Policies, procedures reduce errors, while trials increase
Policies, procedures reduce errors, while trials increase
Pharmacy department creates best practices
The Cleveland Clinic had its number of studies more than double in a two-year period but, at the same time, the number of deficiencies related to pharmacy and study drug control was cut to a negligible number.
"We track how many deficiencies we were finding on our investigational drug inspection checklist and, prior to our changes, we found quite a few," says John M. Petrich, RPh, MS, investigational drug service coordinator for the Cleveland Clinic. Petrich spoke about study drugs and site management at the 15th Annual Society of Clinical Research Associates (SoCRA) Conference: Clinical Research: Changing the Future. . .Touching Lives, which was held Sept. 22-24, 2006, in Chicago, IL.
When the deficiencies were checked a year later, there was a dramatic decrease despite an increase in studies, and two years later, the trend continued, Petrich says. (See bar chart.)
The Cleveland Clinic is a 1,000-bed academic medical center, which also has many outpatient visits, generating a great deal of interest in research, Petrich says.
"We have in house 100 studies or so that we directly monitor for storage, dispensing, recordkeeping, and everything," Petrich explains. "And we have another 200 studies that are monitored by my service on a quarterly basis."
One of the key tools in the pharmacy department's monitoring and quality control is an investigational drug inspection checklist. The one-page checklist has 25 items that must be inspected for each study. (See investigational drug checklist.)
"The checklist is derived from JCAHO of Oakbrook Terrace, IL] standards," Petrich says. "I did a Google search and found the standards and narrowed it down to investigational drugs."
Another tool used by the clinic is a pre-printed physician order form, which is instrumental in preventing both prescription errors and study drug billing errors, Petrich says.
"This is one of the major ways we can answer the question about how potential errors can be minimized," Petrich says. "We recognize that medication errors are frequently caused by transcription errors, confusion between look-alike and sound-alike drugs. By using pre-printed order forms, we can diminish medication errors."
Although the clinic hasn't assessed outcomes since initiating use of the form, officials are certain it cuts down on errors significantly, Petrich says.
The one-page form has a carbon copy that goes to the pharmacy, and the top page stays in the patient's chart. The form, while derived from a template, is individualized for each clinical trial, and it takes items directly from the study protocol, Petrich says.
"We include a basic statement about what the drug is and how the patient will receive it, and there's an area for the physician to sign," he says. "And you can look at the signature on the order form and compare it to the site responsibility log and know that the physician who signed the form is authorized to use the drug."
One question Petrich sometimes is asked by clinical trial sites is how the pharmacy department was able to get the form approved by the clinic's form committee, which in many institutions can be a time-consuming and cumbersome process.
"What we've done is take verbiage directly out of the protocol and put it verbatim in the physician order form," Petrich explains. "Since the IRB has already approved the protocol, there should be no problems."
The form has been used for about 10 years, and its use occasionally is questioned by investigators, but they typically are satisfied with hearing that it uses protocol language, Petrich notes.
Making a new form for each study is Petrich's job, and it typically takes him about an hour a week, he says.
"It's a priority, and it helps eliminate transcription errors," Petrich adds. "It also is a mechanism to ensure billing compliance."
Use of the form eliminates the possibility of inadvertent double-billing, which would run foul of Medicare regulations, he says.
"All drugs on the form are research drugs provided free by the sponsor, so we should not be billing for them," Petrich says.
"If the study drug is processed through the pharmacy system, there's a long process that goes on prior to the drug being dispensed," he says.
Petrich built the electronic system to send files with a name that begins with either INV or IRB to the billing department with a zero charge. The form still includes all of the drugs given to subjects, but there will be a zero charge beside the study drugs, and it is an automatic part of the system, so it's not subject to human errors.
"I worked with the finance department to set up this system behind the scenes," Petrich explains. "When the pharmacist keys it in, it's only six to eight keystrokes and it's done, but it will present a complete and comprehensive drug profile and a bill."
Also, the file names used for study drugs are very different from any other types of file names, which prevents a mistype from being sent to the billing department with unintended charges, he adds.
Another process that helps to ensure efficiency and safety with study drugs involves a set of criteria for investigators and nurse coordinators, which they can use to decide how to manage the study drug, Petrich says.
For example, here are some of the criteria:
- For a pharmacy-controlled study drug, if it needs sterile preparation or sterile handling, then it should go to the pharmacy to be handled and stored.
- If the study needs to be blinded, then the pharmacy is the ideal third party to provide the drug in a blinded fashion, he says.
- If the drug needs to be repackaged in any way, it should go to the pharmacy.
- If an investigator doesn't have space in his or her office area, then the drug should go to the pharmacy.
- And if an investigator lacks the time and resources to manage monitors and auditors, then the study drug should go to the pharmacy, he adds.
The criteria for investigator storage of study drugs are as follows:
- Any outpatient study in which the oral drug is already packaged and labeled for dispensing could have the study drug stored by the investigator, Petrich says.
- If the above criteria is met and there is an additional convenience factor in which the pharmacy is located some distance from the study location, making it less convenient for subjects, then investigators could store the study drug.
Too often, investigators will store drugs for themselves to save a little money in the study budget, but this often isn't the best strategy, especially from a quality assurance perspective, Petrich says.
"Once I came across a study where the drug bottle only said, 'Formula B,'" Petrich recalls. "The patient was on this study drug and was admitted to the local hospital, where clinicians had no idea of what Formula B was."
The study drug was a seizure medication, but it was impossible for the hospital staff to find this out during an emergency situation, whereas it the drug had been labeled properly in a pharmacy, they would have had an immediate way to learn what their patient was taking, Petrich adds.
Other quality controls include having a technician who monitors inventory and makes certain a drug is dispensed during the month it was designated. The technician also checks the inventory page's expiration line item once a month, Petrich says.
When the pharmacy handles small, investigator-initiated studies, pharmacists will encapsulate the study drug and create a placebo drug of identical size and color, he notes.
"For larger, industry-sponsored studies, they usually manufacture the placebos for us," Petrich says.
"We have a certain lot number we assign to placebos in the pharmacy, but nobody else knows what it is, and the label will say that the drug either is study drug A or placebo," Petrich explains.
The pharmacy funds its full-time technician's job of quality monitoring the checklist and quarterly inspections through fees charged to studies, Petrich says.
"Since this process is based on JCAHO standards, we feel we can do this," he says. "The fee is determined based on the sponsor and whether it's for an industry-sponsored study or an investigator-initiated study."
The fee is based on a benchmarked fee process charged by similar research institutions, Petrich says.
And, the pharmacy department has learned from past experience to charge an annual maintenance fee for studies, since some might continue for years past the anticipated closing date, he says.
"Also, investigators send me a copy of the protocol, and I look at it, and if I see anything that's extraordinary about it, then the investigator knows that our fees will be going up from the baseline."
Through benchmarking, the department has set its fees at the median of what other centers charge, Petrich says.
"Everything takes care of itself when you adjust for time and effort," he says. "If you have a study that requires a lot of resources, then you know to raise the fee so you won't lose money."
The Cleveland Clinic had its number of studies more than double in a two-year period but, at the same time, the number of deficiencies related to pharmacy and study drug control was cut to a negligible number.Subscribe Now for Access
You have reached your article limit for the month. We hope you found our articles both enjoyable and insightful. For information on new subscriptions, product trials, alternative billing arrangements or group and site discounts please call 800-688-2421. We look forward to having you as a long-term member of the Relias Media community.