Patient Information Leaflets
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A package insert is a document included in the package of a
medication Medication (also called medicament, medicine, pharmaceutical drug, medicinal product, medicinal drug or simply drug) is a drug used to medical diagnosis, diagnose, cure, treat, or preventive medicine, prevent disease. Drug therapy (pharmaco ...
that provides information about that drug and its use. For
prescription medication A prescription drug (also prescription medication, prescription medicine or prescription-only medication) is a pharmaceutical drug that is permitted to be dispensed only to those with a medical prescription. In contrast, over-the-counter drugs ca ...
s, the insert is
technical Technical may refer to: * Technical (vehicle), an improvised fighting vehicle * Technical area, an area which a manager, other coaching personnel, and substitutes are allowed to occupy during a football match * Technical advisor, a person who ...
, providing information for
medical professionals A health professional, healthcare professional (HCP), or healthcare worker (sometimes abbreviated as HCW) is a provider of health care treatment and advice based on formal training and experience. The field includes those who work as a nurse, physi ...
about how to prescribe the drug. Package inserts for prescription drugs often include a separate document called a "patient package insert" with information written in
plain language Plain language is writing designed to ensure the reader understands as quickly, easily, and completely as possible. Plain language strives to be easy to read, understand, and use. It avoids verbose, convoluted language and jargon. In many countr ...
intended for the
end-user In product development, an end user (sometimes end-user) is a person who ultimately uses or is intended to ultimately use a product. The end user stands in contrast to users who support or maintain the product, such as sysops, system administrato ...
—the person who will take the drug or give the drug to another person, such as a minor. Inserts for
over-the-counter medication Over-the-counter (OTC) drugs are medicines sold directly to a consumer without a requirement for a prescription from a healthcare professional, as opposed to prescription drugs, which may be supplied only to consumers possessing a valid pres ...
s are also written plainly. In the United States, labelling for the healthcare practitioner is called "Prescribing Information" (PI), and labelling for patients and/or caregivers includes "Medication Guides", "Patient Package Inserts", and "Instructions for Use". In Europe, the technical document is called the "summary of product characteristics" (SmPC), and the document for end-users is called the "patient information leaflet" (PIL) or "package leaflet". Similar documents attached to the outside of a package are sometimes called ''outserts''.


Responsible agencies

Each country or region has their own regulatory body. In the European Union, the
European Medicines Agency The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products ...
has jurisdiction and the relevant documents are called the "summary of product characteristics" (SPC or SmPC) and the document for end-users is called the "patient information leaflet" or "package leaflet". The SPC is not intended to give general advice about treatment of a condition but does state how the product is to be used for a specific treatment. It forms the basis of information for health professionals to know how to use the specific product safely and effectively. The package leaflet supplied with the product is aimed at end-users. In the United States, the
Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...
(FDA) determines the requirements for patient package inserts. In the United States, the FDA will occasionally issue revisions to previously approved package inserts, in much the same way as an auto manufacturer will issue recalls upon discovering a problem with a certain car. The list of 1997 drug labelling changes can be found on the FDA's website
here
The first patient package insert required by the FDA was in 1968, mandating that
isoproterenol Isoprenaline, also known as isoproterenol and sold under the brand name Isuprel among others, is a sympathomimetic medication which is used in the treatment of acute bradycardia (slow heart rate), heart block, and rarely for asthma, among other ...
inhalation medication must contain a short warning that excessive use could cause breathing difficulties. The second patient package insert required by the FDA was in 1970, mandating that
combined oral contraceptive pill The combined oral contraceptive pill (COCP), often referred to as the birth control pill or colloquially as "the pill", is a type of birth control that is designed to be Oral administration, taken orally by women. It is the oral form of combi ...
s must contain information for the patient about specific risks and benefits. The patient package insert issue was revisited in 1980 and in 1995 without conclusive action being take

Finally, in January 2006, the FDA released a major revision to the patient package insert guidelines, the first in 25 years. The new requirements include a section called Highlights which summarizes the most important information about benefits and risks; a Table of Contents for easy reference; the date of initial product approval; and a
toll-free number A toll-free telephone number or freephone number is a telephone number that is billed for all arriving calls. For the calling party, a call to a toll-free number is free of charge, unless air-charges apply for mobile telephone service. A toll-free ...
and Internet address to encourage more widespread reporting of information regarding suspected adverse events. Other national or international organizations that regulate medical information include the Japanese Ministry of Health, Labour, and Welfare (MHLW). Other country-specific agencies, especially in the case of EU (
European Union The European Union (EU) is a supranational union, supranational political union, political and economic union of Member state of the European Union, member states that are Geography of the European Union, located primarily in Europe. The u ...
) countries and candidates, plus countries of South America and many in Asia and the Far East, rely heavily on the work of these three primary regulators.


Sections of the Prescribing Information

The Prescribing Information follows one of two formats: "physician labeling rule" format or "old" (non-PLR) format. For "old" format labeling a "product title" may be listed first and may include the proprietary name (if any), the nonproprietary name, dosage form(s), and other information about the product. The other sections are as follows: * Description - includes the proprietary name (if any), nonproprietary name, dosage form(s), qualitative and/or quantitative ingredient information, the pharmacologic or therapeutic class of the drug, chemical name and structural formula of the drug, and if appropriate, other important chemical or physical information, such as physical constants, or pH. *
Clinical Pharmacology Clinical pharmacology is "that discipline that teaches, does research, frames policy, gives information and advice about the actions and proper uses of medicines in humans and implements that knowledge in clinical practice". Clinical pharmacology ...
- tells how the medicine works in the body, how it is absorbed and eliminated, and what its effects are likely to be at various concentrations. May also contain results of various
clinical trial Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel v ...
s (studies) and/or explanations of the medication's effect on various populations (e.g. children, women, etc.). * Indications and Usage - uses (indications) for which the drug has been FDA-approved (e.g. migraines, seizures, high blood pressure). Physicians legally can and often do prescribe medicines for purposes not listed in this section (so-called "
off-label use Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration. Both prescription drugs and over-the-counter drugs (OTCs) can be used in off-label ways, although mo ...
s"). *
Contraindications In medicine, a contraindication is a condition (a situation or factor) that serves as a reason not to take a certain medical treatment due to the harm that it would cause the patient. Contraindication is the opposite of indication, which is a rea ...
- lists situations in which the medication should ''not'' be used, for example in patients with other medical conditions such as kidney problems or allergies * Warnings - covers possible serious
side effects In medicine, a side effect is an effect of the use of a medicinal drug or other treatment, usually adverse but sometimes beneficial, that is unintended. Herbal and traditional medicines also have side effects. A drug or procedure usually used ...
that may occur (e.g.,
boxed warning In the United States, a boxed warning (sometimes "black box warning", colloquially) is a type of warning that appears near the beginning of the package insert for certain prescription drugs, so called because the U.S. Food and Drug Administratio ...
) * Precautions - explains how to use the medication safely including physical impairments, food (
grapefruits The grapefruit (''Citrus'' × ''paradisi'') is a subtropical citrus tree known for its relatively large, sour to semi-sweet, somewhat bitter fruit. The flesh of the fruit is segmented and varies in color from pale yellow to dark red. Grapefru ...
) and drug interactions; for example "Do not drink alcohol while taking this medication" or "Do not take this medication if you are currently taking MAOI inhibitors" * Adverse Reactions - lists ''all'' side effects observed in all studies of the drug (as opposed to just the dangerous side effects which are separately listed in "Warnings" section) * Use in specific populations (
pregnancy Pregnancy is the time during which one or more offspring gestation, gestates inside a woman's uterus. A multiple birth, multiple pregnancy involves more than one offspring, such as with twins. Conception (biology), Conception usually occurs ...
,
lactation Lactation describes the secretion of milk from the mammary glands and the period of time that a mother lactates to feed her young. The process naturally occurs with all sexually mature female mammals, although it may predate mammals. The process ...
( breast-feeding),
female An organism's sex is female ( symbol: ♀) if it produces the ovum (egg cell), the type of gamete (sex cell) that fuses with the male gamete (sperm cell) during sexual reproduction. A female has larger gametes than a male. Females and ...
s and
male Male (Planet symbols, symbol: ♂) is the sex of an organism that produces the gamete (sex cell) known as sperm, which fuses with the larger female gamete, or Egg cell, ovum, in the process of fertilisation. A male organism cannot sexual repro ...
s of reproductive potential,
pediatric Pediatrics (American English) also spelled paediatrics (British English), is the branch of medicine that involves the medical care of infants, children, adolescents, and young adults. In the United Kingdom, pediatrics covers many of their youth ...
,
geriatric Geriatrics, or geriatric medicine, is a medical specialty focused on addressing the unique health needs of older adults. The term ''geriatrics'' originates from the Greek γέρων ''geron'' meaning "old man", and ιατρός ''iatros'' mean ...
) *
Drug Abuse Substance misuse, also known as drug misuse or, in older vernacular, substance abuse, is the use of a drug in amounts or by methods that are harmful to the individual or others. It is a form of substance-related disorder, differing definitions ...
and Dependence - provides information regarding whether prolonged use of the medication can cause
physical dependence Physical dependence is a physical condition caused by chronic use of a tolerance-forming drug, in which abrupt or gradual drug withdrawal causes unpleasant physical symptoms. Physical dependence can develop from low-dose therapeutic use of certa ...
(only included if applicable) * Overdosage - gives the results of an
overdose A drug overdose (overdose or OD) is the ingestion or application of a drug or other substance in quantities much greater than are recommended. Retrieved on September 20, 2014.
and provides recommended action in such cases * Dosage and Administration - gives recommended dosage(s); may list more than one for different conditions or different patients (e.g., lower dosages for children) * How Supplied - includes the
dosage form Dosage forms (also called unit doses) are pharmaceutical drug products presented in a specific form for use. They contain a mixture of active ingredients and inactive components ( excipients), configured in a particular way (such as a capsule she ...
(s), strength(s), units in which the dosage form(s) are ordinarily available, identifying features of the dosage form(s) such as the National Drug Code (NDC), and special handling and storage conditions (e.g., "Store between 68 and 78°F ")


Other uses and initiatives

In addition to the obvious use of inclusion with medications, Prescribing Information have been used or provided in other forms. In the United States, the Prescribing Information for thousands of prescription drugs are available at the
DailyMed DailyMed is a website operated by the United States National Library of Medicine, U.S. National Library of Medicine (NLM) to publish up-to-date and accurate drug labels (also called a "package insert") to health care providers and the general publ ...
website, provided by the National Library of Medicine. South Africa has taken the initiative of making all package inserts available electronically via the internet, listed by trade name, generic name, and classification, and Canada is working on a similar capability. The UK-based electronic medicines compendium provides freely available online access to both Patient Information Leaflets (intended for consumers) and Summary of Product Characteristics (aimed at healthcare professionals) for products available in the UK. Patient information is, understandably, usually generated initially in the native language of the country where the product is being developed. This leads to inconsistency in format, terminology, tone, and content. PILLS (Patient Information Language Localisation System) is a one-year effort by the
European Commission The European Commission (EC) is the primary Executive (government), executive arm of the European Union (EU). It operates as a cabinet government, with a number of European Commissioner, members of the Commission (directorial system, informall ...
to produce a prototype tool which will support the creation of various kinds of medical documentation simultaneously in multiple languages, by storing the information in a database and allowing a variety of forms and languages of output.


See also

*
Drug labelling Drug labelling, also referred to as prescription labelling, is a written, printed or graphic matter upon any drugs or any of its container, or accompanying such a drug. Drug labels seek to identify drug contents and to state specific instructions o ...
*
Patient education Patient education is a planned interactive learning process designed to support and enable expert patients to manage their life with a disease and/or optimise their health and well-being. Overview Education may be provided by any healthcare profes ...


References


External links


South African Electronic Package InsertsEMA guidance on preparing SmPCElectronic Medicines Compendium
which published SmPCs and Package Leaflets in the UK
dailymed.nlm.nih.gov
Drug labels at DailyMed website
labels.fda.gov
Drug labels at FDA website {{Authority control Health informatics drug marketing and sales Packaging Labels