I only want Vicodin, not the Amoxicillin.

"I only want the Vicodin, not the Amoxicillin." "Don't you have the yellow ones? The white ones don't work for me." "What do you mean the refill is five day's early. I'm out!"

Sound familiar? Most pharmacists have dealt with potential abuse issues time and time again. Lately, it seems like the FDA agrees. On October 24, Janet Woodcock, Director of the Center for Drug Evaluation and Research, released a statement announcing it's intent to pursue Schedule II status for all hydrocodone products, instead of the Schedule III classification combination products currently have. While the FDA cannot singlehandedly reclassify a drug's status, it is submitting a recommendation to Health and Human Services and then to the Drug Enforcement Agency regarding it's potential for abuse and misuse.

Prescription pain medications are powerful indeed: in 2007 alone, 28,000 Americans died from unintentional drug overdose. Of those, approximately 12,000 were from opiods. It seems like non-medical use can also be a slippery slope, as 29% of people ages 12 and older who used illicit drugs for the first time chose to do it via prescription painkillers; most obtained the drugs from friends. Additionally, prescription drugs made the list as the #2 abused drug category in the U.S., right behind marijuana.

On a regional level, the Substance Abuse and Mental Health Services Administration estimates that 4.33% of Texans ages 12 and older have used prescription pain relievers for non-medical purposes during 2010-2011, with the highest percentage of users between 18-25 years of age. The State has implemented programs to attempt to decrease non-legitimate use, such as the Texas Prescription Program, which allows practitioners and prescribers to search a database storing information about a patient's controlled substance usage and dates issued or filled. Many other states have similar existing programs or are in the process of implementing such programs, but are these measure enough to deter prescription drug abuse?

Despite the prevalence of opioid abuse and misuse, there are many legitimate patients for whom prescription painkillers are a necessity. The Institute of Medicine's June 2011 report, Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education and Research, estimates that chronic pain affects about 100 million U.S. adults. Caring for these patients presents its own challenges, and a whole host of associations and subspecialties have sprung up in the past thirty years to address them, including the American Academy of Pain Medicine, the American Academy of Pain Management, and the American Society of Interventional Pain Physicians. These practitioners see an ever increasing number of patients suffering from chronic pain due to a wide variety of diseases ranging from diabetes to cancer.

If hydrocodone products are reclassified as a Schedule II drug, chronic pain patients may suffer due to increased regulatory control. Since Schedule II prescriptions must be written for no more than a 90-day supply, and cannot be faxed or phoned in, this may cause a significant obstacle for chronic pain patients who often find it difficult to visit a physician regularly. Acute pain issues would also be directly affected, potentially causing a drastic increase in visits to emergency rooms and urgent care centers to manage immediate pain needs.

In the past few years, we have seen an increase in both legitimate pain prescription usage and an increase in drug diversion and abuse. States have tightened their restrictions on controlled substance dispensing (see: carisoprodol, a common muscle relaxant, reclassified in Texas as a Schedule IV substance, and many other states moving tramadol to controlled substance status.) Databases have been created to trach controlled substance use, and pharmacists use their best judgement to decide whether a prescription is appropriate. While on the pharmacist's end we are not privy to the patient's entire medical record, we do share a responsibility to ensure the prescription in question is dispensed according to the course of professional practice and for legitimate medical purposes.

The debate: two major pharmacists' associations, the American Pharmacists Association and the American Society of Health-System pharmacists, are in opposition on this matter. APhA wrote a letter to Health and Human Services in Association with many other groups (the Academy of Managed Care Pharmacy, the American Society of Consultant Pharmacists, the National Alliance of State Pharmacy Associations, the National Association of Chain Drug Stores, and the National Community Pharmacists Association) expressing its reservations regarding the proposed change. "Rescheduling will have a profoundly negative impact on patients who legitmately need these medications and a negligible impact on drug abuse." ASHP, on the other hand, released a statement calling "concerns regarding record-keeping and security processes resulting from rescheduling 'valid,'" but countered this by stating that they are "outweighed by the public health benefit arising from increased control of durgs with high abuse potential."

What do you think: In the end, will the legitimate patient suffer due to increased regulatory control, or does the potential decrease in drug abuse outweigh these problems?

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 12^th, 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.

What's the problem? Too many to list. What's the solution? Pharmacists.

Earlier this year the U.S. Surgeon General was quoted as saying, "We have the evidence health leaders and policy makers need to support evidence-based models of cost-effective patient care that utilize the expertise and contribution of our nation's pharmacists as an essential part of the health care team."

The Surgeon General specifically identified three demands within the health care system that pharmacist-delivered patient care can help meet:
  1.  providing care for chronic disease patients;
  2.  increasing access to care, addressing insufficient time for focused medication management;
  3.  and supplementing the primary care provider workforce.

Health reform through pharmacists delivering expanded patient care services?  Absolutely.  Through testing in the federal sector, several practices have been implemented and embraced, including a health care delivery model through physician-pharmacist collaboration.  This model has demonstrated that patient care services delivered by pharmacists can improve patient outcomes, promote patient involvement, increase cost efficiency, and reduce demands affecting the health care system.

Another opportunity for pharmacists: Studies conducted by the Association of American Medical Colleges show that America is producing a consistently stagnant number of doctors each year relative to our continually growing population.  Since 1980, the U.S. population has grown by 70 million while the number of M.D. graduates has remained flat at about 16,000 per year.

Experts have warned that there won't be enough doctors to treat the millions of newly insured under health care reform laws.  It is predicted that the U.S. could face a shortage of as many as 150,000 doctors in the next 15 years; 45,000 physicians short by 2020.  This data clearly predicts an even more limited access to health care providers.  What profession will step up and fill this need?

Over the past 10 years, we have seen signs of pharmacy going from a product-focused - or medication-focused - profession into a patient-focused profession.  The medication is no longer our product - the patient and their outcome is.  Every element of pharmacy is broadening.  A few more steps and pharmacists will no longer be, in large part, "dispensers" or "verifiers".  Visualize pharmacists as conduits of health; providers of education; builders of relationships and trust; and the rising professionals who will affect change in the health care industry.

Through EMR and EHR, the technology is in place for collaborative practice agreements where pharmacists can:
  1.  perform patient assessments;
  2.  have prescriptive authority - to initiate, adjust, or discontinue treatment; to manage disease   through medication use; and deliver collaborative drug therapy or medication management;
  3.  order, interpret, and monitor laboratory tests;
  4.  provide care coordination and other health services for wellness and prevention;
  5.  and develop partnerships with patients for ongoing care.

More and more of the pharmacy profession is impacted by external events, but the pharmacist's core continues to remain the same - to treat those who are ill, relieve suffering, and act in the service of our community.  The degree to which we can 'treat' is an exciting evolution that we are lucky enough to be experiencing during our careers.  The progression may be coming in stops and starts, but we are moving forward like never before.

77% of pharmacy patients say their pharmacist is a valuable resource; 28% of patients interact with them.

The pharmacy health and wellness market is a lucrative one, expected to reach $170 billion by the end of 2012.  This industry continues to experience rapid loyalty growth, in part due to the numbers - customer spending and repeat shopping is on the rise.

Pharmacy companies are investing in and revitalizing customer loyalty programs to booster sales and grow loyalty.  Tracking customer sales allows companies to understand where and how often customers are spending, enabling personalized offers and rewards.  It's a win-win - customers are saving money and feeling valued, and pharmacies and health and wellness businesses are gaining better customer insight, increasing sales and retaining customers.

According to research released in October by AccentHealth and Boeringer Ingelheim, 90% of pharmacy patients have a preferred pharmacy - and for 98% of that group, it isn't mail-order.  The key to success is being the most "preferred."  But it also means that converting customers to your pharmacy will probably take some effort.  Thus far in 2012, only one in ten patients has changed their pharmacy.

Factors Affecting Patient Preference:

• 75% of surveyed patients rated convenience/location as their first priority.
• 57% of patients rated customer service as their second priority.
• 34% of patients said the pharmacist is a "very important factor" in choosing their preferred pharmacy.

It's Always about the Money
When all things are equal - specifically cost - there is no doubt that satisfied pharmacy patients are fiercely loyal to their preferred store.  But if cost is a considered factor, then:

• 32% of patients said they would change pharmacies for a savings of $5 or less.
• 8% of patients said they would change for a savings of $1 or less.

As 40% of patients would change pharmacies to save $5 or less (if cost is important), the pharmacy staff needs to work to develop that customer loyalty.  Research shows that engagement with pharmacists varies by pharmacy type: in 2012, independent and food store customers interacted the most; chain pharmacy customers interacted the least.  Customer engagement with the pharmacist has little correlation with the time they wait to speak with their pharmacist, and filling wait times have no direct correlation with increased spending in the store.  But let's not mince words - wait times directly affect overall customer satisfaction.

Perception v. Reality
77% of patients believe that the pharmacist at their preferred pharmacy is always available to answer questions and discuss medications, but only 28% say they interact often with their pharmacist.  One can conclude that the pharmacist plays an important role in patients choosing a pharmacy; and yes, they are a trained, valuable, accessible resource.  But very few people are reporting that they utilize the pharmacist as a regular source of information.

Chain pharmacists have a distinct advantage - chain customers are shopping at their primary pharmacy 4.4 times per month on average, which leads all other pharmacy types.  The advantage?  This frequency gives the pharmacy staff ample opportunity to provide the service and care the patient requires, certainly increasing loyalty.

A parting thought - a clear majority of surveyed patients believe that chain drug stores have the most professional and trained pharmacists.

Theory is now reality. Welcome to the future.

We all know that politicians are still fighting about health reform, but health providers (including Texas Health Resources) have made their decision: The big overhaul is coming regardless of what happens in the November elections.  There has been an acknowledgement of the inevitable - and the unsustainable.  Health spending has reached a high of 18% of GNP, up from 12% in 1990.  Accountable Care is not just a theory anymore... it's reality.

Providers are feeling the pressure of offering more consistent care at a lower price.  Accountable Care Organizations are a big part of health law - get the right treatment at the right time at the right price; and keep patients healthy by bringing together primary care doctors, specialists, hospitals, pharmacy, and more.  This is the beginning of the end of our crippling fee-for-service system.

Texas Health Resources facilities treat one in four patients in this region.  The group has already spent $200 million on electronic medical records systems and a data analysis company, Healthways.  The tracked health data will identify congruent health issues among patients and the most effective protocols; smartphone tools will record follow-up treatments, medications and several other measurable effects.

Cost control efforts are being seen across the spectrum.  Next month Medicare will enforce new policy for hospitals with high re-admission numbers to be paid less than hospitals with fewer preventable re-admissions.  A New England Journal of Medicine study shows that 20% of Medicare patients return to the hospital within 30 days of discharge - their conditions still serious and costing the U.S. about $17 billion each year.  34% of patients are re-hospitalized within 90 days of discharge.

Admittedly, many of the returning patients are high-risk; they may be frail, have chronic conditions, or are unable to get to their follow-up medical appointments.  To add another layer, hospitals tend to transfer patients to less costly settings once their conditions are stable.  Follow-up care at home or through a skilled nursing facility is an option many patients prefer, but their condition needs to be carefully managed for the best outcome.

The Affordable Care Act is expected to allow countless seniors to live longer, healthier lives.  The ACA brings lower drug costs, more free preventative health screenings and an annual consultation with a physician to create a personal health plan.  And, it should also mean an end to obscene increases in medical costs.  Senior advocate organizations have strongly supported the health care bill, and virtually all the major health care and health insurance associations have given it their full support.

New rules allowing for administrative simplification are gradually being rolled out and accepted as part of new health care law.  These changes are expected to save providers and health systems about $4.6 billion over the next 10 years.  How?  By eliminating the red tape.  Directed by Health and Human Services Secretary Kathleen Sebelius, a universally used administrative process is essential in providing cost-effective, patient-care focused treatment plans that lead to more time with the patient, less time filling out forms, and more positive patient outcomes.

And Missouri Stands Alone…

49 states have now passed legislation to electronically monitor controlled substance and

narcotic prescriptions, with the exception of Missouri.  Senator Rob Schaaf of St. Joseph, Missouri, is a first time senator and family practitioner.  Schaaf is adamant that Missouri will not adopt a prescription database, as he believes – along with other critics – that the database represents an infringement on personal liberty.  Protecting a patient’s confidentiality should be a priority, Schaaf has said, adding that citizens “shouldn’t have to give up their right to privacy just to stop people from doing bad things.”

The Texas Department of Public Safety (DPS) officially launched their secure online prescription monitoring program, called Prescription Access in Texas (PAT), in July 2012.  This database is available to a select group of practitioners, pharmacists, and law enforcement officials.  Very recently, DPS has extended program access to additional physicians and law enforcement, mid-level practitioners, medical board and nursing board investigators.

Advocates of the program contend the database allows doctors and pharmacists to better monitor patients who frequently seek prescription medications; the program is aimed at stopping “doctor shopping,” by which people get prescriptions from multiple physicians to feed an addiction or to sell.  The number of deaths as a result of prescription drug use and abuse are greater than heroin and cocaine overdose deaths combined.  The most recent year with statistics available – 2009 – shows that nearly 21,000 deaths in the U.S. were attributed to prescription drug overdoses.

The Centers for Disease Controll says overdose dealths from prescription painkillers such as hydrocodone, methadone, and oxycodone have skyrocketed in the last 10 years.  Some estimate that deaths from prescription drug overdoses exceed those from car accidents.  In Dallas County, 14.5 percent of high school students have admitted using an illegally obtained prescription drig in the last 30 days.   

It appears that online tracking of controlled drugs will, at the very least, decrease access.  Florida was once known as the “pill mill capital.”  A few years ago, more than 90 of the nation’s top 100 prescription-dispensing physicians were in Florida.  In 2009, the state instituted a tracking program and today, the number is down to 13 physicians in the top 100.  People who fail to disclose that they are receiving pain medication, controlled substances, or narcotics from other doctors could face legal consequences. 

Pharmacists have been required to send prescription information to the Texas Department of Public Safety since 1982, now called the Texas Prescription Program.  It was once an effective and efficient tool for investigation and preventing drug diversion.  The new online PAT system does not require every prescription written to be entered in the database; pharmacists are required to report each prescription they fill for narcotics.  PAT will hold physician, patient, and controlled substance information for one year, allowing law enforcement and health care professionals’ immediate access to dispensing data.

Texas has taken measures to ensure the data is secure on PAT, and that it can only be accessed by licensed practitioners and pharmacists; however the American Civil Liberties Union has reservations about the program.  The ACLU refers to the program as “government surveillance.”  Is this another example of Big Brother tracking our every move?  Does this program violate personal liberties? 

Let’s not over-think this…  I think PAT allows providers access to data that will help them make appropriate decisions for their patients. 

A Little Less Conversation, A Little More Action

Although a slew of political controversy succeeded in distracting our attention for about five minutes, I think we’re all getting used to idea that the health care system as we know it is changing.  When we think about reform, let’s keep two things in mind: currently, the United States spends more than twice as much as any other country in the world on health care; and, despite our huge investment, our national health status is near the bottom of the developed world.

We hear political candidates sparring about a “repeal of health care reform”, but most experts think it unlikely.  Analysts and industry specialists assert health care reform will continue out of necessity, whether through the Affordable Care Act or the momentum it already has created since being passed over two years ago.  Many think it’s time to stop talking about everything that is wrong with the ACA, and just go on about it.  The odds of repeal?  Slim.  According to a Kaiser Health Tracking Poll released recently, only about 20% of U.S. voters are pushing for a full repeal.

In large part, health care reform boils down to several points:

·       If you don't have health coverage in 2014, you will have to pay a penalty.  The fee is capped at $285 per family, or 1% of income, whichever is greater; $2,085 per family, or 2.5% of income, by 2016.  Individual penalties will be $95 in 2014; $625 in 2016.

·       Employers must provide coverage for adult dependents of workers up to age 26; health plans must cover basic preventive services without charging a deductible, co-pay or coinsurance; insurers can't impose a maximum annual or lifetime dollar limit on a customer's medical care. 

·       Beginning in 2014, insurers can't drop an individual if they become sick and they cannot refuse coverage for a pre-existing condition.

·       Industry experts predict that employers who offer insurance will be even more focused on controlling their health care costs, especially since the individual mandate is expected to add more people - including more high-risk individuals - to their plans.  Expect increases in premiums and deductibles.

·       Consumers with incomes between 139% and 400% of poverty will be eligible for tax credits to offset the cost of buying coverage through exchanges.  According to the Congressional Budget Office, the average subsidy per enrollee in the exchange will be $4,780 in 2014; $5,780 by 2018.

Medicaid is expected to include more low-income Americans – those earning up to 133% of the poverty level are eligible – with the federal government paying 100% initially and decreasing to 90% over the long term.  But individual states are given the choice of expanding their Medicaid program.  Currently, 22% of the Medicaid program is paid by the individual state.

Certainly one question looms large…  Who pays?  The answer is still murky.  The government?  Taxpayers?  Will free enterprise take over and drive costs down?  Although some analysts say the middle class will be hit the hardest, repeal at this point would add $109 billion to the deficit. 

This we do know… The federal government will shift health care cost increases to governors and states, as 160 million Americans—or one out of every two—will be receiving their health care directly from the state or through a state created and operated exchange.  This includes state employees, the 80 million individuals expected to purchase healthcare through the exchanges, and an additional 75 million on Medicaid.

Wonder what Rick Perry is thinking right now…

“I trust my drug dealer. I’ve had him for ten years.”

Customer: “Do you have real Xanax back there?”

Pharmacist: “All of the drugs in the pharmacy are real and approved by the FDA, ma’am.”

Customer: “I think I got some bad Xanax.  I don’t feel right.”

Pharmacist: “If you’re not well, I think you should go to the hospital to be checked.  There’s been a lot of synthetic Xanax in the area and it’s very dangerous.”

Customer: “No.  I trust my drug dealer.  I’ve had him for ten years.”

I heard this and didn’t know if I wanted to cry, put it on a t-shirt because it’s so ridiculous, or become a Republican.  You should probably know that this posting will most likely not be politically correct, and it is 100% the views and unqualified opinions of me – the blogger.  As far as I know, my words do not represent anyone or anything other than myself.

A friend told me another one this week…  People are getting high on “bath salts,” going crazy, and becoming cannibals.  I thought she was crazy, but I called on my most trusted resource – Google – and started reading.  She’s right.  People are injecting, snorting and smoking this new designer drug.  The main synthetic “Bath Salts” ingredients:

·         mephedrone
·         MDPV
·         methylone

These chemicals, along with others formulated by “street chemists”, were being sold in gas stations and convenience stores – displayed right on the counter near the cash register.  Now they are being sold on line and from behind the counter in smoke shops and c-stores.  Customers are currently required to ask for the product by name: Ivory Dove Ultra is $16 for a 200-mg packet.  The package clearly warns that the product is not for human consumption.

Well, humans are consuming.  Earlier this month, Miami News reported a 31-year old man high on “bath salts” attacked an older man and ate his face.  The attacker could not be subdued and was shot and killed by police officers.  Other cities are reporting incidents of users acting as “psychotic ravaging beasts,” clearly a preface to the cannibalistic activities.

                BREAKING NEWS: as of June 29^th, toxicology reports showed that marijuana

                was the only illegal drug in the Miami attacker’s system.  Scientists admit,

                however, that they don’t know what other chemicals to test for, or do not

                have tests developed to look for the known synthetic ingredients.

Cannibalism.  As a society, how have we gotten to this point?  I get that people can be addicted to things  - like video games, smart phones, fast food, alcohol, cigarettes.  Some is human nature – some people are predisposed more than others towards addictiveness.  But as healthcare professionals, are we required to show compassion to everyone?  My gut says we are, but I’m having a hard time wrapping my head around ravaging cannibals and kindness.

As adults, I believe we need to do whatever is required to protect our youth, but at what point is my obligation to my fellow man fulfilled?  There are many days where I feel like I’ve done my part, but then my conscience gets the better of me.  Perhaps I can find a balance of compassion and concern while not condoning one’s behavior?  I support the First Amendment as much as the next guy, but when we need the Second Amendment to protect ourselves from people making conscious decisions to use drugs like "bath salts”, you have to wonder… Where it will end?

Where is your end?  Where is your line in the sand?

Watch Me Say No

… is another download that teens can use to design their own anti-drug t-shirts, posters, and stickers from the National Institute on Drug Abuse website.  The NIDA website was created to educate adolescents (as well as parents and teachers) on the science behind prescription drug abuse.  It is hoped that understanding science-based facts will prompt teens to make better decisions about using drugs.  Teens were instrumental in developing the site to ensure the content addresses appropriate questions and timely concerns.

The non-medical use of controlled medications in teens has surpassed all illicit drugs except for marijuana.  Smart Moves, Smart Choices – a website sponsored by Dr. Drew Pinsky, Janssen Pharmaceuticals, Inc., and the National Association of School Nurses – is a group dedicated to educating the public on teen prescription drug abuse.  At this time, 19% of high school students have admitted to taking a prescription medication that was not prescribed to them; 33% have admitted to trying marijuana.

Research shows that prescription and over-the-counter drugs are among the most commonly abused drugs by teens, along with alcohol, marijuana, and tobacco.  Many young people access prescription drugs easily and perceive prescription medications to be less dangerous than other drugs – they believe them to be safer and have fewer side effects than street drugs.  An alarming 60% of teens who have abused prescription drugs have tried them before age 15. 

Many accuse U.S. adults of having a “casualness” about taking prescription medications – that controlled drugs are without consequence.  Some believe this attitude is helping to fuel the drug problem we now see in teens.  64% of abused prescription drugs are coming from friends or relatives; some misuse originates from a legitimate prescription.

The most abused classes of drugs are benzodiazepines, psycho stimulants, and opiates.  The most problematic class is opiates - every day, 2500 more teens use a prescription pain reliever to get high for the first time.  According to Reuters Health research released in May, one in eight U.S. teenagers has used powerful painkillers without prescriptions.  Both medical and recreational use of these drugs has increased across the United States over the last two decades, as have deaths due to painkiller overdoses.  The CDC estimates that 14,800 Americans died of an opiate overdose in 2008 – three times the number of such deaths 20 years earlier.

The health risks of drug abuse are the consequences that have plagued teens longer than our memory allows: unwanted pregnancy, intoxication, sexually transmitted diseases, violent acts, manic behavior, depression, suicide, death.  Teens who said they used prescription medication for non-medical purposes were more likely to use marijuana and binge drink, adding to the already volatile risks.

Preventing drug use before it begins is certainly the most cost-effective way to address teen drug abuse.  Successful prevention means fewer will develop substance use disorders, and the consequence of substance use – including health care, treatment costs, and criminal justice system costs – will decrease. 

What’s a fishbowl party? Teens dump random pills into a bowl and everyone takes one to see what happens.  Drug abuse is not just the problem of the individual – the cost of abuse has far reaching tentacles that touch all of us.  The adult populations can’t afford to be casual.  A potent reminder: research shows time and again that adult influencers are still the most powerful force in the lives of young people.  It is our responsibility – or even obligation - to exert that influence.

What Was, and What's Expected to Be

Earlier this month, Pembroke Consulting and Drug Channels released their official analysis of prescription data and industry trends in the report The Use of Medicines in the United States: Review of 2011. 

A quick summary:

·         the total number of retail prescriptions dispensed grew only 0.3% from 2010

      ·         chains pharmacies won again, growing six times faster than the overall industry

·         all other retail formats – independents, supermarkets, and mail order – shrank in both   absolute size and market share

·         chain drugstores filled 2,212,000,000 prescriptions in 2011, a 1.8% increase from the 2010 numbers; 2011 chain drugstore market share was 52.5%, an increase of 0.8%

·         independents filled 740,000,000 prescriptions in 2011, a decrease of 1.1%; independent market share decreased by .2% to 17.6%; independents’ market share in 1992 was 37.1%

·         supermarkets filled 483,000,000 prescriptions 2011, a decrease of 1.2%; supermarket market share decreased 0.1% to 11.5%; supermarkets filled about the same number of prescriptions since 2008, showing zero growth in four years

·         mail order pharmacy prescriptions reached 780,000,000, a decrease of 1.5%; total market share dropped to 18.5%, a decline of .3%

·         for the five-year period from 2007 to 2011, the number of prescriptions filled at chains grew twice as quickly as the overall market

 In 2011, drugstore chains and mass merchants with pharmacies continued to gain market share at the expense of all other dispensing formats.  CVS and Walgreens prevailed with new store openings, organic growth from larger and busier pharmacies, and acquisitions of regional chains.  Wal Mart, now the third-largest chain, used its $4 generic program to continue to increase traffic at its pharmacies.  2012 is expected to tell a slightly better story for non-chains, which have been picking up numbers from the 90 million Express Scripts prescriptions previously filled at Walgreens.  Stay tuned for how the ESI story develops.

Pharmacy’s next growth spurt?  Specialty drugs.
According to research conducted by IMS Health – a technology based analytics and services company – and Pembroke Consulting, a specialty drug dispensing boom is expected in the coming year.  The projected growth is encouraging market entry, drawing investment capital into the pharmacy industry, and increasing competition for specialty pharmacy services.  Dispensing of specialty pharmaceuticals will become less concentrated as regional chains and independents penetrate this market, and manufacturers will face increased pressure to broaden limited distribution networks.

Revenues in the pharmaceutical industry will shift from traditional brand-name drugs to specialty drugs over the next few years.  While a majority of specialty drugs are dispensed via a specialty pharmacy, any licensed pharmacy can dispense a specialty drug as long as the product can be purchased from a manufacturer or via an authorized wholesale distribution channel.  As a result, numerous pharmacies with specialty drug capabilities will compete vigorously to dispense these expensive therapies.

Top 10 U.S. Selling Drugs – 2010 vs. Expected Numbers in 2016:

** names in pink print are specialty drugs


2010             2016

Plavix                        Rituxan
Lipitor                       Humira
Seretide/Advair      Avastin
Seroguel                  Januvia

Epogen/Procrit      Advair

Actos                        Revlimid
Abilify                       Lantus
Enbrel                      Enbrel
Singulair                  Remicade
Remicade               Atripla

Wednesday, March 28, 2012

It's all about the dollars. And the change.

On March 23, 3010, President Obama signed the Affordable Care Act, a law allowing comprehensive health care reform to roll out over several years.  We have already seen a number of these changes influence public and private insurance, with many more policy changes to come.  Good or bad, we are experiencing a complete overall of the healthcare industry as we know it.   Perhaps the gradual changes allow us to steadily adapt instead of throwing us into the deep end of the reform pool.  All of these alterations appear to be building up to the backbone of the health reform laws – The Health Insurance Exchanges.

Mandated to be in place by January 1, 2014, these state-based health insurance marketplaces will be enrolling 32 million of the 50 million Americans who, at present, do not have health coverage.  The exchanges represent a grand plan to make health insurance accessible and affordable to those who now struggle to find and keep coverage.  Individual consumers and small business will be able to shop online for competitively priced coverage, and many will receive government subsidies to help pay premiums or be granted tax credits.

According to a recent study, 44 percent of employers believe they will provide employee health benefits through a corporate exchange in the next three to five years, although 72 percent declared they are “very or somewhat interested” in exploring corporate exchange models.  To give employers power in numbers many are trying to create a group purchasing option to negotiate lower rates from the insurers.  Corporate or private exchanges solicit group-specific insured rates while the employer determines the contribution for employees to use in purchasing coverage.  The employee then makes their final decision about coverage.  In the same study, 86 percent voted that the ability to reduce costs was the most important feature of a corporate exchange.    

States will be submitting their “Exchange Blueprint” for approval in 2013, but if a state hasn’t made much progress, the federal government can intervene and make the final decisions.  The Obama administration's request for $800 million to operate federal exchanges has gotten a frosty reception from congressional Republicans.  For things to go smoothly, state and federal officials must work together to verify private personal and financial details for millions of people, make sure that consumers are enrolled in the right health plan, and accurately calculate how much government aid, if any, each household is entitled to.

The White House is giving states some flexibility in setting standards for their marketplace, as the state gets to decide who runs the new market and which insurance companies get to participate, however Health and Human Services will certify which exchanges are – and are not – able to deliver the customer experience that the White House wants to see, including things like allowing consumers to easily compare plans and having an enrollment mechanism for both private insurance and Medicaid.

The Affordable Care Act assigns most Americans a legal responsibility to carry health insurance, either through their employer, a government program or by buying their own.  Millions will receive financial assistance for their premiums.  Whether that amounts to an unconstitutional expansion of federal power, as a group of Republican governors allege, is among the subjects of a showdown that began March 26 when the Supreme Court heard three days of arguments.  A decision is expected by June.

It’s a Managed World, After All.

With much fanfare, anticipation, anxiety and expectancy, March 1^st hales the beginning of Medicaid Managed Care in Texas.  We’re certainly not the first state experiencing this transition; many have come before us and lit the path.  But because it’s happening to US, this change is much BIGGER and MORE IMPORTANT than any state has experienced prior to NOW.

Texas’ expanded Medicaid Managed Care Organizations will provide incentive payments for health care improvements, monthly stipends to physicians for coordinating patients’ care (including preventative care, acute care, and hospitalization), and direct more funding to hospitals that serve large numbers of uninsured patients.  Communities and hospitals will form regional health partnerships that support more localized health care solutions, and the partnerships will qualify for incentives by identifying ways to improve health services in their region.

Under MCOs, Texas pays a set fee each month to a health plan to provide care for the Medicaid client, who selects a primary doctor from the plan’s network to coordinate his or her care.  MCOs boast more coordinated and efficient patient treatment and by their calculation Texas is expected to save about $100 million over the next two years.  Patients are being assured “benefits will not be cut to those in need” and MCO’s are looking for even more populations to enroll in an effort to save everyone more money.  Wink, wink.

Prescription drug benefits for Texas’ 3,313,960 Medicaid patients will be delivered through Pharmacy Benefits Managers with a state-approved formulary.  A recent study showed that Texas’ dispensing fee under the Medicaid/Vendor Drug Program-administered prescription plan was among the highest in the country, although pharmacies were paid less of the product cost.  According to a coalition of Texas pharmacists, the dispensing fee per prescription is predicted to fall from about $6.50 with VDP system to as little as $1.35 with the new PBM system.

Many things are confusing but this nugget jumps to front of mind: adding multiple for-profit MCO and PBM middlemen will probably increase total healthcare costs.  Why would Texas want to surrender day-to-day management of prescription drug plans to the most highly litigated and highest profit-margin vendors in health care - PBMs?

A quick Google search showed PBM Express Scripts 2010 net income of $1.2 billion, an increase of 82%; 2011 net income reached $1.3 billion, an increase of 8%.  PBM SXC Health Solutions 2011 revenue was $5 billion, a 42% increase from 2010.  PBM Medco’s 2011 net revenue was $19 billion, an increase of 12.2% from 2010.

A final thought:  Americans have been fighting the good fight, but many are still feeling the residual effects of the recession that began in late 2008.  It’s impossible to calculate the number of people who left prescriptions go unfilled because money was needed for other things.  Millions are trying to make their way in this new economy, and we see proof of that every day in our stores.  Meanwhile PBMs are posting record profits and MCOs are promising to save everyone more money.  But at what cost to the patient?