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FDA’s Resources for Evaluating and Monitoring Medicines and New Science

By Michael D. Miller MD
April 24th, 2008

For several years it has been clear that funding limitations are impairing the FDA’s ability to attract and retain qualified clinicians and scientists to review applications for new drugs and biologics, and to support their internal research and analysis concerning new drug development, manufacturing and monitoring technologies – particularly for biologic medicines. In addition, the FDA hasn’t been able to update its information technology systems to maximize staff productivity. (I suspect some people will be tempted to comment on the “productivity” of government employees, but I have found the FDA’s professional staff generally very qualified and hard working.)

On Tuesday, the Energy and Commerce Committee in the US House of Representatives held a hearing about the FDA’s ability to adequately oversee foreign production of medicines being sold in the US. This was part of the ongoing dialogue that was heightened by the contaminated heparin from China.  (The Government Accountability Office also released their study about foreign drug inspections on Tuesday.)

What I found interesting about reports from the hearing was its predictable political theatrical aspects: Chairman Dingell excoriating the FDA Commissioner for not admitting that the FDA needs more resources, and Commissioner von Eschenbach responded that he had asked for more funds to increase foreign inspections. But he also adhered to the Administration’s rhetoric that reforms are needed in addition to some extra funding. As the NY Times reports him saying, “the solution needs to be much more comprehensive than simply inspecting a facility.”

While this hearing focused on foreign inspections – which are clearly a concern – I believe the FDA also needs to step up their monitoring of medicines once they are already here in the US. While counterfeit medicines don’t appear to be a major problem in the US (at least yet), the continuing news reports of problems with generic medicines are worrisome – including a Wall Street Journal report that including the information that one patient’s generic pills had no markings, which is a violation of FDA regulations.

The FDA’s budget, staffing and technology challenges, together with the growing domestic and international quality and safety problems with various medicines raises concerns about how well prepared the FDA is to review and monitor biosimilar medicines and genomic based diagnostics.

I believe that Congressman Dingell is right, and that Commissioner von Eschenbach needs to be a stronger advocate for increased funding for the FDA, even if it means tearing up the Administration’s script he’s told to stick with. This Administration has only another 9 months of shelf life, so he doesn’t need to worry about being fired for speaking off-script – unless he is planning on running for office and wants to remain the good graces of the Republican Party. And if this is the case, then he is violating his duty as FDA Commissioner to fulfill the agency’s mission:

The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

I’ll get off my soapbox now, and check to see if the soap that came in it was made in China.

Posted in FDA, Politics, Quality of Care & Safety | No Comments »

1 of 100 Adults Gets Free Government Health Care

By Michael D. Miller MD
April 21st, 2008

A recent report from the Pew Foundation indicated that 1 out of 100 adults in the US get free government health care with no premiums, deductibles or co-payments. The reason this report didn’t get more media attention was because the 1% of Americans getting free government health care are behind bars – as in prison or jail.

The Pew report indicates that for the first time, more than 1 in 100 adults in America are in prison or jail. That’s over 2.3 million in state or federal prisons or local jails, and the numbers and percentages have been growing. (See the Department of Justice chart below)

Rise in Prison Population in the US

This data is an interesting launching point into other aspects of our current health care system’s problems:

First, health care costs for people behind bars represent about 10% of the costs of incarceration. (In 2004 this was about $3.7 billion.) And as the Pew report notes, “Under the 1976 U.S. Supreme Court ruling Estelle v. Gamble, states are compelled to provide a constitutionally adequate level of medical care, or care that generally meets a “community standard.” (I assume that Federal prisons are required to meet a similar standard.)

This was the basis for Harris Wofford’s 1991 successful campaign message, (in a special election for the US Senate), that Americans in jail have a guaranteed right to health care, but nobody else does. He was quoted in the New York Times in 1994 as saying about health insurance: “The wealthy have it. The poor have it. If you go to jail, you have it. Only the middle class doesn’t have it, and I don’t think that makes much sense.” (It will be interesting to see how the health care issues of costs and access play out in this year’s elections.)

Second, upon leaving prison (or jail) these individuals are not automatically enrolled in any type of health insurance. Given that they are likely making a difficult transition back into unincarcerated society, health insurance paperwork is probably not their highest priority. A study done by the American Public Health Association of parolees in Los Angles County described these challenges:

Many of the parolees’ illnesses go undiagnosed and untreated by prison physicians. To exacerbate the problem, California’s prison-based health care system does not prepare parolees to use public and private health clinics in the counties where they will reside. There is no coordination between counties and prisons in planning for the continued care of inmates after they are released.

Most parolees do not have medical insurance or stable sources of medical services. Eligible parolees may sign up for various programs but few do, often because they are unable to complete required application forms, do not possess appropriate personal identification documents, and/or have no permanent address. If parolees do succeed in applying for public health insurance programs, they often experience long delays while their enrollments are finalized.

Third, these individuals have more health care needs than average. As the APHA report found, parolees in LA County had:

  • 4 times higher rate of active tuberculosis
  • 9-10 times higher rate of hepatitis C
  • 5 times higher rate of AIDS
  • 1.5 -5 times higher rate of mental illness

Fourth, about 25% of children get health insurance through Medicaid or the State Children’s Health Insurance Program (~34 million), about another 24 million adults have insurance through Medicaid, about 3 million Americans get health care from the Veterans Affairs (VA) health system, and over 8 million have health insurance benefits through the Federal Employees Health Benefits Program.

Together this all paints a picture where multiple government health systems lack coordination. One of the most likely pairs for coordination would be the government run Department of Defense and Veterans Administration health programs, but they have had significant coordination problems that they continue to work on today. Conversely, one of the best examples of coordination may be in the private sector, where people can transition from one private insurer to another if they maintain insurance coverage. However, this ability is not an innate result of the market, but was a provision in the Health Insurance Portability and Accountability Act (HIPAA) of 1996, and illustrates the managed-market reality of the US health care system.

Some would argue that this all just means we should have a single-payer health care system. However, while that may look good in theory, the challenges of getting from our current system to a single payer program are beyond huge. And even if that is our ultimate goal, getting better coordination between programs would make lots of sense – as would making it easier (or routine) for people being released from behind bars to get health insurance. After all, we do this for people leaving their jobs by enabling them to continue their employee coverage (this was in the 1986 COBRA law), and then transition to another private insurance plan under HIPAA. So we should be able to do something similar for people being released from jail, shouldn’t we?

What do you think?

Posted in Access to Healthcare, Delivery of Healthcare, Economics & Financing, Medicaid, Politics, Private-Employer Based Health Insurance | No Comments »

A Perfect Stormy Mess for Health Reform

By Michael D. Miller MD
April 15th, 2008

A year ago the hype in healthcare was about state-based reform initiatives. Massachusetts was implementing its law, and several other states - including California - were considering their own proposals for increasing insurance coverage as a first step towards universal coverage and cost containment.

How things have changed in a year. Not only has California’s initiative crumbled under the expected costs to employers, but the economic downturn has undercut states’ healthcare expansion ideas, and may force them to cut back Medicaid enrollment and/or services. This week’s National Journal has an article titled “State’s Rapidly Shifting Gears,” that discusses these and other issues, including how a few years ago states cut their Medicaid payments to providers, so that on average Medicaid pays physicians 69% of Medicare levels, and how pending Federal Medicaid rules and proposals would reduce funding for State Medicaid programs making it difficult for states to reverse these payment reductions.

The importance of our current economic uncertainty for health reform initiatives is tremendous. Consider the following facts:

  • Massachusetts’ Medicaid waiver is up for renewal this summer. If this isn’t successfully negotiated and renewed, it could mean the collapse of the state’s insurance expansion program - which is already running well over budget because of underestimates of the number of uninsured who would enroll.
  • As the economy falters, not only do more people end up out of work, but they also end up uninsured - with about 40% of them enrolling in Medicaid or SCHIP.
  • Medicaid costs represent about 20-24% of state budgets, and 49 states have requirements for balanced budgets.
  • National Journal’s poll of political insiders (April 12th issue) showed that 83% of Democrats and 79% of Republicans believe that the economy is much more important issue national security for the 2008 presidential election. AND, these percentages are WAAAAY up from November 2007, when they were only 35% (D) and 34% (R), and national security were deemed more important at 56%(D) and 59%(R).
  • The Kaiser Family Foundation’s analysis of public opinion polls found a similar dramatic rise in voters’ interest in the economy as an issue for the 2008 campaign:

Health Care Polling and the 2008 Elections

The key factors that I believe will determine the fate of health reform intiatives over the next several years are:

  • How deep the economic downturn goes
  • How long it lasts
  • What actions the states and the Federal government take to preserve or dismantle the healthcare delivery, financing and public health systems
  • When the economy rebounds, how well prepared the states and the Federal government are to pursue health reform initiatives, and what resources are available for these initiatives

The economic drain imposed by the ongoing conflicts in Iraq and Afghanistan, and the inflationary ripple rising energy costs are sending through the world economy are also factors that may very well undermine anyones ability to expand coverage, while at the same time, increasing incentives and efforts to control healthcare costs.

As Homer Simpson might paraphrase James Carville from the 1992 Presidential campaign, “It’s the Stupid Economy.”

Posted in Access to Healthcare, Delivery of Healthcare, Economics & Financing, Federal Healthcare Reform, Health System Reform, Medicaid, Politics, State-Level Healthcare Reform | 4 Comments »

The Stressed and Strained Health Care Workforce

By Michael D. Miller MD
April 15th, 2008

The Institute of Medicine put out a report yesterday titled “Retooling for an Aging America: Building the Health Care Workforce.” The report discusses how the aging of the baby-boom generation will create greater needs for health care providers (of all types) who are trained in caring for the elderly with chronic conditions. The report’s recommendations fall into three categories: training, system transformation and financing. Like many reports about health system improvement, their recommendations all make sense - particularly within the context of the three categories. However, like many IOM reports, the writing by Committee process is a bit evident in that, (at least from the Executive Summary), it doesn’t seem to describe a complete plan, nor does it prioritize any of its recommendations - either in terms of funding or which actions should be done first.

In addition, while the report recognizes that the elderly in the coming decades will be healthier than those of 20 or 30 years ago, it doesn’t seem to fully address how this will change the healthcare services needed by the future elderly.

It seems to me, that one of the major challenges facing the healthcare system of the future is how to better manage chronic conditions - regardless of the patient’s age. Thus, rather than retrain clinicians (or train more caregivers) in geriatrics, there needs to be more across the board efforts in chronic care management and coordination among all levels of caregivers. This would benefit the growing elderly population - many, but not all of whom will have multiple chronic conditions - as well as the non-elderly with chronic diseases like diabetes, and the many neuromuscular degenerative diseases like MS or rheumatoid arthritis. This type of system-wide transformation seems like a better use of resources than segmental/specialized retraining and recruitment.

What are your thoughts?

Posted in Access to Healthcare, Clinician-Patient Relationships, Delivery of Healthcare, Medicaid, Medicare, Public Health | 2 Comments »

Information Can Change Medical Practice, Patient Behaviors, and Kill Kids

By Michael D. Miller MD
April 10th, 2008

Medical information can change how clinicians treat patients, how patients care for themselves, and how healthcare payers promote or prevent the use of treatments and diagnostic tests. However, this information can act as either a broad sword or a scalpel, and produce good or bad outcomes.

A recent report from a Canadian new service about an article from the Canadian Medical Association Journal describing the outcomes from warning about the use of anti-depressants in children brings this issue down from a general concept to being very specific. This news report stated:

Two years after Health Canada warned about prescribing anti-depressants to children, the number of children and teens who died by suicide increased 25 per cent after years of steady decline, major new Canadian research shows.

And the increased suicide rate coincided with a 10-per-cent decrease in the rate of visits to doctors for the treatment of depression in children.

For the study, researchers tracked what happened in Manitoba before and after Health Canada warned in 2004 that newer antidepressants may be associated with an increased risk of “suicide-related” events in patients under 18.

They found the warning was followed by an overall 14-per-cent drop in antidepressant use among children and adolescents, fewer visits to doctors for depression, and - among eight- to 17-year-olds - increased rates of completed suicide.

More than 90 per cent of the children and teens who killed themselves were not taking antidepressants when they died.

Published Tuesday in the journal of the Canadian Medical Association Journal, the study is the first to document “such a wide range of unintended health consequences” from a major drug warning, the authors say.

Lead author Dr. Laurence Katz, a child and adolescent psychiatrist in Winnipeg, warns the increased risk of suicide could be a “random fluctuation.”

“We can’t say the warning, or the change in antidepressant use or the physician office visits caused changes in suicide rates,” says Katz.

The suicide rate among children and teens was also still relatively small, from 0.04 for every 1,000 children and adolescents before the warning, to 0.15 per 1,000 after.

But Katz worries the widely publicized drug warnings have led to more cases of untreated depression, and an impact “beyond what was intended.” The drop in doctors visits for depression suggests that some vulnerable children are getting no treatment, including psychotherapy, at all. He says his hunch is that families were afraid to go to the doctor for fear their child would be put on medication.

“But that’s not the only treatment for depression. Not going to the doctor deprives you of all forms of treatment.”

If anything, researchers expected office visits to go up after the warning was issued because physicians were urged to increase the monitoring of patients for potential adverse reactions.

Katz, an associate professor of psychiatry at the University of Manitoba, says the drug warnings and media response may have “generated a lot of fear.”

“Understandably parents who kept bringing their children, their teenagers in for troubles with depression were already struggling, and fearful (and) often appropriately cautious about whether their child or teenager should be put on a medication.”

Katz believes the findings could be applied to any Canadian jurisdiction. Other studies coming out of the U.S. are showing similar results. [Emphasis added]

The antidepressant warning involved drugs known as SSRIs, or selective serotonin re-uptake inhibitors, a class that includes Prozac, Paxil and Zoloft, as well as serotonin noradrenaline re-uptake inhibitors (SNRIs), which include Effexor. The drugs have not been approved in Canada for children, but doctors have prescribed them “off-label,” which they are legally permitted to do, to tens of thousands of toddlers, children and teens for depression, social phobia, anxiety and obsessive-compulsive disorders.

In 2003 the U.K. banned antidepressants for children. The only exception was Prozac. Studies have shown the drug is safe and effective in children.

A year later, Health Canada warned that people taking the newer-generation antidepressants may experience behaviour or emotional changes that may put them “at increased risk of self-harm or harm to others.”

Katz says he didn’t have a problem with the warnings themselves. But he says some people leaped to the assumption “that these medications lead people to kill themselves.”

[The report also notes that, “For young adults, there was no significant change in the rate of completed suicide.”]

Obviously, the outcomes found in this study are very worrisome, but it also a too dramatic example of the principle of unintended consequences.

It also reminds me of how a news story in the early 1990s about adverse reactions with the second medicine to treat AIDS.  This news report caused many AIDS patients to stop taking the medicine, and given that there was only one other medicine to treat AIDS, this certainly wasn’t a good thing for their long-term survival

Although correlations don’t prove causations, I think this study definitely underscores the importance of healthcare regulators - and their media colleagues - carefully considering how they present new health information and notices to the public - for both good findings or dire warnings. With all the proposals to empower patients to make their own decisions through consumer directed insurance plan, and to give people more health information, there should also be much more research into how people respond to health related information delivered in different forms from various sources.

Posted in Clinician-Patient Relationships, Comparative Effectiveness, Delivery of Healthcare, FDA, Information & Communications, Public Health, Quality of Care & Safety | No Comments »

Toxic Dietary Supplements

By Michael D. Miller MD
April 10th, 2008

I’m usually either supportive or neutral about alternative therapies because they generally aren’t harmful, and can be beneficial. However, there seem to be more and more recalls of these products by the Food and Drug Administration (FDA) for mislabelings that are significant, although seemingly not extremely dangerous.

On the other hand, I was struck by a press release I got yesterday from the FDA about a recall for the dietary supplement products “Total Body Formula” and “Total Body Mega Formula.” The recall was because these products had more than 200 times the amount of selenium than was printed on the products’ label – and the press release noted that, “Excessive intake of selenium is known to cause symptoms to include significant hair loss, muscle cramps, diarrhea, joint pain, fatigue, loss of finger nails and blistering skin.”

I guess this is another instance of how too much of something that is normally good, can be, well, not so good. And with 43 adverse reactions reported to the FDA, the recall seems like a very good thing.

UPDATE: The FDA updated their warning and information on this issue this afternoon - click here to see the FDA website notice.

Posted in FDA, Nutrition, Public Health, Quality of Care & Safety | No Comments »

More on the Supply of Primary Care Clinicians

By Michael D. Miller MD
April 9th, 2008

Yesterday, when I wrote about “Ensuring Enough Primary Care Clinicians,” I didn’t realize that public radio station WBUR would be doing a story this week on the same topic. (The WBUR story can be heard/read on their web-site.)

Nor did I know that this was an agenda item for today’s Medicare Payment Advisory Commission (MedPAC) meeting. While the one-page MedPAC briefing summary doesn’t include their draft recommendations, Modern Healthcare reports that they are recommending budget-neutral adjustments to Medicare’s fee schedule to increase payments to physicians who provide primary-care services – including office and home visits, and visits to patients in non-acute facilities. (Presumably they are recommending Congress enact these payment changes to start in 2009.)

According to Modern Healthcare:

HHS would establish criteria to determine which physicians would be eligible to receive the adjustment. Specialty physicians could stand to lose financially under this proposal, however, and some specialty societies are hoping that Congress will pursue other avenues to improve primary-care payments. In rewarding some physicians under a budget-neutral proposal, “You also have to be careful about who you hurt,” said MedPAC Commissioner Karen Borman, a surgeon who voted against the recommendation.

[Disclosure note: Many years ago I worked with MedPAC’s Executive Director Mark Miller at the White House Office of Management and Budget, but we are not related.]

I don’t see Congress doing anything significant with this problem this year, but with a new Presidential Administration, it certainly could be a very hot issue in 2009 and beyond. Any other perspectives on when or how this should be addressed?

Posted in Access to Healthcare, Delivery of Healthcare, Economics & Financing, Medicare, Politics | No Comments »

Ensuring Enough Primary Care Clinicians

By Michael D. Miller MD
April 8th, 2008

Like many complicated problems in the US healthcare system, setting a goal can be easy, but achieving it can be hard. In recent years there has been a number of proposals for increasing the use of primary care clinicians to help patients with chronic diseases (like diabetes) manage their care and avoid long-term complications - and to presumably lower long-term healthcare spending. For example, the “Patient Centered Medical Home” proposal supported by a dozen organizations, (including companies and family practice and pediatrics associations), doesn’t specifically use the term “primary care,” but it gets to the same result - heightened relationships and communications between patients and a particular clinician or clinic. This .

Increasing the use of primary care clinicians is a great concept, but as has been seen in Massachusetts, increasing relationships between primary care clinicians and patients often runs into a wall when you improve insurance coverage. A recent New York Times article reported on what people here in Massachusetts have been talking about for some time: Before the start of the Massachusetts insurance expansion program there were parts of the state where it was hard to find primary care doctors taking new patients. Now that the program has expanded insurance coverage to about 340,000 more people, it has gotten really hard - particularly in Western Massachusetts. (A friend of mine moved to the most Western part of the state last summer, and almost had to go 90 minutes to Hartford, CT to find a primary care doctor.)

The options for increasing the number of primary care clinicians have both logistical and cultural challenges: Training more physicians takes many years, and as the Wall Street Journal on-line reported, until a few years ago, it had been 30 years since a new medical school granting the MD degree had opened in the US. (Several new osteopathic medical schools have opened.) Another option is retraining specialized physicians to practice primary care. This not only takes time for the retraining, but almost invariably, the potential income from practicing primary care will be less than practicing in a specialty area - which is why physicians aren’t lining up to go back into primary care.

The cultural barriers to increasing the supply of primary care clinicians involve biases that vary in different parts of the country towards osteopathic physicians (ODs DOs) and foreign born physicians, as well as against physician assistants (PAs), and nurse practitioners (NPs). Too many patients - and particularly around places like Boston - want to see an MD that trained at an Ivy league medical school and hospital. (Having graduated from an Ivy league medical school, I can tell you that’s a credential which alone is certainly not a perfect measure of a clinician’s quality.)

Another interesting proposal has been raised in the United Kingdom, where according to the Financial Times, the UK’s National Health Services wants to start having pharmacists provide some primary care services - “pharmacists prescribing drugs and administering tests for minor ailments will free up time for family doctors.”

Of course what this all comes down to is money. The UK pharmacists welcome the proposal, as long as it is backed up with funding to pay them for their increased work. And with the battle over Medicare payments to physicians looming with the 0.5% increase in the Sustainable Growth Rate set to expire at the end of June, (and then revert to the default formula’s 10.1% reduction), it would be nice if Congress (or Medicare itself) could weigh into this policy problem and adjust how they pay clinicians to increase incentives for primary care services. However, my understanding is that Medicare still pays according to the type of service (e.g. intermediate office visit), without regard to the type of physician (e.g. primary care or specialist).

So my conclusion is that while money seems to be a driving force behind the primary care clinician shortage, there needs to be some more good thinking about how to redirect money to increase the supply and availability of primary care, as well as how to use other forms of influence to address some of the cultural and logistics problems keeping the functional supply of primary care clinicians smaller than it could be.

Any ideas? Criticisms? Rants? Raves?

Posted in Access to Healthcare, Clinician-Patient Relationships, Delivery of Healthcare, Economics & Financing, Health System Reform, Politics | 3 Comments »

Canada’s Proposal for Subsequent Entry Biologics

By Michael D. Miller MD
April 1st, 2008

After writing about Follow-On Biologics in a recent posting, I saw a notice about Health Canada’s proposal for how they would approve biologic products that are similar to already approved biologics whose patents have expired. They call these products Subsequent Entry Biologics (SEBs), and the proposal is open for public comment from March 14, 2008 until April 16, 2008.

While the draft guidance is lengthy, it does strike an overall well-balanced tone:

  • “SEBs are not ‘generic biologics’”
  • Approval of an SEB does not mean it can automatically be substituted for the original biologic that it is “similar” to
  • Comparative studies will be required to generate data showing similarity to the original biologic in terms of quality, safety and efficacy

In many ways, the draft guidance is similar (no pun intended) to the process the US FDA used to approve some generic drugs prior to the 1984 Hatch-Waxman Drug Price Competition and Patent Term Restoration Act. (This was the law that created the abbreviated new drug application (ANDA) process which allowed generic drugs to only demonstrate bioequivalence, and obviated the requirement that they replicate the original drugs safety and efficacy trials.) By referencing published studies about the innovator drug as proof of safety and efficacy, these so called “Paper-NDAs” allowed generic companies to be approved much faster and more cheaply.

Health Canada’s “paper biologic licensing application” like proposal, would allow them to rely on published information about the original biologic, while also handling each SEB application individually to decide what additional studies need to be done to demonstrate quality, safety and efficacy of the SEB.

As I pointed out in my previous post, there are many levels of structural and biological complexity with biologic treatments, so Health Canada’s draft approach seems very appropriate and reasonable.

What do you think?

Posted in Economics & Financing, FDA, Patents & IP, Politics, Quality of Care & Safety, Therapeutic Substitution & Interchange | No Comments »

More on Counterfeit Medicines & Safety

By Michael D. Miller MD
March 27th, 2008

My last post contained some perspectives about fake medicines. That same day, the LA times ran an article about California’s long-delayed pedigree requirements for tracking prescription medicines. This law was prompted by the discovery of fake medicines for HIV/AIDS in 2000, and was intended to achieve what the FDA has been trying to implement for many years.

The LA Times article blames the delays in the state’s drug tracking system on the industry - from the manufacturer to the retail pharmacy. I suspect that the real challenge is not in the technical or cost aspects from the manufacturers - who certainly have lots to gain by stopping counterfeits of their products from being sold instead of the real thing, but from the wholesalers and to a lesser extent the pharmacies.

I’m assuming that wholesalers don’t knowingly sell counterfeit medicines, but under the current system, they can potentially make a lot of money doing so - particularly when buying them allows for a larger mark-up to the pharmacies than the real medicine. This is part of the economic reality of wholesalers, who in effect are arbitraging the differential costs of pharmaceuticals as a commodity by buying someone else’s excess supply and delivering it where it is needed. Now normally this would be market forces working to efficiently delivery medicines to where they were needed. However, without adequate pedigrees (i.e. paper or electronic documentation demonstrating the entire chain of custody of the medicines from the time it left the manufacturer), there is a great economic incentive for counterfeiters to push their fake medicines into this supply chain and make a huge profit.

Of course, the pedigree system needs to be sophisticated enough that it too can’t be forged - otherwise it is worthless. This is why retail pharmacies may be balking at the cost of implementing a system where they aren’t going to benefit, and don’t believe they are part of the problem. In general, pharmacies, don’t have great incentive for selling fake medicines - they would get paid the same dispensing and product fees whether the product was real of fake. The only case where pharmacies would increase their profits is if they were to be able to buy the fake medicines for less, but this would probably only occur for large chain pharmacies where they are essentially acting as their own wholesalers and wouldn’t be the case for the independent pharmacies - the few that are left.

Because pharmaceutical companies have incentive to track shipments of their medicines and make sure they aren’t stolen, some are starting to use RFID technology. This is surely a big investment that is worth the cost. Implementing a secure pedigree tracking system might be more costly, but would certainly be a worthwhile expense to ensure the safety and quality of medical care.

In general health policy people in the US don’t like to talk about counterfeit medicines because it raises the potential that people won’t trust their medical systems or their medicines. That attitude would be OK if there was nothing to be done about it, but since there is a solution, I think it should be talked about. The other challenge to pushing for drug tracking systems is that as health reform initiatives go, it’s not as “sexy” as electronic medical records, checklists, “evidence based medicine” or eliminating fraud and abuse and using the savings to expand insurance coverage to the uninsured. But it is a doable improvement. The challenge is figuring out how to pay for it, and convincing all the stakeholders effected to work together to make it happen.

Posted in Access to Healthcare, Delivery of Healthcare, Economics & Financing, FDA, Information & Communications, Public Health, Quality of Care & Safety | No Comments »

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