Evaluation of the sterility of single-dose medications used in a multiple-dose fashion

Elizabeth P Martin1, Jean Mukherjee1, Claire R Sharp1

  • 1Cape Cod Veterinary Specialists, 11 Bourne Bridge Approach, Buzzards Bay, Massachusetts 02532, USA (Martin); Tufts University Cummings School of Veterinary Medicine, 200 Westboro Road, North Grafton, Massachusetts 01536, USA (Mukherjee); College of Veterinary Medicine, School of Veterinary and Life Sciences, Murdoch University, 90 South Street, Murdoch, Western Australia 6150 (Sharp); Angell Animal Medical Center, 350 S Huntington Avenue, Boston, Massachusetts 02130, USA (Sinnott-Stutzman).

Insights

Bacterial contamination risks were assessed for multi-dose medications. Hydroxyethyl starch and heparinized saline should not be used in multi-dose vials due to microbial growth potential.

Area of Science:

  • Microbiology
  • Infectious Diseases
  • Pharmaceutical Science

Background:

  • Single-dose medications are sometimes used in multi-dose formats, raising concerns about contamination.
  • Previous studies have not fully evaluated the microbial growth potential of specific intravenous solutions when repurposed for multi-dose use.

Purpose of the Study:

  • To investigate bacterial proliferation in commonly used intravenous solutions when administered in a multi-dose fashion.
  • To assess the risk of contamination and microbial growth in specific medications, including hydroxyethyl starch and heparinized saline.

Main Methods:

  • Experimental puncture of five different single-dose medications.
  • Intentional inoculation of selected intravenous solutions (hydroxyethyl starch, heparinized saline, 50% dextrose) with bacteria.
  • Incubation and monitoring for bacterial growth over a defined period.

Main Results:

  • One out of 75 experimentally punctured vials (50% dextrose) showed contamination.
  • Hydroxyethyl starch and heparinized saline demonstrated significant support for microbial growth when intentionally inoculated.
  • 50% dextrose showed a lower risk of contamination in experimental puncture compared to the other tested solutions.

Conclusions:

  • Hydroxyethyl starch and heparinized saline pose a significant risk of bacterial proliferation and should not be used in multi-dose regimens.
  • Healthcare professionals should exercise caution when considering the multi-dose use of intravenous medications, especially those supporting microbial growth.
  • Further research into safe multi-dose practices for intravenous solutions is warranted.

Related Concept Videos

Bioavailability Study Design: Single Versus Multiple Dose Studies01:11

Bioavailability Study Design: Single Versus Multiple Dose Studies

Bioavailability studies are essential for understanding how a drug is absorbed, distributed, metabolized, and excreted in the body. These studies assess the extent and rate at which the active pharmaceutical agent becomes available at the site of action. The design of bioavailability studies can involve single-dose or multiple-dose regimens, each with distinct advantages and limitations.Single-dose studies are the preferred approach due to their simplicity and reduced drug exposure for...
256
Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence01:22

Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence

Generic intravenous (IV) drugs are considered bioequivalent to their branded counterparts due to their 100% bioavailability upon administration. However, variations in stability among different drug products can significantly influence their therapeutic performance, even if they are pharmaceutically equivalent.Cefuroxime, a prophylactic antimicrobial, is often used as a single-dose IV injection for patients undergoing coronary artery bypass grafting surgery. A 3 g dose typically provides...
217
Drug Accumulation During Multiple Dosing: Repetitive IV Injections01:21

Drug Accumulation During Multiple Dosing: Repetitive IV Injections

Calculating drug dosage and accumulation in multiple-dose regimens is crucial for achieving therapeutic efficacy while avoiding toxicity. This involves determining the plasma drug concentrations over time to optimize dosing schedules. The principle of superposition is fundamental in this process, allowing for the prediction of drug concentration in plasma following multiple doses based on single-dose data.The principle of superposition asserts that the plasma concentration-time curves from...
318
Dosage Regimen: Fixed Dose01:01

Dosage Regimen: Fixed Dose

Fixed-dose regimens are a common approach to administer drugs to achieve and maintain desired levels of the drug in the body. In this dosing strategy, a specific amount of medication is given at regular intervals, often multiple times a day, to ensure a consistent drug concentration in the bloodstream.
Fixed-dose regimens can be used for various routes of administration, including intravenous (IV) injections and oral medications. For IV administration, a predetermined amount of the drug is...
2.4K
Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence

Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...
192
Dosage Interval and Administration Route: Determination Methods01:19

Dosage Interval and Administration Route: Determination Methods

A medication’s effectiveness largely depends on its appropriate dosage and the route of administration. Dosage ensures that a sufficient drug concentration is maintained in the bloodstream to elicit the desired therapeutic effect without causing toxicity. The route of administration affects the drug's bioavailability, rate of absorption, and onset of action, which are crucial for achieving optimal therapeutic outcomes. Drug dosage calculations are critical to tailoring therapy to...
297