"The addition of Compounding Today.com is fantastic. It is now my "one-stop" shopping for compounding information and it keeps getting better."

Linda F. McElhiney, PharmD, RPh
Compounding Pharmacist
Clarian Health Partners, Inc.

Editorial: Editorial: Orphan Drugs: Part II

Orphan drugs are not generally commercially available because of economics, insufficient market/use, commercial viability, and patent problems. Without the support of private industry or federal agencies, these compounds will not be fully tested and commercially marketed; this provides an opportunity of service for compounding pharmacies.

A New Drug Application required by the U.S. Food and Drug Administration (FDA) requires exhaustive research on the safety and effectiveness of a drug prior to commercial marketing. However, this is not economically feasible with orphan drugs. The questions that arise are: (1) Is all that testing really necessary for a limited number of patients?, and (2) What is the cost vs benefit vs risk for these patients?

Obviously, research or clinical studies are important and are needed. However, this requires money to do the research. If a pharmaceutical company spends the money for the research, they generally have little or no protection from other companies taking advantage and there is no guarantee of financial recovery. Thus, many orphan drugs remain a "secret" while the creators try to find them a "home."

If the FDA approves an orphan drug and the company decides to market it, then it should be available through normal channels. If not FDA approved, the sponsor of the orphan drug may make it available on a compassionate use basis. Pharmacists may be able to provide the drug through compounding, as appropriate.

Compounded orphan drug examples over the past couple of years have included 4-aminosalicylic acid for ulcerative colitis in patients intolerant to sulfasalasine, intravenous acetylcysteine for moderate to severe acetaminophen overdose, albuterol to prevent paralysis caused by spinal cord injury, baclofen for intractable spasticity caused by multiple sclerosis or spinal cord injury, bromhexine for the treatment of mild to moderate keratoconjunctivitis sicca in Sjogren syndrome, caffeine in the treatment of apnea of premature infants, and calcium gluconate solution and gel as a wash for hydrofluoric acid spills on human skin.

Additional examples include cascara sagrada fluid extract for oral drug overdosage to speed lower bowel evacuation, clonidine epidural injection as adjunctive pain therapy in cancer patients tolerant or unresponsive to intraspinal opiates, cromolyn sodium 4% ophthalmic solution for vernal keratoconjunctivitis, dimethyl sulfoxide topical treatment for the prevention of soft tissue injury following extravasation of cytotoxic drugs, fampridine in the treatment of multiple sclerosis and spinal cord injuries, glycerin to decrease intracranial hypertension and/or alleviate cerebral edema in patients who may benefit from osmotherapy, hydroxyurea in the treatment of sickle cell anemia as shown by the presence of hemoglobin S, short chain fatty acid solution in the active phase of ulcerative colitis, sterile talc in the treatment of malignant pleural effusion, and tranexamic acid in congenital coagulopathies in patients undergoing surgical procedures.

The process of developing an orphan drug involves an assessment of the need, formulation considerations, market considerations, and timing. Generally, the FDA approval time is shorter than for regular drugs.

When compounding is appropriate, considerations involve the availability of the bulk chemical, formulation characteristics, stability, dosage form selection, and patient education and counseling.

As mentioned in Part 1 of this 2-part series, there have been 1,494 products designated as orphan products and only 268 approved products marketed. Those unmarketed products may be an option for patients that may need the support of a physician and a compounding pharmacist to provide needed but unavailable therapy.

Compounding orphan drug products is routine but must be done appropriately, following all necessary standards and regulations. A good list of orphan drug products is contained in the current issue of Facts and Comparisons.

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

Finding the perfect Standard Operating Procedure for your pharmacy has gotten a lot easier. CompoundingToday.com has more than 330 SOPs that can be downloaded and customized for your particular purposes and needs. These SOPs can be searched in two ways: 1) by category or 2) by keyword search.

There are 13 SOP categories to choose from including:

• Administration
• Facility and Environment Maintenance
• Facility - Cleaning
• Equipment
• Personnel
• Compounding Procedures
• Quality Assurance
• Inventory Control
• Reference Documents
• Veterinary Compounding
• Miscellaneous

There is also a keyword search to help find SOPs. If you are looking for all of the SOPs related to chemicals, type in the word "chemical" and the list of SOPs from all categories with the word "chemical" in the title appears with a direct link.

The twelfth electronic quick click reference tool will be added to CompoundingToday.com next week. This is an exceptionally practical tool for your sterile compounding needs. It will provide: 1) information on which disinfectant agent is best for the type of surface or equipment in your clean room; 2) the main characteristics and applications of the disinfectant; and 3) the main brand names of disinfectants used in clean rooms. Get access to this tool and 11 others when you join www.CompoundingToday.com!

Did you know you can purchase Ebay items through CompoundingToday.com? Ebay sells hundreds of thousands of items. Instead of spending hours searching for just the thing you want, go to www.compoundingtoday.com and view the pharmacy related items currently for sell on Ebay. Today you can view and purchase a 200-plus mortar & pestle collection. Check it out at www.compoundingtoday.com.

This week on CompoundingToday.com's literature search database more than 35 articles were added on the topic of sports medicine. Here are a few samples:

• Mason L, Moore RA, Edwards JE et al. Topical NSAIDs for chronic musculoskeletal pain: Systematic review and meta-analysis. BMC Musculoskelet Disord 2004; 5: 28.
• Paoloni JA, Appleyard RC, Nelson J et al. Topical glyceryl trinitrate application in the treatment of chronic supraspinitus tendinopathy: A randomized, double-blinded, placebo-controlled clinical trial. Am J Sports Med 2005; 33(6): 806-813.
• Paoloni JA, Orchard JW. The use of therapeutic medications for soft-tissue injuries in sports medicine. Med J Aust 2005; 183(7): 384-388.
• Spacca G, Cacchio A, Forgacs A et al. Analgesic efficacy of a lecithin-vehiculated diclofenac epolamine gel in shoulder periarthritis and lateral epicondylitis: A placebo-controlled, multicenter, randomized, double-blind clinical trial. Drugs Exp Clin Res 2005; 31(4): 147-154.
• Tokish JM, Kocher MS, Hawkins RJ. Ergogenic aids: A review of basic science, performance, side effects, and status in sports. Am J Sports Med 2004; 32(6): 1543-1553.

Last week, Dana Reed-Kane, her husband Mike and I had the opportunity of attending and presenting lectures at the X Congreso De Formulacion Magistral (Tenth Congress of Pharmaceutical Compounding) in Valladolid, Spain. There were about 230 participants and the sessions were very interesting and informative. Dana presented "Bio-Identical Hormone Replacement Therapy for Men and Women. A Focus on Compounding" and I presented a session on "New Standards for Sterile Compounding in the USP."

This is the same meeting that Linda McElhiney presented last year on "Compounding for Pediatric Patients." It is a great experience for anyone enjoying international travel and learning more about pharmacy in other countries.

An interesting observation is that pharmacists in Spain CANNOT compound using commercial products; they must use bulk chemicals. Somewhat the opposite of our regulations for compounding for veterinary patients where commercial products are required, with few exceptions!

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

Novartis Recalls Nonprescription Eye Medications

BETHESDA, MD, 23 November 2005 - Novartis Ophthalmics has recalled specific batches of two nonprescription hydroxypropyl methylcellulose products amid concerns that the medications may not be sterile.

The recall affects lots Z12468 (expiration date, 1/2006), Z12900 (expiration date, 4/2006), and Z13161 (expiration date, 5/2006) of GenTeal Gel 10 mL and lots Z12912 (expiration date, 3/2006) and Z13314 (expiration date, 6/2006) of GenTeal Gel 3.5 mL. About 142, 500 tubes of these lots were distributed from March to November 2004, according to a company press release posted on FDA's Web site.

Also recalled were GenTeal GelDrops 15 mL, lot 51139 and GenTeal GelDrops 25 mL, lot 51283, both with an expiration date of 7/2007. About 12,000 dropper bottles from these lots were distributed in October 2005, the company stated.

Novartis said that the recalled lots were made under contract by another manufacturer. According to Novartis, some samples of the GenTeal gel were found to contain mold, prompting the recall of that product. The recall of the GelDrop formulation is being conducted because Novartis cannot guarantee that the product is sterile.

Consumers who purchased the affected lots should call Novartis Ophthalmics at 866-393-6336 for additional information.

-Kate Traynor

EPS� Press-In Bottle Adapters

EPS®, INC. is pleased to announce yet another addition to its growing line of medication dispensing aids... the EPS Press-In Bottle Adapter.

The new EPS Press-In Bottle Adapter lets you easily dispense liquids from stock bottles into oral syringes. They're available in three different sizes to fit virtually all standard prescription bottles.

Just press the adapter into the bottle's opening and attach your oral syringe to the adapter's port. Then withdraw your dose of medication from the bottle. It's that simple! They make any bottle into a ready mediation reservoir!

EPS's Press-In Bottle Adapters are produced in 24 mm, 28 mm and 33 mm sizes. And they even fit most TampAlerT� and EPS's Prescription Bottles. Plus the EPS Press-In Bottle Adapters can be used with EPS's line of Oral Syringes too (available in 1, 3, 6 and 10 ml---in both clear and ultraviolet inhibitant amber). Packaged in bags of 25, EPS Press-In Bottle Adapters are ready for immediate shipment. Quantity pricing is available on as few as 5 packs.

For samples or more information, please contact us at
Phone: 800-523-8966, 215-396-8600
Fax: 800-323-8966, 215-396-6662
E-Mail: info@medidose.com
Web Site: www.medidose.com

Retrieving Those Stir Bars
It's a good idea to remove magnetic stir-bars from beakers, flasks, etc. prior to placing them in a dishwasher. This is easily accomplished by either purchasing a "stir bar retriever" or using a screen, about 10 or 20 mesh, to pour the contents of the beaker or flask through into the sink. The screen will retain the stir-bars. Other items that work would be a sieve or a small sifter; even a tea-strainer or a flour sifter as used in the kitchen can be used if desired.