Editorial: Should Pharmacists Handle Dangerous Chemicals

I was somewhat discouraged to pick up a national pharmacy periodical a few weeks ago and an author of an article recommended that Glacial Acetic Acid be removed from the shelves and not be allowed for pharmaceutical compounding any longer. I respectfully disagree with that author.

Pharmacists should be receiving the necessary training and skills to handle dangerous chemicals as a part of their daily work routine. In fact, pharmacists handle dangerous chemicals all day every day! Think about it:

• The drug products that are dispensed every day are potentially dangerous chemicals; but we don't see individuals calling for their removal?
• Commercial drugs used in preparing intravenous admixtures are potentially dangerous chemicals, but we don't see individuals calling for their removal?
• Compounding pharmacists routinely use commercial and potentially dangerous bulk chemicals as a part of our daily job; should they be removed?
• Nuclear pharmacists use potentially dangerous drugs; but we don't see individuals calling for their removal?

Why should someone make a statement like that? Quite possibly it can be attributed to errors that have occurred and may have even resulted in patient harm or death. Does that mean, then, that every time we have a problem with a drug or chemical, that we remove it from use? I would hope not. Think about all the deaths due to gasoline ingestion, insecticides, and even misuse of nonprescription drugs. Should all these be removed?

Instead of a knee-jerk reaction, why not look at the source of the problem and see if we can come up with some suggestions. Quite possibly, the source of the glacial acetic acid problem resulted from inadequate training or education and lack of attention to the task at hand.

Do pharmacists know the difference between Glacial Acetic Acid, Acetic Acid and Dilute Acetic Acid, all USP-NF monographed items? If not, they should if they are handling them. Glacial Acetic Acid USP is 100% acetic acid by weight; Acetic Acid NF is 36% acetic acid by weight; and Diluted Acetic Acid NF is 6% w/v acetic acid. As one can tell, if a formula calls for acetic acid and glacial acetic acid is used, then the amount of acetic acid is about 3 times what it should be. This can be a real problem if the preparation was a sterile bladder irrigant.

We must all know the differences in the forms of chemicals and drugs with which we are working. One has suggested that it is confusing. Well, when we use Hydrochloric Acid NF, it is 36.5-38.0% w/w pure, Diluted Hydrochloric Acid NF is 10% w/v, Sulfuric Acid NF, is 95.0-98.0% pure; Nitric Acid NF is about 70% pure, Phosphoric Acid USP is 85-88% pure and we routinely do calculations with these acids; acetic acid is no different. We have, as official USP-NF monographs, Dilute Hydrochloric Acid and Dilute Acetic Acid; one is 10% and one is 6%; these are just things that compounding pharmacists should know, or look up as needed.

I'm not aware that physicians, including surgeons, do away with a procedure just because it is dangerous. Instead, they become educated and trained in what they are doing so they can do it correctly. This is a lesson we all can learn. We don't throw something out just because an adverse event has occurred. We increase our educational preparation and continuing education so that we, too, can do it correctly.

If all these topics are being taught at Colleges of Pharmacy, then education should not be a problem. It may involve the lack of attention to the task at hand. If that is the problem, then those involved must pay more attention to detail and use their education in their activities. If the individual responsible was not a pharmacist but a technician, then where was the pharmacist that signed-off on the work of the technician?

Obviously, this is an editorial that is "preaching to the choir". However, it is quite upsetting to see some of our profession that are not associated with manipulations of drugs, i.e., pharmaceutical compounding, recommend that something be done away with when our focus as pharmacists needs to incorporate more about the "product", as we are supposed to be the experts on drugs. Being an expert on drugs includes competent knowledge of the physicochemical properties and behavior of the drug substance and dosage forms.

After all, if we get rid of the dangerous chemicals (acids, oncology drugs, and even all drugs), what will be left for pharmacists to do? Instead, let's educate and validate!

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

CT.com has changed it's trial membership in an attempt to give trial users a better understanding of what all www.compoundingtoday.com has to offer. Instead of only having access to certain pieces of information within each CT.com category, CT.com now allows trial users a set number of downloads of information per day of their trial.

For example, trial users can go to the "Formulations" section of CT.com and download two formulas or the "Literature Search" section and download several citations or the "Standard Operating Procedures" tool and pick and choose several SOPs and download them. So, start your trial today and get the information you need. Once you login on to CT.com, you'll never want to logoff!

More Standard Operating Procedures were added to www.compoundingtoday.com this week. The new ones added include:

• 8.038.4 - Change TOC title to Bard Infuser Reservoir Filling - Models No. 100 and 250
• 8.047 - Change TOC title to Reconstitution of a Sterile Powder
• 8.048 - Change TOC title to Reconstitution of a Nonsterile Powder
• 8.053 - Change TOC title to Pulverization of Tablets or Crystals Using an Electronic Mortar and Pestle
• 8.054 - Change TOC title to Compounding Nonsterile Cytotoxic Drugs

A group of citations were added to CT.com's literature database this week. Here is a sampling of what was added to more than 1000 citations already in the database:

• Birnie C. Resources for today's compounding pharmacist. J Am Pharm Assoc (Wash DC) 2004; 44(4): 526.
• Generali J. Medication safety. Hosp Pharm 2005; 40(1): 100-102.
• Greenberg MD, Ridgely MS, Bell DS. Electronic prescribing and HIPAA privacy regulation. Inquiry 2004-2005; 41(4): 461-468.
• [No authors listed.] Discontinued products-2004. Hosp Pharm 2005; 40(2): 195-198.
• Trissel LA, Gentempo JA, Anderson RW et al. Using a medium-fill simulation to evaluate the microbial contamination rate for USP medium-risk-level compounding. Am J Health Syst Pharm 2005; 62(3): 285-288.

Dr. Allen's Four White Papers written to educate and inform are now available in Portuguese and Spanish as well as English at http://compoundingtoday.com/WhitePapers/. The White Papers are titled:

1. Pharmacy Compounding? Did you know that without pharmacy compounding:...?
2. What do you know about pharmacy compounding?
3. Recent advances in quality pharmacy compounding.
4. Reasons the FDA should not be involved in pharmacy compounding.

These White Papers can be framed and displayed in your patient waiting areas for a permanent display and/or can be provided as patient handouts. Please feel free to use them when you are involved in giving presentations to groups about compounding.

These White Papers can be downloaded or professional copies can be obtained by calling the IJPC Customer Service office. Please use them to educate and inform all who will read them about the value of individualized patient care through pharmacy compounding.

This last week on the Compounders' Network where thousands of pharmacists come together to discuss compounding pharmacy, some of the topics included:

• A source for ofloxacin
• Autoimmune dermatitis to progesterone
• A few weeks back a U.S. pharmacist asked for help across the sea on a formula of what looked like a German product requested by a local physician. This week one of our German pharmacists who has been on vacation answered with the formula for Jellin (R).

Join the Compounders' Network. It's informative. It's where compounders come to talk. Best of all�.it's free!