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Legally Speaking

 

Issue: February, 2005
Author: Roxanne Homar, R.Ph.

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Get Educated On Your Medications

Recently there has been some controversy over the Food and Drug Administration’s (FDA) approval process for new drugs and the tracking of safety information. This was prompted by the recent removal of Vioxx (rofecoxib), a medication used to treat pain and inflammation. Concerns about the increased risk of heart attack and stroke caused the drug manufacturer to remove Vioxx from the market. This has led to questions regarding similar products as well as several other medications, and increased scrutiny of the FDA’s process for drug approvals and safety tracking in general.

The Food and Drug Administration (FDA) has processes in place to review drug entities for both effectiveness and safety. A brief description of the new drug approval (NDA) process and post approval safety monitoring follows.

New Drug Approval (NDA) Process
All new drugs marketed in the United States are approved through the FDA. It is an extensive process and the FDA estimates it takes approximately 8.5 years to study and test a new drug before it is approved for general use and marketing.

The initial stage of the new drug approval (NDA) process is called “pre-clinical” research and involves animal testing. The purpose is to develop adequate data to support a decision to move forward with human trials.

If a drug entity makes it past the pre-clinical stage it will enter the next step, the “clinical studies” phase. During the clinical studies phase the NDA must provide sufficient information for the FDA reviewers to believe that the drug is safe and effective for proposed use. The FDA reviewers want to know that the benefits of the medication outweigh the risks and that it is reasonably safe to proceed with human trials.

According to the FDA website the results of this testing comprise the single most important factor in approval or disapproval of a new drug.

Post Approval Safety Monitoring
The FDA maintains post-marketing surveillance and risk assessment programs to identify adverse events that did not appear during the clinical trial period. The clinical trial period involves smaller numbers of individuals than those who would be exposed when the medication is available to the general public. In addition, the people chosen to participate in clinical trials must meet specific criteria and those with other underlying conditions are normally excluded. Therefore, other side effects and/ or adverse events may appear when a medication is available to more people who may have other underlying conditions.

The FDA uses the Adverse Events Reporting System (AERS) and the Medwatch program for tracking and communicating safety problems and adverse events to the medical community.

The most recent controversy involving the removal of Vioxx, brought into question the FDA’s processes for approving and monitoring the safety of medications. Dr. David Graham, a 20 year veteran of the FDA, testified to the Congressional Senate Finance Committee that “the FDA as currently configured is incapable of protecting America against another Vioxx". Graham contends the FDA has an inherent conflict of interest that triggers "denial, rejection and heat" when safety questions emerge about products it has approved. Dr. Graham’s testimony ignited a firestorm of speculation about the FDA and its medication safety monitoring.

New information has surfaced regarding a survey conducted by the Department of Health & Human Services Office of Inspector General. The survey was conducted two years ago but was recently released after two public interest groups filed a freedom of information act to obtain it. The survey's results echo the concerns of Dr. David Graham.
The survey indicates that more than one third of FDA scientists have some doubts about the process for approving new drugs.

In addition, two-thirds of the FDA scientists surveyed were not highly confident that the FDA "adequately monitors safety of prescription drugs" once on the market. One in five said they'd been "pressured to approve" a drug "despite reservations about its safety" or other concerns, according to a CBS report.

According to Dr. Graham the five most worrisome drugs that demand action include:

• Meridia – A medication moderately effective for weight-loss. Do the benefits outweigh the risks of higher blood pressure and stroke among people taking it? "I don't think Meridia passes that test," Graham said.

• Crestor - An anti-cholesterol medication. Dr. Graham believes the government should evaluate the occurrence of renal failure and other serious side effects among people taking Crestor.

• Accutane - A medication used to treat severe acne. It is a very effective medication, but can cause birth defects. The problem is that pregnancies continue to occur despite strict registration programs and mandatory pregnancy blood tests. Graham said the drug represents a 20-year "regulatory failure" by the FDA and sales should be restricted immediately.

• Bextra - An anti-inflammatory medication used mainly for arthritis or other joint pain. Graham said the drug poses the same heart attack and stroke risk as Vioxx. He recommended designing studies to look at the drug's cardiovascular risks.

• Serevent - An asthma treatment which can lead to increased risks when used improperly. Dr. Graham said that Serevent was shown, with 90 percent certainty in a long-term trial in England, to cause deaths due to asthma. "We've got case reports of people dying, clutching their Serevent inhaler," Graham said. "But Serevent is still on the market."

The comments from Dr. Graham raise some issues of concern for consumers. All medications carry some level of risk associated with their use. It is up to the patient and his health care team (physicians, pharmacists, etc.) to evaluate this risk and decide what is best for the patient. Ideally, the patient should play an active role in treatment decisions, including medication usage. At a minimum an educated consumer should know the following about his/ her medication regimen:

• The name and strength of all medications;
• How to take the medication and for what length of time;
• What the medication is prescribed for; and
• Potential side effects of the medication and what to do if a side effect occurs.

Wyoming has developed an innovative program called the WY PharmAssist program to help educate consumers about their medications. Many people take five or more medications, increasing their risk of side effects, and have difficulty paying for their prescriptions. Circuit pharmacists are in place throughout the state to conduct comprehensive assessments for qualified individuals. The program is available for a nominal fee of $5.00 and is not restricted by age, insurance status or income. Consumers may access the program by calling 877-246-4114.

In addition, Wyoming’s AARP program’s website has a terrific resource for medication information called the “Rx Resource Center”. The information can be found at http://www.aarp.org/states/wy/. An educated consumer or caregiver provides one of the best defenses against medication problems. Get educated!


Roxanne Homar, R.Ph., is the State Pharmacist for the Wyoming Department of Health. In this capacity she supervises a staff of five and oversees the Medicaid pharmacy program, the state funded pharmacy program called the Prescription Drug Assistance Program (PDAP), the statewide pharmacist consultation program called WY PharmAssist, and works with other areas throughout the department on pharmacy related issues. Ms. Homar also serves as the policy advisor on prescription drug issues for the department.

Mrs. Homar has worked for the Department since 1997 and has held the positions of Deputy Administrator for Medicaid Primary Care services and, the Medicaid Pharmacy Program Manager. Prior to this she worked as a dispensing pharmacist for a large chain.

Mrs. Homar is tasked with providing information to the legislature on topics related to prescription drugs, such as escalating Medicaid prescription drug expenditures, cost containment strategies, and prescription drug coverage for low income seniors.

Mrs. Homar received a Bachelor of Science degree in Pharmacy from the University of Wyoming and is an adjunct professor for the Wyoming School of Pharmacy. She is currently pursuing her Doctor of Pharmacy degree from the University of Kansas. She is a member of local and national pharmacy associations and was named the 2000 Distinguished Young Pharmacist by the Wyoming Pharmacist Association.


     

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