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 Joe Ross, director of business services at McKesson Pharmacy Systems, talks in this interview with ComputerTalk senior editor Will Lockwood about existing and anticipated regulations that are changing what drug sales pharmacists are required to log. State and Federal regulations that require tracking the sale of non-prescription methamphetamine precursors have contributed to a demonstrable reduction in the illegal use of these drugs. More regulation may be in store, since the FDA is currently considering a behind-the-counter class of drugs.
CT: There's an increasing need for pharmacists to track and report
products that fall outside the regular pharmacy dispensing flow.
Tracking Methamphetamine precursors, such as pseudoephedrine, is a
great example. What are the current pharmacy compliance needs McKesson
is seeing?
Ross: For many pharmacies, the passing of the combat
methamphetamine epidemic act [CMEA] introduced the burden of having to
manually track and log the sale of what used to be over-the-counter
products. Our pharmacy customers quickly realized that traditional
paper logbooks would no longer suffice for meeting their regulatory
requirements. The workflow and data retention issues combined with
complex and ever-changing local, state, and Federal sales and reporting
requirements necessitated an automated solution. Beyond PSE
[pseudoephedrine] products, this necessity will only grow stronger with
the movement of other products, such as Dextromethorphan, into this
regulated category.
CT: There are other challenges on the horizon as
well, aren't there? For example, Melissa Sherer wrote in the
January/February 2008 issue of ComputerTalk about the possibility of a
new class of behind-the-counter [BTC] drugs. What are some of the
strategic and compliance issues you see developing for such a class of
drugs?
Ross: I agree with the position expressed in Melissa's
article that the de facto creation of this third class of drugs began
with the movement of PSE products from over-the-counter to
behind-the-counter. Whether it's a drug transitioning from OTC to BTC,
or Rx to BTC, the expansion of this category is inevitable and will
include an abundance of product-specific sales requirements. These
requirements will likely fall outside the traditional dispensing flow,
create gaps between processes and systems, and inevitably create more
work for already time constrained pharmacists. At the same time that
this category is expanding, pharmacists are increasing their role as
healthcare providers through medication therapy management programs.
The strategic challenge for pharmacies will be how to efficiently
capitalize on these new categories of products and services. Our focus
is to provide technology solutions that will limit this burden and help
our customers better serve their patients.
CT: So how are you applying this focus currently?
Ross:
As a customer-centric company, McKesson Pharmacy Systems is committed
to delivering solutions based on feedback from our customers. What
we've learned from our pharmacies is that there is a strong desire for
an automated solution to enable them to easily sell this new class of
drugs. In response to this need, we have formed a long-term strategic
partnership with Pharmitas, a compliance-technology company based in
Bellevue, Wash., to deliver a fully automated solution called
ComplyScan. This solution provides end-to-end compliance with all
local, state, and Federal regulations for the sale of BTC drugs,
including pseudoephedrine products as mandated by the CMEA. ComplyScan
replaces onerous and time-consuming paper-based logbooks with an
electronic data capture and management system that instantly reads
consumers' identification and product purchases.
CT: Tell us a little more about how this product and the partnership developed.
Ross:
As I mentioned earlier, ComplyScan began as a customer-driven
initiative to streamline pseudoephedrine (PSE) product purchases and
ensure 100% compliance with the Combat Methamphetamine Epidemic Act.
Using a wired or wireless connection to the Internet, the ComplyScan
solution utilizes a scanning device along with proprietary data
collection and management software to instantaneously capture a
customer's identification information, recognize the PSE product being
purchased, automatically check to ensure that the customer has not
exceeded their PSE product purchase limit, and securely store the
purchase transaction record.
One of the compelling aspects in
partnering with Pharmitas is the ease with which additional products
and services can be rolled onto the ComplyScan platform. As this market
continues to evolve, we see ComplyScan and our partnership with
Pharmitas as a key component in providing innovative and timely
solutions to meet the changing needs of our pharmacy customers.
CT: How are HIPAA and data security issues handled with this kind of solution?
Ross:
McKesson Pharmacy Systems has long recognized the importance of
protecting the personal information entrusted to us by our customers.
While HIPAA requirements for these emerging products and services may
vary, McKesson and Pharmitas have adopted and adhere to strict
standards of security and confidentiality to protect customer
information. In our view, HIPAA compliance is a strategic priority,
both in terms of achieving compliance, as well as monitoring and
managing internal processes to ensure continued compliance.
CT: What
resources are available for pharmacists who want to learn more about
OTC compliance, how the possible BTC class is developing, and
technological solutions in this new regulatory environment?
Ross:
We're dedicated to educating our customers on changes in the
marketplace and we've scheduled several upcoming educational sessions
pharmacists can attend to learn more about this topic. McKesson
Pharmacy Systems will be hosting an online Webinar on Thursday, June
26th for customers wanting to learn more about OTC compliance and the
impacts to their business. Customers can go to the MPS homepage or
click here to register. In addition, McKesson customers can register
for one of our continuing education courses at the annual McKesson
Pharmacy Strategies conference in Las Vegas this July where Melissa
Sherer will be a guest speaker on this subject. Key discussion points
will include understanding the direction of the OTC/BTC product class,
compliance requirements, and solutions. Pharmacists may also want to
read the transcript of the pubic meeting FDA held on behind the counter
availability of certain drugs. A PDF is available by searching for
"behind the counter drugs" on regulations.gov or by clicking here:  FDA BTC Public Meeting Transcript 374.14 Kb.
CT: This sounds like an important issue for pharmacists to pay attention to. Thanks for your perspective, Joe.
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McKesson Pharmacy Systems (MPS) President Stanton McComb sat down with ComputerTalk
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