How does a manufacturer obtain information about drugs and their side effects

J Pharm Technol. 2021 Jun; 37(3): 161–164.

Abstract

Pharmacists use a myriad of drug resources for patient care; however, the drug manufacturer is often overlooked and underutilized as a resource for drug information. Pharmaceutical companies have a medical information department that is responsible for providing drug information to pharmacists and the public about the company’s products. This article will explain the purpose and functions of the medical information department within a pharmaceutical company. In addition, the type of information that may be requested and the ways to request drug information will be discussed.

Keywords: pharmaceutical industry, pharmacists, drug information, patient care, drug manufacturer

Introduction

Patient care requires pharmacists to reference all appropriate resources to find the most current and accurate drug information. Pharmacists in any setting may use tertiary databases such as Lexicomp, Micromedex, UpToDate, and primary literature accessed through secondary resources such as PubMed or OVID. Although there is a wide variety of subscription-based and free drug resources available, an underutilized drug information resource that pharmacists may not consider is the drug manufacturer. Pharmaceutical companies have a medical information (MI) department that is responsible for providing drug information to health care professionals and the public about the company’s products. This article will provide background on the functions and staffing of the MI department and how health care professionals can obtain drug information from manufacturers.

Functions of the Medical Information Department

Within the pharmaceutical industry, the MI department or call center is established by the manufacturer to provide drug information about products approved by the Food and Drug Administration (FDA).1 There are several FDA requirements the MI department must follow when providing drug information to health care professionals and consumers. Based on the 2011 FDA draft guidance on responding to unsolicited requests for off-label information about prescription drugs and medical devices, inquiries submitted must be unsolicited or initiated by persons or entities that are completely independent of the manufacturer.1 Moreover, requests for information cannot be prompted by an agent of the manufacturer such as a sales representative. The MI department must ensure the information disseminated is unbiased, nonpromotional, and cannot go beyond the scope of the request.1 The FDA recommends that responses to inquiries encompass data that support the efficacy and safety of a drug; however, negative or contradictory results should also be included. Data must be retrieved from full text scientific reprints or literature and not solely from summary documents or abstracts prepared by the manufacturer. In addition, the response may consist of unpublished data or data on file if the information is relevant to the specific request.1

Information that can be requested from the manufacturer include safety and efficacy of the product(s) in specific patient populations (ie, pediatrics) and/or health conditions (ie, kidney impairment; Table 1). Other information such as stability and compatibility, temperature excursion data, administration route, and excipients in medications may also be requested. For questions related to stability or excipients, the department may escalate the inquiry to another department (typically the quality department) if the information is not readily available. Note that when calling, the representative may ask for the National Drug Code and/or lot number of the product prior to providing the information. MI departments may also provide off-label uses of their products. Written responses to these inquiries are required to include the off-label data along with the approved indication(s), safety information, and a statement outlining the off-label information has not reviewed by the FDA.1

Table 1.

Types of Drug Information Provided by Medical Information Departments.

Health systems and managed care organizations may also request a dossier of a newly approved medication for the purpose of formulary development. The same aforementioned principles on providing unbiased information and collecting data from additional sources such as literature searches would apply to the dossier created by the manufacturer.

Callers may expect for the specialists to screen for adverse events and product complaints as mandated by the FDA especially when asking about an inquiry that may be related to safety information or content in medications (eg, corn or gluten allergy). Details of the patient may be requested for the report and the Health Insurance Portability and Accountability Act Privacy Rule does not discourage adverse event reporting in this case. The Privacy Rule permits covered entities such as pharmacists in any setting to report adverse events and other information related to the quality, effectiveness, and safety of FDA-regulated products both to the manufacturers and/or directly to the FDA.2

Due to the highly regulated nature of MI departments, the specialists can only utilize documents and resources that have been approved by the manufacturer to answer questions; therefore, they cannot offer any medical advice to health care professionals or consumers. In addition, information is not interchangeable for drugs with the same active ingredient(s) so callers will need to contact the manufacturer of the respective generic or branded product to obtain data.

Medical Information Department Staffing and Training

The FDA recommends that medical or scientific personnel have specialized backgrounds in responding to unsolicited requests for drug information.1 Because of this recommendation, MI departments are staffed by MI specialists (MISs) that have a health care degree such as RN, MD, and/or PharmD. In addition to the minimum education requirement, some manufacturers may choose to hire candidates who have completed postgraduate training in drug information and/or medical information/medical affairs. Previous work experience of the MISs may vary and can include non-drug information practice in hospital and retail settings.3

The scope and practice of MI departments have evolved over the years because of technological advances, growth in requests for medical information, and complexity of therapeutic agents. These changes augment the need for specialists to be knowledgeable about the product’s life cycle from development to postmarketing.4 To prepare staff in the MI department to appropriately handle inquiries submitted by the public, pharmaceutical companies have a rigorous onboarding process for new hires. The onboarding process may range from disease and product training, competitor product, and day-to-day task training.5 As part of the disease and product training, the MIS must learn the product labeling, clinical trial data, and frequently asked questions about the product. In addition, the MIS may be required to learn FDA regulatory requirements, structure of the pharmaceutical industry, and standard operating procedures.5 A key aspect of the onboarding process is learning the best practices for handling live calls and answering complex inquiries.6 The onboarding process may take up to 5 weeks depending on the company and the job responsibilities.5

Pharmaceutical companies may also require MIS to undergo refresher training courses to review content or updates relevant to the products or therapeutic area. The refresher courses may be provided annually, biannually, or as needed to ensure continuous quality assurance with delivering MI services.5

How to Request Drug Information

There are several ways to request drug information from the manufacturer, and some of the options can be found on the company’s website (Table 2). Each pharmaceutical company provides their MI department’s contact number on the website. The toll-free number typically connects to a phone tree and in some cases will have a representative that will triage your inquiry to the appropriate department. Calling the manufacturer and speaking directly to a MIS will provide the quickest turnaround time for urgent questions. Another option is filling out a submission form accessed through the company’s website. The requestor may expect a longer turnaround time compared with reaching out to the company via phone call. Some manufacturers have also implemented a Live Chat function that allows for connection with a MIS in real time during operating hours. Self-service access to drug information and disease education is also available on some of manufacturer’s website. This online library may include clinical study data, gluten information, patient information leaflets, and drug safety information. The prescribing information along with frequently asked questions can also be accessed.7 If the information is not provided on the website or needs further explanation, other means of contacting the manufacturer may be warranted.

Table 2.

Methods to Request Drug Information.

An additional self-service access option is through a website developed by phactMI (Pharma Collaboration for Transparent Medical Information), a consortium of pharmaceutical manufacturers that provide information about their drugs to health care professionals.8 There are 31 pharmaceutical companies in the United States that are members of this consortium, and each company contribute their respective product labeling and MI responses to the website.9 This option may be ideal in situations where information on multiple drugs from different manufacturers are needed as there are approximately 3000 products featured on the website.

Health care professionals may also request drug information through a medical information request form that is submitted by a sales representative or a medical science liaison during visits or presentations at the pharmacy setting. The requestor may expect to receive a response directly from the MI department as some companies do not allow sales representatives to view written responses that may contain off-label information.

Conclusion

Pharmaceutical companies offer pharmacists in all settings access to the most accurate and up-to-date data on their products along with unpublished data that are not available in the public domain. Pharmacists should continue to utilize other drug resources available; however, contacting the MI department may be an adjunct resource to ensure optimal care for patients.

Footnotes

Declaration of Conflicting Interests: The author declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding: The author received no financial support for the research, authorship, and/or publication of this article.

ORCID iD: Cambrey Nguyen

References

3. Wu K, Schmelz LS, Doshi SM. Medical information specialists: benchmarks in practice. Ther Innov Regul Sci. 2013:47:190-197. doi: 10.1177/2168479012461442 [PubMed] [CrossRef] [Google Scholar]

4. Shah I, Janajreh I, Fung SM. Medical information practices across the pharma industry: what can we learn from benchmarking surveys? Ther Innov Regul Sci. 2020;54:1259-1262. doi: 10.1007/s43441-020-00226-z [PubMed] [CrossRef] [Google Scholar]

5. Jaisinghani J, Patel S. Training new-hire medical information specialists in the pharmaceutical industry: a benchmarking survey. Ther Innov Regul Sci. 2013;47:356-362. doi: 10.1177/2168479013478418 [PubMed] [CrossRef] [Google Scholar]

6. Bowers D, Fish T. Medical information contact centers: challenges and best practices. Ther Innov Regul Sci. 2013;47:209-213. doi: 10.1177/2168479013475459 [PubMed] [CrossRef] [Google Scholar]

7. Helmich ML. Reducing call volume at medical information centers by switching to a web-based self-service facility—what to consider? Providing customers with digital medical information on the internet. Ther Innov Regul Sci. 2017;51:327-331. doi: 10.1177/2168479016682061 [PubMed] [CrossRef] [Google Scholar]

8. Giffin SA, Shah R, Soloff A, et al. Pharma collaboration for transparent medical information (phactMI) benchmark study: trends, drivers, success factors, and value of globalization in medical information. Ther Innov Regul Sci. 2019;53:332-339. doi: 10.1177/2168479018779920 [PubMed] [CrossRef] [Google Scholar]

9. Pharma Collaboration for Transparent Medical Information. What we provide? Accessed March 13, 2021. www.phactmi.org/home

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