by brant bullard | Aug 8, 2016 | News
Pharmacogenomics can play an important role in identifying responders and non-responders to medications, avoiding adverse events, and optimizing drug dose. Drug labeling may contain information on genomic biomarkers and can describe:
- Drug exposure and clinical response variability
- Risk for adverse drug events
- Genotype-specific dosing
- Mechanisms of drug action
- Polymorphic drug target and disposition genes
The table below lists FDA-approved drugs with pharmacogenomic information in their labeling. The labeling for some, but not all, of the products includes specific actions to be taken based on the biomarker information. Pharmacogenomic information can appear in different sections of the labeling depending on the actions. For more information, please refer to the appropriate labeling guidance.
Biomarkers in the table include but are not limited to germ-line or somatic gene variants, functional deficiencies, expression changes, and chromosomal abnormalities; selected protein biomarkers that are used to select patients for treatment are also included.
This table does not include non-human genetic biomarkers (e.g., microbial variants that influence sensitivity to antibiotics), or biomarkers that are used solely for diagnostic purposes (e.g., for genetic diseases) unless they are linked to drug activity or used to identify a specific subset in whom prescribing information differs. For drugs that are available in multiple dosage forms, salts, or combinations, a single representative product is listed. In the case of combination products, the single agent associated with the biomarker is listed unless the agent is only approved as a combination product, in which case all agents are listed. ~FDA
See complete list of drugs at: FDA.com
For more information on pharmacogenetic testing, contact:
PGx Medical
info@pgxmed.com
405-509-5112
by brant bullard | Mar 3, 2016 | News
Maintaining a healthy mind, body, and spirit is as important to the caregiver as it is older adults.
Making sure your elderly family member is taking the right medications is important to getting them up, out and active.
A recent survey of 17,000 Medicare beneficiaries found that 2 out of 5 patients reported taking five or more prescription medicines.
According to Drugwatch.com, adults 65 and older often take multiple medications, both prescription and over-the-counter (OTC) drugs. When people take more than one drug at the same time, it is called polypharmacy. While medications are intended to improve lives and relieve symptoms, in some cases they cause more problems.
Older adults may also fail to take the drugs in the proper way because they lose track of them, and sometimes certain drugs may interact with each other, causing additional symptoms and health problems.
By 2030, about 72 million people will be 65 or older. Today’s seniors live longer than before, which makes it important to make your extra years as fun-filled and pain-free as possible.
Adverse reactions attributable to prescription drug use cause an estimated 100,000 deaths and more than two million serious reactions in the United States each year, costing the healthcare industry more than $136 billion annually.
The PGx Medical Metabolic Validation Program can help reduce unnecessary medications and the risk for adverse drug reactions (ADR). A simple swab of the cheek can tell your healthcare provider what medications your body is able to metabolize which eliminates the trial and error process. This test can improve clinical outcomes and reduce the overall cost of prescription drugs by enabling better drug selection, earlier favorable results and lower rates of ADRs.
For more information, contact PGx Medical at (405) 509-5112 or info@pgxmed.com. www.pgxmed.com
by brant bullard | Dec 20, 2015 | Journal articles
Personalized medicine is an area of medicine that is only moving in one direction, forward. The more we know the better our care will be.
What works for one person does not always work the same way for someone else. So it should not be a surprise that people and their prescription drug outcomes are not created equal.
In a recent article in prescriptionintelligence.com, they discuss our genes and how they can impact a drug’s effectiveness and its potential side effects. Before DNA testing became widespread in forensics, and crime shows blanketed over primetime broadcast television, distinguishing bloodtypes was the most effective forensic tool. In the mid 20th Century, if a common blood type was found at a crime scene it would be little help to the investigation, but if a rare blood type was discovered the forensic science would be significant. DNA profiling has completely changed every aspect of forensic science. Genetic mapping and pharmacology are having a similarly ascendant moment in medicine. Everyday brings a new discovery and there is plenty of work remaining, but the importance of these advances are indisputable. Genetics will only prove to be more and more important in individual patient care.
Full genetic mapping for every patient is currently impractical and unaffordable. Even if doctors had every patient’s genome mapped, not all information is relevant when considering drug interactions and effectiveness. However there are certain genes and genetic expressions where current science has a depth of knowledge. In these areas, genetics and drugs have fostered gene-specific treatments, and further advancements will only broaden the understanding of genetic differences when prescribing medication. As the science and expense of genomic mapping improves, prescription drug outcomes guided by pharmacogenetics will improve and costs should be lowered across all areas.
Specific genes impact liver function, and different people have different outcomes with medications based on certain genetic predispositions. These variations in genetic expression are called polymorphisms. Many drugs are broken down by the liver and they can be separated into two categories: drugs that enter the body in an active or inactive form.
For drugs that are already in an active form — which means that the drug has immediate effect on the body — enzymes in the liver break the drug down to make it inactive, so the body can then discard it.
Genetic variations within liver metabolism can cause some patients to have decreased metabolism or increased metabolism of the drug, resulting in increased or decreased efficacy, and effecting variation in side effects or interactions with other drugs.
The other category of drugs enter our bodies in an inactive state as a pro-drug, and are activated when they are broken down in the liver. The liver enzymes that break the drug down are critical to making it work. For drugs that are converted into an active [form] in the liver, genetic variations can mean that a person needs to take a different kind of drug entirely.
In this scenario it has been discovered that some drugs are significantly more effective than others in reducing negative outcomes. The way the body absorbs a medication impacts not just the proper dose for optimal care, but the prescribed medication itself. Genetic information can lead to better outcomes and the applications are very real in many areas of pharmacological science.
The public sector is invested in personalized and genomic medicine. President Obama’s 2015 State of the Union Address called for the launch of the Precision Medicine Initiative. Just recently the NIH announced it “has committed up to $72 million in preliminary funding opportunities for the [PMI] in 2016.”
With a public policy backing and a clear economic initiative, personalized medicine will be a major component of future health science. The medical and financial benefits will be hard to predict, but the impact will be enormous. With the rate of scientific discovery and advancement of big-data in every area of healthcare, it is easy to foresee genomic mapping improving the outcomes of medical treatment while reducing the costs once benefits are mainstreamed. The future may already be here, but it is far from being fully explored:
It is easier to imagine a future where one hundred would seem like a small number of drugs with pharmacogenetic labels. Genetic data will soon become ubiquitous in every element of care. New genetic discoveries and market forces will increase efficiency and lower costs, hastening the advent of mainstream precision medicine.
For more information on pharmacogenetic testing, contact:
PGx Medical
Individualized Care – Personalized Medicine
Info@pgxmed.com
405-509-5112
source: prescriptionintelligence.com
by brant bullard | Nov 15, 2015 | Testimonials
Below are testimonials we’ve received from doctors, directors of nursing, pharmacists and government officials regarding our medication management program, via pharmacogenetic testing.
PGx Medical is the trusted and experienced resource for the implementation of pharmacogenetics in the field of aging services.
Pharmacogenetics aligns current and future medication with each persons unique genetic profile.
As we work alongside long-term care communities, clinics and pharmacies, we have the privilege of receiving success stories on how pharmacogenetics has impacted residents, patients, family and staff.
Pharmacogenetic Testing Addresses Clinical Concerns Such As Falls, Dementia, Sleep, Pain And Overall Staff Efficiencies.
We recently implemented pharmacogenetic testing and feel it is very easy to administer. The test results are helpful when dosing or treating our residents, and saves our staff time and frustration as providers by making sure our patients are on the correct medications. On average, approximately 90% of our patients need a dose change, med change or to discontinue a medication after testing.
We had one patient we had tried so many SSRI/SNRIs and after her PGx test, we were able to find the right medication regimen and now she feels great! We would recommend this program to anyone who has patients on multiple medications. ~Rachel Moore, PA-C~
I have found the pharmacogenetic test to be very useful for patients in my clinic practice as well as my nursing home patients. It is quick to use! In fact, my nurses do all of the work and then they go thru the results and alert me of the medications that are less likely to work for those patients. It takes no time for me at all! The paperwork is very minimal and nurses can fill it out. It takes less than a minute to swab the inside of both cheeks. Then it gets mailed off and the results come back in just a few days.
I had a patient in my clinic that had seen multiple doctors, a psychiatrist and several counselors for her depression. She had tried many medications to help her depression but she complained that none of them made her feel better. We did a pharmacogenetic test and found out that the patient had a gene mutation that kept ALL of the antidepressants from working. No wonder she never felt better with the medications! From the test results we found some alternative medications that could be used to treat her depression. She was so relieved that there was a really good reason for the previous anti-depressants not to work.
I had a patient who had shoulder surgery who kept complaining that the Hydrocodone did not help his pain. The Naproxen actually did better in controlling his pain. We did a pharmacogenetic test and found out that Hydrocodone does not work well for his pain but Naproxen works best. This is helpful information if he ever has to use pain medication again.
I had a patient who complained that his pain meds were not working at all and would ask for more and more. I suspected he was a drug seeker but could not prove it. We did a pharmacogenetic test on him and discovered ALL of the narcotics work well for him. We now know he is a drug seeker and treat him appropriately.
The PGx Medical Pharmacogenetic test is helpful if a patient is not responding to a medication as well as we think they should. This helps us chose appropriate medications that are more likely to work and avoid those that may cause problems for the patient. It is very helpful with resistant depression, psychosis and ADHD medication failures. I am even starting to use the testing first before prescribing any medication. Patients love the testing because we can avoid the medications that are not likely to work or those that could cause adverse reactions; they get on the right medications quicker with less trial and error. Insurances like it because it saves them money by getting quicker results without multiple medication changes.
Nursing Home surveyors encourage nursing homes to use the pharmacogenetic testing on patients to try to keep patients off of multiple medications and to use those that work well. It also decreases the adverse reactions and helps keep patients off of anti-psychotics or at least on minimal doses of anti-psychotics. ~ Dr. Jami Benton ~
“The PGx Medical pharmacogenetic test program has yielded great results at our home. It is now a fully implemented tool my clinical staff reviews with all of our residents. The reports are easy to understand with clear actionable recommendations. I am thankful we were allowed to be the first to have such a tool to use here at our home. Each resident deserves our very best.”~Treva, MD~
“Seems too good to be true, but always produces positive results. I utilize the testing daily now in my practice. For Geriatrics provides the tool for easy medication adjustments. The reports are not complex. Very beneficial for identifying the effectiveness of analgesics in residents who are unable to communicate. There are residents that we may have labeled as ‘drug seekers’, and when the DNA test report is returned we discover that the analgesic they were prescribed is not being metabolized in their body and they are getting no relief from their pain. So they have legitimate pain and the analgesic has not been effective in reducing their pain. This test only has to be performed on each resident one time in their life. That makes it very cost effective. And the reimbursement process has been very easy. The families love it! It tells them exactly what their loved one metabolizes and what is best for them”. The DNA Test results give confidence to the residents that they are being prescribed the correct medications. Yes, would highly recommend this program! CMS should mandate the test for all residents on Antipsychotics!” ~Dr. Mike M, Long Term Care Physician~
“It is important to me to ensure that each of our veterans in all of our State VA homes are cared for on an individual basis. I was excited to learn of the potential the PGx Medical Pharmacogenetic Program offered and I brought it forward to our administrative and clinical teams, as it seemed to be a ‘no brainer’ for our homes to implement. I’ve heard nothing but positive results and praises of both the Program and PGx Medical.” ~Maj Gen (ret) Secretary of Military and Veterans Affairs~
“This DNA Testing has been a Win-Win for both the residents and families! By utilizing the DNA test results we know exactly which medication is effective for the residents. It is a tremendous cost saver on medications. Not all people that we think are ‘pain seekers’ really are. We had one resident that kept begging for more and more pain meds. We did the DNA Swab Test on her and the test revealed that she was metabolizing zero percent of the pain medication. So she was truly in pain. We are such Believers in this program! It is a wonderful Marketing Tool! We can advertise that we provide the best care possible for residents on these medications!”~Brenda W. Clinical Manager~
“I was privileged to introduce the PGx Medical Pharmacogenetic Testing Program to the Oklahoma Department of Veterans Affairs. As a State Representative, I felt this program was in the best interest of each of our Veterans living in the seven ODVA homes, and to those who are in the homes caring for and assisting them everyday. This program has been exceptional and has produced wonderful results while helping the homes practice a level of personalized care that was previously unattainable. The program has also been clinically and economically beneficial to veterans living in homes.”~State Representative~
“I perform about 20 of the DNA Tests a week. The results are a tremendous help in my practice. The DNA Report provides an objective list to choose from to help my patients. Not knowing the metabolic profile of the patients increases the risk of side effects. It is hit and miss without the test. There is no trial and error period when you use the DNA swab testing. It allows me to select from a list of medications that will help my patients. I recommend this program to many other Doctors and patients. It gives you an individualized report with objective information to correctly order the right medication.”~Dr. Timothy B, Pain Management Specialist~
“We initiated this DNA Testing program in response to the CMS Directive to reduce our Antipsychotic usage. Through the metabolic reports, we have identified that residents were receiving antipsychotics that were actually adverse for them. These residents have shown a marked improvement in abilities and a reduction in side effects. The residents are doing so much better now that they are off these medications. The Family members are very excited about the results. All the medication changes have been positive. When the swab reports come back we have been amazed. We then understand why the residents have been exhibiting behaviors and mood swings. This program is very individualized. It has positive results for everyone, but first and foremost the residents. Our Administrator Markets this DNA Testing as a great program for our residents and the facilities. We have multiple Physicians that see our residents. Some of the Physicians were skeptical at first, but now they are really happy with the results. When we had our Survey, we had signed up with AssureRx but had not put the program into place. The Surveyors asked that we write a letter for them to take back to their Office about out Pending DNA Antipsychotic Program. They were so interested that the Surveyor called back and asked if we would fax them copies of the results. The Surveyor stated their Supervisors were very impressed with the individualized data provided.”~Jennifer H., Director of Nursing~
“The PGx Pharmacogenetic Test was easy for us to see the clinical value it offers, even before implemented. The implementation process that PGx offered was very simple, with very little interruption to our staff. As a pharmacist, the information is extremely valuable on my monthly med reviews and for all new residents upon admission. It helps address the issues of polypharmacy, unnecessary medications and more importantly is another tool to help assure that our residents are getting the best therapy for them. It is a great tool for any pharmacist to have.”~Valarie, DHP~
For more information on how you can implement pharmacogenetics into your community, clinic or pharmacy, contact us at:
PGx Medical
Empowerment at the Source of Treatment
Individualized Care – Personalized Medicine
405-509-5112
info@pgxmed.com
