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Editorial: Orphan Drugs: Part I

The U.S. Office of Orphan Products Development is charged with the responsibility of promoting the development of products that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions. The office was created in 1982 and interacts with the medical and research communities, professional organizations, academia, the pharmaceutical industry, and the rare disease groups. It administers the major provisions of the Orphan Drug Act which provides incentives for sponsors to develop products for rare diseases. More than 200 drugs and biological products for rare diseases have been brought to market since 1983.

Orphan drugs are designated for a "rare disease or condition", which is any disease or condition which (A) affects less than 200,000 persons in the U.S., or (B) affects more than 200,000 in the U.S. and for which there is no reasonable expectation that the cost of developing and making available in the U.S. a drug for such disease or condition will recover from sales in the U.S. of such drug. Application is made by a manufacturer or sponsor of a drug.

Since its inception, there have been 1,494 products designated as orphan products and 268 approved products marketed. During the first 8 months of 2005, there were 79 products designated as orphan drugs and three approved products marketed.

Looking at the list of products designated during 2005, there are a number of new drugs, etc. as would be expected. However, the list includes the following items as well:

• Paromomycin
• Alfentanil
• Arsenic trioxide
• Capsaicin
• Clotrimazole
• Digitoxin
• Hydroxyurea
• Mannitol
• Misoprostol
• Myo-inositol
• Nitric oxide
• Sodium phenylacetate/sodium benzoate
• Tacrolimus
• Tramadol hydrochloride
• Valproic acid, sodium

Drugs don't have to be new chemical entities for consideration for orphan drug status, as is evidenced by the above list. Next week, we'll continue looking at "Orphan Drugs" and see what role compounding can play.

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

There are 334 SOPs on CompoundingToday.com including this one that has just been added:

• 6.003.1 - Brass Sieves-Use

Download and customize the SOPs you need to be compliant at www.compoundingtoday.com/SOP

Need to narrow your search to compounding? Start at CompoundingToday.com's literature search database. There you will find more than 2300 citations and abstracts from 700 publications all related to compounding. This week more than 30 citations representing compatibility and stability studies were added to the database. Here is a sampling of some of those studies:

• Blondeel S, Pelloquin A, Pointereau-Bellanger A et al. Effect of freezing on stability of a fortified 5 mg/mL ticarcillin ophthalmic solution. Can J Hosp Pharm 2005; 58(2): 65-70.
• DiGiacinto JL, Olsen KM, Bergman KL et al. Stability of suspension formulations of lansoprazole and omeprazole stored in amber-colored plastic oral syringes. Ann Pharmacother 2000; 34(5): 600-605.
• Johnson CE. Stability of pantoprazole in 0.9% sodium chloride injection in polypropylene syringes. Am J Health Syst Pharm 2005; 62(22): 2410-2412.Li X, Blondino FE, Hindle M et al. Stability and characterization of perphenazine aerosols generated using the capillary aerosol generator. Int J Pharm 2005; 303(1-2): 113-124.
• McCarron PA, Donnelly RF, Andrews GP et al. Stability of 5-aminolevulinic acid in novel non-aqueous gel and patch-type systems intended for topical application. J Pharm Sci 2005; 94(8): 1756-1771.

This week compounding pharmacists worldwide discussed a variety of topics. Here are some of the headings:

• Creative ideas for holiday gifts for physicians
• Compounder in Brazil for a patient traveling there
• Syringe lubrication issues
• Topical nitrogen mustard (meclorethamine)

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

NCPA Resolution Addresses Compounding
The National Community Pharmacists Association (NCPA) House of Delegates approved a number of resolutions, including one relating to Pharmacy Compounding, at NCPA's 107th Annual Convention and Trade Exposition. We salute NCPA and its members for this bold statement in support of pharmacy compounding. Click here to read the resolution.

Health Care Logistics Introduces 200+ New Solutions in "Lamb Chop," the 2006 Catalog
Health Care Logistics (Circleville, Ohio) has released Lamb Chop, the company's 2006 catalog featuring its signature line of unique and hard-to-find items for virtually every facet of the health care industry. More than 200 new solutions join HCL's inventory of 6,000+ items, most all of which are included in this full-color annual resource guide. Detailed descriptions, photo illustrations and suggestions for multiple uses make it easier than ever for customers to find the right product right away. As always, comic relief is close by with HCL's entertaining blend of artwork and interactive extras.

For more information about the 2006 Lamb Chop catalog or to request a free copy, call 800-848-1633 or visit HCL online at www.HealthCareLogistics.com.

EPS Resealable and Ultraviolet Inhibitant Bags
EPS®, INC. is pleased to announce we have widened our growing line of resealable and Nultraviolet UV inhibitant bags. We now stock a full array of imprinted bags in a variety of sizes for the protection and transfer of medication. They range from 2" x 2" to 13" x 15". They're available clear, with white writing blocks or with a variety of color imprints. Freeze, IV, STAT, Refrigerate, Return to Pharmacy and PRN are just a few of the many printed bags we offer. We also stock resealable narcotic return envelopes as well as chemotherapy, biohazard and laboratory specimen bags. All of these bags complement our popular assortment of Nultraviolet UV inhibitant bags. They're stocked from 2 ½" x 8 ½" to 11" x 18". All our bags are ready for immediate shipment. Of course, if you don't see what you need, please let us know and we'll make it for you. Resealable and Nultraviolet Bags by EPS.

To order or to request samples, please contact us at any of the numbers below.
www.medi-dose.com or Email: info@medidose.com

Tired of burned fingers from handling hot beakers, etc.?
Visit a gourmet cooking shop at the nearest mall and purchase one of the new thermal mitts. They appear to be made from a polymeric material that can easily be rinsed or washed. You might also investigate the new flexible, unbreakable, polymer "cake pans" that may have some applications where heat is required and it is not advisable to use metal. They are flexible and do not break like glass.