Legal News

The Food and Drug Administration's "Medication Guide" program, set up nine years ago as a major avenue of informing patients about risks or special issues with certain drugs, has a host of problems, according to pharmacists and other witnesses at a recent hearing.

In proposed legislation that could save millions of taxpayer dollars in drug costs, the U.S. Senate is considering extending current 340B program discounts to include inpatients.

Delegates at the National Association of Boards of Pharmacy debate ePedigrees, medical errors, and Internet pharmacies

RFID progress still slow; ezScriptWriter for legible Rxs; reducing drug diversion through ImageWare Forensic Medicine Technology; Know Your Number health-risk addessment tool; e-prescriptions grow

The FDA is weighing whether to allow a system for electronic insert information for most prescription drugs, replacing paper Rx inserts.

Some state legislatures move to increase Medicaid dispensing fees in preparation for the implementation of the new Medicaid AMP rule

Chronically underfunded, these agencies struggle to meet their responsibilities while fighting state and federal groups for control.

At press time, the Senate has passed the Food & Drug Administration Revitalization Act (S. 1082), which gives the FDA more powers to require manufacturers to conduct postmarketing studies to improve patient safety.

Hospitals should hold manufacturers accountable for their drug claims in their contracts

The use of intravenous (IV) syringes for non-IV applications such as enteral feedings poses many risks, especially for the pediatric and neonatal population which has a majority of their oral and enteral doses provided through a gastric tube. The Baxa Corporation recently announced the launch of a new educational campaign to make healthcare providers aware of these problems and offer solutions.

CMS issues final rule for competitive acquisition program for DMEPOS suppliers

The use of intravenous (IV) syringes for non-IV applications such as enteral feedings poses many risks, especially for the pediatric and neonatal population which has a majority of their oral and enteral doses provided through a gastric tube. The Baxa Corporation recently announced the launch of a new educational campaign to make healthcare providers aware of these problems and offer solutions.

CMS officials urge pharmacists to get NPI numbers and health plans to develop contingency plans.

Less than two months before a May 23 deadline, CMS has finally offered public recognition that many healthcare providers may not be ready for the changeover to the National Provider Identifier (NPI) standards.

The clinical success of an ongoing pay-for-performance (P4P) pilot project by the Centers for Medicare & Medicaid Services requires extensive participation by health-system pharmacists.

Now that we have electronic record technology, how should we set up a postmarketing surveillance system for drugs, biologicals, and medical devices?

Diabetes is a deadly, common and costly disease, so the debate about biogenerics is ardent when it concerns insulin. The drug is expensive and indispensable, and scientists agree that creating generic insulin is simpler than creating most other potential biologic equivalents.

A group of researchers at the University of Florida College of Pharmacy recently submitted a citizen's petition asking the Food & Drug Administration to increase the maximum allowable dose of phenylephrine (PE) from 10 mg to 25 mg and to withdraw approval of phenylephrine for children under 12 years of age. The petition also called for additional research to validate the safety and effectiveness of the higher recommended dose.

Pharmacy industry critics are "gravely concerned" that the Safe Drug Compounding Act of 2007, a draft Senate bill, would sharply curtail the practice of compounding by giving the Food & Drug Administration authority to regulate compounding. A coalition of nine pharmacy organizations drafted a letter to the bill's expected sponsors-Senators Edward Kennedy (D, Mass.), Pat Roberts (R, Kan.), and Richard Burr (R, N.C.)-insisting that the bill "would negatively impact patient access to necessary compounded prescription medications and create onerous, new requirements for prescribers and pharmacists."

The National Community Pharmacists Association is warning that implementation of a proposed rule for reimbursement for generic drugs through Medicaid may result in many pharmacies pulling out of the program or going out of business. Citing the results of a recent Government Accountability Office study and its own internal polling of members, Bruce Roberts, NCPA executive VP/CEO, warned that under the new rule patients would face a "serious danger of losing access to lifesaving prescriptions. What we're faced with is not a natural disaster but a public policy disaster."

Seeking to provide hard data on the efficacy and impact of medication therapy management (MTM) sessions, a Florida Quality Improvement Organization (QIO) is studying the MTM results of Humana and AvMed Medicare patients in that state. The Florida Medicare Quality Improvement Organization (FMQAI) is working with the two prescription drug plans (PDPs) and pharmacists to set up the programs and educate patients and will publish its results in late 2007. FMQAI is the third-largest QIO in the country and has the second-largest beneficiary population.

NIOSH, the National Institute for Occupational Safety and Health, is updating its list of hazardous pharmaceutical products. The new list will become part of the organization's 2004 alert, Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings.

When Michelle Rutledge, Pharm.D., heard about the fatal shooting of a hospital pharmacist at Shands Jacksonville hospital in Florida last November, it really hit home. The victim, 37-year-old Shannon McCants, was a fellow graduate of the Florida A&M College of Pharmacy. McCants was shot by a customer who was waiting for a prescription to be filled in the outpatient pharmacy. Rutledge, an associate investigator at the James A. Haley VA Hospital in Tampa, said that e-mails from former student-colleagues began pouring in.

Last month, the House Ways and Means Committee held a hearing on patient safety and quality issues regarding end-stage renal disease (ESRD) treatment. In his opening remarks, outgoing committee chairman Rep. Bill Thomas (R, Calif.) acknowledged that Medicare payments for the treatment of ESRD increased by almost 50% between 1998 and 2003. In fact, epoetin alfa (Epogen, Amgen) has been identified as the single largest drug expenditure in Medicare Part B each year.

South Carolina officials looking to reduce costs in the state Medicaid program have tapped pharmacists to help in the effort by improving drug selection and adherence. The South Carolina Department of Health & Human Services is offering a $1.98 million grant to the South Carolina College of Pharmacy (SCCP) to implement the program, which will focus on Medicaid patients diagnosed with mental health disorders, HIV/AIDS, or cancer.

The Food & Drug Administration continues to warn pharmacies that compounded medications are new drugs under FDA jurisdiction. The FDA is insistent, despite a U.S. District Court ruling in August 2006 that called into question the federal agency's authority to regulate compounded medications. In at least eight instances covering a range of compounded medications, the FDA has warned pharmacies that the compounded drugs either posed danger to patients or too closely resembled FDA-approved products.

State and federal authorities are increasingly cracking down on pharmacies for fraud, waste, and abuse

Consultant pharmacists are busy preparing to implement the Centers for Medicare & Medicaid Services' newly revised survey guidance for Pharmacy Services and Unnecessary Medications (F-Tags 329, 425, 428 and 431) in Appendix PP of the State Operations Manual (SOM). CMS released the revised guidelines on Sept. 15, with the changes scheduled to become effective on Dec. 18. They represent the first substantive changes in these sections in nearly seven years.

Are you liable for technician mistakes?

In a move that surprised both compounding proponents and advocates, the American Medical Association Board of Trustees adopted a resolution calling for Food & Drug Administration oversight of pharmacy-compounded bioidentical hormones. The resolution, which, according to sources at the AMA, passed with little opposition, also included an amendment that called on the FDA to regulate the use of the term bio-identical hormones.