SUPERmarket PHARMACIST

A pharmacist's look at the supermarket and beyond

Month: April 2015

We Need a Third Class of Drugs

For pharmacists reading this, I ask you, don’t you think your education and experience qualifies you to prescribe an ED drug like Viagra or Cialis? Wouldn’t you rather be able to order triamcinolone cream instead of hydrocortisone? Could you feel comfortable ordering a topical antibiotic for a patient with acne? For patients reading this, wouldn’t you be happy to have a pharmacist actually give you the product that they are recommending for your concern? Within reason, of course, I don’t want full prescriptive authority, but surely there is a rational middle ground.

The subject of a third class of drugs under the purview of pharmacists has been discussed for over half a century and yet we still labor under the illogical two classifications of Over-The-Counter (OTC) and prescription only (Rx). We currently have many potent, previously Rx only medications widely available as OTC products. We are hearing discussion of making certain statins (cholesterol-lowering drugs), oral contraceptives, and even Cialis, the erectile dysfunction drug, is said to be heading for non-prescription status by 2017. I would suggest that the FDA needs to take a long hard look at our drug classification system (finally!) and redefine and create more appropriate categories of medications for distribution in this country.

I’ve already blogged about the mis-classification of marijuana. Looking at some of the drugs that were once Rx drugs, I am sometimes baffled by the choices that the FDA has made. I am fairly certain that many decisions were driven more by economics than by medicine. Take for example, Tagamet. Tagamet (cimetidine) started out as a novel Rx drug to decrease stomach acid and was very successful. As with any successful Rx med, imitators soon followed and today we have a wide variety of these H2 antagonists to choose from. But why was Tagamet approved for OTC use? Here is a drug that when choosing a brand name, the company came up with the truthful, yet ironic, TAGaMET, perhaps because cimetidine is know to anTAGonize the METabolism of so many other drugs. I commented on this last year in this blog.

We certainly need to devise more rational way to classify drugs. Having a third class of drugs that could be ordered and monitored by pharmacists seems a very logical approach to me, but of course, I’m a pharmacist and obviously biased. But really, who is better suited to provide these drugs to patients. Pharmacies already have all the tools to monitor the use of drugs and wouldn’t it be much wiser and safer to give pharmacists a role in this process rather than suddenly have a potent drug move from within the pharmacy to wide distribution in the open market?

We really need to get this done. I am disappointed that the American Pharmacists Association has not been able to accomplish this, but then again, I have been disillusioned with that organization for some time now. The phrase paper tiger comes to mind. I still believe that we can have an effective voice of pharmacy and that APhA is the best way to make that happen. Each and every pharmacist must be involved though, and that is where the profession suffers. So many of us just go along for the ride and never make any attempt to paddle or steer the ship we are on.

I last wrote about this third class of drugs in 2004 in an article published in Pharmacy Today (the APhA magazine!). Some of the info is dated but the gist of the article still represents a solid viewpoint so I’m offering it here for your perusal.

Should the U.S. Have a Third Category of Drugs?” an essay published in the November 2004 issue of Pharmacy Today.

In Australia, you can only buy nicotine patches from a pharmacist. In Singapore, you must visit a pharmacist to purchase a pack of Orbit gum. In New Zealand, medications for a variety of conditions can be purchased as pharmacist only products. In the United Kingdom, simvastatin (Zocor –Merck) went over-the-counter (OTC).

It is a past time to give careful consideration to creation of a third “Pharmacist Only” class of medications in this country. Under our current system, medications make a giant leap from the very restricted and regulated prescription distribution system to the incredibly extensive non-prescription marketplace. Making some of these medications so widely available may not be in the best interest of patients’ health. Granting pharmacists control over a specific group of prescription medications might serve to improve care in a cost-effective manner. So why hasn’t this innovation taken place?

The National Association of Boards of Pharmacy (NABP) has long advocated what they call a third, transitional class of drugs. In their May 1995 meeting they passed a resolution calling for “creation of a class of drugs that does not require a prescription, but does require counseling.” In the NABP National Newsletter (April 2004), they reiterated the belief that a counseling class of drugs is important to the safety of public health. The APhA has been supportive of a third, pharmacist-only, class of drugs, but recently has begun exploring a “pharmacy-only” class of drugs. It is thought that a pharmacy-only classification would not require the extensive regulatory changes required to create a pharmacist-only drug classification. In either case, pharmacists have the necessary knowledge and skills to serve as “learned intermediaries” in this critical function of patient care. Others have suggested a “behind the counter (BTC) classification for these drugs.

Unfortunately, attempts to get enabling legislation introduced in Congress have all met with failure. Powerful groups with effective lobbyists and ample funding have strenuously opposed these efforts. The American Medical Association (AMA) and the Consumer Healthcare Products Association (CHPA), oppose a transitional class of drugs.
But, consider that the sheer number of medications available directly to consumers is becoming overwhelming. Many people are under the impression that OTC medications are safe since “the government” has seen fit to make them available to the general public. As pharmacists, we know the naiveté of that belief, as well as the dangers inherent in many of the products sold indiscriminately in so many outlets. Pharmacists know that they have tremendous impact on their patients’ health when they advise and guide the selection and use of medications. Numerous studies have demonstrated the value in both dollars and outcomes when pharmacists are involved in drug therapy management. A third class of drugs would provide consumers with more choices and give them access to professional guidance toward effective health care. Of course, the added benefit would be that pharmacists would enhance the triage function that they already provide, referring patients for physician-provided medical care when indicated.

Randy P. Juhl, Ph.D., Vice Chancellor for Research Conduct and Compliance at the University of Pittsburgh believes that “we are better off pursuing collaborative care arrangements where our efforts are directed at caring for patients regardless of the FDA classification of the drugs or devices being used and in concert with physicians and other providers.” Yet not all practice sites are conducive to collaborative practices, while a national third class of drugs would allow access to effective medications wherever a pharmacist was willing to provide his or her expertise. Over 40 states allow some kind of collaborative practice.

The 1993 New Mexico Pharmacist Prescriptive Authority Act, which permitted pharmacists with advanced training in physical assessment and board certification as pharmacotherapy specialists to prescribe and authorize refills, is worth taking a look at and in 1985, Florida enacted the Florida Pharmacist Self-Care Consultant Law. There is little data gauging the impact of these laws that granted pharmacists permission to prescribe from a very narrow formulary. A study by Eng et al, published in The Annals of Pharmacotherapy, October 1990, showed very little prescribing by pharmacists under the new law. The reasons for this lack of enthusiasm were listed as: 1) the formulary was inadequate, providing little that was of more benefit than available OTCs; 2) new liabilities were perceived and pharmacists’ liability policies were altered; and 3) time constraints. The Florida experience should be examined and improved upon to make a realistic national pharmacist-only formulary. This class of drugs could provide a valuable exploratory step towards full OTC status. This class of drugs would also answer many of the concerns recently expressed in the debate on making Plan B, statins and other drugs OTC.

In 1995, to determine whether a third class of drugs would be of any benefit, the House Committee on Commerce asked the GAO to look at drug distribution in ten countries. The report is extensive, examining the ten other countries but also examining relevant practices in the US, including exempt C-V drugs, the Florida law and pharmacists as “dependent prescribers,” i.e. in a collaborative practice. The GAO report can be found in its entirety at http://www.gao.gov/archive/1995/pe95012.pdf and is recommended reading for those interested in this issue. Remember, the purpose of the third class would be to improve access to beneficial medications, not restrict access to OTC products.

A pharmacist-only class of drugs would be in the best interests of our patients and would have little negative impact on corporate profit margins or on physicians’ ability to provide medical care. Actually, there is great potential to broaden the availability of consumer products and enhance the delivery of medical care. This is an idea whose time has finally come. The idea of a pharmacy-only class of drugs is also being considered and may serve as an important transitional step toward a more intelligent distribution system for the myriad of drug products available in this country. Think about the possibilities!

Carl Labbe R. Ph.

Do You Trust Your Honey?

Honey is in a pickle, people. Honey is truly a super-food. Since ancient times it has been a great all-natural sweetener and an important source of nutrition, as well as a key ingredient in many early fermented beverages. Now though, most of us buy our honey off supermarket shelves. I did a little digging when I happened to see a side comment about honey purity in an article about the decline of bee populations.

It turns out that the honey marketplace, at the industrial level, is a complex marketplace with buyers relying on trust, technology, or both to guide them to a quality product. Of course some distributors of honey, as in other enterprises, care only about profits. So what could possibly go wrong with one of nature’s purest foods?

There are multiple alerts on the FDA web site concerning honey that has been diluted with corn syrup or simple sugar syrup. In February 2015 there was an import alert warning of honey with traces of antibiotics such as ciprofloxacin, nitrofurantion, and even chloramphenicol. Although antibiotics can be used to treat infection in honey bees, these three are NOT approved for bee use in the US. The honey in question was sourced to China, which has a nasty habit of dumping all kinds of tainted products, including foods, into any market. From there, bulk purchases of honey may be repackaged under a variety of labels or even mixed with honey from other sources, and perhaps a little more profit can be eked out by adding some cheap corn syrup. Of course, your honey may have already been “stepped on” with added rice syrup before it left China.

Amazingly, in 2006, the American Beekeeping federation petitioned the FDA to adopt a “standard of identity” for honey based on recognized standards. They merely wanted:

  • a definition of honey based on its composition.
  • increased enforcement to prevent adulteration.
  • promote fair dealing in the food industry where honey is used as an ingredient
  • That doesn’t seem like too much to ask, yet the petition was denied on the grounds that FDA already had standards and principles in place to address the beekeepers’ concerns. The FDA does have strong language in its regulatory code to define misbranding and adulteration. FDA states that the common definition of honey as “a thick, sweet, syrupy substance that bees make as food from the nectar of flowers and store in honeycombs,” is a sufficient definition. The FDA goes on to say that the floral source of the honey does not need to be declared. The FDA alerts recommend that field agents detain any imported honey that they think contains a fluoroquinolone, for example, without physical examination. The product could not be released into US distribution until cleared via testing.

    Much of the honey sold in stores in filtered. Natural honey, straight from the honeycomb, contains pollen. A process called ultra-filtration removes pollen from honey. The presence of pollen is likely very important for the beneficial aspects of pure honey. But a recent examination of honey sold in our supermarkets showed that 76% of samples tested had all pollen removed and that number rose to an incredible 100% for drugstore honey. The ultra-filtered honey has a longer shelf life and has a clear appearance, making it attractive to sellers and buyers. Longer shelf life?!? Haven’t we found jars of honey that were thousands of years old and it was still good? As for clarity, if you have eaten a fresh honeycomb, you did not care how clear the honey was!

    The other factor in pollen removal from honey is that it makes the honey virtually impossible to trace back to its source. Many experts think that much of our honey is reaching our market from countries like China, Malaysia, Viet Nam and others where there is little or no regulation of food production. There is documentation showing that China began shipping its cheap honey to other countries where it was put in different shipping drums with new labeling and documentation in response to new higher tariffs imposed in 2001. There are still websites that will accommodate this practice called transshipping. It is estimated that 60% of our imported honey comes from Asian countries and we often have no way of knowing exactly where the honey came from. FDA likely inspects only 5% of honey reaching our shores.

    I must admit that I am guilty of buying the store “Value” brand of honey simply because it looks OK and tasted much like honey should. Now I know better and have tasted store brand honey side by side with real local honey and the difference in taste and texture was apparent. So what is a consumer to do? Buy local! You’ll have to do a little research perhaps, but it will be well worth your effort. Fortunately, our beekeeper friends have a great honey locator page that gets you to the honey people in your state or city. Happy hunting and stay sweet!