User:Roberto La Ferla/sandbox

Medical Information service in pharmaceutical companies is a function (department, team of people), responding to unsolicited inquiries about the Company’s products. Inquiries may reach the Company from healthcare professionals (physicians, pharmacists), patients, consumers or the general public. How these different classes of customers are considered and managed might depend on the regulations about the specific healthcare product (see Scope...), on the nature of the question being asked (e.g., within the approved indications or "off-label"), on the requestor (a healthcare professional or a member of the general public), and on the media used to disseminate/forward the response.

Medical information responses are personal (non-public) and may be verbal or in written form. In the most general sense, pharmaceutical companies generate and disseminate "medical" information to support and promote the safe and effective use of medicines, and to disclose the evidence gathered through their sponsored and supported research and development programs. This may be through publications, press releases, services and regulated product promotion. However, Medical Information as a function is mainly dedicated to responding to specific and unsolicited scientific questions.

Structure of Medical Information function
Medical information teams are mostly staffed by pharmacists, nurses, physicians or other life scientists. In several curricula, pharmacists are specifically trained to provide complex information about medicines to patients and might be preferred for a Medical Information role. Other needed areas of expertise of Medical Information are medical or technical writing, communication, and scientific library and information science. However, there are no general requirements as qualification for a Medical Information role in the pharmaceutical Industry.

Scope of Medical Information
Medical Information teams are usually a function (either structural or through outsourcing) of bio-pharmaceutical companies in the broadest sense. Although in most cases these are manufacturers or marketing authorization holders of medicines, medical information can also be organized for other regulated healthcare industries (e.g., medical devices, in vitro and in vivo diagnostics, biologic and biotechnology products, nutritional products and food supplements, cosmetics, or veterinary products). The Medical Information function is usually dedicated to medical/clinical aspects of medicines and conditions, rather than to regulatory or pharmaceutical aspects. Depending on the pertinent regulations, Medical Information may not be limited to responses about products on the market, nor on aspects falling within the approved product information. Several collateral functions might fall under the responsibility of a Medical Information function: The common factor of any Medical Information function is that it is dedicated to responding to unsolicited, spontaneous inquiries, and as such it is not subject to the regulations concerning the promotion of medicines or other healthcare products.
 * first management of adverse event and product complaint reporting;
 * development of standard response letters and "frequently asked questions" documents;
 * scientific literature surveillance and syndication of alerts or reviews;
 * review of medical and scientific aspects of the company's promotional material
 * production or review of presentations or other communication tools to be used outside the company;
 * support to other company departments with scientific literature updates and information.

Compliance Aspects, Regulations and Guidelines
Regulations about Medical Information as provided (directly or indirectly) by pharmaceutical companies are scarce. Medical Information as a service by a medicine marketing authorization holder is mentioned in some guidelines or codes of conduct of industrial pharmaceutical association, but most regulation refer to medical information by exclusion.

European Union
The EU code on medicines (Directive 2001/83/EC ) defines part of the Medical Information activity by omission, since responding to questions about medicinal products is explicitly excluded from the range of activities covered by the Title VIII on advertising (Art. 86.2):

Later, Directive 2004/27/EC amended Art. 86.2, adding:

It is important to remind that the subject of the above regulations is a current or prospective medicine marketing authorization holder (MAH). Therefore, the activity of responding to questions about a particular medicinal product is not subject to the regulations about advertising, provided that it is in response to unsolicited questions, and its content is non-promotional. Conversely, general information about human health or disease disseminated by the MAH is not subject to the regulations about advertising provided that "there is no reference, even indirect, to medicinal products", disregarding whether or not the information was proactively disseminated or in response to a question. In summary, medical information on medicines provided by a MAH in response to a question could undergo scrutiny about the unsolicited origin of the question and about the non-promotional content of the response. Medical information on "human health or diseases" can be provided by a MAH either proactively or in response to questions, provided that there is no reference to any product.

United Kingdom
The ABPI (Association of the British Pharmaceutical Industry) Code of Practice for the Pharmaceutical Industry specifies In other words, as the EU Directive, the UK ABPI Code specifies that Medical Information responses are excluded from the definition of promotional information, together with general information about human diseases, factual information and documents (which are more precisely defined). In the supplementary information to the above mentioned Clause 1, the Code further specifies that

In the supplementary material to Clause 14 of the Code, ABPI specifies that

In the following Clause 22 of the Code, ABPI specifies that with the following supplementary information

Canada
The Canadian health authority issued a policy with a similar clarification:

Of note, “Drugs”, as defined in s. 2 of the Canadian Food and Drugs Act, include all health products (prescription and non-prescription medications, biologics including vaccines, natural health products and radiopharmaceuticals), except medical devices.

USA
The Code of Federal Regulations Title 21 (Food and Drugs), Chapter 1, Part 99 (21CFR99.1) defines in Subpart A - General Information

A FDA Social Media Guidance provided directions for the appropriate use of social media to respond to unsolicited medical information.

On December 27, 2011, the FDA also issued a draft guidance about "Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices"; the guidance (which has also been opened to public comments) provides recommendations to manufacturers and distributors that would like to respond to unsolicited requests for information about off-label uses. Insofar as an entity responds to an unsolicited request for information about an off-label use in the manner described in the draft guidance, the FDA has indicated that it does not intend to use such responses as evidence of the firm’s intent that a product be used off-label. (The U.S. Department of Justice is not, of course, bound by this guidance from the FDA.)

The guidance defines an “unsolicited request” as one initiated by a person or entity that is completely independent of the firm that responds to the request for information; a request that is prompted in any way by a manufacturer or its representatives is not an unsolicited request. The guidance document divides unsolicited requests between the nonpublic and public varieties. A nonpublic unsolicited request is an unsolicited request that is directed privately to an entity via one-on-one communication. Conversely, a public unsolicited request is an unsolicited request made in a public forum, whether directed to an entity specifically or to a forum at large. The agency notes that there have been changes to communications brought about by the rise of social media and defines a public unsolicited request to include a request made via emerging electronic media, such as a product website, discussion board, chat room or other public electronic forum. The FDA makes the following recommendations with respect to a company’s response to a nonpublic unsolicited request for off-label information:


 * The response should be provided only to the individual making the request;
 * The response should be tailored only to answer the specific question(s) asked;
 * The response should be truthful, non-misleading, accurate and balanced;
 * The response should be scientific in nature;
 * The response should be generated by medical or scientific personnel independent from the entity’s sales or marketing department.

Additionally, the FDA recommends the response be accompanied by the following:


 * A copy of the product’s FDA-approved labeling;
 * A prominent statement notifying the recipient that the FDA has not approved or cleared the product as safe and effective for the use addressed in the materials provided;
 * A prominent statement disclosing the indication(s) for which the FDA has approved or cleared the product;
 * A prominent statement providing all important safety information including, if applicable, any boxed warning for the product;
 * A complete list of references for all of the information included in the response.

Finally, the FDA recommends the manufacturer/distributor maintain records describing:
 * The nature of the request for information;
 * The information provided to the requester;
 * Any follow-up inquiries or questions from the requestor.

In considering how entities should respond to a public unsolicited request, the FDA expressed concern that entities may post, in a chat room for example, detailed online responses to questions about off-label uses in a manner that would make such information accessible to individuals who have not requested such information. The FDA also expressed concern that due to the enduring nature of online responses, specific information provided in response to such requests may become outdated. With these considerations in mind, the FDA makes the following recommendations for responses to public unsolicited requests for information about off-label uses:
 * An entity should respond only when the request pertains specifically to its own named product (i.e., the request is not solely about a competitor’s product);
 * The entity’s public response should be limited to providing the firm’s contact information and should not include any off-label information. Any substantive communication about off-label uses for the product that is provided in response to the original unsolicited off-label question, should occur solely between the firm and the individual who made the request;
 * Representatives who provide public responses should clearly disclose their involvement with a particular firm;
 * The response should not be promotional in nature or tone.

Unsolicited, Spontaneous Inquiries
See 'Position on the Concept of Solicited and Unsolicited Requests' (April 22, 1982) ("[T]he Division of Drug Advertising and Labeling will not regulate as labeling any and all unsolicited requests received from outside the company for information about a drug manufactured, distributed, or repacked by the company. These types of legitimate requests from scientists/individuals for drug information will be regarded and treated as a personal communication between the requestor and firm.")

Any activity and service provided by Medical Information teams must also comply with pharmacovigilance, copyright and data privacy regulations, and with codes of conduct about the disclosure of transfers of value to healthcare professionals.

Non-Promotional Information
In USA, the 59 Fed. Reg. 59820, 59823 (November 18, 1994) states that manufacturers may respond to unsolicited requests for information with "responsive, nonpromotional, balanced scientific information, which may include information on unapproved uses, without subjecting their products to regulation based on the information".

On-Label and Off-Label Inquiries
Kux L. US Food and Drug Administration: Guidance for industry. Responding to unsolicited requests for off-label information about prescription drugs and medical devices. 2011; 76:82303-82306. Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM285145.p df? source =govdelivery. Accessed June 25, 2013.

Private, Non-Public Information
Medical Information is not an office staff counterpart of sales representatives over the territory. In fact, according to most regulations and guidelines, a Medical Information service can provide answers only to unsolicited questions, and provides non-promotional scientific evidence.

Other Names for Medical Information
Different names have been used in the past, and still are in use by some pharmaceutical companies; to some extent, names being used in the past seem to reflect different approaches or scope of action.
 * Drug Information is still used, although it apparently originated with the establishment of such centers in academic structures, often within medical libraries.


 * Medical Documentation Department was active at Sandoz (Basle, CH).


 * Professional Services is a term possibly reflecting a scope of action limited to the provision of medical/drug information to healthcare professionals. For instance, in the organization of Roche Laboratories (Nutley, NJ, US) Professional Services included four major sections: Services, Medical Information, Medical Planning and Professional Relations. Two of these, the Services Section and the Medical Information Section, were more directly involved with drug information.
 * The Services Section was primarily concerned with the handling of requests for information.
 * The Medical Information Section dealt with retrieval of information, provision of documentation, and also staffed medical writers. As such, the term Medical Information was restricted to the preparation of content to be provided as response to inquiries.
 * The Medical Planning Section was staffed by physicians, and ensured oversight of the whole departmental activity, as well as direct handling of calls.
 * Finally, the Professional Relations Section was the Company representative to the academic community and also directed several special programs, including the Roche Indigent Patient Program, Postgraduate Medical Education Program, Roche Medical Reprint Program and others.


 * In Lederle Laboratories (Pearl River, NY, US) there was a distinction between Professional Medical Services, and Professional Pharmaceutical Services.
 * Professional Medical Services were dedicated to correspondence from physicians and pharmacists relating to the clinical use of prescription products (approved or unapproved indications for use, dosages, incidence of adverse effects, possible drug interactions, and a wide array of comparative clinical or in vitro information).
 * Professional Pharmaceutical Services were primarily dedicated to inquiries from pharmacists about pharmacokinetics, drug administration, pharmaceutical issues (active or inert formulation ingredients, storage, compatibility and stability of reconstituted products), as well as information to consumers about over-the-counter products.
 * Finally, Professional Medical Information Services were dedicated to written correspondence, literature surveillance, alerting and review, and content development.

Over time, the availability of electronic databases and access to online services has simplified such organizational complexity.

Professional Services Drug Information Medical Communication