The genomics revolution has begun in pharmacy
It’s often the case that those in the midst of revolutionary times don’t really see how fundamentally the world around them is changing until long after the changes have occurred. So let’s start by declaring that the revolution has begun: Genomic research will dramatically transform both the practice of pharmacy and the way patients are treated with medications for many diseases.
The sequencing of the human genome was a huge scientific breakthrough, and it’s spawning additional breakthroughs as genetic testing labs spring up and the cost of testing individual patients for their ability to metabolize a particular drug drops to affordable levels for health plan payers.
A patient can now submit to a buccal swab by a pharmacist or even, in some cases, just spit in a cup. The saliva sample is sent to a lab for genetic profiling and identification of a particular gene or enzyme that will guide the pharmacist and prescribing physician to what the American Pharmacists Association calls “a new patient-specific parameter” in medication therapy. Since patients don’t respond to many drugs the same way — and a significant percentage of them can’t even tolerate some medications because their particular genetic traits create different metabolic pathways for some meds — the result will be fewer adverse drug reactions and more targeted and more effective drug therapies.
“Discoveries in genomics relevant to medication selection and management are advancing exponentially,” the APhA reports. “Genomic discoveries provide the basis for the evolution of offering care tailored to the genetic makeup of the individual — an approach that has come to be known as personalized medicine.”
Pharmacists, says the APhA, “have a tremendous opportunity to lay claim to the field.”
Look for a longer story from me about the exploding field of pharmacogenomics in the next issue of Collaborative Care magazine, a publication of the Drug Store News Group. And please take a few moments to share your own take on the science and its impact on pharmacy. If you’re a student, do you feel you’re getting the classroom and lab preparation to become proficient in this kind of personalized patient care? And if you’re already a practicing pharmacist, are you already seeing changes in some patients’ medication therapy based on genomics?
At the most recent APhA meeting in Los Angeles, there was a company that exhibited that is committed to building out a clinical service for a retail pharmacy using this exact technology. They called in a personalized medicine program and they were in the process of recruiting pharmacy partners. Their web address is: www.naturalmolecular.com.
Genetic testing for the variants of the drug metabolizing enzyme CYP2C19 is being performed routinely in some medical centers, including regional, somewhat rural centers, such as in West Central Ohio, where pharmacists are interpreting the genetic information and making recommendations based on the information. More extensive pharmacogenetic testing is being performed in many settings. Additionally, work is being done in the community pharmacy setting (J Am Pharm Assoc. 2012;52;e259–e265.) While not associated with this, I would encourage pharmacists to visit the Pharmacogenomics Education Program (PharmGenEd) online from the University of California at San Diego (http://pharmacogenomics.ucsd.edu/). There are also some CE programs available. Incorporation of pharmacogenomics into medication therapy management is a model for the community setting and has been proposed by APhA (http://www.japha.org/article.aspx?articleid=433123) Drug-gene interactions will be as common to pharmacists as are drug-drug interactions. Glad to see this subject presented here!
FDA delays approval of GSK vaccine
LONDON — The Food and Drug Administration has declined to approve a bird flu vaccine made by GlaxoSmithKline due to an administrative issue, the drug maker said.
GSK said it received a complete response letter from the FDA for its vaccine for pandemic influenza A virus monovalent adjuvanted candidate vaccine, also known as Q-Pan H5N1. The FDA issues a complete response letter when it needs additional time to review a drug application for approval.
The vaccine is designed for adults who are at risk of exposure to the H5N1 influenza virus. The program to develop the vaccine is supported by the Department of Health and Human Services’ Biomedical Advanced Development and Research Authority.
GSK said it was working with the agency to resolve the matter, and that the FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously to support approval of the vaccine.
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FDA approves Actavis drug for opioid dependence
PARSIPPANY, N.J. — The Food and Drug Administration has approved a drug for opioid dependence made by Actavis, the company said.
Actavis announced the approval of buprenorphine hydrochloride and naloxone hydrochloride dehydrate sub-lingual tablets in the 2 mg/0.5 mg and 8 mg/2 mg strengths.
The drug is a generic version of Reckitt Benckiser’s Suboxone, which had sales of about $625 million in 2012, according to IMS Health.
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