Incident Reports

Function/Purpose

An incident report is not part of the patient’s chart, but it may be used later in litigation. A report has two functions:

  1. It informs the administration of the incident so management can prevent similar incidents in the future.
  2. It alerts administration and the facility’s insurance company to a potential claim and the need for investigation.

Regulations issued under OSHA require all employers with more than ten employees at any time during the previous calendar year to maintain records of recordable occupational injuries and illnesses.

When to Report

Incidents that must be reported and documented include:

  1. Exposure Incidents: skin, eye, mucous membrane or parental contact with blood or other potentially infectious materials that may result from the performance of an employee’s duties.
  2. Accident, Injury: patient, visitor, employee slips or falls, or other incident, which results or may result in injury.
  3. Event, Behaviors, or Actions: incidents that are unusual, contrary to agency policy or procedure or which may result in injury.
  4. Vaccine Adverse Event Reporting System: reaction to vaccine administered at agency (use VAERS form, instructions and sample in Immunization section).
  5. Medication reaction: reaction to any drug administered at or provided by health department. Complete Adverse Drug Reaction Form. For more information,call 1-800-332-1088.
  6. Property damage or missing articles.
  7. Administration of wrong medication or vaccine.
  8. Improper administration of medication or vaccine.

Background

Patient safety event reporting systems are ubiquitous in hospitals and are a mainstay of efforts to detect patient safety events and quality problems. Incident reporting is frequently used as a general term for all voluntary patient safety event reporting systems, which rely on those involved in events to provide detailed information. Initial reports often come from the frontline personnel directly involved in an event or the actions leading up to it (e.g., the nurse, pharmacist, or physician caring for a patient when a medication error occurred), rather than management or patient safety professionals. Voluntary event reporting is therefore a passive form of surveillance for near misses or unsafe conditions, in contrast to more active methods of surveillance such as direct observation of providers or chart review using trigger tools. The Patient Safety Primer Detection of Safety Hazards provides a detailed discussion of other methods of identifying errors and latent safety problems.

Characteristics of Incident Reporting Systems

An effective event reporting system should have four key attributes:

Box. Key Components of an Effective Event Reporting System
  • Institution must have a supportive environment for event reporting that protects the privacy of staff who report occurrences.
  • Reports should be received from a broad range of personnel.
  • Summaries of reported events must be disseminated in a timely fashion.
  • A structured mechanism must be in place for reviewing reports and developing action plans.

FINDINGS

  • All sampled hospitals had incident reporting systems to capture events, and administrators we interviewed rely heavily on these systems to identify problems
  • Hospital staff did not report 86 percent of events to incident reporting systems, partly because of staff misperceptions about what constitutes patient harm
  • Nurses most often reported events, typically identified through the regular course of care; 28 of the 40 reported events led to investigations and led to policy changes
  • Hospital accreditors reported that in evaluating hospital safety practices, they focus on how event information is used rather than how it is collected

 

INCIDENT/COMPLAINT REPORT

EMPLOYEE: Return this COMPLETED FORM to your SUPERVISOR as soon as possible.

Name of Person Involved: ______________________________________________________________

Address: ____________________________________ City: ___________________________________

Phone Number: _____________________ Age: ________ DOB: _____________ Sex: M ____ F _____

SS#: _________________________ Date of Incident: _____________ Time: ______ am/pm

Exact Location of Incident: ______________________________________________________________

Check Type of Accident: Check:

  • Clerical/Data Entry _____ Patient

  • Communications _____ Employee

  • Testing Process _____ Visitor

  • Result reporting _____ Volunteer

  • Safety _____ Other

  • Medical Device Failure

  • Policy/Procedural Violations

  • Adverse Drug Reaction

  • Vehicle Accident

  • Needlestick

  • Exposure to Hazardous Substance

  • Medication Error (Wrong: Route, Dosage, Medication, Schedule)

EMPLOYEE: Involved _____ yes _____ no

Were they doing their regular job duties: _____ yes _____ no Observed by employee yes

Hire Date: ____________ Marital Status: ____________ Situation observed only by employee yes

Employee Classification: ______________________________

Protective Equipment being used: _____ yes _____ no

If not used, Why: ___________________________________________________________________________________

___________________________________________________________________________________

Description of Incident/Complaint (Who, What, Where, How, Why, Include sequence of events, personnel involved, body part injured, reason incident occurred) (If medication error include brand name, manufacturer, dosage) (Use additional form if necessary)

____________________________________________________________________________________

____________________________________________________________________________________

____________________________________________________________________________________

____________________________________________________________________________________

____________________________________________________________________________________

Actions Taken by Staff Members: _________________________________________________________

____________________________________________________________________________________

____________________________________________________________________________________

_________________________________________________________________________________________________________________________________________________________________________

Witness Name: ________________________________ Phone Number: _________________________

Address: ___________________________________________________________________________

Witness Name: __________________________________ Phone Number: _______________________

Address: ___________________________________________________________________________

MEDICAL FOLLOW-UP: Was Medical Attention Sought: _____ yes _____ no

Treatment Refused: _____ yes _____ no First Treatment Date: _____________________________

Treating Physician: ________________________________ Phone Number: ____________________

Address: ___________________________________________________________________________

First Day Off Work: _________________________ Return to Work Date: _______________________

Duties Restricted: _____ yes _____ no Explain: ___________________________________________

INCIDENT/COMPLAINT REPORT

Incident Reported By: __________________________________ Date: ________________________

Supervisor Notified: _____ yes _____ no Date: _________________ Time: _______________

Name of Supervisor: __________________________________________________________________

Signature and Title of Person Preparing Report: ______________________________ Date: _________

Supervisor Comments: ________________________________________________________________

____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Supervisor Signature: ___________________________________________________ Date: ________

Corrective Action Taken/Follow-Up: (Things that have been or will be taken to prevent recurrence)

____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Director Comments: ___________________________________________________________________

____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Director Signature: ______________________________________________________ Date: ________

Nursing Administrator Signature: ___________________________________________ Date: ________

Administrator Signature: __________________________________________________ Date: ________

Signature of Person making Complaint: ______________________________________ Date: ________

Worker Compensation first Report Sent: _____ yes _____ no Date: _______ OSHA 300 Log # : ______

_____ I understand the potential risks related to the exposure to the incident that occurred and agree to receive an examination and/or treatment for the exposure, as recommended by my physician. This includes serological testing for Hepatitis B and the HIV virus as indicated.

_____ I understand the potential risks related to the exposure incidents that occurred and DO NOT agree to have an examination or treatment for the exposure.

Employee Signature: _________________________________________________ Date: ___________

Supervisor Signature: ________________________________________________ Date: ___________

I understand the information above will be used by my employer to help determine liability for injury. I acknowledge that the above statements are true and accurate representation of the requested information.

Employee Signature: ___________________________________________________ Date: _________

Job Title: ___________________________________________

Testing for HBV: Baseline and 6 months*

Testing for HIV: Baseline, 6 weeks, 3 months, 6 months, and 1 year**

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Environmental Stressors

There is mounting evidence that the physical work environment affects job performance, job satisfaction, employee injuries, worker behaviors, communication patterns, employee fatigue, employee error rates, and physical and psychological stress.

Odor

The perception of odor is dominated by pleasant or unpleasant dimensions. Odor can affect mood because of the overlap of the olfactory and emotional systems in the brain.6 Just as pleasant odors contribute to a sense of well-being and health, malodors have the ability to produce an organismic response that can be most unpleasant and even possibly harmful.6 Odors are on a continuum and can be viewed as a range or levels, such as “no odor” to “highly odiferous,” but these are not clearly defined.

Noise

Many researchers have examined the effects of noise on patients, but comparatively few studies are available for healthcare staff.7 There is evidence that nurses are adversely affected by high noise levels. Such levels have been associated with increased stress and annoyance, fatigue, emotional exhaustion, and burnout.8Increased feelings of noise-related stress and burnout can lead to an increase in turnover intention. A recent study by Blomkvist and colleagues9 examined the effects of higher versus lower noise levels on a group of coronary intensive-care nurses over a period of months. Lower noise levels were linked with a number of positive effects on staff, including reduced perceived work demands, increased workplace social support, improved quality of care for patients, and better speech intelligibility.7 These positive outcomes for the staff have the potential to decrease nurses’ intention to turnover.

Light

Most healthcare settings are lit by a combination of daylight entering through windows (natural light) and electric light sources (artificial light). There are few empirical studies that have examined the impact of light, artificial or natural, on mood or task performance in healthcare settings. Constant exposure to artificial light, in particular, fluorescent tube light, is commonly mentioned by nurses as one of the most draining aspects of work on a nursing unit.10 One study of 141 nurses in Turkey found that nurses exposed to natural daylight for at least 3 hours a day experienced less stress and were more satisfied at work.11 Furthermore, looking out at natural light can improve health outcomes, including agitation, sleep, and circadian rest-activity rhythms.12This can apply to both patients and nurses.

Researchers from the Center for Health Design confirm from previous research that the most obvious effect of light on humans is that of enabling vision and performance of visual tasks. According to Boyce and colleagues,12 the nature of the task, as well as the amount, spectrum, and distribution of the light, determines the level of performance that is achieved. Performance on visual tasks improves as light levels increase.

Another factor that affects performance on visual tasks is age. The need for light increases as a function of age because of reduced transmittance of aging eye lenses.13 This is significant in that the nursing work-force is aging, and there is a need to critically assess the lighting provisions for different types of tasks performed by nurses. Individuals may feel stressed if they are unable to perform tasks because of inadequate levels of lighting.

Color

Color is an essential element of visual stimulation with well-documented psychological and physiological effects. Reds, yellows, and oranges have longer wavelengths and are considered warm, stimulating colors. Blues, greens, and purples have shorter wavelengths and are considered cool, soft, soothing colors. Warm colors, especially when accompanied by high illumination levels, have been found to encourage activity or movement, whereas cool colors promote more passive behavior.10 Because greens and blues are calming, these may be highly appropriate in the adult workplace as green has also been found to stimulate growth and balance emotions and is highly preferred by adults.14

These characteristics can be applied to specific clinical areas. For example, a postoperative unit can promote a feeling of calmness with cool, soft colors such as greens and blues. A more stimulating environment can be created with vibrant warm colors and may be appropriate for a geriatric unit.10

In summary, odors affect mood, noise affects stress, the type and amount of light affect stress, and certain colors are preferred by adults and affect behavior.

PCA Pump

Patient-controlled analgesic (PCA) infusion pumps allow patients to give themselves pain relieving medication within certain limits as prescribed by a doctor or other licensed professional. PCA therapy is used for patients after an operation, obstetric patients, terminally ill patients and patients who have a serious injury. PCA pumps deliver medication through a needle (e.g.,intravenously) and allow patients to give themselves the medication by the push of a button. Many of the of the reports showed confusion about the medication order. The U.S. Food and Drug Administration’s Manufacturer and User Device Experience (MAUDE) database shows that PCA-related events are three times more likely to result in injury or death than events involving general purpose-infusion pumps.

Other healthcare leaders also have strongly advocated for process simplification and standardization, including the Institute for Safe Medication Practice as published in their most recent safety improvement recommendations (summarized):

Assess vulnerability to serious errors. Medication safety teams should review current practices around the use of custom concentrations.

Limit concentrations. When possible, a single, standard concentration for each PCA drug should be used. If more than one concentration is deemed necessary by the organization, the number of standard concentrations should be limited to two at the most. Additionally, the use of custom concentrations should be minimized and, when possible, restricted to selected patient care areas.

Distinguish custom concentrations. When a custom concentration is necessary, the container label should be very distinctive and should not look like the standard PCA syringe/bag label. Auxiliary labels (e.g., “High-Potency”) and a different color pharmacy label with specific instructions for programming the pump should be used for custom concentrations.

Clarify the label. ISMP usually recommends presenting the total drug concentration in the bag/syringe first, followed by the amount of drug per mL below this within the same background or border on the product label. Depending on the PCA pump vendor, the user may be prompted to enter the concentration in a mg/mL strength. In these cases, it would be safer to express the concentration with the amount of drug per mL listed first, and then the total amount of drug/total volume in the syringe/bag.

Match the MAR to the label. The concentration on the Medication Administration Record (MAR) should be listed the same as the PCA label.

Employ an independent double-check. The narcotics used for PCA are high-alert medications; thus, an independent double-check of the product and pump programming should be considered. When replacing an empty syringe/bag, the empty container should be compared to the new container to verify the concentration is the same.

• Use barcoding technology. Some infusion pumps incorporate barcoding technology. Scanning the barcode on the PCA bag would help ensure the correct concentration is entered during PCA programming.

Use smart pumps. PCA pumps with Dose Error Reduction System (DERS) should be used whenever possible. Because the significance of a low concentration alert during pump programming is not fully appreciated, low concentration limits should always be set as hard limits. Additionally, clinical advisories should be in place to reinforce caution when using custom concentrations.

PCA by Proxy (Patient Controlled Analgesia)

PCA is intended to be patient-controlled analgesia. Probably the most tragic error or event associated with PCA involves what is referred to as PCA by proxy, where someone other than the patient presses the button to inject a dose of pain medication into the patient.

A very important safety feature of PCA is that patients who are oversedated from having received too much opiate will not be able to press the button to obtain additional doses of the drug. This safety feature is overridden if someone else pushes the button for them.

Family members may believe that they are helping the patient remain pain-free by pushing the button for them. When other individuals push the PCA button, they may seriously misjudge the patient’s level of sedation, resulting in extreme oversedation, respiratory depression, and potential respiratory arrest. Like many medication errors, the exact incidence of PCA by proxy is unknown. The difficulty in determining an overall frequency of the problem is that the numerator and denominator are not known because the exact number of PCA prescriptions is not available. However, it is clear that this practice has led to fatal incidents.

ISMP has investigated several error reports involving PCA, including one involving an otherwise healthy teenage girl who died when her PCA button was pushed continuously by her mother. As a result of incidents such as this, there has been a call for action regarding PCA by proxy.

At a minimum, there should be hazard warnings on the PCA equipment to caution family members and even health care practitioners about the dangers of PCA by proxy. Family members and medical staff should also be provided with education and training on proper PCA use. PCA by proxy may be legitimately used by nurses in certain situations, but it is probably more appropriate to call this practice nurse-assisted analgesic dosing.

Nurse-assisted analgesic dosing can be used safely when the healthcare professionals involved are authorized, properly educated on pain assessment and opioid toxicity, and required to follow a protocol. Unauthorized PCA by proxy involving a spouse, family member, or friend is far more likely to result in patient harm. When other individuals push the PCA button, they may seriously misjudge the patient’s level of sedation, resulting in extreme oversedation and respiratory depression. by proxy situations may be more controversial, such as when parents control the administration of the drug by pushing the button for their child. Many children can be taught to use PCA, and although healthcare organizations may elect to have an age limit for this method of pain management, each case should be evaluated individually. Hospitals should develop policies and procedures to address family and nurse administration of PCA.

 

Safe Practice Recommendations: ISMP urges all healthcare facilities that provide PCA for patients to reassess their current safeguards around this mode of pain management to ensure adequate prohibition of PCA by proxy and patient monitoring to quickly detect and correct signs of opioid toxicity. Perhaps over the years, the initial steps taken to prevent tragedies associated with PCA by proxy may no longer be rigorously applied.

Patient selection criteria

Assess current policies and practices regarding the proper selection of patients for PCA use. Stringent patient selection criteria for PCA may be included in protocols and order sets to support candidates who have the mental alertness and cognitive, physical, and psychological ability to manage their own pain, but the criteria may no longer be followed or enforced. The benefits of PCA, along with a lack of current reports of harm from PCA by proxy, may have led providers over the years to extend its use to less than ideal candidates who require practitioner-initiated PCA doses, including infants, young children, confused or incapacitated patients, or other inappropriate candidates such as patients on additional drugs that potentiate the effect of opioids or contribute to respiratory depression. Since an important safety feature with PCA is that the patient delivers each dose, proper patient selection is critical. (Also, The Joint Commission requires adherence to established patient selection criteria for PCA therapy, and the Centers for Medicare & Medicaid Services [CMS] Conditions of Participation require a documented assessment of the capacity of the patient to successfully administer any self-administered medications.)

Patient monitoring

Review current policies and practices related to patient monitoring during PCA use to determine their effectiveness in identifying and acting upon respiratory insufficiency to avoid patient harm. The Anesthesia Patient Safety Foundation (APSF) suggests continuous monitoring using pulse oximetry as well as capnography to detect unrecognized hypoventilation and carbon dioxide retention (www.apsf.org/newsletters/html/2011/fall/pdf/fall_2011.pdf). APSF recommends the use of pulse oximetry to detect hypoventilation when supplemental oxygen is not being used. For patients receiving supplemental oxygen, monitoring ventilations with capnography is necessary to provide an additional measure of safety. Because oversedation has occurred in patients with certain comorbid conditions such as pre-existing respiratory disease, obesity, and sleep apnea, or when using concurrent drugs that potentiate opioids, an effective screening process is also necessary to identify these risk factors and, if PCA is still used, to employ extra safeguards including capnography. Also be sure that any alarms in use (e.g., pulse oximetry, capnography, apnea alarms) are recognized and responded to appropriately and in a timely manner—an unheard alarm or lack of response due to alarm fatigue can be deadly.

Educate patients and staff

Despite widespread awareness in the past about PCA by proxy, don’t assume this is an old problem that has been resolved. Ensure that all patients, family members, and new staff who work in clinical units are educated about this potential knowledge gap. Patient education should not take place in the post-anesthesia care unit but rather before surgery while the patient is alert. If family members or clinical staff feel the patient is not receiving adequate pain relief with PCA, the patient’s physician should be notified to determine if a different form of analgesia is needed for the patient.

Assess the need for warning signage

Assess whether warning signs are necessary on PCA cords to alert family members and remind staff that PCA doses should be administered only by patients. If used, be sure the warning is clear and understandable to patients, family members, and staff (e.g., WARNING: BUTTON TO BE PRESSED ONLY BY THE PATIENT).

Drug Nomenclature

Drug nomenclature is the systematic naming of drugs, especially pharmaceutical drugs. Drugs, in the majority of circumstances, have 3 types of names: chemical names, the most important of which is the IUPAC name; generic or nonproprietary names, the most important of which are the International Nonproprietary Names (INNs); and trade names, which are brand names. Generic names for drugs are nowadays constructed out of affixes and stems that classify the drugs into different categories and also separate drugs within categories. A marketed drug might also have a company code or compound code.

Chemical names

The chemical names are the scientific names, based on the molecular structure of the drug. There are various systems of chemical nomenclature and thus various chemical names for any one substance. The most important is the IUPAC name. Chemical names are typically very long and too complex to be commonly used in referring to a drug.[1] Sometimes, a company that is developing a drug might give the drug a company code,[3] which is used to identify the drug while it is in development. For example, CDP870 is UCB’s company code for Cimzia.[1] Many of these codes, although not all, have prefixes that correspond to the company name. Example: 1-(Isopropylamino)-3-(1-naphthyloxy) propan-2-ol (propranolol).

Nonproprietary (generic) names

During development, the company will apply for regulatory approval of the drug by the relevant national regulatory agency (such as the U.S. Food and Drug Administration [FDA]), and it will apply for a generic (nonproprietary) name for that country (such as the United States Adopted Name [USAN] or Japanese Accepted Name [JAN]). It will also apply for an International Nonproprietary Name (INN) through the World Health Organization (WHO). Nowadays the national nonproprietary names are usually the same as the INN. The generic names usually indicate via their stems what drug class the drug belongs to.[4] For example, one can tell that aciclovir is an antiviral drug because its name ends in the -vir suffix.

Combination drug products

For combination drug products—those with 2 or more drugs combined into 1 dosage form—single nonproprietary names beginning with “co-” exist in both British Approved Name (BAN) form and in a formerly maintained USP name called the pharmacy equivalent name (PEN). Otherwise the 2 names are simply both given, joined by hyphens or slashes. For example, suspensions combining trimethoprim and sulfamethoxazole are called either trimethoprim/sulfamethoxazole or co-trimoxazole. Similarly, co-codamol is codeineacetaminophen, and co-triamterzide is triamterenehydrochlorothiazide. The USP ceased maintaining PENs, but the similar “co”-prefixed BANs are still current.

Trade (brand) names

For drugs that make it all the way through development, testing, and regulatory acceptance, the pharmaceutical company then gives the drug a trade name. The term trade name is a standard term in the pharmaceutical industry for a brand name or trademark name. For example, Lipitor is Pfizer‘s trade name for atorvastatin, a cholesterol-lowering medication.

 

An international nonproprietary name (INN) is an official generic and nonproprietary name given to a pharmaceutical drug or active ingredient.[2] International nonproprietary names make communication more precise by providing a unique standard name for each active ingredient, to avoid prescribing errors.[1] The INN system has been coordinated by the World Health Organization (WHO) since 1953.

Having unambiguous standard names for each drug (standardization of drug nomenclature) is important because a drug may be sold by many different brand names, or a branded medication may contain more than one drug. For example, the branded medications Celexa, Celapram and Citrol all contain the same active ingredient: citalopram; and the branded preparation Lemsip contains two active ingredients: paracetamol and phenylephrine.

Each drug’s INN is unique but may contain a word stem that is shared with other drugs of the same class, for example the beta blocker drugs propranolol and atenolol share the -olol suffix, and the benzodiazepine drugs lorazepam and diazepam share the -azepam suffix.

The WHO issues INNs in English, Latin, French, Russian, Spanish, Arabic, and Chinese, and a drug’s INNs are often cognate across most or all of the languages, with minor spelling or pronunciation differences, for example: “paracetamol” (en) “paracetamolum” (la), “paracétamol” (fr) and “парацетамол” (ru). An established INN is known as a recommended INN (rINN), while a name that is still being considered is called a proposed INN (pINN).

 

Name Stem examples are:[3]

Drug Labeling

General Requirements for Prescription Drug Labeling

  • Summary for the safe and effective use of the drug
  • Informative and accurate
  • Not promotional, false, or misleading
  • No implied claims or suggestions for use if evidence of safety or effective is lacking
  • Based whenever possible on data derived from human experience

Highlights: Concise, one-half page summary of information in the Full Prescribing Information

  • Limitations Statement
  • Product Names and Date of Initial U.S. Approval
  • Boxed Warning
  • Recent Major Changes
  • Indications and Usage
  • Dosage & Administration
  • Dosage Forms & Strengths
  • Contraindications
  • Warnings & Precautions
  • Adverse Reactions (listing of most common ARs)
  • Drug Interactions
  • Use in Specific Populations
  • Patient Counseling Information Statement

 

Complete Physician Labelling Rules as listed in 21 CFR 201.56

Title 21Chapter ISubchapter CPart 201Subpart B → §201.56


Title 21: Food and Drugs
PART 201—LABELING
Subpart B—Labeling Requirements for Prescription Drugs and/or Insulin


§201.56   Requirements on content and format of labeling for human prescription drug and biological products.

(a) General requirements. Prescription drug labeling described in §201.100(d) must meet the following general requirements:

(1) The labeling must contain a summary of the essential scientific information needed for the safe and effective use of the drug.

(2) The labeling must be informative and accurate and neither promotional in tone nor false or misleading in any particular. In accordance with §§314.70 and 601.12 of this chapter, the labeling must be updated when new information becomes available that causes the labeling to become inaccurate, false, or misleading.

(3) The labeling must be based whenever possible on data derived from human experience. No implied claims or suggestions of drug use may be made if there is inadequate evidence of safety or a lack of substantial evidence of effectiveness. Conclusions based on animal data but necessary for safe and effective use of the drug in humans must be identified as such and included with human data in the appropriate section of the labeling.

(b) Categories of prescription drugs subject to the labeling content and format requirements in §§201.56(d) and 201.57. (1) The following categories of prescription drug products are subject to the labeling requirements in paragraph (d) of this section and §201.57 in accordance with the implementation schedule in paragraph (c) of this section:

(i) Prescription drug products for which a new drug application (NDA), biologics license application (BLA), or efficacy supplement was approved by the Food and Drug Administration (FDA) between June 30, 2001 and June 30, 2006;

(ii) Prescription drug products for which an NDA, BLA, or efficacy supplement is pending on June 30, 2006; or

(iii) Prescription drug products for which an NDA, BLA, or efficacy supplement is submitted anytime on or after June 30, 2006.

(2) Prescription drug products not described in paragraph (b)(1) of this section are subject to the labeling requirements in paragraph (e) of this section and §201.80.

(c) Schedule for implementing the labeling content and format requirements in §§201.56(d) and 201.57. For products described in paragraph (b)(1) of this section, labeling conforming to the requirements in paragraph (d) of this section and §201.57 must be submitted according to the following schedule:

(1) For products for which an NDA, BLA, or efficacy supplement is submitted for approval on or after June 30, 2006, proposed conforming labeling must be submitted as part of the application.

(2) For products for which an NDA, BLA, or efficacy supplement is pending on June 30, 2006, or that has been approved any time from June 30, 2005, up to and including June 30, 2006, a supplement with proposed conforming labeling must be submitted no later than June 30, 2009.

(3) For products for which an NDA, BLA, or efficacy supplement has been approved anytime from June 30, 2004, up to and including June 29, 2005, a supplement with proposed conforming labeling must be submitted no later than June 30, 2010.

(4) For products for which an NDA, BLA, or efficacy supplement has been approved anytime from June 30, 2003, up to and including June 29, 2004, a supplement with proposed conforming labeling must be submitted no later than June 30, 2011.

(5) For products for which an NDA, BLA, or efficacy supplement has been approved anytime from June 30, 2002, up to and including June 29, 2003, a supplement with proposed conforming labeling must be submitted no later than June 30, 2012.

(6) For products for which an NDA, BLA, or efficacy supplement has been approved anytime from June 30, 2001, up to and including June 29, 2002, a supplement with proposed conforming labeling must be submitted no later than June 30, 2013.

(d) Labeling requirements for new and more recently approved prescription drug products. This paragraph applies only to prescription drug products described in paragraph (b)(1) of this section and must be implemented according to the schedule specified in paragraph (c) of this section.

(1) Prescription drug labeling described in §201.100(d) must contain the specific information required under §201.57(a), (b), and (c) under the following headings and subheadings and in the following order:

Highlights of Prescribing Information

Product Names, Other Required Information

Boxed Warning

Recent Major Changes

Indications and Usage

Dosage and Administration

Dosage Forms and Strengths

Contraindications

Warnings and Precautions

Adverse Reactions

Drug Interactions

Use in Specific Populations

Full Prescribing Information: Contents

Full Prescribing Information

Boxed Warning

1 Indications and Usage

2 Dosage and Administration

3 Dosage Forms and Strengths

4 Contraindications

5 Warnings and Precautions

6 Adverse Reactions

7 Drug Interactions

8 Use in Specific Populations

8.1 Pregnancy

8.2 Lactation

8.3 Females and Males of Reproductive Potential

8.4 Pediatric use

8.5 Geriatric use

9 Drug Abuse and Dependence

9.1 Controlled substance

9.2 Abuse

9.3 Dependence

10 Overdosage

11 Description

12 Clinical Pharmacology

12.1 Mechanism of action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 Nonclinical Toxicology

13.1 Carcinogenesis, mutagenesis, impairment of fertility

13.2 Animal toxicology and/or pharmacology

14 Clinical Studies

15 References

16 How Supplied/Storage and Handling

17 Patient Counseling Information

(2) Additional nonstandard subheadings that are used to enhance labeling organization, presentation, or ease of use (e.g., for individual warnings or precautions, or for each drug interaction) must be assigned a decimal number that corresponds to their placement in labeling. The decimal numbers must be consistent with the standardized identifying numbers listed in paragraph (d)(1) of this section (e.g., subheadings added to the “Warnings and Precautions” section must be numbered 5.1, 5.2, and so on).

(3) Any reference in Highlights to information appearing in the full prescribing information must be accompanied by the identifying number (in parentheses) corresponding to the location of the information in the full prescribing information.

(4) Omit clearly inapplicable sections, subsections, or specific information. If sections or subsections required under paragraph (d)(1) of this section are omitted from the full prescribing information, the heading “Full Prescribing Information: Contents” must be followed by an asterisk and the following statement must appear at the end of Contents: “* Sections or subsections omitted from the full prescribing information are not listed.”

(5) Any risk information that is required under §201.57(c)(9)(iv) is considered “appropriate pediatric contraindications, warnings, or precautions” within the meaning of section 505A(l)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355A(l)(2)), whether such information appears in the “Contraindications,” “Warnings and Precautions,” or “Use in Specific Populations” section of labeling.

(e) Labeling requirements for older prescription drug products. This paragraph applies only to approved prescription drug products not described in paragraph (b)(1) of this section.

(1) Prescription drug labeling described in §201.100(d) must contain the specific information required under §201.80 under the following section headings and in the following order:

Description

Clinical Pharmacology

Indications and Usage

Contraindications

Warnings

Precautions

Adverse Reactions

Drug Abuse and Dependence

Overdosage

Dosage and Administration

How Supplied

(2) The labeling may contain the following additional section headings if appropriate and if in compliance with §201.80(l) and (m):

Animal Pharmacology and/or Animal Toxicology

Clinical Studies

References

(3) Omit clearly inapplicable sections, subsections, or specific information.

(4) The labeling may contain a “Product Title” section preceding the “Description” section and containing only the information required by §201.80(a)(1)(i), (a)(1)(ii), (a)(1)(iii), and (a)(1)(iv) and §201.100(e). The information required by §201.80(a)(1)(i) through (a)(1)(iv) must appear in the “Description” section of the labeling, whether or not it also appears in a “Product Title.”

(5) The labeling must contain the date of the most recent revision of the labeling, identified as such, placed prominently immediately after the last section of the labeling.

(6) The requirement in §201.80(f)(2) to reprint any FDA-approved patient labeling at the end of prescription drug labeling or accompany the prescription drug labeling must be implemented no later than June 30, 2007.

[71 FR 3986, Jan. 24, 2006, as amended at 79 FR 72101, Dec. 4, 2014]

Communication Protocols

Health communication is the study and practice of communicating promotional health information, such as in public health campaigns, health education, and between doctor and patient. The purpose of disseminating health information is to influence personal health choices by improving health literacy.

Because effective health communication must be tailored for the audience and the situation, research into health communication seeks to refine communication strategies to inform people about ways to enhance health or to avoid specific health risks.Academically, health communication is a discipline within communication studies

Health communication may variously seek to:

  • increase audience knowledge and awareness of a health issue
  • influence behaviors and attitudes towards a health issue
  • demonstrate healthy practices
  • demonstrate the benefits of behavior changes to public health outcomes
  • advocate a position on a health issue or policy
  • increase demand or support for health services
  • argue against misconceptions about health