PHARMACY

Chain reaction: Addressing patients’ nutrition deficiencies

BY Michael Johnsen

Americans by and large have lousy diets, pharmacist and supplement expert James LaValle, CEO of Integrative Health Resources, told DSN Collaborative Care recently. Over a lifetime, those nutrient-poor diets contribute to the development of such chronic disease states as obesity, hypertension and diabetes. The medicines prescribed to treat those conditions then further deplete essential vitamins and minerals.

“Because of the poor nutrition status of people … there’s a lot more irritable bowel disease, colitis and hyperthyroidism. There’s a lot of conditions that relate to your ability to absorb nutrients from your food,” he said. “And when you combine that with food that isn’t as nutrient-dense, and then you combine that with medications that are depleting nutrients, it creates somewhat of a chain reaction, or momentum, that accelerates people toward [poor health] issues.”

For example, magnesium plays a role in maintaining healthy blood-sugar levels and is the most-identified nutrient depletion with the development of Type 2 diabetes and metabolic syndrome. “Culturally, we don’t get a lot of magnesium in our diet,” LaValle said. “And then if I put you on a medication that depletes magnesium, it exasperates the situation.”

It’s a vicious cycle. But it’s a cycle to which more practitioners are becoming sensitive. “With the advent of people studying nutrigenomics, what we’re seeing is that interface between a drug that depletes a nutrient and someone who’s genetically predisposed toward the depletion of that nutrient,” LaValle said. “That can accelerate the potential side effects that can occur from the drug.”

Some of the more significant medications causing nutrient depletion are oral contraceptives, which cause vitamin B-6 deficiency that triggers bouts of depression. The study of nutrigenomics has revealed that vitamin B-6 deficiency inhibits the methylation of serotonin and results in feelings of depression.

That’s just one example of how a nutrient depletion can contribute to the side effects associated with a particular medicine, which in turn could impact adherence to a medicine regimen if the side effect is too jarring to the patient. Paying attention to which medicines deplete which nutrients, and thereby avoiding some of these side effects, could improve medication adherence,  LaValle suggested.

Having a firm grasp of the importance of nutrient depletion is key for another reason: Many of those Americans who have poor lifestyle choices are enabled by medicines. So knowing what nutrients are important for specific disease states and medicine regimens can help turn the tide in getting those patients off those medicines because they no longer need them.

For example, men on statins are twice as likely to have low testosterone. Low testosterone has been linked to a higher risk of cardiovascular disease. To make testosterone, men need magnesium and zinc. However, to help control high blood pressure, physicians may prescribe a thiazide, which depletes magnesium and zinc. So a physician prescribing a statin and thiazide can in fact lead to increased cardiovascular risk for the patient if underlying nutrient depletions are not addressed in conjunction with the drug therapy.

There’s a curriculum trend in support of teaching the consequences of nutrient depletion and poor lifestyle choices at medical schools, LaValle noted. LaValle is the course director of George Washington University’s new Integrative and Metabolic Medicine program, a 270-hour course for physicians learning about exercise, lifestyle, stress response and nutrition. “All those aspects are not taught in school [currently],” LaValle said. “And there are other programs like that that are beginning to percolate everywhere in academia that are more oriented toward teaching physicians lifestyle, behavior, nutrition and prevention. Truly emphasizing to [medical students] the value of the type of diets that they put their patients on, the value in trying to get the patient to manage their health better so that the medications can be limited.”

Beyond lifestyle choices and prescription regimens, certain demographics may influence nutrient depletion. Members of high-income households (i.e., more than $75,000) are less likely to have nutrient shortfalls than households with less income. Obesity also raises the risk of nutrient depletion. Patients with a normal BMI typically have inadequate intake of calcium and vitamins A and C, but those who are overweight and obese also struggle with magnesium, and vitamins D and E.

A large percentage of older Americans have inadequate intakes of vitamins A, C, D and E; calcium; and magnesium, according to the National Health and Nutrition Examination Survey.

Of particular note, practically all older Americans are not meeting the recommended intake for vitamins D and E. These nutrients have important roles in bone and heart health, and in providing antioxidant support. And older Americans tend to consume fewer calories due to a decreased appetite, posing a challenge to correcting nutrient shortfalls through a food-only approach.

That makes it important to know which medicines deplete which nutrients, LaValle said, no matter what age you are.

 

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PHARMACY

Cause and effect: Demystifying the Drug Quality and Security Act

BY Ann Latner

In 2012, compounding made headlines when 64 people died as a result of fungal meningitis caused by contaminated compounded products.

History
In the fall of 2012, an outbreak of fungal meningitis was reported, and the Centers for Disease Control and Prevention tracked the outbreak to contaminated steroid injections, packaged and marketed by the New England Compounding Center in Framingham, Mass. The contaminated products had been distributed to 75 facilities in 23 states, and doses were given to approximately 14,000 patients. Of those, more than 750 fungal meningitis cases were reported, including 64 fatalities.

While pharmacists have long been mixing compounded products for patients with individual prescriptions, over the past several decades, mass compounding — with some pharmacies selling thousands of doses of regularly used compounded products for doctors to keep on hand for the future — had become increasingly popular.

The Drug Quality and Security Act
At the end of November 2013, President Barack Obama signed into law H.R. 3204, The Drug Quality and Security Act. The new law creates federal oversight for large volume compounding operations, but still allows pharmacists to provide traditional compounding services to individual patients. The idea was to give the Food and Drug Administration oversight for “outsourcing facilities,” a new class of compounding facility that is allowed to sell products in bulk to hospitals and physician practices without requiring individual prescriptions.

How much impact the new law will have is still largely unknown. The act allows traditional pharmacies to continue to be regulated by state boards of pharmacy; however, larger compounding facilities will be monitored via a system of voluntary registration. Once registered, these compounding facilities will be monitored by the FDA in much the same way as typical drug manufacturers are.

Who has registered so far?
As of the beginning of January 2014, only 11 compounding pharmacies had registered with the FDA. These pharmacies hope that registering with the FDA will give them a marketing advantage. Those who registered with the FDA are required to pay a fee, comply with good manufacturing standards, be subject to routine FDA inspections and report adverse events associated with their products.

The FDA hopes that healthcare organizations will prefer to purchase compounded medications from an FDA-regulated facility, and in early January, FDA commissioner Margaret Hamburg sent out hundreds of letters to hospitals urging them to buy compounded medications only from FDA-registered facilities.

“As a purchaser of compounded drugs, you can play an important role in improving the quality of compounded drugs by requiring compounding pharmacies that supply drugs to your facility to register as outsourcing facilities,” Hamburg wrote.

FDA draft guidance
Meanwhile, at the end of 2013, the FDA issued draft industry guidance about the new compounding law. The guidance suggests that compounding be done in accordance with U.S. Pharmacopeia chapters 795 and 797. While this would not be burdensome for non-sterile compounding, compliance with USP 797 could create implementation costs for compounding pharmacies. The second piece of guidance from the FDA would limit compounding pharmacies that do not have an agreement in place between the FDA and their state from shipping more than 5% of their compounded products outside of the state. Finally, the draft guidance also indicates that the FDA will regulate the bulk substances drug list. Comments to the guidance were due in early February.

Practically speaking
Will the new law affect most pharmacists?  No — particularly if the compounding is the typical mixing of a lotion in a mom-and-pop pharmacy. The new law really is targeting large operations compounding sterile — often injectable — medications, and selling them to hospitals, large physician practices and across state lines. As the year progresses and more compounding pharmacies register with the FDA, it will become clearer what the long-term effects of the new law will be.


Ann W. Latner, JD, a former criminal defense attorney, is a freelance medical writer in Port Washington, N.Y.

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H1N1 virus returns at high levels this flu season

BY Michael Johnsen

The same H1N1 virus to cause a pandemic in 2009 is by far the predominant influenza virus for the 2013-2014 season. This is the first season that the H1N1 virus has circulated at high levels since the pandemic.

However, the Northern Hemisphere quadrivalent and trivalent vaccines for the 2013-2014 season are well-matched to the H1N1 virus in circulation, according to the Centers for Disease Control and Prevention’s FluView report for the week ended Jan. 4.

Even though flu incidence started picking up later into the season, more people had gotten flu shots this season. “Overall, about 40% of the general population had reported getting a flu vaccine by mid-November,” noted Ann Schuchat, CDC’s director of the National Center for Immunization and Respiratory Diseases. “That is about three percentage points higher than last year at the same time, and most of the increase that we see is increases in adults getting vaccinated.”

“We estimate based on a conservative model that during last year’s flu season, … flu vaccination prevented at least 6.6 million people from getting sick with the flu, 3.2 million people from going to see a doctor or other healthcare professional and at least 79,000 hospitalizations,” said Tom Frieden, CDC director. “We’ve looked at the last few flu years going back with a similar model, all the way back to 2005, and this is by far the largest number of hospitalizations and other illnesses we’ve seen prevented. The high numbers prevented from last year were partly attributable to the fact that last year was a relatively severe season.”

As of Jan. 4, 35 states were experiencing widespread activity, and 20 states were reporting high levels of influenza-like illness. However, flu incidence this year is less pervasive than last year, running 5% to 10% below last year.
Nationwide for the week ended Jan. 4, 4.4% of patient visits reported through the U.S. Outpatient Influenza-like Illness Surveillance Network were due to influenza-like illness. This percentage is above the national baseline of 2%. Influenza-like illness is defined as a temperature of 100°F or greater, and cough and/or sore throat.

The neuraminidase inhibitors Tamiflu (oseltamivir) and Relenza (zanamivir) are currently the only recommended influenza antiviral drugs.
While the vast majority of the viruses that have been tested are sensitive to Tamiflu and Relenza, three additional 2009 H1N1 viruses proved resistant to Tamiflu during the week ended Jan. 4. So far this season, 13 (1.2%) 2009 H1N1 viruses have shown resistance to Tamiflu. No viruses have shown resistance to Relenza.

As in recent past seasons, high levels of resistance to the adamantanes — Symmetrel (amantadine) and Flumadine (rimantadine) — continue to persist among 2009 H1N1 and influenza A (H3N2) viruses. Adamantanes are not effective against influenza B viruses. Adamantanes are not recommended for use against influenza this season, the CDC noted.

 

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