Friday, April 20, 2007

What a Relief: Uncle Sam Is't in Our Medicine Cabinets

In the middle of an ABC story about the Virginia Tech massacre was the following paragraph which raises some disturbing questions.

Some news accounts have suggested that Cho had a history of antidepressant use, but senior federal officials tell ABC News that they can find no record of such medication in the government's files. This does not completely rule out prescription drug use, including samples from a physician, drugs obtained through illegal Internet sources, or a gap in the federal database, but the sources say theirs is a reasonably complete search.

Does the federal government have a database of all prescriptions issued in the United States? Do the feds know whether your girlfriend is on the pill? Can someone in Washington check to see if you are taking Viagra? This would be a massive invasion of our privacy. Yet I had never heard about the existence of such a database. I could recall no debate about aggragating this information and putting in to the hands of the feds or establishing policies which would insure that it wasn't abused. I decided to Google my way to a more informed state.

Well, we can relax. There is no federal database. However, thirty-three states do have Prescription Drug Monitoring Programs (PDMP), but the programs only monitor controlled substances. There are five different schedules of controlled substances. Schedule I drugs are those drugs which have no medical use, for example herion. The drugs in schedules II through V are prescription drugs. The higher the schedule number the less potential for abuse of the drugs in the schedule. Which schedules are monitored varies from state to state. Some of these programs are very old. California for example has had one in place since 1940. Congress in 2002 authorized federal grants to states, called Harold Roger grants, to either put into place PDMPs or to beef up exisiting ones. These grants are administered through the Department of Justice. In 2005, Congress established a second grant program through the National All Schedules Prescription Electronic Reporting Act of 2005 (NASPER) which in essence did the same thing as Harold Rogers. But this program, which is to be administered by Health and Human Services, has yet to receive any funds.

To learn more about these state programs I recommend this 2002 GAO report (pdf). The report does a good job of summarizing the potential problems with these programs.

Both physicians who legitimately prescribe prescription drugs and patients who legitimately use them are concerned that the information collected, centrally maintained, and monitored by state PDMPs may be used inappropriately or compromised. All states, regardless of whether there is a state PDMP, have the authority under their laws to conduct investigations of the records of individuals alleged to be involved in prescription drug diversion and abuse, including the records of prescribing physicians and dispensing pharmacies. PDMPs, particularly those with electronic databases, raise additional confidentiality concerns, however, because their databases contain complete dispensing records that can more quickly identify individual patients, physicians, and pharmacies and provide an individual report on their prescription drug history. Physicians are concerned that their prescribing decisions and patterns may be questioned and that they could be investigated without sufficient cause. Some physicians contend that patients may suffer because physicians willbe reluctant to prescribe appropriate controlled substances to manage a patient’s pain or treat their condition. Patients are concerned that their personal information may be used inappropriately by those with authorized access or shared with unauthorized entities. Pharmacists havealso expressed concerns. In New Mexico, the Board of Pharmacy repealed the administrative regulations necessary to operate the state’s electronic PDMP following confidentiality concerns raised by some pharmacists who were apprehensive they might be targeted for investigation based on the volume of controlled substance drugs they dispensed.

Some states have attempted to address these concerns statutorily. For example, some state laws to regulate controlled substances and to operate a PDMP include health privacy protection provisions.16 In addition, states with PDMPs generally have statutory and regulatory protections to limit access and use of confidential health care data, as well as statutory penalties for misuse. Under Kentucky’s electronic PDMP, for example, the authorized users of its information are statutorily delineated, the knowing misuse of the data can result in a felony conviction, and the PDMP itself is statutorily accountable for ensuring that only authorized users receive its data. Kentucky law also prohibits any person who receives PDMP data from sharing that information with anyone else, unless required by a court, and the Kentucky PDMP advises data recipients of this prohibition. Nevada’s state law similarly protects the confidentiality of its PDMP information by requiring a court order for disclosure to nonauthorizedentities. Also, Nevada’s Board of Pharmacy has legal authority to discipline and fine an individual for violating the confidentiality law. For example, the board brought legal action against a pharmacist who provided an employer with prescription utilization information on a worker whom the employer subsequently fired. The pharmacist was fined $2,000 and was given probationary discipline.

I think these programs should be given closer scrutiny for possible violations or our civil liberties. In particular the programs which use private contractors may be abused. To be sure, I have seen no evidence to date that wide spread violations have occurred, but I haven't really dug too deep.

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