A Medical Device Daily

The tracking and verification of post-approval (PA) studies for medical devices has been a bone of contention between FDA and various stakeholders, with some of the agency's critics charging that FDA is not doing enough to enforce compliance with PA study requirements.

Finally responding to that criticism, the Center for Devices and Radiological Health (CDRH) at FDA has gone live with a web page for PA studies, listing more than 40 such studies in a format that can be downloaded into a spreadsheet.

Criticism of the agency's thoroughness in its PA strategy may not go away, however.

The page lists little more than general information about the studies and whether the reports are coming in on time. None of the listings include study data that tell anything about the impact of the study product. The listings include information on the schedule of reports and the dates of actual reports, including an asterisk if that report was filed late.

At present, FDA lists 44 studies, including descriptions of the PA studies and copies of the approval letter. The site also lists summaries of safety and effectiveness as well as product labeling.

In some cases, FDA lists some of the standards used in designing the device.

For instance, in the listing for the Duraloc Option ceramic hip system, manufactured by Depuy Orthopaedics (Warsaw, Indiana), the listing describes briefly the standards for material integrity that the sponsor used in developing the device. The American Society for Testing and Materials (ASTM; West Conshohocken, Pennsylvania) developed the standards in question, and Depuy has committed to a 10-year follow-up, which may reflect FDA concerns about the prospects for decay of ceramic material and its impact on health.

Depuy was more than two months late with its second report, but a brief review of some other PAS listings shows that this was not unusual.

According to FDA, some sponsors had assumed "that there was a 30-60 day grace period past their due date to submit their reports," but the agency addressed this in a December 2006 PA studies guidance document. As a nod to the widespread erroneous impression, the agency "has added an asterisk next to the Overdue/Received status for reports prior to April 6, 2007, to indicate that the delay was due to a temporary extension."

According to the press release FDA posted with the new web page over the weekend, companies are typically required to submit reports every six months for the first two years of a study, and then annually thereafter until the conclusion.

The listing is for all post-approval studies stipulated after Jan. 1, 2005, but the data do not include clinical data "because the studies may be ongoing and include personal and confidential information."

At press time, FDA, the Advanced Medical Technology Association (AdvaMed; Washington) and the Medical Device Manufacturers Association (MDMA; Washington) had not responded to calls for comment on the new listing.

Docs not wild about e-prescribing

E-prescribing is sometimes billed as a panacea for prescription drug errors, but a recent report in the journal Health Affairs shows that the road to an electronic future is still littered with potholes.

The article, written by a team led by Joy Grossman, PhD, a senior health researcher at the Center for Studying Health System Change (HSC; Washington), said that while many doctors like the idea of e-prescribing, those programs "often lacked advanced features or, if they had them, physicians often did not use them because of implementation hurdles or the perception that the features did not add value," according to an HSC press release.

Grossman said in the press release that "the gap between policymakers' visions for e-prescribing to improve the safety, quality and efficiency of care and the reality in physician practices is pretty wide."

The HSC study consists of "44 discussions conducted between November 2005 and March 2006 with representatives of 26 organizations," including 15 medical practices that had the software and six that did not. Ten of the 15 with e-prescribing software used it as part of a suite of programs and the balance had purchased stand-alone programs.

One of the problems with e-prescribing software had to do with lack of patient prescription data from outside the doctor's practice, and many practices had difficulty getting data on the drug formulary offered by the patient's plan. The press release stated that doctors in slightly more than half the practices "did not have access to formulary data electronically because either the system did not have the feature or because the practice had chosen not to enable it," although the article did not enumerate the respective ratios of these two groups.

The remaining doctors were able to access formulary data for varying percentages of their patients, ranging from one in four to nine in 10, but many in this group "questioned the data's reliability and "in many practices, physicians routinely ignored it."

Clinical decision support (CDS) systems also got less than a warm welcome from doctors because of "general agreement that pop-up alerts were triggered too easily," and "physicians typically overrode them."

The press release also states that while all but one of the e-prescribing systems offered CDS, only half the practices reported that the CDS allowed them to check for drug allergies "and only 20% for drug-condition contraindications."

As is seemingly always the case when introducing a new technology into a business, physician practices ran into more headaches getting e-prescribing up to speed. According to HSC's statement, most office managers "were not prepared for the amount of interaction needed with outside parties, such as vendors, state regulators and local pharmacies, to implement and maintain the systems."