Pharmacy Legislation

April 23, 2018

The Effectiveness of a New Law Absolving Negligent Pharmacists of Criminal Liability Is Questionable

Medical errors, including Maryland pharmacy errors, are commonly believed to be one of the leading causes of death in the United States. However, the actual number of pharmacy errors is up for debate because, as is the case in Maryland, most states do not require pharmacists to report the vast majority of the errors that occur.

Under the laws of most states, pharmacists need only report errors that end up causing an “adverse medical event.” Essentially, this means that an error does not need to be reported unless the patient suffers some kind of harm as a result of the error. Thus, errors that are caught before the medication is delivered to the patient do not need to be reported.

It is widely believed, however, that the best way to reduce errors is to learn from common mistakes. In most professions, the industry can learn from many common errors as a whole, meaning that pharmacists in Maryland may develop a better way to prevent an error and can share that new method with other pharmacists nationwide. However, in order for that learning process to work, pharmacists must be open about the number and types of errors.

January 22, 2018

Major U.S. City Takes Steps to Reduce Pharmacy Errors

by Lebowitz & Mzhen

Maryland medical errors – including misfilled prescriptions – are one of the leading causes of death in the state and across the country. Indeed, a 2016 study by Johns Hopkins concluded that, if properly tracked, medical errors would be the third-leading cause of death in the United States. However, due to the fact that the law allows for voluntary reporting of most errors, many Maryland pharmacy errors go unreported.

According to a recent industry news report, Chicago is taking affirmative steps to combat the growing number of pharmacy errors. The city’s actions follow a report by a local paper indicating that of the 25 pharmacies surveyed, over 50% committed at least one error. The city’s attempts are premised on the longstanding and verified belief that the more prescriptions a pharmacist fills per shift, the higher is the chance that the pharmacist will make a medication error in the type, dose, or administration of a drug.

In an attempt to reduce future errors, Chicago lawmakers have proposed a number of pharmacy regulations. For example, one proposed regulation limits the total number of prescriptions a pharmacist can fill by hour to 10. Another regulation requires that pharmacists who have been working in excess of eight hours notify patients as they fill their prescription. Lawmakers have also proposed that pharmacists be required to take one 30-minute lunch break and several 15-minute breaks per eight-hour shift.

June 29, 2017

Pharmacy Error Rates May Be Artificially Low Due to a Lack of Mandatory Reporting Requirements

by Lebowitz & Mzhen

Chances are anyone who has followed the news over the past few months has noticed at least one serious pharmacy error occurring at either a hospital or a retail pharmacy. Indeed, the Food and Drug Administration estimates that there is on average one death per day in addition to approximately 1.3 million people harmed per year by pharmacy errors. However, these statistics are only estimates because the real number of errors cannot be determined, due to discretionary reporting requirements.

As the law stands now, pharmacies are not required to report most of the errors that their pharmacists make. While some errors come to the public’s attention due to widespread press coverage or because a pharmacy error victim files a personal injury lawsuit, many errors go unreported. Thus, the true number of pharmacy errors is unknown.

According to a recent article, our neighbors to the north in Ontario, Canada have begun to implement mandatory reporting requirements. Evidently, the change in the law was spurred on by the death of an eight-year-old boy last year. The report indicates that the boy suffered from sleeping problems and was prescribed tryptophan by his pediatrician. The boy’s mother called in the prescription and went to pick up what she thought was tryptophan, but what she was given was actually baclofen, a powerful muscle relaxer. After the boy’s death, the coroner reported that “logic would dictate that baclofen was substituted for tryptophan at the compounding pharmacy in error.”

April 8, 2014

FDA Proposes New Guidelines Regarding Off-Label Promotion of Drugs

by Lebowitz & Mzhen

The 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.

March 5, 2014

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

by Lebowitz & Mzhen

Pharmacies 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.

May 13, 2013

Florida Considers Bill Potentially Impacting Patient Safety

by Lebowitz & Mzhen

Last month, the Florida House of Representatives passed a bill, by a vote of 101 to 16, that would double the number of pharmacy technicians each pharmacist can supervise from three to six. pills%20in%20hand.jpg

The pharmacists remain responsible for signing off on all of the medication orders, regardless of whether they fill them personally or a trained pharmacy technician fills them under supervision.

Opponents of the bill argue that it puts corporate profits at more of a priority than patient safety.

Under current law, pharmacies have to petition the State Board of Pharmacy in order to have each pharmacist supervise more than one, up to three, technicians. But the bill would allow up to six techs per pharmacist without any prior board approval. Thus, the bill is essentially eliminating the current oversight, and creating the opportunity for a six fold increase in the number of techs without requiring any special application process.

Critics further point to the incidences of pharmacy error that are occurring with the 1:3 ratio, and imply that this would only become more prominent with less oversight.

Major pharmacy retailers, such as Walgreen’s, CVS and Publix, support the bill, claiming that they operate in several states which do not have any mandated ratios, and according to their statistics do not have a difference in quality across these different states. If pharmacies are able to hire more pharmacy technicians, who are paid much less than pharmacists, their potential profits could rise because they could sell more medicine in the same amount of time.

February 27, 2013

Serious Safety Concerns Regarding Compounding Pharmacies Reveal Recurring Bacterial Outbreaks

by Lebowitz & Mzhen

The lack of comprehensive regulations regarding compounding pharmacies is cause for great concern. For example, records and other documents show that grave safety lapses, such as that which occurred at a Massachusetts pharmacy last fall linked to a deadly meningitis outbreak, was not an isolated occurrence. Alarming revelations predate the New England Compounding Center’s contaminated steroid shots, which were linked to 45 deaths and 651 illnesses.

Compound pharmacies are entities which compound certain drugs for use in hospitals and the like, which are then used to treat patients. Examples of such compounds include intravenous fluids used to treat various conditions. Compound pharmacies evolved out of the need for hospitals to have readily available intravenous drugs, that couldn’t conveniently and accurately be compounded on site.

A Washington Post analysis reveals unsanitary and loose practices at large specialty pharmacies that have in turn been linked to illnesses and deaths over the past 10 years. The Post reviewed hundreds of documents, including lawsuits and FDA documents, and found serious issues with at least three of the fifteen large scale compounding pharmacies that dominate the industry.

January 26, 2013

Lawmakers Attempt to Strengthen Regulation of Compounding Pharmacies

by Lebowitz & Mzhen

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.

October 9, 2012

Appellate Court Denies State Access to Pharmacy’s Medication Error Data, Citing Federal Privacy Laws: Department of Financial and Professional Regulation v. Walgreen Company

by Lebowitz & Mzhen

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.

June 14, 2012

Court Rejects State Effort to Obtain Patient Data In Pharmacy Error Investigation

by Lebowitz & Mzhen

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.