EDITORIAL
Home-based chemotherapy confronts pharmacists with stability and compatibility problems ~ H . Be~nen Most parenteral cytotoxic agents are reactive and chemically unstable compounds. This has been recognized for a long time by manufacturers and pharmacists. Many stability and compatibility data with recommendations are now available in package inserts and in the literature. However, the information provided by the pharmaceutical industry is restricted mainly to licensed regimens and other data are often limited to the circumstances in the clinic where the drugs are given as a bolus injection or short-term infusions, shortly after reconstitution and dilution. With the rapid emergence of prolonged continuous infusions and domiciliary chemotherapy programmes the currently available cytotoxic drugs are handled under other conditions than formerly. Home-based chemotherapy aims at the patient to receive parenteral anticancer drugs in his own home with a minimum of visits to the hospital. Pre-filled syringes or other medication reservoirs are delivered by the hospital (or community) pharmacist and, after home-coming, are usually stored in the refrigerator prior to administration. During ambulatory infusion the drug solutions may achieve temperatures of 34-37 ~ when worn under the patient's clothing. The reported stability and compatibility data are usually not related to these conditions. It is essential, however, that these data are available and generated under conditions identical to those in which the cytotoxics are packed, transported, stored and administered, with safe margins. It is obvious that knowledge on these matters is a prerequisite before home-based therapy can be put into practice. Microbiological aspects must also be considered and validation of the procedures should be included. It is doubtful whether all these aspects are
investigated sufficiently before a home-based chemotherapy programme starts. The enormous recent advances in the development of administration sets, filtration systems, catheters, venous access ports, etc., and the new materials from which these devices have been manufactured also demand specialized knowledge on, among other things, compatibility issues. In this Issue of PWS Dine and co-workers (p. 365) report the stability and compatibility of four anthracycline antitumour drugs during simulated conditions of prolonged infusions. Their results are of importance for current practice. Not only the drug itself but also the formulation can be the cause of incompatibility. As an example, the novel investigational anticancer drug taxol is formulated in a mixture of ethanol and Cremophor EL | (1:1). For infusions bags and lines without polyvinyl chloride (PVC) must be used because of the leaching of plasticizers by the surfacrant Cremophor EL | Protein drugs are gaining a more and more important place in the armamentarium of the medL cal oncologist and home-based therapies for interferons, interleukins, haematopoietic growth factors are gaining momentum. Their interaction and adsorption with a wide variety of surfaces of container materials and membrane filters are notorious. Adsorption of the proteins usually results in their loss and destabi]ization, which, of course, must be prevented. The new developments in home-based parenteral (chemo)therapy require profound pharmaceutical expertise and active involvement of pharmacists who investigate these issues. Pharmacists, pre-eminently, are the right persons to meet these exciting pharmaceutical challenges.
J.H. Beijnen: Department of Pharmacy, Slotervaart Hospital/Netherlands Cancer Institute, Louwesweg 6, 1066 EC Amsterdam, the Netherlands.
EDITORIAL
NOTICE
Last Issue of Pharmaceutisch Weekblad Scientific edition This Issue of Pharmaceutisch Weekblad Scientific edition (PWS) - Number 6, Volume 14 is the last that will be published. But PWS will not vanish. We are pleased to inform you this Journal will be published as of 1 January 1993
14(6) 1992
Pharmaceutisch Weekblad Scientific edition
under a new name: "Pharmacy World & Science." The first Issue of PWS will appear on 19 February 1993. In that first Issue we shall explain why and how this change of name and appearance was brought about.
337
Home-based chemotherapy confronts pharmacists with stability and compatibility problems ~ H . Be~nen Most parenteral cytotoxic agents are reactive and chemically unstable compounds. This has been recognized for a long time by manufacturers and pharmacists. Many stability and compatibility data with recommendations are now available in package inserts and in the literature. However, the information provided by the pharmaceutical industry is restricted mainly to licensed regimens and other data are often limited to the circumstances in the clinic where the drugs are given as a bolus injection or short-term infusions, shortly after reconstitution and dilution. With the rapid emergence of prolonged continuous infusions and domiciliary chemotherapy programmes the currently available cytotoxic drugs are handled under other conditions than formerly. Home-based chemotherapy aims at the patient to receive parenteral anticancer drugs in his own home with a minimum of visits to the hospital. Pre-filled syringes or other medication reservoirs are delivered by the hospital (or community) pharmacist and, after home-coming, are usually stored in the refrigerator prior to administration. During ambulatory infusion the drug solutions may achieve temperatures of 34-37 ~ when worn under the patient's clothing. The reported stability and compatibility data are usually not related to these conditions. It is essential, however, that these data are available and generated under conditions identical to those in which the cytotoxics are packed, transported, stored and administered, with safe margins. It is obvious that knowledge on these matters is a prerequisite before home-based therapy can be put into practice. Microbiological aspects must also be considered and validation of the procedures should be included. It is doubtful whether all these aspects are
investigated sufficiently before a home-based chemotherapy programme starts. The enormous recent advances in the development of administration sets, filtration systems, catheters, venous access ports, etc., and the new materials from which these devices have been manufactured also demand specialized knowledge on, among other things, compatibility issues. In this Issue of PWS Dine and co-workers (p. 365) report the stability and compatibility of four anthracycline antitumour drugs during simulated conditions of prolonged infusions. Their results are of importance for current practice. Not only the drug itself but also the formulation can be the cause of incompatibility. As an example, the novel investigational anticancer drug taxol is formulated in a mixture of ethanol and Cremophor EL | (1:1). For infusions bags and lines without polyvinyl chloride (PVC) must be used because of the leaching of plasticizers by the surfacrant Cremophor EL | Protein drugs are gaining a more and more important place in the armamentarium of the medL cal oncologist and home-based therapies for interferons, interleukins, haematopoietic growth factors are gaining momentum. Their interaction and adsorption with a wide variety of surfaces of container materials and membrane filters are notorious. Adsorption of the proteins usually results in their loss and destabi]ization, which, of course, must be prevented. The new developments in home-based parenteral (chemo)therapy require profound pharmaceutical expertise and active involvement of pharmacists who investigate these issues. Pharmacists, pre-eminently, are the right persons to meet these exciting pharmaceutical challenges.
J.H. Beijnen: Department of Pharmacy, Slotervaart Hospital/Netherlands Cancer Institute, Louwesweg 6, 1066 EC Amsterdam, the Netherlands.
EDITORIAL
NOTICE
Last Issue of Pharmaceutisch Weekblad Scientific edition This Issue of Pharmaceutisch Weekblad Scientific edition (PWS) - Number 6, Volume 14 is the last that will be published. But PWS will not vanish. We are pleased to inform you this Journal will be published as of 1 January 1993
14(6) 1992
Pharmaceutisch Weekblad Scientific edition
under a new name: "Pharmacy World & Science." The first Issue of PWS will appear on 19 February 1993. In that first Issue we shall explain why and how this change of name and appearance was brought about.
337
