Inventory Management

1. Inventory Management • Purchasing Systems • Independent Purchasing: a single pharmacy entity establishes a contractual agreement with a pharmaceutical manufacturer or wholesaler. • Group Purchasing: contractual agreement between a manufacturer or a wholesaler and a group of pharmacies • I.e.. CVS , Walgreens and other chains as well as a health system pharmacies like the medisys system which includes Jamaica, Flushing and other hospitals in the NY area • Competitive pricing and better terms

2. Purchasing Methods • Direct Purchasing • Involves buying directly from drug companies • Not commonly done, only for restricted items Wholesalers and primary vendors are not direct purchasing venues but rather are firms whose business is to provide a warehouse of drugs where pharmacies can order multiple drugs, both brand and generic from a single source. Examples include Cardinal Health, McKesson and AndaGenerics. They offer next day service (sometimes same day). Higher cost than direct purchasing but more convenient

3. Order Process • Generating the order can be done manually by a technician surveying the inventory and creating the order. Automated methods involve drugs that a pulled from selves which are scanned and the quantity deducted from inventory. When the inventory falls below a certain level the drug is ordered. • Confirmation of an order requires an inspection of the order before it is transmitted • Submit the order (usually by computer) • Processing the order by wholesaler • Order Delivery by courier • Order Verification: matching the invoice with the original order to determine if any items are missing that should have been sent • Inventory Adjustment: computerized adjustment of inventory • Stocking of medications

4. Returns and Recalls • Sometimes drugs can be returned to the wholesaler because it’s damaged, ordered in error, or simply not needed • Expired drugs are either destroyed or returned to the manufacturer. Companies like, Stericycle and Pharmacologistics handle these issues for hospitals. • Recalls are FDA or manufacturer initiated and involve the voluntary or mandatory surrender of drugs by pharmacies and consumers. It may involve pharmacies contacting customers and retrieve drugs. Often only certain lots are required to be surrendered. • This is why state laws requires the NDC to be recorded on the Rx label when dispensing. Manufacturer will list NDC and affected lots • Class 1 recalls are serious and can cause death • Class 2 recalls are not as serious • Class 3 recalls usually involve misbranding and other regulatory issues

5. Insurance • Health Maintenance Organizations or HMOs are organizations that contract with healthcare providers to provide services to their clients. Insurance clients select a primary care physician who acts as a gatekeeper for other services. Often the most competitively priced insurance but with the most restrictions • Preferred Provider Organizations or PPO’s are similar to HMO with the exception that clients can see out of network providers but pay a higher copay for this privilege.

6. Government run Health Insurance • Medicaid and Medicare were formed by title 18 and title 19 amendments to the social security act of 1935 passed in 1965. • Medicaid serves people of limited income and disabilities. • Medicaid is funded by the state and federal government jointly. • Medicare is a coverage program that is offered to elderly people (over 65) and certain young people with disabilities to include end stage renal disease. • Plan A covers hospital costs. Plan B medical expenses. Plan D is the prescription drug coverage plan established in 2003. • Plan D is administer through private plans across the country. • Plan “C” or Medicare advantage offers coverage to patients via Medicare contracts through private insurance companies. • Paid for through payroll taxes (FICA) on all working Americans (2.9% total)

7. Insurance Billing and Terms • Copay. The portion of the bill that the patient pays • Deductible. The amount that an insured pays before coverage “kicks in”. Deductibles are satisfied all at once or a portion at a time. • Pharmacy Benefits Manager (PBM): a processor contracted by the primary insurance to handle Rx benefits. • Preferred formulary drug: the drug in a class that is paid for by the insurance. It can be called a tier one drug • Non preferred formulary drug: a drug in a class that is not covered or covered at a higher copay. Tier 2 drug • Non Coverage Drug is a drug that can not be covered unless the provider ,usually the doctor, calls the insurance and receives a “prior authorization”

8. Introduction to Compounding • Compounding in Pharmacy refers to the special preparation of drug products that are uniquely tailored to a patient’s needs medically and otherwise. • Extemporaneous is often an adjective that describes this unique characteristic of compounding. • Today relatively few prescriptions are compounded but in 1938 when the FDCA was passed about 50% of Rx were compounded. Pharmacy is an art as well as a medical profession. The Pharmacist could add favorants and other excipients to make a drug more aesthetic and/or more palpable to children or animals

9. Compounded items can be: creams, ointment, solutions, suspensions, intravenous solutions, capsules, suppository, etc. • Solutions are homogenized mixtures of drug in aqueous medium. • Suspensions are heterogeneous mixtures of a drug in aqueous medium. These mixtures often require the shaking of the drug before the suspension can be given. • Intravenous solutions are aqueous drug mediums that are free of particles; they are sterile and pyrogen free • Capsules are oral dosage forms that are enclosed in a gelatin casing that dissolves in the stomach and small intestine • Suppositories are dosage forms that are applied rectally. They are usually made of material like glycerin which melts at slightly below body temperature. Used for patients that can’t swallow due to neurological disorders (dysphagia)

10. Special Compounded Dosage Forms • Emulsions are mixture of two non mixable liquids in a stabilized medium. Normally, oil in water do not mix; however, a compound can be made (an emulsion) where the two liquids can be “mixed” with each other. • Examples in pharmacy are creams and lotions. • Examples in food are mayonnaise and milk (fat mixed in water) • Two types of emulsion are oil in water (o/w) or (w/o) • When a surfactant or an emulsifier in added to the mixture the mixture ‘solubilizes’. Examples of emulsifiers are Lecithin, gum Arabic, Polysorbate 80 and stearly alcohol

11. References for Compounding • Remington’s Pharmaceutical Sciences • Trissel’sStability of Compounded Formulations • Drug Facts and Comparisons • United States Pharmacopeia • The International Journal of Compounding Pharmacists

12. Compounding Equipment • A more complete list is mention in the text • The more important ones are following • Balance, class A, required in every pharmacy by the state board • Beakers • Filter papers • Graduated cylinders • Hotplates • Molds • Mortar and pestle • Ointment slab • Spatulas • Weighing paper

13. Mortar and Pestle • Very important in compounding • represents a symbol of the pharmacy profession. Shown as • Used to comminutate or triturate a substance to smaller particle sizes. Smaller particle sizes are a key to make certain compounds more appealing to the touch and taste. • Glass mortar is used to triturate gritty liquids and porcelain is used for granular powders

14. Suspensions • Some drugs are in tablet form and are perhaps needed to be given in very small quantities. (i.e. neonates who need a fraction of the dose an adult would need) • A required number of tablets are crushed and triturated in a mortar and pestle. • An agent called a suspending agent is added. A very common one is Ora Plus®. Others are carboxymethylcellulose, etc. Used to make the particles repel each other to “homogenize” a suspension when its shaken. • A sweetening agent can be added like simple syrup or Ora Sweet ® • After this the suspension is brought to final volume with water. • Strength of a suspension is measured in usually mass per volume like mg/ml, g/l , or percentage %v/v. When used without qualification , % strength usually means grams per 100 ml. • For example in IV terminology an IV solution of normal saline is 0.9% sodium chloride USP. Its strength is 0.9 grams of sodium chloride per 100 ml of solution. Question: one liter of saline has how grams of NaCL? • Other question: How much volume is needed to deliver 27 grams of saline?

15. Other Compounded Dosage Forms • PLO gel. A transdermal gel enhances absorption of drug through the skin. A gel is a suspension basically that “congeals” in contact with skin or at a certain temperature. Contains a suspending agent and surfactant called Pluronic Lecithin Organogel. • Ophthalmic Preparations are usually solutions but can be suspensions or even ointments, which are semisolid mixtures of drug in a semisolid base. They are usually pH balanced and sterile. • Otic Preparations are used for the ear. Can be solutions but are mostly suspensions that are thick enough to be held in the ear canal for the drug to act. • Nasal Preparation are used for the nose and are mostly sterile and prepared with isotonic fluids like 0.9% sodium chloride USP

16. Ointments • Semisolid dosage forms where solid drugs are incorporated in a solid oily base substance, or just called a base. • Normally the drug is triturated in a mortar and pestle to reduce its particle size and to prevent “grittiness” in the final ointment dosage form. • Commonly used bases: • Vaselin® or simple white petrolatum USP. Its is a high hydrocarbon base obtained from crude oil processing. • Forms an occlusive layer on the skin to prevent dryness • Used for drugs that are unstable in water

17. Commonly Used Bases • Lanolin, Anhydrous. A base that contains fatty acid esters that when treated is a water absorbable base. Comes from the wool of sheep and other animals and is sometimes called “wool fat”. • Used for water stable drugs • Typically has Ok drug –skin penetrating ability

18. Hydrophilic Petrolatum • Hydrophilic Petrolatum USP • It’s a “water Loving” base that is a chemical modified form of white petrolatum USP • USP listing requires the following ingredients • 86 grams white petrolatum • 8 grams white wax • 3 grams cholesterol • 3 grams stearyl alcohol in 1,000 grams total preparation

19. Water in oil base • Emulsion base • Has good drug skin penetration • Has good washablilty • Examples are Hydrous Lanolin, Cetaphil® and Eucerin® • Typically called lotions or creams • PEG bases are made from polyethylene glycol bases and are excellent for drug penetration and are able to be washed off easily.

20. Introduction to Sterile Products • A sterile product is a product that is free of contamination, microorganism free, and pyrogen free • Examples of sterile products are intravenous products (IV), ophthalmic products (for the eye), and nasal products (for the nose), Intramuscular (into the muscle) and subcutaneous (under the skin) • Aseptic technique refers to the procedure of properly performing the preparation of sterile products. • Includes the environment, equipment, and personnel garb • Provides guidelines for the procedure

21. Normally any agent that bypasses the skin or the gastrointestinal tract must be both sterile and pyrogen free. This is because the skin and the GI tract have a protective role in filtering out damaging foreign substances or microorganisms. • The blood is a sterile body fluid that requires sterile drug products. Blood is filtered by the spleen and then by the lymph nodes as its becomes lymph; however, when a drug is introduced directly into the blood it must be sterile. • Consequences of contaminated IV products can be serious

22. Most IV drug products are contaminated by touch contamination. • Bacteria, fungus, and other microorganism colonize the skin • Common skin microorganisms are: Candida, Dermatophytes, and Staphylococcus bacteria. Others are common as well. • Contaminated products can “colonize” the blood and produce bacteremia and fungemia. Infections can evolve into septic shock and death. • Watch : http://www.youtube.com/watch?v=KC8qgxNB2FA

23. Environment for Sterile Products Preparation • Class 100 environment is an environment that has air that contains no more than 100 particles (0.5 microns) or larger in one cubic foot of air. • Laminar flow hoods provide this environment. • Horizontal flow hoods filter air and pass it through a HEPA filter and outward out of the hood. • Vertical flow hoods blow filtered air down towards the surface of the hood. • Biological Safety Cabinets are vertical flow hoods that pulls air through vents in the front and back of the hood to prevent the preparer from receiving this air. It is used to make chemotherapy drugs.

24. USP 797 • Introduced in 2004 by the US Pharmacopeia. • Consists of standards for the environment to be considered in the preparation of sterile products • Endorsed by JCAHO and other regulatory agencies • Followed in most hospitals with others moving towards compliance. • Standards include wall/ceiling, wall/wall and wall/floor junction specifications, etc

25. In general, sterile products are prepared in laminar flow hoods in similarly compliance air quality rooms • Such rooms are called “clean rooms” • Usually have partitions that separate areas of the room for storage of IV products, gloves, and needle and syringes • Rooms are usually positively pressurized to “push” contaminates out and to keep other particles from being pulled in.

26. Other Sterile Product Equipment • Needle are sterile puncturing devices meant to access drug solutions in vials and to administer drugs to patients. • Normally are 3/8 of an inches to 3.5 inches in length • The diameter, or bore, of the needle is determined by its gauge. • The larger the gauge the smaller the bore of the needle • In general, 25 or 27 gauge needles are under for subcutaneous injections, 22 gauge for IM injections with 18 gauge and 16 gauge meant for pharmacy compounding of IV products. 13 gauge is typically the larger bore needle you will find.

27. Syringes are the containers that hold the drug solution after its been drawn from a vial. • Consists of a tube with graduations marks, a piston, a plunger with grip collar and at the other end a luerlok tip (most syringes). • This luerlok tip is designed to be a twist on to attached to a needle or to a injection port on a catheter to administer an injection Author: William Rafti of the William RaftiInstitute from Wikipedia

28. Source: wikimedia commons page

29. Intravenous Solutions • Normal saline (0.9%) is one of the most common because its isotonic with plasma. Isotonic means equal to it in terms of “tonicity”. i.e. plasma has a tonicity valve of about 290 mOsm. Normal saline or NS is about 300 mOsm. • Tonicity of a solution determines if bodily fluid shifts will occur • Dextrose 5% in water (D5W) is the second most common type. Consists of glucose or dextrose in water to make it 285 mOsm (isotonic) • D5WNS is a combination of the two and is used when some calories in the form of glucose is needed. Hypertonic (580 mOsm about) but it is Ok to use. • 3 % Saline (NaCL) is only used to treat certain brain conditions. Very hypertonic and can cause death if used improperly • 23.4% saline (NaCL) used only in certain rare conditions and in small volumes. Will cause death if used improperly (remember Emily Jerry?)

30. Type of IV therapy • IV primary infusion consists of a drug that is given continuously through a large volume parenteral solution • IV Piggyback is a IV administration of a drug that is normally piggybacked to another primary IV via a Y site connection on the primary IV tubing. • IV Piggyback sets are designed to be small in volume usually 50 ml to 100 ml and are hung above the primary bag on the IV pole. (see next page) • Rate of infusion can be controlled by gravity and a roller clamps or by an electronic pump

31. Picture of IV Piggyback set up

32. A word about filters • At times a filter is needed to filter IV solutions • i.e. when breaking an ampule you need to use a filter needle to draw the solution to prevent glass particles from entering the IV. • A 0.22 micron filter is a special filter that is called a “sterilizing” filter that can sterilize a fluid as it is passed through the filter.