Ch 5. Compounding in hospital.pptx hospital

Hospital

1. Compounding in Hospitals. Bulk compounding, IV admixture services and incompatibilities, Total parenteral nutrition

2. Bulk compounding It serves an important role for patients whose medical needs cannot be fulfilled by an FDA-approved drug. Reasons for bulk compounding in hospital Drug shortage in hospital. Adjustment of dose require in premature infants. Changes need in dosage form to make medication easier to ingest in children and elder patients. Patient has an allergy and needs a medication to be made without certain dye. Individual doses of drugs that hospitals use on regular basis such as IV preparations, eye drops, injections, IV admixture services, TPN .

3. Planning For Bulk Compounding Pharmacist should consider two points for control of the manufacturing program 1.Budgetory control :-To regulate the economic aspects of the program. 2.Quality control :-To govern the Quality,purity,and strength of the manufactured products . Budgetary Control IF we must provide manufacturing program the hospital pharmacist require to prepare the inventory and consumption rate for the finished product, raw material requirement, manufacturing capacity ,available personnel and operating cost.

4. Planning For Bulk Compounding Pharmacist should consider two points for control of the manufacturing program 1.Budgetory control :-To regulate the economic aspects of the program. 2.Quality control :-To govern the Quality,purity,and strength of the manufactured products . Budgetary Control IF we must provide manufacturing program the hospital pharmacist require to prepare the inventory and consumption rate for the finished product, raw material requirement, manufacturing capacity ,available personnel and operating cost.

5. 1.Manufacturing Requirement :- Review the records of previous year and compare the figures At first end pharmacist realizes that he has overestimated or underestimated his requirements whichever case may be corrective steps may be placed into effect for the second quarter. Either increase the rate of volume of production or reduce the batch quantity or frequency of manufacture or eliminate one batch of the product. 2.Material Requirements:- Once the hospital pharmacist has decided what products he plans to manufacture and in what quantity,he must take the next steps for the procurement of the nnecessary supplies. These supplies includes raw materials, containers,labels,and supplementary materials sauch as paper,filter pads,boxes and special labels.

6. The first step in this direction is to take each formula and determine the quantity of chemical or other material which will be required to produce the annual supply. This is done by taking the quantities of raw material from the working formula and packaging specifications of each item and multiplying these quantities by the number of times the formula must be produced to fulfill the estimated annual need. The second step is to enter these quantities on a summary sheet becoz the same drug chemical or container may be required by many different formulas. 3.Manufacturing Capacity : Manufacturing capacity is depending on the availability of equipment and its capacity to manufacture the desired qty for manufacturing.

7. 4.Manufacturing Equipment and its Sources :- The size of manufacturing equipment in hospital pharmacy may vary from institution to institution .Manufacturing program must be consider. The quantities to be produced during any production The length of time that will be required to consume the pdt . The availability of personnel The availability of physical facilities. Modern technology has developed equipment to fulfill every production need. The machinery can handle manufacturing capacity for a small or medium sized hospital. addition, the larger hospitals have available to them automatic and Semi-automatic duty production equipment which may be competent for managing large volume.minimum of time.

8. 4.Manufacturing Staff :- The manufacturing section of the pharmacy must be supervised by a technically competent,legally qualified pharmacist. In addition, he must be supported with ancillary personnel who can be trained to carry on such non-technical pursuits as bottling, filtering, labeling, etc. Too many personnel will raise the cost of a manufactured product and too little help may mean the inability to maintain an adequate production schedule and chances potential errors. Accordingly, production time must be determined for each formula in order that proper planning and scheduling be affected.

9. 5. Operating Cost Operating cost consists of direct cost only- direct labor and cost of material but it should include both direct and indirect cost. The terminology &Over head cost is usually interchangeably with Indirect cost includes the cost of supervisory personnel, space rent, insurance of equipment depreciation, maintenance, housekeeping etc. The indirect cost should be compared with direct costs for the purpose of calculating a ratio of overhead. Quality control is required to supervise the quality, purity and strength of the manufactured product that will ensure the integrity of product. This can best be accomplished by developing a series of cross checks and laboratory analyses. Hospital pharmacist has responsibility to follow cGMP for ensuring the high pharmaceutical standards of product.

10. IV admixture service and incompatibilities IV admixture :An IV admixture is a preparation of a pharmaceutical mixture of two or more drugs added into IV fluids alone or in combination for medication purposes.

11. PREPARATION OF IV ADMIXTURE   Upon receipt of the physician original order sheet, a pressure sensitive label must be prepared. which provide the following information: Patient name Patient location Physician's name Name of the drugs with quantities added Date of compounding Expiration date Name of the pharmacist preparing the product

12. Prepare the admixture under the laminar flow hood using sterile needles and syringes or double ended transfer needles Once the transfer is made, met a disc of the container must be replaced with a new seal crimped. For safety purposes, A different colored seal should be utilized that it warns individuals regarding drugs that have been added. Pharmacists must inspect the final product before dispensing the final admixture. The inspection should contain a review of the label, clarity of the solution, and the calculation involved in the preparation.

13. IV ADMIXTURE INCOMPATIBILITY Definition : It is the simultaneous dilution and/or administration of two or more drugs that interfere with the therapeutic efficacy of the medications and patient safety. The types of incompatibilities related with intravenous administration are Physical incompatibility Chemical incompatibility Physical incompatibility (PI): It occurs when a drug mixture produces changes in the appearance of a solution. It is also known as "Pharmaceutical Incompatibility or Visual Incompatibility". Chemical incompatibility : It occurs due to the chemical degradation of the admixed drugs. It appears as change in colour , precipitation and turbidity. Therapeutic incompatibility may happen when two or more drugs are administered concurrently resulting in undesirable pharmacological activity.

14. Types of Incompatibilities A) Physical incompatibility B) Chemical incompatibility C) Therapeutic incompatibility 18-Feb-23 14

15. A) PHYSICAL NCOMPATIBILITY When two or more than two substances are combined together, a physical change take place and an unacceptable product is formed. Physical incompatibility is usually due to Immiscibility Insolubility Precipitate formation or Liquefaction of solid materials Physical incompatibility usually visible and can be easily corrected by applying the pharmaceutical skill 18-Feb-23 15

16. Physical incompatibilities may be corrected by using following methods Change the order of mixing of ingredients of the prescription Emulsification Addition of suspending agent Change in the form of ingredients By addition, substitution or omission of therapeutically inactive substance to help in compounding of the prescription 18-Feb-23 16

17. Examples of Physical compatibilities and Their Methods of Correction 1. Immiscibility : Oils and water are immiscible with each other. They can be made miscible with water by emulsification. Example:1 Castor oil : 15 ml Water : 60 ml Emulsifier 18-Feb-23 17

18. 2.Insolubility Liquid preparation containing indiffusible solids such as chalk powder, acetyl salicylic acid, phenacetin , zinc oxide etc. A suspending agent , which increase the thickness of the preparation & give uniform distribution of the insoluble substances. 18-Feb-23 18

19. Example: 2 Phenacetin 3 gm Caffeine 1 gm Orange syrup 12 ml Water up to 90 ml Make a mixture. In this prescription phenacetin is an indiffusible substance. Tragacanth mucilage is used as a suspending agent to make a stable suspension 18-Feb-23 19

20. B) Drugs such as sulphur , antibiotic & certain corticosteroids are insoluble in water and are difficult to wet with water. Wetting agents like saponin & polysorbates are used to distribute the powder in water. 18-Feb-23 20

21. 3. Precipitation Drug in solution may be precipitated, if it is not soluble in solvent . Resins: Resins are insoluble in water, forming indiffusible ppt. This can be prevented by slowly adding the diluted tincture with vigorous stirring to the diluted suspension or by adding some suitable thickening agent. 18-Feb-23 21

22. 2. Gums: Gum such as acacia, tragacanth and agar, sugars and many other hydrocolloids are precipitated from their aqueous solutions by alcohol or by electrolytes through dehydration process. 3. Volatile oils Volatile oils are soluble in alcohol. When water is added into the alcoholic solution of volatile oil, the non-aromatic portion of the oil get precipitated and tuInrcobmipdatiibtilyity appears. 18-Feb-23 22

23. 4. Liquefaction When certain low melting point solids are mixed together, a Iiquid or soft mass is produced known as eutectic mixtures. This occurs due to the lowering of the melting point of mixture to below room temperature. Eg : camphor, menthol, thymol , phenol, chloral hydrate and aspirin. 18-Feb-23 23

24. To avoid this problem these substances can be dispensed by anyone of the following methods:- (i) Triturate together to form liquid and mixed with an absorbent like light kaolin or light magnesium carbonate to produce free flowing powder. (ii) The individual medicament is powdered separately and mixed with an absorbent and then combined together lightly. (iii) Individual medicament is packed separately & label to mix before administration. 18-Feb-23 24

25. B) CHEMICAL INCOMPATIBILITY When two or more than two substances are combined together, chemical interactions occurs and toxic or inactive product may be formed. While dispensing such prescriptions, precautions should be taken either to prevent the formation of harmful product or to correct them and the prescriber must be informed in this regard. 18-Feb-23 25

26. Chemical incompatibilities often occur due to 1. Oxidation- reduction, 2. Acid base hydrolysis 3. or combination reactions These reactions may be noticed by Precipitation Effervescence, Decomposition, Color change or Explosion. 18-Feb-23 26

27. Types of Chemical incompatibilities Tolerated: In tolerated incompatibilities, the chemical interaction can be minimized by changing the order of mixing or mixing the solutions in dilute forms but no alteration is made in the formulation. Adjusted: In adjusted incompatibilities the chemical interaction can be prevented by addition or substitution of one of the reacting ingredients of a prescription with another of equal therapeutic value. Intentional: When the prescriber knowingly prescribes the incompatible drugs; Un-intentional: When the prescriber prescribes the drugs without knowing that there is incompatibility between the prescribed drugs. 18-Feb-23 27

28. Precipitate Yielding Interactions Strong solutions faster rate of reactions & thick precipitate formation & ppt is indiffusible . Dilute solutions slow rate of reactions & light wt. precipitate formation & ppt is diffusible. Hence the reacting substances should be diluted to the maximum extent before mixing them. 18-Feb-23 28

29. Precipitate Yielding Interactions Method A - The method is followed when diffusible precipitates are formed in small quantity. Method B - The method is followed when indiffusible precipitates are formed in large quantity. Suitable quantity of compound tragacanth powder is used (2 g per 100 ml ) or mucilage (1/4 th volume of finished product) A secondary label "SHAKE WELL BEFORE USE" should be fixed on the container whenever method A or method B is followed . 18-Feb-23 29

30. CAUSES OF INCOMPATIBILITY Incompatibility generally occurs between: Two drugs (drug-drug incompatibility) Drugs and materials of IV containers When these are mixed together in the similar infusion line or the similar IV container When these are administered one after the other in the same infusion line Drugs and unsuitable diluents Drugs and adjuvants such as stabilizer and solvent

31. . Major consequences of incompatibility are Damage from toxic products   Multi-organ failure, Severe liver dysfunction, Toxic shock, Local embolus, Myocarditis Respiratory difficulties, Systemic allergic reactions, Local allergic reactions, Thrombosis Thrombophlebitis, Phlebitis, Local redness Particulate emboli from crystallization and separation A large quantity of particles in injections is considered a potentially life-threatening health hazard. Drug incompatibility reactions may not only produce particles in the infusion but also alter the drug into an inactive form and injurious effects on the patient prescribed drug regimen. Tissue irritation due to major pH modifications Therapeutic failure Adverse effects of drug incompatibilities extend time span and total cost of patient's hospitalization in hospital.

32. Pharmacist role in intravenous admixture service Permanent supervision and involvement of Clinical Pharmacist in IV admixture services. Prepares protocol and establish reporting error system for IV admixture service. Provides expert advice on compatibility and stability for the use of multiple drugs. To updates staff on new clinical practice guidelines. Can prevent dangerous incompatibility through the available literature, databases, services and information material.   Color coding is given for preventing incompatibility. Prepare individual labeling for each drug preparation. It always checks the alternative methods of administration and uses multi-lumen catheters.

33. Total parenteral nutrition (TPN) is a method that bypasses the GIT gastrointestinal tract, because of its absorptive capacity is reduced. Fluids are administered into a vein to deliver most of the nutrients the body needs.. TPN provides a mixture of fluid, electrolytes, carbohydrate, lipids (fats), amino acids (protein), vitamins, minerals.   Definition : Total parenteral nutrition (TPN) is intravenous administration of nutrients in adequate quantities to achieve tissue synthesis & anabolism.

34. What is Total Parenteral Nutrition (TPN) Hyperalimentation? TPN or Hyperalimentation is the IV infusion of a nutritionally, complete formula, including amino acids (protein/nitrogen) dextrose (carbohydrate/glucose) fat emulsions (fatty acids) vitamins electrolytes minerals trace elements 34

35. What is Total Parenteral Nutrition (TPN) Hyperalimentation? TPN : is the administration of concentrated glucose & amino acid solutions via a central or large diameter peripheral vein. TPN therapy is necessary when the GI tract cannot be used or is not used to meet the Patient nutritional needs. TPN solutions may contain 20%-60% glucose and 3.5% to 10% protein (in the form of amino acids) in addition to various amounts of electrolytes, vitamins, minerals, & trace elements. These solutions can be modified, depending on the presence of organ system impairment and/or the specific nutritional needs of the Patient. To provide necessary amounts of fat and the fat soluble vitamins (A, D, E, and K), intralipids are often administered 2-3x a week along with TPN (monitor triglyceride levels) TPN is often used in hospital, long term care, and subacute care, but is also frequently used in the home-care setting. 35

36. Types of TPN 1.Central Parenteral Nutrition 2.Peripheral Parenteral Nutrition

37. INDICATIONS FOR USE Inability to absorb nutrients via the gastrointestinal tract Patient who is not expected to eat sufficiently Moderate to serve pancreatitis when adequate enteral intake is not expected for 5 to 7 days Chronic intestinal obstruction as in intestinal cancer Organ failures -liver, renal, respiratory Malnourished oncology patients When the patient is unable to sustain nutritional status due to severe diarrhea or vomiting Patient who is not expected to eat sufficiently Malnourished patient before major Surgery

38. COMPLICATIONS Metabolic abnormalities Electrolyte imbalance Liver toxicity Re-feeding syndrome in chronic alcoholic patients Sudden discontinuation cause hypoglycemia hyperglycemia over feeding Pneumothorax Bleeding Air embolism Vascular injury Thrombophlebitis Catheter site infections include bloodstream infection, local skin infection at insertion site

39. CONTENTS OF TPN TPN is mixture of separate components which contain Carbohydrates, Lipids (fat), Amino acids, Electrolytes, Trace elements, Vitamins and Fluids. TPN composition adjusted as per requirement of individual patient. Carbohydrates:  Carbohydrates is the main source of energy. such as galactose, fructose & sorbitol should not be used as energy sources in TPN. Lipids (Fat):  Linoleic acid is used as primary source of essential fatty acid in TPN Electrolytes:  Sodium (Na), Potassium (K), Magnesium (mg) Calcium (Ca), Chloride Vitamins:  Vitamins are required for the metabolism of carbohydrates, proteins, fats. water soluble (B1, B2, B3, B5, B6, B7, B9, B12 & C) & fat-soluble vitamins (A, D, E & K) used in TPN formulation.