Drug Reimportation Stemmed As Counterfeit Adderall Warning Issued

       by Terri Bernacchi, PharmD, MBA,  Cambria Health Advisory Professionals  

Although the general public may be in favor of freely purchasing drugs online or from Canada, there are some good reasons why traditional regulatory controls of these products are a reasonable responsibility of the federal government.  That statement is coming from a “free-market” libertarian minded person! 

The problem is that our FDA cannot sufficiently assure that the contents of a tablet are pure and labeled as what they ACTUALLY are.   A tablet full of placebo or active ingredient (or poison, for that matter) may look identical.  Offshore counterfeiters have become very sophisticated. 

Consider two recent stories and make up your own mind: 

• Counterfeit Adderall Being Sold Online: http://www.kvia.com/news/31134307/detail.html

“The bogus version was discovered "by a consumer, who noticed misspellings on the fake product packaging," according to Denise Bradley, Teva Pharmaceutical's vice president of corporate communications….

Teva's authentic 30mg Adderall tablets are round, orange/peach in color and are imprinted with "dp" on one side and 30 on the other side of the tablet. The tablets are packaged in bottles. The active ingredients in authentic Adderall tablets are dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate. An analysis of the counterfeit tablets revealed they contained tramadol and acetaminophen, both used to treat acute pain, and they were in blister package.   

• The Senate defeated an amendment that would have let Americans buy drugs from Canadian pharmacies.   The chamber voted down the amendment, sponsored by Sen. John McCain (R-Ariz.), in a vote of 43-54. http://thehill.com/blogs/floor-action/senate/229405-senate-defeats-mccain-amendment-on-canadian-pharmacies

Not surprisingly, the ever-compromised Senator McCain completely misses the safety question demonstrated by the first article.  The National Association of Chain of Drug Stores applauded the defeat of the amendment but probably has a bias in perspective. http://drugstorenews.com/article/nacds-lauds-prevention-personal-importation-prescription-medications

The problem about reimportation is not about pricing!  It’s a REAL safety issue!   There are people outside of the reach of our laws and our country that would sell us cow feces and call it Viagra for $4 a pop if they could get away with it. Some structure is necessary to keep the bad guys from hurting us.  This may be one of those structures, in my opinion! 

Terri is the founder of Cambria Health Advisory Professionals.  Among her current clients:  a large health sciences firm serving payers, pharmaceutical and device manufacturers and other stakeholders. a small special needs health plan as a 5 Star Consultant, and several other health related clients.  The thoughts put forth on these postings are not necessarily reflective of the views of her employers or clients nor other Health Thought Leader colleagues.   Terri has had a varied career in health related settings including:  9 years in a clinical hospital pharmacy setting, 3 years as a pharmaceutical sales rep serving government, wholesaler, managed markets and traditional physician sales, 3 years working for the executive team of an integrated health system working with physician practices, 4 years as the director of pharmacy for a large BCBS plan, 12 years experience as founder and primary servant of a health technology company which was sold to her current employer three years ago.   She has both a BS and a PharmD in Pharmacy and an MBA. 

As in the Pharmacy, Message Fatigue Can Be A Key Root Cause of EMR Errors in the Doctor's Office

Terri Bernacchi, PharmD, MBA,  Cambria Health Advisory Professionals 

The International Journal of Medical Informatics in its April 2012 issue has cited a study that I believe is something that practicing pharmacists (in a variety of clinical settings, including retail and hospital), have known for a long time:  the more messages the human brain must handle per hour, the less meaningful the individual messages will be because of a “fatigue factor”.   Indeed, I believe it is one of the key “root causes” of medication errors which get through to the patient despite all of the safety-checks in the pharmacy. Certainly, most retail pharmacy chains modify downward the level of alerts so that pharmacists are not unnecessarily distracted with false-positive warnings as they attempt to do their jobs----these system policies allow only the critical alerts or drug interactions to be pushed to the pharmacist for a traceable response to either override the message or provide an alternate response.   

As physicians are moving into a more fully automated practice of medicine, this phenomenon must also extend to them, by definition.   

The study was supported by the VA Health Services Research and Development Center of Excellence on Implementing Evidence-Based Practice.  Dr. Allisa Russ, PhD, of the Richard L. Roudebush VA Medical Center in Indianapolis noted that some alerts don't give enough information and others contradict common clinical practice. 

This link will take you to a summary of the study from MedPage Today:  www.medpagetoday.com/PracticeManagement/InformationTechnology/32006

The key EMR warning of the study is this:  “Unless we improve medication alerts so they contain information that users need to make decisions, the problem of alert fatigue will grow as (electronic medical record) systems expand beyond single hospitals and share more data."

Terri is the founder of Cambria Health Advisory Professionals.  Among her current clients:  a large health sciences firm serving payers, pharmaceutical and device manufacturers and other stakeholders. a small special needs health plan as a 5 Star Consultant, and several other health related clients.  The thoughts put forth on these postings are not necessarily reflective of the views of her employers or clients nor other Health Thought Leader colleagues.   Terri has had a varied career in health related settings including:  9 years in a clinical hospital pharmacy setting, 3 years as a pharmaceutical sales rep serving government, wholesaler, managed markets and traditional physician sales, 3 years working for the executive team of an integrated health system working with physician practices, 4 years as the director of pharmacy for a large BCBS plan, 12 years experience as founder and primary servant of a health technology company which was sold to her current employer three years ago.   She has both a BS and a PharmD in Pharmacy and an MBA. 

Today’s Supply-Demand Challenges for Generic Pharmaceuticals

Terri Bernacchi, PharmD, MBA,Health Advisory Professionals 

In a world where we have come to rely upon the plentiful supply of low-cost, high-quality generic drugs, shortages and quality problems throw a definite kink into the goal of delivering needed medications to US patients.  Supply shortages stem from a variety of factors, some of which are related to stepped-up manufacturing quality audits by the FDA, the ferocity of competition between generic manufacturers with associated recent company consolidations, and increasing demand, in general.   In some cases, the brand manufacturer which innovated the drug has found it is no longer commercially feasible to produce and market the brand version of the drug.  Thus, without sufficient generic options available, providers are stuck with no supply or sometimes seeking importation from outside the US (if approved by the FDA) where unknown manufacturing quality problems could also be a factor of concern.  Sometimes the patient can be converted to an alternate (but not equivalent) drug; sometimes the needed but unavailable drug does not have a suitable substitute. 

The linked article by Wall Street Journal reporter Jennifer Corbett Dooren (see: http://online.wsj.com/article/SB10001424052748704680604576110613604195324.html )

mentions recent critical shortages of generic injectable cancer drugs and indicates that hospitals are struggling to manage their supplies.  These products may have very complex manufacturing processes which also lengthens the time it takes for other companies to flex and meet supply shortages;  in order to be approved as a producer, a manufacturer needs FDA approval to jump in to fill the gap, which also adds time and challenge to the equation. 

The number of reported drug shortages has more than tripled in the last five years, according to the FDA.  And a spokesman for the American Society of Health System Pharmacists has labeled this a “near-crisis” situation. 

Unfortunately, some of these supply problems are the direct consequence of consolidations and regulations which have made it harder to manufacture and compete for both branded and generic companies.  Some Congressional leaders, not surprisingly, think that more regulations and penalties may improve the situation.  In fact, they add to the burden and may actually make it harder to meet the demand.   

Lest you think this is just another hysterical sound bite in the news, please note that the FDA has a link that you can regularly follow to identify these shortfalls. “The drug shortage program, within the Center for Drug Evaluation and Research (CDER), addresses potential or actual shortages of prescription, over-the-counter, or generic drugs that have a significant impact on public health.”  The link takes a while to refresh so give the page a few seconds to be visible; it details for each short supply product the Drug Name, Company, Reason for Shortage, and Related Information guiding the reader through the details. 

http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm

The solution, I believe, lays in developing policies that encourage generic companies to prosper and thrive so that there is sufficient opportunity to manufacture and market these products in a quality way.  

Terri currently works for a large health sciences firm serving payers, pharmaceutical and device manufacturers and other stakeholders in health care as a Senior Principal in Managed Markets.  The thoughts put forth on these postings are not necessarily reflective of the views of her employer nor other Health Thought Leader colleagues.   Terri has had a varied career in health related settings including:  9 years in a clinical hospital pharmacy setting, 3 years as a pharmaceutical sales rep serving government, wholesaler, managed markets and traditional physician sales, 3 years working for the executive team of an integrated health system working with physician practices, 4 years as the director of pharmacy for a large BCBS plan, 12 years experience as founder and primary servant of a health technology company which was sold to her current employer three years ago.   She has both a BS and a PharmD in Pharmacy and an MBA.

Obamacare Countdown to 2018—Inch by Inch, Rule by Rule

Terri Bernacchi, PharmD, MBA  Health Advisory Professionals 

It’s impossible to predict what the new Congress will do to amend or repeal all or portions of the health care law that we call Obamacare.  Just beholding the tremendous number of provisions of the Patient Protection and Affordable Care Act (PPACA) continues to astonish!  Though the details of the regulations required by each of the elements will unfold only gradually, the timeline has been laid out in an easy-to-use interactive calendar by Employee Benefit News.  (See the link here: http://ebn.benefitnews.com/health-care-reform/timeline.html?mstr_chnnl=ebn_health_care_reform)

Many of us are now several inches deep on specific components (for me, it’s the operational aspects of the Coverage Gap) but only an inch deep on others (for me, it’s almost everything else).  Thus, this 50,000 foot view of the timelines for each provision will continue to be a useful tool. 

Over the course of time, authors contributing to this blog will comment on some of the provisions, as they roll into effect or as they are clarified. 

One of the most insane provisions set to go into effect in 2011  is the one that disallows the use of FSAs, HSAs, or Archer MSAs for covering the cost of an over-the-counter medicine or drug (except insulin) unless a prescription is obtained. This new provision requires that the person must spend ADDITIONAL funds by getting to a physician in order to get the prescription, incurring additional cost for the person but also burdening the provider and payer parts of the system. 

The logic for this new provision? It appears to be tax revenues for the Government to cover the cost burden of Obamacare.

It’s difficult to track down any other logical reason that such a grand idea would be part of PPACA or why this would be in the best interest of any of the players in health care:  new burdens on the doctor, a reduction in the value of the HSA or FSA for the employee, incurring new medical expenses for the health plan or employer by creating MORE reasons to see a doctor.  This stupid provision actually penalizes routine self-care-----patients must again go see a doctor for a prescription for a cough/cold product. 

This seems to simply be a means to reduce the eligible use of pre-tax dollars for health care purposes so that the IRS will have greater access to taxes from that individual. Our IRS lays out its new stipulations in a very matter-of-fact way, but does not offer any other explanation.  Read more about the IRS ruling at the URL:  http://www.irs.gov/pub/irs-drop/n-10-59.pdf.   They would love to hear your comments.

Terri currently works for a large health sciences firm serving payers, pharmaceutical and device manufacturers and other stakeholders in health care as a Senior Principal in Managed Markets.  The thoughts put forth on these postings are not necessarily reflective of the views of her employer nor other Health Thought Leader colleagues.   Terri has had a varied career in health related settings including:  9 years in a clinical hospital pharmacy setting, 3 years as a pharmaceutical sales rep serving government, wholesaler, managed markets and traditional physician sales, 3 years working for the executive team of an integrated health system working with physician practices, 4 years as the director of pharmacy for a large BCBS plan, 12 years experience as founder and primary servant of a health technology company which was sold to her current employer three years ago.   She has both a BS and a PharmD in Pharmacy and an MBA.

Transparency May Have a Few Downsides for Pharma-Doctor Relationships

By---Terri Bernacchi, PharmD, MBA, Health Advisory Professionals 

I received an interesting alert in my email “in-box” today which was linked to a site called ProPublica.org, an investigative web journalism organization sponsored by the Sandler Foundation (See more about the foundation at: http://en.wikipedia.org/wiki/Sandler_Family_Supporting_Foundation). 

The email I received related to the fact that local news organizations can look up how much money an individual physician in their area may have been paid by specific pharmaceutical companies for consulting or speaking engagements.  In theory, the fact that a physician may become tainted or biased by these moneys is something that we all would want to know about; we don’t want the choice of OUR drug to have been bought and biased but to be the right drug for our medical needs. 

However, the facts could also be distorted or misunderstood to malign a physician who is simply a thought leader for other medical professionals in his area and providing educational support to his colleagues.  These programs are often (but not always) partially underwritten by a pharmaceutical manufacturer.  Physicians, like most people, don’t offer their valuable time for free to structure the presentations or do the projects. 

Continuing medical education has been at least partially underwritten by pharmaceutical and device companies for a long time....certainly long before and since I graduated from Pharmacy School the first time in 1979.  Hospitals and medical schools have finite funds for continuing education -------an essential quality requirement for active staff committed to the need for lifelong learning.  (There’s a reason they call it “practice”...the art is always changing as we learn new things.)

And pharmaceutical and device companies DO want to make sure real world practitioners know about evolving trends that cast their products in a favorable light.  However, I have never met a SINGLE professional who is swayed by these programs or the company underwriting them.  When presented, the evidence is shown in a pretty unbiased way, usually, or the speaking physician will endure the snubs and contempt of his audience.  And they won’t come to his programs if he is a shill for the pharma company.

Seven drug companies, including Eli Lilly, GlaxoSmithKline, AstraZeneca, Pfizer, Merck, Johnson & Johnson, and Cephalon have already publicly posted payments to physicians by name and location.  These companies have started posting in anticipation of new regulations: the Physician Payments Sunshine Act requires all US pharmaceutical, device, and biotech companies to disclose all payments over $10 to physicians beginning in 2013. (Read more about the regulation at Kaiser Health: http://www.kaiserhealthnews.org/Stories/2010/April/26/physician-payment-disclosures.aspx  )

The ProPublica group has taken these public postings and created a searchable database to allow “look ups”; the engine includes a place to enter the doctor’s name but also the state. (See: http://projects.propublica.org/docdollars/ )  (Note:  A simple use of a ‘%’ wild card in the doctor’s name box allows you to pull all physicians and payments for the selected geography or for all 30,342 entries.)  

The site has promoted its database to local newspapers so that they can do stories that will “inform” but probably also embarrass some of the very thought leaders that pharmaceutical companies work with to research diseases or bring products to market through active professional interchange.  The industry cannot do this without the participation the medical community and the medical community cannot cure disease without drugs. Of course, we could always conclude that we’ve solved all of our problems and close down the pharmaceutical and device industry. 

While I found the information posted on this site very easy to use, and I believe it to be accurate, I’m not sure if I can conclude anything relevant after having reviewed it for my area.  The names that appear include some folks that are unknown to me.  But I also recognize some leaders from our local Medical Schools and people that have ethics that I personally know are beyond reproach.  Some of them, in fact, have been hostile to the pharmaceutical industry in the past!  

Certainly, there have been findings that are discussed by the ProPublica group involving a small subset of stipend recipients with a history of licensing sanctions.  This may indicate that Pharma needs to better vet their speakers.

At a minimum, the readers of this blog can become informed of the potential uses of information supplied in the name of transparency.  I am afraid one of the unintended consequences of some of this may be, however, a new wet blanket on the funding and support of local continuing education programs, at a time when the budgets of hospitals and medical schools will become ever more constricted due to Health Care Reform and our anemic economy.

Terri currently works for a large health sciences firm serving payers, pharmaceutical and device manufacturers and other stakeholders in health care as a Senior Principal in Managed Markets.  The thoughts put forth on these postings are not necessarily reflective of the views of her employer nor other Health Thought Leader colleagues.   Terri has had a varied career in health related settings including:  9 years in a clinical hospital pharmacy setting, 3 years as a pharmaceutical sales rep serving government, wholesaler, managed markets and traditional physician sales, 3 years working for the executive team of an integrated health system working with physician practices, 4 years as the director of pharmacy for a large BCBS plan, 12 years experience as founder and primary servant of a health technology company which was sold to her current employer three years ago.   She has both a BS and a PharmD in Pharmacy and an MBA.

Drug Coupon Programs, the Empowered Patient, and the New Debate

by Terri Bernacchi, PharmD, MBA, Health Advisory Professionals 

Not that it’s a spectator pass-time, exactly, but I’ve been avidly watching from the sidelines the development of a new contact sport between pharmaceutical companies and health plans:  the war that is being waged over the propriety of drug coupon programs. 

On the one side is a pharmaceutical manufacturer trying to squeeze as much as it can out of a finite and rapidly-expiring patent, surmounting obstacles involving managed care, formularies, REMS, health care reform with new mandates like the Coverage Gap discount, and countless new compliance questions, not to mention a generally bad economy.  Who can blame the product manager for trying to effectively market a product with savings coupons to a patient whose doctor has just prescribed it for an appropriate use?  The empowered patient may actually begin to demand them.   (It’s done all the time in consumer products.) 

On the other side is the health plan (also pressured by competition, cost concerns and the looming reality of reform) that is picking up the tab for whatever is left over after the patient pays his or her established copayment. 

When a coupon is introduced into that drug selection decision, reducing the person’s out-of-pocket cost, it may have negative effects on the plan’s loss ratio (assuming the plan’s cost is higher than an alternate product).  The coupon undermines the formulary and benefit design that underwriters used to predict costs against the premium.  No wonder they’re upset.  It’s wreaking havoc in a cost forecast!  And the cost benefit goes all to the patient and not to the health plan!

According to the Bloomberg article attached to this link, sales using these copay-reduction coupons have more than tripled in the past four years.   It is this growth that has stimulated a lot of dialogue and debate.  And the FDA is reviewing them in the context of “safety”.  (See:  http://webcache.googleusercontent.com/search?q=cache:nKMRppUOPwoJ:www.bloomberg.com/news/2010-10-27/drug-coupon-use-soars-prompting-safety-and-spending-concerns.html+Bloomberg+article+coupon+drug&cd=1&hl=en&ct=clnk&gl=us )

Certainly, there will be more discussion on this topic as the debate goes national and some payers are advocating for local, state or federal regulation that would put a halt to these practices.  

For my part, I think these programs can provide benefit to all parties if they can be done in a collaborative way.  The challenges to the patient, the plan, and the pharma company are real----the copay subsidy or coupon can provide each side with a win-win-win opportunity if structured properly. 

I think the future will show that it would be a mistake to eliminate these programs and lose that prospect altogether.

Terri currently works for a large health sciences firm serving payers, pharmaceutical and device manufacturers and other stakeholders in health care as a Senior Principal in Managed Markets.  The thoughts put forth on these postings are not necessarily reflective of the views of her employer nor other Health Thought Leader colleagues.   Terri has had a varied career in health related settings including:  9 years in a clinical hospital pharmacy setting, 3 years as a pharmaceutical sales rep serving government, wholesaler, managed markets and traditional physician sales, 3 years working for the executive team of an integrated health system working with physician practices, 4 years as the director of pharmacy for a large BCBS plan, 12 years experience as founder and primary servant of a health technology company which was sold to her current employer three years ago.   She has both a BS and a PharmD in Pharmacy and an MBA.

Patient Medication Adherence May Result in Medical Misadventures – PATIENT

Terri Bernacchi, PharmD, MBA Health Advisory Professionals  

Finally!  Someone is recognizing that people don’t always comply with the dosage and instructions for their prescriptions (and are not always forthright with their doctors about the reality of their compliance).  When a physician notes that the medication doesn’t seem to be working, he or she increases the dosage, which may increase side effects and waste resources (at a minimum), if the patient actually does start to comply or is hospitalized and given the higher dose which is "new" to the patient. 

The evidence was collected by Medco Research Institute, the research arm of pharmacy benefit manager Medco Health Solutions.  The study concluded that nearly one-third of patients given increased dosages of antidepressants had not been regularly taking their original prescriptions. This is consistent with other studies of patient non-compliance or non-adherence----and people have a very difficult time being honest about taking or not taking their medications and the reasons they have for not taking them.  http://drugstorenews.com/story.aspx?id=154961&menuid=335

This is a quiet truth, the proverbial elephant in the room---that people lie----that many clinical failures or challenges are directly associated with behaviors that go unrecognized.   The clinical literature itself frequently draws conclusions based on an assumption of subject compliance.  Well-designed studies have measures in place to verify consistent behavior.

Now, the New England Healthcare Institute (NEHI) has called for a “national strategy” to examine the role care teams can have on improving patient adherence to prescription medicines.  The preface to their position paper which calls for Demonstration projects indicates that, “Poor medication adherence in all its manifestations costs the United States upwards of $290 billion per year in unnecessary health care spending, not to mention illnesses and deaths that could be otherwise prevented.”  A copy of the paper can be found at http://www.nehi.net/publications/48/medication_adherence_and_care_teams_a_call_for_demonstration_projects

Terri currently works for a large health sciences firm serving payers, pharmaceutical and device manufacturers and other stakeholders in health care as a Senior Principal in Managed Markets.  The thoughts put forth on these postings are not necessarily reflective of the views of her employer nor other Health Thought Leader colleagues.   Terri has had a varied career in health related settings including:  9 years in a clinical hospital pharmacy setting, 3 years as a pharmaceutical sales rep serving government, wholesaler, managed markets and traditional physician sales, 3 years working for the executive team of an integrated health system working with physician practices, 4 years as the director of pharmacy for a large BCBS plan, 12 years experience as founder and primary servant of a health technology company which was sold to her current employer three years ago.   She has both a BS and a PharmD in Pharmacy and an MBA.