Much has been written about the ability of both medications and individual genetics to affect how people metabolize drugs. But did you know things like herbal supplements, smoking cigarettes and even grapefruit juice could have the same effect?

The U.S. Food and Drug Administration has warned, for example, that certain dietary supplements can boost the effects of other medications as well as change how the human body processes medications. This could change drug blood levels, meaning a patient could be getting too much, or too little, of the medication they need.

For example, birth control pills and drugs designed to treat HIV/AIDS, heart disease and depression are less effective when taken with St. John’s wort, an herbal supplement. Reduced or increased efficacy of certain medications could result in potentially harmful adverse drug events or treatment failures.

FDA officials also warn against combining supplements that thin the blood, such as ginkgo biloba and vitamin E, with warfarin (Coumadin), a common medication prescribed for cardiovascular disease or blood clots. Taking any of these products together may increase the risk for internal bleeding or stroke.

Research has also linked cigarette smoking with increased activity of the CYP1A2 enzyme, which processes many common medications, including the antipsychotics olanzapine (Zyprexa) and clozapine. Stopping or starting smoking could result in increases or decreases of CYP1A2 substrates, necessitating a change in dose.

Also in the CYP enzyme family are CYP3A4 and CYP3A5. These are the most common drug-metabolizing enzymes in the body and process roughly half of the most commonly prescribed drugs on the market, including opioid pain medications, statins, chemotherapeutic drugs and combined oral contraceptives.

In a brochure on pharmacogenetics, the American Medical Association reports common grapefruit juice to be a CYP3A4 inhibitor, meaning it decreases the enzyme’s ability to process drugs. This means that in people regularly drinking grapefruit juice, drugs that require the activity of CYP3A4 will not be metabolized at the same rate as in those who do not drink grapefruit juice regularly.

What’s more, people who are CYP3A4 intermediate metabolizers could see an even greater reduction in metabolism from regular consumption of grapefruit juice since their CYP3A4 activity is already compromised.

The YouScript Personalized Prescribing software database contains hundreds of substances, both prescription and not, and can detect potential interactions between them and many medications.

Health care providers may find reason to celebrate after a recent announcement by the agency that oversees the federal Meaningful Use requirements.

The Centers for Medicare and Medicaid Services (CMS) announced in late January that they intend to “engage in rulemaking” this spring to update the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs, more commonly referred to as the Meaningful use program. The most significant change seems to be the CMS’ intent to alter the 2015 EHR attestation reporting period from 365 days to 90 days.

The bottom line: providers aiming to qualify for this program could need only three months’ worth of reporting data to show they’ve met the requirements for 2015, instead of a year’s worth.

The year-long reporting period for Stage 2 attestation had been a source of much consternation among a variety of health care organizations and had even sparked legislation by a North Carolina congresswoman in the House of Representatives last year to change it. The CMS expects the new rule to be “responsive to provider concerns about software implementation, information exchange readiness, and other related concerns in 2015.”

“These intended changes would help to reduce the reporting burden on providers, while supporting the long term goals of the program,” says Patrick Conway, MD and CMS chief medical officer, writing on the CMS blog.

Stage 1 Meaningful Use requirements, which providers could begin meeting in 2011, include implementing clinical decision support tools (such as the YouScript Personalized Prescribing software) and adding computerized provider order entry systems. Stage 2 focuses on: more rigorous health information exchange, increased requirements for e-prescribing and incorporating lab results, electronic transmission of patient care summaries across multiple settings, and more patient-controlled data.

The CMS summarized the proposed changes this way:

• Realign hospital EHR reporting periods to the calendar year to allow eligible hospitals more time to incorporate 2014 Edition software into their workflows and to better align with other CMS quality programs.
• Modify other aspects of the program to match long-term goals, reduce complexity, and lessen providers’ reporting burdens.
• Shorten the EHR reporting period in 2015 to 90 days to accommodate these changes.

These proposed updates are separate from the forthcoming Stage 3 proposed rule that is expected to be released by early March, the CMS says, with Stage 3 requirements likely beginning in 2016 or 2017. Stage 3 is expected to focus on improved outcomes and include goals such as giving patients access to self-management tools and decision support for national high-priority conditions.

Health care groups like the American Medical Association (AMA) have praised the CMS’ proposed changes, saying they seem to be needed since more than 50 percent of eligible professionals will face payment penalties this year because they could not fulfill Meaningful Use requirements. Only about 3 percent of physicians and other eligible providers had attested to Stage 2 of Meaningful Use in 2014, the AMA reports.

“By making changes to Stage 2 of the program, we can be sure that CMS is listening to physicians,” AMA Board of Trustees Chair Barbara McAneny, MD, writes on the AMA website.

For more on the CMS’s announcement, visit their website here.

By Josh Schwartz

Each year the President of the United States goes before Congress to present a report on the State of the Union. The range of topics covered in this address is typically quite broad, but one of the president’s newest initiatives stood out among the others: Precision Medicine.

In between talking about how to create more jobs in America and how he wants to maintain a “free and open” internet, President Barack Obama announced a push for the use of personalized information in the treatment of disease. He made it clear that it is necessary and expedient to use modern technology to provide personalized treatment for all Americans, not just those suffering from complex diseases:

“I want the country that eliminated polio and mapped the human genome to lead a new era of medicine — one that delivers the right treatment at the right time… Tonight, I’m launching a new Precision Medicine Initiative to bring us closer to curing diseases like cancer and diabetes — and to give all of us access to the personalized information we need to keep ourselves and our families healthier.”

The use of genetics to study and help treat complex diseases like cancer has exploded in the past decade. Writing in the UCLA Journal of Law and Technology, Michael Donovan has pointed out that, “researchers tend to focus their efforts on genes relevant for the pathology being treated” in spite of the fact that there is also a “nearly never-ending playlist” of information regarding how genes impact the body’s response to drugs.

This highlights that an important field in personalized medicine has been largely overlooked – the use of genetic information to gain additional information when treating patients with commonly prescribed drugs. This field of study, known as pharmacogenomics, has only recently started to gain a foothold in clinical practice.

“Pharmacogenomics” describes the broad study of how multiple genes together (and sometimes the entire genome) affect drug therapy and response. “Pharmacogenetics” is then generally used to describe testing for variants in one specific gene that could have an impact on drug response.

Since the 1950’s, scientists have known of the relationship between drug response and genetic variation, according to the textbook “Pharmacogenetics” by Wendell Weber. Yet even in the 21^st century, when many drugs have had specific guidance published in their product inserts regarding which genetic variations affect drug response for years, the utilization of this information has not become a standard of care. This is concerning, considering many patients’ lives depend on drugs that vary in effectiveness based on the specific version of a gene each patient expresses. This, in addition to the potentially life threatening reactions a patient may have to an otherwise helpful drug due to their genetics.

While Donavan writes that some believe physicians are liable for knowing the information in drug labels related to pharmacogenetics, only a small number of clinicians actually use this information regardless of the clear clinical utility of available testing. Surveys have found that barriers to clinician use of this information include a lack of education and a lack of confidence in using the information, even if they have a basic understanding of how the testing could be beneficial.

A key objection from health care providers is the lack of “outcomes data” – research definitively showing the implementation of testing improves patient outcomes, despite other variables at play. Some in the field might feel this is a disingenuous objection considering the mechanism of the interactions caused by genetic variations is well defined in research.

In addition, this information is significant enough to have led the U.S. Food and Drug Administration to update dozens of drug labels in the past decade and consider drug-gene interactions similar in scope to drug-drug interactions. While others may view this as an easy way to divert discussions about implementing a new service requiring additional time investment on their part, I think there is some validity to the concern.

There is little doubt the information provided by a pharmacogenetic test can be critical to finding the right medication or dose for an individual patient, but how that information is presented to a physician, and subsequently used, may have a major impact on treatment outcomes.

A static pharmacogenetic test result may be helpful at the initial point of prescribing, but how does the physician keep that top of mind for each future prescribing decision for that patient? After all, a patient’s genes will never change, and these results should be considered prior to any pharmaceutical treatment for the rest of the patient’s life.

How then is a physician able to quickly use this information to guide future treatment?  If this information – and its effects – aren’t readily available, then physicians will be hard-pressed to use it to improve outcomes beyond the initial diagnosis. So in truth, the test alone may not have the intended outcomes. This is because the accessibility and utility of this information can only be made possible through changes in how EHRs store and process genetic information and leverage clinical decision support tools to usefully put this data to work.

Though research is underway scrutinizing the clinical utility of pharmacogenetic testing, there is no “silver bullet” to encourage the broad implementation of the practice. One thing a presidential initiative may do is provide the requisite publicity to the field of pharmacogenomics. The effect of this is two-fold: public demand to know this information about themselves, and much-needed encouragement to physicians to begin implementing pharmacogenetic testing on a broader scale.

Lastly, while the President did not directly speak about pharmacogenomics in his speech, key language often used to describe the field can be found in a blog article posted on the White House’s Office of Science and Technology Policy website after the State of the Union:

“Today, most medical treatments have been designed for the “average patient.” In too many cases, this “one-size-fits-all” approach isn’t effective, as treatments can be very successful for some patients but not for others,” writes Jo Handelsman, the Associate Director for Science at the White House Office of Science and Technology.

“Precision medicine is an emerging approach to promoting health and treating disease that takes into account individual differences in people’s genes, environments, and lifestyles, making it possible to design highly effective, targeted treatments for cancer and other diseases. In short, precision medicine gives clinicians new tools, knowledge, and therapies to select which treatments will work best for which patients.”

One can hope this initiative will do much more than simply bring additional publicity to pharmacogenomics and personalized medicine in general. Research grants or educational funding surrounding the field of personalized medicine will have far reaching effects on the future of medicine.

Josh Schwartz has worked at Genelex since 2013. Josh holds a master’s degree in security and diplomacy from Tel Aviv University and a bachelor’s degree in political science from the University of Washington.

This post is one in a guest-blogging series PGx in Practice has launched that features subject matter experts from within Genelex discussing issues pertaining to pharmacogenetics and the healthcare industry.