COMPOUNDING IN HOSPITALS

Definition: Compounding in hospital pharmacy is preparation of customized formulations of a medication to fulfil the unique need of patient which cannot be fulfilled by commercially available (FDA-approved) product.

Reasons in which Hospital Pharmacy decides compounding:

• Medication in specific strength: Recommended dosage strength not available in market.
• Needing different medication dosage form: have difficulty swallowing or experience stomach upset when taking oral medication.
• Allergy to inactive ingredients: Patient requiring allergen free medication e.g. without gluten, made with certain dye.
• Shortage in supply: Patients facing supply shortage of their normal drug.
• Poor taste medicine: Available market preparation is bitter so poor acceptance can be improved by compounding. Children who want flavoured additives in liquid drugs.

Most hospital-compounded formulations follow the National Formulary of India (N.F.). These must comply with the Drugs and Cosmetics Act, its Rules, and requirements for labeling and storage.

Benefits of compounded

• Strengthen the patient--pharmacist relationship.
• Improve pharmacists\\\' professional satisfaction and perceived quality of patient care, and imbue pharmacists with a greater responsibility to provide patient-centered care.

Drawback of Compounding

• Pose a higher risk to patients as compounded drugs are not FDA-approved.
• Has no regulatory premarket review for safety, effectiveness, and quality.

Bulk compounding

Bulk compounding refers to the process of creating large quantities of a medication in advance, rather than creating individual prescriptions one at a time. This practice is typically regulated under the Federal Food, Drug, and Cosmetic Act to produce bulk quantities of compounded drugs. This is often done to meet the needs of hospitals or clinics that require a steady supply of certain medications.

Facility must comply with all of the requirements including:

• Compounding drugs in accordance with current good manufacturing practices (cGMPs).
• Compounding drugs without a patient-specific prescription, often in bulk.
• Reporting adverse events to the FDA.
• Providing the FDA with certain information about the products they compound.
• Undergoing FDA inspections on a risk-based schedule.

Intravenous Admixture

An intravenous (IV) admixture is a sterile drug product resulting from the combination of one or more sterile medications with an IV fluid for administration to a patient. This process, known as IV admixture compounding, requires strict adherence to aseptic techniques to prevent contamination, which can lead to serious patient complications.

Key considerations in hospital compounding

Key considerations in hospital compounding include:

• Sterility: ensured via aseptic techniques in laminar flow hoods to prevent microbial, particulate, and pyrogen contamination.
• Compatibility and stability: must be verified to avoid precipitation, degradation, or potency loss due to interactions between drugs, diluents, containers, or tubing.
• Accuracy: in dosage calculation and preparation is critical—errors pose serious risks, prompting use of centralized IV admixture services (CIVAS) or pre-mixed solutions.
• Labeling and storage: require clear patient and drug details, expiration times, handling instructions (e.g., light protection), and appropriate beyond-use dating based on stability and risk level.

Types of IV Admixtures

• Large Volume Parenterals: Typically 500-1000 mL, used for hydration or continuous medication infusions.
• Small Volume Parenterals: Smaller volumes (mini-bags or syringes), often used for intermittent doses like antibiotics.
• Total Parenteral Nutrition (TPN): Complex admixtures that provide a patient\\\'s complete nutritional needs (proteins, carbohydrates, fats, vitamins, electrolytes) through an IV line.
• Premixed Admixtures: Commercially manufactured, ready-to-use bags that offer advantages like longer expiration dates and reduced preparation time in the hospital, minimizing potential for error.

Types of Incompatibility

Incompatibilities are generally classified into three main types:

• Physical Incompatibility: This is the most common type and usually results in a visible change, such as the formation of a precipitate (solid particles), haziness, a change in color, or effervescence (gas formation). For example, mixing ceftriaxone and calcium can form a white precipitate that has been linked to fatal pulmonary emboli in neonates.
• Chemical Incompatibility: This involves a chemical reaction (like hydrolysis, oxidation, or reduction) that degrades the active drug, reduces its potency, or forms toxic byproducts. These reactions may not always be visible but lead to a decrease in the amount of the active drug available to the patient.
• Therapeutic Incompatibility: This occurs when two concurrently administered drugs work against each other pharmacologically, resulting in an undesirable antagonistic effect or an unintended synergistic effect. For instance, chloramphenicol and penicillin should not be administered together because chloramphenicol antagonizes the effects of penicillin.

TOTAL PARENTERAL NUTRITION (TPN) (Model Answer)

Definition: Total Parenteral Nutrition (TPN) is the method of infusing nutrition to the patients through Intravenous (IV) route. The nutrition is in the form of fluids.

Ingredients in TPN

Macronutrients

Amino Acids: Provide essential and non-essential amino acids in specific proportions to support protein synthesis and tissue repair.

Dextrose: Serves as the primary carbohydrate source, supplying energy for metabolic functions.

Lipids: Fat emulsions (often soybean-oil based) supply essential fatty acids and additional calories.

Micronutrients

Electrolytes: Includes sodium, potassium, calcium, magnesium, chloride, and phosphate to maintain fluid balance, nerve function, and muscle contraction.

Trace Elements: Includes zinc, copper, selenium, manganese, chromium, and others in minute amounts to support enzymatic reactions and overall physiological functions.

Other Components

Vitamins: Contains essential water-soluble (e.g., B-complex, vitamin C) and fat-soluble vitamins (A, D, E, K) to support metabolic processes and prevent deficiencies.

Water: Sterile water is used to dilute the solution and facilitate nutrient transport within the body.

Additives: Additional supplements or medications may be added depending on the patient\'s clinical needs.