Given that the system has not yet registered all of the participants in the new drug benefit program, this tactic is not working. In addition, across the country there are many other state funded programs, such as Medicaid, that are paying for claims that Medicare should have been handling. This has caused great concern for many state funded programs.

The lower income populations, disabled and senior citizens have been the most affected. Studies have shown that senior citizens have been overwhelmed with the particulars of the program.

Many are turning to their pharmacist for answers, but pharmacists are faced with the same problem: confusion. Pharmacists have spent countless hours on the telephone over the past few weeks verifying people's plans and putting charges through to the new insurance program. In the process many pharmacists are discovering that patients are not getting the medications they need. The amount of effort it takes to solve this glitch is prolonging the timeframe for a patient to receive their medication.

The main problem seems to be that the government has made the process too complicated for the people who use Medicare Part D. There seems to be more glitches than expected especially since this program was enacted in December 2003. With any luck these issues should be smoothed out over soon.

NEW DRUGS SET TO GO GENERIC

TREND TOWARDS GENERIC DRUGS WILL SAVE PATIENTS AND PHARMACIES MONEY

Over the next year and half, over 18 prescriptions will go generic, and half of those will turn out to be significant cost savers.

In the next several years, patents for more than 200 drugs will expire, including drugs representing the five most costly drug classes—antihyperlipidemics, gastrointestinal, antidepressants, antihypertensive and antidiabetics. This list will also include calcium blockers and beta blockers. This represents an opportunity to manage drug costs.

Most patients are aware that generic drugs are cheaper. In a 2002 study by ChangeWave, over 59 percent of consumers said they ask their doctor if a generic drug is available when receiving a prescription. Another study done by the AARP found:

• 84 percent of Americans believe generics are an important part in controlling rapidly increasing drug costs
• Two thirds of respondents said they usually choose generics over brand names when available
• 90 percent said they were willing to accept generic drugs as a way to reduce their drug costs

To make sure generic drugs are safe, the Federal Drug Administration conducts over 3,500 inspections per year in all pharmaceutical manufacturing firms to ensure that standards are met. The FDA sets strict guidelines and quantity standards to ensure that a generic drug acts in the body with the same strength and rate of absorption as the brand name drug. Generic drugs must meet these strict FDA criteria in order to be considered therapeutically equivalent to brand names.

But note that generic drugs purchased from other countries or over the Internet from sites outside the United States are not regulated by the FDA.

Generic drugs are becoming more popular with consumers. Studies have shown that global sales of generic drugs will rise from $29 billion in 2003 to $49 billion in 2007. Generic drug sales are projected to increase an average of 14 percent per year.

The savings from generic use accrue to both plan sponsors and members. On average, a generic drug costs approximately $45 less than brand drugs, and each 1 percent increase in generic fill rate is estimated to decrease pharmacy spending by nearly 1 percent. Members also pay a lower co-payment for a generic drug, saving an average of $10 on each prescription.

Savings opportunities from increased use of generic drugs have never been greater. Moreover, the opportunities are expected to continue though 2010 as more than $55 billion in brand drugs are scheduled to lose patent protection over the next six years.

FDA Updates

New Drugs

New Drug Warnings, Label Updates and Withdrawals

• Serevent (salmeterol xinofoate inhalation powder), Advair (salmeterol/ fluticasone propionate): The FDA has requested the manufacturers of these three products add new warning information and create medication guides for patients regarding the increased risk of severe and possibly fatal asthma episodes.
• Ortho Evra (ethinyl estradiol/ norelgestromin): The labeling for Ortho Evra has been updated to warn healthcare providers and patients that this transdermal contraceptive exposes women to higher levels of estrogen than most birth control pills. Higher levels of estrogen have been proven to increase the risk of blood clots.

Pipeline Updates

• Two drugs being monitored in the pipeline were recently approved:
• iPlex (mecasermin rinfabate) was approved 12/12/05 for the treatment of severe primary IGF1 deficiency, a condition that affects children and results in growth failure
• Nexavar (sorafenib) was approved 12/20/05 for the treatment of advanced kidney cancer
• Orencia (abatacept) was approved 12/23/05 for the treatment of rheumatoid arthritis
• FDA is set to review Daytrana (methylphenidate transdermal system) for the treatment of attention deficit and hyperactivity disorder (ADHD) on 12/28/05. Daytrana, if approved, will be the first new delivery system for ADHD drug. All current treatments are taken orally.