ADMs Automated dispensing machines Automated dispensing machines A machine comprised of cabinets of various sizes that contain compartments for different medications Security level of Automated dispensing machines The cabinets contain varying degrees of security based on the institutions requirements and the nature of the substances Individual access to medications The items the individual can retrieve depends on the individual's programmed level of access to various items. Effect of ADMs on turnaround time ADMs have decreased turnaround time dramatically Benefits of ADMs Decreases turnaround time for medication orders Benefits of ADMs Provides a high level of security for the hospital or health care facility Tracking access to medications Individuals who gain access to any medication are tracked by the computer system based on their password or biometrics marker Cost savings from ADMs Saves healthcare facilities thousands of dollars Emergency override system in ADMs Contains an emergency override system that can allow for the removal of medications in a critical situation Unit-dose dispensing technology This allows some ADMs to give access to only the exact units of medication that are being used instead of the whole inventory NDC National Drug Code Purpose of the NDC Identifies the drug establishment, drug formulation, and size/type of product packaging Permanent product code for medications The National Drug Code Sets of numbers in NDC Three sets of numbers First set of three numbers of the NDC Indicates the manufacturer Second set of three numbers of the NDC Represents medication strength and dosage form Last set of three numbers of the NDC Represents package size NDC label requirement on prescriptions Must be included on every prescription label to ensure proper identification that the correct medication is being pulled for filling NDC number indication in pharmacies Some pharmacies use barcodes to indicate the NDC number Dispensing legend medications According to the FDA, legend medications can be dispensed by a prescription from a practitioner licensed to administer and prescribe legend medications Labeling requirements for legend medications Pharmacy name and address, serial number or prescription number, date of fill, expiration date, prescriber's name, patient's name, directions for use, cautionary statements FDA labeling of OTC products Safe for self-medicating Label for OTC medications Includes product name, name & address of manufacturer, name of distributor, name of person/place responsible for repackaging, established name of all inactive or active ingredients & the quantities of some other ingredients, net contents, required cautions and warnings, name of any potentially habit-forming medication contained in the formula, adequate directions for use or consumption Behind-the-counter (BTC) medications Nonprescription products that carry an element of risk but can still be purchased without a prescription Reasons for BTC placement Because the pharmacy needs to keep a specific registration and provide extra warnings Examples of medications kept BTC Products that contain pseudoephedrine or ephedrine are kept BTC to control the illegal compounding of methamphetamine Cough syrups Cough syrups that contain guaifenesin and codeine Emergency contraceptives Purchaser must be 17 years old and have a valid ID & pharmacy must keep record Medication recall The pharmacy is notified which lot number is being recalled Original packaging Many medications should be dispensed in original packaging for their protection Dabigatran (Pradax) Dispensing in original packaging protects it from degradation and moisture Azithromycin (Z-Pak) Original packaging contains special instructions for patient Methylprednisolone (Medrol) dose pack Original packaging contains special instructions for patient Antibiotic suspensions Medication powders that need to be reconstituted Nitroglycerin sublingual tablets Original GLASS container should be kept away from heat, moisture, and direct light Manufacturers packaging It reduces the chance that medication is handled inappropriately or exposed to unclean or unsafe environments Personal Protective Equipment (PPE) Some medications with special handling requirements require dispensers to wear PPE when handling these medications Teratogen An agent that can disturb the development of an embryo or fetus Effects of teratogens Teratogens halt the pregnancy or produce congenital malformations or birth defects Common teratogenic medications Finasteride (Proscar Propecia), Dutasteride (Avodart), Thalidomide, Methotrexate, Any chemotherapy or antineoplastic agent REMS Risk evaluation & Mitigation strategies Purpose of REMS A risk management plan that uses strategies beyond professional labeling to ensure that the benefits of certain prescription medications outweigh their risks ETASU Elements to assure safe use Definition of ETASU Required medical interventions health care professionals need to execute prior to prescribing or dispensing medication to a patient Examples of ETASU Providers have specific training, experience, or certifications; Each patient using medication is subjected to monitoring; Medications are dispensed with evidence of safe-use conditions such as a laboratory test result USP <800> Ensures new standards for handling hazardous materials Key elements of USP <800> Facility design: Hazardous medications must be stored in negative/normal/neutral pressure & compounding must be completed in certified biological safety cabinets/compounding aseptic containment isolators in a separate room with negative pressure. Garbing in USP <800> Detains for PPE are based on the function being performed Cleaning in USP <800> Deactivation & disinfection with an oxidizer, cleaning with germicidal detergents, & disinfection with sterile alcohol Administering in USP <800> Closed-system medication-transfer devices should be used when compounding Color of prescription vials The color is to protect the medication from light Counting trays Medications counted on when not dispensed from a machine Ray cleaning The ray should be cleaned before another medication is counted. Common medications causing allergic reactions Penicillin- & Sulfa- containing groups. Factors for medication packaging Medication dosage form, size, shape, form, and amount. Prescription vials measurement Measured in drams, size ranges from 6-60 drams. Ointment jar medication types Ointments, creams, and suppositories. Blister packaging use A medication card that includes individual compartments for each tablet. Poison Prevention Packaging Act of 1970 All medications are required to be packaged in childproof containers unless the patient requests otherwise. Labeling of medication Includes pharmacy name, address, & phone number, prescription number, dispense date, patient name, directions, name, strength, and dosage form of the medication, number of refills, prescriber's name, expiration date (state specific), name or initial of dispensing pharmacist (state specific), and caution: 'Federal law prohibits transfer of this medication to any person other than for whom prescribed.' Auxiliary labels Labels placed on medication containers to help educate patients about proper use of the medication. Popular categories of auxiliary labels Administration and route of administration, dosing, storage, dietary restrictions, expiration, warning and caution. Auxiliary labels relation to pharmacy label Auxiliary labels are an extension of the pharmacy label. Medication guides Paper handouts that the FDA requires to be given to patients on certain medications. Purpose of medication guides To address important patient safety concerns that are particular to a specific medication or medication class. Conditions for medication guides distribution Precautionary information is necessary to prevent serious adverse events, patient decision-making should be informed by information about a known serious side effect with a product, and patient adherence to directions for the use of a product is essential to its effectiveness. Common medication classes requiring guides NSAIDs, antidepressants, ADHD/ADD, long-acting beta-agonists (LABAs), products containing isotretinoin. Location of medication guides list The FDA's website. Patient package insert (PPI) A document provided by the manufacturer with additional information about the medication. Purpose of consumer information sheet To help all consumers understand key information about their prescription medicine; it is required with all new prescriptions. Shipping medications out of state Can require the dispensing pharmacy to have a state license for the state being shipped to. Insulin storage temperature 2.2 to 7.8 degrees C, 36 to 46 degrees F. DME supplies and Medicare Medicare requires patients to sign and date for supplies on the date they are filled & picked up for use, ensuring patients receive correct medication. Location of OTC medications in pharmacy The pharmacy front end. Omnibus Budget Reconciliation Act of 1990 (OBRA '90) Focused on funding of the Medicare & Medicaid programs; mandated that pharmacists perform drug utilization reviews and offer counseling to patients. Impact of e-scripts The increase in the use of e-scripts has decreased the chance of prescriptions being altered. Controlled prescriptions requirements Some states require them to be written on tamper-resistant paper that contains a special watermark of the word 'COPY' visible in the background.