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side effects of opioids

Pharmacogenomic Data May Help Guide Opioid Pharmacotherapy in Patients with Cancer-related Pain

By | Cancer Treatments, Other, Pain Medications, Pharmacogenomics, Provider | No Comments

Opioids are the most potent analgesics and are used to treat severe pain, specifically pain associated with cancer – a significant factor in reducing quality of life and clinical outcomes in such patients as detailed in Cancer Control “Clinical Implications of Opioid Pharmacogenomics in Patients with Cancer” (October 2015).

 

Inter-individual Differences in Genetically Modulated Opioid Response

 
The study reviewed clinical studies involving the pharmacodynamics and pharmacokinetics of opioids. It examined the opioid agents morphine, codeine, tramadol, oxycodone, fentanyl, and hydrocodone and the relationship to single nucleotide polymorphisms (SNPs): OPRM1, COMT (specifically COMT Val Met), CYP2D6, CYP3A4/5, and ABCB1, which the study claimed are responsible for the inter-individual differences in opioid response.

 
The authors specifically found that OPRM1, COMT Val Met, and ABCB1 are most strongly correlated with morphine response. One study combined OPRM1 and ABCB1 and found that patients with both of these genetic variants were the best responders as indicated in patients’ measures of pain intensity. In another study, patients with OPRM1 and COMT Val Met needed the lowest morphine dose compared to other genotypes. All three together demonstrated no difference in morphine dose requirements.

 

CYP2D6 Variants Correlate with Drug Efficacy

 
Similarly, the presence of CYP2D6 variants correlated positively with variations in codeine and tramadol efficacy. CYP2D6 is responsible in converting the analgesic properties of codeine and tramadol. In studies investigating codeine pharmacotherapy in cancer patients, analgesic differences and adverse effects were found for CYP2D6 poor, intermediate, and extensive metabolizers.

 
The authors concluded CYP2D6 testing helps in finding which patients respond positively to codeine. Studies with tramadol focusing on non-cancer pain populations identified CYP2D6 poor metabolizers as having a decreased analgesic response compared to extensive metabolizers. However, the authors noted there has been no specific study relating to tramadol’s analgesic efficacy in cancer populations, arguing tramadol will likely have decreased clinical benefit in patients who are poor CYP2D6 metabolizers.

 

Call for Preemptive Genotyping in Clinical Practice

 
The authors assert that these findings “suggest genotyping patients for some of these genetic variants may help predict responses to pain treatments with good rates of sensitivity and specificity and with greater benefits for patients and decreased health care utilization.” Furthermore, the authors assert that utilizing pharmacogenomics data combined with a preemptive genotyping be a “key element” in guiding treatment decisions for cancer patients.

Overview of the Dangers and Side Effects of Psychotropic Medications

By | ADHD Medications, Antianxiety Medications, Antidepressants, Antipsychotics, Pharmacogenetic Testing, Precision Medicine, Psychiatric Medications | No Comments

Get the Rxight® Genetic Test to Know Your Risks

Psychiatric medications (often called “psychotropics”) are routinely used to treat a variety of psychiatric disorders – ranging from ADHD (attention deficit hyperactive disorder) and depression to bipolar disorder and anxiety to schizophrenia – Psychiatric medications are generally jused as an adjunct to psychotherapy.

 
It is estimated that 17 percent (some 80 million people) in the United States are taking some form of psychiatric medication (Scientific American, “1 in 6 Americans Takes a Psychiatric Drug,”  Dec 13 2016) According to the article, an earlier government report, from 2011, found that just over 10% of adults are taking prescription drugs for “problems with emotions, nerves or mental health,” published in the journal JAMA Internal Medicine.

 
While the potential benefits of psychotropic medications have been demonstrated in research and clinical practice for decades, patients are cautioned to remain vigilant of the many side effects of psychiatric medications.

 
This article presents a detailed summary of the major types of mental health medications and their associated risks for side effects as reported by the U.S. Food and Drug Administration (FDA) and the National Institute of Mental Health (NIMH) and an overview of the benefits of the Rxight® genetic test for psychiatric medications in identifying your unique genetically determined risk for developing side effects or non-response to dozens of these psychiatric medications along with hundreds of other medications across 50 pharmacological classes.

Antidepressant Side Effects

What are antidepressants?
Antidepressants are commonly used to treat depressive disorders. They also are used for other conditions, such as pain, anxiety and insomnia. Although antidepressants are not FDA-approved specifically to treat ADHD, they are sometimes used “off-label” for ADHD treatment.

The most commonly prescribed types of antidepressants today are called . Examples of SSRIs include:

Other types of antidepressants are serotonin and norepinephrine reuptake inhibitors (SNRIs) .These are chemically similar to SSRIs and include and duloxetine (Cymbalta)  and venlafaxine (Effexor).

 
Another antidepressant that is commonly used is bupropion – a third sub-class of antidepressant which acts differently than either SSRIs or SNRIs.  Bupropion is also used to treat seasonal affective disorder (SAD) and for smoking cessation treatment.

SSRIs, SNRIs, and bupropion are commonly used today because they do not cause as many side effects as the older (“first generation”) classes of antidepressants, and moreover are effective in treating a broader range of depressive and anxiety disorders.

 
Older antidepressant medications include tricyclic antidepressants, tetracyclic antidepressants, and monoamine oxidase inhibitors (MAOIs).  These are less commonly prescribed since the development of the newer generation antidepressants.
 
What are the possible side effects of antidepressants?
Some antidepressants may cause more side effects than others. The most common side effects listed by the FDA include:

  • Sexual problems (impotence or inability to orgasm)
  • Nausea and vomiting
  • Weight gain
  • Sleepiness or fatigue
  • Diarrhea

In 2004, the FDA ordered a “black box” label – the most serious warning it issues – on all antidepressants to caution of psychiatric drugs’ increasing suicide risk in children and adolescents. In 2006, the FDA increased the age to include young adults up to age of 25. (FDA, Revision to Product Labeling, 2004)

 
Call your doctor immediately if you have any of the following symptoms, especially if they are new, worsening, or worry you (U.S. Food and Drug Administration, 2011):

  • Suicidal thoughts or actions
  • New or worsening depression
  • New or worsening anxiety
  • Feeling restless or agitated or
  • Panic attacks
  • Insomnia
  • New or worsening irritability
  • Acting aggressively, being angry, or violent
  • Acting on dangerous impulses
  • An increase in activity and talking (mania)

Additionally, drug interactions can occur.  Specifically, combining the newer SSRI or SNRI antidepressants with one of the commonly-used “triptan” medications for treating migraines can cause a life-threatening condition called “serotonin syndrome.” Serotonin syndrome is marked by agitation, hallucinations, high temperature, or unusual blood pressure changes. Serotonin syndrome is usually associated with the older antidepressants called MAOIs, but it can happen with the newer antidepressants as well.

 
Antidepressants may cause other side effects that were not included in this list, as determined by individual genetics and ability to metabolize the drug in the liver.

 
How do patients respond to antidepressants?
Some people respond better to some antidepressant medications than to others.  It is critical to know that some people may not feel better with the first medicine they try. Additionally, sometimes people taking antidepressants feel better and stop taking the medication too soon, and the depression may return.

 
These inter-individual differences are based in genetics, and the Rxight® genetic test will indicate which antidepressants may not work for you right from the start instead of having to go through trial and error with your doctor  With Rxight results, you your doctor can work together to find the best and most effective antidepressant treatment tailored to your unique genetics.

 

Antipsychotic Side Effects

What are antipsychotics?
Antipsychotic medicines are primarily used to manage psychosis, a condition that affects the mind. Psychosis is characterized by some loss of contact with reality, often including or hallucinations (hearing or seeing things that are not really there), or delusions (false, fixed beliefs). It can also be a symptom of a physical condition such as drug abuse or a mental disorder such as schizophrenia, very severe depression (also known as “psychotic depression”), or bipolar disorder.

 
Antipsychotic medications are frequently used in combination with other drugs to treat delirium, dementia, and mental health conditions, including:

The older antipsychotic medications are conventionally referred to as “typical” antipsychotics or “neuroleptics”. Some of the common typical antipsychotics include:

Second generation antipsychotic medications are also called “atypical” antipsychotics. Some of the most common atypical antipsychotics are:

According to a 2013 research review by the Agency for Healthcare Research and Quality , typical and atypical antipsychotics both work to treat of bipolar disorder (preventing mania) and symptoms of schizophrenia Additionally, some atypical antipsychotics have wider applications and are used for treating bipolar depression or general depression.

 
What are the possible side effects of antipsychotics?

Antipsychotics are known to have a large number of side effects (also called adverse events) and risks, including potentially fatal complications.

 
The FDA lists the following side effects of antipsychotic medicines:

  • Constipation
  • Nausea
  • Vomiting
  • Uncontrollable movements, such as tics and tremors (the risk is higher with typical antipsychotic medicines)
  • Seizures Drowsiness
  • Blurred vision
  • Low blood pressure
  • Dizziness
  • Restlessness
  • Weight gain (the risk is higher with some atypical antipsychotic medicines)
  • Dry mouth
  • A low number of white blood cells, which fight infections

Typical antipsychotic medications can also cause additional side effects related to physical movement, such as:

  • Tremors
  • Restlessness
  • Rigidity
  • Muscle spasms

Long-term use of antipsychotic medications may lead to a condition called tardive dyskinesia (TD). Tardive dyskinesia causes uncontrolled muscle movements, commonly around the mouth. TD can range from mild to very severe, and in some people, the problem cannot be cured and becomes disfiguring.

 
Avoid the Risk of Antipsychotic Side Effects with Rxight®

The Rxight® medication panel includes 18 popular antipsychotics on the market. Because the potential side effects of both typical and atypical antipsychotics can be very serious and potentially fatal, knowing your risks ahead of time with Rxight® can be an invaluable test for you and your prescriber.

 

Mood Stabilizer Side Effects

What are mood stabilizers?
Mood stabilizers work by decreasing abnormal brain activity. They are used mainly to treat bipolar disorder and the mood swings associated with other mental conditions including:

  • Depression (usually in conjunction with an antidepressant)
  • Disorders of impulse control
  • Schizoaffective Disorder

Anticonvulsant (anti-seizure) medications are most frequently used as mood stabilizers. They were originally developed for treatment of seizures, but they were found to help control mood swings as well. One anticonvulsant commonly used as a mood stabilizer especially in patients with symptoms of both mania and depression, or those with rapid-cycling bipolar disorder, is valproic acid (sold as Depakote). Anticonvulsants used as mood stabilizers include:

Lithium is a non-anticonvulsant mood stabilizer approved for the treatment of mania and the maintenance treatment of bipolar disorder.

 
What are the potential side effects of mood stabilizers?

Mood stabilizers can cause several side effects, some of which may be serious, especially at high dosages. These side effects include:

  • Potentially fatal rash (Stevens-Johnson Syndrome)
  • Itching
  • Extreme thirst
  • Tremor
  • Nausea and vomiting
  • Fast, slow, or irregular heartbeat
  • Slurred speech
  • Blackouts
  • Changes in vision
  • Hallucinations
  • Loss of coordination
  • Swelling

Mood stabilizers may cause other side effects that are not included in this list. Your unique reaction to anticonvulsants is based in genetics, and the Rxight® genetic test will indicate which mood stabilizer not work for you may right from the start instead of having to go through trial and error with your doctor – a process which can be expensive, lengthy and dangerous.  With Rxight® results, you your doctor can work together to find the best and most effective antidepressant treatment tailored to your genotype, preferably before treatment begins.

 

Anti-Anxiety Medication Side Effects

What are anti-anxiety medications?
Anti-anxiety medications (also called “anxiolytics”) work by reducing the symptoms of anxiety, such as that seen in panic attacks, or extreme worry and fear. The most commonly prescribed anti-anxiety medications are called “benzodiazepines.” Benzodiazepines are most frequently used to treat a condition called generalized anxiety disorder, while in cases of social phobia (social anxiety disorder) or panic disorder (panic attacks). Benzodiazepines are usually second-line treatments, behind antidepressants such as SSRIS.

Benzodiazepines used to treat anxiety disorders – all of which are tested in the Rxight® panel – include:

Short-acting benzodiazepines such as Lorazepam and another class of medication known as beta-blockers are used to treat non-persistent symptoms of anxiety. Beta-blockers are used primarily to manage physical symptoms of anxiety (e.g., shaking, rapid heartrate, and sweating).

 
Buspirone  (which is chemically unrelated to the benzodiazepine family) is sometimes indicated for the long-term treatment of chronic anxiety. It is not effective to use on an “as-needed” basis like the benzodiazepines.

 
How common is addiction to benzodiazepines?
One of the serious risks of anti-anxiety medications is that you can build up a tolerance to benzodiazepines if they are taken over a long period of time and may need increasingly higher doses to get the same effect. There is a serious risk of addiction and dependence. To avoid these problems, doctors usually prescribe benzodiazepines for short periods, particularly in the elderly (NIMH, “Despite Risks, Benzodiazepine Use Highest in Older People”), and people with addiction tendencies. If people suddenly stop taking benzodiazepines, they may have withdrawal symptoms or their anxiety may return.

 
What are the possible side effects of anti-anxiety medications?
Like other medications, anti-anxiety medications may cause side effects, many of which are serious. The most common side effects of benzodiazepines are sleepiness and dizziness. Other possible side effects include:

  • Headache
  • Confusion
  • Tiredness
  • Nausea
  • Blurred vision
  • Nightmares

Tell your doctor immediately if any of these symptoms are severe or do not go away:

  • Drowsiness
  • Difficulty thinking or remembering
  • Increased saliva
  • Dizziness
  • Unsteadiness
  • Problems with coordination
  • Blurred vision

If you experience any of the symptoms below, call your doctor immediately:

  • Swelling of the eyes, face, lips, tongue, or throat
  • Difficulty breathing or swallowing
  • Rash
  • Hives
  • Hoarseness
  • Seizures
  • Yellowing of the skin or eyes (jaundice)
  • Depression
  • Difficulty speaking
  • Difficulty breathing

Common side effects of beta-blockers include:

  • Fatigue
  • Dizziness
  • Weakness
  • Cold hands

 

Stimulant Side Effects

What are Stimulants?
Stimulants increase alertness, attention, and energy, as well as elevate blood pressure, heart rate, and respiration. Stimulant medications are generally prescribed to treat individuals diagnosed with ADHD (attention-deficit hyperactivity disorder). People with ADHD who take prescription stimulants describe a calming and “focusing” effect from the medication.  This is due to its effects on the brain chemical dopamine.

Stimulants used to treat ADHD – all of which are analyzed in the Rxight® DNA test – include:

In 2002, the FDA approved non-stimulant medication atomoxetine (Strattera) for use as a treatment for ADHD. Additional non-stimulant antihypertensive medications, clonidine  and guanfacine, are also approved for treatment of ADHD.

In addition to treating ADHD, stimulants are prescribed to treat other health conditions, including narcolepsy, and occasionally depression.

 
What are the possible side effects of stimulants?
Stimulants may cause side effects, most of which are relatively minor and disappear when dosage levels are lowered. The most common side effects include:

  • Loss of appetite
  • Insomnia
  • Stomach pain
  • Headache

Less common side effects include:

  • Motor tics or verbal tics
  • Personality changes

What are serious side effects of stimulant medications?
While side effects of stimulant medications tend to be minimal, patients and parents of patients are cautioned that serious adverse effects may occur, as reported by the FDA Drug Safety Communication in 2013. Also see
FDA Warns of Psychiatric Adverse Events from ADHD Medications
.

 
Heart-related problems:

  • Sudden death in patients who have heart problems or heart defects
  • Stroke
  • Myocardial infarction (heart attack)
  • Increased blood pressure and heart rate

Mental (Psychiatric) problems:

  • Behavior and thought problems
  • New or worse aggressive behavior or hostility
  • New or worse bipolar illness
  • New psychotic symptoms (or new manic symptoms)
  • Physical or psychological dependence

For additional details on the FDA warnings and manufacturer labeling for medications covered in the Rxight® panel, please refer to our list of medications covered.

 

About Rxight® Pharmacogenetic Testing

The Rxight® genetic test analyzes your risks based on your unique genetic makeup through a process called “SNP genotyping.” The report which will be shared with you in a personal consultation with a pharmacist. The report “red-flags” medications which may cause you to have issues, or conversely highlight medications which may not be effective for you.

 
Rxight® is based on pharmacogenetics — the study of how genes affect a person’s response to medicines. Our panel of over 200 clinically significant medications includes dozens of commonly prescribed psychiatric medications, including antidepressants across five sub-classes, mood stabilizers used in bipolar disorder and schizoaffective disorder, antipsychotics, ADHD medications (stimulant and non-stimulant), and anti-anxiety medications.

 
Based on how well you metabolize those particular medications, which is determined by your genes that encode liver enzymes that break down drugs, you will be at risk for developing side effects or the medication not working well or at all. With the results of the Rxight® test you and your prescriber can find the right medication for you, preferably before treatment begins.

 
Contact us today by phone 1 (888) 888-1932 or email to learn more about how Rxight® pharmacogenetic testing can help you find the right medication, right from the start.

Glipizide (Glucotrol) Uses and Side Effects

By | Diabetes, Sulfonylureas | No Comments

Glipizide is an antidiabetic drug of the chemical sulfonylurea class.  It is an oral and short acting drug that is classified as a second generation sulfonylurea.  It is marketed by Pfizer under the name Glucotrol in the United States. 
 

How Does Glipizide Work?

 
Like other sulfonylurea antidiabetic medicines, glipizide induces insulin release from pancreatic beta cells, but only when there is some beta-cell activity remaining in the pancreas.  This helps control blood sugar to maintain it at normal levels.  Glipizide is used with diet and exercise to have a healthy lifestyle with your type II diabetes diagnosis.  Some patients cannot take glipizide: If you have blockage in your intestines, kidney or liver disease, or a history of heart disease.  Tell your doctor if you have a glucose-6-phosphate deficiency (G6PD), a disorder of the pituitary or adrenal glands.
 

Warnings and Side Effects

 
Some oral diabetes drugs can increase your risk of serious heart issues.  Not taking your diabetes drugs have damage your heart and other organs, so you should talk to your physician about your risks. Other side effects of the sulfonylurea class of diabetes drugs include: low blood sugar symptoms such as dizziness, confusion, sweating, nervousness, weight gain, upset stomach, hunger, skin reactions, and dark urine.
 

How Do Genetics Determine Drug Metabolism?

 
Since the human genome was completed, many genome wide association studies have revealed that there are variations in the many genes that are responsible for processing drugs. processing in your body is also called drug metabolism.  Genes provide ‘instructions’ for the production of the actual enzymes responsible for drug metabolism.  Thus, variations in the genes transfer to the enzyme, which will have variations from the genetic instructions.  Variations in the enzyme may mean that the drug metabolism function is altered.  That could mean that the enzyme responsible for metabolizing several or a number of drugs isn’t working properly, resulting in side effects. 
 

Genetic Testing with Rxight®

 
One important way to know beforehand if you have any drug metabolism variations is to get the Rxight® pharmacogenetics test from MD Labs.  With one simple cheek swab, you and your physician can have at hand the results of this state-of-the-art platform that reveals your genetic disposition to any of the 200 drugs and over-the-counter products on the market.

 

To avoid side effects or medication inefficacy, ask your physician to prescribe the Rxight® pharmacogenetics test from MD Labs.  All that is required is a participating pharmacy and your physician’s prescription.  It also brings precision medicine to you and your physician, utilizing more individualized medical care. 
 

Drug Sensitivity and Your Genetics

By | Adverse Drug Reactions, Drug Metabolism | No Comments

Drug sensitivity is broadly defined as an exaggerated response to a drug in a patient in comparison to the expected response in the general population. Drug sensitivity can range from increased side effects to complete drug intolerance, whereby patients exhibit severe side effects or death. These side effects are often irreversible, as in aspirin induced Tinnitus.

 

Why Do Some People Suffer from Drug Sensitivity?

 
Drug sensitivity should not be confused with drug hypersensitivity. Drug hypersensitivities are caused by a patient’s body mounting an immune response to a drug. These can also be severe, but are different to drug sensitivities. Drug sensitivity results solely from genetic differences in a patient. How can your genetics impact drug metabolism and action? Through polymorphisms of genes coding for enzymes or receptors that directly affect how the body responds to the drug.
 
For instance, an article in Pharmacogenetics and Genomics “VKORC1 Pharmacogenomics Summary” (Oct 2011) states that polymorphisms in the gene VKORC1, which codes for the enzyme Vitamin K epoxide reductase, regulates a patient’s sensitivity to the common anti-coagulant drug Warfarin. The enzyme is the limiting step in the vitamin K cycle and Warfarin acts to inhibit this enzyme, inhibiting Vitamin K’s downstream coagulation effects. Variants 1639A and 1173T require a lower Warfarin dose whereas patients with allele 9041A need a higher dose.
 

Drug Intolerance and Severe Side Effects 

 
Drug intolerance can cause severe side effects in a patient. These are usually rare but in some instances are reasonably common. For instance, Tinnitus is a drug intolerant side effect to the drug Aspirin. At higher doses, aspirin is nown to cause tinnitus according to a study Frontiers in Systems Neuroscience “Salicylate toxicity model of tinnitus” (April 2012), but some patients experience the symptom after a normal dose of the drug.
 
Other examples of drug intolerance include liver failure to Paracetamol, fatal poisoning in infants who breastfeed on mothers who are taking the pain relief drug codeine, hypotension (low blood pressure) in patients taking heart drug Enalapril and hallucinations in patients taking codeine, according to research in Australian Family Physician, “Adverse drug reactions” (Feb 2013).
 
The number of genes that might cause drug sensitivity is massive and many are still not known. At Rxight® we sequence VKORC1 and a panel of other genes to identify how patients will react to more than 200 clinically relevant medications. Genetic testing for drug sensitivity is a faster, cheaper and far safer alternative than watching patients undergo adverse drug reactions and adjusting the dose accordingly.

Drug Metabolism Testing with Rxight®

By | Drug Metabolism | No Comments

 

Both clinicians and patients know that drugs can cause side effects. However, not all patients experience side effects. Variability in drug response is due to many factors including age, weight, number of medications taken and overall health. Genetic variation is also a reason that a patient may experience an adverse reaction to a drug. Pharmacogenetics studies the way that variations in a patient’s genetic makeup affect the metabolism of drugs. Rxight® genetic testing examines specific genes associated with drug metabolism to determine whether an individual’s inherited characteristics may cause side effects, toxicity or result in no therapeutic value.

 

Drug Metabolism and Adverse Reactions

 

To avoid adverse reactions, doctors often use a trial and error method to find appropriate medications for patients. Pharmacogenetic testing provides important information about which medicines may cause unpleasant side effects. Testing also helps clinicians find doses of medications that are appropriate for a patient’s genetic characteristics.

 

Genetic variants affect the rate of assimilation of a drug by the body. Poor metabolism of a drug can cause adverse effects because the drug stays in the body too long. Ultra-rapid metabolism may result in no benefit from the drug because it is eliminated too quickly.

 

The cytochrome P450 enzymes are responsible for approximately 70 percent of drug metabolism. Of the approximately 60 cytochrome P450 genes, six are known to affect drug metabolism and drug-drug interactions. The most significant are CYP2C19, CYP2C9 and CYP2D6.

 

CYP2D6 is responsible for the metabolism of approximately 25 percent of prescription medications. Drugs metabolized by this gene include many antidepressants, beta-blockers, opioids and anti-cancer medicines. Codeine, a pro-drug, is inactive until it is converted by gene CYP2D6 to morphine. Poor metabolizers of codeine do not get any pain relief. Ultra-rapid metabolizers of codeine convert the drug into morphine too rapidly, which may result in side effects or toxicity. The Food and Drug Administration recommends that codeine not be prescribed to nursing mothers who are ultra-rapid metabolizers of CYP2D6 because large amounts of morphine passed through breastmilk can result in infant respiratory failure or death.

 

Approximately 30 variants have been identified for gene CYP2C19. This gene is responsible for the metabolism of clopidogrel, a commonly prescribed antiplatelet medication used by patients with heart disease. Extensive and poor metabolizers have a higher incidence of adverse reactions to this drug. The FDA recommends use of another medication for patients with genetic variants that affect the metabolism of this drug.

 

Rxight® Pharmacogenetic Testing

Rxight® pharmacogenetic testing examines 18 genes that have known associations with drug metabolism, including the six major cytochrome P450 enzymes. A sample of a patient’s DNA is taken by a certified pharmacist and sent to MD Labs for analysis. A detailed report, included in the cost, is provided to each patient and interpreted by the pharmacist. Rxight® certified pharmacists consult with clinicians to ensure that the prescribed medication therapy regimen is best suited for the patient’s genetic characteristics. Doctors can select medicines and doses that may result in fewer side effects and provide better therapeutic value. Patients are more likely to take their medicine when they know that the potential for side effects is reduced. Better adherence to a drug therapy program helps maintain health.

CMS Episode Payment Model to Bolster Hospital Cardiovascular Services

By | CMS Cardiac Bundle | No Comments

MD Labs Offers Turnkey PGx Program for Cath Lab Implementation

 

Heart disease kills 1 in 4 men and women in the United States each year, according to the National Institute of Heart, Lung, and Blood Institute (NHLBI). Additionally, coronary heart disease (CHD) is the number one killer for women. (NHLBI) (National Heart, Lung, and Blood Institute, “What Causes Heart Disease,” April 2014).

 

Risk factors, such as traits, conditions, and habits raise the risk for coronary heart disease and heart attacks in female patients. More than 75 percent of women from ages 40 to 60 have one or several risk factors for CHD.  Despite this, heart diseases can affect women all of ages with symptoms starting as early in childhood (NHLBI).

 

2017 CMS Payment Updates & Potential Savings

Under the Centers for Medicare and Medicaid Services (CMS) FY2017 hospital inpatient final rule as reported in Cath Lab Digest (Cath Lab Digest, “The FY 2017 Financial Future: How the Cath Lab Impacts the Hospital Bottom Line,” October 2016), all cardiovascular (CV) services will receive increases for inpatient payments with hospitals gaining more in reimbursements.  Adjustments will decrease based on evidence of financial productivity, documentation, coding, and adjustments under the Accountable Care Act. There will only be an increase in two-midnight policy adjustments.

 

There is mounting evidence on the cost saving opportunities to hospitals utilizing Pharmacogenetic (PGx) testing for pharmacotherapy following cardiovascular services. In concert with an interventional cardiologist, MD Labs has developed a PGx protocol for Catheter Labs that hospitals are in the process of adopting across the U.S.

 

CMS Inpatient and Outpatient Payments will Affect Hospital Budgets in 2017

 

The CMS proposed the “cardiac bundle” Episode Payment Model (EPM), directly impacting cardiovascular services. CMS recognizes the role that cardiac rehab plays in the 90-day post-discharge continuum of care, and is encouraging hospitals by providing additional payment: $25 per session for the first 11 sessions and $175 per session for each additional session, up to a total of 36 sessions.

 

This EPM will follow the Comprehensive Joint Replacement (CJR) model and will include Coronary Artery Bypass Graft (CABGs) and the Acute Myocardial Infarction (AMI) services. AMIs is one of the highest reasons for patient readmission.

This proposal will also introduce payment models that calculate the costs for Medicare inpatients plus 90 days post discharge for 98 randomly selected Metropolitan Service Areas (MSAs).

 

Since close to 50% of Cath lab procedures are paid as outpatients, CMS recommends that payments for this population must also be seriously considered. “CMS continues to aggressively shift outpatient payments to a true prospective payment system,” according to the Cath Lab Digest article.

 

EPM  Model Incentives Care

 

The EPM proposal will begin July 2017 and continue on a calendar year basis until 2021, called a Performance Year. Throughout the EPM, hospitals, providers, and suppliers will continue to bill and still collect in the fee-for-service payment systems.  After a performance year, all claims data for an episode are put together for an actual episode payment. Then, the actual episode payment will be adjusted compared with a quality adjusted target price.

 

Target prices will be created with a hospital and regional historical data. If the actual payment is less than the target price, the hospital will profit which is called the reconciliation payment. If the actual payment is more than the target price, CMS will receive reimbursement from the hospital.

 

With the proposed EPM model, the efficiency and quality of cardiovascular services is expected to improve and PGx testing will play a crucial role in determining appropriate pharmacotherapy, as bolstered by research such as  Expert Opinion on Drug Metabolism & Toxicology The pharmacogenetic control of antiplatelet response: candidate genes and CYP2C19 (July 2015) which surveyed clinical outcomes of using pharmacogenetics to guide antiplatelet therapy used for preventing ischemic events in patients with acute coronary syndromes (ACS), percutaneous coronary intervention (PCI) and other indications. The pharmacogenetics of available antiplatelet agents – Aspirin, Clopidogrel, Prasugrel and Ticagrelor – were analyzed.

 

Sources:

Cath Lab DigestThe FY 2017 Financial Future: How the Cath Lab Impacts the Hospital Bottom Line” (October 2016).

National Heart, Lung, and Blood Institute “What Causes Heart Disease” (April 2014).

National Heart, Lung, and Blood Institute “Who Is at Risk for Heart Disease” (April 2014).

MayoClinic “Heart Disease in Women: Understand Symptoms and Risk Factors” (June 2016)

Co-Occuring Autism and Depression: A Clinical Challenge

By | Antidepressants, Antipsychotics | No Comments

Is depression more common in patients with autism spectrum disorder (ASD) than in the general population? Yes, according to research on the co-morbidity of mood disorders and ASD – which according to the CDC affects an estimated 1 in 45 children in the U.S.
 
An article published in Dialogues in Clinical Neuroscience, “Challenges in the diagnosis and treatment of depression in autism spectrum disorders across the lifespan” (2015), found that some research points to rates of depression as high as 57 percent in ASD patients. One study of adult patients found the rate of suicide of ASD adults was almost 2 percent, compared to less than.5 percent of adults without autism.
 

Clinicians Face Difficulties Differentiating between Depression and ASD

 
It can be difficult to differentiate between symptoms of autism and those of depression. In fact, diagnosing depression in those with autism represents a clinical challenge that dates back to Leo Kanner’s original description of the condition in his 1943 paper where he identified that individuals with autism spectrum disorders show little facial emotion – called a “flat affect.” However, in autism, affect doesn’t necessarily correspond to the individuals’ mood, which is an internal state not always congruent with emotion.
 
Another challenge that clinicians face in diagnosing depression in patients with autism is the overlap in symptoms. Those of depression typically include a flat facial expression as with autism, reduced appetite, sleep disturbance, low energy, reduced motivation, social withdrawal and reduced desire to communicate with others. Many of these same symptoms can stem from autism rather than depression.
 

Find the Right Medications with Rxight® Pharmacogenetic Testing

 
Two drugs for treating the irritability and aggression that is commonly associated with the autism – risperidone (Risperdal) and aripiprazole (Abilify) – have been approved by the Food and Drug Administration. Additionally, so-called “off-label” medications include naltrexone, which is FDA-approved for the treatment of alcohol and opioid addictions. It can ease disabling repetitive and self-injurious behaviors. (Autism Speaks, “Medicines for Treating Autism’s Core Symptoms”).
 
MD Labs’ CLIA-certified Rxight® genetic testing panel – which among the most comprehensive available – includes risperidone and aripiprazole, along with 26 antidepressant medications across clinically significant antidepressant classes. Over 200 other medication are also covered in the Rxight® panel.
 

Your Insurance May Cover Testing with Rxight®

 
Many insurance companies now cover tetrabenazine (Xenazine), nortriptyline (branded as Pamelor and Aventyl Hydrochloride) and amitriptyline (branded as Elavil, Endep and Vanatrip), antidepressants within the Rxight® panel.
 
If you or a loved one suffers from depression and has been diagnosed with ASD as well, ask your doctor about authorizing the Rxight® Pharmacogenetic Test. Genetic testing with Rxight® enables you and your prescribers to know – preferably ahead of time – which medications may causes potentially dangerous adverse reactions and conversely which may be ineffective.
 
To get started, we invite you to email us today or call 1-888-888-1932 to discover how you may benefit from our pharmacogenetic testing program.

Pharmacogenetic Testing Could Help Reduce Side Effects Caused by Commonly Prescribed Diabetes Medication

By | Antidepressants, Diabetes | No Comments

Diabetes is a serious public health issue, and is projected to be the seventh leading cause of death worldwide by 2030. In the sub-Saharan African region, it is estimated that nearly 1 in 10 people suffer from diabetes, according to the World Health Organization Global Report on Diabetes (WHO, 2016). In the United States, we see similar statistics. The CDC reported in 2014 that nearly 1 in every 11 people in the U.S. are diagnosed with diabetes, accounting for nearly 29.1 million people (Centers for Disease Control and Prevention, 2014 National Diabetes Statistics Report).
 
Complications can arise in those with diabetes and therefore, proper medication therapy is crucial.
Diabetic Peripheral Neuropathy (DPN) is the most common complication of diabetes and occurs in up to half of diabetic patients, according to a recent study in Pharmacogenomics (Chaudhry et al., April 2017).

 
The most common symptoms of diabetic neuropathy are increased pain sensitivity, numbness and spontaneous pain in the limbs. Patients frequently describe the pain as burning and shooting.
 

Amitriptyline: The Drug of Choice for DPN in Developing Countries

 
Since there are currently no treatments available to completely restore nerve function, drug therapy is often aimed at managing the pain. Antidepressants in particular, specifically amitriptyline, are often used to treat DPN.
 
This Pharmacogenomics study investigated the use of amitriptyline for DPN in a South African population. Amitriptyline is used to treat the DPN pain due to its numbing effect on the nerves. It is regarded as the drug of choice to for painful peripheral neuropathy in this population given its cost effectiveness.
 

Genetics Influence How You’ll React to Medications

 
Common side effects of amitriptyline include blurred vision, drowsiness, constipation, urinary retention and dryness of mouth/eyes. More serious side effects include build-up of metabolic toxins in the heart or the nervous system.
 
Genetics play a major role in how the body metabolizes medications. Amitriptyline is mainly metabolized in the liver and cleared by the kidneys. How one’s body metabolizes this medication in encoded by two specific genes and one of these genes is responsible for adverse drug reactions (ADRs).
 
In the case of amitriptyline, patients who are “slow metabolizers” will experience adverse reactions. Patients who are “fast metabolizers” do not experience these adverse reactions. However, since these fast metabolizers clear the drug from their bodies so quickly, they are at risk for not benefiting from treatment.
 

Study Calls for Pharmacogenetic Screening in Amitriptyline Therapy

 
The study concluded that pharmacogenetic testing might be useful for tailoring treatment and thereby improving amitriptyline effectiveness. Chaudhry et al. noted that if a patient is a non-responder to amitriptyline, or experiences severe side effects, pre-emptive genetic screening can be performed so an alternative medication may be considered, or the dose adjusted appropriately.
 
“Our findings…support the use of pharmacogenetic testing in the context of amitriptyline therapy for the management of diabetic pain,” the authors stated, adding that PGx testing can be “valuable to guide drug choice and dosage and thereby improve treatment outcomes in patients with DPN.”

The U.S. Opioid Epidemic and How Your Genetics Factor into Your Risk for Addiction

By | Opioids, Pain Medications | No Comments

Find Out Your Medication Risks with the Rxight® Genetic Test
 
The United States is amidst an opioid epidemic and the numbers are sobering. According to the U.S. Department of Health and Human Services, the rate of overdose deaths involving opioids, including prescription opioid pain relievers, has nearly quadrupled since 1999, and over 165,000 people have died from prescription opioid overdoses. The Rxight® Pharmacogenetics Program can help you understand how your genetics play a role in your likelihood for addiction.
 
On a typical day, more than 650,000 opioid prescriptions are dispensed, 3,900 people use prescription opioids, which include hydrocodone (Vicodin), codeine and tramadol (Ultram), for recreational purpose, and about 80 people die from an opioid-related overdose, according to the HHS. https://www.hhs.gov/opioids/about-the-epidemic/#us-epidemic
 

Tragic Reports of Opioid Overdose, Death Commonplace

 
Accounts of overdose and death from prescription or illicit opioids have been seen in the media with alarming frequency. For example, on Mar 17 2017, three Ohio children discovered their parents dead in bed of an apparent opioid medication overdose. In another gut-wrenching story, a panicked two-year-old from Massachusetts is seen on video attempting to revive her mother, who is unconscious on the floor in a store from an opioid overdose. The opioid epidemic has reached staggering proportions to the point where “[i]t is no longer a shock to see drug users collapse in public,” a September 2016 article in the New York Times stated.
 

Research Shows Certain Gene Variants May Be Linked to Addiction to Opioids

 
Both the ability to metabolize opioids and your susceptibility to becoming dependent on them are grounded in your genetic makeup, according to research published in Addiction Science and Clinical Practice “Pharmacogenetics: A Tool for Identifying Genetic Factors in Drug Dependence and Response to Treatment” (Dec 2010). 
Specifically, the impact of genetic variation on responses to several drugs of abuse including opioid pain medications and several variations have been implicated in likelihood for addiction and dependence. The article states that drugs including opioids activate the pathways that play an essential role in drug reward and reinforcement as well as a general sense of calm and well-being.
 

Your Genetics Can Indicate Your Risk for Overdose

 
Additionally, this study reveals how several oral opioids, such as codeine, oxycodone, and hydrocodone, are metabolized by another enzyme, which gives the users a feeling of a “high.” Some genes are highly variable, with some of these variations leading to a completely inactive enzyme. Individuals who inherit such “defective” alleles from both parents are referred to as “poor metabolizers” and thus less likely to become dependent.
Individuals proven to be poor metabolizers of these drugs are also more susceptible to toxicity and overdose at standard doses. Conversely, individuals who are “fast metabolizers” are more prone to addiction.
 

Pharamcogenetic Testing for Opioids with Rxight®

 
MD Labs’ Rxight® is the most comprehensive pharmacogenetics program available on the market, grounded in the analysis of 18 genes and their alleles. The Rxight® genotyping technology tells you how you might respond to over 200 clinically relevant prescription and over-the-counter medications, including 15 common opioid pain medications. This genetic guidance can help you determine if you could have an adverse reaction at standard doses, or conversely not respond to the medication. Rxight® specifically identifies whether you are a slow, normal or rapid metabolizer of the medications on the panel. It also flags the medications that could be of concern to you and your prescribers. Since your DNA does not change, your Rxight® test results are good for life.
 
Contact Rxight® by phone (888) 888-1932 or email us at info@rxight.com to get started today.

Utility of PGx Testing in Hospitals Bolstered by Research on the Pharmacogenetics (PGx) of Antiplatelet Response

By | CMS Cardiac Bundle, Provider | No Comments

MD Labs Has Turnkey PGx Program for Hospital Implementation

Target Audience: Hospital Executives; Hospital-based Cardiologists, Quality Directors and Pharmacists
 
There is mounting evidence on the cost saving opportunities of applying Pharmacogenetic (PGx) testing following percutaneous coronary intervention (PCI) and coronary stent procedures. In concert with an interventional cardiologist, MD Labs has developed a PGx protocol for Catheter Labs that U.S. hospitals are in the process of adopting. This is of particular importance given the new CMS Cardiac Bundle being introduced into hospitals.
 
The benefits of this protocol are bolstered by studies such as the one in Expert Opinion on Drug Metabolism & Toxicology “The pharmacogenetic control of antiplatelet response: candidate genes and CYP2C19” (July 2015) which surveyed clinical outcomes of using pharmacogenetics to guide antiplatelet therapy used for preventing ischemic events in patients with acute coronary syndromes (ACS), percutaneous coronary intervention (PCI) and other indications. The pharmacogenetics of available antiplatelet agents – aspirin, clopidogrel, prasugrel and ticagrelor – were analyzed.
 

CYP2C19 Implicated in Clopidogrel Response Variability

 
The authors found abundant data in its literature meta-analysis supporting the clinical validity of CYP2C19 and clopidogrel response variability among ACS/PCI patients, stating “[t]he increased risks for reduced clopidogrel efficacy among ACS/PCI patients that carry CYP2C19 loss-of-function alleles should be considered when genotype results are available.” It was also found that “insufficient candidate genes” have thus far been implicated for prasugrel or ticagrelor.
 

The Clinical Utility of Pre-emptive PGx Testing for Plavix

 
The authors concluded by citing the need for pre-emptive PGx testing for clopidogrel (Plavix), for which they found a “clear association” with CYP2C19, explaining that pre-emptive pharmacogenetics testing would circumvent the issue of the need for rapid turnaround which is one of the frequently cited barriers to implementing CYP2C19 genetic testing for antiplatelet therapy.
 
A  pre-emptive approach – as offered by genotyping platforms such as MD Labs’ Rxight® – would integrate CYP2C19 genotype data into cath labs and the patient EMRs to alerts prescribers through clinical decision support at the point-of-care if and when clopidogrel is ordered and the patient carries an at-risk CYP2C19 genotype.
 
“Although this model has inherent challenges … pre-emptive CYP2C19 genetic testing has recently been deployed at several academic medical centers,” the authors stated. The authors called for “an ongoing effort towards the application of clinical pharmacogenetics by increasing clinician education and acceptance.”
 

CMS Cardiac Bundle Paves Way for PGx Testing for ACS Patients

 
With the coming of the CMS Cardiac Bundle program for hospitals (effective Oct 1, 2017) there is now added financial incentive to implement PGx testing as part of the standard of care for cardiac patients about to undergo antiplatelet pharmacotherapy.
 
1,200 participating hospitals in 98 metropolitan areas in the U.S. are mandated to be held financially accountable for the costs of heart attacks and bypass surgery under the CMS protocol for cardiac care.  There is therefore significant incentive to reduce costs through various measures such as integrating PGx testing into standing orders for coronary stent procedures and percutaneous coronary interventions (PCIs). For these treatments, anti-platelet pharmacotherapy is an established standard of care to reduce thrombotic risk, with Plavix (clopidogrel) as a first-line agent tested.
 

Implementing PGx in Your Hospital

 
A crucial part of MD Labs’ Rxight® turnkey program is the incorporation of PGx trained and certified pharmacists as part of the protocol to serve as expert resources for physicians and to provide consultations with the patients; pharmacist involvement in patient care has been shown to reduce hospital readmission rates.  DNA test kits are provided by MD Labs, and results are accessible via online provider and patient portals. Contact MD Labs (1-888-888-1932 or info@rxight.com) for details on the PGx protocol as applied to PCI and stent procedures, and how to integrate the Rxight® pharmacogenetics program into your cath lab.

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