Drug database bill passes

The Alaska House of Representatives voted 23-16 Wednesday to pass a senate bill creating a prescription drug database in Alaska despite objections that it could threaten the privacy rights and security of Alaskans.
The bill empowers the Alaska Board of Pharmacy to place in an electronic file information about every prescription dispensed in the state for certain medications controlled under state law (schedules IA through VA), including medicinal narcotics such as painkillers, stimulants, tranquilizers, sedatives and other drugs that the Legislature might add to the scheduled drug statutes.
The law would apply to patients receiving medications through a pharmacy, not inpatients in a licensed health care facility.
The bill is designed to curb misuse of prescription drugs in Alaska and to deter so-called “doctor hopping” by patients. It would not collect any data that is not already required by the federal Drug Enforcement Agency, supporters say.
It will include the date prescriptions were written and filled, how those patients paid the bill, along with their names, addresses and dates of birth, the drug code of the controlled substance, and the name of the pharmacy and pharmacist or practitioner dispensing the drugs.
That kind of information could be used to track prescribing practices and dispensing patterns, and to determine if practitioners are prescribing in an unlawful manner. It would also track individuals obtaining controlled substances with a frequency or in a manner beyond recognized standards for dosage „ exactly the kind of information needed to deter abuse of prescription drugs, sponsors have claimed.
If the system is hacked, however, that data could easily be misused, including alerting criminals to the location of the homes of patients holding prescription drugs, opponents have argued.
Supporters, such as Rep. Jay Ramras, R-Fairbanks, said he shared the concerns for privacy that opponents expressed during debate.
“I value personal privacy. I don’t know that there is a person in this room that does not,” he said. “However, I also value the safety and security of soccer moms and the rest of us as we enjoy and pursue the quiet enjoyment of our lives.”
He noted the information to go into the database already is collected in paper form by pharmacists. He said passing the bill would make communities safer by reducing the availability of illegal prescription drugs.
He also said Alaska was joining 40 other states with similar laws in place and following “best practices” on implementing the program.

Beware of Prescription Drug & Medical Information Databases

The drumbeat for internet-accessible medical records is growing louder, as are calls in Georgia and other states for prescription-monitoring programs mandated by law. If patients care about retaining some semblance of confidentiality for their most private of information their personal medical and prescription drug records they will pay much greater attention to such moves than appears to be the case thus far.
In Georgia, the pressure for establishing a statewide data base for all prescriptions administered by doctors throughout the state is being fueled by the continuing reaction (some say, over-reaction) to the murder-suicide of wrestler Chris Benoit and his family last summer. The physician in Carrollton, Georgia who allegedly prescribed large quantities of steroids and painkillers to the wrestler in the period before he went off the deep end, is under federal indictment and is being impliedly blamed for the wrestler’s bizarre and ultimately tragic behavior.
Following the example of gun control advocates, legislators moving to establish legally-mandated prescription-drug monitoring programs appear to have concluded the best way to punish the few bad apples who abuse their medical licenses by over-prescribing drugs, is to inconvenience everyone who obtains a prescription for medication, and endanger the privacy of all such citizens. The data base that would be established by Republican-sponsored legislation would require pharmacists to report to the Georgia State Board of Pharmacy all prescriptions filled for drugs listed in Schedules II, III, and IV of the Georgia Controlled Substances Act. Those three lists cover the vast majority of medications subject to abuse or over-use, including pain-management and depression-control medications.
The new data base would include large amounts of sensitive data for each prescription thus reported; including the name, quantity and dosage of the medication, information identifying the prescribing physician, the patient’s name, date of birth and address, the “approved prescriber identification number,” and “other data elements.” The state’s Drugs and Narcotics Agency would monitor and enforce the reporting and data-basing requirements of the law. The data would be available to a wide variety of users, including law enforcement agencies, medical boards, and retail pharmacists.
While the legislation and its proponents assure the public the data base that would be established would be secure, the fact of the matter is no data base subject to so many user agencies and individuals can be “secure.”
States that already have established prescription drug data bases, or, like Georgia are in the process of doing so, are motivated also by the lure of federal dollars. President Bush, for example, signed legislation three years ago establishing grants for states to cover the costs of such programs…
…Until private citizens wake up to these dangers and demand protection for their medical records, state and federal legislators will continue to undermine such concerns.

D.C. bill would regulate pharma reps, use of Rx data

A bill to regulate pharmaceutical sales representatives was approved 7-6 on first reading by the District of Columbia Council on Dec. 11.
The bill, said to be the first of its kind, would require the licensing of those sales reps, prohibit using physicians’ private prescription data for marketing purposes without their consent, and create a program for educating doctors on the latest drug research as a way of countering biased marketing-driven information they receive from sales representatives.

Cops Become Drugstore Cowboys in Vermont

Most politicians support measures like so-called “prescription monitoring programs” mindlessly, figuring that if allowing the government access to medical records of scummy drug addicts will reduce their numbers, all is good.
But when state police start entering pharmacies to get full prescribing records of anyone taking a Schedule II controlled substance like Oxycontin– as the Green Mountain Daily blog [hat tip to Daily Kos] says is now happening in Vermont– perhaps they’ll wake up and smell the sickly odor of the death of the 4th Amendment. In the eyes of the police, every pain patient — and consider that some 30 percent of the population suffers some form of chronic pain — is junky slime.
Says Siobhan Reynolds, founder of the indispensable Pain Relief Network, “We saw from the beginning of the government’s shift to the “war on prescription drug abuse” that this was where this whole thing was headed. Until now, the systematic violation of patient’s 4th Amendment rights was more or less hidden from public view. Now, the Vermont police have pulled back the veil for all of us to see the vicious witch hunt being perpetrated against people unfortunate enough to require Controlled Substances for the treatment of serious illness.”

Judge strikes down N.H. prescription information law

A federal judge on Monday struck down New Hampshire’s first-in-the-nation law that makes doctors’ prescription-writing habits confidential, saying it violates the First Amendment. Drug company sales representatives use the information to target particular doctors and tailor their sales pitches to each one, a practice known as “detailing.”
Signed on June 30, 2006, by Gov. John Lynch, the law took effect immediately. It made New Hampshire the first state to try to block pharmaceutical companies’ hard-sell pitches by restricting access to data that identifies doctors and other prescribers. Information containing prescribers’ zip codes, location and medical specialties is allowed. The law does not prohibit information from being used for care management, clinical trials and education.
Pharmaceutical company salespeople prize doctors’ information because it profiles prescribing habits — they can learn which doctors favor brand names or generics, and who is more willing to prescribe new drugs — and steer their strategies accordingly.
Less than a month after the law took effect, IMS Health Inc., headquartered in Norwalk, Conn., and Verispan LLC, headquartered in Yardley, Pa., filed a complaint in U.S. District Court asking a judge to declare it unconstitutional.
{How could a judge decide that a data mining company has a right to free speech and strike down the NH law to stop prescription data mining? This is an absurd finding. Companies do not have free speech rights—only people have free speech rights. The real issue is the patient’s fundamental right to the privacy of his/her medical records. Prescriptions are medical records! IMS Health and Verispan LLC have no right to eliminate prescribing doctors’ or patients’ privacy. Access to prescription records should be controlled by patients. Research always requires obtaining consent before using records. Researchers do not deserve a free pass to our medical records, they can ask us if we are willing to participate in research. Does anyone think that Americans should be compelled to turn over their records for research? Do we live in a gulag? Furthermore, public health uses of medical data require that a strong public consensus exists to justify violating anyone’s medical privacy (like the powerful public consensus that supports the laws requiring doctors to report child and sexual abuse victims). There is no such public consensus that supports prescription data mining. Unfortunately the NH law was so narrowly drawn that it only addressed marketing uses of prescriptions. There are far more damaging uses of prescription records than that. Insurers use patients’ prescription records for underwriting and employers use it for discrimination in hiring and promotions. Prescriptions should not be data mined by anyone for any purpose without informed consent. This systemic corporate thievery must be stopped. ~ Dr. Deborah Peel, Patient Privacy Rights}

Letter: Ban data mining and sale of prescription records

Maine wants to ban the data mining and sale of identifiable prescription records to drug companies. It’s about time. But marketing to doctors is not the only unwanted and illegal use of your personal prescription records.

Identifiable prescription records have been data mined daily from every pharmacy in the U.S. for over a decade and sold to insurers for underwriting and to large employers. These secret uses result in discrimination, job loss, and increased insurance rates or even insurance denial. Losing your job is far worse than having drug companies pressure doctors and pharmacists to change your prescriptions.

Patient Privacy Rights leads a broad bipartisan coalition of national consumer groups working to save medical privacy. We are urging Congress to ban the illegal and unethical uses of everyone’s highly sensitive medical and prescription records. In 2006, our coalition letters to the House stopped a bill to build a national electronic health system without consumer control of electronic medical records.

The nation’s electronic health care system is hemorrhaging personal health information. Our medical and financial records are being used and sold for purposes that no one would want.

No one should have to choose between health care and privacy. We should decide who sees our medical records, not over 600,000 health-related businesses and government agencies.

Stop the illegal data mining of prescriptions in Maine — but tell Congress to also restore your rights to medical privacy and control of your health records.

Dr. Deborah C. Peel
Chair, Patient Privacy Rights Foundation

{The state of Maine is considering a law to ban the use of prescription data for marketing, which is not nearly enough. See Mining our own business in the Kennebec Journal. The author of the story and the people of Maine do not know that their prescription records are also being sold to insurers and employers for underwriting and employment decisions. Those harmful uses should also be banned. ~ Dr. Deborah Peel, Patient Privacy Rights}

Visit KennebecJournal.com

Nevada lawmakers pass many bills, but reject prescription privacy

Scores of bills passed but a few died – including one to block pharmacies from peddling doctors’ prescription information to data.m.ining firms – as Nevada lawmakers rushed Monday to meet a deadline for action on measures.
SB231, strongly opposed by pharmaceutical and medical data.m.ining companies, lost on a 9-12 vote in the state Senate. Republicans split on the bill, sponsored by Sen. Joe Heck, R-Henderson, an emergency room doctor, while most Democrats opposed the plan.
Senate Minority Leader Dina Titus, D-Las Vegas, said the bill would hurt public access to such information, and that an American Medical Association program that gives doctors the option of restricting use of their data was sufficient.
“I’ve never been one to help the pharmaceutical companies,” said Titus. “Just by coincidence, you know, sometimes strange bedfellows come from politics. They may oppose it for one reason – they like the marketing. I’m opposing it because I think it rolls back transparency and it lets you hide information about who’s prescribing what.”
Pharmaceutical and medical datamining companies contended that the prescriber-specific data has important uses in law enforcement and research.
{It’s clear that most people in Nevada and the nation do not realize that their identifiable prescription records are data mined and sold for uses besides targeted marketing to doctors—patient-specific data is sold to insurers for underwriting many types of insurance (health, life, disability) and to large employers for decisions about hiring and promotions—without consent and without any notice to patients or recourse. HHS will not act on complaints about violating prescription privacy because prescription datamining does not violate HIPAA—prescriptions can be used for “health operations purposes” without patient consent. Clearly state laws requiring consent before disclosure of medical records, common law, and medical ethics are violated by this use of our sensitive data, but without audit trails to prove who disclosed and received our prescription records, it is difficult for consumers to prove damages. This illegal and unethical universal practice of datamining the nation’s prescriptions has been going on under the radar for over a decade. It is impossible to keep your prescription records private by paying cash since every prescription is entered into the pharmacy’s electronic database and datamined daily. If there are legitimate research needs for anyone to learn what medicines your family takes, they can ask your permission first and see if you agree to participate in the research project. Forced research without the informed consent of patients is both illegal and unethical. In addition, anytime your family’s prescription or medical records are entered into yet another electronic database, you are exposed to great risk of having that sensitive information sold yet again, used for other purposes you would never agree to, or having your personal information stolen by identity thieves. ~ Dr. Deborah Peel, Patient Privacy Rights}

Chasing Paper from Medicine

Glen Tullman didn’t invent information technology, but he is one of those people who figured out early how to aim it with effect. Case in point: the 3 billion often illegibly marked paper prescriptions that Americans get from their doctors each year.

Tullman, CEO of the electronic health records company Allscripts, would like to whittle that number to zero. Prescription errors, he points out, injure 1.5 million and kill 7,000 patients annually–and most mistakes could be avoided if scripts were written electronically. “Seven thousand deaths is the equivalent of one Boeing 737 crashing every week for a year,” he says. “If one of them crashes, there’s an investigation and a public outcry.” In January, Allscripts teamed with Dell and a host of technology, insurance and health-care firms to launch the National ePrescribing Patient Safety Initiative (NEPSI). The consortium will provide electronic prescribing free to doctors across the country. Tullman estimates the cost at about $100 million over five years.

The NEPSI project captures part of what motivates Tullman to work. “The opportunity to make a difference, to tackle a big problem, is what gets me excited,” he says. But he isn’t all high moral purpose. So there’s another biggie: pleasure. In creating, succeeding, repeating. “You spend way too many hours doing it to not have fun doing what you do,” he says. “And when you’re having fun, it’s not work.”

{The idea that e-prescribing will save lives and injuries caused by illegible handwritten prescriptions is a myth. Forcing physicians to e-prescribe will not reduce errors, because all handwritten prescriptions are already electronically entered into computers by pharmacists—and have been for more than a decade. If a pharmacist cannot read a handwritten prescription, he/she calls the doctor to obtain the correct information to enter into a database. What Tullman is really selling is a scary story designed to mislead and push the public into believing that e-prescriptions are safer than paper prescriptions—he says that he thinks e-prescribing will enable him to sell more software. Tullman doesn’t tell the public that every electronic prescription is being data mined and sold daily to insurers and employers for medical underwriting and to discriminate against people seeking jobs. If paper prescription errors could be eliminated simply by using e-prescriptions, why didn’t that happen 10 years ago, when pharmacists began entering all prescriptions into computers electronically? ~ Dr. Deborah Peel, Patient Privacy Rights}

Hands Off Prescribing Data, Says Vermont

Vermont is considering a new bill that would make it the second state in the country to ban the sale of physician prescribing data. The state would be keeping up with its next-door neighbor–New Hampshire’s eight-month-old Prescription Confidentiality Law is currently being challenged in a court case there. Data companies IMS Health and Verispan brought the suit, arguing that law compromises their freedom of speech.
Like the New Hampshire law, Vermont’s bill would bar third-party entities like pharmacists, insurers, and data-collection companies from selling prescription data “for any commercial purpose”–namely the marketing and promotion of prescription drugs. The bill is intended to keep the data away from drug reps, who use it to tailor their sales calls to individual physicians.
But Vermont is also adding another provision to prevent “unconscionable pricing” of prescription drugs. “Unconscionable” is defined as a wholesale price that is more than 30 percent higher than the price available to federal agencies, the state’s Healthy Vermonters program, or the “most favored purchase price.”
The state’s Senate Finance Committee has so far endorsed the bill, and the Health and Welfare Committee will review it next. The Vermont Medical Society–like its counterpart in New Hampshire–is also backing the bill. On the other side of the fence, a team from PhRMA is lobbying against the restrictions on drug marketing and price caps. The New Hampshire suit, which is awaiting a decision, could also have an impact on the bill’s future.
{The pharmaceutical industry is vigorously defending the illegal practice of data mining your prescriptions without consent. It is critical to note that besides using your identifiable prescription records to influence the medications your doctor, your hospital, and your health plan provide, your prescription records are data mined and sold daily to the insurance industry for underwriting not just health insurance, but life and disability insurance; and also sold to employers for decisions about hiring and promotions. ~ Dr. Deborah Peel, Patient Privacy Rights}

Physician works to heal flawed medical record-keeping

In April 2004, President Bush set a 10-year goal of equipping most Americans with electronic medical files and prescription drug records.

The ambitious initiative promises to improve the safety, quality and efficiency of health care nationwide, but it also faces major hurdles: chiefly, the enormous upfront costs involved and the need to radically transform the paper processes used in medical care today.

Heading up the monumental task is Dr. David Brailer, a medical doctor and researcher who has devoted much of his professional career to expanding the use of technology in health care. Brailer was working for a nonprofit research group in San Francisco when he was hired by the White House in August 2003 as a consultant to develop policy options for equipping all Americans with electronic health care records. The following May, he was appointed by the secretary of the Health and Human Services Department as the first national coordinator for health information technology where he will execute policies he helped create and encourage doctors and hospitals to embrace greater use of information technologies.

Although Brailer’s immediate staff is small — growing from 15 to 40 in the next year — hundreds of employees from 35 federal agencies are working on the initiative. Brailer’s not sure how long he’ll be overseeing the effort — for the past two years, he has been commuting to Washington every week from San Francisco, where his wife and 5-year-old son live. But he says he won’t leave until he’s sure his team is well on its way to fulfilling the president’s mandate.

Brailer discussed with Federal Times the benefits and challenges of the project, including his frustrations at working in a federal bureaucracy:

Q: What’s driving the need for this?

Brailer: A few things. First, we now for the first time really know how bad medical errors are. Secondly, there’s huge cost pressure. And finally, we have a consumer that’s becoming more and more sophisticated.

Q: How bad are the medical errors?

Brailer: They’re significant. At least 50,000 people die every year in a hospital from medical errors. At least 2 million Americans are injured every year from outpatient drug prescribing, and thousands of people die from that. So it’s big, it’s huge.

Q: How will information technology help reduce those errors?

Brailer: If the doctor prescribes a drug, the first thing [the technology] does is validate that it’s the right patient. The next thing it does is check the allergies, and it won’t allow the doctor to continue if the patient has an allergy. If the patient is taking a drug that has a dangerous interaction, it stops the doctor. Plus there’s no handwriting. The order gets transmitted right to the pharmacy. They don’t have to read the doctor’s writing to figure out what he or she meant. When [the medication] goes to the [hospital] nurse, they can bar-code scan the patient [identification] to make sure they’re giving it to the right patient. It fixes the whole system.

Q: How prevalent is the use of this type of technology now?

Brailer: Most of the surveys are kind of patchy and narrow. But our estimate from all the various patchwork studies is around 10 percent.

Q: What are the main barriers to expanding its use?

Brailer: Two big ones. One is cost. In health care we pay by the piece. If you were my patient, I would be paid for seeing you, depending on how long I saw you, and I would be paid the same amount if I made a mistake or if I didn’t. There’s no incentive for quality or incentive for efficiency. Health IT increases quality and efficiency, but it doesn’t increase the doctor’s bottom line.

The other one is know-how. These systems are complicated, not just technically. They’re about changing the way practices operate, changing the culture of practice, changing the way people communicate, the way decisions get made, the role of the patient. And that requires a lot of change management and organizational re-engineering know-how.

Q: So, what are some of your ideas for getting over those barriers?

Brailer: First, one single set of information standards, so information always means the same thing regardless of the doctor’s hospital, the clinic, the laboratory, the pharmacy. Secondly, we’re going to start certifying electronic health records [systems], so the doctor can have a lot more certainty and comfort that they’re buying the right product. Also, we’re working on developing new advances in privacy and security. This is ultimately about the consumer’s data, and we want to make sure their data’s protected.

Q: What will this mean ultimately for the consumer?

Brailer: They should have no worries that when they show up to their doctor’s office that their data won’t be there. If they’re evacuated from New Orleans or from the next place that has a catastrophe, their data goes with them. We learned with Hurricane Katrina that people were being saved from New Orleans and dying in shelters because the doctors there didn’t know what drugs they were taking. So we created in seven days a database that had all the drug data for most of the evacuees, and it saved a lot of lives.

Q: How much is it going to cost, and who’s going to pay it?

Brailer: It is expensive. There have been estimates of the cost of this ranging from $100 billion to $200 billion. But all the estimates of cost also are paired with an estimate of savings, and they show that over a decade it might cost $200 billion but the savings will be more like $700 billion or $800 billion. Every time somebody has a medical error, besides the fact that they could die — which is horrible in its own right — they lose their productivity. People don’t just die; they die after a month in the hospital. It costs us a fortune.

Q: How might the Federal Employees Health Benefits Program (FEHBP) serve as a model?

Brailer: It’s already started. In April, the first page of the Office of Personnel Management’s letter [to insurance companies] explaining what the government was looking for was about health IT and how important it was that health plans support local adoption of health IT among their doctors and hospitals. And that’s had a huge response. Every health plan’s paying attention to it. They’re all looking at their own programs, they’re gearing up to do things, they’re adding new programs, new efforts, they’re assessing what’s going on in their own markets. We’ll do another turn of that [next April] to be able to say . . . here’s some of the criteria you should judge this [expansion of IT] with. I think FEHBP is going to be a big driver of this.

Q: Are some federal programs already forerunners of this?

Brailer: The Veterans Affairs Department has been using a fully automated paperless record in its hospitals and clinics for 10 years. They were one of the early movers. Once people go into the VA, basically, the VA bears the cost of their care from then to the end of time. Therefore it’s in the VA’s interest to put in investments to lower costs. But if you look at the typical hospital, that’s not how it works. They just get paid when someone comes through the door, so it’s in their interest to have people come more often.

Q: How has your experience been working in a bureaucracy like this? What surprised you about it, either good or bad?

Brailer: I’ve really been impressed with how good federal people are just across the board. Whenever I want a specialist on some kind of large-scale security architecture, I can find some of the best in the world working for the federal government. Negative surprises are — the list is so large we could spend a lot of time on it. In health care, the government only has one purpose in general, which is to regulate the market, create mandates. I find that to be one of the real problems with health care. I came in to drive a market-based agenda and I’ve been fighting uphill because it’s just a regulatory environment. If you go around this building, people, when they think of doing something with health care, they think of a regulation. If we want to have a freer market, it has to start with the government . . . starting to free up the stranglehold of regulations on the market that keep it from having innovation.

Q: This is a 10-year effort the president outlined. Do you expect to be here for the long haul?

Brailer: No. I never came in to do the long haul. I’m frankly shocked I’m still here. Not because I’m not having a good time, not because I don’t think it’s important, not because I frankly don’t love the people I’m working with. I just viewed myself as someone who would come in, get it set up, get the strategy worked out, get the team in place.

Q: How will you know you’ve done enough so the momentum will continue?

Brailer: I’ve got several criteria for that — when there’s a leadership team in place here in the federal government that can really drive it forward; when we have all of our external infrastructure in place, with the key drivers, the contractors, the entities who can do this on the outside; and when there is a really broad recognition that this is inevitable and it has to keep going.