Personalized Prescribing in Action: Case Study

You don’t need genetic information to benefit from YouScript™!

A 62-year-old male doctor whose health conditions, at the time, included hyperlipidemia, erectile dysfunction, dental carries, and insomnia. His daily medications consisted of aspirin, Lipitor, Viagra (as needed), and chlorhexidine mouth rinse, also valerian root, melatonin, and Benadryl for sleep. Along with coffee and energy drinks, the subject had been taking over-the-counter medications including: fish oil, coenzyme Q10, Niacin 1000mg, L-carnitine, Voltaren gel (purchased from Mexico) and IBU 400-600 mg daily as needed for need pain. He had no known drug allergies.

His ophthalmologist instructed him to start taking the over-the-counter herbal medications Wobenzyme, red yeast rice, curcumin powder, and grape seed as supplements.

Soon after adding the supplements to his daily regimen, the doctor began to experience muscle aches, pains, and flu-like symptoms.

Unfortunately, the ophthalmologist had advised the doctor to take substances that interacted with the prescribed medications he was taking. The interactions were severe and based on the report may have been early signs of rhabdomyolysis.

Had either the doctor or the ophthalmologist utilized YouScript™ prior to initiating the OTC herbals, they would have seen the following interactions:

·         Red yeast rice contains the compound lovastatin which is in the same class of drugs as Lipitor. The subject was already on high dose Lipitor. This combination alone could have resulted in the adverse reactions described. This combination is not advised.

·         Levels of lovastatin may be increased up to 150% by grape seed due to 3A4 inhibition. Levels of Lipitor might also be increased but to a lesser extent. This interaction could also help explain the adverse reaction the patient had.

·         Clinical studies show that co-administration of niacin and lovastatin has been found to increase the risk of rhabdomyolysis. The lovastatin product insert recommends no more than 20 mg daily when niacin levels exceed 1 gram per day – however, since the patient was taking lovastatin in a non-standardized form, it is unknown how much he was truly receiving.

Once the doctor stopped taking the drugs and herbal preparations recommended by his ophthalmologist, the problems resolved.

You don’t need a patient’s genetic information to benefit from YouScript™. It is a powerful algorithm-based program that can help patients and practitioners predict clinically significant drug interactions before they happen. YouScript™ predictions are based on clinical studies and the most up to date expert opinions in the field.

Identifying Twins: DNA Straight Talk

Some may not see the value in knowing the difference between identical and fraternal twins, but to the parents of twins, it can matter a great deal. It’s a part of their children’s identity.

Unfortunately, according to a new study, a fair number of parents were misinformed due to a common misconception that twins who gestate in separate placentas are fraternal. Actually, 25-30 percent of identical twins have separate placentas and amniotic sacs.

A 2004 survey among members of the American College of Obstetricians and Gynecologists found that 81 percent of doctors were under this misconception. This new study, published in the journal BJOG this past February, showed 14.7 percent of  the 1,302 parents of same-sex twins were misinformed that their twins were either identical or fraternal.

The type of twins was confirmed through DNA testing, which may be a lesson learned for the future. With the availability, accuracy, and simplicity of DNA testing, the “rule of thumb” no longer need apply.

“I think there are a lot of parents who just want to know. A lot of parents finding out later on felt they just didn’t know their own children.” -Abi Fisher,an author of the study

New Look, New Brand, and New Pharmacists

After more than a decade, the medical and insurance communities are beginning to embrace DNA-based analysis as a powerful tool in selecting and optimizing pharmaceutical treatments. Genelex has been a consistent front-runner in these technologies.

GeneMedRx and our drug sensitivity tests are combining under our new YouScript™ brand. Over the next few months, you’ll notice changes in our informational materials and a major upgrade to our services.

Tyler Mamiya & Paul Verbeurgt  

For those who haven’t taken advantage of GeneMedRx, our new YouScript™ Personalized Prescribing System is a comprehensive, long-term solution for safer, more targeted prescribing. Most patients taking a series of drugs have genetic variations that affect their ability to process those drugs – to either eliminate or activate them. This includes most classes of routinely prescribed drugs, over-the-counter medicines, many herbal preparations, and some dietary supplements and foods. Cytochrome P450 testing detects those genetic variations.

Now, whenever a major or significant drug-drug or drug-gene interaction risk is noted, YouScript™ will generate a medication advisory report including potential alternative drug or dosing recommendations based on the patient’s DNA test results and overall medication regimen.

To bring more clarity to the prescribing process, we have a new team of clinical pharmacists: Paul Verbeurgt and Tyler Mamiya. They are busy analyzing patient medication regimens, DNA test results, and recommending specific actions to help improve prescribing outcomes. They are available to help prescribers, patients, and other pharmacists understand specific cases and to guide users in getting the most out of the YouScript™

system.

We’re celebrating the evolution of our state-of-the-art personalized prescribing services. We encourage you to join in the excitement, and the opportunity to improve patient care, by taking advantage of our new services today!

Happy Holidays from everyone at Genelex!

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Pharmacogenomics in Clinical Practice: Where Do We Go From Here?

In an interview with Medscape, Mark J. Ratain, MD, Professor of Medicine at the University of Chicago and Founding Director of the University's Center for Personalized Therapeutics, pointed out that pharmacogenomic testing needs to move from the realm of reflex lab testing to part of the physical exam….

“I think we need to take genetic testing out of the domain of laboratory testing and move it to the domain of physical examination. It can then be one more piece of information for the physician to consider and we wouldn't need to focus on the cost.”

“There are a lot of things we do during a physical examination that have never been demonstrated to be cost-effective. Physicians look at their patients' toes as part of an annual physical. Have you ever seen a study that shows that looking at your toes is cost-effective?”“We need to conceptualize genetic testing as a part of the physical exam rather than as a laboratory test that needs to be ordered so you can have the information at the time you are seeing the patient. For example, if you're starting a patient on warfarin, or you are considering whether to start him on warfarin, and you already know that he is going to metabolize warfarin a lot more slowly or that he's going to be a lot more sensitive to it, you can take that into account in the same way you would probably use a lower dose if your patient were frail or elderly. That is where I think the field needs to move.”

“The solution is one that we are piloting here, which is to genotype all patients for all polymorphisms that may affect drug response. You'll then have the results when you need them and your costs will be much lower than doing each test as a one-off laboratory test.
In the current system, you see the patient and want to prescribe a drug, and you say to yourself, ‘Maybe I should order a pharmacogenetic test. But I don't know how to do that, I don't know how long it is going to take to get results, and I don't know if my patient is going to get reimbursed for it. Oh, who cares. I am just going to prescribe the drug.'

“Unless someone says that you can't prescribe the drug without doing the test, or unless we change the way we look at how pharmacogenomic testing should be incorporated into clinical practice, the system is unlikely to change.”

DNA in the News

Another case-control study published in October pointed out increased risk of stent thrombosis for patients taking Plavix with variations in a gene called CYP2C19. Patients with adverse events were two times more likely to have half of the gene be non-functional. Called intermediate metabolizers, this represents about one-third of patients. Patients with no CYP2C19 function, called poor metabolizers, were seven times more likely to have an adverse event. About 2-4% of Caucasians, 10% of Africans, and 20% of Asians are poor metabolizers. If you or a loved one is taking Plavix, ask about DNA Drug Sensitivity Testing.

See more at theheart.org/article/1300023.do

Bringing Personalized Prescribing to the Community Pharmacy

An interview with Brian Hocum, PharmD of Wasem’s Pharmacy who has recently made personalized prescribing available to at-risk customers.

Why do you think genetics is important?
I tell my patients that through DNA technology, we are able to determine what type of drug metabolizer they are. I explain how this information can be used to help predict if they are at risk of having bad reactions to drugs (too much drug exposure) or poor response to drugs (too little exposure to the medication). Genetics is important because it allows Health Care Providers, like myself, to predict who will have “bad reactions” or “poor responses” to medications.

How would you define personalized prescribing in your own words?
‘Personalized prescribing” is the analysis and incorporation of patient specific factors (i.e. CYP450 metabolizing capacity–derived from DNA testing) prior to prescribing, dispensing and/ or choosing new medications (including OTC, vitamins, herbals) and doses. While we typically think of “prescribing” as something only Physicians do, I feel “personalized prescribing” is something we can all embrace; Physician, Pharmacist & Patient.

Why did you decide to launch this program at Wasem’s?
As a Pharmacist working in a community pharmacy, my number one goal is to serve the patients of the community. Our services are what bring patients into the store and they are what keep them coming back for years. Keeping patients safe through more informed medication and dose choices is the best service we can provide and “personalized prescribing” is the best tool I know of to do so.

What efforts have you made to educate physicians and patients in your community about personalized prescribing?
We have in the past and continue to educate the community through newspaper advertisements, co-marketing posters and speaking with community volunteer groups like the Rotary, Lion’s club and retirement centers.

Since pharmacists are able to order laboratory tests in Washington State for the purpose of monitoring drug therapy, I often find that the prescribers are unacquainted with “personalized prescribing.” I send them a fax describing what the genetic results mean, and any alternate medications or dose adjustments that they might considered based on the results. The response has been all positive. Doctors are noting the recommendations in their patient charts. I plan to host a dinner soon for Health Care Providers to educate them about “personalized prescribing.”

You have now made several successful interventions on a patient’s behalf; can you share one of these stories?
Yes, here is one of the first testimonials I received after a successful pharmacogenetic intervention. This patient struggled with adverse drug reactions her whole life, and was relieved that science and technology are finally beginning to understand and incorporate “personalized prescribing:”

“Thank you so much for guiding me through the new way to approach medication. Armed with the letter to my health care provider, I feel confident that finally my doctor will be able to adjust some of my medications. Maybe some day genetic testing will be a routine procedure before prescribing meds. How much misery and money could be saved if we get it right the first time…”