Patient brochures

Several methods of educating practitioners and patients have been developed, including use of printed materials, lectures or symposia, and one-on-one discussions. Printed materials can include formularies, newsletters, brochures, and booklets. Having formulary information available for prescribers can improve their familiarity with, and ideally their use of,... 

Other printed materials can be used alone or in conjunction with oral education. Newsletters are published regularly and can be used to convey information addressing specific treatment issues. For example, a newsletter article might address current treatment approaches for pediatric asthma. Because newsletters also contain information that may be of general interest to practitioners and patients, they can have broad exposure. Brochures and booklets can be used to communicate a focused message in an efficient manner. These materials typically are given to people who are expected to have an interest in the topic within. 

In a promotional brochure sent to physicians in October 1937, the S. E. Massengill Company of Bristol, Tennessee, announced "A New Sulfanilamide" (1 ). "Our research department has just released an Elixir Sulfanilamide," the report read, "40 grs to the fluidounce. It is ideal for your patients who can take liquids—but little else. Also, it is not unpleasant to take, so is suitable for children. The color is brilliant red.. .."... 

The IRB is responsible for judging all studies to be conducted at the centre concerned by reviewing protocols, the informed consent sheet, the investigator s brochure and other materials relating to the conduct of clinical trials. The IRB is also responsible for monitoring whether the clinical trials are conducted in compliance with both GCP and IRB s requirements, if any. When the study period of a clinical trial exceeds 1 year the IRB should review the study every year. As the new GCP allows the study sponsor to pay a reasonable amount of money to the study subjects, the IRB is expected to review whether the amount and method of payment is reasonable and does not infringe upon the ethical aspects of the study. Also, the advertisement of a trial for patient recruitment is allowed, but the IRB s approval to implement this at the study centre is required. 

Under the CTN scheme the sponsor of the clinical trial provides detailed information about the proposed trial to the principal investigator who submits an application to conduct the clinical trial to the HREC at the institution or other site at which the trial is proposed to be conducted. The clinical trial application generally includes the protocol, the investigator s brochure, related patient information, supporting data and the CTN form. HRECs usually have their own standard format for applications to conduct a CTN trial at their institution. The HREC evaluates the scientific and ethical validity of the proposed clinical trial and the safety and efficacy of the medicine in the context of its stage of development. The TGA does not evaluate any information about the clinical trial. 

Many pharmacies have used these tools successfully to spread the word about new and existing goods and services. Newspaper, radio, and television advertisements are used commonly by pharmacies. Pharmacies also employ promotional tools such as telephone book listing, coupons, newsletters, brochures, prescriber and patient mailings, health screenings, and presentations to civic groups. Some pharmacies have worked with the media to inform the public about their participation in public health events such as the Great American Smokeout or Talk About Prescriptions month. 

A brochure about the Med Check Program will be mailed to patients using at least four medications regularly. 

Inseparability of services refers to the situation that services typically are produced and consumed at the same time. This means that the service provider and the patient are both part of the service experience. Thus provider—patient interactions are an important facet of pharmacy services. Service interactions can go more smoothly if both the provider and the patient are ready to perform their respective parts. Some effort, such as using brochures, can be made to train patients to help a service episode go as planned. 

In Canada more progress has been made in the recognition of MCS than in most countries of the world. Canada took many measures to improve the lives of MCS patients and others who have environmentally induced respiratory problems, like asthma patients. See, for example, the brochure of the Canadian Lung Association www.nb.lung. ca/pdf/NoScentsMakeSense.pdf Just like the U.S., Canada has several clinical ecological centers to help diagnose and support people with environmental illnesses. 

This informational brochure about MCS is double-sided and can certainly, with permission from the author and the publisher, be reproduced for distribution many times over. It contains basic and necessary information about MCS and serves as an introduction to the disease. The aim is to stimulate the recipient to further study the subject and/or enable the recipient to be considerate of the patient. This brochure can also be downloaded at www.the-abc-of-mcs.com (click on the book cover image). 

Having classihed the IMBP based on its effects on immune function, the next and hnal step would be to make a risk assessment and to communicate the risk to physicians and to the patients receiving therapeutic doses of the IMBP. This can be accomplished through the existing mechanisms of the Investigator s Brochure, Informed Consent documents, and ultimately, the product label. 

Together, these specialists can provide both the criteria for all aspects of the study and the rationale used to develop them. Once the specific objectives of the protocol have been established, it is customary for a protocol introduction to summarize these objectives, give a brief overview of the information found in the Investigator s Brochure (referencing the Brochure), and state the purpose of conducting the study. The rationale for the criteria to be used for patient selection, exclusion, and randomization (if any) and the clinical variables to be monitored during the trial should also be stated. 

Appropriate precautions should be taken in clinical studies to guard against inadvertent exposure of fetuses to potentially toxic agents and to inform subjects and patients of potential risk and the need for precautions. In all cases, the informed consent document and the investigator s brochure should include all available information regarding the potential risk of fetal toxicity. 

The review of the protocol ensures that there are adequate selection criteria and procedures to protect vulnerable study populations. In addition, information within the protocol, the informed consent, and the Investigator s Brochure are reviewed to assess safety information that may affect subjects. Institutional review boards are empowered with the authority to approve or disapprove research activities that are covered by regulations, as well as to require modifications to secure approval. Informed consents will be reviewed to assure that all the information provided is in accordance with 21 CFR 50.25 the IRB may also require that additional information be provided to study subjects in a separate format, such as a patient information sheet. If this requirement is waived, a written statement may be given to the subject. If a very short window of opportunity exists to dispense a research treatment to avoid a devastating or fatal outcome, a waiver for this requirement may be requested. It is important to note, however, that the sponsor must clearly describe or define the situations that would require testing without administering a written informed consent. Also, provisions that will be made to obtain the consent from family members must be in place. This issue will be discussed in more detail in the section on informed consent. In summary, the following criteria are used by IRBs to approve research ... 

Institutional review board records that do not adequately track or log research documents that have been submitted by the clinical investigator, including protocols, amendments, consent forms, Investigator Brochures, IND safety reports, advertisements, patient information sheets, and correspondence between the investigator and the IRB. 

Investigator binder Request that all study correspondence be maintained in the binder so that all documents can be easily located in one area. The monitor s log is completed at every trip conducted by the monitor, and the patient screening log should be kept up to date. The sponsor is responsible for ensuring that an up-to-date investigator s brochure (IB) is available to document that the investigator is informed promptly of relevant information as it becomes available. 

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