Drug Development Articles

As California's e-pedigree requirements draw ever nearer, drug companies are scrambling to figure out how to meet the requirements. Backers have long touted the advantages of radio frequency identification technology. In one typical report, Micoh, a company that secures RFID tags, reported that 95% of respondents to a survey it conducted identified RFID as the ideal solution to protect pharmaceutical integrity. Still, according to a report from TheTimes of London, GlaxoSmithKline, which had been one of the leading proponents of RFID, is reconsidering its plans to expand the use of RFID tags to combat counterfeiting. "The question is whether it is a valid technology," a GSK spokesman told the Times. "Is it a technology that could be applied to a significant part of the business?" Another spokesman later said that the company was still testing RFID and had not given up on the technology. GSK has begun to include RFID tags for Trizivir (abacavir/lamivudine/zidovudine), an HIV drug.

Q. How do I set up a collaborative practice protocol with a physician?

John E. Dinardo, R.Ph., J.D.

A. Modern pharmacy practice has grown professionally to unprecedented levels—from traditional dispensing functions to sophisticated clinical roles. One important area is collaborative drug therapy management (CDTM), whereby, according to the National Association of Boards of Pharmacy (NABP), a pharmacist has voluntarily agreed to work with a practitioner under a protocol within which the pharmacist may perform certain patient care functions authorized by the practitioner under specified conditions and/or limitations. A collaborative pharmacy practice agreement, signed among one or more pharmacists and one or more practitioners, provides for collaborative drug therapy management of patients.

Gadzooks! This has got to be a remarkably modern idea, the proposal that there be a new class of drugs. These drugs would be initially ordered by a legal prescription written by a licensed prescriber. After that, all bets are off because medications in this new fourth class of drugs will be renewable at the pharmacist's discretion.

What a remarkably forward-looking idea. Pharmacists are perfectly capable to assist in the streamlining of the system, helping patients in need get the appropriate medications. However, you know and I know that the American Medical Association will hesitate to give up that kind of power. That organization of physicians even put up a fuss about Plan B being sold at the discretion of pharmacists. With AMA, it is all about power.

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About a dozen years ago, a Nigerian member of the International Pharmaceutical Federation (FIP) made an impassioned plea for the organization to take up the challenge of identifying and destroying the seamy world of counterfeit drugs. The call did not fall on deaf ears. Since that time activities have been carried out in many areas of the globe.

This year's FIP meeting, held in Beijing, addressed the progress in identifying and dealing with issues related to ersatz (or replacement) drug products. During a joint session of the FIP Board of Pharmaceutical Practice and the FIP Board of Pharmaceutical Sciences, representatives from the United States, the United Kingdom, China, and India presented updates on the current status of the problem.

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Get ready for a slew of vitamins and supplements that are intended to promote eye health. Here's a sampling:

Bausch & Lomb is premiering Ocuvite DF, a product intended to provide nutritional support for people with diabetes. The supplement contains genistein, a compound found in soy, as well as alpha lipoic acid, vitamins C and E, and B vitamins.

According to John Stewart, Bausch & Lomb's senior product manager for nutritionals, preclinical studies have shown that high levels of genistein slow the progression of blood vessel growth in the retina. "Diabetic retinopathy is a vascular disease of the retina. It is the leading cause of vision loss in the working age population in the United States. About 10% of people who have Type 2 diabetes get diabetic retinopathy," he said.

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With her contractions coming every two to three minutes, Michelle Tattoli wasn't sure she'd make it to the hospital in time to give birth to her fifth child.

EMS technicians weren't so sure, either. They rushed Tattoli to Saint Clare's Hospital in Sussex Borough, N.J.—a tiny 41-bed facility with no maternity department—that is less than two miles from her home. There, she labored for seven hours before giving birth to a 7-lb., 7-oz. baby girl.

Any pharmacist may be thrust into the role of "first responder" in the aftermath of a local disaster, and it is therefore prudent for all pharmacists to be prepared in advance. This article will also emphasize the "psychological precautions" as well as logistical considerations that should be followed when serving in a first responder capacity to minimize the risks of clinical errors and/or long-term adverse reactions and assist with personal preparation and planning for local disasters.

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Just days before the Medicaid tamper-resistant prescription pad rule was set to go into effect, a flurry of activity is promising to give healthcare providers a reprieve. In late September, both the Senate and House of Representatives passed bills to delay the rule's implementation for six months. The rule mandates that all nonelectronic Medicaid Rxs be written on tamper-resistant Rx pads to discourage fraud. At press time, the bill had not yet been signed by President Bush. Still, even with an extra six months to prepare, pharmacists and doctors around the country are just beginning to learn what the rule's impact will be.

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An effort coordinated by the National Heart, Lung, and Blood Institute, the National Asthma Education and Prevention Program has created a comprehensive update to their asthma guidelines. The new guide emphasizes the importance of keeping the condition under control and highlights the fact that part of the process means appropriate use of both quick-relief and long-term control medications.

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The Food & Drug Administration most emphatically is not against compounding of drugs, Steven Silverman, a key enforcement officer in that agency, told the National Association of Boards of Pharmacy recently.

Asserting that the kinds of compounding the agency brings enforcement actions against are "outliers," operations that really don't come under the rubric of traditional compounding, Silverman said, "There has been a certain amount of hysteria generated by a select few organizations" that the agency's objective is to end compounding.

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