understand how to take medications properly, and provide them with a better overall picture of their health.

According to UCSF, citing the Centers for Disease Control and Prevention (CDC), eighty-two percent of people in the U.S. take medication on a daily basis. Twenty-nine percent take at least five medications per day. Medication errors can occur at any stage of the treatment process, with doctors making a prescription error, pharmacies dispensing the wrong medication or wrong dosage, and patients not following the directions for their medication. UCSF cites statistics from the National Consumers League stating that three-fourths of Americans do not always follow medication instructions, while about one-third do not always take prescribed medications at all. Medication errors cause as many as 1.5 million injuries, 700,000 emergency room visits, and 7,000 deaths every year, at a cost of around $3.5 billion.

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March 19, 2014

Study of "Collaborative Pharmaceutical Care" Finds 3/4 Reduction in Hospital Medication Errors

by Lebowitz & Mzhen

Trinity_College_Library_-_long_room.jpgA new study, conducted in Irish hospitals and published in a British journal, reviewed the effectiveness of a “collaborative” model of managing hospital patients’ medications. The model, known as the Collaborative Pharmaceutical Care in Tallaght Hospital (PACT), involves close involvement of clinical pharmacists in all stages of patient care during their stay in the hospital. The study, which was uncontrolled, found that PACT resulted in a reduction in the rate of medication errors by more than three-fourths.

The study was published in the online edition of the British Medical Journal Quality & Safety on February 6, 2014. The researchers compared the benefits of PACT to “standard ward-based clinical pharmacy,” with a focus on adult hospital patients receiving acute care, who were prescribed at least three medications in the hospital, and who left the hospital alive. The study included 112 patients receiving care based on PACT, and 121 patients receiving standard care. They measured the rates of medication errors and of potentially severe errors per patient.

According to the description provided in the study, the primary goal of PACT is to reduce the rate of medication errors that commonly occur when a patient is transferred between doctors or departments within a hospital, or transferred from one facility or organization to another, by improving the process of “medication reconciliation” (MedRec). This involves comparing a patient’s current medication orders to the medications a patient has been taking in order to prevent omission of a necessary drug, inclusion of an unnecessary or dangerous drug, or incorrect dosages.

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March 12, 2014

Over-Prescribing of Antibiotics May Be Putting Hospital Patients at Risk

by Lebowitz & Mzhen

Staphylococcus_aureus_VISA_2.jpgMedication errors, such as dispensing the incorrect dosage of a medication or the wrong medication altogether, are unfortunately common occurrences in hospitals and local pharmacies all over the country. Doctors can make errors by prescribing the wrong dosage or the wrong medication. A recent report by the Centers for Disease Control and Prevention (CDC) found that a significant number of antibiotic prescriptions may be unnecessary, prescribing either too much of a drug or a drug that the patient does not need. Overuse of these medications may be causing additional health problems for some patients, but doctors and pharmacists may be able to work together to improve service to patients and reduce the risk of errors and injuries.

The CDC’s Vital Signs report for March 2014 discusses antibiotic prescriptions in hospitals. Its three main findings are rather troubling. First, the report states that over half of all patients receive antibiotics in some amount during a hospital stay. Next, it states that hospitals vary widely in the amount of antibiotics they prescribe for patients, with doctors in some hospitals prescribing up to three times as many antibiotics as those in other hospitals. Overuse of antibiotics can have a negative impact on patients’ health, according to the CDC’s report, including growing antibiotic resistance and potentially deadly bacterial infections. Its third main finding is that reducing the use of antibiotics classified as “high-risk” could bring a corresponding reduction in these infections.

Antibiotics are used to treat bacterial infections. The CDC reports that the most common uses for antibiotics are to treat lung infections, urinary tract infections (UTIs), and infections by methiciliin-resistant Staphylococcus aureus (MRSA), an increasingly-common drug-resistant form of bacteria. As many as one-third of antibiotic prescriptions written for UTIs, the CDC found, contained errors, such as insufficient testing or diagnosis, or courses of treatment that were too long. Bacteria can build up resistance to antibiotics, as demonstrated by MRSA infections, and excessive or unnecessary antibiotic prescriptions add to that problem.

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March 5, 2014

Proposed Laws Increasing Ratio of Pharmacy Technicians to Pharmacists Could Adversely Impact Patient Safety

by Lebowitz & Mzhen

Mail_order_pharmacy_dispensers.jpgPharmacies often rely on a team of medical professionals to meet the demands of customers. These teams consist of pharmacists, who must meet educational and licensing requirements in all U.S. states and the District of Columbia; and pharmacy technicians, who are not always subject to such strict credentialing requirements. Some states set a maximum ratio of pharmacists to pharmacy technicians, while others simply require that the pharmacist have adequate support from staff and technology to perform their professional duties. Pending legislation that would increase the number of technicians that can work under a pharmacist has raised concerns about patient safety.

To obtain a pharmacy license, an individual must obtain a degree from an accredited pharmacy school, pass several examinations, and maintain continuing education requirements. Many states do not require as many credentials to work as a pharmacy technician. Maryland requires a person to have a high school diploma or equivalent, complete a 160-hour training program or obtain certification from a national pharmacy organization, and complete annual continuing education. Supervision of pharmacy technicians by licensed pharmacists is critically important to patient safety.

According to a report by Tampa’s WFTS on pending legislation in Florida, errors occur in an estimated 0.09 percent of all prescriptions filled in the United States. While this seems like a small number, the Kaiser Family Foundation estimates, based on data from 2011, that doctors write more than 59 million prescriptions per year in Maryland alone. That means that more than 53,100 pharmacy errors may occur per year in this state. Most of these errors do not cause any harm, but injuries from pharmacy misfills can be severe.

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February 27, 2014

Washington DC News Investigation Finds Multiple Medication Errors at National Pharmacy Chain

by Lebowitz & Mzhen

Kirby_Lester_KL30_pharmacy_automation_counting_%26_verification_system.jpgIn a report on its investigation of the national pharmacy chain CVS/pharmacy, Washington DC’s NBC affiliate, News 4, claims to have found numerous alleged medication errors and other problems. Consumers reported receiving the wrong prescription and, in at least one case, meeting with indifference from employees. A former CVS pharmacist with more than thirty years at the company filed a whistleblower lawsuit last year, alleging in part that the company fired him in retaliation for reporting his concerns about an increasing rate of medication errors due to staff reductions. CVS has denied the allegations against it and publicly stated its commitment to protecting patients’ health and safety.

Washington’s News 4 reported a woman’s claim that CVS made a mistake when refilling her prescription for potassium citrate, which she took for her kidneys. She noticed that the pills did not look familiar, and saw that the pharmacy had given her a bottle of potassium chloride instead of citrate. The pills look similar and have similar names, but they have very different uses. Potassium chloride is used to treat hypokalemia, or low blood potassium, and can cause serious, even fatal, complications for some kidney patients. The woman claimed that when she notified the pharmacy manager of the mistake, he responded “Well, potassium is potassium.”

The report also looked at automatic refills, a service offered by CVS and other pharmacies. This allows the pharmacy to refill a prescription at regular intervals, so that the patient does not have to call and request a refill. Problems may occur, however, if the pharmacy refills prescriptions that the patient does not want or need. An elderly patient told the news team that he ended up with more Lidoderm patches, which contain an extremely strong painkiller, than he wanted, based on the auto refill system. This could lead to confusion for some patients, who might not realize that they are receiving medications they did not request.

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February 20, 2014

Pharmacy Allegedly Dispenses Adult's Prescription to Child with the Same Name, Resulting in Near-Fatal Drug Reaction

by Lebowitz & Mzhen

Typical_antipsychotics.JPGThe family of a five-year old boy in the Chicago area is claiming that a case of mistaken identity resulted in the boy receiving the wrong medication and suffering a near-fatal reaction with possible long-term health effects. They have filed a negligence lawsuit in Cook County Circuit Court seeking $50,000 in damages. Pharmacies and the medical professionals they employ owe a duty of care to consumers to verify not only the type and dosage of medication dispensed, but also that the correct patient receives the correct medication.

The child reportedly had a routine checkup with a physician in January 2012. The doctor discussed allergy medication with the boy’s parents, but did not write a prescription at that time. A Walgreens pharmacy allegedly called the family two days later to tell them that their prescription was ready. Believing it to be the allergy medication they had discussed with the doctor, the boy’s mother picked the prescription up and began giving it to him according to the instructions on the bottle.

The lawsuit, filed in January 2014, states that the boy slept for almost two full days after taking the medication. When the child woke up, he exhibited unusual symptoms. His neck flared, leading his parents to call 9-1-1, but it soon subsided. The boy later fainted, so his parents took him to the doctor, who told them to go immediately to the hospital. The prescription that they thought was for allergies, they learned, was actually haloperidol, an antipsychotic medication intended for an adult with the same name as the child.

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February 13, 2014

Hospital Uses "Storytelling" Approach to Prevent Medication Errors

by Lebowitz & Mzhen

file0002003501002.jpgA hospital in Houston, Texas has adopted a “narrative-based approach” of communicating the details of medication errors to hospital staff (login required). A medication safety consultant employed by the hospital found that the prior approach, which relied on unit managers to pass along information to their teams, was not leading to greater institutional knowledge about how to avoid medication errors. The new approach involves the production of short videos detailing the issues that led to a specific medication error. The success of the program is difficult to measure, as it is based solely on self-reporting by hospital leaders who seemed to perceive a substantial reduction in medication errors during the eight-month pilot program. The program bears some similarities to how many attorneys approach claims for pharmacy and medication errors, as a narrative story told to the judge and the jury.

MD Anderson Cancer Center ran a pilot program from October 2012 to June 2013. Every month, a team consisting of a nurse, a pharmacist, and a patient safety specialist would review recent medication errors to identify important concerns. They would decide on three events or issues, and another multidisciplinary team would pick one to use in a video. The hospital’s communications department would handle the actual production, including writing a script, shooting and editing the video, and formatting it into a PowerPoint presentation.

Once the hospital administration approved the final video, it would be uploaded to the hospital’s intranet. The hospital’s various department heads and team leaders would be notified of the new video. The leaders would then be responsible for showing the video to their teams. The hospital produced one video a month for eight months. Hospital leaders reportedly accessed the videos more than 3,500 times during that period, and eighty-three percent of them showed the videos during staff meetings. A majority of leaders said in survey responses that the videos were a “very” or “extremely” successful means of communication. The hospital permanently adopted the program, and has expanded it to share other information besides medication errors.

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February 6, 2014

Hospital Allegedly Gives Infant Incorrect Dosage of Medication for Meningitis Treatment

by Lebowitz & Mzhen

file8421285496858.jpgThe parents of an infant allege that a California hospital is responsible for injuries that required their child to go on life support. Hospital staff reportedly administered far more than the prescribed dosage of medication while treating the child for meningitis. Doctors, nurses, pharmacists, and other medical professionals have a very high degree of responsibility to their patients and the public. A catastrophic injury can result from a seemingly simple pharmacy error, such as a misspelled word or a transposed digit that causes a patient to receive far too much, or not nearly enough, of a drug.

According to news sources, the child was born several weeks premature. He was calm and quiet at first, but began to get “fussy” when he reached one month old. A doctor diagnosed him with viral meningitis, an infection of the membranes around the brain and spinal cord that can be debilitating or fatal if not treated promptly. The child’s parents took him to a hospital for treatment.

A physician at the hospital prescribed an antiviral medication called Acyclovir. After the drug was administered, the hospital pharmacist reportedly told the family that the child had accidentally received about ten times the prescribed amount. The child’s heart stopped several hours later, and his brain started swelling. According to the most recent reporting, he had some brain activity but required the use of a ventilator. The child’s father said that hospital staff told him there was not much more they could do for the child, who was by then six weeks old. One possible option, as described by the press, was for the hospital to provide a ventilator the child could use at home.

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January 30, 2014

Consulting Pharmacist Owed No Duty of Care to Nursing Home Resident Injured Due to Nurse's Transcription Error

by Lebowitz & Mzhen

Ativan05mg.jpgIn order to recover damages for injuries caused by a pharmacy error, a plaintiff must prove that the defendant breached a duty of care that it owed to the injured person. A state appellate court ruled that the husband of a nursing home patient who died due to a medication error could not recover damages from a third-party pharmacy services company or the consulting pharmacist. Thompson v. Potter, 268 P.3d 57 (N.M. App. 2011). The patient’s death, according to the plaintiff’s complaint, was caused by a nurse’s transcription error that resulted in an incorrect medication dose. The court held that the defendants had no authority or control over the nurse, and that they therefore did not breach a duty of care directly to the decedent. With no duty of care, they could not be held liable for negligence or malpractice.

The patient was admitted to a long-term nursing care facility in Alamogordo, New Mexico in February 2004. Her doctor diagnosed her with early dementia and prescribed Ativan, an anti-anxiety medication, to manage her agitation and prevent seizures associated with dementia. The doctor instructed the staff to administer Ativan three times a day and on an as-needed (“PRN”) basis. On January 10, 2005, the doctor told a nurse to discontinue the PRN dose. The nurse transcribed the doctor’s order incorrectly, resulting in written instructions to discontinue the three-times-a-day Ativan dose. The patient missed twenty-one regular doses, suffered a grand mal seizure and a fractured hip on January 17, and later died.

The patient’s husband sued the company contracted by the nursing home to provide pharmacy services and its registered pharmacist, asserting causes of action for breach of contract, negligence, and negligence per se. He did not sue the nursing home, the doctor who prescribed Ativan and changed the dose instructions, or the nurse who made the transcription error. The plaintiff alleged that the sudden withdrawal of Ativan caused his wife’s seizure, and that the injuries sustained due to the seizure caused her death. The defendants breached a duty of care in their capacity as providers of pharmacy services, the plaintiff claimed. The trial court granted the defendants’ motions for summary judgment on all of the plaintiff’s claims.

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January 22, 2014

Pharmacist Can Give Expert Testimony About Physician's Duty to Obtain Informed Consent, Maryland Appellate Court Rules

by Lebowitz & Mzhen

Johns_Hopkins_Hospital.jpgA pharmacist may offer expert testimony in a wrongful death lawsuit regarding a physician’s alleged failure to obtain a patient’s informed consent, according to a ruling by the Maryland Court of Special Appeals. Fusco v. Shannon, 63 A.3d 145 (Md. Spec. App. 2013). The trial court excluded testimony from the plaintiffs’ expert witness, a pharmacist, holding that he was not qualified to offer an opinion on a physician’s professional duties. The case went to trial without the pharmacist’s testimony, and the jury found in favor of the defendants. The appellate court reversed the judgment and remanded the case to the trial court.

The decedent, Anthony Fusco, Sr., was eighty-two years old when he received a diagnosis of “low-risk” prostate cancer in 2001. By early 2003, he and his doctor decided to begin a course of treatment that included radiotherapy. He met with a doctor who explained the nature and risks of radiation treatments, including possible inflammation of surrounding organs. The doctor referred him to Dr. Shannon to prescribe a protectant medication to reduce the risk of radiation damage. Dr. Shannon prescribed Amifostine, and would later claim that he explained the risks associated with the drug, such as nausea, skin reactions, and blood pressure issues.

The Amifostine treatments began in April 2003 and continued for about a month. He received twenty-three injections, seemingly without incident, but on May 17, 2003, the day after receiving his twenty-fourth dose, Mr. Fusco was hospitalized with a severe skin reaction. He was diagnosed with Stevens-Johnson syndrome, a rare but serious skin condition, which Dr. Shannon suggested was a reaction to the Amifosine. After several hospitalizations, Mr. Fusco died of a stroke allegedly resulting from Stevens-Johnson on December 4, 2003.

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