Term
| Drug Efficacy Study Implementation (DESI) |
|
Definition
| Allows generic competitors of approved brand name drugs to submit an abbreviated new drug application (ANDA) showing proof of bioavailability, bioequivalence and information on manufacturing and controls |
|
|
Term
| Who controls OTC advertising? |
|
Definition
|
|
Term
| Who controls Rx drug advertising? |
|
Definition
|
|
Term
| Advertising to Health Care Professionals by Manufacturers |
|
Definition
| True statement which provides information related to name of drug, active ingredients, and summary of information regarding side effects, contraindications, and clinical effectiveness |
|
|
Term
| When ddvertising to Health Care Professionals by Manufacturers does not apply: |
|
Definition
Reminder advertisements with no indications or dose recommendations;
Ads for bulk sale of drugs;
Ads by pharmacists regarding compounding |
|
|
Term
|
Definition
| Brochures, booklets, mailing pieces price lists, references, etc provided by manufacturer for use by health care professionals |
|
|
Term
| PhRMA Code on Interactions with Healthcare Professionals |
|
Definition
Voluntary attempt by manufacturers to reduce undue influence of manufacturers on prescribing habits;
Resulted in companies spending less on marketing and programming;
Focus on ensuring fair and balanced information from pharmaceutical companies |
|
|
Term
| Direct to Consumer Advertising |
|
Definition
Must contain true statement, a brief summary, and be fair and balanced;
Must contain adequate provisions to provide consumers with information regarding medication, uses and side effects |
|
|
Term
| FDA Adequate Provision Requirements |
|
Definition
Summary of risks in audio/visual format as long as it provides adequate provision for obtaining complete prescribing information from:
Toll free number,
Website,
Print advertisement in a concurrently running publication and,
Referral to a health care provider--”Ask your doctor or pharmacist” |
|
|
Term
|
Definition
| must provide summary of side effects, etc and adequate provisions to obtain further information |
|
|
Term
|
Definition
| does not name product and directs consumers to health care professional |
|
|
Term
|
Definition
Governmental agencies
Must provide peer-reviewed journal information;
Sales force generally must refer to medical science staff to provide this type of information;
FDA must approve content |
|
|
Term
| VA Definition: Proprietary Drugs |
|
Definition
Drugs that meet FDA requirements for OTC medications;
Cannot be a controlled substance or require a label indicating that it might be habit-forming;
Cannot be a product that must be administered by a licensed practitioner or dispensed by a pharmacy |
|
|
Term
| Does NOT include transportation of mixed, diluted, or reconstituted products for the purpose of administration by a practitioner in an office setting directly to patients |
|
Definition
| Dispensing; only includes delivery of a drug and prescribing and administering, packaging, labeling or compounding |
|
|
Term
| What is it called when physicians and other providers inject or provide medications in their office? |
|
Definition
|
|
Term
| Dispensing pharmacists and pharmacies exempt from extensive labeling requirements so long as the label: |
|
Definition
Meets the requirements established by the state;
Is not false or misleading;
Packaging and labeling conform to official compendia standards;
Drugs packaged and labeled appropriately;
Drug is packaged in conformance with the Poison Prevention Packaging Act when required; |
|
|
Term
| Dispensed prescriptions must contain: |
|
Definition
Name and address of dispenser (pharmacy);
Serial number of rx (pharmacy’s assigned number);
Date of rx or filling;
Name of prescriber (not address);
Name of patient (not address);
Directions for use and cautionary statements if necessary |
|
|
Term
| Poison Prevention Packaging Act of 1970 (PPPA) |
|
Definition
Designed to protect children from accidental poisonings with household substances, including prescription drugs;
Delegates authority to the Consumer Products Safety Commission to regulate and ensure compliance with requirements |
|
|
Term
| PPPA Requirements for Pharmacy |
|
Definition
Requires use of child-resistant containers for most OTC drugs and for all prescription drugs dispensed directly to consumers;
Containers meeting these requirements will be proven by manufacturer such that 80% of children less than 5 years of age cannot open them but at least 90% of adults can open them |
|
|
Term
| Do drug packaging for residents of long-term care facilities apply to the PPPA requirements? |
|
Definition
| Prescription drugs packaged for residents of long-term care facilities and other institutional settings exempt if the facility personnel will administer the medications to the patient |
|
|
Term
| PPPA exemptions for drugs that can be dispensed in vials without safety caps |
|
Definition
OTC products marketed specifically for elderly or disabled individuals with proper notation that the packaging is not child-resistant;
Exceptions for certain drugs dispensed in special containers or for certain uses;
Request could be oral but should be documented;
VA requirements under Special Packaging -
May post a sign near pharmacy department outlining policy;
Pharmacy must maintain a release of such request form the patient or authorized agent and be maintained for at least 2 years from dispensing date |
|
|
Term
| Who governs pharmamacist compounding? |
|
Definition
|
|
Term
| Actions that require pharmacists to register as manufacturers |
|
Definition
| Actions by pharmacists that result in changing the container, wrapper or labeling of products |
|
|
Term
| Compounding Nonprescription Products |
|
Definition
Must be labeled according to FDA provisions as any other OTC agent;
Cannot be prepared with any prescription ingredients |
|
|
Term
|
Definition
Involves mixing drug products for use by a patient pursuant to manufacturer’s instructions;
Not considered compounding |
|
|
Term
| VA Compounding Provisions |
|
Definition
Combining 2 or more ingredients into a single preparation and
Includes mixing, assembling, packaging or labeling of a drug or device; Prescribers that mix, dilute, or reconstitute a manufacturer’s product for the purpose of administration to a patient not compounding |
|
|
Term
| Labeling for Compounding Rx must include: |
|
Definition
Conform with VA standards for prescription label;
Name and strength of medications or list of active ingredients and strengths;
Pharmacy must number the prescription consistent with the compounding record;
Beyond use date determined by the pharmacist in compliance with USP-NF standards for pharmacy compounding;
Quantity |
|
|
Term
| Record-keeping for compounding |
|
Definition
| May be maintained electronically or manually so long as the information is readily retrievable |
|
|
Term
| When products compounded in advance of dispensing, use of bulk drug substances used: |
|
Definition
Generic name and quantity;
Name of manufacturer;
Manufacturer’s lot number and expiration date for each component or if unknown, the source of acquisition of each component;
Assigned lot number if subdivided;
Unit or package size and number of units prepared;
Beyond use date |
|
|
Term
|
Definition
FDA-registered facilities that must comply with GMPs, including all labeling requirements and product integrity requirements;
Repackages drugs from manufacturers and places them into new packaging; Repackaging different from prepackaging where pharmacy packages drugs from manufacturer’s container to a customized unit dose or other type of unique dispensing systems for direct patient use |
|
|
Term
|
Definition
3 segment unique code identifying drug product and packaging type;
First 4 numbers: manufacturer or distributor;
Second 4 numbers: drug;
2 final numbers: package type |
|
|
Term
|
Definition
| placing any drug from a manufacturer’s original container into different packaging |
|
|
Term
| Requirements for Drug Repackagers |
|
Definition
Applies to bulk reconstitution, bulk compounding, or repackaging;
Records must be maintained for one year or until the expiration date of the product, whichever is greater; MUST INCLUDE THE EXPIRATION DATE (Current guidelines: 6 months or one year if packaged in containers “better than PVC”) |
|
|
Term
| Requirements for Drugs Placed into Automated Counting Devices or Dispensers |
|
Definition
| Must maintain filing record either manually or in a computerized record that is readily retrievable; Manufacturer’s control or lot number for all lots placed into bin at time of filling |
|
|
Term
| Pharmaceutical equivalent |
|
Definition
| Contains the exact same product and the same salts as the original, brand name drug |
|
|
Term
| Pharmaceutical equivalent |
|
Definition
| Contains the exact same product and the same salts as the original, brand name drug |
|
|
Term
| Pharmaceutical alternative |
|
Definition
| exact product but different salts or excipient ingredients |
|
|
Term
|
Definition
Rate and extent of absorption of product;
Includes the requirements for the composition of the product |
|
|
Term
| FDA Requirements for Generic Substitution |
|
Definition
Compares bioavailability of the drug in 24-36 healthy volunteers;
Examines the AUC and peak drug concentrations (CMax);
Looks for a variation of AUC and CMax of between 20%-25% above or below brand name product |
|
|
Term
|
Definition
| allowed unless physician specifically requires drug dispensed as written |
|
|
Term
|
Definition
| requires provider authorization |
|
|
Term
| Dispensing of therapeutically equivalent drug products |
|
Definition
Permits pharmacists (not requires) dispensing of a therapeutically equivalent product written for a brand name product unless:
Prescriber indicates “brand medically necessary” OR
Patient insists on brand name drug |
|
|
Term
| Reference for therapeutic equivalence |
|
Definition
|
|
