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Pharmaceutical industry procedures for obtaining pharmaceuticals
- group purchasing organization: negotiates prices for hospitals and institutions but does not make the actual purchase for the institution
- purchase from drug merchandiser: allows pharmacies to purchase in bulk, resulting in a savings for the company. Wholesalers may not always stock specific medications because of storage conditions, expense, or low demand.
- purchase from wholesalers: stocks medications from all manufactures. Pharmacies are able to purchase when they need a product, rather than far in advance. Wholesalers may provide special services, automated ordering systems, or automated purchasing systems.
- Government: requires pharmacies to used Drug Enforcemnet Agence DEA form 222 to purchase schedule ll drugs
Purchasing policies, procedures and practices
- Just in time ordering: ordering a product before running out; the product is shipped to the pharmacy immediatel. the pharmacy will normally receive it the same day or the next business day. A method to keep an inventory low and maximize profit.
- Point of sale: Item is deducted from inventory as it is dispensed and in many situations is automatically reordered.
- Purchase order: A form that is used to order drugs and supplies from a wholesaler. Information foundon a purchase order include the following:
- name and address of the institution
- shipping address
- date the order was placed
- vendors name and address
- purchase order number - a tracking number used to identify a purchase order
- ordering departments name and location
- expected date of delivery
- shipping terms
- account name or billing designation
- description of items ordered
- quantity of items ordered
- unit price
- extended price
- total price of the order
- buyers name and phone number
A dosage form is a system or device for delivering a drug to a biologic systerm.
- advantages of solid dosage forms
- easy to package, transport, store, and dispense
- convenient for self medication
- lack smell or tast
- extremely stabel for products that are not stable in liquid form
- predivided dosage form
- suited for sustained or delayed release medication
examples of solid dosage forms
- tablets: prepared either by compressing or by molding. The dosage form is accurate, compact, portable, and easy to administer. May come in various shaped; may be scored (able to be broken in havles or quarters). The most commone types of marketable tablets include standard compressed, enteric coated, sugar coated, film coasted, sublingual or buccal, multiple compressed, chewable, sustained-action, and delayed-action tablets.
- Capsules: A drug is contained in a shell of gelatin (either soft or hard) that dissolves in 10 to 20 minutes. Drug may be in either a solid or liquid form. Shape of dosage form may be spherical or ovoid. Capacity of capsule may bary by up to 1g. Can be produced manyally by using the punch method.
- Effervescent salts: granules or powders; when dissolved in water, they effervesce and release carbon dioxide.
- Implants or pellets: dosage forms that are placed under the skin through injection and are effective for a long period.
- Lozenges, troches, or pastilles: solid dosage forms with flavoring that dissolves in the mouth.
- Pellets: small culinders that are implanted subcutaneously for continuous absorption.
- Plasters: medicated or nonmedicated preperations that adhere to the skin by a backing material.
- powders: finely ground substances that can be administered internally or externally. chief disadvantages are their taste and that they are not stable when exposed to the atmosphere. may be dispensed in a bulk form, in a multidose form, or as a divided dose such as a powder paper.
- suppositories: solid dosage forms to be inserted in body orifices, such as the rectum, vagina, or urethra. may work either locally or systemically. mechanism of action is either through melting or dissolving and release of medication over time. not all products are available as suppository. major disadvanteages if a suppository are that itmay be easily expelled from the body and thet absorption of medicaiton into the body can be erratic.
oral sustained-release dosage forms
- constant release
- continuous action
- continuous release
- controlled action
- controlled release
- delayed absorption
- delayed action
- extended action
- extended release
- gradual release
- long acting
- long lasting
- long term release
- programmed release
- prolonged action
- prolonged release
- protracted release
- repeat action
- slow acting
- sustained action
- sustained release
- sustained-release depot
- time disintegration
- timed release
- advantages of liquids:
- effective more quickly than a solid dosage form because the drug is already dissolved in a liquid
- easier to swallow than a solid dosage form for many patients
- drugs may be available only in liquid form owing to convenience of administration
- uniformity and flexibility of dosage form
- certain medications may cause gastrointentinal distress if administered in solid dosage form
- disadvantages of liquid:
- deterioration and loss of potency occur more quickly than in a solid dosage form
- may require special sweetening or flavoring to be palatable
- incompatibilities of dissolved substances
- may require preservatives to prevent bacteria or mold from developing
- inaccurate measureing of a dose for a patient my occur
- bulkier to carry than solid dosage forms
- interactions may develop from changes in solubility
solutions contain a solute that is dissolved in a solvent. They may be aqueous, alsoholic, or hydroalcoholic.
- aromatic waters: solutions of water-containg oils that have a smell and are volatile
- collodion: topical dosage form that contains pyroxylin and is dissolved in alcohol and ether
- elixir: a clear, sweetened, flavored hydroalcoholic solution, containing water and alcohol, that may or may not be medicated
- enema: a sollution administered rectally for either cleansing or drug administration
- extract: a process by which active ingredients are removed from their source through the application of solvents
- douche: an irrigating or bathing solution
- isotonic (iso-osmotic): having the same tone or osmolarity of another substance. there is no loss or gain of water by the cell. dilution of an isotonic solution may affect the composition of solution. an example is an opthalimic solution
- liniments: either alcoholic or oleaginous solutions or emulsions that are applied through rubbing
- spirits: alcoholic or hydroalcoholic solutions containing volatile aromatic ingredients
- syrups: aquesous solutions containing sucrose or sucrose substitutes
- tinctures: alcoholic or hydroalcoholic solutions of pure chemicals or extracts.
Dispersion consists of a solute dispersed through a dispersing vehicle
- suspension: a two phase system in which solid particles are dispersed in a liquid vehicle. a suspension may be oral, topical, or injectable. suspended material should not settle rapidly and should pour freely. Topical solutions should be fluid enough to spread over the affected area, but should not run off the surface of application. They dry quickly. The provide a protective film and have an acceptable color and odor.
- Emulsion: One liquid is despersed in another liquid; may be water in oil (w/o), or oil in water (o/w). Emulsions are stabalized through the use of an emulsifying agent. Oral emulsions are o/w preparartions; topical emulsions may be either o/w (washable and nonstaining) or w/o. An o/w emulsion will become diluted with water, but a w/o emulsion will not.
- Lotion: A liquid for topical application that contains insoluble solids or liquids.
- Gels: A two-phase system containing an extremely fine solid particlew that, when mixed, has a semi-solid form. It is very difficult to distinguish between the two phases.
- Ointment: A semisolid dosage form topical application. Anhydrous ointments absorb water but are insoluble in water and are not water washable. Oleaginous ointments are insoluble in water, do not contain or absorb water, and are not water soluable.
- Pastes: Similar to ointments but contain more solid materials.
- Creams: topically applied o/w emulsions.
Inhalants are gases, vapors, solutions, or suspension intended to be inhaled either orally or intranasally.
- Aerosol: a spray in a pressurized container that contains a propellant, an inert liquied, or gas under pressure meant to carry the active ingredient to its location of application. Particles may be either a fine solid or a liquid. Aerosols are used for administration into body cavities. They are convenient and easy to apply.
- Spray: A dosage form that consists of a container with a valve assemble that when activated, will emit a dispersion of liquid, solid, or gaseous material.
Transdermal products provide systemic therapy for acute or chronic conditions that do not involve the skin.
A transdermal product delivers a controlled dose of medication through the skinand is absorbed directly into the bloodstream. It is a convenient system that results in improved patient compliance, accurate drug dosage, and regulation of drug concentration.
Formulary or approved stock list
- Formulary: A list of drugs taht are approved for use in an institution such as a hospital or whose cost will be reimbursed by a third-party carrier to a pharmacy. Formulary systems include open formulary (all pharmaceutical products carried) closed formulary (limited number of products of each drug classification convered) or restricted formulary (a hybrid of both open and closed formularies.) Formularies may define policies, procedures, and guidelines established by the medical staff regarding a medicaitons usage. Formularies are revised yearly and a process must be in place for revisions.
- Pharmacy and therapeutices (P&T) committee: A committee composed of pharmacists, physicians, nurses, pharmacy buyers, and accountants who develop a formularty for a hospital. The most effectivetherapeutic agents are chosen for an institution. A formulary may contain a generic and name-brand name index, dosage forms and strengths, formulations, packaging and sizes available, dosage guidelines, approved abbreviations for the institution, policies on investigational medication for the institution, policies on investigational medications, electrolyte content of large volume parenterals, and lists of available nutritional and sugar-free products,
- Third party (managed care) provider: a provider that may develop a formulary for its member regarding products covered for reimbursement. They are referred to as pharmacy benefits providers.
Par and reorder levels and drug usage
- PAR value (periodic automatic replacement): The amount of drug that is automatically reordered. In automatic reordering systems, when a drug falls below a predetermined quantity, it is automatically reordered.
- Minimum and maximum: A predetermined number that states the minimum and maximum amount of medication to be kept on a shelf. The smaller the range, the more accurate the quantitiy to be stocked. This system eliminates guesswork from the individual ordering the medication. The system is based on historical data for an institution and current trends.
Inventory receiving process
- verify incoming merchandise (drug, dosage form, strength, package size, number of units, and expiration date) against packing slip or invoice.
- Any merchandise requiring special storage, such as refrigeration, should promptly be verified and placeds in proper conditions to avoid damage or loss of potency.
- Sign and date invoice.
- Forward documentation to accounts payable.
- Place merchandise on shelf, and rotate product by placing product with shortest dating in front and longest dating behind it.
- Retain appropriate paperwork in the pharmacy as outlined in the Controlled substances act (OSHA) requirement, or the institutions policy and procedure manual.
Bioavailability standards and generic substitutes
- Bioavailability of pharmaceutical products: A measurement of both the rate of absorption and the total amount of drug that reaches the general circulation from an administered dosage form. Dissolution of the pharmaceutical product affects the absorption of the drug, which is also affected by the properties of the drug and the dosage form. All generic drugs must contain the same active ingredients as the original brand indications; meet the same batch requirements for identity, strength, purity, quality; and yield similar blood absorption and urinary excretion curves as the active ingredient.
- Therapeutic equivalent; A drug product that when administered in teh same amount, will provide the same therapeutic effect and pharmacokinetic characteristics as another drug with which it is compared.
- Therapeutic substitution: The substitution of a new drug product with another that differs in comosition but is considered to have the same or very similar pharmacologic and therapeutic activity.
Regulatory requirements regarding record keeping for repackaged, recalled, and refunded products
- Labeling: the labeling must contain the following information:
- generic name of the drug
- dosage form
- manufacturers name and lot number
- expiration date after repackaging
- Repackagin log: The log contains documentation required for repackaging medication and must be signed by the pharmacist with:
- date of repackating
- name of drug
- dosage form
- drug manufacturer
- manufacturers expiration date and lot number
- pharmacy lot number
- expiration date assigned by the pharmacy
- quantity of drug repackaged
- pharmacy technicians initials (if tech repackaged)
- licensed pharmacists initials
Expiration date of repackaged drugs: Federal law mandates that the expiration date cannot exceed 6 months and cannot exceed 25% of the remaining time on the manufacturers original expiration date on bulk containers.
- Recalled medications:
- Pharmacy notified by manufacturer or wholesaler by mail or fax.
- pharmacy determines if recalled medication is currently in stock.
- pharmacy contacts patients who may have received medication. If a customer has the recalled product, the medication should be returned to the pharmacy for refund or substitution.
- Recalled medication returned to manufacturer for credit.
- Reorder medication that has been recalled. Notify physician of recalled medication; inquire if the physician wishes to change the medication order, especiallyh if product may not be available for a long period.
- Refunded products:
- unit dose: may be redispensed if not tampered with or beyond use date
- multidose vial: cannot be redispensed in many states. A pharmacy technician must be aware of state pharmacy regulations on this issue. Many states are examining this issue.