For years it has been apparent that we are in need of a third class of drugs here in the US. I'm not talking about (1) Prescription, (2) Nonprescription, nor (3) Pharmacist-Only medications (although that would be great!), but a third class of drugs like the "Specials" in the United Kingdom (UK).

In a sense, these "Specials" are similar to "Tweeners," a young person between a child and a teen, usually considered to be about 11 or 12 years old going on 18. (Having raised three daughters, we are quite familiar with this.) The "Tweens," or "Specials" in this case, are pharmaceutical products that are manufactured or prepared by a pharmacy that is between a "compounder" and a "manufacturer." Let's look at it in more detail.

Before we get started, however, I need to mention that in the UK it is common to use the term "manufacture" instead of "compound." Actually, today many US hospitals still use the term "manufacture." When I was at the US Public Health Service hospital in Boston, Massachusetts, we "manufactured" an extensive list of both nonsterile and sterile items that were used in the hospital every day. So as you are reading this and the associated references, keep in mind that the terms "manufacture" and "compound" are often used interchangeably. Also, sometimes a distinction is made between a "manufactured product" (a compounded preparation) and a "commercially manufactured product" (a UK Medicines and Healthcare products Regulatory Agency-approved product).

In the UK, "Specials" are unlicensed medicines prepared in response to a prescription for an individual patient for whom a licensed commercial product is not available. The prescription is prepared to meet a specific patient's requirements. Sounds like compounded medications so far, right? Well the difference is that these are "manufactured" in large quantities prior to the receipt of individual prescriptions and can be provided to other pharmacies for dispensing (resale) to their individual patients. In the US, this is currently considered "manufacturing" and not compounding, as we cannot compound for resale.

There are many compounded medications in the US that are routinely and very widely prescribed, compounded, and dispensed. Think of all the discontinued drugs that could continue to be provided which large pharmaceutical companies are no longer interested in due to lack of economic incentives. Also, there are pediatric formulations that are desperately needed but, again, not available due to economics. We already have quite a number of compounding pharmacies that do extensive compounding of large quantities, i.e., they have many, many patients. For these facilities, it may be beneficial to be able to compound or "manufacture" large quantities of select formulas and provide them to other pharmacies for dispensing.

Also, there are some pharmacies that have opted out of compounding, both nonsterile and sterile, because of the costs, both perceived and real, of becoming compliant with the United States Pharmacopeia Standards. If these pharmacies could be served by the "Specials" compounding pharmacies, their patients could continue to be provided with compounded medications along with local patient counseling services. In other words, the pharmacists could receive compounded prescriptions from the "Specials" compounding or manufacturing pharmacies and dispense them (resell them) as they do commercially manufactured products.

Are there sufficient "standardized formulas" with documented stability, etc. that might be considered for this type of compounding? In the UK, it is estimated that there are between 3,000 and 4,000 different formulations being manufactured (compounded) somewhere in the NHS manufacturing units. More on this subject next week...

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

In the CompoundingToday Newsletter of November 4, 2005, Volume 2, Issue 42, "Letter from the Editor" entitled "Editorial: Commercially Manufactured Bioidentical Hormones", there is an error in the second paragraph, in the parenthetical statement. It should read "(Estriol may not be commercially available now but has been in the past.)" The original states estrone. Sorry for the error.

Even though we will discuss "specials" next week, there is a good article on the following website for further reading that was published in the Pharmaceutical Journal, by the Royal Pharmaceutical Society. The website is: www.pjonline.com/pdf/features/pj_20051217_specials.pdf. We are also preparing a comprehensive article on this topic for a future issue of IJPC.

More than 30 articles were added to the literature search database this week on the topic of palliative care. Here is a sampling:

• Levy MH, Samuel TA. Management of cancer pain. Semin Oncol 2005; 32(2): 179-193.
• Lossignol DA, Obiols-Portis M, Body JJ. Successful use of ketamine for intractable cancer pain. Support Care Cancer 2005; 13(3): 188-193.
• Lussier D, Huskey AG, Portenoy RK. Adjuvant analgesics in cancer pain management. Oncologist 2004; 9(5): 571-591.
• Mercadante S. Cancer pain management in children. Palliat Med 2004; 18(7): 654-662.
• Muller-Bush HC, Lindena G, Tietze K et al. Opioid switch in palliative care, opioid choice by clinical need and opioid availability. Eur J Pain 2005; 9(5): 571-579.
• Negro S, Martin A, Azuara ML et al. Stability of tramadol and haloperidol for continuous subcutaneous infusion at home. J Pain Symptom Manage 2005; 30(2): 192-199.

...on the Compounders Network List each week. This week these pharmacists talked about:

• Levothyroxine in PLO for a Parrot and Cat
• Negatan for aphthous ulcers
• Vaseline Hair Tonic
• Letters to patients and media regarding BHRT

There are now more than 330 SOPs on CompoundingToday.com. The latest one added is:

• SOP 1.082 -Talc USP Suppliers and Gamma Irradiation Services

Too Much DHEA?
Health products and supplements are often "tested" on healthy adult men. Perhaps that's how the recommended dosage of dehydroepiandrosterone (DHEA) was determined. Most commercial brands of this important prohormone are available in 25- or 50-mg doses that are to be taken once daily.

Either dosage works fine for women - for a few days or weeks. Then, adverse effects begin to develop, and some women even experience a masculinizing reaction to treatment. Why? Perhaps a daily dose of 25 to 50 mg is just too much DHEA for women. After all, DHEA is androgenic and is converted in the body to testosterone.

John R. Lee, MD,¹ a noted expert on bioidentical hormone replacement therapy, suggested that women take a single 5-mg dose of DHEA at bedtime. That small amount, coupled with a properly balanced dose of progesterone, can be helpful in resolving some of the more common symptoms of menopause such as hot flashes, foggy thinking, etc.

Some women may experience sleep irregularities when they take DHEA at bedtime because their hormone levels "spike" 4 to 6 hours after taking that supplement. To avoid this adverse effect, a woman can take her dose of DHEA in the morning so that any spike in hormone levels will occur during waking hours.

Some commercial supplement manufacturers offer a 5-mg strength of DHEA. If you have difficulty finding that dose, contact your local compounding pharmacist. He or she has access to pure DHEA powder and can prepare a customized supplement for you in any dose.

1. Lee JR, Hanley J, Hopkins V. What Your Doctor May Not Tell You About Premenopause: Balance Your Hormones and Your Life from Thirty to Fifty. NY, NY: Warner Books; 1999:157. Availible for $5.99 from Amazon.com

Alabama Pharmacist Charged in Drug Fraud Scheme
Read the complete article at http://www.pharmalive.com/News/Index.cfm?articleid=305607

New Mini-Liquidose^TM Labels
EPS� is pleased to release its latest addition to its LiquiDose label line... the NEW MINI- LIQUIDOSE LABEL.

The MINI LiquiDose label was designed primarily for use with syringes and ampules. When used with our new MILT, Version 2.2 by Medi-Dose software, this 1/2" x 1 1/4" label can accommodate 3 lines of text...with up to 25 characters per line. And, if bar coding is a necessity, MINI LiquiDose can contain 2 lines of text and a complete bar code... plus packager's identification and beyond-use dating!

Mini LiquiDose can be imprinted with ANY laser or ink jet printer---no new equipment is needed! The labels have been sized correctly so they won't occlude syringe markings or fluid levels or tear away from the syringe!

For more information, please view the LiquiDose page on our web site at www.medidose.com. Of course, please feel free to contact us at any of the numbers listed below.
Phone: (800) 523-8966 or (215) 396-8600

HollisterStier Laboratories to Build Compounding Suite
Spokane-based HollisterStier Laboratories has signed a contract to build a new compounding suite for products being developed by MGI Pharma, Inc.

MGI Pharma, based in Minneapolis, develops an assortment of acute-care pharmaceutical products, include several that target cancer. It's worked in the past with HollisterStier, said Janelle Jovick, spokeswoman for the Spokane company.

Terms of the contract will not be disclosed, said Jovick.

The agreement calls for HollisterStier to build a 1,000-square-foot compounding suite at its north Spokane manufacturing facility.

Moving Large Items
Ever need to move or "scoot" large boxes or items around the floor of the pharmacy? Why not use the commercially available furniture moving disks? These are generally round-shaped disks about 6 to 8 inches in diameter, made or coated with a slick material like Teflon or silicon. Simply place these re-usable disks under the object to be moved (it may take several depending on the size of the object), and then scoot the object where it is needed.