Editorial: Ethiopia Project

The following e-mail was received yesterday from a very close friend of mine, who is from Spain and with whom I visit every year. He is part of a compounding pharmacy organization that set up a facility to provide compounded medications in Ethiopia. Below is his e-mail which I think you will find interesting:

Dear Loyd,

I am back from Ethiopia. I feel tired but very happy, as everything has turned out in the best possible way. In Gambo Rural Hospital, 250 km south from Addis Abeba you can find today a pharmaceutical compounding laboratory fully equipped, according to international quality standards, with new equipment and SOPs for every activity, producing a list of 64 formulas including antiseptic solutions, creams and ointments, adult capsule treatments and paediatric syrups!

In two weeks, a team of 7 Spanish pharmacists, we have set up a compounding laboratory from scratch: a) electric wires and plugs, b) plumbery and plastic painting of walls, c) lab furniture, d) lab equipment (2 unguators, 4 precision balances, thermostatic bath, magnetic stirrers, beakers, cylinders, etc), e) protocolization of processes (SOPs), adapted from IJPC and ASHP guidelines for in-house manufacturing in hospital pharmacies, f) standardization of a list of 64 basic formulas that will be produced on a regular basis, g) PowerPoint talks with the medical wards and other hospital staff guarantee coordination of the project, h) interviews and training of technical staff from Ethiopia to work in the laboratory... That is, a huge programme that has taken almost 2 years of plannification and 15 days of execution, with long working days and very little sleep!

With respect to the continuity of the project over time, two Spanish pharmacists will stay in Gambo until June, when they will be replaced by other 1 or 2 pharmacists for another six month period. We are educating Ethiopian staff for the routine laboratory work. And a group of 4 pharmacists (including me and Mart�n Mu�oz, president of AEFF) will be the "Scientific Committee" that will give technical support to the pharmacists in Gambo.

As we discussed before leaving for Ethiopia, if you are interested I can write an article on this project for IJPC and send some graphic material. I think that it is the very first time that pharmaceutical compounding is used in a cooperation project in the third world. Also, after our experience in Ethiopia, we are fully convinced that this lab will play a key role in the quality of life of the patients at Gambo Hospital and are already thinking about exporting this experience to other hospital with similar needs in developing countries.

Regards,
Diego

www.farmaciamarro.com

Also, for additional information, please visit the website of the Foundation: www.fundacionelalto.org.

Editors Note: Diego Marro, PhD, is Executive Vice President of the International Society of Pharmaceutical Compounding. Visit www.isphc.com for more information on the Society.


Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief

Last friday, the FDA proposed guidelines that would allow drug and device manufacturers to provide physicians with copies of articles that discuss off-label uses of a drug. FDA also proposed that drug companies do not have to provide adequate testing for the off-label or unapproved use that is discussed in the article. Advocates state that physicians would have access to credible scientific data that could potentially save lives; however, critics state that allowing this could compromise patient safety and result in unreliable research on the benefits of drugs and devices. Company-sponsored research may be an issue to follow in the future.

This week, it first came to light that the situation with Baxter's heparin source in China had never been inspected by the FDA. The next day, it was announced that the FDA inspectors actually did an inspection, but it was the wrong facility. Meanwhile, APP is gearing up to provide heparin injection to the marketplace while Baxter recovers.

As you may know, the USP's General Chapter <797> has been revised and will become official on June 1, 2008. The USP is offering a series of Webinars and Workshops to educate compounding professionals on the newly revised standard so they can appropriately interpret and implement the standard. (See www.usp.org/hottopics/generalChapter797.html?hlc for full details on these programs.)

The Webinars will provide direct dialogue with two compounding experts and ample time to address questions related to the standard. The Workshops will provide added interaction plus hands-on demonstrations related to environmental monitoring, contamination control, and aseptic testing.

Given the increased emphasis on patient safety, it's critical that healthcare practitioners and compounding facilities understand and implement best practices. Take advantage of this unique opportunity and plan to participate in one or more of these programs. Go to: www.usp.org/hottopics/generalChapter797.html?hlc

The Society of Veterinary Hospital Pharmacists are supporting the USP's standards for compounding preparations for veterinary formulations and supporting the use of the Pharmacists' Pharmacopeia and the United States Pharmacopeia-National Formulary. Visit the site (www.svhp.org/) for more information.

There are a lot of opportunities for pharmacists to serve in humanitarian and mission projects around the world. Many U.S. pharmacists travel overseas each year to help in various countries. Organizations like Feed the Children also have a great impact with food and medicines internationally.

Those listings in bold are regular advertisers and supporters of the International Journal of Pharmaceutical Compounding.

Correction: Last week's newsletter listed an incorrect URL to the web site of Spectrum Pharmacy Products. The correct URL is www.spectrumrx.com. We apologize for any inconvenience this may have caused.

Hand-to-Hand Sanitizing!
With all the cases of flu going around, display hand sanitizing products close to checkout registers and close to the pharmacy and take the opportunity to educate patients on the transmission of flu by hand contact, sneezing into the hand, etc. If patients cannot wash with soap and water, the hand sanitizing products work well. To illustrate the spread of a sneeze, fill a nasal spray bottle with water and spray it; kids especially do not know that sneezing and coughing spread disease and this is a good object lesson.