SPLITTING THE DIFFERENCE - PART TWO. At Shamrock Medical, we have some past experience with tablet splitting.

In my last post, I spoke of the FDAs new drug application (NDA) regarding scoring drugs. I raised the issue that the recommendations are not simply a matter of splitting a tablet.

There are 5 FDA guidelines by which a scored tablet’s characteristics will be evaluated:

1. The dosage amount meant to be achieved after splitting the tablet should not be below the minimum therapeutic dose indicated on the approved labeling.

2. The split tablet should be safe to handle and not pose risk of unintended drug exposure.

3. Modified release products for which the control of drug release can be compromised by tablet splitting should not have a scoring feature.

4. The split tablet, when stored in pharmacy dispensing containers (no seal/no desiccant), should demonstrate adequate stability for a period of 90 days at 25º C, plus or minus 2º C/60 percent Relative Humidity (RH), plus or minus 5 percent RH.

5. The split tablet portions should meet the same finished-product testing requirements as for a whole-tablet product with equivalent strength.

According to the FDA, data to indicate all requirements are met must be provided to the Agency for evaluation, and the assessment should be undertaken on both tablets that are split non-mechanically (by hand) and tablets that are split mechanically (with a tablet splitter), on a minimum of 12 individual split tablet portions.

These are our concerns at Shamrock Medical: Currently, we at Shamrock don’t do that type of testing on tablets. To do so might require outsourcing or other measures costly to the customers we serve, and　the demand for split tabs may not support the cost of compliance.

To my knowledge, hospital pharmacies have a small number of drugs that need to be split to achieve the dose ordered by the physician. Are you splitting tablets in your pharmacy and sending a half tablet? How do you label them, and how do you handle the NDC issue?

It also appears, upon reading the full document that the FDA seems to discourage the splitting of tabs for economic reasons. Some drugs are priced the same whether the strength is 25mg or 50mg, for example; thus you can create two 25mg tabs from a 50mg tab, and save the cost of one tablet.

In many hospitals, the tablets are split by the nurse on the nursing unit, using a small hand held device. In that setting, one half of the tab gets wasted, and the patient gets the other, and the hand held device seldom gets cleaned, thus leaving the opportunity for "cross contamination" between drugs. The Joint Commission (Hospital Accreditation organization) often cites hospitals for having unclean tablet splitters on the nursing unit.

I believe we can help alleviate the problems hospitals have with drug splitting, but creating a "raw edge" from splitting a tab does affect the stability and we don’t currently do drug stability studies to determine an expiration date.

What are your thoughts on the FDAs recommendations for drug splitting? Does it make sense to you in the hospital environment? Is it safe? Does it raise costs unnecessarily? This may become a bigger issue in the future, and your feedback will provide valuable input.

Here's to better solutions,
Dave Bystrom