Wednesday, May 22, 2013

WILL UNIVERSAL DRUG TRACKING IN THE U.S. EVERY SEE THE LIGHT OF DAY?

On May 17, the House Energy and Commerce Committee approved its version of the prescription-drug tracking bill, HR 1919, “by voice vote Wednesday, the Senate Health, Education, Labor and Pensions Committee will mark up” its version, S 957, on May 22. Both bills aim to “move to an interoperable, electronic, unit-level tracing system throughout the drug supply chain,” but they differ in terms of how fast they would transition from lot-level tracking to the unit level. The Senate’s bill would “transition to a unit-level tracing system over 10 years, with the Food and Drug Administration conducting pilot projects and holding public meetings for comment on moving toward the interoperable, electronic, unit-level system.” In contrast, the House’s measure “would establish national standards for a lot-level tracing system and create a process” for the FDA and supply chain stakeholders to work together, but the agency would not have to propose any regulations until 2027. The Energy and Commerce Chair Fred Upton (R-MI) has vowed to get the bill to Obama by the August recess.

Well, it's good to know there's some movement afoot since May 8, when bipartisan legislation gave federal regulators the power to track individual medications. (As a side note: At Shamrock Medical we currently are developing a system for e-pedigree for tracking at the lot-level, which is a requirement for VAWD accreditation.)

Essentially, the bill is designed to close loopholes in the supply chain and aim to prevent counterfeit drugs from reaching consumers, thus preventing harm to patients. It's also supposed to ensure that overlapping red tape does not impose dramatic costs on patients in the form of higher prescription drug costs or potential drug shortages.

I've read about squabbling among party lines already, such as, the regulatory framework will take too long to implement, as the bill will not require regulations from the FDA until 2027, and grumblings in the House that the burden that these new requirements may place on small pharmacies.

Dr. Janet Woodcock, the director of the FDA's Center for Drug Evaluation and Research summarized the situation accurately when she stated, "Criminals are getting more sophisticated at copying drug labels and profiting from putting counterfeit medications in the $300 billion U.S. prescription drug market (and) if we don't know the chain of custody of a product... if we have to reconstruct that later, through questioning people, that could cause great delays..." (in recalling the product or finding out where the problem occurs).

The sad truth is, in recent years very little has passed through a divisively bipartisan government. What are your feeling about this bill seeing the light of day?

Here's to better solutions, 
Dave Bystrom

Thursday, May 2, 2013

PLAGUED BY MEDICUS INTERUPTIS. Do you suffer from this potentially lethal problem?

Obviously, there's no such disease as Medicus Interuptis, but as medical professionals we're all plagued by constant interruptions while documenting medical reports, seeing patients, or, in the case of pharmacists, dispensing medications that are designed to help patients.

Actually, studies indicate that nurses administering medications and pharmacists and technicians dispensing medications are distracted and interrupted as often as once every two minutes!

While we are all subject to interruptions during our work day, the argument that distractions and interruptions contribute to medication errors is pervasive in recent studies on this topic. One study suggests that the risk of any medication error increases 12.7% with each interruption, and the risk of a harmful medication error is doubled when nurses are interrupted four times during a single drug administration and tripled when interrupted 6 times (Westbrook JI, Woods A, Rob MI, Dunsmuir WT, Day RO. Association of interruptions with an increased risk and severity of medication administration errors: Archives of Internal Medicine 2010; 170(8):683-690).

While distractions and interruptions in healthcare can't be fully eliminated, there are tactics that may help cut down on some of them:

STAFF EDUCATION: Ask all staff to avoid interruptions during the preparation, mixing, labeling, or checking of medications, except during a significant emergency. Educate staff about the risks involved, and set up specific hours for interaction with staff for updates and other important matters.


BEST TIME FOR NECESSARY INTERRUPTIONS: If interruptions or notifications are necessary when dispensing medications, attempt to intervene during transitions between subtasks, such as between medications being prepared.

PREPARATION: To minimize interruptions, make sure all needed supplies and documents are available before preparing medications.

SYSTEM IMPROVEMENTS: Attempt to identify the sources of regular interruptions and try to remedy them. For example, the system may be improved by providing medications to patient care units in the most ready to use form to minimize interruptions associated with mixing, diluting, or crushing. Also, consider establishing a fax, email, or other electronic form of communication between nurses and pharmacists for routine issues to help minimize minor interruptions.

These are just a few examples of how to diminish the constants flow of interruptions that plague most of us during critical periods of time. I'd like to hear what you may find helps during your work day.

Here's to better solutions,
Dave Bystrom