I've decided that 2014 is the "Year of the Pharmacist." As we see the pharmacy profession and pharmacy industry transform before our eyes, stay tuned for information you need to stay current. We try to explore subjects that are timely and relevant to pharmacy, and propose topics you may be thinking about.

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Happy New Year! Wecome to the Year of the Pharmacist!

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Who Says?

Does the government have the right to tell us what to do?  What to drink?  What to wear?  In Texas, it’s against the law to take more than three sips of beer while standing.  In the crosshairs in New York, but voted down at the end of July, is the sweetened-sodas-larger-than-16-ounces issue.  Diet drinks have not been attacked.  Let’s also not forget the short-lived law in several cities across the country that made it illegal to wear saggy pants, as “exposed underwear poses a threat to the public.”  

Earlier this month, the Food and Drug Administration announced a preliminary determination that partially hydrogenated oils, the main source of artificial trans fats in processed foods, are unsafe to eat and should not be allowed in foods in the United States.  Although consumption of trans fats has declined over the last two decades, it is argued that current intake remains a significant public health concern.  Trans fats can be found in processed foods like microwave popcorn, frozen pizza, margarines and certain desserts.

The FDA proposes elimination of these fats from foods in the U.S. by classifying them as unsafe food additives and thus permitting them only in certain cases.  Manufacturers might not be very happy – the initial cost of changes and recipe reformulations could exceed $8 billion.  It is hoped manufacturers will find new ways to make the foods while keeping them as good as the way they are right now.

It’s well known that artificial trans fats are a major contributor to cardiovascular disease, and the UnitedHealth Group has just released projections that as many as 50% of Americans could have pre-diabetes or diabetes by 2020, coming with a healthcare price tag of $3.35 trillion over the decade.  On November 12th, the American Pharmacists Association summarized the guidelines for treating lipid and weight disorders as including stronger recommendations for using statins over other lipid-lowering drugs, and a call for more research into weight-loss medications.  Yes, more weight-loss medications.

The Declaration of Independence clearly states that all endowed have, “certain unalienable Rights, that among these are Life, Liberty and the pursuit of Happiness.”  As sometimes happens over hundreds of years, in this case 237 years, the original meaning of a statement can pale, or perhaps can be interpreted in a different way.  Maybe now it means that all endowed have, “to buy mandatory medical insurance so the U.S. can afford to treat your diabetes and cardiovascular disease." 

Another possibility… ”Life, Liberty and the pursuit of Happiness” could also mean “You get cheaper medical insurance if you are not diabetic, are not overweight, have a triglyceride level under 100, wear skinny jeans, drink diet soda – but if standing, two sips or less at one time – and only eat the newly formulated Twinkies that taste like rice cakes stuffed with green seaweed protein.”

Since 1812, the U.S. has been referred to as the ‘land of the free.’  We are also the ‘home of the brave.’  It doesn’t take a whole lot of bravery to follow a bunch of mandatory laws, and if that’s the case, someone should really rethink that 220-year old second Amendment thing. 

Painkillers as just plain killers.

The U.S. consumes 99 percent of the world-wide hydrocodone supply; prescription drug abuse deaths have quadrupled in the U.S. over the past 10 years and have exceeded traffic related fatalities for at least the past three years.  Figures from the U.S. Centers for Disease Control and Prevention reveal that drug fatalities increased 3 percent in 2010, the most recent year for which complete data are available.  

Preliminary data for 2011 indicate the trend has continued.  The increase was propelled largely by painkillers including hydrocodone and oxycodone, according to just-released analyses by CDC researchers.  The numbers were a disappointment for public health officials, who had expressed hope that educational and enforcement programs would stem the rise in fatal overdoses.

The numbers come amid mounting pressure to reduce the use of prescription painkillers.  The U.S. Food and Drug Administration is considering a proposal to limit daily doses of painkillers and restrict their use to 90 days or less for non-cancer patients.  The proposal also would make such drugs available to non-cancer patients only if they suffer from severe pain.

Among the most promising tools to combat the problem are computerized drug monitoring programs that track prescriptions for painkillers and other commonly abused narcotics from doctor to pharmacy to patient.  Texas launched their program – Prescription Access in Texas (PAT) – in June 2012.  The White House Office of National Drug Control Policy leader, R. Gil Kerlokowske, calls for aggressive monitoring of databases by state medical boards.  Some believe such programs should be used to monitor doctors' prescribing as well as patients' use. 

But the system needs to be used proactively in order to see change.  Lynn Webster, president-elect of the American Academy of Pain Medicine, said the new figures underscored the need for further action, such as educating physicians to recognize patients who are at risk for abusing painkillers.

Florida was the media’s first “pill mill capital.”  The state was a place where loose or nonexistent regulations let illicit pain clinics and unscrupulous doctors overprescribe oxycodone and other powerful medications to drug dealers and addicts.  Thanks to an effective state task force, the U.S. Drug Enforcement Administration oversight, and the online Prescription Drug Monitoring Program, the Florida doctors listed as top buyers of oxycodone have plummeted from 90 in 2010 to zero today.

But amid pharmacy retailers enhancing schedule II dispensing policy, state legislatures voting in new, more aggressive regulation, and DEA involvement, what else can be done to control painkiller abuse?

A group of Brigham Young University students redesigned the prescription bottle and have developed a high-tech regulator of medication.  Their invention, called Med Vault, lets a pharmacist give instructions to the bottle, which then dispenses painkillers accordingly to the patient.  The students claim the complex gadget is tamper-resistant and break-resistant.  The Med Vault requires users to put in an access code to get a pill, making it harder for the drugs to get into the wrong hands.

The project began as part of BYU’s Engineering Capstone program.  At this time, a patent has been filed and the team’s sponsor wants to take the bottle into production.  (Pictures on the right bar.)

Hang on... Things are starting to get interesting.

“Adherence” is a big buzz word in healthcare – a means of achieving the goals of improved outcomes and cost savings.  As we know, medication non-adherence continues to be a burden on the healthcare system.  The New England Healthcare Institute estimates the national annual costs of medication non-adherence to be about $290 billion.

In 2006, the Center for Medicare and Medicaid Services (CMS) established a general framework allowing sponsors to implement a Medication Therapy Management (MTM) program for its members.  MTM is a comprehensive approach to improve medication use, adherence, and reduce the risk of adverse events; it is not disease-specific disease management.  In 2010, after extensive analysis, MTM requirements were expanded for increased consistency among sponsors’ programs, and CMS pushed the service forward.

In November 2012, the Congressional Budget Office issued a statement summarizing the results of recent research estimating that greater prescription drug use by Medicare beneficiaries contributes to a reduction in Medicare’s spending for medication services.  In recent years, comprehensive MTM legislation has been pushed to the back by other more pressing healthcare efforts: namely the Affordable Care Act (ACA) and Health Information Technology for Economic and Clinical Health Act (HITECH).

In 2013 and the coming years, Centers for Medicare and Medicaid Services would like to expand the access to better target the beneficiaries who most need MTM, and through improved data collection, be able to more specifically evaluate the impact of MTM at the beneficiary level.  Today, each Medicare Part D sponsor is required to incorporate an MTM program into their plan’s benefit structure. 

In June 2011, CMS initiated a two-year project to examine the impact of Part D MTM programs on the Medicare Part D beneficiary population, with a particular focus on specific high-risk populations with strong clinical incentive to maintain drug therapy.  Interim reports show evidence of Medicare beneficiaries enrolled in MTM programs in 2010 – particularly those who received annual comprehensive medication reviews (CMR) – experienced significant improvements in drug therapy outcomes when compared to beneficiaries who did not receive any MTM services. This supports the hypothesis that the annual CMR may be one of the more crucial elements of MTM.

Recently, industry leaders sent a letter to CMS Innovation asking the group to clarify that pharmacists are providers for the purposes of participating in new delivery system models.  Pharmacy has a critical role in the future of healthcare…  Positive outcomes and cost savings are getting more attention in both policy circles and the marketplace, and pharmacy needs to continue its push for becoming a major participant in the effort to meet these two objectives.

More exciting news... Within the last month, U.S. Senators in Kansas, North Carolina, and Washington introduced legislation written to lower healthcare costs by helping more seniors better manage their prescriptions.  The Medication Therapy Management Empowerment Act will allow seniors with any high-cost chronic illness to review all their medication and develop a plan of action with a pharmacist.

Hang on... Things are starting to get interesting.

It All Ties Together

It has long been understood that there exists a direct correlation between healthcare literacy and patient outcomes.  Health literacy is the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions.  People with limited health literacy often lack knowledge or have misinformation about the body and the nature or causes of disease; without this understanding, one may not realize the relationship among lifestyle choices, healthcare options and health.

According to the U.S. Department of Health and Human Services and the Office of Disease Prevention and Health Promotion, only 10 percent of the U.S. population is fully health literate; 40 percent have only "basic" or "below basic" health literacy levels.  If patients don't understand providers' instructions, it can easily become dangerous for the patient and costly for the health care system.
  • Current cost of health illiteracy = between $106 billion and $236 billion annually.
    • Adding in future costs resulting from current health inattention is estimated between $1.6 trillion and $3.6 trillion.
  • The human cost of health illiteracy:
    • Higher rates of disease and mortality (up to 100,000 deaths per year);
    • more frequent use of emergency rooms and inpatient care; and
    • lower use of basic preventative care measures.
A recently released report by the National Research Council and the Institute of Medicine details how the U.S. is one of the wealthiest nations in the world, yet we have an increasingly unhealthy population.  Specifically, U.S. citizens live shorter lives, are in worse health, and have the poorest health outcomes than citizens of our 16 "peer" countries.  In this report, the healthcare system and the high cost of care are being blamed for our national health status.

But health illiteracy may not be directly connected with the cost of care, nor is illiteracy merely the result of patients being unable to understand their providers or communicate effectively in return.  Some argue that physicians must accept the bulk of the responsibility, as they have a long history of being poor communicators.  Confusion about medications tops the list of complications.  Additionally, literacy is dependent on:
  • Communications skills of lay persons and professionals;
  • lay and professional knowledge of health topics;
  • patients' culture; and
  • demands of the healthcare and public health system.
The fiscal fallout of low health literacy lands directly on federal, state and local governments.  To begin to counter the effects, federal agencies have started to take action.  HHS's Agency for Healthcare Research and Quality is providing $100 million in grants in support of health literacy initiatives, and the National Plan to Improve Health Literacy seeks to engage organizations, professionals, policymakers, communities, individuals, and families in a linked effort for improvement.  Their principals:
  • Everyone has the right to health information that helps them make informed decisions.
  • Health services should be delivered in ways that are understandable and beneficial to health, longevity, and quality of life.
Like most other complicated issues, health literacy is complicated because of the depth and reach of contributing factors.  However, as one of the 17 richest countries in the world, you would think we could figure it out.

There's Always Someone to Blame

We have heard much over the past few months about the tragic outbreak of fungal meningitis blamed for sickening 620 people across the country, including 39 who have died.  The New England Compounding Center (NECC) of Framingham, Massachusetts, produced the tainted steroids leading to the public health crisis.  As often happens after a national catastrophic event, we hear one resounding question - "Who do we blame?"

NECC supplied dozens of medicines to hospitals and doctors around the country.  The company prepared and shipped bulk orders of solutions without proof of the legally required individual prescriptions.  After the meningitis outbreak, NECC recalled its products and stopped operating amid a government investigation.  Barry Cadden, its president, stopped practicing.

Sterile compounding, the process used by NECC, must be performed in very controlled settings.  After the calamity, state and federal inspectors found that NECC used non-sterile raw ingredients and operated in unsanitary conditions.  They were caught even as they pursued aggressive company expansion while under the lax oversight of the Massachusetts State Board of Pharmacy.  But, sadly, not before 39 people had died.

All evidence shows the outbreak to be directly linked to the lack of controls at NECC; however, media coverage paints pharmacy in a negative light and creates repercussions for the entire industry.  Immediately following the outbreak, emergency regulations that tighten the oversight of all compounding pharmacies were put in place.

Traditional compounding pharmacies are intended to produce custom-made drugs for individual patients.  They work to support the needs of their local communities and have been a part of the practice of pharmacy since the beginning of the profession.  Drug manufacturers, conversely, produce drugs on a large scale like NECC produced.  State boards of pharmacy oversee compounding pharmacies; the US Food and Drug Administration monitors drug manufacturers.

As a result of the crisis, Federal regulation is being considered for all compounding pharmacies.  A new bill is being pushed forward by US Representative Edward Markey (D-Mass) supporting stronger regulations.  The National Association of Chain Drug Stores is in support of FDA and state pharmacy boards working in collaboration to identify sites that violate FDA's compounding guidelines.

The National Community Pharmacists Association has a clear stance: "The proposed legislation to create new board requirements on traditional pharmacy compounding could negatively impact both patients' access to essential medications and the community pharmacists that provide them.  As currently drafted, the legislation would create new roadblocks for patients by requiring waivers for pharmacists to make medications they have been making safely and effectively for decades."

In November hearings, congressional representatives and senators began to tackle an appropriate response to the outbreak.  In general, lawmakers from both parties criticized the FDA for not doing more to prevent the catastrophe.  FDA Commissioner Margaret Hamburg, MD, proposed creating a distinction between "traditional" compounding pharmacies and "nontraditional" compounding pharmacies, which would be required to follow rules that apply to drug manufacturers.

As of December 21st, the New England Compounding Center filed for Chapter 11 bankruptcy protection, and is currently setting up funds to compensate victims and their families.  NECC is clearly to blame - not only for the loss of 39 people, but for the potential future restrictions to the average patient needing a compounded drug.

As is typical of state and federal legislation, all will suffer because of the actions of a few.  In the end, we all are forced to absorb the blame.