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ASHP Guidelines for the Management of Investigational Drug Products

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ASHP Guidelines for the Management of Investigational Drug Products Research–Guidelines 645 ASHP Guidelines for the Management of Investigational Drug Products Purpose Clinical research pharmacy is a specialized area of pharmacy practice that has evolved to meet the needs of the The purpose of these guidelines is to describe a standard- clinical study sites, help ensure research participants’ safety, ized approach for the management of investigational drug and protect the integrity of clinical study data. Clinical re- products by the clinical research pharmacy, pharmaceuti- search pharmacists possess an expert working knowledge of cal industry, and cooperative and research network groups. the clinical research study process, human subject protec- The scope of these guidelines includes the receipt, account- tion, and national and local regulations governing drug re- ability, storage, handling, preparation, dispensing, and fi- search. They are responsible for providing information to the nal disposition of investigational drug products to ensure appropriate healthcare team members, including pharmacy inspection readiness and compliance with regulations as staff, who may be unfamiliar with the investigational drug provided in the Code of Federal Regulations (CFR), 21 product, enabling them to correctly dispense it as described CFR, Part 312,1 as well as International Conference on in the clinical protocol and ensure its safe use. Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) E6 Good Clinical Clinical Research Pharmacy Models Practice2 (GCP) (described in 21 CFR Part 312, section 120) 3 and Good Manufacturing Practice (GMP) (described in 21 A clinical research pharmacy may be as simple as a part-time CFR Part 211), and the approved clinical study protocols. pharmacist or as complex as a team of dedicated clinical re- These guidelines will facilitate the adoption of best practices search pharmacists, technicians, and coordinators. It most by new and established clinical research pharmacies (e.g., commonly is part of the larger pharmacy organization (e.g., investigational drug service [IDS]) in collaboration with the the hospital pharmacy). In rare cases, it may be a freestand- pharmaceutical industry for the optimal management of in- ing entity. As the complexity and volume of clinical studies vestigational drug products. The ultimate goals of standard- at an institution increases, the decision to create a dedicated izing the management of investigational drug products are clinical research pharmacy with highly trained and special- to improve patient safety, improve efficiency, and provide ized personnel and management can be made. robust clinical data that allow new and innovative medica- When establishing a clinical research pharmacy, the tions to reach the patients who need them. appropriate institutional metrics (e.g., staffing-to-order vol- ume ratios)6,7 should be used to determine the appropriate Value of a Clinical Research Pharmacy staffing, facility, and storage requirements needed to manage investigational drug products. A comprehensive approach Since 1962, the Kefauver-Harris Amendments4 to the will allow institutional leadership to fully support the cre- Federal Food, Drug and Cosmetic Act have required drug ation of a clinical research pharmacy and should include a manufacturers to prove that new drugs are safe and effective. review of the types and therapeutic areas of studies that will This requirement is the foundation for clinical studies as be handled. they are known today. The pharmaceutical industry spends Each institution must also establish a funding model billions of dollars each year to test investigational drug prod- to support the clinical research pharmacy. This model may ucts for safety and efficacy, and it may take a decade or more include (1) direct cost recovery from the sponsor–investiga- for a drug product to obtain market approval.5 Thousands tor, (2) indirect funding (e.g., based on institutional over- of subjects have been asked to consent and take part in the head such as grants to conduct research), (3) foundation clinical research study process. underwriting of the research, or (4) institutions absorbing The current practice of the biopharmaceutical indus- the cost of the clinical research. Clinical research pharmacy try is to manufacture, distribute, and monitor investigational fees should be included at an early stage during the nego- drug products for clinical research use while utilizing the tiation of each clinical study budget. Investigational drug expertise of healthcare providers, especially pharmacists, products provided by sponsors at no cost to the clinical who manage the products at clinical study sites. It is impera- study site for use in clinical studies must not be charged to tive that pharmacists participating in these studies have the study participants. expertise to manage investigational drug products appropri- Within the organization, pharmacy leadership, the clin- ately. The clinical research pharmacist is a critical member ical research pharmacist, institutional research leadership, of the clinical study site team and has the expertise to under- and investigators should establish the locations where re- stand the special handling requirements of investigational search participants will receive their care with the appropri- drug products.6 Clinical research pharmacists understand the ate pharmacy support. A review of pharmacy activities and importance of managing and properly documenting inves- workflow for investigational drug product handling should tigational product receipt, storage, dispensing, returns, and be performed for the following locations, as appropriate: (1) final disposition. Failure to accurately document investiga- inpatient units, (2) clinical research unit, (3) ambulatory care tional product accountability can undermine the validity of or outpatient clinic setting, and (4) a combination of inpa- clinical study data, which could spur sponsors to halt a site’s tient and outpatient areas. The organization should develop participation in current or future studies and result in a loss a mechanism to handle participants being treated at multiple of local patients’ access to clinical studies. locations and facilities. 646 Research–Guidelines A dedicated team should be identified as the clinical tor (PI) must be notified. Prompt direction from the sponsor research pharmacy staff. In institutions with a large volume regarding how to handle the quarantined product must be of clinical studies, the clinical research pharmacy staff may adequately documented and kept in the site study file. form an IDS with the appropriate management structure If the investigational drug product is sensitive to hu- depending on the practice environment. Members of the midity, the sponsor must work directly with the clinical clinical research pharmacy staff must have knowledge and research pharmacy regarding monitoring requirements for documented training on ICH GCP,2 the Health Insurance relative humidity. Portability and Accountability Act,8 institutional review All locations, including refrigerator, freezer, and board (IRB) review and protection of human subjects,9 the room-temperature areas, storing the investigational drug Belmont Report,10 and all other competencies and policies product must have a temperature monitoring device or sys- required by the institution or the pharmacy. tem. In addition, the temperature monitoring system should be calibrated at least annually to meet National Institute of Facilities, Security, and Limited Standards and Technology standards.13 Documentation of Staff Access the calibration of each device must be maintained and avail- able for inspection. If an electronic temperature monitoring system is not available, a calibrated manual thermometer According to GCP guidelines, the investigational drug prod- with the ability to capture daily maximum and minimum uct should be stored in a secure location as specified by the temperatures should be used. A daily record of the maximum sponsor and in accordance with all applicable regulatory requirements.2 Some institutions may have separate rooms and minimum temperatures should be maintained. for the storage of investigational drug products; others may Equipment used to store investigational drug product have a separate storage area within the pharmacy depart- should be connected to a backup power supply in the event ment. In either case, the area should be secured (e.g., by key of power failure. All refrigerators and freezers shall have or electronic lock), with entry restricted to clinical research preventive maintenance completed annually. All calibration pharmacy or delegated staff. and maintenance records should be archived per institutional Each institution must evaluate its ability to provide policy. secure, limited access to investigational drug products. A clinical research pharmacy that does not have continuous Site Qualification (24-hour/365-day) support to provide access to investiga- tional drug products may mitigate the need for access by The site qualification by the sponsor determines whether the utilizing regular pharmacy staff and considering on-call sup- site meets the potential protocol requirements.11 A pharmacy port by the clinical research pharmacists to supplement this assessment should be part of the sponsor’s site qualification. staff. Ideally, the sponsor’s agent should review the site’s policies and procedures and applicable sponsor site qualification re- Temperature Control and Monitoring
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