Compounding in Hospitals

It describes how the compounding of drugs takes place in Hospital

1. COMPOUNDING IN HOSPITALS Prepared by, Ms. KOTE R. B. Lecturer PRES’s Institute of Pharmacy Loni .

2. BULK COMPOUNDING Compounding in hospital pharmacy is preparation of customized formulations of a medications to fulfill the unique need of patient which cannot be fulfilled by commercially available product. Physicians may choose to prescribe a compounded medications for a patient with an unusual health need such as: Patients who cannot take commercially prepared formulations of a drug. Patient requiring limited dosage strength, i.e. very small dose for infants. Patient requiring different formulations such as turning pill /tablet into liquid

3. BULK COMPOUNDING 4. Patient requiring allergen free medication e.g. without gluten 5. Patient facing supply shortage of their normal drug. 6. Children who want flavoured additives in liquid drugs.

4. Some of the formulations that are compounded In hospital pharmacy include : Mixtures-expectorant mixtures, antidiarrhoeal mixtures, sodium citrate mixture Syrups- Vasaka ,codeine and Ipecacuanha syrup Solutions Suspensions

5. Topical Semisolids: Ointments- Sulphur ointment, zinc oxide ointment Creams-Calamine cream, cetrimide cream Paints-Crystal violet compound paint Pastes-Zinc gelatin paste Gargles: Potassium permanganate gargle Lotions -Calamine lotion Some of the formulations that are compounded In hospital pharmacy include:

6. Regulation in the United States In U.S. the compounding pharmacies are licensed and regulated by states . Further the Federal Food Drug and cosmetics Act(FFDCA) states that pharmacies compounding only “patient specific” preparation made in response to prescription cannot be required to obtained FDA approval for such products. Due to rising cost of compounding and drug shortages some hospitals outsource their compounding needs to large scale compounding pharmacies, particularly the sterile injectable medications. Compounding preparations of a given formulation, as opposed to preparation for a specific patient, is known as “ non-traditional ” compounding.

7. Regulation in the United States 3. FFDCA has created new class of FDA- regulated entities known as “Outsourcing facilities”. Registered outsourcing facilities unlike traditional compounding facilities are subject to FDAs oversight.

8. MISUSE PROMPTING REGULATORY CHANGES: FDA claims that larger compounding pharmacies as like drug manufacturers and yet circumvent FDA regulations under the banner of compounding. Compounded drugs can be cheaper and overcome shortages but can pose greater risk of contamination . some such firms make large amounts of compounded drugs that are copies or near copies of FDA approved commercially available drugs. Hence, ideas have been proposed to expand U.S regulations for stricter enforcement of longstanding distinctions between compounding versus manufacturing .

9. INTRAVENOUS ADMIXTURE SERVICES AND INCOMPATIBILITIES Intravenous fluids are finding greater use as the means of administering other drugs because of convenience, the means of reducing the irritation potentials of the drug and the desirability for continuous and intermittent drug therapy. The use of IV fluids for this purposes requires compounding specific intravenous admixture to meet the clinical need of a given patient . However addition of drugs substances into IV fluids may be associated with parenteral incompatibilities .

10. INTRAVENOUS ADMIXTURE SERVICES AND INCOMPATIBILITIES 3. There may be antagonistic effects of contents of IV fluids and drugs added to it or synergistic effects leading to undesirable effects . Moreover, such addition may interfere the stability of the contents of the product. In addition such compounding procedures may lead to contamination of IV fluid, if adequate aseptic conditions and guidelines are not followed. Thus, safety of both medication and patient is of great concern in preparation of IV admixtures. 4. Intravenous admixtures are sterile solutions prepared by mixing one or more medications with intravenous fluid and are administered via IV-administration set directly to patient’s veins. IV fluids are sterile solutions of sugars, amino acids or electrolytes which are easily carried by circulatory system and assimilated.

11. IV FLUIDS COMMONLY USED FOR IV ADMIXTURE Injection Concentration pH Therapeutic Use 1. Dextrose 2.5% - 50% 3.5 – 6.5 Fluid and nutrient replenisher 2. Dextrose and sodium chloride Dextrose 5% to 20% with sodium chloride 0.11 to 0.9% 3.5 – 6.5 Fluid and nutrient replenisher 3. Lactated Ringer’s (Hartmann’s) Nacl KCL CaCl2 Na-lactate 0.6% 0.03% 0.02% 0.3% 6 – 7.5 Systemic alkalizer, fluid and electrolyte replenisher 4.Sodium chloride 0.45%,0.9%,2%,5% 4.5 – 7 Fluid and electrolyte replenisher

12. Uses of Intravenous fluids : Correction of disturbances in electrolyte balance Correction of disturbances in body fluids Means of providing basic nutrition For providing total parenteral nutrition and 5. As a vehicle for other drug substances To maintain sterility, freedom from particulate matter and pyrogens, it is necessary that manipulations be carried out in suitable environment using aseptic techniques.

13. TOTAL PARENTERAL NUTRITION (TPN) Parenteral nutrition (PN) refers to feeding of nutritional products to a person intravenously, by passing the usual process of eating and digestion. When nutrition mix containing glucose ,salt, amino acids, lipids and vitamins is administered to a person, it is called as total parenteral nutrition. Indications for TPN : The diseases such as short bowel syndrome, small bowel obstructions, active gastrointestinal bleeding, enteric-cutaneous fistulas and pseudo-obstruction with complete intolerance to food require use of TPN .

14. TOTAL PARENTERAL NUTRITION (TPN) Patients with following disorder require TPN: Gastrointestinal Disorders : Patient who do not have functioning GIT or who require complete bowel rest including bowel obstruction, short bowel syndrome, severe Crohn’s disease or ulcerative colitis have only feasible option for providing nutrition is TPN. Geriatric population: In geriatric population in general there is poor nutrition due to physical, physiological and psychological factors. Moreover in geriatric patients there is delayed muscle restoration and cardiac, renal impairments and insulin resistance, all theses factors leads to deficiencies in vitamins.

15. 3. Cancer patients : Cancer patient are at greater risk of malnutrition. Such malnutrition is attributed to decreased food intake, need of energy and the alteration of metabolism. Patient with cancer need to be assessed early for nutritional risk . TPN is indicated in patients in whom it is not possible to access digestive tract or if the tract is ineffective . 4. Condition like accident, surgery or digestive disorders : Long term PN is sometimes needed in patients suffering from such disorders. .

16. Complications of TPN : The most common complications of TPN include hypophosphatemia, hypokalemia, hyperglycemia, hypercapnia and decreased GI motility. The possible complications which may be significant are discussed below. Infection: TPN involves long term IV access using catheters. The most common complication is infection due to catherters . Infection is common cause of death in this patients and death usually results from septic shock. Blood clots: Chronic IV access leaves a foreign body in vascular system and blood clots on this IV line are common. Such clots upon breaking if travels to lungsmay lead to pulmonary embolism and death.

17. Fatty liver/liver failure: In TPN linoleic acid is used as a source of calories. These component is responsible for liver disorders usually as a long term complication of TPN . Hunger: In TPN the taste, smell and physical fullness of stomach requirement are not fulfilled and so the patient experiences the hunger, although the body is being fully nourished. Cholecystitis : Due to complete disuse of GIT, incase of TPN, there may be bile stasis in Gall bladder and other hepatobiliary dysfunctions such as steatosis, steatohepatits, cholestasis etc .

18. Hypersensitivity : The components of TPN such as lipid emulsion, amino acid solution and multivitamin solution may cause hypersensitivity reactions in certain patients. It occurs rarely but may be significant complication of TPN therapy. Medications : Patients receiving TPN also receive medications, that too intravenously. Addition of medications to TPN fluid may result into incompatibility that can be observed through discolouration, phase separation or precipitation.

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