The Investigational DrugService (IDS) is an inte-gral part of the researchprocess at many institu-tions that participate in

clinical trials. The concept of the IDSbegan in the mid-1980s when the FDAfirst required that pharmacists, ratherthan researchers, handle the drug-related aspects of clinical trials. Whileacademic health centers were the firstto implement investigational drug serv-ices, by the late 1990s, several hundredhospitals of varying sizes reportedbeing involved in the dispensing ofdrugs used for clinical research, pro-viding at least the basic services of dis-pensing and inventory control.

Responsibilities ofPharmacists DispensingResearch DrugsWhile the investigator is ultimatelyresponsible for all aspects of a study,including the investigational drugs, thisis an area that is usually delegated topharmacy. The responsibilities of phar-macists managing and dispensinginvestigational drugs are based onGood Clinical Practice (GCP) guide-lines as described in the Code ofFederal Regulations, Title 21. GCP isan international standard for thedesign, conduct, recording, and report-ing of studies that involve human subjects. Compliance with these standardsassures the public that study subjects are protected and that the data resultingfrom clinical trials are credible.

GCP guidelines require strict maintenance and control of investigationalagents used in clinical trials. Proper control insures that investigational drugswill be administered only to subjects under the investigator’s supervision.Subjects must sign an informed consent to participate in the study and mustagree to remain under the direct care of the investigator. Only then can theyreceive investigational drugs.

These guidelines also mandateappropriate documentation and recordmaintenance. Pharmacists are requiredto maintain records that document thereceipt of the drug, when it is dis-pensed to patients, and final disposi-tion of the drug when the study isclosed. Unused drugs must be returnedto the sponsor or destroyed at the siteof the study. In either case, records ofthe final disposition must be retained inthe study file.

Inventory control and managementis a central aspect of the IDS operation.The FDA requires complete accounta-bility of all investigational drugs sup-plied for a clinical trial. This involveskeeping a drug accountability log. Thelog accounts for every unit of drug pro-vided for the study, from the beginningof the study to its conclusion. Afterpatients are enrolled in the study anddrugs are dispensed, the doses givenare recorded on the accountability log.When the study closes, return ordestruction is also recorded.

Improving the Research DrugAccountability Process Traditionally, drug accountability hasbeen a manual process with pharma-cists using an Investigational DrugAccountability Record (IDAR) to doc-ument drug dispensing, receipt, and

drug return. IDS pharmacists may use the sponsor’s IDAR, though now manyhave created institution-specific IDARs. However, these paper logs pose sev-eral problems. The process of manually signing drugs out is not only slow andinefficient, but is also error prone. In addition, many sponsors require IDSpersonnel to complete accountability logs designed specifically for their stud-ies. This leads to further inefficiency as IDS personnel then must completemultiple forms, all in various formats, for different studies.

To address these challenges, many IDS pharmacists are looking to auto-mate their processes, either by developing an in-house system or by purchas-

Investigational Drugs By Susan Rogers, RPh

6 � June 2009 � www.pppmag.com PHARMACY&Purchasing Products

Automating InvestigationalDrug Service Operations

Investigational Drugs

ing a protocol management system. At EmoryUniversity, we decided to computerize our oper-ation in 2007 and purchased WebIDS, a protocolmanagement program that automates many IDSfunctions and helps to improve accuracy, safety,and efficiency. The choice to purchase a system,rather than develop one in-house, was simple aswe realized developing an in-house system assophisticated as WebIDS was impossible.

Automating IDS to Manage Increasing ProtocolsThe IDS at Emory University began in the early1980s with a few protocols for hematology/oncology. It was a voluntary service available toinvestigators who elected to use it. Over theyears, the number of protocols and the scope ofour service grew significantly. By 2007, we weremanaging about 150 protocols for both medicaland surgical services at Emory.

In 2008, the university established a mandaterequiring investigators involved in drug studies touse the IDS to manage and dispense study drugs.Included under this mandate are all studies

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involving drugs provided free of charge to study subjects, whether investigationalor marketed drugs. The mandate was driven by FDA requirements, The JointCommission (TJC) standards, Georgia law, and standards of the Association forthe Accreditation of Human Research Protection Programs (AAHRPP). TheFDA has specific requirements for investigators and sites regarding the manage-ment of drugs, including drug accountability and standards for dose preparation.TJC specifically requires oversight of investigational drugs by pharmacy, and fur-ther requires that investigational drugs dispensed to inpatients be done so by theIDS. Georgia’s laws allow physicians to dispense drugs, but require the physicianto be present, so tasks cannot be delegated solely to a research nurse. Finally,AAHRPP, the body that accredits institutional review boards, requires that over-sight for investigational drug management be handled by the institution’s IDS.As part of Emory’s accreditation by AAHRPP, investigators are required use IDSto handle investigational drugs.

The ultimate goal of our IDS is to insure that investigational agents are han-dled safely, effectively, and efficiently in the hospital and clinical environment.In addition, IDS makes sure that hospitals and clinics are in compliance with TJCrequirements, and the requirements of other governing agencies, such as theFDA and AAHRPP, for investigational drugs in the institutional setting.

The university anticipated that after the IDS mandate was put in place thatIDS-managed protocols would increase from 150 to 200-300 protocols. At thatpoint, our staff included two pharmacists and one technician. Clearly, we couldnot almost double our protocols and manage the process at the same staffing lev-els. We evaluated the WebIDS program and determined that we could managethe growth by implementing an automated system. Since the mandate, we haveadded one pharmacist and currently manage 250 protocols.

The automated IDS system offers complete protocol management; it maintains protocol and drug information, patient profiles, randomization assign-ments, inventory records, and dispensing and patient return information. Thesystem is fully HIPAA and 21 CRF11 compliant and its drug accountability andtracking is far superior to manual logs. Key safety features include patient man-agement functions that prevent dispensing to patients who are not enrolled in aspecific study, product selection that is limited to drugs used for the current pro-tocol, and automated checks to identify expired drug inventory. In terms of effi-ciency, with the automated system, we can record dispensing and inventory used,generate charges, print labels, and track workload in a single process. In addi-tion, billing is automated and invoices are generated on a monthly basis.

Automating our IDS operation was the essential component that supportedour growth. Just as the number of protocols we manage has grown significantlyin recent years, we also have seen an increase in the complexity of the studies wemanage. With the automated approach, not only are our drug accountability andtracking processes superior to manual logs, but we also have seen improved effi-ciencies across the department. For example, our billing rate has improved as thesystem generates automatic monthly invoices. Finally, since the paperwork anddocumentation are automated, our IDS pharmacists are now able to focus moreon the research, the patients, and working with investigators. �

Susan Rogers, RPh, received her bachelor of science in pharmacy from theUniversity of North Carolina. Susan completed a residency in drug informationat The New York Hospital, and began her career in 1980 as the drug informa-tion pharmacist for Emory University Hospital in Atlanta, Georgia. During themid 1980s, she initiated the Investigational Drug Service, which has grown frominitially overseeing a few hematology/oncology protocols to currently manag-ing 250 protocols for all Emory University investigators.

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www.pppmag.com � June 2009 � 9