Articles Posted in Pharmacy Legislation

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.

Continue Reading

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.

Continue Reading

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.

Continue Reading

The lack of comprehensive regulations regarding compounding pharmacies is cause for great concern. For example, records and other syringes.jpgdocuments 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.

Continue Reading

Dpk-meningitis-exserohilum2.jpgA 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.

Continue Reading

5294_6589.jpgA 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.

Continue Reading

PharmacistsMortar.jpgAn 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.

Continue Reading

320px-Plane_crash_into_Hudson_River_%28crop%29.jpgThe 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.

Continue Reading

Prescription_Sigmund_Freud.jpgHandwritten 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.

Continue Reading

987822_95717228_01242012.jpgOnline 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.

Continue Reading

Contact Information