Also provides information on what to do if a patient misses a dose of medication. Limitations to Package Inserts The Biggest limitation is that EVERY word MUST be FDA approved and any updates to a product will take time to be approved and added to the Package Insert.
With respect to the PDR generally, the AMA states that a medication package insert “should not be regarded as a legal standard of acceptable or accepted medical practice nor as a substitute for clinical judgment or experience nor as a limitation on usage of the drug in medical practice” (9).
What information should be included in the package insert?
The package insert follows a standard format for every drug. After some identifying information, such as the drug’s brand name, generic name, and year when the drug was first approved by the FDA, most to all of the following sections appear, in this order:
What is an FDA package insert?
Package inserts (also known as Prescribing Information) are available for all prescription medications approved by the FDA. Similar information is available for nonprescription medicines and for some herbal medicines and dietary supplements as well.
What is required to be included in a product information package (Pi)?
The information included in the PI must be supported by substantial evidence. Such data and their supporting evidence are provided to the FDA by the manufacturer as part of the New Drug Application (NDA) and may be included in the PI only after they are reviewed and approved by the FDA.
How do you read a package insert for a drug?
How to Read a Package Insert. The package insert can usually be found online on the drug manufacturer’s web site and is also available in a reference book called the Physicians’ Desk Reference (PDR), which you may be able to find at your local library or can access online at PDR.net.
What do package inserts include?
The package insert includes details and directions that health care providers need to prescribe a drug properly, including approved uses for the drug, contraindications, potential adverse reactions, available formulations and dosage, and how to administer the drug.
What is a package insert clinical trials?
Although the package insert isn’t a comprehensive view of all clinical data regarding the medication, it does provide a brief snapshot or overview to help clinicians quickly review the trials that the FDA evaluated when deciding whether or not to approve the medication.
What are the required categories of a package insert?
The following sections can be found in all package inserts
What is an FDA package insert?
Patient Package Inserts (PPI) – Patient labeling that is part of the FDA-approved prescription drug labeling.
Are package inserts required?
Under US Food and Drug Administration (FDA) rules brought in on 24 January 2006, prescription (Rx) drug manufacturers are now obliged to send at least one copy of an authorised package insert (PI) for each container of medication they dispatch.
Which drugs require package inserts?
The Food and Drug Administration (FDA) amends its patient package insert regulations to list ampicillin and phenytoin as drugs that must be dispensed with patient package inserts. The ampicillin patient package insert applies to drug products containing amoxicillin, ampicillin, or hetacillin.
What does the Clinical Pharmacology section of a package insert list?
This section lists the effects that this medicine may have on other prescription or over-the-counter medicines you may be taking. This section also might warn that you should not take this medicine with a particular food or other product (such as an antacid).
How do you cite a package insert?
Please use the following format. Drug name. Place of publication: Manufacturer’s name; Year of publication. Albuterol.
What is the difference between SPC and PIL?
The SPC is the basis of information for health professionals on how to use the medicinal product safely and effectively. The Patient Information Leaflet (PIL) shall be drawn up in accordance with the SPC. This guideline provides advice on the principles of presenting information.
Which of the following medications do not require patient package inserts?
Which of the following medications does not require that a patient package insert be given to the patient? b-An ACE inhibitor does not require a patient product insert to be given to the patient.
Which medication must be accompanied by a patient package insert quizlet?
Estrogenic substances are the only drug agents required by law that a patient package insert be provided the patient upon each and every dispensing of this category of drug.
For what medication is it not mandatory to include the patient package insert?
A package insert. The Poison Prevention Packaging Act requires childproof packaging for all medications except: Nitroglycerin.
Is a PIL a legal requirement?
Patient information leaflets (PILs)
Unless all the information is on the pack, all medicines must include a PIL, regardless of how patients get them.
What is the role of the package insert?
The package insert, which is jointly authored by the U.S. Food and Drug Administration and the manufacturer of the drug, is a summary of all of the preclinical and clinical data accumulated during the successful development of a new drug. Despite the role of the package insert in the safe practice o …
What is required to be included in a product information package (Pi)?
The information included in the PI must be supported by substantial evidence. Such data and their supporting evidence are provided to the FDA by the manufacturer as part of the New Drug Application (NDA) and may be included in the PI only after they are reviewed and approved by the FDA.
How to Read a Package Insert
- What Is in the Package Insert
- How Should I Use the Package Insert
- What Is in the Package Insert
Whenever you begin taking, or are considering taking, a new HIV medication, your health care practitioner will go over some fundamental facts with you.The prescription is filled and you are given extra written information, which is standard practice.Depending on the pharmacy, you may only receive a quick summary or you may receive a highly extensive ″package insert″ that contains information given by the medicine manufacturer and authorized by the United States Food and Drug Administration (FDA).Each nation or area has its own regulatory organization that oversees the distribution of medications and is responsible for providing the information that customers (users) get along with their prescriptions.The Central Drugs Standard Control Organization (CDSCO) is responsible for this in India (CDSCO).In Europe, the European Medicines Agency (EMA) is in charge of the package insert, which is referred to as the patient information leaflet in this country (PIL).
- Prescription drug package inserts (often referred to as Prescribing Information) are accessible for all prescription medications approved by the Food and Drug Administration (FDA).
- Information about nonprescription medications, as well as herbal medicines and nutritional supplements, is provided on the same basis as for prescription medications.
- In most cases, you can find the package insert online on the drug manufacturer’s website.
- It is also available in a reference book called the Physicians’ Desk Reference (PDR, which also stands for Prescribers’ Digital Reference, the book’s online version), which you may be able to find at your local library or that you can access online.
What Is in the Package Insert
- The information contained in a package insert is written in a specialized technical style. It is typically exceedingly extensive and difficult to comprehend in its entirety. However, it is a good idea to go through it because it contains crucial information about the medicine that should not be overlooked. Please consult with your health care practitioner or pharmacist if you have any queries. It’s also possible to speak with an instructor at your local AIDS care agency. Every drug’s package insert follows a standard format that is followed by all of them. In the following parts, which occur in this order: after some identifying information, such as a medicine’s brand name, generic name, and the year when the drug was initially authorized by the FDA, most to all of the following sections appear: Precautions and Warnings
- Warnings and Precautions
- Adverse Reactions
- Drug Interactions
- Use in Specific Populations
- Clinical Pharmacology
- Nonclinical Toxicology
- Clinical Studies
- How supplied/storage and handling information
- Patient Counseling information
When it comes to HIV medications, certain package inserts begin with ″Boxed Warnings,″ which emphasize particularly significant (and even life-threatening) adverse effects that have been recorded but are extremely rare.The generic name of the medication will be used in the package insert the majority of the time (the scientific name for its main ingredient or ingredients).Patients are accustomed to knowing a medicine by its brand name (the name under which it is sold), thus this might be perplexing for them.Also keep in mind that the brand name of a medicine may change from one country to the next.If you have any queries about HIV medications in the United States, you can consult our HIV Drug Chart/Overview, which covers each medication by brand and generic name.It should be able to find the drug’s various names by conducting a simple search online using the name you have (e.g., if what you have is the generic name, most websites that mention the drug will also list its brand name and possible abbreviations).
- While there is no specific section of the package insert dedicated solely to women, information that is relevant to women (for example, indications for use in pregnant or breastfeeding women, dosing adjustments based on body weight, drug interactions with birth control pills or hormone replacement therapy) can be found in various sections throughout the package insert, including the following: The following is an outline of what you may expect to discover in each section:
Highlights of Prescribing Information
This first part provides a succinct review of the material that is most crucial for readers to be aware of before continuing. It directs the reader to the appropriate section(s) of the packaging insert for more, more specific information on the product.
Recent Major Changes
In this section, if there have been any changes to a drug’s boxed warning, indications, and usage, dosing and administration, contraindications, warnings, and/or precautions in the last 12 months, those changes are described in depth.
Indications and Usage
This section is a list of the indications (or uses) for which the medicine has been authorized by the Food and Drug Administration (FDA).The use of all HIV medications in conjunction with other authorized HIV medications is recommended, unless the HIV medication is already a combination tablet (e.g., Atripla).This section will also specify whether the medicine can be administered to patients who have previously taken HIV medications (ART-experienced), patients who have never received HIV medications (ART-naive), or a combination of the two.It may specify which drug class it belongs to as well as whether other HIV medications should or should not be taken in conjunction with it.A full summary of the clinical research for this medicine will be provided, which will frequently contain graphs and charts, as well as other supporting information.
Dosage and Administration
This section contains information on the suggested dosages (doses) of the medication, as well as information on whether the medication should be taken with or without meals.It is possible that you may notice different sections for each usage of the drug if it is indicated for more than one (for example, to treat HIV and hepatitis B).Women of a certain weight, youngsters, the elderly, or those suffering from specific medical conditions may also receive specific instructions on how to take their medications.
Dosage Forms and Strengths
The color and shape of the medication are described in this section (e.g., capsule, ointment). In such form, it also includes a list of the medication’s strength or dosage. For the same medication, several distinct strengths and form descriptors may be stated on the label.
This section discusses scenarios in which the medicine should be taken with care or not at all, depending on the circumstances.Contraindications are medical terms that describe these situations.Someone who has had an allergic response (hypersensitivity) to the same drug or a medication that is similar should not be administered that prescription, nor should someone who is taking another medication that interacts with the medicine in a hazardous way be prescribed that medicine.This section may also advise health-care professionals not to administer the medication to persons who have specific medical problems because they are at increased risk of experiencing hazardous side effects from the medication.You may find out here whether you have a serious medical condition and whether taking this medication will make it worse or whether it will be unaffected by it.Additionally, it is for this reason that it is critical that you do not share your prescriptions with others.
- If someone else is using your prescription and they have a medical condition that you are not aware of, your drug might be dangerous to them.
Warnings and Precautions
This section highlights the potentially life-threatening adverse effects that may occur in patients who use this medication.It does not necessarily follow that every side effect will occur in your case, but it is critical that you pay attention to these cautions in order to notice any symptoms that might indicate a potentially significant condition.It is possible that a ″Boxed Warning″ will appear on the first page of the package insert if particularly severe or life-threatening problems have been discovered.As the name implies, this information is shown prominently in capital letters within a black box to ensure that it is not missed by the reader’s attention.Ideally, when you begin taking an HIV medication with warnings that may have an impact on you, your health care provider should explain what the warnings indicate and what you should look out for in order for any issues to be detected as soon as possible.If you have any questions or concerns regarding a warning or symptoms you are experiencing while taking the medication, contact your healthcare practitioner or pharmacist straight away.
This section addresses the potentially life-threatening adverse effects that may occur in patients who use this medication..It does not necessarily follow that you will have every side effect, but it is critical that you pay attention to these cautions in order to spot any signs that might indicate a major problem.The first page of the packaging insert may have a ″Boxed Warning″ if any very serious or life-threatening concerns were discovered.It is important to note that, as the name implies, this information is shown in large letters within a black box to ensure that it is not missed.Your health care provider should explain to you what the warnings imply and what you should look out for in order to detect any issues as soon as possible if you begin taking an HIV medicine that has warnings that may be relevant to you.If you have any questions or concerns regarding a warning or symptoms you are experiencing while taking the medication, contact your healthcare practitioner or pharmacist immediately.
If you are taking any other prescription or over-the-counter medications, this section will tell you about the interactions that this medicine may have with them.The warning section may also state that you should not take this medication with a certain meal or other product (such as an antacid).It is a good idea to browse over this area to see if there are any medications or other things that you take on a daily basis that are not listed there.Maintain complete and accurate records of all medications you are taking, even if you only use them rarely.This includes over-the-counter medications, prescription pharmaceuticals, illegal street drugs, nutritional supplements, and herbal remedies.
Use in Specific Populations
This section describes what is known about the drug’s safety and efficacy when it is administered to specific categories of people.To be more specific, it indicates whether or not it is safe for use by nursing or pregnant women, children (″Pediatric Use″), and the elderly (″Geriatric Use″).It is possible that not enough information is accessible at any one time.This does not imply that it is harmful among these categories of people; rather, it indicates that not enough study has been done in this area.
- Taking too much of the medicine, or taking an overdose of the medicine, can have serious consequences.
- This section explains what these consequences are and how an overdose should be managed.
- This type of information is mostly beneficial to medical professionals.
- If you believe that you or someone else has taken an excessive amount of medicine, call a poison control center or go to the nearest emergency hospital straight away.
- This section contains the chemical name of the medicine as well as a diagram showing the drug’s chemical composition.
- It specifies whether the medication is in tablet form, capsule form, liquid form, or powder form, as well as whether it should be used orally or intravenously.
- It also includes a list of all non-active components, such as fillers, artificial colors, and flavorings, as well as active ingredients.
- You may use this tool to determine if there are any substances in a product that may cause you difficulties if you have food sensitivities.
- This section describes the action of the medication in the body.
- This section also tells you whether studies conducted on different groups of people discovered any differences in how it works for treatment-experienced patients (those who have previously taken HIV drugs) and treatment-naive patients (those who have never taken HIV drugs before), as well as for women, children, and the elderly.
- This section may be quite technical in nature and may not be written in a manner that the majority of people can comprehend.
- It is critical that you communicate with your healthcare practitioner about any questions or concerns you may have regarding your treatment.
- This section also covers how the medicine is metabolized in your body as well as how your body eliminates the drug from your system.
- For people with certain medical conditions, such as kidney or liver illness, this is one of the areas your health care provider will review before choosing whether or not to prescribe this sort of medication for you, and if so how much to give you.
This section indicates if the medicine has a high proclivity to create cancer or whether it has the ability to induce cells to alter, or mutate. Also included in this part may be information on how the medication affects fertility (ability to become pregnant). Much of this material is based on animal studies or studies of human cells, and in some cases, all of it is (not real people).
- This section contains the findings of studies or clinical trials that were conducted to demonstrate the drug’s efficacy in various groups of people.
- Results are frequently presented as a comparison between this medicine and another drug, with the difference in effectiveness between the two drugs being demonstrated.
- In addition, the descriptions of the research provide information on how long the study was done, how many people participated, and the fundamental characteristics of study participants, among other things (e.g., age, race, whether they have used HIV drugs before).
In this part, the reader is directed to additional scientific sources of information, which is seldom included.
How Supplied/Storage and Handling
- This section contains all of the many dosage forms of this medication, which may include tablets or capsules in a variety of sizes, as well as liquids or powders.
- Each one is distinguished by its color, shape, and markings, allowing you to be certain of which one you are selecting.
- It is important to note that while reading the package insert for Fuzeon (an HIV therapy that is administered intravenously), this section will discuss how to reconstitute (or mix) the powdered medication with sterile water.
- In addition, storage instructions are provided in this section.
- This is where you will learn whether or not you should store the medication in the refrigerator.
- It also indicates whether or not the tablets are susceptible to being harmed by heat, light, or moisture.
- For example, it is normally not recommended to leave medication out in direct sunlight when the temperature exceeds 30 degrees Celsius (86 degrees Fahrenheit).
- In other words, if you’re picking up your prescription at the pharmacy on a hot day, don’t leave it in the car while you go about your business.
Patient Counseling Information
- This section contains important information for health care practitioners to utilize when discussing the medicine with patients about how to take it.
- In accordance with the drug, this section may include information on proper dose, expected adverse effects, and potential medication interactions.
- When you receive a new medication, it is a good idea to go over this area.
- It draws attention to the facts that you and your health-care practitioner should review together.
- You should stop and consult with your provider or pharmacist if you have any questions about what is in this part, or if you do not recall your provider telling you about what is in this area.
How Should I Use the Package Insert?
- In addition to any instructions you may have received from your health care practitioner, nurse, or pharmacist, the package insert can be a valuable source of information to consult.
- You should carefully read the package insert for any medication you are starting for the first time, and you should check it again if anything about your health has changed.
- If you have any questions after reading it, you should speak with your healthcare practitioner or pharmacist for clarification.
The Package Insert
- United States Pharmacopeia 2015;40(5):8-10.
- The healthcare practitioner of today has access to a great amount of practice-related information at his or her fingertips.
- Pharmaceutical information is available to pharmacists from a variety of sources, including print publications, subscription-based electronic databases (e.g., Clinical Pharmacology, Facts & Comparisons eAnswers, Lexicomp Online, Micromedex Solutions, UpToDate), and/or free Internet resources, among other sources (e.g., Drugs.com, Medscape.com).
- As a result, when a pharmacist is looking for pharmacological information, he or she is frequently confronted with the dilemma of having too many resources from which to pick, not a lack of resources.
- The medicine label, often known as the prescribing information or the package insert, is an essential source of information that pharmacists and other practitioners have access to, but that they occasionally neglect (PI).
- Because of its accessibility, simplicity of use, content, and legal weight, the PI is a resource that should be used as a starting point whenever a search for drug information is initiated.
Evolution of the PI
- Consumer items in interstate commerce are required to be truthfully and informatively labeled under the 1966 Fair Packaging and Labeling Act.
- The Food and Drug Administration (FDA) is responsible for enforcing these regulations for foods, pharmaceuticals, cosmetics, and medical devices.
- 1 As a result, the need of educating customers about the items they use is widely acknowledged.
- Although it is normally the obligation of the maker of any product to inform the user of the hazards connected with the product’s usage, manufacturers of prescription pharmaceuticals are not compelled to inform each patient who takes their goods.
- It is the manufacturer’s responsibility instead to provide prescribing physicians with information about the proper use and risks of a product so that the prescriber is better equipped to educate the consumer or patient about the drug’s use and risks; this is referred to as the learned intermediary doctrine.
- 2 Because of the complexity of the information pertaining to prescription pharmaceuticals, it is necessary to have an intermediary who can explain or interpret the advantages and hazards connected with the drug’s usage to the final user—the patient—in order for the drug to be legally prescribed and prescribed.
- The standards governing the labeling of over-the-counter drugs, which were established in 1972, are distinct.
- In contrast to the Patient Package Insert (PPI), which provides information intended for patients, the PI is not required to be included as part of the FDA-approved labeling for a pharmaceutical product.
- 4 Content and format of labeling for human prescription drugs and biological products were updated on June 30, 2006, and are described in Title 21 of the Code of Federal Regulations (CFR), especially part 201, sections 201.56 and 201.57 of the Code of Federal Regulations (CFR).
5 In the United States, these requirements are currently applicable to practically all prescription medications that are brought to the market in the country.6
- When the FDA established a standard format for the PI in 1979, it was the first time that the format had been changed.
- When the FDA updated the format of the PI in 2006, it was the first time that the format had been changed since 1979.
- 7 For the most part, the 2006 change was motivated by an increase in the volume and complexity of information contained in the PI, which made it difficult to utilize efficiently.
- The FDA conducted research and held consultations with healthcare experts before making the changes to the PI structure.
- 7 Drugs authorized by the FDA more than 5 years prior to June 2006 are exempt from the new labeling rules; nevertheless, manufacturers may choose to reformat the package insert (PI) of these medications.
- Significant evidence must be provided to support the information included in the PI.
- In such cases, the manufacturer provides the FDA with data and supporting evidence as part of the New Drug Application (NDA), and the data and supporting evidence may only be included in the PI after they have been evaluated and authorized by the FDA.
- Depending on information gathered by the FDA from mandatory industry reports to its Adverse Event Reporting System (AERS), manufacturer-submitted postmarketing studies, and/or voluntary adverse event reports from clinicians and patients following the initial approval, the PI may need to be revised by the FDA.
- In the same way, a manufacturer might request a label modification to support a new marketing claim or to make a warning more explicit.
In a similar vein, the FDA must examine and approve the amended material before it can be put into action.8 In its present form, the prescription information (PI) is divided into two parts: the highlights of prescribing information (HPI) and the entire prescribing information (FPI).9 According to the FDA, the goal of the HPI is to ″give instant access to the information to which practitioners most frequently refer and perceive as most significant.″ 9 The information in the HPI is cross-referenced to the information in the FPI that corresponds to that information.Furthermore, practitioners are specifically warned that ″these highlights may not include all of the information needed to use full prescribing information safely and effectively.″ 9 The HPI also includes the date of the most recent amendment to the label, which may be found at the end of the document.Similarly, the FPI part, which is the second major element, offers extensive information about the medicine, which is organized in a certain way (TABLE 1).9
Pharmacists are recommended to familiarize themselves with the structure and contents of the PI before using it. The key to effective and efficient use of drug information resources, like with other information resources, is familiarity with the resource by the user.
- Upon approval, generic medicine products must bear the same labeling as the brand-name drug with which they were compared at the time of submission (reference listed drug).
- 10 Exceptions to this criteria include inevitable changes in formulation, bioavailability, and pharmacokinetics, among other things.
- The FDA has also typically held that a generic medicine must keep the same labeling as the referenced drug throughout the life cycle of the generic drug product, as has been the case in recent years.
- As a result, after the FDA has authorized the PI, modifications to the labeling of both the brand-name medication and its generic version will be adopted, although there may be temporary variations between the labels of the various products.
Obtaining the PI
- Title 21 of the Code of Federal Regulations (CFR) requires that patient information (PIs) be provided in packages of prescription medications and biologic goods.
- The Physicians’ Desk Reference (PDR), which was originally published in 1947, is a collection of patient information (PIs) for various prescription medicines available in the United States.
- Approximately 11 drug manufacturers provide information to the publisher (PDR Network), which publishes the book on an annual basis.
- (The PDR Network also provides electronic versions of the content.) The most recent printed version of the book is priced at around $100.
- 12 It is crucial to remember that not every medicine that is commercially available in the United States has its PI mentioned in the PDR.
- Furthermore, as is the case with any print reference, the PI contained in the printed version of the PDR may not be the most recent edition, as is the case with any print reference.
- The prescribing information (PI) for newer (recently authorized) medications, which are sold under their trade names, may often be found on the manufacturer’s website.
- More recently approved drugs’ prescribing information (PIs) can often be found by simply typing the drug’s name into a URL (for example, http://www.fda.gov).
- Similarly, the product catalog available on generic manufacturers’ websites will typically link the user to the PI for that particular drug product.
It is also possible to access the PI from the FDA’s website (by utilizing the [email protected] option on the site.This function not only allows the user to receive the most recent label that has been authorized, but it also allows the user to view past versions of the product information.When it comes to finding product information, the National Library of Medicine’s DailyMed service is perhaps the most beneficial (as of April 2015, DailyMed featured the most up-to-date product information for over 73,000 goods).As well as labels for prescription medicine items, OTC goods and veterinary pharmaceuticals are also included in the package inserts for this publication.In the same way, labels for selected herbals, homeopathic items, and nutritional supplements are also supplied for your convenience and information.13 Although a generic Internet search for a drug’s name will almost always result in the identification of a PI for the medicine, the PI discovered may not be the most recent version, resulting in the usage of obsolete information.
As a result, pharmacists are advised from employing this strategy while looking for the PI in question.An interesting side point is that the PI is frequently cited as the source of knowledge for part of the material of professional drug-information resources such as Micromedex Solutions and Clinical Pharmacology, among others.
The PI as Standard of Care
- Additionally, the PI has repercussions for state tort (liability) law in addition to being a helpful tool for practicing attorneys.
- As previously stated, medication makers are obligated to offer instructions on the correct use of the medicine, as well as warnings about potential bad effects and other relevant information, in the form of the patient information sheet (PI).
- The PI is designed for use by healthcare professionals, most notably by prescribers and other decision-makers.
- This idea was developed in the case of Sterling Drug v.
- Cornish, which held that ″in such a circumstance, the purchaser’s doctor acts as a knowledgeable mediator between the consumer and the manufacturer.
- ″ It is quite likely that a damage to a patient can be averted if the doctor is given adequate warning before administering the medication.″ 14 It is necessary to evaluate the activities of the prescriber in cases when patients are injured by medication in comparison to the standard of care; that is, practice that is regarded appropriate by other professionals working in the same sector.
- The PI has been one of the tools utilized by the courts to demonstrate the level of care.
- Notably, the FDA does not have the authority to control the use of a medicine by a practitioner.
- 15 Consequently, once a medicine has been licensed for use in the United States market, a physician may use the drug in a manner that differs from the way it was prescribed by a pharmaceutical company in the PI; for example, for an indication that is not permitted by the FDA (off-label).
When it comes to using the PI as proof of standard treatment, different jurisdictions approach the issue in a different way.16 State laws in some states, such as Florida and Illinois, often allow for the establishment of the standard of care only through the information included in the patient’s medical record.These jurisdictions adhere to the Mulder rule, which holds that the PI is prima facie (self-evident) proof of the established standard of care in the case at hand.When a physician deviates from the guidelines in the PI, the Mulder rule holds that there is often sufficient evidence of negligence to allow the matter to be submitted to a jury for consideration.In direct opposition to the Mulder rule, the FDA and the American Medical Association maintain that the PI is intended solely for informational reasons and does not create a standard of treatment for any patient.15 As a result, the PI is often not accepted as prima facie proof of the standard of care in the majority of other jurisdictions.
These jurisdictions demand independent expert evidence to explain the established standard of care in order to comply with the law.Even though the PI is not admissible as the sole proof of malpractice in these states, the independent expert’s professional opinion of the prescriber’s behavior may be based in part on whether or not the prescriber complied with the guidelines included in the PI.Even in cases where the PI is not accepted as prima facie proof of the established standard of care, the PI may be used to demonstrate malpractice if the patient was not given the opportunity to give informed consent.16 It may be possible to establish malpractice in these situations because the prescriber failed to provide the patient with pertinent safety information described in the PI, which would have allowed the patient to make an informed decision while being aware of all risks associated with taking the medication.Patients who suffer injury as a result of the prescribing physician’s failure to provide the necessary information included in the PI may hold the prescribing physician accountable.PIs are hired with the goal of serving as a knowledgeable intermediary between the drug maker and the drug’s end user.
Despite the fact that the educated intermediary is often the physician, the pharmacist’s instrument (PI) can also be used to demonstrate deviations from standard of care in the case of pharmacists.As a result, when pharmacists get a medication information request or are confronted with a clinical issue, it may be prudent to begin the search for information with the patient information (PI).The information offered therein may be sufficient to correctly and thoroughly address the topic; nevertheless, it is possible that more sites that contain off-label information will need to be explored in addition to this one.
- The PI is a valuable source of information that can be accessed quickly and freely, and the present format of the label has been designed to be user-friendly to make it as accessible as possible.
- Pharmaceutical interns and graduates should become familiar with both the structure and content of the PI.
- When taking into consideration the potential legal significance of the information contained in the PI, pharmacists should be aware of this information, generally follow the manufacturer’s recommendations, and exercise sound clinical judgment when deviations from the labeled information are observed.
- The Food and Drug Administration has been promoting safe and effective pharmaceuticals for 100 years.
- The date was January 8, 2015.
- The American Bar Association is number two.
- The learned intermediary doctrine is contained within it.
- The date was January 8, 2015.
- The Food and Drug Administration (FDA), which provides a history of drug regulation in the United States.
- The date was January 8, 2015.
4.Food and Drug [email protected] instructions: health information.The date was January 8, 2015.5.The Food and Drug Administration (FDA).
CFR—Code of Federal Regulations, Title 21.The date was January 8, 2015.6.P.J.Marroum and J.Gobburu When it comes to the product label, it is all about how the pharmacokinetics and pharmacodynamics get to the prescriber.
Clinical Pharmacology and Therapeutics, Vol.41, No.3, pp.161-169.7.
- Teed Watson K, Barash PG, and colleagues The new Food and Medicine Administration drug package insert has consequences for patient safety and clinical treatment, according to the agency.
- Anesth Analg 2009;108(1):211-218 Eighth is the Congressional Research Service.
How the Food and Drug Administration (FDA) approves medications and controls their safety and efficacy.The date was January 8, 2015.Guidance for Industry: Labeling for Human Prescription Drugs and Biological Products—Implementing the PLR Content and Format Requirements (FDA, guidance for industry).
The date was January 8, 2015.Supplemental applications for authorized medicines and biological products that propose labeling modifications are published in the Federal Register.The date of access was December 17, 2014.The New York Academy of Medicine is number eleven.Books, health, and the past are all important to me.The date was January 8, 2015.
- PDR.net’s product catalog (in English).
- The date of access was December 4, 2014.
- Health and medicine information resources available on the World Wide Web, S.
- Grossman and T.
- Zerilli, 2013.
- J Pharm Pract.
- J Pharm Pract.
- Camp, J.A., and Pappas, G.M.
- The learned intermediary concept in Florida: courts grapple with alleged exceptions to the theory in pharmaceutical and medical device litigation The Florida Bar Journal, vol.
82, no.1, 2008.(11).The date of access was December 9, 2014.Package inserts and the standard of care, 15th edition, Thornton RG.
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- Vaslas B, Schreffler N, et al.
The role of FDA-approved labeling in medical malpractice litigation: a systematic review.FDLI (Federal Department of Labor and Industry).2010 (November/December).On the 10th of December, 2014, I was able to get If you have any comments or questions about this post, please email [email protected]
- Congress mandated that every drug product must be labeled with ″written, printed, or graphic matter″ that is placed on ″the immediate container of any article″ and that contains ″adequate directions for use,″ as well as ″adequate warnings,″ when it passed the Federal Food, Drug, and Cosmetic Act in the United States.
- In the following decades, the labeling information evolved into the package insert (PI), also known as labeling content, or labeling content.
- PIs are produced by specialty printers who are qualified, audited and approved by pharmaceutical manufacturing companies.
- These specialty printers must adhere to current Good Manufacturing Practices (cGMPs), which are mandated by the Food and Drug Administration (FDA) for the drug manufacturers themselves.
- The Food and Drug Administration (FDA) established a significant new regulation on package inserts in 2006.
- The following are all 18 components of content that were specified in the 2006 regulation:
- Warnings and Precautions
- Indications and Usage
- Dosage and Administration
- Dosage Forms and Strengths
- Warnings and Precautions
- Negative side effects, drug interactions, and so on.
- Medications for Specific Populations (pregnancy, pediatrics, geriatrics)
- Clinical Pharmacology (how it works)
- Nonclinical Toxicology (additional long-term consequences such as carcinogenesis or reduced fertility)
- Clinical Studies
- Drug Abuse and Dependence
- How it is supplied / how it is stored / how it is handled
- Detailed patient counseling information (“information essential to ensure that a patient uses a medication safely and effectively”)
- Labeling that has been authorized by the FDA, such as medication guides or patient package inserts, must either be reproduced with the PI or be included with the labeling information.
- The PI is created specifically for healthcare practitioners, who are referred to as ″learned intermediaries″ in legalese.
- Items 1 through 9, as well as item 18, are all very important to patients, according to the FDA’s standards for usable consumer medication information (CMI), as well as the criteria utilized in the research by the University of Wisconsin and the University of Florida.
- It should come as no surprise that many patients and caregivers request and read the official patient information.
Regulated by the FDA
- According to the Food and Medication Administration’s standards for drug information, scientific accuracy delivered without prejudice is the most important factor.
- When the FDA analyzes the labeling information of a drug, as well as the textual contents of the PI, drug producers are held to a high level.
- The FDA has supplied manufacturers with precise instructions not just on the material that must be included, but also on the format that must be used, including legibility, readability, and font size limitations.
- When the Food and Medicine Administration (FDA) authorizes a drug for ″launch,″ the labeling language is often the last aspect to be authorized.
- The FDA is not acting as a rubber stamp in these conversations, which are taking place in secret.
- Many product releases have been postponed because the FDA and the producer were unable to reach an agreement on the language of warnings, precautions, or claims, among other reasons.
Reliable and Readily Available
Consequently, the current method of printed PIs provides unbiased scientific information across the whole pharmaceutical supply chain. When used by healthcare professionals as ″learned intermediaries″ to patients, the PI is the major source of trustworthy, scientific information. When used by involved patients or caregivers, the PI is the primary source of reliable, scientific information.
Benefiting Healthcare Professionals
- The printed literature designs that had developed and evolved in response to the 1938 Food, Drug, and Cosmetic Act were still effectively delivering essential medication information to patients and health-care providers when, following a six-year period of research, the FDA published a set of new requirements for PI in 2006 that were deemed to be more stringent.
- According to the FDA, ″in recent years, there has been a rise in the length, richness, and complexity of prescription medication labeling, making it more difficult for health care practitioners to access precise information about prescription drugs.″ It was intriguing to read the FDA’s cost-benefit analysis of the net savings: over half a billion dollars saved by preventing adverse medication events and saving practitioners’ time, compared against small expenditures for printing and designing in the new format.
- One of the most important provisions of the final regulation was the requirement for a highlights section.
- For material aimed at patients, such as Medication Guides or Patient Package Inserts, the FDA additionally stipulated how small text might be printed (PPIs).
- After being forced to take action, printed packaging providers to the pharmaceutical sector made significant expenditures in order to achieve complete compliance in a timely way.
- These printers, though they are not directly controlled by the FDA, adhere to the same current Good Manufacturing Practices (cGMPs) that the FDA expects of pharmaceutical manufacturers.
Package inserts and the standard of care
- Procedural etiquette (Bayl Univ Med Cent).
- In October 2003, the journal published 16(4): 502–504.
- Several other publications in PMC have mentioned this article in some way.
- Dietary supplements, hormone replacement therapy, cerivastatin (Baycol), oxycodone (OxyContin), troglitazone (Rezulin), thimerosal, and nefazodone hydrochloride are among the claims now pending or newly filed (Serzone).
- The relationship between a medication’s package insert (also known as product information, prescription information, or Physicians’ Desk Referencelisting) and the standard of care relevant to a prescribing physician is a common thread running through all of these statements.
- As part of a broader defense strategy, the manufacturer will utilize this information to try to shift the blame away from itself and toward the prescribing physician, or to prove the application of the ″learned intermediary″ theory in the event of a lawsuit.
- In addition, jurors frequently place a high value on package insert information and might be led to conclude that this material establishes a standard of care or practice guideline for a given product.
- Package insert information is therefore utilized by claimants in drug lawsuit claims and general malpractice cases to develop and/or substantiate conclusions regarding the appropriate standard of care and deviations from that standard.
- This is why the purpose of package insert information (whether in the form of product information, prescribing information, or PDR entry) and its relationship to the practice of medicine must be understood and communicated to the court and jury at all stages of a claim involving the use of a medication defense.
Otherwise, the prescribing physician runs the danger of being unfairly evaluated based on material that is not intended to create or reflect the appropriate standard of care, does not include or lay forth a standard of care, and is not a practice guideline in any way shape or form.
- For the purposes of this article, the phrase ″package insert″ refers to any type of product information that is included with a product (the insert, prescribing information, and PDR listing).
- If we look at it from the perspective of the pharmaceutical business, product information and prescription information appear to be universal terms of reference for information about a product’s qualities, hazards, and suggested applications.
- The information contained in the packaging insert and the PDR listing appear to be subsets of this information.
- The package insert refers to the information on the drug that is included with the medication itself, as opposed to the medication itself.
- Occasionally, this information is only provided in the bulk form of the medicine, from which prescriptions are filled or samples are issued, and not in the individual dosage forms.
- With other cases, such as with oral contraceptives, the insert is included in the package of medication that is given to the patient by the pharmacy staff.
- A PDR listing comprises product information that has been authorized by the Food and Drug Administration (FDA) and is published in the main PDR volume as well as its supplements A and B.
- In the context of pharmaceutical claims, the information provided in the PDR is the information that is most commonly in dispute.
- This is the information that practically all prescribing physicians have access to since they get complimentary copies of the Prescription Drug Report (PDR).
Maintain your awareness of the fact that the maker of a drug creates information like the package insert in accordance with the FDA’s regulatory structure.Rather of establishing a medical standard of care, this information is needed by a pharmaceutical producer in order to sell, advertise or otherwise promote a product (1).When a drug is prescribed, the goal is to advise the customer of the dangers associated with using it, which supposedly reduces the manufacturer’s exposure to tort responsibility for the prescription (2).Understanding the context in which this information is being presented is the first step toward dealing with it properly.
- The Prescription Drug Report (PDR) is a compilation of information on prescription pharmaceuticals that is released yearly by Thomson Medical Economics with two supplements.
- The information contained in the PDR is provided by the medication’s manufacturer, who also pays for the publishing of the material.
- It is not the responsibility of Thomson Medical Economics to independently evaluate or examine the representations and recommendations that are included in each medication’s listing; instead, it merely checks for grammar and spelling (3).
- The PDR’s main hardbound volume is issued in November or December of the year before the year in which it was published.
- A hardbound 2004 PDR will be distributed to clinicians beginning in November or December 2003, as an illustration.
- When it comes to supplements, Supplement A is sent in June, and Supplement B is delivered in mid-September.
- Information for inclusion in the main volume of Thomson Medical Economics must be submitted to Thomson Medical Economics no later than September of the prior year (3).
- As a result, producers must submit information by September 2003 in order to have it included in the main 2004 volume of the publication.
- Information must be submitted by April in order to be considered for inclusion in supplement A, and information must be submitted by July in order to be considered for inclusion in supplement B.
ROLE OF THE PRODUCT INFORMATION IN PATIENT TREATMENT
- In the context of health care liability lawsuits, the most important question is whether the package insert should be used in the review of physician behavior, if at all.
- It is primarily when a prescribing physician uses a medicine for an indication or at a dose that is not addressed or advised by the package insert that this concern arises (4).
- The FDA, on the other hand, is prohibited by law from regulating the use of a medication by a prescribing physician, and the Federal Food, Drug, and Cosmetic (FD&C) Act (the legislation that governs the package insert requirements) does not place any restrictions on the manner in which a physician may prescribe an FDA-approved drug.
- It is recognized by the FDA that, after a medicine has been authorized for marketing, a physician may prescribe such prescription for reasons that are not specifically stated in the package insert (5).
- These kinds of applications are referred to be unapproved, unlabeled, or off-label applications.
- Moreover, the Food and Drug Administration acknowledges that there are cases in which the ″appropriate and logical″ use of a medicine is not reflected by the package insert and is instead represented by experience and reports in the medical literature, as defined by the FDA (5).
- Perhaps more crucially, the FDA’s stance on the matter is that ″with respect to its function in medical practice, the package insert is strictly informative″ (5).
- As a result, the Food and Drug Administration does not hold that the package insert established the medical standard of care.
The medical profession’s position
- A number of prescribing physicians have also addressed this problem in medical papers, most frequently in relation to the administration of drugs to pediatric patients prior to the passage of the Food and Drug Administration Modernization Act of 1997.
- As a result, relatively few drugs had explicit indications for use in pediatric patients before 1997, owing to the fact that pharmaceutical companies did not typically evaluate their products in this patient population.
- According to the FDAMA, drug manufacturers were asked to conduct pediatric studies for new drugs and drugs already on the market in exchange for an additional six months of market exclusivity.
- This was done because pediatric patients were frequently prescribed medications without the benefit of studies to document the safety and efficacy of medications in them, or without studies to establish age-appropriate doses of medications (6).
- When considered in this light, prior to the FDAMA, well-respected physicians acknowledged and endorsed the concept that prescribing drugs for off-label reasons was totally appropriate (4, 7).
- The proviso was that such usage had to be ″based on reliable medical evidence, done in good faith in the best interests of the patient, and done without fraudulent purpose,″ and that it had to be done with the ″same judgment and discretion…
- employed in ordinary medical practice″ (8).
- Additionally, physicians were conscious of the fact that if they rejected a potentially helpful therapy to a patient only because the treatment was not approved in the package insert, the physician may be susceptible to a medical malpractice lawsuit (8).
These statements demonstrate that the medical profession understands that the package insert does not determine the standard of treatment.
American Medical Association position
- According to policies adopted by the American Medical Association (AMA) House of Delegates, this matter has also been addressed.
- Generally speaking, the American Medical Association (AMA) states that a medication package insert ″should not be regarded as a legal standard of acceptable or accepted medical practice, nor as a substitute for clinical judgment or experience, nor as a restriction on the use of the drug in medical practice″ (9).
- The American Medical Association (AMA) also emphasizes that, while the Prescription Drug Report (PDR) is one of several tools available to physicians, it ″does not provide the single standard of proper use of medications in the practice of medicine″ (10).
- At long last, according to the American Medical Association, it is permissible and lawful for physicians to prescribe authorized medications for uses not specified in their official labeling when such prescriptions are backed by logical and established medical practice (11).
- The American Medical Association clearly does not think that the package insert establishes the standard of treatment.
- The FDA, physicians, and the American Medical Association (AMA) are all supported by Thomson Medical Economics, the publisher of the PDR.
- There is a disclaimer in the prologue of each PDR that states: ″The FDA has also acknowledged that the FD&C Act does not, however, limit the way in which a physician may utilize an authorized medicine.″ Following approval for marketing, a physician may opt to prescribe a product for purposes, treatment regimens, or patient demographics that are not specifically listed on the product’s authorized labeling.
- According to FDA, recognized medical practice includes drug usage that is not represented in authorized drug labeling, and this is something that has to be addressed (12).
Pharmaceutical industry position
- While representatives of the pharmaceutical business will extol the fullness and validity of the information contained in their product’s package inserts, they typically agree that the product insert is a legal document rather than a medical document when called to testify in a deposition.
- In addition, they acknowledge that the product insert does not represent, and is not intended to represent, a summary or synopsis of the medical standard of care for the use of the medicine, and that it is not intended to do so.
- In reality, such officials have confirmed, and it is widely known, that pharmaceutical firms would give material that discusses off-label usage of their products upon request from a physician.
THE LEGAL EFFECT OF PRODUCT INFORMATION IN DETERMINATION OF THE STANDARD OF CARE
- Regardless of the widespread agreement and awareness that product inserts do not dictate the standard of care for the use of prescription pharmaceuticals, the most pressing worry in a health care liability lawsuit is how the courts will decide on this issue in their respective jurisdictions.
- The decisions are rarely consistent and can differ significantly from one state to another.
- They are also heavily influenced by the evidence presented in court, which is typically in the form of expert witness testimony on the subject matter.
- There are two concerns that need to be addressed in terms of the eventual legal impact of package insert material in malpractice claims.
- First, does this information establish the relevant standard of care, or can it be used as evidence in determining the applicable standard of care?
- Second, may this information be used as evidence in determining the applicable standard of care?
- Second, may this material be utilized in the cross-examination or impeachment of a witness in the same way as any other ″learned treatise″ (13), such as a book, can be used?
- It is generally agreed upon that a package insert does not constitute the standard of care in and of itself.
- It can be used to support or cross-examine an expert on the standard of care, and it is regularly utilized in this capacity.
A rule of thumb has been established by courts that the package insert does not serve as prima facie (14) proof that the appropriate standard of care has been met (1).The package insert, on the other hand, has been deemed prima facie proof of the standard of care in Illinois and Minnesota, respectively (15).This is referred to as the Mulder rule in the state of Minnesota.Mulder Rule was established by the Minnesota Supreme Court, which states: When a pharmaceutical company makes recommendations to doctors about: (1) the circumstances in which their product should be used, (2) the conditions for which it is intended to be used, 3) the precautionary measures that should be observed, and 4) the risks associated with its use, a doctor’s deviation from those recommendations is prima facie evidence of negligence if there is competent medical testimony that the deviation was caused by the doctor’s negligence (16).The Mulder rule was later amended by the Minnesota Supreme Court to clarify that for a package insert to constitute prima facie evidence of the standard of care, the suggestions and directions included within the package insert must be ″clear and unambiguous″ (17).Contrary to the Mulder rule, it is not apparent that the courts in Texas and most other states agree with this conclusion.
Unless it is shown as such by expert medical testimony or if it is demonstrated to be a ″learned treatise″ (13) by expert witness, package insert information in Texas cannot be considered evidence of the standard of care (18).The court may remove package insert material from evidence if there is no expert testimony establishing that the information is the