Principles of Pharmacy Practice: Drug Info Resources Flashcards
Package inserts
- FDA requires drug manufacturers to supply a package insert for all prescription meds
- Also known as “prescribing information” or “PIs”
- Intended for use by healthcare professionals NOT patients
Sections of package inserts, 1 (in order)
- highlights
- table of contents
- indications and usage
- dosage and administration
- contraindications
- warnings and precautions
- adverse reactions
- drug interactions
- use in specific populations
Highlights
- Contains most important prescribing information about benefits and risks of using the drug
- Helps find important information quickly
- Contains boxed warnings, the most serious safety alerts
Table of contents
• A reference area for the location of detailed or specific prescribing information
Indications and usage
- Lists disease states/conditions the medication is approved to treat
- Off-label uses are NOT listed on the package insert
Dosage and administration
• Contains recommended doses, dosing schedules, and administration requirements
Contraindications
• Lists situations when the medication should NOT be used
‒ Certain disease states
‒ Interacting drugs
‒ Allergic reactions
Warnings and precautions
- Lists situations that require caution while taking the medication
- Contains boxed warnings
- Lists lab tests that can affect the drug
Adverse reactions
• Lists reported side effects from the drug’s testing phases
• Contains postmarketing experience
‒ Side effects reported AFTER the drug hit the market
Drug interactions
- Lists the most significant drug-drug interactions involving the medication
- Lists lab tests that can affect the drug
Use in specific populations
• Lists safety concerns when using the drug during pregnancy, during labor and delivery, while
breastfeeding, in children, and in the elderly
Drugs that were approved BEFORE Just 30, 2001…
…are not required to follow the same formatting.
The adverse reactions area of the Highlights section contains a phone number and web address for…
…FDA’s MedWatch Program.
Reminder: off-label indications are…
…NOT listed in the package inserts. Inserts only list FDA-approved indications.
The dosage forms and strengths section provides…
…info about the forms the medication comes in, such as tablets or capsules, plus the strength for each form.
The contraindications section lists situations when…
…a drug can NOT be used.
Side effects reported AFTER a drug hits the market are known as what kind of experience?
Postmarketing. This can be found under the Adverse Reactions section.
Pregnancy ratings were…
…removed in 2020, as they oversimplified the risks to pregnancy.
Sections of Package Inserts, 2 (in order)
- drug abuse and dependence
- overdosage
- product description
- clinical pharmacology
- nonclinical toxicology
- clinical studies
- how supplied
- patient counseling information
- package insert limitations
Drug abuse and dependence
- Lists the medication’s controlled substance classification
* Lists the abuse and tolerance potential of the drug
Overdosage
• Lists the signs, symptoms, and treatment options during an overdose situation
Product description
• Provides the medication’s – Chemical name – Structural formula – Active ingredients – Inactive ingredients (dyes, fillers, flavorings, etc.)
Clinical pharmacology
- Used mostly by pharmacists and prescribers
- Contains information on how the medication works (mechanism of action)
- Explains how the medication is absorbed, metabolized, and eliminated from the body
- Gives explanations of the studies performed with the medication, in different populations
Nonclinical toxicology
- Used mostly by pharmacists and prescribers
* Lists any cancer and fertility risks from using the medication
Clinical studies
- Used mostly by pharmacists and prescribers
* Provides information from the clinical studies showing how well the drug works for its approved indications
How supplied
• Lists the medication’s
– Dosage forms
– Color
– Markings
– Special storage and handling instructions
• Some package inserts will list the shape of the medication
Patient counseling information
• Highlights the most important counseling points about the medication for the pharmacist or prescriber
Package insert limitations
- Takes significant time to update since wording must be approved by FDA
- May not have up-to-date information
Examples of commonly seen and reliable drug information include:
Clinical Pharmacology, Micromedex, and Lexicomp
The Orange Book…
- Informs which generics are equivalent to which brand name drugs
- Helps determine if substitution is allowed
- Contains “Therapeutic Equivalency” ratings or “TE codes”
Therapeutically Equivalent Definition
• Generic products must be identical in active ingredients, strength, and dosage form to the brand
name
‒ Must also absorb and release identically in the body
• Expected to have the same safety profile and chemical effect
Therapeutically Equivalent Ratings
• The rating code is usually comprised of two letters and sometimes numbers
• TE Codes – 1st Letter
‒ Usually begins with “A” or “B”
‒ “A” designates products that demonstrate therapeutic equivalence
‒ “B” designates products that have not demonstrated therapeutic equivalence
• TE Codes – 2nd Letter
‒ “A” indicates oral dosage form
‒ “B” indicates bioequivalence
‒ “N” indicates a product for aerosolization
‒ “P” indicates parenteral/injectable products
‒ “T” indicates topical dosage form
Other drug info resources
• Journals
• Professional magazines
• Newsletters (Pharmacy Technician’s Letter)
• May be available as electronic or print formats
• Keeps technicians informed of new technology, new medications, recalled meds, and new
trends affecting the practice of pharmacy
Facts and comparisons eAnswers
- Online drug reference
- Allows for side-by-side comparison of drugs
- Contains a drug identification tool
- Can search for product availability and generic alternatives
- Print version Drug Facts and Comparisons has been discontinued
Physicians’ Desk Reference or Prescribers’ Digital Reference (PDR)
• Print version Physician’s Desk Reference is a compilation of package inserts
‒ No longer published after June 2017
• Online reference is Prescribers’ Digital Reference
• Provides same drug information as print version plus FDA safety updates
• Includes information on medications from drug companies that are willing to pay to advertise
• Contains the same drug information that is found in package inserts attached to drug bottles
and packages
United States Pharmacopeia-National Formulary (USP-NF)
• Defines the standards for medications:
‒ Dosage forms
‒ Drug substances
‒ Excipients or inactive ingredients
• Contains the official title of a medication
• Sets standards for strengths and purity
• Sets procedures for proper handling and storage
• Contains formulas for manufacture and preparation
• Provides recipes and specific information for the materials used when compounding
Handbook on Injectable Drugs
• Also referred to as Trissel’s • Provides information about parenteral meds ‒ Intravenous ‒ Intramuscular ‒ Subcutaneous • Available dosage forms • Trade or brand names • Administration requirements • Stability information • Special preparation requirements • Compatibility or incompatibility issues with other meds
Natural Medicines
• Provides up-to-date information on dietary supplements, vitamins, minerals, and other natural
remedies
• Available as an online database
• Has a drug-herb interaction checker and product ratings
• Contains the Natural Medicines Watch
• Allows healthcare professionals to alert researchers and FDA about any suspected adverse
effects of supplements, vitamins, and minerals
