PHARMACY

Could pet meds be the new flu shots?

BY Alaric DeArment

WHAT IT MEANS AND WHY IT’S IMPORTANT — The past two weeks have seen two new additions to the list of retailers selling prescription drugs for pets, showing that this space, while still small, is growing in importance and offers a good way for retailers to drive customer traffic.

(THE NEWS: Kmart and Kerr Drug launch pet med programs. Click here and here to read the stories.)

As Drug Store News reported in its April 23 Annual Report issue, two key trends are converging to make drugs for animals an increasingly important component of the prescription drug category, to say nothing of OTC products.

First, there’s a growth in pet ownership, driven by younger people putting off having children and older people becoming empty nesters and looking for "fur kids" to replace the human ones who have moved out. Second, like their human owners, pets are living longer and becoming more susceptible to chronic diseases, such as cancer, cardiovascular disease and diabetes.

At the moment, the pet drug category is dominated by veterinarian offices, which have traditionally been able to buy animal-specific drugs directly from manufacturers, while retailers have to go through distributors and thus pay extra, though many human drugs dispensed at lower doses can be used in animals as well. But even if, for the time being, retailers can’t guarantee the lower prices that vets can, they can offer convenience. Offering pet meds in a retail pharmacy allows customers to pick up all their drugs at once, and the fact that many retailers launching pet med programs are also hiring vets who can answer customers’ questions only adds to the convenience.

Another thing that might help is a bill going through Congress, H.R. 1406, the Fairness to Pet Owners Act of 2011, which would require vets to allow pet owners to have prescriptions filled anywhere instead of making them obtain drugs at the office.

According to Packaged Facts, sales of pet medications through online and brick-and-mortar retailers and veterinarian offices reached $6.7 billion in 2011. That’s not a huge number compared with, say, the annual sales of a single blockbuster human drug, but analysts think pet meds could be a way to bring more customers into stores, whether or not they make a lot of money in and of themselves, thus benefitting retailers in the same way that vaccinations do.

And the retailers that offer pet meds — ranging from national chains to independent pharmacies — have reiterated variations of the same point: One’s family comprises more than just its bipedal members.

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PHARMACY

‘Third class of drugs’ could quickly become industry fighting words

BY Michael Johnsen

WHAT IT MEANS AND WHY IT’S IMPORTANT — There is an important distinction to be made here, one that could place pharmacy operators and over-the-counter manufacturers on opposite sides of the aisle. And that’s the call for a codified third class of drugs, made more or less by both the National Association of Chain Drug Stores and the National Community Pharmacists Association in their written submissions to the Food and Drug Administration on expanding the switch paradigm. The Consumer Healthcare Products Association, in its written comments, maintains the current two-class drug system, not three-class, is the way to go. 

(THE NEWS: NACDS expresses to FDA cautious optimism on the ‘new paradigm’ for third class of drugs. For the full story, click here.)

During a CHPA Annual meeting in 2007, then FDA commissioner and keynote speaker Andrew von Eschenbach captured every executive’s immediate and rapt attention when he advocated the creation of a codified third class of drugs. It was like he was advocating dog fighting at a PETA convention. Every person in that room stopped what they were doing and asked themselves, "Did he just say what I think he said?"

That’s because there is a significant danger associated with establishing a legal definition for a third class of drugs — one that would restrict access as opposed to broaden access to appropriate medicines in the self-care space, one that would prove as a disincentive to any potential switch applicant as the prospect of recouping any research and development expenditures, not to mention a profit, quickly dwindles.

There already is a stark example of a medicine that’s mandated by law to be merchandised from behind the pharmacy counter: pseudoephedrine. There are no pharmacological reasons for that "reverse switch," no safety and efficacy concerns that would preclude availability on the shelf and without a pharmacist intervention. It’s sold behind the counter because a small percentage of criminals use PSE cold tablets as one of the raw ingredients in their backyard recipes for methamphetamine. When PSE went from OTC to behind the counter, sales plummeted.

PSE also happens to serve as a good example as to why retail pharmacy would be a lot more comfortable with the inclusion of the pharmacist in any switch paradigm if there were actually a codified third class of drugs. Because the fact is many pharmacists have to "dispense" that PSE product upon request; they have to process that transaction after checking a photo ID, after obtaining the appropriate signatures and after running that transaction through the appropriate vetting system. It’s a consultation to be sure, but it’s not a consultation where pharmacists see any kind of reimbursement for their time.

Neither retail pharmacy nor consumer healthcare companies would advocate replicating this "reverse switch" example with another medicine. But that’s one danger in a codified third class of drugs. It would make it easier to take any OTC medicine that presented adverse results when misused or abused, and place that medicine into BTC status. Worried that your children are chugging dextromethorphan? Make it BTC. Concerned about those acute overdoses of acetaminophen, whether by accident or with purpose? Make it BTC.

To be sure, both DXM and APAP could be mandated behind-the-counter today. But today it takes an act of Congress to do it; there is no fast and easy mechanism that can be used to quickly move medicines back and forth between drug classes.

Retail pharmacy’s concerns are not unfounded, however. Pharmacists already play a significant role in moving the needle toward better healthcare outcomes; and in more and more cases, they are getting appropriately compensated for that professional intervention. And that needs to continue: Broader inclusion of the pharmacist in any patient’s disease-state protocol represents a big savings opportunity for health care. But they’re not volunteers; they are learned health professionals who have the same six-year-plus student loans to pay off as their nurse and doctor counterparts.

So what’s the solution? How do you create a switch protocol that a) expands access without inadvertently restricting access, b) prevents pre-existing OTC therapies from being "reverse switched" or prevents switch applicants to be forever trapped in a transitory BTC status and c) includes a mechanism through which a pharmacist can be appropriately compensated for their time? Sound off below! Or send comments to senior OTC editor Mike Johnsen at mjohnsen@lf.com.

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Amgen offers testimony at FDA biosimilars hearing

BY Alaric DeArment

THOUSAND OAKS, Calif. — Biotech drug maker Amgen has joined the list of companies offering testimony at a Food and Drug Administration hearing on biosimilars Friday.

Amgen said Friday that it would send SVP research and development Joseph Miletich to urge the FDA panel to establish approval standards that "advance patient safety and promote confidence in biosimilars marketed in the U.S."

"While much more is known today than 30 years ago, the FDA’s guidance documents should candidly acknowledge that there are some things we still do not scientifically know today," Miletich said in a statement.

Miletich plans to make three recommendations to the agency as it finalizes its guidances: Adopt policies to facilitate attribution of adverse events and foster manufacturer accountability; conduct a communications campaign about biologics and biosimilars; and foster supply chain stability.

Sandoz, the generics division of Swiss drug maker Novartis that makes biosimilars for the European market, announced Wednesday that it would be testifying as well. The hearing relates to draft guidances concerning the development of biosimilars that the agency released February.


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