CSP in pharmacy most commonly refers to Compounded Sterile Preparations.
Compounded Sterile Preparations (CSPs) are medications prepared by pharmacists and other trained healthcare professionals in a sterile environment. These preparations are created by combining, mixing, or altering drug products to create a medication tailored to the specific needs of an individual patient. CSPs are essential when a commercially available medication does not meet a patient's requirements due to factors such as:
- Dosage: The required dose is not available commercially.
- Formulation: The patient requires a different formulation (e.g., liquid instead of tablet).
- Allergies: The patient is allergic to an ingredient in the commercially available product.
- Unavailability: The medication is not commercially available.
Because CSPs are not mass-produced, but rather individually prepared, stringent standards and guidelines must be followed to ensure their sterility and safety. These standards are primarily outlined in USP <797>, Pharmaceutical Compounding – Sterile Preparations.
Key aspects of CSPs include:
- Sterility: Preventing microbial contamination is paramount. This involves proper hand hygiene, garbing, and aseptic technique.
- Stability: Ensuring the compounded medication maintains its potency and integrity throughout its shelf life.
- Accuracy: Precise measurements and calculations are crucial for delivering the correct dose.
- Quality Control: Implementing procedures to monitor and verify the quality of the compounded product.
- Training: Pharmacists and technicians who compound CSPs must undergo specialized training and demonstrate competency in aseptic technique.
Examples of CSPs:
- Intravenous (IV) medications
- Ophthalmic solutions
- Injections
- Irrigation solutions
The Importance of USP <797>
USP <797> provides guidelines for all persons who prepare CSPs and is designed to prevent harm to patients resulting from:
- Microbial contamination (nonsterility)
- Excessive bacterial endotoxins
- Variability in intended strength of correct ingredients
- Unintended chemical and physical contaminants
- Incorrect ingredients in compounded sterile preparations.
Failure to comply with USP <797> standards can lead to serious patient harm and legal consequences.
Beyond USP <797>:
Other guidelines and regulations may also apply, depending on the specific CSP and the practice setting. State boards of pharmacy also have specific requirements for compounding pharmacies.
In summary, CSPs are a critical component of pharmaceutical care, providing tailored medications to meet the unique needs of patients. Strict adherence to standards and guidelines is essential to ensure the safety and effectiveness of these preparations.
