Articles Posted in Pharmacy Legislation

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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A pharmacy resisted a subpoena from Illinois regulators seeking information on medication errors, citing a federal law that encourages pharmacies to track medication errors, but protects the confidentiality of those records. The trial court agreed with the pharmacy’s position in Department of Financial and Professional Regulation v. Walgreen Company, 970 N.E.2d 552 (Ill. App. 2nd Dist. 2012), and granted its motion to dismiss the subpoenas. The Illinois Court of Appeals affirmed the ruling, finding that federal law privileged the medication error records from disclosure to the state government. Although federal law encourages pharmacies to track medication errors, it limits the uses to which the government may put the resulting records.

The Illinois Department of Financial and Professional Regulation (DFPR) issued three subpoenas to Walgreens in July 2010, seeking reports of medication errors involving three specific pharmacists in Walgreens’ employ. It petitioned the circuit court to enforce the subpoenas in October 2010. Walgreens quickly moved to dismiss the petition, claiming that the records sought by the DFPR were privileged under the Patient Safety and Quality Improvement Act of 2005 (PSQIA).

The PSQIA provides mechanisms for reporting and analyzing a wide array of medication error data. The law provided for the establishment of Patient Safety Organizations (PSOs) under the Agency for Healthcare Research and Quality (AHRQ). PSOs are independent organizations that gather and analyze medication error reports from doctors, pharmacies, hospitals, and other health care facilities within a designated geographic area. They cooperate and collaborate with the AHRQ and other PSOs with the goal of developing improvements in patient safety and reductions in the number of medication errors. The PSQIA provides that all reports made by pharmacies and other organizations to their local PSO are “patient work product,” and therefore are privileged from disclosure.

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An appellate court in Illinois has rejected an effort by the state’s Department of Financial and Professional Regulation (DFPR) to obtain quality control reports from a pharmacy. Walgreens Pharmacy refused to comply with a subpoena from DFPR seeking information on several pharmacists under investigation. Walgreens argued that producing the reports would violate patient privacy rules. Under 2005’s federal Patient Safety and Quality Improvement Act (PSQIA), pharmacies are encouraged to report information on prescription misfills and other medication errors to groups known as patient safety organizations (PSO). The law provides that these reports, intended for use in promoting patient safety, are protected from discovery or disclosure. The court ruled that Walgreens’ quality control reports fall under the PSQIA’s protection.

DFPR was conducting an investigation of three pharmacists employed by Walgreens. On July 1, 2010, it served a subpoena on the company, requesting “incident reports of medication error involving” the three pharmacists. Walgreens objected in writing and refused to comply with the subpoena. DFPR filed a petition in circuit court seeking judicial enforcement of its subpoena on October 8, 2010.

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The National Transportation Safety Board (NTSB), the federal agency that reviews highway and aviation accidents and makes recommendations for safety regulations, could serve as a model for an entity to monitor patient safety, according to a number of celebrities and other advocates. A medical journal article co-authored by actor Dennis Quaid and airline pilot Chesley B. “Sully” Sullenberg III argues for the creation of such an entity to apply lessons of previous medication errors and other mistakes towards the prevention of future problems. They cite the NTSB’s success at recommending effective revisions to airline safety regulations.

In an article published in the March 2012 issue of the Journal of Patient Safety, Quaid and Capt. Sullenberg join a medical doctor and an attorney in calling for creation of a safety board for patients. All four authors have experience as jet pilots, and all four have experience in aviation safety. Quaid additionally has endured a medical “near-death experience” with his twin children. They describe a “healthcare financing crisis” due in part to inefficient healthcare spending and waste, based on decisions made by corporate boards and administrators rather than doctors. They recommend adoption of “best practices” based on past experience, similar to the way the aviation industry has improved safety with the assistance of the NTSB.

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

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

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

The FDA’s guidelines address unsolicited requests from consumers for information about “off-label” uses. Generally, companies should not directly answer questions posted online about off-label uses, but should refer people to their websites or hotlines for more information. Answering such questions, the FDA says, is not unlawful per se, but could count as “evidence of a new intended use.”
Major pharmaceutical companies, or “Big Pharma,” spent $1 billion on online marketing in 2011, according to Ad Age. This number is expected to keep increasing, but it still represents a small percentage of pharmaceutical marketing. The industry expected clear, definitive guidelines on social media use, but got something more vague. The FDA has stated that, because of the ever-evolving nature of social media, it will not issue platform-specific guidelines for each social media service. It says it plans to issue further guidelines in the future.

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

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

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

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

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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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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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