TO DOSE OR NOT TO DOSE...

As a young boy I always loved Halloween. Candy? Costumes? What's not to love. I believe that young children enjoy another aspect of Halloween. The anticipation of the unexpected. Who's going to come out from behind the tree and yell "Boo!"

As we become adults we find less enjoyment in the unexpected. Especially as a pharmacist, I wanted to know what is exact, specific, accurate.

With that in mind, I thought it might be helpful to discuss repackaged doses. I believe pharmacists should consider whether they want to deliver the stated volume (dose), or do they want the cup to contain the stated volume (dose)?

For example, when pouring the dose from the unit dose cup (estimated at about 4 seconds), there is a residual amount of drug remaining on the inner surface of the cup. When repackaging, we account for the volume of this residual by re-creating the “administration of the dose” of the specific drug being repackaged. Before we can do that, we must know the specific gravity of the drug. To determine that, our technician will weigh a series of one milliliter samples of the drug, and calculate the grams per milliliter. Knowing that information, we can weigh, or tare, an empty cup, then fill it with the dose required, and deliver a 4 second “pour”; then weigh the cup again to determine the weight in grams of the residual, which can be used to calculate the milliliters of the residual.

This volume, in milliliters, is the amount of drug added to the desired dose volume in milliliters, to arrive at the “to deliver” volume needed. In other words, the amount of drug in a unit dose cup for a 5 milliliter dose may actually be 6 milliliters.

At times, this can be a critical issue, as pharmacists may not consider the residual, and they may order the “to contain” dose in the cup. When this occurs, we contact the pharmacist and review the options. Pharmacists always choose to have the patient get the “delivered” dose. (Of course, this is not an issue if the drug is packaged in an oral syringe, because the entire content is expelled when the plunger is depressed to the fullest, and there is no remaining residual.)

(We find some drugs to be exceptions to the rule, and they are topical oral use medications. Since they are ordered to be administered in a “rinse, swirl, gargle, and spit” form, there is no specific dose needed, only a volume to be contained in the cup.)

Being trained to accurately measure medications, naturally, pharmacists don’t want any surprises. At Shamrock Medical, we agree. Let's save the surprises for Halloween.

Here's to better solutions, 

Dave Bystrom

SPEED DATING ON DRUGS

We just returned from the 2012 Fall Hospital Pharmacy Conference, sponsored by Health Connect Partners. The conference connects healthcare providers and suppliers through educational meetings conferences and networking so that providers learn real solutions and suppliers understand their real needs.

This year, the Fall Hospital Pharmacy Conference offered educational sessions on topics such as nuclear pharmacy, a fatal medication error, and healthcare business models. The conference is known for its innovative approach to supplier and health-system pharmacist networking, including a unique large scale Reverse Expo staffed by hospital pharmacy management. 

I like to think of the Reverse Expo as speed dating, because it offers us the rare opportunity to meet face-to-face with more than 200 pharmacists in the network for 5 minutes each. With so little time, we got right to the core of their problem or needs, without flirting around the issues.

The Reverse Expo lasts two hours per session, and we prepared in advance. We made sure to bring plenty of business cards, our best “elevator pitch” and a warm smile.

HERE'S WHAT WE LEARNED

Some of the critical issues we heard from pharmacists attending the show include the following: 

• They have trouble obtaining all the dosage forms they need in a unit dose form, with a readable barcode
• Drug shortages continue, especially liquid unit dose
• Some repackagers are experiencing very slow turnaround times
• Hospitals continue to struggle with the “make or buy” decisions

HERE'S HOW WE CAN HELP

Of course, we're prepared to help hospital pharmacies with questions and help, anytime.

We want to make pharmacy directors aware of Shamrock Medical Solutions, the FDA registered repackager. We also want pharmacy directors to know that we are specialists in repackaging unit dose liquids (cups and syringes) as well as oral solids, and that we produce robot ready unit doses as well as robot ready kits. Still have questions? Let us know. We're prepared to help you.

                                Here's to better solutions, 

                  Dave Bystrom

DRUG SHORTAGES: REAL, IMAGINED, WHY?

A recent story on Boston's NPR station WBUR, stated that, to help first responders deal with drug shortages, Oregon has taken the unusual step of temporarily allowing ambulance services to carry and administer expired drugs.

And Oregon isn’t alone. The drug shortage crisis is hitting the whole country. Some blame a regulatory crackdown by the FDA. The FDA disputes that claim, and says the shortage is due to manufacturing and quality problems. And others say there’s little incentive to make generic drugs because of a low profit margin.

When did these shortages become so bad? And why?

The shortages go back to at least 2010. The majority of the drug shortage problems are with generic injectable products, which account for about 74% of the shortages; but the more critical issues to patient care are with injectable chemotherapy and anesthesia drugs. These products are more “medically necessary” than the non-sterile generic liquids that affect the drug repackaging world.

It has been noted that posting of drug shortages exacerbates the shortage, as a result of hoarding. (In early July 2012, President Obama signed “The Food and Drug Administration Safety and Innovation Act” to minimize the impact of drug shortages on patients. Hopefully this will help reduce the shortages of critical drugs.)

Other issues which contribute to the shortages include the JIT (just in time) mentality in the supply chain, and the existence of opportunists in the grey market, who acquire these critical products and make them available through alternate supply chains at a great mark-up in price.

For the most part, the product shortages that have had impact on the repackaging world are the generic liquids. They are relatively inexpensive. Also, they are not promoted in the grey market because they are relatively inexpensive and they are not considered “medically necessary”, as compared with chemotherapy and anesthesia drugs (often, these are not even prescription drugs.) The shortages we presently see are a result of manufacturers failing to supply these generic liquids in unit dose cups, and these products are still generally available in bulk packaging.

In my opinion, the newly passed legislation will have little or no impact on this class of drugs. As an FDA registered repackager, we look forward to filling this void in the marketplace with a high quality product, which allows our hospital customers to focus on their core competencies involving patient care, rather than repackaging liquid doses.

Have you experienced drug shortages in your facility? How do you feel the problem might be solved?

Here's to better solutions,  

             Dave Bystrom