Glossary of Pharmacy-Patient Communication Terminology
This is a brief glossary of terminology and concepts used on this website.
Auxiliary warning labels
Labels on pill bottles that provide supplementary instructions, such as “Take with food” or “Do not chew or crush, swallow whole.”
A relatively rare warning issued by the FDA to notify physicians and patients about a potential serious safety concern or risk posed by a medication. The boxed warning, when issued, is required to be put prominently on or within the drug’s box or packaging.
Other Names: Also referred to as “Black Box Warning.”
Consumer Medication Information (CMI) leaflets
Federal law (P.L. 104-180) in the US requires that new prescriptions be dispensed with written CMI. The law further requires that content and format of CMIs must be useful for patients, as defined by criteria developed by the Keystone Committee.
The content and format of each written consumer medication information sheet, i.e., a CMI leaflet, that is dispensed by a pharmacist with a prescription is usually developed by private companies. Provided voluntarily by pharmacies to meet goals established by Congress, it is usually stapled to the outside of or put in the pharmacy bag with the patient’s prescription.
While these leaflets are based on FDA-approved labeling, their specific content and format are not subject to FDA approval. However, the FDA has authority to evaluate these pharmacist-delivered CMIs for usefulness. If the private sector fails to meet the goals of the Keystone Committee by 2006, the FDA has the authority to regulate the content and format of all future written information dispensed to patients with prescription drugs.
Other Names: A one-page leaflet from Lexi-Comp Inc. is marketed as Patient Advisory Leaflet (PAL).
Drug Label is an FDA approved document written by the drug manufacturer. The Drug Label constitutes the official description of a drug product. It has several mandatory sections, including the statement of the drug’s intended use, it’s clinical pharmacology (how the medication works in the body), contraindications (who should not take the drug), any known side effects and safety information for the patients. The Drug Label also has specific instructions about the medication’s use by pregnant women, children, other special at-risk
populations, and safety information for the patient.
The term used by the European Medicines Agency (EMEA)—the European Union’s equivalent of the FDA—is called a Patient Information Leaflet (PIL).
Although labels are often found inside drug packaging, Drug Labels do NOT have to be given to patients.Drug Labels can be up to several dozen pages long and use technical, scientific language and concepts.They are written primarily for physicians and pharmacists and are not expected to be understood by the average consumer.
Other Names: “Drug Product Label,” “Professional Label” or “Package Insert” (the latter should not to be confused with “Patient Package Insert” or PPI).
Limited English Proficiency (LEP)
Refers to people who are unable to communicate effectively in English because their primary language is not English and they have not developed fluency in the English language.Most regulations covering language access in pharmacies stipulate the threshold of proficiency that is adequate to communicate about safe and effective administration of prescription medications.
Generally, individuals who self-identify as unable to speak English “very well” are considered by federal agencies to be LEP.
Medication Guide (MedGuides)
Medication Guides are paper handouts that come with some, but not all, prescription medicines.The guides must be given to patients with every new and refilled prescription.
The guides are written by drug companies for consumers, but they are mandated by the FDA and the language of the MedGuides is approved by the FDA. MedGuides are generally issued under circumstances where the drug is considered to have significant safety issues that puts patient or public health at risk.
MedGuides primarily emphasize risks as opposed to benefits. There are just over 200 medications currently requiring MedGuides. The current list of covered drugs and their MedGuides is available on the FDA’s Drug Safety portal.
Patient Information Leaflet (PIL)
The term used by the European Medicines Agency (EMEA) for the Drug Label.
Package Insert (PI)
See Drug Label.
Patient Information Sheets (PIS)
Currently, PIS exist solely on the FDA’s website and, unlike private sector CMI leaflets, PIS are not disseminated through community pharmacies. Healthcare professionals are encouraged by the FDA to download and provide PIS to consumers.
Patient Package Insert (PPI)
PPI’s are only issued for oral contraceptives (birth control pills) and medicines with estrogen, as well as some other prescription medicines as decided by the FDA or the drug company. PPI’s are generally contained on the unit-of-use package. The text of the PPIs is written by drug manufacturers and approved by the FDA.
℞ (Rx, Prescription, Script)
“Rx” is an abbreviation of the Latin “recipe”, the imperative form of “recipere” which means “take thus”. A prescription is a physician’s directive to the pharmacist with instructions on preparing and administering medicine or other therapy. It normally consists of four parts:
- The superscription section (above the ℞ sign, hence the name) contains the date of the prescription and patient’s name and address;
- The inscription specifies the ingredients and quantities of the medication;
- The subscription section contains dispensing directions to the pharmacist, possibly including compounding instructions or quantities.
- The SIG section contains directions to the patient on how and when to take the medicine prescribed (see SIG, below).
SIG is a standard part of a written prescription that specifies directions for use of the medicine. It is normally printed on the label of the pill container itself, along with the name of the medication, names of the patient and the prescriber, refills remaining, etc.
SIGs provide physician’s or pharmacist’s instructions to the patient on how, how much, when and how long the drug is to be taken.They usually specify frequency, route of administration, and any special instructions important in administering the medication. Examples of SIGs include “Take one tablet by mouth every four to six hours,” or “Take 2 tablets by mouth once daily on day one then 1 tablet once daily on days two through five.”
SIGs should not be confused with SIG Codes .
Sig Codes are common Latin abbreviations used by physicians and pharmacies when communicating prescription information to each other. Common examples of Sig codes are QD, from Latin “quaque die” or “once a day” , TID (Latin “ter in die”, or “three times a day”), and PO (Latin “per os”, or “by mouth”). Sig codes originated from Latin medical terminology – in fact, the term “SIG” itself is the abbreviation of the Latin word “signa”, which means “label”.
SIG codes, unlike SIGs themselves, are not meant to be understood by patients. A typical SIG written by a physician for the pharmacist may read “1-2TQ6-8P”.It is then translated by the pharmacy technician into (arguably) more readable English in the process of entering a new prescription into the pharmacy dispensing system or PMS. In this case, the translation of 1-2TQ6-8P would be the SIG “TAKE 1 OR 2 TABLETS EVERY 6 TO 8 HOURS AS NEEDED”.
How to Learn More about RxTran Pharmacy Language Services
To get more information about our pharmacy language services, call 617-621-0945 or email firstname.lastname@example.org to find out how RxTran can help you provide a more comprehensive set of services to your pharmacy clients.
Available 24/7 365 days a year in over 150 languages:
- No Monthly Fees
- No Minimum Usage
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Massive online, growing database of foreign language drug instructions to print directly onto prescription labels:
- Directions for Use (SIGs)
- Auxiliary Warning Labels
- Patient Education Sheets
Available 24/7 365 days a year in over 150 languages:
- Help your Limited English Proficiency Patients understand how to take their medication
- Download CMI Leaflets instantly when you need them
- Fast, Convenient and Integrated with you Pharmacy Management System