Compounding For Office Use-Some Observations and Comments

As most of us are aware, there have been some tragic events related to the prescribing for office use and misuse of high concentrations of lidocaine gels. Notice that this editorial refers to the �prescribing for office use� and the �misuse� of high concentrations of lidocaine gels.
Let�s take a minute and look at the procedures involved and answer the following questions.

Questions:

1. Who initiates the order for the lidocaine gel, or other office use preparations?
2. Whose responsibility is it to order and use the gel properly for office use preparations?
3. Is �office use� compounding legal and appropriate?
4. What does �office use� generally mean?
5. Are compounded prescriptions for �office use� any different than other compounded prescriptions?
6. What are the standards for �office use� compounded prescriptions?
7. What is the pharmacist�s responsibility for office use compounding?
8. In the cases involving office use compounding recently, have the pharmacists been at fault?
9. How should one respond to the media when faced with this situation?
10. Why can pharmacists make �home-made� drugs; a term often used by the media?

Answers:

1. The physician should initiate the order for the lidocaine gel or any office used preparation based upon his/her experience and practice setting. I understand that the pharmacists were responding to a legitimate prescription order from the physician.
2. In the physician�s office or clinic, it is their responsibility to order and use the lidocaine gel or other office use properly. I believe in these cases, the gel was provided to the patient to take home and apply prior to returning to the office or clinic for their procedure. These �office use� prescriptions are NOT to be provided to the patient for their own administration. They are to be used in the �office�; hence the name, �office use�. If they were to be provided to the patient, they should have been written as an individual prescription for a specific patient along with specific instructions, etc.
3. �Office use� compounding is legal in many states and is very appropriate. In fact the FDA recognizes the need for Office Use compounding, as indicated during the hearings on the implementation of FDAMA-97 and the FDA Compounding Advisory Committee approval of some bulk substances for office use only.
4. �Office use� means for use in the office by or under the supervision of the health professional.
5. Compounded preparations for �office use� do not generally have specific instructions since they are not for individual patients and the use may vary between patients. They do need to be labeled for �office use�. Some states are requiring that �signup� sheets be sent along with the compounded �office use� preparation for completion listing the patients on whom the preparation was used by the physicians office/clinic and then returned to the pharmacy.
6. The compounding standards for �office use� are exactly the same as those for individual patients; the standards described in USP Chapters <795> for nonsterile and <797> for sterile preparations should be followed.
7. The pharmacists responsibility involves compounding according to the state laws and regulations governing compounding and compounding according to USP standards. The compounded prescriptions should be labeled �For Office Use Only� along with appropriate beyond-use dates, etc. and other information required by the individual state.
8. Of the information received by this office, it appears that the pharmacists were compounding the preparations correctly and labeling them correctly. The issue may involve how the compounded medications were used at the office and even provided to patients to take home.
9. Explain that as pharmacists we dispense and compound prescriptions in response to a legitimate order received from a physician�s office or clinic. Our compounded prescriptions are prepared according to standards in the US Pharmacopeia, which also provides standards for the pharmaceutical industry.
10. Pharmacists do not make �home-made� drugs. Pharmacists are trained to prepare appropriate dosage forms for individual, specific patients. This has been the history of pharmacy. In the hospital, individual intravenous admixtures are prepared for tens of thousands of patients daily. In the community pharmacy, individual prescriptions are compounded for tens or hundreds of thousands of patients daily, including those for all age groups. Compounding has become a very sophisticated part of pharmacy practice requiring specialized training and investment in state-of-the-art equipment, etc. USP and NF grade ingredients, the same as those used in the pharmaceutical industry, are required for pharmaceutical compounding. As appropriate, compounded medications are analyzed in many of the same laboratories used by the pharmaceutical industry. New standards for pharmaceutical compounding are continually introduced to enhance patient safety and ensure quality-compounded preparations.

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

Here is a sampling of a citations for abstracts you kind find on CT.com�s literature search service: his week. Search �pain management� from http://compoundingtoday.com/articles/ and find hundreds more related to this topic.

• Arici MK, Sumer Z, Guler C et al. In vitro potency and stability of fortified ophthalmic antibiotics. Aust N Z J Ophthalmol 1999; 27(6): 426-430.
• Elmore RL, Contois ME, Kelly J et al. Stability and compatibility of admixtures of intravenous ciprofloxacin and selected drugs. Clin Ther 1996; 18(2): 246-255.
• Grillo JA, Gonzalez ER. Ramaiya A et al. Chemical compatibility of inotropic and vasoactive agents delivered via a multiple line infusion system. Crit Care Med 1995; 23(6): 1061-1066.
• Rudich Z, Peng P, Dunn E et al. Stability of clonidine in clonidine-hydromorphone mixture from implanted intrathecal infusion pumps in chronic pain patients. J Pain Symptom Manage 2004; 28(6): 599-602.
• Stiles ML, Allen LV Jr. Stability of nafcillin sodium, oxacillin sodium, penicillin G potassium, penicillin G sodium, and tobramycin sulfate in polyvinyl chloride drug reservoirs. Am J Health Syst Pharm 1997; 54(9): 1068-1070.

Here is what they talked about last week:
� A pharmacist in Singapore has a patient moving to San Antonio, TX and asked a San Antonio pharmacist to contact him.
� A pharmacist asked where to get compounding training?
� A pharmacist setting up a new compounding lab wanted to purchase some used equipment.
� There was in-depth discussion about Promethazine in PLO and formulations were shared.
� There was a discussion about the best methods of measuring HRT dosages.

Your Senators and Representatives will be in their home districts from March 21 to April 4 for a spring recess. We encourage you to attend local town hall meetings held during this time. This is also an excellent time for store owners to meet with your Senator or Representative or to invite them to visit your pharmacy. If your Senator or Representative is unable to visit your store during this time, inviting a member of the district staff is an excellent alternative. You may access contact information for your elected officials by entering your zip code at http://www.congress.org/