INTRODUCTION Clinical pharmacologists have a service role in the provision of drug information to individuals both in hospitals and primary

health care. We present here a systematic approach in answering questions in a drug information centre (DIC), and describe the working method and the documentation of the work in a question answer (Q/A) data base. Drug line is a full-text data base offering problem-oriented drug evaluation comparable to a clinical consultation. The drug information is produced in a noncommercial drug information centre sponsored by the national health care sector and the National Corporation of Swedish Pharmacies, and run jointly by clinical pharmacologists and pharmacists. A minor part of Drug line is available in English for online searching, in parallel with Medline at the database host, the Medical Information Centre at the Karolinska Institute Library and Information Centre, and the users represent mainly medical libraries, hospital pharmacies, university clinics, and the pharmaceutical industry. A network of DICs has been organized in Swedish university hospitals with access to Drug line for searching and the storage of questions and answers. This network has the potential for expansion throughout Europe. It offers the unique possibility of complementing drug product information with problem-oriented drug information emerging from cases in the real world of prescribing. Advice and information services provide factual information on drugs and drug treatment. The advice and information should be provided in an accessible and meaningful (in terms of context, language, comprehensibility) to the recipient. The advice and information provided can be conveyed in a variety of ways such as verbal, written, audio-visual, in person or over the telephone. Advice and information may cover topics such as: potential psychological and physical implications of drug misuse ; guidance on how to reduce or stop drug misuse safely;harm reduction information and guidance where to get help Harm Reduction Services This category incorporates drug treatment services that primarily fulfill a drug-related harm reduction function. A needle exchange operates by providing sterile injecting equipment to injecting drug users and disposing of used injecting equipment, with the aim of reducing infection. arm

reduction schemes may also offer the following: immunization against hepatitis B information on the prevention of infection from blood-borne diseases, such as HIV and hepatitis vice and information on HIV, hepatitis and drug problems;advice and information on overdose prevention/response, safer sex and sexual health. 1.Community Prescribing Specialist Community prescribing services offer the provision of a medically supervised substitute to an illicit drug misuser. The substitute maintains the individuals tolerance to the drug of misuse. The prescribing programme is the basis for providing medical and psychosocial counseling and support. Most prescribing in the UK is for opiate dependence.The most common pharmacotherapy in the UK concerns substituting an opioid substitute (usually oral methadone) for illicit heroin, at a level that will prevent the onset of withdrawal symptoms. pharmacotherapy for dependent users of amphetamines is also available. There is currently no pharmacotherapy aimed at cocaine and crack cocaine dependence.In UK policy, it is recommended that community prescribing takes place within a context in which the co-existing physical, emotional, social and legal problems are addressed as far as possible. 2.Community Prescribing GPs There is currently no pharmacotherapy aimed at cocaine and crack cocaine dependence.In UK policy, it is recommended that community prescribing takes place within a context in which the co-existing physical, emotional, social and legal problems are addressed as far as possible Community prescribing services offer the provision of a medically supervised substitute to an illicit drug misuser. Based on recent Department of Health guidelines (1999), which stressed the importance of a shared care approach between primary (GPs) and secondary care (specialist drug treatment) in the management of drug misusers. GPs are encouraged to provide specialist treatment programmes which may involve them prescribing substitutes. They are also encouraged not to prescribe in isolation but to liaise with other professionals Community prescribing services offer the provision of a medically supervised

substitute to an illicit drug misuser. Based on recent Department of Health guidelines (1999), which stressed the importance of a shared care approach between primary (GPs) and secondary care (specialist drug treatment) in the management of drug misusers. 3.Structured Counseling Structured counseling is defined as formal counseling approaches with assessment, clearly defined treatment plans and treatment goals and regular reviews. It is distinct from advice and information, drop-in support and informal key-working. 3.1. Structured Day Programmes Drug treatment providers in this category offer intensive community-based support, treatment and rehabilitation. Programmes of defined activities for a fixed period of time will be on offer and will require a specific level of attendance, usually four to five days a week. Drug Treatment services Structured counseling is defined as formal counselling approaches with assessment, clearly defined treatment plans and treatment goals and regular reviews. It is distinct from advice and information, drop-in support and informal key-working. Drug treatment providers in this category offer intensive community-based support, treatment and rehabilitation. Programmes of defined activities for a fixed period of time will be on offer and will require a specific level of attendance, usually four to five days a week. Drug Treatment services providing structured support for clients on exit from another programme. The development of an appropriate package of aftercare and support should take place in the final phase of the treatment episode of service users aiming to achieve abstinence. 3.2. Inpatient Detoxification Inpatient detoxification programmers are specialized units for people with substance

misuse disorders, which provide medically supervised withdrawal medical cover (and usually relapse prevention) and aftercare referral services . 3.3. Residential Rehabilitation These drug treatment providers offer intensive and controlled residential or hospital inpatient environments. structured

with

24-hour

programmes

in

Some crisis intervention services have open access, others require formal referral via a health or social care agency. Rehabilitation services vary in approach programme structure, intensity and duration. The majority of residential rehabilitation services require users to be drug-free on entry, although some may have on-site detoxification facilities. 3.4.Criminal justice interventions Individuals accessing drug treatment services may have done so as a result of engagement in a criminal justice intervention. The follow describes specific criminal justice drug treatment interventions that are provided in the community. These definitions are taken from Enhancing Drug Services, Drug Scope (forthcoming). Other more informal interventions may be provided in partnership with Probation and young people, those under 19, may also receive drug treatment as a result of engagement with a Youth Offending Team. Arrest Referral Schemes Arrest Referral Schemes treatment services by appropriate treatment prosecution. were introduced nationally from 1st April 2000. The aim of is to bridge the gap between the criminal justice system and identifying drug user detainees and referring them into shortly after arrest. Referral is not an alternative to

3.5.Drug Treatment and Testing Orders Drug Treatment and Testing Orders (DTTO) are a community sentence introduced as part of the Crime and Disorder Act 1998. The order targets persistent offenders aged 16 years and over, that offend to fund serious drug dependency. The aim is to promote a reduction and/or cessation in drug use therefore reducing drug related crime. DTTOs run for 6 months

to no more than 3 years. A DTTO can be imposed alone or alongside a Community Rehabilitation Order (replaced Probation Orders), duration of the treatment and testing period must be specified within the order and subject to regular court review hearings. Frequent urine analysis is mandatory through out the order. Offenders are required to give their consent before a DTTO can be made. The principle of consent is fundamental to the order due to the general medical principle that a person should not be compelled to undergo treatment without giving consent . 3.6. Drug Abstinence Orders Drug Treatment and Testing Orders (DTTO) are a community sentence introduced as part of the Crime and Disorder Act 2000. The order has similarities to Drug Treatment and Testing Orders as it compels the individual serving the order to undergo regular drug testing, however, there are differences. Firstly, the aim is to be drug abstinent rather than reduce drug use, and secondly drug treatment is not a formal part of the order, although this may be undertaken voluntarily. Drug-related illness in the United States factors substantially in health care costs, although often these illnesses and their attendant costs are preventable. One strategy for minimizing adverse drug reactions is to provide drug information to consumers in the form of prescription counseling at pharmacies. The Omnibus Budget Reconciliation Act of 1990 (OBRA 1990) contained provisions for mandating such counseling to Medicaid patients. OBRA 1990 was implemented in 1993, but most states acted quickly to extend counseling services to all patients receiving prescription drugs. We looked at the extent and quality of prescription counseling available in community pharmacies 1 decade after OBRA 1990 was written. We evaluated the counseling services afforded at large chain pharmacies, independent community pharmacies, and on-line pharmacies for a hydrochlorothiazide prescription. We found that most (69%) pharmacies offered to provide prescription counseling service, and that average counseling index scores, a measure of the quality or extent of information provided as determined by a Rasch analysis, were generally satisfactory.Our observations based on a single prescription for hydrochlorothiazide,

along with other studies, suggest that there is a positive upward trend in the number of pharmacies providing prescription drug information, and that the extent of information provided suggests that the objectives of OBRA 1990 and related legislation to reduce ADRs are being fundamentally satisfied. 4. Adequate Provision An alternative way for drug companies to provide risk information about a drug in a broadcast ad. Drug companies generally must include all of a drug's risk information in a product claim ad. In print ads, they usually do this in the "brief summary." This brief summary would take many minutes to read or scroll down a TV screen. The law allows broadcast ads to include only the most important risk information if the ads tell viewers or listeners how to get the full FDA-approved prescribing information, which has all the drug's risks. To meet the "adequate provision" requirement, the broadcast ad must provide ways to find the drug's FDA-approved prescribing information. Broadcast ads can meet the "adequate provision" requirement by giving a number of sources for finding a drug's prescribing information. These include:

A healthcare provider (for example, a doctor) A toll-free telephone number The current issue of a magazine that contains a print ad A Web site address

4.1. Advertisement Federal law treats advertisements and promotional labeling differently. Advertisements generally appear in:

Print periodicals, such as journals, magazines, and newspapers Broadcast media, such as television and radio, as well as through telephone systems 4.1.1.Advertising and Promotional Labeling Branch (APLB)

The APLB is the group within the Center for Biologics Evaluation and Research (CBER) that regulates the promotion of biological products, including vaccines, tissues, and blood-related products, including allergenics, and cellular and gene therapy 4.1.2.Benefit A benefit is help provided by a drug for the person who is taking it. For example, the

benefit of a drug used to treat cholesterol is that it lowers the levels of bad cholesterol (low-density lipoprotein, or LDL, cholesterol). A drug could also raise the levels of good cholesterol (high-density lipoprotein, or HDL, cholesterol). This is another possible benefit. The law does not allow drug companies to advertise benefits unless they are related to the FDA-approved use. Also, advertised benefits must be supported by "substantial evidence" or substantial clinical experience. However, healthcare providers can prescribe a drug for uses other than its FDA-approved use. 4.1.3.Boxed Warning Drugs that have special problems, particularly ones that may lead to death or serious injury, may have this warning information displayed within a box in the prescribing information. This is often referred to as a "boxed" or "black box" warning. Drugs that have such boxed warnings are not permitted to have reminder ads. 4.1.4.Brand Name A drug's common name, which is the generally advertised name. Drugs that have the same underlying active substance may be made by different companies and can have different brand names. 4.1.5.Brief Summary This is the technical name for the detailed information that appears in ads for prescription drugs. The law requires that print ads making claims about a drug (product claim ads) include a "brief summary" with all the risks listed in the drug's "prescribing information" and at least one FDA-approved use of the drug. The brief summary generally includes:

Who should not take the drug When the drug should not be taken Possible serious side effects of the drug and, if known, what can be done to lower the chance of having them Frequently occurring, but not necessarily serious, side effects

The "brief summary" includes a lot of information, so it is usually presented on its own page of a print ad. When the "brief summary" is part of an ad directed at the consumer, the FDA encourages drug companies to use language consumers can easily understand.

4.1.6.Claim A claim says something about the advertised drug or what it does. Claims usually relate to benefits. Claims can be made directly by stating, for example, "Brand X treats heartburn." Claims also can be made indirectly by the use of pictures or other graphics. For example, an ad with a picture of a playground full of children may suggest a claim that the advertised drug treats children.The law says that ads for prescription drugs can only make claims that are consistent with the drug's "prescribing information." Further, the truthfulness of claims must be supported by "substantial evidence" or substantial clinical experience. 5.Direct-to-Consumer (DTC) Advertisements DTC ads are published in magazines and newspapers that are distributed to a general audience rather than to healthcare providers such as doctors, nurses, and pharmacists. DTC ads can also be broadcast through television or radio. Other types of materials, such as brochures, booklets, or pamphlets distributed to patients, caregivers, or other non-healthcare providers are considered DTC promotions. While many people would think these are ads, they are technically considered a different category, called promotional labeling. 5.1. Fair Balance The law requires that product claim ads give a "fair balance" of information about drug risks as compared with information about drug benefits. This means that the content and presentation of a drug's most important risks must be reasonably similar to the content and presentation of its benefits.This does not mean that equal space must be given to risks and benefits in print ads, or equal time to risks and benefits in broadcast ads. The amount of time or space needed to present risk information will depend on the drug's risks and the way that both the benefits and risks are presented. 5.2.Generic Name A drug's generic name is one that a non-government organization assigns to the drug's active ingredient. Different "brand names" can be used for the same generic name ingredient. For example, the active ingredient in Synthroid is levothyroxine. Levothyroxine is also the active ingredient in Levoxyl. Levothyroxine is the generic name for both of the brand names Synthroid and Levoxyl. 5.3.. Interaction Drugs sometimes interact with other drugs (prescription and non-prescription), supplements, foods, or beverages. These interactions may affect how the drug works,

or may cause side effects. To avoid problems, a person thinking about taking a drug should know its possible interactions. They should also tell their healthcare provider about all the drugs and supplements they take. 5.4.Major Statement The "major statement" is a term that is relevant only to broadcast (TV or radio) ads for prescription drugs. It refers to the presentation of the drug's most important risks. This presentation must be spoken. It also can be included in the video part of TV advertisements. The amount and type of included risk information will vary by drug because different drugs have different risks. 6.Office of Prescription Drug Promotion (OPDP) OPDP regulates the promotion of prescription drugs within the FDA's Center for Drug Evaluation and Research (CDER). 6.1.Prescribing Information Prescribing information is also called product information, product labeling, or the package insert ("the PI"). It is generally drafted by the drug company and approved by the FDA. This information travels with a drug as it moves from the company to the pharmacist. It includes the details and directions healthcare providers need to prescribe the drug properly. It is also the basis for how the drug company can advertise its drug. The prescribing information includes such details about the drug as:

Its chemical description How it works How it interacts with other drugs, supplements, foods, and beverages What condition(s) or disease(s) it treats Who should not use the drug Serious side effects, even if they occur rarely Commonly occurring side effects, even if they are not serious Effects on specific groups of patients, such as children, pregnant women, or older adults and how to use it in these populations

Sometimes, manufacturers draft prescription drug information designed for patients that the FDA approves. These are often called "Patient Package Inserts," "Patient Product Information," or "PPIs." When the information is for an especially risky or difficult to use drug, it is called a Medication Guide. Patients should be given this

information when they fill their prescription. Patients may also get information that is produced independently of the FDA and the drug company. 6.2.Promotional Labeling Promotional labeling and advertising are both used to help sell prescription drugs. Promotional labeling differs from advertising in the way it is distributed. Ads are usually broadcast on TV or radio, or are published in newspapers or magazines. Promotional labeling includes additional types of materials and ways to get them to the consumer, for example:

Brochures and booklets Mailed materials, including letters to patients Videotapes Refrigerator magnets, cups, and other giveaways that show a drug's name

Promotional labeling about a drug is said to "accompany" that drug, even if the promotional labeling is not physically attached to a drug container. Promotional labeling must be accompanied by the drug's prescribing information. 6.3.Risks/Side Effects The risks of a drug refer to what can go wrong when the drug is used. A drug's prescribing information states these risks, which can include:

What groups of patients should not use the drug because it may do them more harm than good When the drug should not be used Serious side effects Side effects seen in special populations, such as children, pregnant women, or older patients Commonly occurring side effects The chance of the drug causing abuse or dependence The chance of the drug causing withdrawal effects

6.4 Substantial Evidence (Substantiation) Substantial evidence refers to the data needed to support claims about an advertised drug. Before the FDA approves a drug for marketing, drug companies must complete studies to show that the drug does what they say it does. These studies are also required to support advertising claims about the drug. Drug companies need to have at least two studies to support these claims.

10

This site was developed as a collaborative effort between FDA and EthicAd to educate consumers about DTC prescription drug advertisements. 7.Advertising and Promotional Labeling Branch (APLB) The APLB is the group within the Center for Biologics Evaluation and Research (CBER) that regulates the promotion of biological products, including vaccines, tissues, and blood-related products, including allergenics, and cellular and gene therapy. For information about CBER's enforcement activities, visit their 7.1.Benefit A benefit is help provided by a drug for the person who is taking it. For example, the benefit of a drug used to treat cholesterol is that it lowers the levels of bad cholesterol (low-density lipoprotein, or LDL, cholesterol). A drug could also raise the levels of good cholesterol (high-density lipoprotein, or HDL, cholesterol). This is another possible benefit. The law does not allow drug companies to advertise benefits unless they are related to the FDA-approved use. Also, advertised benefits must be supported by "substantial evidence" or substantial clinical experience. However, healthcare providers can prescribe a drug for uses other than its FDA-approved use. 7. 2.Boxed Warning Drugs that have special problems, particularly ones that may lead to death or serious injury, may have this warning information displayed within a box in the prescribing information. This is often referred to as a "boxed" or "black box" warning. Drugs that have such boxed warnings are not permitted to have reminder ads. 7.3.Brand Name A drug's common name, which is the generally advertised name. Drugs that have the same underlying active substance may be made by different companies and can have different brand names. 7.4.Brief Summary This is the technical name for the detailed information that appears in ads for prescription drugs. The law requires that print ads making claims about a drug (product claim ads) include a "brief summary" with all the risks listed in the drug's "prescribing information" and at least one FDA-approved use of the drug. The brief summary generally includes:

11

Who should not take the drug When the drug should not be taken Possible serious side effects of the drug and, if known, what can be done to lower the chance of having them Frequently occurring, but not necessarily serious, side effects

The "brief summary" includes a lot of information, so it is usually presented on its own page of a print ad. When the "brief summary" is part of an ad directed at the consumer, the FDA encourages drug companies to use language consumers can easily understand. 7.5.Claim
A claim says something about the advertised drug or what it does. Claims usually relate to benefits. Claims can be made directly by stating, for example, "Brand X treats heartburn." Claims also can be made indirectly by the use of pictures or other graphics. For example, an ad with a picture of a playground full of children may suggest a claim that the advertised drug treats children.The law says that ads for prescription drugs can only make claims that are consistent with the drug's "prescribing information." Further, the truthfulness of claims must be supported by "substantial evidence" or substantial clinical experience.

12

INTRODUCTION Clinical pharmacologists have a service role in the provision of drug information to individuals both in hospitals and primary health care. We present here a systematic approach in answering questions in a drug information centre (DIC), and describe the working method and the documentation of the work in a question answer (Q/A) data base. Drug line is a full-text data base offering problem-oriented drug evaluation comparable to a clinical consultation. The drug information is produced in a noncommercial drug information centre sponsored by the national health care sector and the National Corporation of Swedish Pharmacies, and run jointly by clinical pharmacologists and pharmacists. A minor part of Drug line is available in English for online searching, in parallel with Medline at the database host, the Medical Information Centre at the Karolinska Institute Library and Information Centre, and the users represent mainly medical libraries, hospital pharmacies, university clinics, and the pharmaceutical industry. A network of DICs has been organized in Swedish university hospitals with access to Drug line for searching and the storage of questions and answers. This network has the potential for expansion throughout Europe. It offers the unique possibility of complementing drug product information with problem-oriented drug information emerging from cases in the real world of prescribing. Advice and information services provide factual information on drugs and drug treatment. The advice and information should be provided in an accessible and meaningful (in terms of context, language, comprehensibility) to the recipient. The advice and information provided can be conveyed in a variety of ways such as verbal, written, audio-visual, in person or over the telephone. Advice and information may cover topics such as: potential psychological and physical implications of drug misuse ; guidance on how to reduce or stop drug misuse safely;harm reduction information and guidance where to get help Harm Reduction Services This category incorporates drug treatment services that primarily fulfill a drug-related harm reduction function. A needle
13

exchange operates by providing sterile injecting equipment to injecting drug users and disposing of used injecting equipment, with the aim of reducing infection. arm

reduction schemes may also offer the following: immunization against hepatitis B information on the prevention of infection from blood-borne diseases, such as HIV and hepatitis vice and information on HIV, hepatitis and drug problems ;advice and information on overdose prevention/response, safer sex and sexual health. 1.Community Prescribing Specialist Community prescribing services offer the provision of a medically supervised substitute to an illicit drug misuser. The substitute maintains the individuals tolerance to the drug of misuse. The prescribing programme is the basis for providing medical and psychosocial counseling and support. Most prescribing in the UK is for opiate dependence.The most common pharmacotherapy in the UK concerns substituting an opioid substitute (usually oral methadone) for illicit heroin, at a level that will prevent the onset of withdrawal symptoms. pharmacotherapy for dependent users of amphetamines is also available. There is currently no pharmacotherapy aimed at cocaine and crack cocaine dependence.In UK policy, it is recommended that community prescribing takes place within a context in which the co-existing physical, emotional, social and legal problems are addressed as far as possible . 2.Community Prescribing GPs There is currently no pharmacotherapy aimed at cocaine and crack cocaine dependence.In UK policy, it is recommended that community prescribing takes place within a context in which the co-existing physical, emotional, social and legal problems are addressed as far as possible Community prescribing services offer the provision of a medically supervised substitute to an illicit drug misuser. Based on recent Department of Health guidelines (1999), which stressed the importance of a shared care approach between primary (GPs) and secondary care (specialist drug treatment) in the management of drug misusers. GPs are encouraged to provide specialist treatment programmes which may involve them prescribing substitutes. They are also encouraged not to prescribe in isolation but to liaise with other professionals
14

Community prescribing services offer the provision of a medically supervised

substitute to an illicit drug misuser. Based on recent Department of Health guidelines (1999), which stressed the importance of a shared care approach between primary (GPs) and secondary care (specialist drug treatment) in the management of drug misusers. 3.Structured Counseling Structured counseling is defined as formal counseling approaches with assessment, clearly defined treatment plans and treatment goals and regular reviews. It is distinct from advice and information, drop-in support and informal key-working. 3.1. Structured Day Programmes Drug treatment providers in this category offer intensive community-based support, treatment and rehabilitation. Programmes of defined activities for a fixed period of time will be on offer and will require a specific level of attendance, usually four to five days a week. Drug Treatment services Structured counseling is defined as formal counselling approaches with assessment, clearly defined treatment plans and treatment goals and regular reviews. It is distinct from advice and information, drop-in support and informal key-working. Drug treatment providers in this category offer intensive community-based support, treatment and rehabilitation. Programmes of defined activities for a fixed period of time will be on offer and will require a specific level of attendance, usually four to five days a week. Drug Treatment services providing structured support for clients on exit from another programme. The development of an appropriate package of aftercare and support should take place in the final phase of the treatment episode of service users aiming to achieve abstinence. 3.2. Inpatient Detoxification

15

Inpatient detoxification programmers are specialized units for people with substance

misuse disorders, which provide medically supervised withdrawal medical cover (and usually relapse prevention) and aftercare referral services . 3.3. Residential Rehabilitation These drug treatment providers offer intensive and controlled residential or hospital inpatient environments. structured

with

24-hour

programmes

in

Some crisis intervention services have open access, others require formal referral via a health or social care agency. Rehabilitation services vary in approach programme structure, intensity and duration. The majority of residential rehabilitation services require users to be drug-free on entry, although some may have on-site detoxification facilities. 3.4.Criminal justice interventions Individuals accessing drug treatment services may have done so as a result of engagement in a criminal justice intervention. The follow describes specific criminal justice drug treatment interventions that are provided in the community. These definitions are taken from Enhancing Drug Services, Drug Scope (forthcoming). Other more informal interventions may be provided in partnership with Probation and young people, those under 19, may also receive drug treatment as a result of engagement with a Youth Offending Team. Arrest Referral Schemes Arrest Referral Schemes treatment services by appropriate treatment prosecution. were introduced nationally from 1st April 2000. The aim of is to bridge the gap between the criminal justice system and identifying drug user detainees and referring them into shortly after arrest. Referral is not an alternative to

3.5.Drug Treatment and Testing Orders Drug Treatment and Testing Orders (DTTO) are a community sentence introduced as part of the Crime and Disorder Act 1998. The order targets persistent offenders aged 16 years and over, that offend to fund serious drug dependency. The aim is to
16

promote a reduction and/or cessation in drug use therefore reducing drug related crime. DTTOs run for 6 months

to no more than 3 years. A DTTO can be imposed alone or alongside a Community Rehabilitation Order (replaced Probation Orders), duration of the treatment and testing period must be specified within the order and subject to regular court review hearings. Frequent urine analysis is mandatory through out the order. Offenders are required to give their consent before a DTTO can be made. The principle of consent is fundamental to the order due to the general medical principle that a person should not be compelled to undergo treatment without giving consent. 3.6. Drug Abstinence Orders Drug Treatment and Testing Orders (DTTO) are a community sentence introduced as part of the Crime and Disorder Act 2000. The order has similarities to Drug Treatment and Testing Orders as it compels the individual serving the order to undergo regular drug testing, however, there are differences. Firstly, the aim is to be drug abstinent rather than reduce drug use, and secondly drug treatment is not a formal part of the order, although this may be undertaken voluntarily. Drug-related illness in the United States factors substantially in health care costs, although often these illnesses and their attendant costs are preventable. One strategy for minimizing adverse drug reactions is to provide drug information to consumers in the form of prescription counseling at pharmacies. The Omnibus Budget Reconciliation Act of 1990 (OBRA 1990) contained provisions for mandating such counseling to Medicaid patients. OBRA 1990 was implemented in 1993, but most states acted quickly to extend counseling services to all patients receiving prescription drugs. We looked at the extent and quality of prescription counseling available in community pharmacies 1 decade after OBRA 1990 was written. We evaluated the counseling services afforded at large chain pharmacies, independent community pharmacies, and on-line pharmacies for a hydrochlorothiazide prescription. We found that most (69%) pharmacies offered to provide prescription counseling service, and that average counseling index scores, a measure of the quality or extent
17

of information provided as determined by a Rasch analysis, were generally satisfactory.Our observations based on a single prescription for hydrochlorothiazide,

along with other studies, suggest that there is a positive upward trend in the number of pharmacies providing prescription drug information, and that the extent of information provided suggests that the objectives of OBRA 1990 and related legislation to reduce ADRs are being fundamentally satisfied. 4. Adequate Provision An alternative way for drug companies to provide risk information about a drug in a broadcast ad. Drug companies generally must include all of a drug's risk information in a product claim ad. In print ads, they usually do this in the "brief summary." This brief summary would take many minutes to read or scroll down a TV screen. The law allows broadcast ads to include only the most important risk information if the ads tell viewers or listeners how to get the full FDA-approved prescribing information, which has all the drug's risks. To meet the "adequate provision" requirement, the broadcast ad must provide ways to find the drug's FDA-approved prescribing information. Broadcast ads can meet the "adequate provision" requirement by giving a number of sources for finding a drug's prescribing information. These include:

A healthcare provider (for example, a doctor) A toll-free telephone number The current issue of a magazine that contains a print ad A Web site address

4.1. Advertisement Federal law treats advertisements and promotional labeling differently. Advertisements generally appear in:

Print periodicals, such as journals, magazines, and newspapers Broadcast media, such as television and radio, as well as through telephone systems 4.1.1.Advertising and Promotional Labeling Branch (APLB)

The APLB is the group within the Center for Biologics Evaluation and Research (CBER) that regulates the promotion of biological products, including vaccines, tissues, and blood-related products, including allergenics, and cellular and gene therapy

18

4.1.2.Benefit A benefit is help provided by a drug for the person who is taking it. For example, the

benefit of a drug used to treat cholesterol is that it lowers the levels of bad cholesterol (low-density lipoprotein, or LDL, cholesterol). A drug could also raise the levels of good cholesterol (high-density lipoprotein, or HDL, cholesterol). This is another possible benefit. The law does not allow drug companies to advertise benefits unless they are related to the FDA-approved use. Also, advertised benefits must be supported by "substantial evidence" or substantial clinical experience. However, healthcare providers can prescribe a drug for uses other than its FDA-approved use. 4.1.3.Boxed Warning Drugs that have special problems, particularly ones that may lead to death or serious injury, may have this warning information displayed within a box in the prescribing information. This is often referred to as a "boxed" or "black box" warning. Drugs that have such boxed warnings are not permitted to have reminder ads. 4.1.4.Brand Name A drug's common name, which is the generally advertised name. Drugs that have the same underlying active substance may be made by different companies and can have different brand names. 4.1.5.Brief Summary This is the technical name for the detailed information that appears in ads for prescription drugs. The law requires that print ads making claims about a drug (product claim ads) include a "brief summary" with all the risks listed in the drug's "prescribing information" and at least one FDA-approved use of the drug. The brief summary generally includes:

Who should not take the drug When the drug should not be taken Possible serious side effects of the drug and, if known, what can be done to lower the chance of having them Frequently occurring, but not necessarily serious, side effects

19

The "brief summary" includes a lot of information, so it is usually presented on its own page of a print ad. When the "brief summary" is part of an ad directed at the consumer, the FDA encourages drug companies to use language consumers can easily understand.

4.1.6.Claim A claim says something about the advertised drug or what it does. Claims usually relate to benefits. Claims can be made directly by stating, for example, "Brand X treats heartburn." Claims also can be made indirectly by the use of pictures or other graphics. For example, an ad with a picture of a playground full of children may suggest a claim that the advertised drug treats children.The law says that ads for prescription drugs can only make claims that are consistent with the drug's "prescribing information." Further, the truthfulness of claims must be supported by "substantial evidence" or substantial clinical experience. 5.Direct-to-Consumer (DTC) Advertisements DTC ads are published in magazines and newspapers that are distributed to a general audience rather than to healthcare providers such as doctors, nurses, and pharmacists. DTC ads can also be broadcast through television or radio. Other types of materials, such as brochures, booklets, or pamphlets distributed to patients, caregivers, or other non-healthcare providers are considered DTC promotions. While many people would think these are ads, they are technically considered a different category, called promotional labeling. 5.1. Fair Balance The law requires that product claim ads give a "fair balance" of information about drug risks as compared with information about drug benefits. This means that the content and presentation of a drug's most important risks must be reasonably similar to the content and presentation of its benefits.This does not mean that equal space must be given to risks and benefits in print ads, or equal time to risks and benefits in broadcast ads. The amount of time or space needed to present risk information will depend on the drug's risks and the way that both the benefits and risks are presented. 5.2.Generic Name A drug's generic name is one that a non-government organization assigns to the drug's active ingredient. Different "brand names" can be used for the same generic name ingredient. For example, the active ingredient in Synthroid is levothyroxine.
20

Levothyroxine is also the active ingredient in Levoxyl. Levothyroxine is the generic name for both of the brand names Synthroid and Levoxyl. 5.3.. Interaction Drugs sometimes interact with other drugs (prescription and non-prescription), supplements, foods, or beverages. These interactions may affect how the drug works,

or may cause side effects. To avoid problems, a person thinking about taking a drug should know its possible interactions. They should also tell their healthcare provider about all the drugs and supplements they take. 5.4.Major Statement The "major statement" is a term that is relevant only to broadcast (TV or radio) ads for prescription drugs. It refers to the presentation of the drug's most important risks. This presentation must be spoken. It also can be included in the video part of TV advertisements. The amount and type of included risk information will vary by drug because different drugs have different risks. 6.Office of Prescription Drug Promotion (OPDP) OPDP regulates the promotion of prescription drugs within the FDA's Center for Drug Evaluation and Research (CDER). 6.1.Prescribing Information Prescribing information is also called product information, product labeling, or the package insert ("the PI"). It is generally drafted by the drug company and approved by the FDA. This information travels with a drug as it moves from the company to the pharmacist. It includes the details and directions healthcare providers need to prescribe the drug properly. It is also the basis for how the drug company can advertise its drug. The prescribing information includes such details about the drug as:

Its chemical description How it works How it interacts with other drugs, supplements, foods, and beverages What condition(s) or disease(s) it treats Who should not use the drug Serious side effects, even if they occur rarely Commonly occurring side effects, even if they are not serious Effects on specific groups of patients, such as children, pregnant women, or older adults and how to use it in these populations

21

Sometimes, manufacturers draft prescription drug information designed for patients that the FDA approves. These are often called "Patient Package Inserts," "Patient Product Information," or "PPIs." When the information is for an especially risky or difficult to use drug, it is called a Medication Guide. Patients should be given this

information when they fill their prescription. Patients may also get information that is produced independently of the FDA and the drug company. 6.2.Promotional Labeling Promotional labeling and advertising are both used to help sell prescription drugs. Promotional labeling differs from advertising in the way it is distributed. Ads are usually broadcast on TV or radio, or are published in newspapers or magazines. Promotional labeling includes additional types of materials and ways to get them to the consumer, for example:

Brochures and booklets Mailed materials, including letters to patients Videotapes Refrigerator magnets, cups, and other giveaways that show a drug's name

Promotional labeling about a drug is said to "accompany" that drug, even if the promotional labeling is not physically attached to a drug container. Promotional labeling must be accompanied by the drug's prescribing information. 6.3.Risks/Side Effects The risks of a drug refer to what can go wrong when the drug is used. A drug's prescribing information states these risks, which can include:

What groups of patients should not use the drug because it may do them more harm than good When the drug should not be used Serious side effects Side effects seen in special populations, such as children, pregnant women, or older patients Commonly occurring side effects The chance of the drug causing abuse or dependence The chance of the drug causing withdrawal effects

22

6.4 Substantial Evidence (Substantiation) Substantial evidence refers to the data needed to support claims about an advertised drug. Before the FDA approves a drug for marketing, drug companies must complete studies to show that the drug does what they say it does. These studies are also required to support advertising claims about the drug. Drug companies need to have at least two studies to support these claims.

This site was developed as a collaborative effort between FDA and EthicAd to educate consumers about DTC prescription drug advertisements. 7.Advertising and Promotional Labeling Branch (APLB) The APLB is the group within the Center for Biologics Evaluation and Research (CBER) that regulates the promotion of biological products, including vaccines, tissues, and blood-related products, including allergenics, and cellular and gene therapy. For information about CBER's enforcement activities, visit their 7.1.Benefit A benefit is help provided by a drug for the person who is taking it. For example, the benefit of a drug used to treat cholesterol is that it lowers the levels of bad cholesterol (low-density lipoprotein, or LDL, cholesterol). A drug could also raise the levels of good cholesterol (high-density lipoprotein, or HDL, cholesterol). This is another possible benefit. The law does not allow drug companies to advertise benefits unless they are related to the FDA-approved use. Also, advertised benefits must be supported by "substantial evidence" or substantial clinical experience. However, healthcare providers can prescribe a drug for uses other than its FDA-approved use. 7. 2.Boxed Warning Drugs that have special problems, particularly ones that may lead to death or serious injury, may have this warning information displayed within a box in the prescribing information. This is often referred to as a "boxed" or "black box" warning. Drugs that have such boxed warnings are not permitted to have reminder ads. 7.3.Brand Name A drug's common name, which is the generally advertised name. Drugs that have the same underlying active substance may be made by different companies and can have different brand names. 7.4.Brief Summary

23

This is the technical name for the detailed information that appears in ads for prescription drugs. The law requires that print ads making claims about a drug (product claim ads) include a "brief summary" with all the risks listed in the drug's "prescribing information" and at least one FDA-approved use of the drug. The brief summary generally includes:

Who should not take the drug When the drug should not be taken Possible serious side effects of the drug and, if known, what can be done to lower the chance of having them Frequently occurring, but not necessarily serious, side effects

The "brief summary" includes a lot of information, so it is usually presented on its own page of a print ad. When the "brief summary" is part of an ad directed at the consumer, the FDA encourages drug companies to use language consumers can easily understand. 7.5.Claim
A claim says something about the advertised drug or what it does. Claims usually relate to benefits. Claims can be made directly by stating, for example, "Brand X treats heartburn." Claims also can be made indirectly by the use of pictures or other graphics. For example, an ad with a picture of a playground full of children may suggest a claim that the advertised drug treats children.The law says that ads for prescription drugs can only make claims that are consistent with the drug's "prescribing information." Further, the truthfulness of claims must be supported by "substantial evidence" or substantial clinical experience.

24

INTRODUCTION Clinical pharmacologists have a service role in the provision of drug information to individuals both in hospitals and primary health care. We present here a systematic approach in answering questions in a drug information centre (DIC), and describe the working method and the documentation of the work in a question answer (Q/A) data base. Drug line is a full-text data base offering problem-oriented drug evaluation comparable to a clinical consultation. The drug information is produced in a noncommercial drug information centre sponsored by the national health care sector and the National Corporation of Swedish Pharmacies, and run jointly by clinical pharmacologists and pharmacists. A minor part of Drug line is available in English for online searching, in parallel with Medline at the database host, the Medical Information Centre at the Karolinska Institute Library and Information Centre, and the users represent mainly medical libraries, hospital pharmacies, university clinics, and the pharmaceutical industry. A network of DICs has been organized in Swedish university hospitals with access to Drug line for searching and the storage of questions and answers. This network has the potential for expansion throughout Europe. It offers the unique possibility of complementing drug product information with problem-oriented drug information emerging from cases in the real world of prescribing. Advice and information services provide factual information on drugs and drug treatment. The advice and information should be provided in an accessible and meaningful (in terms of context, language, comprehensibility) to the recipient. The
25

advice and information provided can be conveyed in a variety of ways such as verbal, written, audio-visual, in person or over the telephone. Advice and information may cover topics such as: potential psychological and physical implications of drug misuse ; guidance on how to reduce or stop drug misuse safely;harm reduction information and guidance where to get help Harm Reduction Services This category incorporates drug treatment services that primarily fulfill a drug-related harm reduction function. A needle exchange operates by providing sterile injecting equipment to injecting drug users and disposing of used injecting equipment, with the aim of reducing infection. arm

reduction schemes may also offer the following: immunization against hepatitis B information on the prevention of infection from blood-borne diseases, such as HIV and hepatitis vice and information on HIV, hepatitis and drug problems ;advice and information on overdose prevention/response, safer sex and sexual health. 1.Community Prescribing Specialist Community prescribing services offer the provision of a medically supervised substitute to an illicit drug misuser. The substitute maintains the individual s tolerance to the drug of misuse. The prescribing programme is the basis for providing medical and psychosocial counseling and support. Most prescribing in the UK is for opiate dependence.The most common pharmacotherapy in the UK concerns substituting an opioid substitute (usually oral methadone) for illicit heroin, at a level that will prevent the onset of withdrawal symptoms. pharmacotherapy for dependent users of amphetamines is also available. There is currently no pharmacotherapy aimed at cocaine and crack cocaine dependence.In UK policy, it is recommended that community prescribing takes place within a context in which the co-existing physical, emotional, social and legal problems are addressed as far as possible . 2.Community Prescribing GPs There is currently no pharmacotherapy aimed at cocaine and crack cocaine dependence.In UK policy, it is recommended that community prescribing takes place within a context in which the co-existing physical, emotional, social and legal problems are addressed as far as possible Community prescribing services offer the
26

provision of a medically supervised substitute to an illicit drug misuser. Based on recent Department of Health guidelines (1999), which stressed the importance of a shared care approach between primary (GPs) and secondary care (specialist drug treatment) in the management of drug misusers. GPs are encouraged to provide specialist treatment programmes which may involve them prescribing substitutes. They are also encouraged not to prescribe in isolation but to liaise with other professionals Community prescribing services offer the provision of a medically supervised

substitute to an illicit drug misuser. Based on recent Department of Health guidelines (1999), which stressed the importance of a shared care approach between primary (GPs) and secondary care (specialist drug treatment) in the management of drug misusers. 3.Structured Counseling Structured counseling is defined as formal counseling approaches with assessment, clearly defined treatment plans and treatment goals and regular reviews. It is distinct from advice and information, drop-in support and informal key-working. 3.1. Structured Day Programmes Drug treatment providers in this category offer intensive community-based support, treatment and rehabilitation. Programmes of defined activities for a fixed period of time will be on offer and will require a specific level of attendance, usually four to five days a week. Drug Treatment services Structured counseling is defined as formal counselling approaches with assessment, clearly defined treatment plans and treatment goals and regular reviews. It is distinct from advice and information, drop-in support and informal key-working. Drug treatment providers in this category offer intensive community-based support, treatment and rehabilitation. Programmes of defined activities for a fixed period of

27

time will be on offer and will require a specific level of attendance, usually four to five days a week. Drug Treatment services providing structured support for clients on exit from another programme. The development of an appropriate package of aftercare and support should take place in the final phase of the treatment episode of service users aiming to achieve abstinence. 3.2. Inpatient Detoxification Inpatient detoxification programmers are specialized units for people with substance

misuse disorders, which provide medically supervised withdrawal medical cover (and usually relapse prevention) and aftercare referral services . 3.3. Residential Rehabilitation These drug treatment providers offer intensive and controlled residential or hospital inpatient environments. structured

with

24-hour

programmes

in

Some crisis intervention services have open access, others require formal referral via a health or social care agency. Rehabilitation services vary in approach programme structure, intensity and duration. The majority of residential rehabilitation services require users to be drug-free on entry, although some may have on-site detoxification facilities. 3.4.Criminal justice interventions Individuals accessing drug treatment services may have done so as a result of engagement in a criminal justice intervention. The follow describes specific criminal justice drug treatment interventions that are provided in the community. These definitions are taken from Enhancing Drug Services, Drug Scope (forthcoming). Other more informal interventions may be provided in partnership with Probation and young people, those under 19, may also receive drug treatment as a result of engagement with a Youth Offending Team.

28

Arrest Referral Schemes Arrest Referral Schemes treatment services by appropriate treatment prosecution.

were introduced nationally from 1st April 2000. The aim of is to bridge the gap between the criminal justice system and identifying drug user detainees and referring them into shortly after arrest. Referral is not an alternative to

3.5.Drug Treatment and Testing Orders Drug Treatment and Testing Orders (DTTO) are a community sentence introduced as part of the Crime and Disorder Act 1998. The order targets persistent offenders aged 16 years and over, that offend to fund serious drug dependency. The aim is to promote a reduction and/or cessation in drug use therefore reducing drug related crime. DTTOs run for 6 months

to no more than 3 years. A DTTO can be imposed alone or alongside a Community Rehabilitation Order (replaced Probation Orders), duration of the treatment and testing period must be specified within the order and subject to regular court review hearings. Frequent urine analysis is mandatory through out the order. Offenders are required to give their consent before a DTTO can be made. The principle of consent is fundamental to the order due to the general medical principle that a person should not be compelled to undergo treatment without giving consent. 3.6. Drug Abstinence Orders Drug Treatment and Testing Orders (DTTO) are a community sentence introduced as part of the Crime and Disorder Act 2000. The order has similarities to Drug Treatment and Testing Orders as it compels the individual serving the order to undergo regular drug testing, however, there are differences. Firstly, the aim is to be drug abstinent rather than reduce drug use, and secondly drug treatment is not a formal part of the order, although this may be undertaken voluntarily. Drug-related illness in the United States factors substantially in health care costs, although often these illnesses and their attendant costs are preventable. One strategy for minimizing adverse drug reactions is to provide drug information to consumers in the form of prescription counseling at pharmacies. The Omnibus Budget Reconciliation Act of 1990 (OBRA 1990) contained provisions for mandating such
29

counseling to Medicaid patients. OBRA 1990 was implemented in 1993, but most states acted quickly to extend counseling services to all patients receiving prescription drugs. We looked at the extent and quality of prescription counseling available in community pharmacies 1 decade after OBRA 1990 was written. We evaluated the counseling services afforded at large chain pharmacies, independent community pharmacies, and on-line pharmacies for a hydrochlorothiazide prescription. We found that most (69%) pharmacies offered to provide prescription counseling service, and that average counseling index scores, a measure of the quality or extent of information provided as determined by a Rasch analysis, were generally satisfactory.Our observations based on a single prescription for hydrochlorothiazide,

along with other studies, suggest that there is a positive upward trend in the number of pharmacies providing prescription drug information, and that the extent of information provided suggests that the objectives of OBRA 1990 and related legislation to reduce ADRs are being fundamentally satisfied. 4. Adequate Provision An alternative way for drug companies to provide risk information about a drug in a broadcast ad. Drug companies generally must include all of a drug's risk information in a product claim ad. In print ads, they usually do this in the "brief summary." This brief summary would take many minutes to read or scroll down a TV screen. The law allows broadcast ads to include only the most important risk information if the ads tell viewers or listeners how to get the full FDA-approved prescribing information, which has all the drug's risks. To meet the "adequate provision" requirement, the broadcast ad must provide ways to find the drug's FDA-approved prescribing information. Broadcast ads can meet the "adequate provision" requirement by giving a number of sources for finding a drug's prescribing information. These include:

A healthcare provider (for example, a doctor) A toll-free telephone number The current issue of a magazine that contains a print ad A Web site address

4.1. Advertisement

30

Federal law treats advertisements and promotional labeling differently. Advertisements generally appear in:

Print periodicals, such as journals, magazines, and newspapers Broadcast media, such as television and radio, as well as through telephone systems 4.1.1.Advertising and Promotional Labeling Branch (APLB)

The APLB is the group within the Center for Biologics Evaluation and Research (CBER) that regulates the promotion of biological products, including vaccines, tissues, and blood-related products, including allergenics, and cellular and gene therapy 4.1.2.Benefit A benefit is help provided by a drug for the person who is taking it. For example, the

benefit of a drug used to treat cholesterol is that it lowers the levels of bad cholesterol (low-density lipoprotein, or LDL, cholesterol). A drug could also raise the levels of good cholesterol (high-density lipoprotein, or HDL, cholesterol). This is another possible benefit. The law does not allow drug companies to advertise benefits unless they are related to the FDA-approved use. Also, advertised benefits must be supported by "substantial evidence" or substantial clinical experience. However, healthcare providers can prescribe a drug for uses other than its FDA-approved use. 4.1.3.Boxed Warning Drugs that have special problems, particularly ones that may lead to death or serious injury, may have this warning information displayed within a box in the prescribing information. This is often referred to as a "boxed" or "black box" warning. Drugs that have such boxed warnings are not permitted to have reminder ads. 4.1.4.Brand Name A drug's common name, which is the generally advertised name. Drugs that have the same underlying active substance may be made by different companies and can have different brand names. 4.1.5.Brief Summary

31

This is the technical name for the detailed information that appears in ads for prescription drugs. The law requires that print ads making claims about a drug (product claim ads) include a "brief summary" with all the risks listed in the drug's "prescribing information" and at least one FDA-approved use of the drug. The brief summary generally includes:

Who should not take the drug When the drug should not be taken Possible serious side effects of the drug and, if known, what can be done to lower the chance of having them Frequently occurring, but not necessarily serious, side effects

The "brief summary" includes a lot of information, so it is usually presented on its own page of a print ad. When the "brief summary" is part of an ad directed at the consumer, the FDA encourages drug companies to use language consumers can easily understand.

4.1.6.Claim A claim says something about the advertised drug or what it does. Claims usually relate to benefits. Claims can be made directly by stating, for example, "Brand X treats heartburn." Claims also can be made indirectly by the use of pictures or other graphics. For example, an ad with a picture of a playground full of children may suggest a claim that the advertised drug treats children.The law says that ads for prescription drugs can only make claims that are consistent with the drug's "prescribing information." Further, the truthfulness of claims must be supported by "substantial evidence" or substantial clinical experience. 5.Direct-to-Consumer (DTC) Advertisements DTC ads are published in magazines and newspapers that are distributed to a general audience rather than to healthcare providers such as doctors, nurses, and pharmacists. DTC ads can also be broadcast through television or radio. Other types of materials, such as brochures, booklets, or pamphlets distributed to patients, caregivers, or other non-healthcare providers are considered DTC promotions. While many people would think these are ads, they are technically considered a different category, called promotional labeling. 5.1. Fair Balance

32

The law requires that product claim ads give a "fair balance" of information about drug risks as compared with information about drug benefits. This means that the content and presentation of a drug's most important risks must be reasonably similar to the content and presentation of its benefits.This does not mean that equal space must be given to risks and benefits in print ads, or equal time to risks and benefits in broadcast ads. The amount of time or space needed to present risk information will depend on the drug's risks and the way that both the benefits and risks are presented. 5.2.Generic Name A drug's generic name is one that a non-government organization assigns to the drug's active ingredient. Different "brand names" can be used for the same generic name ingredient. For example, the active ingredient in Synthroid is levothyroxine. Levothyroxine is also the active ingredient in Levoxyl. Levothyroxine is the generic name for both of the brand names Synthroid and Levoxyl. 5.3.. Interaction Drugs sometimes interact with other drugs (prescription and non-prescription), supplements, foods, or beverages. These interactions may affect how the drug works,

or may cause side effects. To avoid problems, a person thinking about taking a drug should know its possible interactions. They should also tell their healthcare provider about all the drugs and supplements they take. 5.4.Major Statement The "major statement" is a term that is relevant only to broadcast (TV or radio) ads for prescription drugs. It refers to the presentation of the drug's most important risks. This presentation must be spoken. It also can be included in the video part of TV advertisements. The amount and type of included risk information will vary by drug because different drugs have different risks. 6.Office of Prescription Drug Promotion (OPDP) OPDP regulates the promotion of prescription drugs within the FDA's Center for Drug Evaluation and Research (CDER). 6.1.Prescribing Information Prescribing information is also called product information, product labeling, or the package insert ("the PI"). It is generally drafted by the drug company and approved by the FDA. This information travels with a drug as it moves from the company to the

33

pharmacist. It includes the details and directions healthcare providers need to prescribe the drug properly. It is also the basis for how the drug company can advertise its drug. The prescribing information includes such details about the drug as:

Its chemical description How it works How it interacts with other drugs, supplements, foods, and beverages What condition(s) or disease(s) it treats Who should not use the drug Serious side effects, even if they occur rarely Commonly occurring side effects, even if they are not serious Effects on specific groups of patients, such as children, pregnant women, or older adults and how to use it in these populations

Sometimes, manufacturers draft prescription drug information designed for patients that the FDA approves. These are often called "Patient Package Inserts," "Patient Product Information," or "PPIs." When the information is for an especially risky or difficult to use drug, it is called a Medication Guide. Patients should be given this

information when they fill their prescription. Patients may also get information that is produced independently of the FDA and the drug company. 6.2.Promotional Labeling Promotional labeling and advertising are both used to help sell prescription drugs. Promotional labeling differs from advertising in the way it is distributed. Ads are usually broadcast on TV or radio, or are published in newspapers or magazines. Promotional labeling includes additional types of materials and ways to get them to the consumer, for example:

Brochures and booklets Mailed materials, including letters to patients Videotapes Refrigerator magnets, cups, and other giveaways that show a drug's name

Promotional labeling about a drug is said to "accompany" that drug, even if the promotional labeling is not physically attached to a drug container. Promotional labeling must be accompanied by the drug's prescribing information.

34

6.3.Risks/Side Effects The risks of a drug refer to what can go wrong when the drug is used. A drug's prescribing information states these risks, which can include:

What groups of patients should not use the drug because it may do them more harm than good When the drug should not be used Serious side effects Side effects seen in special populations, such as children, pregnant women, or older patients Commonly occurring side effects The chance of the drug causing abuse or dependence The chance of the drug causing withdrawal effects

6.4 Substantial Evidence (Substantiation) Substantial evidence refers to the data needed to support claims about an advertised drug. Before the FDA approves a drug for marketing, drug companies must complete studies to show that the drug does what they say it does. These studies are also required to support advertising claims about the drug. Drug companies need to have at least two studies to support these claims.

This site was developed as a collaborative effort between FDA and EthicAd to educate consumers about DTC prescription drug advertisements. 7.Advertising and Promotional Labeling Branch (APLB) The APLB is the group within the Center for Biologics Evaluation and Research (CBER) that regulates the promotion of biological products, including vaccines, tissues, and blood-related products, including allergenics, and cellular and gene therapy. For information about CBER's enforcement activities, visit their 7.1.Benefit A benefit is help provided by a drug for the person who is taking it. For example, the benefit of a drug used to treat cholesterol is that it lowers the levels of bad cholesterol (low-density lipoprotein, or LDL, cholesterol). A drug could also raise the levels of good cholesterol (high-density lipoprotein, or HDL, cholesterol). This is another possible benefit. The law does not allow drug companies to advertise benefits unless they are related to the FDA-approved use. Also, advertised benefits must be supported

35

by "substantial evidence" or substantial clinical experience. However, providers can prescribe a drug for uses other than its FDA-approved use. 7. 2.Boxed Warning

healthcare

Drugs that have special problems, particularly ones that may lead to death or serious injury, may have this warning information displayed within a box in the prescribing information. This is often referred to as a "boxed" or "black box" warning. Drugs that have such boxed warnings are not permitted to have reminder ads. 7.3.Brand Name A drug's common name, which is the generally advertised name. Drugs that have the same underlying active substance may be made by different companies and can have different brand names. 7.4.Brief Summary This is the technical name for the detailed information that appears in ads for prescription drugs. The law requires that print ads making claims about a drug (product claim ads) include a "brief summary" with all the risks listed in the drug's "prescribing information" and at least one FDA-approved use of the drug. The brief summary generally includes:

Who should not take the drug When the drug should not be taken Possible serious side effects of the drug and, if known, what can be done to lower the chance of having them Frequently occurring, but not necessarily serious, side effects

The "brief summary" includes a lot of information, so it is usually presented on its own page of a print ad. When the "brief summary" is part of an ad directed at the consumer, the FDA encourages drug companies to use language consumers can easily understand. 7.5.Claim
A claim says something about the advertised drug or what it does. Claims usually relate to benefits. Claims can be made directly by stating, for example, "Brand X treats heartburn." Claims also can be made indirectly by the use of pictures or other graphics. For example, an ad with a picture of a playground full of children may suggest a claim that the advertised drug treats children.The law says that ads for prescription drugs can only make claims that are consistent with the drug's "prescribing

36

information." Further, the truthfulness of claims must be supported by "substantial evidence" or substantial clinical experience.

37