Editorial: To Split or Not to Split-That is the Question: and the Answer is NO!!!!

It seems health insurers are looking at every conceivable way possible to save (and make) money, even if it involves dangerous acts. I'm referring to "tablet splitting". Tablet splitting can be done appropriately if the dosage form is designed to split evenly (deep cuts on the tablet, elongated tablets, etc.) but it can also result in uneven dosages for the patient; too much drug one day and too little the next day. The pharmaceutical industry has assisted in this new push to split tablets by pricing different strengths of the same drug about the same or in some cases, identical; in other words, a 40 mg tablet costs about the same as a 10 mg or 20 mg tablet. It makes one wonder if the drug itself is not a major cost factor and the rest of the manufacturing processes make up the majority of the cost of the drug. If that is so, then why don't all drugs cost about the same? Obviously, in some cases the cost of the drug may be a factor but in others is may involve the pricing strategies of the industry which are not necessarily based on the cost of production but on what the market will bear.

Now we have the nation's second-largest health insurer, UnitedHealthcare, giving away "pill-splitters" and offering half-price on drugs for those who split double-strength pills, cutting the patient's insurance co-payment in half. But look at this! They are offering "half-price" drugs to their clients. Please note that the patient only saves HALF of the COPAYMENT while the insurer saves HALF THE COST OF THE DRUG? Seem fair? I don't think so. In fact one example published in the Pharmacist e-link newsletter noted that one patient saves about $31 for a six-month supply of his medication. He is quoted as saying "It's like I'm making good money per minute if you figure it out." Yes, Randy, let's figure it out. You saved $31 for a six month supply; that is about $5 per month, or about $1.25 per week. For $1.25 per week you are taking a chance on receiving an incorrect dose of the drug which may result in a relapse, additional visits to the doctor, hospitalization, etc. Not a very cost-effective way to go unless you are the health-insurer.

Should a pharmacist volunteer to split the tablets for the patients? ABSOLUTELY NOT!!!!!! As pharmacists, we are bound or obligated to dispense medications that meet USP-NF or FDA standards. If a standard for a commercial medication is that the tablet will contain not less than 95% nor more than 105% of the labeled amount of the drug, how is one going to guarantee that the split sections are within that range? You can't. One reason is you don't really know the actual distribution of the drug in the tablet. Another is that the tablets may not split equally and just exactly how much can you "miss the mark" and still be okay? Does this open the pharmacists up for liability? It could as you may be dispensing "out of specification" drugs. What happens if one-half of the tablet splits into two parts�..and this happens several times but all the "parts" are placed in the vial. Do you tell the patient to take "the equivalent of" one-half tablet? Or, do you throw the parts away and only dispense the good halves? Then, who pays for the unusable parts? (I wonder).

If health-insurers are adamant about splitting tablets, they should consider allowing the pharmacist to compound the smaller dosage strengths. In other words, a compounding pharmacist could take a 40 mg tablet and make four 10 mg tablets which should meet the specifications of quality. However, that can't be done because compounding is not supposed to involve commercially available products. It can be done if the strength required is not commercially available, however.

So what is the answer to this dilemma? Let the patient know the problems with splitting tablets and recommend that they refuse to be a part of the practice where they save very little money and possibly put their health at risk; meanwhile, the health-insurer pockets the big savings. Should pharmacists split the tablets for the patients? As stated above, "No, there is too much liability and if you charged the health insurer for it, you probably would not get paid for it".

It seems the managed care companies have inserted themselves into the healthcare industry and positioned themselves to "take charge" of everything, from the physicians to the pharmacists. I thought that originally they were to be a "service" to the healthcare industry, but they have become the "driving force". If I remember correctly, we healthcare practitioners and patients were doing quite well, and probably much better, before they came along. Is it possible that this latest push to reap more profits at the expense of quality healthcare is driving another nail into the coffin of these companies?

Loyd V. Allen, Jr., Ph.D., R.Ph
Editor-in-Chief

Compoundingtoday.com has added the most used drug solution concentrations - 0.5, 1, 2, 3, 4, and 5% to the NaCl Equivalent Value Tool In addition, this valuable tool got a facelift making it even easier and faster to find a NaCl equivalent value. Just click on the first letter of the desired drug then find that drug on the list. With 2 clicks, the correct equivalent value for the drug solution is provided�.compound away!

Accuracy in pharmaceutical calculations is critical, which is why Compoundingtoday.com has improved its Base-Salt-Ester (BSE) calculations tools.

The improved tool includes 244 conversion factors for 188 different base chemicals. Previously the tool included 59 conversion factors for only 44 base chemicals.

In addition to a more comprehensive listing, an extensive introductory text with calculation examples has been included to assist in converting drug values from base to ester and vice-versa and/or even accounting for water of hydration in a chemical. Unsure about which chemical to use or how much to weigh a chemical when the prescription differs from a chemical on the shelf, come and try the BSE tool. It is extremely easy!

Nearly 1500 citations and abstracts from 509 publications are now available for searching and researching in Compoundingtoday.com's literature search. This week 30 articles related to stability and compatibility were added. Below is a sample of the citations added:

• Abanmy NO, Zaghloul IY, Radwan MA. Compatibility of tramadol hydrochloride injection with selected drugs and solutions. Am J Health Syst Pharm 2005; 62(12): 1299-1302.
• Alvarez JC, De Mazancourt P, Chartier-Kastler E et al. Drug stability testing to support clinical feasibility investigations for intrathecal baclofen-clonidine admixture. J Pain Symptom Manage 2004; 28(3): 268-272.
• Gard JW, Alexander JM, Bawdon RE et al. Oxytocin preparation stability in several common obstetric intravenous solutions. Am J Obstet Gynecol 2002; 186(3): 496-498.
• Ichikawa M, Ide N, Shiraishi S et al. Effects of various halide salts on the incompatibility of cyanocobalamin and ascorbic acid in aqueous solution. Chem Pharm Bull (Tokyo) 2005; 53(6): 688-690.
• McKenzie JE, Cruz-Rivera M. Compatibility of budesonide inhalation suspension with four nebulizing solutions. Ann Pharmacother 2004; 38(6): 967-972.

Biological indicators (BIs) verification of Compounded Sterile Preparations (CSP's) quality methods has a name change. Ampuls used to verify that a CSP is sterile after being processed via autoclave, dry-heat oven or ionizing radiation (gamma radiation) contained spores formerly called Bacillus stearothermophilus have been renamed to Geobacillus stearothermophilus. For more information see:
http://www.ravenlabs.com/taxonomy.pdf and http://ijs.sgmjournals.org/cgi/content/abstract/51/2/433

Frequently on the Compounders Network List, a free e-network for compounding pharmacists, a colleague will offer some valuable educational tools and resources. Because the network doesn't allow attachments, the resources and downloadable information will be placed for all CT.com subscribers at http://compoundingtoday.com/CNLSharedInfo/.

This week a downloadable, printable "Scream Cream" handout was added. Other information available in this shared information on CT.com includes, Lidocaine, Ephinephrine, Tetracaine (LET) Gel formulation and its base with references and Amiodarone Suspension formulation with references.

The Compounders Network List is just shy of a thousand participants from 20 different countries.

This Regulatory Update has been provided by the International Academy of Compounding Pharmacists. For more information, www.iacprx.org.

Ohio Office Use Legislation Enacted
SB 18, legislation allowing compounding for office use, was signed into law by the Ohio governor on May 18, 2005. It becomes effective 90 days after signing. Click here to view a copy of the law.