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 | Dec 1, 2015 | News
Plavix Clopidogrel
Plavix is an anti-clotting medication, used to prevent blood clots that can lead to heart attacks or strokes in certain patients. It only works once it is converted or metabolized into its active form (clopidogrel) by the liver enzyme CYP2C19.
But on March 19th, 2014, Hawaii Attorney General David M. Louie filed suit against the manufacturers of the popular drug Plavix®. Louie claims that the manufacturers knew and did not disclose that the medication would be ineffective or only partially effective in certain patient populations due to genetic variations.
Plavix is metabolized by the drug-processing enzyme CYP2C19. Certain genetic variations can affect the activity of this enzyme. Patients with these variations are at a higher risk of treatment failure or adverse drug events, even on a normal dose.
Hawaiians would be especially vulnerable to treatment failures due to the state’s ethnic makeup. It’s estimated that between 38-79% of Pacific Islanders and 40-50% of East Asians would have these variations. These two ethnicities together made up 48.6% of the Hawaiian population according to the 2010 census.
The FDA added a boxed warning to Plavix in 2010, which warned about diminished efficacy in poor metabolizers, however, the Hawaii Attorney General alleges that Bristol-Myers Squibb and Sanofi-Aventis, Plavix’s manufacturers, knew about the risk as early as 1998 and failed to inform the public. He is seeking $10,000 for each deceptive or unfair act, plus an additional $10,000 for each act directed towards the elderly, as well as the disgorgement of $10 million in profits from Plavix sales in Hawaii.
Plavix is a common medication prescribed to prevent blood clots. It’s estimated that 115 million patients take the prescription worldwide with 50 million inside the United States. Plavix sales were worth $6.6 billion in 2011. Hawaii is the fifth state to sue the manufacturers of Plavix. California, Louisiana, Mississippi and West Virginia have also filed their own lawsuits. The manufacturers have declined to comment on the lawsuit. The U.S. Department of Justice is also now investigating.
Whether or not these lawsuits are successful in the courts, this may signal the beginning of a sea-change in the way drug manufacturers create and market their medications. The public has shown a greater interest in individualized therapies and a reaction against block buster development. According to the New England Healthcare Institute, adverse drug events may cost US healthcare system nearly $300 billion each year. Better development practices on the part of manufacturers may help alleviate some of that burden.
_______________________________________________________
Fifty-two plaintiffs sue Plavix maker Bristol-Myers Squibb in St. Clair County
Sep 18, 2012
The makers of the popular medication, Plavix face a St. Clair County lawsuit filed by 52 people who claim they suffered strokes and heart attacks after taking the drug.
Touted as a “super aspirin,” Plavix can allegedly cause heart attacks, internal bleeding, strokes, blood disorders or death, according to the recently filed complaint.
Lead plaintiff Mary Miller and 51 others claim they suffered such maladies after taking Plavix, a drug manufactured by defendants Bristol-Myers Squibb Company and Sanofi Aventis.
Christopher Cueto and Michael Gras of the Law Office of Christopher Cueto in Belleville; Robert L. Salim of Salim-Beasley in Natchitoches, La., and Julie B. Isen of The Miller Firm in Orange, Va., will be representing them.
The plaintiffs say they began taking the drug after its makers promoted the drug to be more effective than aspirin to prevent heart attacks and strokes. In addition, the companies said the drug “would give a person even greater cardiovascular benefits than a much less expensive, daily aspirin while being safer and easier on a person’s stomach than aspirin,” the suit states.
In addition, Bristol-Myers Squibb and Sanofi allegedly marketed their drug as safe for use with aspirin, although such a claim had not been established, the complaint says. In fact, the claim has been proven false, and the combined therapy is even more dangerous in patients who do not have peripheral arterial disease and acute coronary syndrome, the plaintiffs allege in their complaint.
The FDA has cracked down on Bristol-Myers Squibb and Sanofi a number of times for this and other marketing ploys that misinformed patients and their physicians, according to the complaint.
“The result is that physicians are prescribing Plavix to people who could be cheaply and effectively protected against ischemic events by a simple aspirin, than to pay approximately $4.00 a day for a dose of Plavix,” the suit states.
“Defendants’ nearly eight-year run of misleading physicians and to the public about the safety and efficacy of Plavix for the sole purpose of increasing corporate profits is evidenced by these scientific studies that reveal that not only is Plavix not worth its high price — it is dangerous.”
Bristol-Myers Squibb and Sanofi have sold $3.8 billion worth of Plavix annually, the plaintiffs claim.
In addition to their exaggerated marketing claims, the makers of Plavix failed to adequately warn of the dangers of the drug in package inserts included in the medication’s packaging, the suit states.
“Despite the growing body of scientific knowledge that the four-dollar Plavix pill was not much better than a four-cent-a-day aspirin, Defendants kept promoting it to the public and to physicians, using hyperbole and outright falsification in the process,” the suit states.
Because of the defendants’ actions, the plaintiffs have suffered severe and permanent injuries in addition to their heart attacks, strokes, excessive bleeding and stent replacements, the complaint says. They also suffered physical impairment, disfigurement, physical pain and suffering; lost their enjoyment of life; and incurred medical costs, the plaintiffs claim.
In their complaint, the plaintiffs allege strict products liability, manufacturing defect, failure to warn and negligence against the defendants.
The plaintiffs seek economic and compensatory damages, plus costs, attorney’s fees and other relief the court deems just.
St. Clair County Circuit Court case number: 12-L-455.
Plavix Hemorrhage Plaintiffs Head to Court
October Filings
Plavix lawyers at Pintas & Mullins report that dozens of plaintiffs have filed suit against manufacturers Sanofi and Bristol-Myers Squibb over the blood-thinner Plavix (clopidogrel). Patients in the U.S. and abroad are claiming the drug made them develop autoimmune diseases and suffer severe hemorrhages.
U.S. plaintiffs took their claims to New York state court recently after taking Plavix to recover from strokes, stent placements, and other medical events requiring blood-thinning medications. Patients require blood-thinners to keep blood from creating dangerous, potentially fatal clots in veins and arteries.
Our Plavix attorneys recently reported that the consumer watchdog group Public Citizen requested that the FDA place a Black Box Warning, the agency’s most severe caution, on the drug’s labels. Public Citizen cited several studies which found that patients taking Plavix for long periods of time (at least one year) not only failed to improve in health, but had an increased risk of fatal internal bleeding as well. Plavix already includes a Black Box warning, implemented in 2010, which tells consumers that 2 to 14% of the population cannot properly metabolize the drug and will not benefit from its use.
Indeed, recent medical breakthroughs have shown that nearly a third of the millions of patients taking Plavix have a genetic variant of the enzyme needed to convert the drug to its active form. This means that one-third of those paying $4 a pill for Plavix are not benefitting from it, and are unnecessarily at an increased risk from blood clots and fatal bleeding episodes. Had the drug been subjected to a more rigorous approval process, this surely would have been made known sooner.
The complaints filed by plaintiffs in New York are all common in that they accuse Plavix of being defective and dangerous for human health. They also accuse Sanofi and Bristol-Myers of advertising a drug unfit and unsuitable for consumption, and for placing profits over patient safety in expediting Plavix’s approval in the U.S.
Plavix submitted an application to the FDA for approval after only one clinical study had been conducted. After a rare priority regulatory review, the FDA approved Plavix in 1997, however, several members of the federal panel expressed concerns about the drugs’ actual benefits. They were not convinced that Plavix was any more effective than over-the-counter Aspirin. As additional studies were conducted on the drug, this concern was brought to light and eventually confirmed.
Despite this, by 2012, Plavix was the world’s second-best-selling medicine, due in no small part to Sanofi and Bristol-Myers’ deep pockets and masterful (and illegal) marketing campaigns. In July 2013, over three dozen Plavix users and their families sued the drug makers over allegations that they pushed physicians to over-prescribe the drug. They claim that the companies knowingly ignored clinical evidence that Plavix was no more beneficial than Aspirin and carried severe, life-threatening risks.
These lawsuits also include the master complaint filed against Plavix in 2012 on behalf of those who died or became severely ill after using the blood thinner. This master complaint argues that Plavix was improperly labeled and failed to warn patients of the dangers associated with its use.
Other lawsuits regarding Plavix stem from accusations of off-label marketing. These suits allege that the drug makers created and acted on a scheme to market Plavix as superior to its competitors despite this falsehood. This fraudulent marketing caused several government health programs, such as Medicare, to pay for prescriptions they otherwise would not have.
Further compounding its legal woes, Sanofi and Bristol-Myers are also accused of manipulating clinical trial data to support its marketing claims of superiority. Plaintiffs claim the companies also knowingly downplayed the drugs’ side effects and health risks, which include the risk of developing haemophilia, a rare autoimmune disease.
Plavix attorneys at Pintas & Mullins have decades of experience in pharmaceutical litigation and are currently reviewing cases concerning Plavix injuries and wrongful death. If you or a loved one was prescribed Plavix and suffered a serious bleeding episode, you may be entitled to compensation for your medical bills and lost wages, and should contact an experienced attorney as soon as possible.
The attorneys at Morgan & Morgan are investigating potential lawsuits on behalf of Plavix users who suffered serious injuries, including internal bleeding. It has been alleged that the drug’s manufacturer falsely advertised that Plavix provides superior cardiovascular benefits to those of aspirin and failed to properly warn consumers about the severe risks of taking the drug, which may include heart attack, stroke, gastrointestinal bleeding, cerebral hemorrhaging and death.
Plavix Linked to Serious Injuries
Plavix has been linked to a number of serious injuries including the following:
Recurrent and bleeding ulcers: Plavix users develop 12 times as many ulcers as those taking aspirin in combination with heartburn pill Nexium, according to a study published in a New England Journal of Medicine. This study suggests that Plavix users should consider switching to a cheaper and potentially safer alternative, such as aspirin plus a heartburn pill, according to some doctors.
Thrombotic Thrombocytopenic Purpura (TTP): A study published in 2000 in the New England Journal of Medicine reveals that even short-term use of Plavix can increase the user’s risk of developing Thrombotic Thrombocytopenic Purpura. TTP is a rare disorder of the blood-coagulation system which causes blood clots to develop in small blood vessels throughout the body. TTP can cause heart, brain and kidney damage.
Heart Attack, Stroke and Death: Plavix is designed to prevent blood clots in people who have recently suffered a heart attack or stroke, as well as those suffering from certain heart or blood vessel disorders; however, research has suggested that, in some patients, the drug may increase the risk of a heart attack or stroke – the conditions it was designed to prevent.
______________________________________________________________
File your Plavix Complaint and seek compensation:
Patients who take Plavix to ward off heart attack or stroke may find that the risk of Plavix side effects is greater than the potential benefit. Studies suggest a link between Plavix and bleeding and a risk of Plavix interactions with other medications. Patients who have been harmed by use of Plavix may be eligible to file a Plavix lawsuit against the drug’s maker.
REE CASE EVALUATION
Plavix Clopidogrel
Plavix is an anti-clotting medication, used to prevent blood clots that can lead to heart attacks or strokes in certain patients. It only works once it is converted or metabolized into its active form (clopidogrel) by the liver enzyme CYP2C19.
Normally, platelets in the blood clump together and form blood clots that stop bleeding. However, in some patients, these platelets clump together in narrow arteries, resulting in a clot in the artery, which can prevent proper blood flow. When blood flow is stopped in arteries that lead to the brain, the brain does not receive an adequate supply of oxygen, which can cause a transient ischemic attack. When arteries to the heart are blocked for a short time, patients experience angina (chest pain). When that blockage occurs for longer, patients experience a heart attack.
Plavix is prescribed to help prevent blood clots from forming in the arteries. The top-selling drug is made in the US by Bristol-Myers Squibb and internationally by Sanofi-Aventis.
Plavix Warnings
On November 28, 2009, the US Food and Drug Administration (FDA) issued a warning that patients who take Plavix should avoid using Prilosec or Priolosec OTC (omeprazole). The warning was issued because the FDA was concerned that when taken together, Plavix’s effectiveness was reduced by approximately half.
“Patients at risk for heart attacks or strokes who use Plavix to prevent platelet aggregation will not get the full effect of this medicine if they are also taking Prilosec,” said Mary Ross Southworth, Pharm.D., of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research.
Because Plavix does not work properly until it is converted or metabolized into its active form by the liver enzyme CYP2C19, Prilosec’s blocking of that enzyme reduces the effectiveness of Plavix. According to the FDA, information provided by the manufacturers supported “the existence of a significant interaction that could negatively impact a person’s health.”
Other drugs that patients are urged to stay away from while taking Plavix include Nexium, Tagamet and Tagamet HB, Diflucan, Nizoral and Prozac.
Plavix CHARISMA Study
In 2006, a study published in The New England Journal of Medicine called the Clopidogrl for High Atherothrombotic Risk and Ischemic Stabilization Management and Avoidance (CHARISMA) study found that there was no added benefit to treating patients with both clopidogrel and aspirin combined as compared with aspirin and a placebo.
Researchers further found that in a subgroup of participants who were given the combined medications as a preventative measure, but were not symptomatic of stroke or heart attack, the risk of moderate to severe bleeding increased. Furthermore, the risk of death increased in patients who were given clopidogrel. Among asymptomatic patients, the rate of death from cardiovascular causes was 3.9 percent among those who were given clopidogrel and 2.2 percent among those given a placebo.
Plavix Stomach Bleeding
A study published in The New England Journal of Medicine (as reported by The New York Times; 01/20/05) found that patients taking Plavix suffered 12 times more ulcers than patients who took aspirin plus a heartburn medication. Many patients were reportedly put on Plavix because it was believed to have lower rates of ulcers than aspirin, a belief that was reportedly undermined by the study. The study found that of patients who took Plavix during the analysis, 8.6 percent had a bleeding ulcer during a 12-month period, while 0.7 percent of those given aspirin and Nexium had a bleeding ulcer.
Researchers recommended that some patients who took Plavix be switched to aspirin and a heartburn medication because the aspirin not only appears safer, but is also reportedly less expensive than Plavix.
For more information on pharmacogenetic testing, contact:
PGx Medical
Individualized Care – Personalized Medicine
405-509-5112
info@pgxmed.com
Source: Hawaii.gov
fda.gov
wsj.com
New England Journal of Medicine
by brant bullard | Oct 7, 2015 | News
Poor medication adherence is a well-known problem, particularly in patients with chronic conditions, and is associated with significant morbidity, mortality and health-care costs. Multi-faceted and personalized interventions have shown the greatest success. Pharmacogenetic (PGx) testing may serve as another tool to boost patients’ confidence in the safety and efficacy of prescribed medications. Here, we consider the potential impact (positively or negatively) of PGx testing on medication-taking behavior.
Pharmacogenetic (PGx) testing provides information about a patient’s likelihood to have an adverse response and/or a therapeutic response to a medication, enabling the potential for a tailored and personalized approach to medication therapy. Genetic variation has been estimated to account for 20–95% of the variation in individual responses to medications. A total of 113 drug labels approved by the US FDA (Food and Drug Administration) include information about variability in patient response secondary to genetic variability, a handful including information about more than one gene. Although the primary focus of PGx testing has been on improving drug selection and dosing in patient populations or individuals, a secondary potential benefit of testing may be the improvement of medication adherence. Poor medication adherence is a well-known problem, particularly in patients with chronic conditions, resulting in greater morbidity, mortality and health-care costs. Although the potential benefit of PGx testing to improve adherence has been recognized for chronic diseases such as attention-deficit/hyperactivity disorder and diabetes, it is just beginning to be evaluated as an intervention, either alone or in combination with other interventions. Successful implementation of PGx testing into clinical practice, which assists patients and providers with therapy decisions, is consistent with current national goals to improve health care, engage patients and reduce health-care costs. In this paper, we discuss the potential mechanisms by which PGx testing may affect medication-taking behavior—either positively or negatively.
The continuing challenege of medication adherence
It is estimated that the annual economic burden of non-adherence is about $300 billion in the United States, and that about one-third to one-half of all patients in the United States do not take their medications as directed by their health-care providers. However, due to inconsistent definitions and measures of adherence in the literature and in clinical practice, the exact prevalence of non-adherence and associated cost is unknown. The World Health Organization broadly defines patient medication adherence as the extent to which a person’s medication-taking behavior corresponds with agreed recommendations from a health-care provider.
As shown in below, many factors, often in combination, have been reported to be associated with medication non-adherence including side effects, perception that the medication is unnecessary, low health literacy and cost or lack of insurance coverage. In particular, poor medication adherence has been well documented for chronic conditions given that effective management typically requires long-term use of one or more medications.
Factors affecting patient medication adherence. Factors highlighted in gray may potentially be addressed with pharmacogenetic testing.
Improving medication adherence
Effective strategies to promote adherence to a prescribed regimen(s) are desperately needed to reduce this ongoing problem in health care. However, given the complexity and heterogeneity of factors influencing medication adherence, it has been challenging to develop effective interventions to improve adherence. In general, the success rate of tested interventions has been relatively low, though even a small increment in adherence may result in substantial cost savings.Multifaceted interventions and/or personalized interventions may be necessary to reduce medication non-adherence in the United States. The most promising types of interventions to enhance medication adherence involve simplification of the drug regimen and addressing barriers to adherence such as improving convenience of care and providing information, counseling, reminders, self-monitoring, and reinforcement and follow-up. Patient-tailored interventions that explicitly address patients’ concerns and perceived necessity, and engage them in treatment decisions may be more likely to succeed in improving adherence.
Potential positive consequences of PGx testing on medication adherence
In addition, a few studies have suggested some positive impact with PGx testing in improving medication adherence and clinical outcomes.The inherent personal nature of learning of one’s genetic likelihood of having a positive therapeutic response or not having an adverse effect from the medication may increase the perceived efficacy/necessity or decrease the patient concern, respectively, ultimately improving medication adherence. The act of testing alone may reduce anxiety about the medication, contributing to increased adherence. Having patients engaged in medication selection or dosing decisions based upon the results of PGx testing may not only improve patient knowledge of their disease and treatment options, but also improve patient trust resulting in improved medication adherence. Patient’s confidence in a physician’s recommendations contributes to likelihood of drug initiation and discussion of therapeutic options provides a personal risk assessment and perhaps a greater sense of shared decision-making. Even if patients decline to have PGx testing after discussing it with their physician, the discussion about testing may improve patient satisfaction and feelings of shared decision-making. PGx-informed therapeutic decisions may result in reduced patient burden and costs associated with trial and error of medications for treatment and follow-up care required for management of adverse effects. The reduced burden and cost to the patient could positively influence medication adherence and thereby improve long-term outcomes and health costs.
Potential adverse consequences of PGx testing on medication adherence
As is the case for many types of genetic tests, PGx testing may result in beneficial or harmful outcomes, depending on the interpretation and communication of the test results. Thus, PGx testing may yield its own adverse effects that need to be carefully weighed. For example, while a PGx test result predicting that a patient will benefit from a given treatment or have a low risk of adverse events may improve adherence, prediction that the guideline-recommended treatment may not be as effective or associated with a higher potential risk of side effects may negatively influence adherence by both the provider and the patient. In particular, reduction in initial or long-term dose based on the PGx test result may raise doubt and reduce confidence about the safety and/or effectiveness of the treatment. Patients’ familiar with or having a preference for a particular drug may be disappointed if the PGx test result indicates that other drugs may be safer or more effective. Similarly, patients may perceive that a ‘targeted’ drug (designed to target specific genetic aberrations) is more effective, and thus, the use of a non-targeted drug is less effective, negatively impacting adherence to the alternatively prescribed drug. Furthermore, patients’ anxiety may be heightened following receipt of an ‘unfavorable’ result resulting in non-adherence and increased concerns about their health and provider’s ability to effectively care for them.
In addition, there are potential negative consequences for providers. Specifically, if a guideline-recommended medication is not used due to results of the PGx test demonstrating a lack of efficacy or high risk of adverse effects, then the clinician may be required to provide justification for their decision and potential negative impact on his/her performance measures or the performance measures of his/her clinic or hospital. In addition, depending upon the strength of evidence demonstrating the anticipated lack of benefit or increased risk, the clinician may be opening himself/herself up to potential litigation if outcomes are not as expected.
A number of other factors associated with non-adherence may be exacerbated by PGx testing. For instance, studies of public attitudes toward PGx testing have reported concerns that genetically tailored drugs would be more costly and result in greater health disparities. Therefore, patients and clinicians may be concerned that PGx testing may result in greater health-care costs and health disparities. Some patients may interpret PGx test results as determinant of an outcome, a concern if PGx test results are perceived to be unfavorable. Even tests that indicate no increased risk for an adverse event, however, may not reduce patient concerns and even raise anxiety in some patients.
Readiness of PGx testing for clinical care
Despite the FDA’s efforts toward providing information for health professionals about the impact of genetic variation on drug response or risk of adverse responses through revised drug labeling, there is substantial debate about the clinical utility of PGx testing, due in part to the lack of evidence. Cost-effective data for some tests are ambiguous and insurance coverage is not wide-spread, further limiting uptake. However, several studies have reported that the public is generally supportive of PGx testing, and physician and patient demand may override concerns of the lack of clinical evidence for PGx testing. Furthermore, implementation of PGx testing would fit well with the current movement toward patient-centered care model supported by recent health care reform in the United States (Affordable Care Act). The scope of clinical utility should be expanded to include medication adherence and the design of clinical trials to assess utility of PGx testing should also include measures of the impact of PGx test results on adherence.
While the reporting of results and communication between patient and provider about the interpretation and implications of the results is consistent with a patient-centered care model, full implementation in the clinical practice setting may be challenging. For example, some clinical practices may have policies on only reporting abnormal laboratory findings. As such, ‘normal’ results such as the results of the PGx test that does not indicate the need for a drug or dose adjustment may not be automatically reported to the patient. However, it is precisely this type of result that should be reported to potentially boost patient’s confidence in the efficacy of the drug or reduce concerns about adverse effects, thereby, potentially increasing adherence. Likewise, if the ‘normal’ result is reported simply as ‘normal’ without some explanation as to its significance to the patient’s likelihood to respond favorably to the prescribed drug or have a lower risk to experience an adverse effect, the meaning of the result may not be clear to the patient and the potential benefit of increased adherence will also be lost.
Understanding PGx test results will be a challenge for all patients, particularly those with lower health literacy. Millions of Americans have inadequate health literacy.PGx testing typically provides risk estimates or categorical risks (for example, increased likelihood) instead of definitive results, which may also be challenging to understand for many individuals, particularly those with low numeracy skills.Educational materials designed for patients with low health literacy about PGx testing and the results should be presented in a manner understandable for patients of varying levels of literacy to minimize confusion and misinterpretation. As PGx testing can inform future therapeutic decision-making, it is particularly important to understand the meaning and significance of the results when they are first ordered to increase the likelihood that the results will be disclosed or shared with future health-care providers.
Conclusion
Much of the uncertainty surrounding the clinical use of PGx testing at this time may be a reflection of the novelty of testing as it remains a heavily investigated area of research. Although it is unlikely that any recommendations for PGx testing will be based on its impact on medication adherence, this potential benefit should not be overlooked. PGx testing in combination with other inventions may serve to improve adherence in combination with other interventions. A small proportion of patients demonstrating improved medication adherence due to PGx testing could result in substantial health savings. With the movement toward patient-centered care, it appears to be an opportune time to investigate the benefit of PGx testing for medication adherence and how testing can be smoothly integrated into various health delivery systems to realize such potential benefit. Understanding the relationship between PGx test results and medication adherence will be useful in other areas of research such as risk communication, cost-effectiveness, analyses of interventions, and patient acceptance and engagement in self care.
References/Source:
nature.com
Acknowledgement:
This work was supported by funding from the US National Institutes of Health 5R01-GM081416-05.
