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Critical Protection for Providers and Patients |
Products introduced into the venous system travel through increasingly larger diameter vessels until reaching the heart, after which the vessels decrease in size to the minute capillary beds of the pulmonary system. Pulmonary capillaries are approximately 6 to 9 µm in diameter, just large enough for a single red blood cell to pass. Rigid particles, equal to or greater than 6 µm in size, can become trapped in the vascular bed, occluding capillaries, and can cause multiple pulmonary infarctions.3 Foreign particles can also produce emboli in the capillaries of other vital organs, and phlebitis at the infusion site.
A collaborative study conducted by the Pharmaceutical Manufacturers Association described size-dependent localization of particles in different rat organs after intravenous injection of varying quantities and sizes of latex particles.4
| Particle Size | End-Organ Particle Localization |
| 40 µm | Lung and heart tissue 13 of 18 animals died within 5 minutes of injection |
| 10 µm | Lung primarily; also kidney Liver, spleen, heart, and brain |
| 4 µm | Lung, liver, and spleen |
Furthermore, pathological studies in Europe have shown that particles that are too small to block even the smallest blood vessel can irritate blood vessel lining and act as a condensation nuclei for clot formation. Post-mortem studies of patients given unfiltered infusions revealed the presence of very small particles associated with thrombi in the lung and in large granulomata.5
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The preparation of pharmaceutical solutions in hospitals, home care, infusion clinics, and long-term care facilities often requires filtration to remove viable and non-viable particulate matter to make solutions clear or sterile. To remove large particles from solutions, a membrane filter with a rated pore size of 5 µm or higher is required. Sterilization requires a filter with a rated pore size of 0.2 µm or smaller. Many facilities also choose to use end-line filters at the point of infusion to remove sub-micron particles, including those contributed by the infusion system.
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For health care pharmacy professionals, improving patient outcomes begins with safe and effective preparation of pharmaceutical solutions. Reconstitution of sterile cytotoxic drugs involves procedures to protect patients and health care workers during handling, dispensing, and administration of drugs.
Health care workers may be at risk while preparing or administering antineoplastic injections, including exposure to cytotoxic or hazardous drug aerosols during drug reconstitution, or during the withdrawal of drugs from rubber-sealed vials. This exposure can result in skin and eye irritation and has the potential for cumulative damage to liver, kidneys, and chromosomes of health care workers.6
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The PharmAssure family of filtration products offers a complete range of products for the pharmacy and clinical wards to ensure the quality and safety of compounded products. Additionally, vented vial access devices protect pharmacy professionals and nurses from the hazards associated with exposure to cytotoxic or hazardous drugs from the preparation or administration of antineoplastic products.
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- Particles are present in all IV solutions.
- Infused particles can result in serious complications.
- Parenteral solutions must be sterile and free of particulates before delivery.
- Reconstitution of cytotoxic drugs poses risks to health care providers.
- PharmAssure is a complete line of filtration and venting products specifically designed for the health care pharmacy.
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- Backhouse CM; Ball PR; Booth S; Kelshaw MA; Potter SR; McCollum CN. Particulate contaminants of intravenous medications and infusions. J Pharm Pharmacol. 1987;39(4):241-5.
- Groves MJ and Wong J. A simple index for measuring particulate contamination in parenteral solutions. Drug Development and Industrial Pharmacy. 1987; 13:193-206.
- Duma, Akers MJ, Turco S. Parenteral Drug Administration: Routes, Precautions, Problems, and Complications. Pharmaceutical Dosage Forms: Parenteral Medications 2nd Ed., Marcel Dekker, New York, 1991.
- Gesler RM, et al. The biological effects of polystyrene latex particles administered intravenously to rats: A collaborative study. Bull. Parenter. Drug Assoc 1973; 27:101-113.
- Puntis JWL, Wilkins KM, Ball PA, and Booth IW. Hazards of Parenteral Treatment: Do particles count? Archive of Disease in Childhood. 1992; 67:1475-1477.
- American Society of Hospital Pharmacists. ASHP Technical Assistance Bulletin on Handling Cytotoxic and Hazardous drugs. Am J Hosp Pharm. 1990; 47:1033-49.
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