Congress Eyes New Rules for Pharmacist Compounding
Some pharmacists are abusing their prescription drug compounding privileges by preparing medications for patients for "economic reasons rather than genuine medical need," the FDA's top drug regulator told Congress. Testifying at a new round of Senate hearings exploring whether legislation is needed to expand federal controls over pharmacist compounding activities, FDA Center for Drug Evaluation and Research Acting Director Steven K. Galson said that his agency has "seen abuses, such as large-scale drug manufacturing under the guise of pharmacy compounding." Galson acknowledged that "the vast majority of pharmacies engaging in pharmacy compounding provide a valuable medical service that is an integral part of our modern health care system." He added, however, that some pharmacists use unapproved or "experimental" ingredients in their compounded products. "In other instances, drugs are compounded even though [the] FDA has removed them from the market after determining that they were unsafe," he told Congress. "We also have seen drugs compounded that are essentially copies of commercially available products." Other witnesses at the hearings defended pharmacy's traditional right to compound medications. American Pharmacists Association President-Elect Daniel A. Herbert (a compounding pharmacist himself) called the practice "a critical component of the American health care system" that enables pharmacists to "fulfill a legitimate and essential need providing patients with medications tailored to their needs." Pharmacist Kevin Kinkade, executive director of the Missouri Board of Pharmacy, said that isolated examples of compounding abuses should not be used as an excuse to restrict the role of pharmacists. "The profession of pharmacy should not be indicted for the outrageous and demoralizing acts of one individual," he told Congress. "Criminal behavior must be dealt with separately from the enforcement of administrative laws over professional practice standards."
Independent Pharmacy Sales Surge, Study Shows
While most US businesses were suffering the effects of the national economic downturn, independent pharmacies were enjoying a solid growth surge, according to freshly released figures from the 2003 NCPA-Pfizer Digest. The report, which tracks the performance of independent community pharmacies each year, found that the average independent posted sales of $2.85 million during 2002 a 15% gain over the year before. Prescription drug sales showed even stronger growth, increasing by 22% to $2.55 million per store 90% of the average independent pharmacy's total dollar sales. Profits also improved for independents, but more modestly, according to the Digest. Gross margins in the typical independent pharmacy increased slightly to 23.5% of total sales, whereas median net profits before taxes reached 3.8% of sales?an average of $96,125 per store. Other findings from the NCPA-Pfizer Digest study were as follows:
- On average, independent pharmacists dispense 174 prescriptions per day
- They consult with physicians 7.1 times daily
- They continue to be leaders in providing disease-management services to patients
- Blood pressure monitoring is offered by 62% of independents
- Diabetes education services are provided by 41%
FDA Warns of Antidepressant Suicide Risks
The FDA is warning pharmacists and other health care professionals of new evidence that children participating in clinical trials for various pediatric antidepressant drugs may show signs of suicidal behavior. In a recent public health advisory on the problem, the FDA said that reports of suicidal thoughts and actual suicide attempts had been identified among pediatric patients taking antidepressants for major depressive disorder (MDD). Currently fluoxetine (Prozac) is the only drug labeled for use in pediatric MDD, but 8 other antidepressants citalopram, fluoxetine, fluvoxamine, mirtazapine, nefazodone, paroxetine, sertraline, and venlafaxine are being studied under provisions of the FDA Modernization Act designed to encourage research on drugs for children. (Although fluvoxamine data are being reviewed along with those of the other drugs, it is not approved as an antidepressant in this country.) "While occurrences of suicidality are not unexpected in patients with MDD, preliminary data suggest an excess of such reports for patients assigned to several of these antidepressant drugs compared to those assigned to placebo," FDA officials warned in a "Dear Health Care Professional" letter. Although the letter said that at this time "the data do not clearly establish an association between the use of these drugs and increased suicidal thoughts or actions" by children, "it is not possible at this point to rule out any increased risk of these adverse events for any of these drugs."
FDA Alerts US Consumers to Canadian Rx Recall
The sharp increase in purchases of Canadian prescription drugs by US patients has prompted the FDA to alert consumers in this country to product recalls north of the border. The first such alert was issued after 3 GlaxoSmithKline asthma medications sold in Canada Ventolin Diskus, Flovent Diskus, and Serevent Diskus? were recalled in that country "because the products' drug delivery system may not function properly and may deliver too little of the drug or none at all." The agency emphasized that Diskus products sold in the United States through "legitimate marketing channels" are not subject to this recall. FDA officials said, however, that "because some US residents have obtained prescription drugs from Canada and elsewhere through on-line or storefront operations, they may have received these potentially substandard and ineffective products."
Court Shuts Down Rx Depot Drug Imports
A US District Court in Oklahoma has slammed the door on a controversial "storefront" marketer of unlawfully imported prescription drugs, ruling that the Rx Depot chain "openly and notoriously violated the law" by engaging in pharmaceutical importing practices that "expose the public health to risk." In addition to ordering the chain to shut down its operations nationwide, the court directed the company to inform all of its customers that its "business violates the law and that the safety, purity, and efficacy of drug product obtained through [Rx Depot] cannot be assured." FDA officials said that the court's ruling "sends a clear signal that those who would put profit before safety will not be allowed to threaten the public health." Officials of the National Association of Chain Drug Stores a leading opponent of storefront Rx import operations said that the decision "affirms the FDA's rightful role in stopping prescription drug distribution schemes that endanger the safety of patients. The court's decision should send a strong signal to all individuals and so-called 'storefronts' that are engaged in the facilitation or assistance of importing prescription drugs from any place outside the United States."
Illinois Pharmacists Could Lose Immunization Rights
State and national pharmacy leaders are protesting a drive in Illinois that could strip pharmacists in that state of their authority to administer immunizations. Under a proposed new interpretation of the state's pharmacy practice act, pharmacists in Illinois would be specifically denied the right to administer flu vaccines or to participate in other immunization activities. American Pharmacists Association (APhA) officials warned that the controversial new interpretation "could disrupt the care pharmacists are providing today" to residents of Illinois. The officials told the state's Department of Professional Regulation that placing new restrictions on pharmacist immunization authority "in the midst of the influenza vaccination season" would undermine the profession's role in promoting public health. "This new interpretation would severely limit the scope of authority for pharmacist administration of medication and patient access to these vital and often lifesaving services," APhA officials said. At a minimum, they argued, the state should allow Illinois pharmacists to continue providing immunizations through the current flu season.