Brought to you by the International Journal of Pharmaceutical Compounding
December 30, 2004 Volume 1, Issue 6
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Letter from the Editor

The Science and Technology of Pharmaceutical Compounding
�..Worldwide (ISPhC)
Loyd V. Allen, Jr., Ph.D

Although discussed at various meetings in Spain and Portugal over the last several years, discussions were held in earnest over a year ago at a major compounding pharmacy meeting in Pontevedra Spain at the VIII CONGRESO CIENTIFICO of the Asociacion Espanola de Farmaceuticos Formulistas (ACF2, Spanish Association of Pharmaceutical Compounding). Individuals from many countries (Spain, Portugal, Belgium, Germany, Brazil, Netherlands, etc.) have expressed interest in the formation of the new scientific organization devoted to pharmacy compounding. Due to the efforts of many, especially compounding pharmacists in Spain and Portugal, the new International Society of Pharmaceutical Compounding (ISPhC) was officially constituted on November 13, 2004 in Ciudad Real, Spain where the First International Congress on Pharmaceutical Compounding was held.

The need was apparent and had been established for international cooperation and sharing of scientific and technical pharmaceutical compounding information by those from many countries. Pharmacists have similar opportunities and problems; providers of compounding equipment, supplies and chemicals have similar opportunities and problems; academicians from different countries have similar opportunities and problems. Many academicians from throughout the world wish to be involved in pharmaceutical compounding (medical as well as pharmacy schools) and this is a great opportunity. Think about where much of the equipment and chemicals are sourced that is used in pharmaceutical compounding; much is from countries throughout the world. Also, there is some unique equipment used in different countries that have application in the U.S.

The science and technology of compounding crosses borders all over the world. One learns much from interaction with those from other countries. The IJPC listerv is an excellent example with daily problem-solving communication from pharmacists from over 30 countries throughout the world. Think what could happen if you started attending the various scientific Congresses and meetings on Pharmaceutical Compounding in countries throughout the world! Every meeting I attend is a new learning experience with much valuable information obtained. True, every country has their own individual political and governmental situations with which to deal; but, the need for and the desire for the compounding of quality preparations is prevalent in all countries.

International travel is, in many cases, less expensive than travel within the U.S. In other words, one can often fly to Europe for less than the cost of a ticket to some locations within the U.S. These meetings have interpreters for the different languages and the interaction and friends that are made are really appreciated and enjoyed. Experiencing different cultures with pharmacist-friends is quite an experience, as well as the sight-seeing opportunities that may involve museums containing pharmacy artifacts that are several hundred years old.

ISPhC is addressed in Madrid Spain, Porto Portugal and New York, NY. The elected trustees are Renaat Kinget from Leuven, Belgium; Marisol Lopez from San Juan, Puerto Rico; Aldo Mario Naddeo from Aires, Argentina; Rafael Padilla Papaceit from Nieuwerker a/d ljssel, The Netherlands; Rafael Puerto Cano from Madrid, Spain; Vania Regina de Sa from Heliopolis, Belo Horizonte, Brazil and Luis Solorzano from Medellin, Colombia and Gerhard Zueck from Knittlingen, Germany. Current officers include Loyd V. Allen, Jr., as President (USA), Diego Marro as Executive Vice-President (Spain) and Carlos Mauricio Barbosa (Portugal) as Treasurer.

ISPhC is planning on having biennial meetings; the second is tentatively scheduled for Brazil at the time of the FIP meeting in 2006. The new website of ISPhC is: www.isphc.com. We have a lot to learn and we have a lot to share; join in and enjoy the world of pharmaceutical compounding.

 
Abstracts added to CompoundingToday.com

All of these articles feature sterility and cleanroom design.

  • Akers MJ, Wright GE, Carlson KA. Sterility testing of antimicrobial-containing injectable solutions prepared in the pharmacy. Am J Hosp Pharm 1991; 48(11): 2414-2418.
  • Allan EL, Barker KN, Severson RW, Lane JM, Wilson JM, Mangum DA. Design and evaluation of a sterile compounding facility. Am J Health Syst Pharm 1995; 52(13): 1421-1427.
  • Arnold JF, Price JM. A method for demonstrating appropriate environmental protection for capping aseptically filled and plugged vials. PDA J Pharm Sci Technol 2003; 57(6): 425-428.
  • Avis KE, Levchuk JW. Special considerations in the use of vertical laminar-flow workbenches. Am J Hosp Pharm 1984; 41(1): 81-87.
  • Beasley R, Fishwick D, Miles JF, Hendeles L. Preservatives in nebulizer solutions: risks without benefit. Pharmacotherapy 1998; 18(1): 130-139.
  • Chandler SW, Trissel LA, Wamsley LM, Lajeunesse JD, Anderson RW. Evaluation of air quality in a sterile-drug preparation area with an electronic particle counter. Am J Hosp Pharm 1993; 50(11): 2330-2334.
  • Chu PI, Doyle D. Development and evaluation of a laboratory-scale apparatus to simulate the scale-up of a sterile semisolid and effects of manufacturing parameters on product viscosity. Pharm Dev Technol 1999; 4(4): 553-559.
  • Clarke AJ, Watkins RE. Nitroglycerin injection manufactured by a hospital pharmacy. Am J Hosp Pharm 1985; 42(7): 1542-1546.
  • Combeau D, Rey JB, Fontan JE, Nouaille-Degorce B, Brion F. Baxa MicroMacrocompounder for parenteral nutrition solutions in a pediatric hospital. PDA J Pharm Sci Technol 1999; 53(5): 226-230.
  • Condella F, Baptista RJ, Griffin RE. More efficient system for preparing total parenteral nutrient solutions. Am J Hosp Pharm 1983; 40(12): 2146-2149.
  • Crawford SY, Narducci WA, Augustine SC. National survey of quality assurance activities for pharmacy-prepared sterile products in hospitals. Am J Hosp Pharm 1991; 48(11): 2398-2413.
  • Dirks I, Smith FM, Furtado D, White SJ, Godwin HN. Method for testing aseptic technique of intravenous admixture personnel. Am J Hosp Pharm 1982; 39(3): 457-459.
  • Doss HL, James JD, Killough DM, Snodgrass GL. Microbiologic quality assurance for intravenous admixtures in a small hospital. Am J Hosp Pharm 1982; 39(5): 832-835.
  • Driscoll DF. Compounding TPN admixtures: then and now. JPEN J Parenter Enteral Nutr 2003; 27(6): 433-438.
  • Favier M, Hansel S, Bressolle F. Preparing cytotoxic agents in an isolator. Am J Hosp Pharm 1993; 50(11): 2335-2339.
  • Fitch DP, Hall KW. Survey of sterile product compounding practices in Canadian hospital pharmacies. Can J Hosp Pharm 1993; 46(6): 249-260.
  • Flynn EA, Pearson RE, Barker KN. Observational study of accuracy in compounding i.v. admixtures at five hospitals. Am J Health Syst Pharm 1997; 54(8): 904-912.
  • Frieben WR. Control of the aseptic processing environment. Am J Hosp Pharm 1983; 40(11): 1928-1935.
  • Grom JA, Bander LC. Compounding of preservative-free high-concentration morphine sulfate injection. Am J Health Syst Pharm 1995; 52(19): 2125-2127.
  • Hung JC. The potential impact of USP general chapter <797> on procedures and requirements for the preparation of sterile radiopharmaceuticals. J Nucl Med 2004; 45(6): 21N-26N.
  • Hung JC. USP general chapter <797> pharmaceutical compounding--sterile preparations. J Nucl Med 2004; 45(6): 20N, 28N.
  • Kastango ES, Bradshaw BD. USP chapter 797: Establishing a practice standard for compounding sterile preparations in pharmacy. Am J Health Syst Pharm 2004; 61(18): 1928-1938.
  • Kay BG, Boyar RL, Raspante PS. Designing a modern hospital pharmacy. Am J Hosp Pharm 1986; 43(2): 339-343.
  • Larrouturou P, Huchet J, Taugourdeau MC. Centralized preparation of hazardous drugs. A choice between isolator and laminar airflow. Pharm Weekbl Sci 1992; 14(3): 88-92.
  • Ledebo I. On-line preparation of solutions for dialysis: practical aspects versus safety and regulations. J Am Soc Nephrol 2002; 13 Suppl 1: S78-83.
  • Levchuk JW, Nolly RJ, Lander N. Method for testing the sterility of total nutrient admixtures. Am J Hosp Pharm 1988; 45(6): 1311-1321.
  • Madsen RE. Real compliance and how to achieve it. PDA J Pharm Sci Technol 2001; 55(2): 59-64.
  • McKinnon BT, Avis KE. Membrane filtration of pharmaceutical solutions. Am J Hosp Pharm 1993; 50(9): 1921-1936.
  • Morris AM, Schneider PJ, Pedersen CA, Mirtallo JM. National survey of quality assurance activities for pharmacy-compounded sterile preparations. Am J Health Syst Pharm 2003; 60(24): 2567-2576.
  • O'Neal BC, Schneider PJ, Pedersen CA, Mirtallo JM. Compliance with safe practices for preparing parenteral nutrition formulations. Am J Health Syst Pharm 2002; 59(3): 264-269./li>
  • Pluhator-Murton MM, Fedorak RN, Audette RJ, Marriage BJ, Yatscoff RW. Extent of trace-element contamination from simulated compounding of total parenteral nutrient solutions. Am J Health Syst Pharm 1996; 53(19): 2299-2303.
  • Santell JP, Kamalich RF. National survey of quality assurance activities for pharmacy-prepared sterile products in hospitals and home infusion facilities--1995. Am J Health Syst Pharm 1996; 53(21): 2591-2605.
  • Scala SM, Anderson E Jr. Activity analysis of sterile products technicians. Hosp Pharm 1992; 27(12): 1089-1090, 1092, 1094-1095.
  • Sebastian G, Thielke TS. Work analysis of an admixture service. Am J Hosp Pharm 1983; 40(12): 2149-2153.
  • Sundaram S, Auriemma M, Howard G Jr, Brandwein H, Leo F. Application of membrane filtration for removal of diminutive bioburden organisms in pharmaceutical products and processes. PDA J Pharm Sci Technol 1999; 53(4): 186-201.
  • Tillett L. Barrier isolators as an alternative to a cleanroom. Am J Health Syst Pharm 1999; 56(14): 1433-1436.
  • Wright B. Detailed planning to upgrade the sterile-products preparation area to a cleanroom. Am J Health Syst Pharm 1995; 52(16): 1750, 1753-1755.
 
Compounding Pharmacy in the News
New origin, same worry for menopause hormones
BY JUDY PERES
Chicago Tribune

CHICAGO - (KRT) - Menopausal women, scared off traditional hormone therapy by studies showing the pills cause breast cancer and heart disease, are seizing on another approach: "bioidentical" hormones. A recent best-selling book gave a huge impetus to bioidentical hormones, saying the "natural" substances can cure the insomnia, irritability and indifference to romance that often accompany menopause.
For full story, http://www.ledger-enquirer.com/mld/ledgerenquirer/news/nation/10492458.htm

 
DUSA Pharmaceuticals Files Suit Against Compounding Pharmacy

WILMINGTON, Mass.--(BUSINESS WIRE)--Dec. 27, 2004--DUSA Pharmaceuticals, Inc. (NASDAQ NMS:DUSA) reported today that it has filed a lawsuit against New England Compounding Center (NECC) of Framingham, Massachusetts alleging violations of U.S. patent law. The suit has been filed in the United States District Court in Boston, Massachusetts.
For full story, http://home.businesswire.com/portal/site/google/index.jsp?ndmViewId=news_view&newsId=20041227005160&newsLang=en

 
 
New Products

UnguatorAssist
RS Software is pleased to announce UnguatorAssist, our newest addition to the pharmacy software suite. This software is designed to automate the operation of its companion, the Unguator 2000 Electro mortar and pestle. UnguatorAssist along with the Unguator 2000 prepares everything from reaction mixes to high-speed homogenizations thanks to its flexible speed range of 120 rpm to 2,500 rpm. Pre-programmed mixing parameters automate preparations making compounding a breeze. If there is not a preprogrammed parameter, manual programming for formulation mixing is optional and very user friendly. The computer-assisted design allows for automatic recipe saving, customization, and retrieval. Together this duo allows you to print labels, results, log entries, and other types of documentation. This new addition to our family has made compounding more consistent and efficient than ever before for your pharmacy.

For More Information:
RS Software 877-290-7774
Website : www.rssoftware.net..