Has the following scenario ever happened to you?
A pharmaceutical representative comes into your office and asks why you are not prescribing his company’s medication named “Best Moisturizer Ever,” though other dermatologists are. Taken aback, you reply that you do not know that much about the medication named “Best Moisturizer Ever” and do not know anyone prescribing or using it. The representative replies that the dermatologist across the street from you, who trained at the same residency program as you, uses a lot of “Best Moisturizer Ever.” In fact, that dermatologist writes three scripts a day, and his patients seem really happy.
The rep leaves and you go on to see more patients. Then a bit later, you look up and another rep is waiting by the receptionist’s counter. As soon as she sees you she springs toward you. Avoiding pleasantries, she asks you why you write for a medication named “Upstart Brand” 65% of the time and for her medication, “Proven Brand”, only 35% of the time though both medications are chemically similar.
You are surprised because you do not know the ratio for which you write one medication over another and are curious about where she gets her information.
Doctors’ Prescribing Data: Big Business
I’ve had similar scenarios happen to me, and I’ve found them to be quite obtrusive and inappropriate.
Since 1993,2 pharmaceutical companies have had access to all doctors’ prescribing data. According to a New York Times article by Stephanie Saul, “the leading compiler and vendor of prescription data is IMS Health, a publicly traded company based in Fairfield, CT, that had revenue last year of $1.75 billion.1
IMS and its competitors gather the data through contracts with retail pharmacy chains and companies that manage drug plans for insurers, and then sell it to pharmaceutical companies.”
The American Medical Association, makes more than $40 million a year selling physician data to third parties (mostly ultimately used by pharmaceutical companies).2,3 This information allows companies to target doctors who use new medications early and to try to change the minds of doctors who use competing brands.
Some of the numbers surrounding pharmaceutical sales are startling. There are about 100,000 to 115,000 pharmaceutical representatives in the United States. Spending in the United States for prescription drugs was $179.2 billion in 2003 and almost $220 billion in 2005.
Drug manufacturers spent $22 billion on direct marketing to doctors in the United States during 2003.3 Pharm-aceutical companies have paid fines of $3.5 billion since 2001 for wrongful promotions.
No Legal Protection for Physicians’ Activities
Privacy laws protect patients’ data and not physicians’ activities. Several recent articles1,2,3 and pieces of pending state legislation have addressed this issue.
Recently, state legislatures in New Hampshire, Hawaii, West Virginia and Arizona have addressed data tracking issues. Maine lawmakers also considered such legislation but enacted a limited version that focused only patient privacy.
What Else Is Happening?
The state medical association in California, which is opposed to tracking, is beginning its own program. This program will enable doctors who do not opt out under the AMA system to receive comparisons of their prescribing patterns in 17 classes of drugs from the data companies. This pilot program is intended to be extended statewide.1
Perhaps to head off formal regulations and calls by organizations, such as the American College of Physicians, to ban the sale of data, the AMA announced that:
On July 12,3 physicians can begin to restrict access to information about their prescription practices for pharmaceutical company sales representatives. Under this proposed system, doctors listed in an AMA database called Masterfile can signify in a new online registry that pharmaceutical company sales representatives should not have access to such information for 3 years.2,3
Masterfile includes information on about 1 million U.S. medical school graduates and foreign medical school graduates licensed in the United States. This program won’t cover nurse practitioners, physicians assistants or dentists.2,3
The AMA program is not a cure-all. Musacchio and Hunkler2 noted that under the AMA new system: “The Prescribing Data Restriction Program (PDRP) will take data from reps and their direct supervisors, but leave it available to the company for marketing, compensation, and research. The rules allow the industry to retain access to prescribing data for most purposes, but they require companies to police their own sales forces.”
Still Saul1 noted that while “the AMA’s new registry . . . will enable doctors listed in its Masterfile to indicate they do not want their prescribing data shared with pharmaceutical sales representatives, the ‘opt out’ will remain in force for 3 years. But even those doctors’ prescription information will still be collected and transmitted to drug companies . . . .”
Saul1 further noted that “A Gallup Poll commissioned by the American Medical Association in 2004 found that two-thirds of doctors surveyed opposed the release of such data to pharmaceutical representatives but that 77% felt that an opt-out program would alleviate concerns about the release of data.
The survey also found that: Nearly one-quarter of the doctors were not even aware that the pharmaceutical industry had access to such information.”
What Will Change?
If you do not want drug representatives to use your data, you as a dermatologist will have new protections based on laws in some states and self-imposed regulations nationally. Prescription data will still be compiled and analyzed by drug companies.
How these new rules will affect the interaction of dermatologists and detail people remains to be seen.
Details of AMA plan/PDRP Adapted from Musacchio and Hunkler2
• PDRP enrollment will begin on the AMA’s Web site so that the program can take effect on Jul. 1, 2006. Enrolling in the program is sometimes known as “election”.
• Enrollment will remain in effect for 3 years from the date on which the AMA receives the physician’s election.
• Pharmaceutical companies will have ample time (about 90 days from receiving notice that a physician has enrolled) to make the internal system changes needed to suppress data from being released to restricted employees.
• Physicians may revoke the election at any time by notifying the AMA.
• Pharmaceutical employees having direct contact with physicians will be blocked from accessing restricted data on PDRP physicians. The block-outs apply to part-time and temporary sales employees and contractors, as well as full-time sales reps and first-line sales managers.
• Restricted data are defined as any product-level data regarding the prescribing practices of an identifiable physician who has made the PRDP election. This includes measures of prescription volume in absolute and percentage terms, the associated dollar value of a physician’s prescribing, any indicators of change in these measures, as well as any means of ranking, benchmarking, or grouping physicians that may reveal prescribing habits for a particular product. Furthermore, sales representatives must not “reverse engineer” or re-identify any prescribing information of a PDRP physician.
• The restrictions do not apply to:
a. deciles at the market or therapeutic class level
b. segmented data that are not likely to reveal the actual or estimated
activity of an individual physician
c. data on products ordered by physicians from pharmaceutical companies.
• A physician’s participation in the PDRP has no bearing whatsoever on the AMA’s “No Contact List,” which has been in place for more than 20 years to prevent
listed physicians' names from being licensed for marketing purposes.
• Compliance will be gauged by physician complaints to the AMA.
• Isolated and minor infractions will likely result in an investigation, followed by a warning. Those manufacturers who show a disregard for the program’s requirements by maintaining a pattern of abuse may lose access to AMA data, and, if infractions continue, may subsequently lose access to health information organization data.
• The information available to the “home office” will not change, regardless of physician enrollment in PDRP. This program will not affect headquarter business systems. As long as the industry complies with PDRP, the program will
not restrict access to information used in efficient marketing and compensation practices. n
To sign up for the AMA’s Prescribing Data Restriction Program, doctors can link to the Prescribing Data Information Center’s Web site
(www.ama-assn.org/go/prescribingdata ).
To ensure security, doctors must to use their members-only username and password. Non-members must sign up for an AMA Internet ID. For assistance with the online opt-out process, contact the center by phone (800-621-8335) or e-mail (pdrp@ama-assn.org).
STATUS OF STATES’ LEGISLATION ON LIMITING THE USE OF PHYSICIANS’ PRESCRIBING DATA
Arizona
HB 2800
Rep. Cahill.
(Filed and referred to committee 2/6/06)
This legislation would require a licensed pharmacist or pharmacy to keep confidential prescription information containing identifiable patient and prescriber data and would prohibit the release or sale of this information for any commercial purpose. Any such release or sale of confidential prescription information would constitute unprofessional conduct.4
Section 1. Title 32, chapter 18, article 3, Arizona Revised Statutes, is amended by adding section 32-1973, to read:32-1973. Prescription information; sale; prohibition; unprofessional conduct
A. A pharmacist or pharmacy licensed pursuant to this chapter must keep confidential prescription information containing identifiable patient and prescriber data and may not release or sell this information for any commercial purpose.
B. A pharmacist or pharmacy that releases or sells confidential prescription information commits an act of
unprofessional conduct.
Hawaii
HB 1873
Rep. Takumi
(Filed and referred to committee 1/19/06; passed House, 3/7/06)
This legislation would prohibit prescription records containing identifiable patient and prescriber data from
being sold for commercial purposes.4
SECTION 1. Chapter 329, Hawaii Revised Statutes, is amended by adding a new section to be appropriately
designated and to read as follows:
§329- Prescription information; confidentiality; penalty. Records relative to prescription information containing identifiable patient and prescriber data shall not be transferred or sold by any pharmacy benefits manager, insurance company, electronic transmission intermediary, retail, mail order or Internet pharmacy for any commercial purpose. In addition to other appropriate remedies under this chapter, a violation of this section is an unfair or deceptive act or practice within the meaning of section 480-2. Any right or remedy set forth in section 480-13 may be used to enforce the provisions of this section.”
SECTION 2. Section 461-13, Hawaii Revised Statutes, is amended to read as follows:
§461-13 Prescription records; confidentiality. (a) Records relative to prescription information containing identifiable patient and prescriber data shall not be transferred or sold by any pharmacy benefits manager, insurance company, electronic transmission intermediary, retail, mail order or Internet pharmacy for any commercial purpose. In addition to other appropriate remedies under this chapter, a violation of this section is an unfair or deceptive act or practice within the meaning of section 480-2. Any right or remedy set forth in section 480-13 may be used to enforce the provisions of this subsection.
(b) A pharmacy shall keep prescription records of each prescription compounded or dispensed at the pharmacy for a period of not less than 5 years. The prescription records shall at all times be open to inspection by the board of pharmacy and other law enforcement officers.”
SECTION 3. Statutory material to be repealed is bracketed and stricken. New statutory material is underscored.
SECTION 4. This Act shall take effect upon its approval.
West Virginia
HB 4676
Rep. Perdue
(Filed and referred to committee 2/21/06)
Would prohibit any pharmacy benefit manager, insurance company, electronic transmission intermediary, retail, mail order or Internet pharmacy from transferring or selling for any commercial purpose records relative to prescription information containing identifiable patient and prescriber data.4
CHAPTER 30. PROFESSIONS AND OCCUPATIONS.
ARTICLE 5. PHARMACISTS, PHARMACY TECHNICIANS, PHARMACY INTERNS AND PHARMACIES.
§30-5-12c. Prescription information to be kept confidential. Records relative to prescription information containing identifiable patient and prescriber data shall not be transferred or sold by any pharmacy benefit manager, insurance company, electronic transmission intermediary, retail, mail order or Internet pharmacy for any commercial purpose.
In addition to other appropriate remedies under this chapter, a violation of this section is an unfair trade practice within the meaning of article eleven-a, chapter forty-seven of this code. Any right or remedy set forth in article eleven-a, chapter forty-seven may be used to enforce the provisions of this section.
CHAPTER 60A. UNIFORM CONTROLLED SUBSTANCES ACT.
ARTICLE 4. OFFENSES AND PENALTIES.
§60A-4-412. Prohibited acts; prescription information to be held confidential. Pursuant to section twelve-c, article five, chapter thirty of this code, records relative to prescription information containing identifiable patient and prescriber data shall not be transferred or sold by any pharmacy benefit manager, insurance company, electronic transmission intermediary, retail, mail order or Internet pharmacy for any commercial purpose. In addition to other appropriate remedies under this chapter, a violation of this section is an unfair trade practice within the meaning of article eleven-a, chapter forty-seven of this code. Any right or remedy set forth in article eleven-a, chapter forty-seven may be used to enforce the provisions of this section.
NOTE: The purpose of this bill is to ensure the confidentiality of prescription drug information and to prevent the
sale of the information.
New Hampshire
HB 1346
Rep. Rosenwald
(The New Hampshire state Senate unanimously passed legislation May 4 and it has gone to the governor for approval.)
This bill would prohibit prescription information from being transferred or sold for any commercial purpose except for
the limited purpose of reimbursing the pharmacy.4
Records relative to prescription information containing identifiable patient and prescriber data shall not be used transferred, licensed or sold by any pharmacy benefits manager, insurance company, electronic transmission, intermediary retail mail order or Internet pharmacy, or other similar entity for any commercial purpose except for the limited purposes of pharmacy reimbursement care management and utilization review by the patient’s insurance provider or the provider’s agent.
Commercial purpose includes but is not limited to advertising marketing promotion or any other purpose that could be used to influence sales or market share of a pharmaceutical product influence or evaluate the prescribing behavior of an individual healthcare professional except for evaluation by an insurance provider or the provider’s agent for the purpose of compliance with the provider’s formulary or evaluate the effectiveness of a professional detailing sales force.
Has the following scenario ever happened to you?
A pharmaceutical representative comes into your office and asks why you are not prescribing his company’s medication named “Best Moisturizer Ever,” though other dermatologists are. Taken aback, you reply that you do not know that much about the medication named “Best Moisturizer Ever” and do not know anyone prescribing or using it. The representative replies that the dermatologist across the street from you, who trained at the same residency program as you, uses a lot of “Best Moisturizer Ever.” In fact, that dermatologist writes three scripts a day, and his patients seem really happy.
The rep leaves and you go on to see more patients. Then a bit later, you look up and another rep is waiting by the receptionist’s counter. As soon as she sees you she springs toward you. Avoiding pleasantries, she asks you why you write for a medication named “Upstart Brand” 65% of the time and for her medication, “Proven Brand”, only 35% of the time though both medications are chemically similar.
You are surprised because you do not know the ratio for which you write one medication over another and are curious about where she gets her information.
Doctors’ Prescribing Data: Big Business
I’ve had similar scenarios happen to me, and I’ve found them to be quite obtrusive and inappropriate.
Since 1993,2 pharmaceutical companies have had access to all doctors’ prescribing data. According to a New York Times article by Stephanie Saul, “the leading compiler and vendor of prescription data is IMS Health, a publicly traded company based in Fairfield, CT, that had revenue last year of $1.75 billion.1
IMS and its competitors gather the data through contracts with retail pharmacy chains and companies that manage drug plans for insurers, and then sell it to pharmaceutical companies.”
The American Medical Association, makes more than $40 million a year selling physician data to third parties (mostly ultimately used by pharmaceutical companies).2,3 This information allows companies to target doctors who use new medications early and to try to change the minds of doctors who use competing brands.
Some of the numbers surrounding pharmaceutical sales are startling. There are about 100,000 to 115,000 pharmaceutical representatives in the United States. Spending in the United States for prescription drugs was $179.2 billion in 2003 and almost $220 billion in 2005.
Drug manufacturers spent $22 billion on direct marketing to doctors in the United States during 2003.3 Pharm-aceutical companies have paid fines of $3.5 billion since 2001 for wrongful promotions.
No Legal Protection for Physicians’ Activities
Privacy laws protect patients’ data and not physicians’ activities. Several recent articles1,2,3 and pieces of pending state legislation have addressed this issue.
Recently, state legislatures in New Hampshire, Hawaii, West Virginia and Arizona have addressed data tracking issues. Maine lawmakers also considered such legislation but enacted a limited version that focused only patient privacy.
What Else Is Happening?
The state medical association in California, which is opposed to tracking, is beginning its own program. This program will enable doctors who do not opt out under the AMA system to receive comparisons of their prescribing patterns in 17 classes of drugs from the data companies. This pilot program is intended to be extended statewide.1
Perhaps to head off formal regulations and calls by organizations, such as the American College of Physicians, to ban the sale of data, the AMA announced that:
On July 12,3 physicians can begin to restrict access to information about their prescription practices for pharmaceutical company sales representatives. Under this proposed system, doctors listed in an AMA database called Masterfile can signify in a new online registry that pharmaceutical company sales representatives should not have access to such information for 3 years.2,3
Masterfile includes information on about 1 million U.S. medical school graduates and foreign medical school graduates licensed in the United States. This program won’t cover nurse practitioners, physicians assistants or dentists.2,3
The AMA program is not a cure-all. Musacchio and Hunkler2 noted that under the AMA new system: “The Prescribing Data Restriction Program (PDRP) will take data from reps and their direct supervisors, but leave it available to the company for marketing, compensation, and research. The rules allow the industry to retain access to prescribing data for most purposes, but they require companies to police their own sales forces.”
Still Saul1 noted that while “the AMA’s new registry . . . will enable doctors listed in its Masterfile to indicate they do not want their prescribing data shared with pharmaceutical sales representatives, the ‘opt out’ will remain in force for 3 years. But even those doctors’ prescription information will still be collected and transmitted to drug companies . . . .”
Saul1 further noted that “A Gallup Poll commissioned by the American Medical Association in 2004 found that two-thirds of doctors surveyed opposed the release of such data to pharmaceutical representatives but that 77% felt that an opt-out program would alleviate concerns about the release of data.
The survey also found that: Nearly one-quarter of the doctors were not even aware that the pharmaceutical industry had access to such information.”
What Will Change?
If you do not want drug representatives to use your data, you as a dermatologist will have new protections based on laws in some states and self-imposed regulations nationally. Prescription data will still be compiled and analyzed by drug companies.
How these new rules will affect the interaction of dermatologists and detail people remains to be seen.
Details of AMA plan/PDRP Adapted from Musacchio and Hunkler2
• PDRP enrollment will begin on the AMA’s Web site so that the program can take effect on Jul. 1, 2006. Enrolling in the program is sometimes known as “election”.
• Enrollment will remain in effect for 3 years from the date on which the AMA receives the physician’s election.
• Pharmaceutical companies will have ample time (about 90 days from receiving notice that a physician has enrolled) to make the internal system changes needed to suppress data from being released to restricted employees.
• Physicians may revoke the election at any time by notifying the AMA.
• Pharmaceutical employees having direct contact with physicians will be blocked from accessing restricted data on PDRP physicians. The block-outs apply to part-time and temporary sales employees and contractors, as well as full-time sales reps and first-line sales managers.
• Restricted data are defined as any product-level data regarding the prescribing practices of an identifiable physician who has made the PRDP election. This includes measures of prescription volume in absolute and percentage terms, the associated dollar value of a physician’s prescribing, any indicators of change in these measures, as well as any means of ranking, benchmarking, or grouping physicians that may reveal prescribing habits for a particular product. Furthermore, sales representatives must not “reverse engineer” or re-identify any prescribing information of a PDRP physician.
• The restrictions do not apply to:
a. deciles at the market or therapeutic class level
b. segmented data that are not likely to reveal the actual or estimated
activity of an individual physician
c. data on products ordered by physicians from pharmaceutical companies.
• A physician’s participation in the PDRP has no bearing whatsoever on the AMA’s “No Contact List,” which has been in place for more than 20 years to prevent
listed physicians' names from being licensed for marketing purposes.
• Compliance will be gauged by physician complaints to the AMA.
• Isolated and minor infractions will likely result in an investigation, followed by a warning. Those manufacturers who show a disregard for the program’s requirements by maintaining a pattern of abuse may lose access to AMA data, and, if infractions continue, may subsequently lose access to health information organization data.
• The information available to the “home office” will not change, regardless of physician enrollment in PDRP. This program will not affect headquarter business systems. As long as the industry complies with PDRP, the program will
not restrict access to information used in efficient marketing and compensation practices. n
To sign up for the AMA’s Prescribing Data Restriction Program, doctors can link to the Prescribing Data Information Center’s Web site
(www.ama-assn.org/go/prescribingdata ).
To ensure security, doctors must to use their members-only username and password. Non-members must sign up for an AMA Internet ID. For assistance with the online opt-out process, contact the center by phone (800-621-8335) or e-mail (pdrp@ama-assn.org).
STATUS OF STATES’ LEGISLATION ON LIMITING THE USE OF PHYSICIANS’ PRESCRIBING DATA
Arizona
HB 2800
Rep. Cahill.
(Filed and referred to committee 2/6/06)
This legislation would require a licensed pharmacist or pharmacy to keep confidential prescription information containing identifiable patient and prescriber data and would prohibit the release or sale of this information for any commercial purpose. Any such release or sale of confidential prescription information would constitute unprofessional conduct.4
Section 1. Title 32, chapter 18, article 3, Arizona Revised Statutes, is amended by adding section 32-1973, to read:32-1973. Prescription information; sale; prohibition; unprofessional conduct
A. A pharmacist or pharmacy licensed pursuant to this chapter must keep confidential prescription information containing identifiable patient and prescriber data and may not release or sell this information for any commercial purpose.
B. A pharmacist or pharmacy that releases or sells confidential prescription information commits an act of
unprofessional conduct.
Hawaii
HB 1873
Rep. Takumi
(Filed and referred to committee 1/19/06; passed House, 3/7/06)
This legislation would prohibit prescription records containing identifiable patient and prescriber data from
being sold for commercial purposes.4
SECTION 1. Chapter 329, Hawaii Revised Statutes, is amended by adding a new section to be appropriately
designated and to read as follows:
§329- Prescription information; confidentiality; penalty. Records relative to prescription information containing identifiable patient and prescriber data shall not be transferred or sold by any pharmacy benefits manager, insurance company, electronic transmission intermediary, retail, mail order or Internet pharmacy for any commercial purpose. In addition to other appropriate remedies under this chapter, a violation of this section is an unfair or deceptive act or practice within the meaning of section 480-2. Any right or remedy set forth in section 480-13 may be used to enforce the provisions of this section.”
SECTION 2. Section 461-13, Hawaii Revised Statutes, is amended to read as follows:
§461-13 Prescription records; confidentiality. (a) Records relative to prescription information containing identifiable patient and prescriber data shall not be transferred or sold by any pharmacy benefits manager, insurance company, electronic transmission intermediary, retail, mail order or Internet pharmacy for any commercial purpose. In addition to other appropriate remedies under this chapter, a violation of this section is an unfair or deceptive act or practice within the meaning of section 480-2. Any right or remedy set forth in section 480-13 may be used to enforce the provisions of this subsection.
(b) A pharmacy shall keep prescription records of each prescription compounded or dispensed at the pharmacy for a period of not less than 5 years. The prescription records shall at all times be open to inspection by the board of pharmacy and other law enforcement officers.”
SECTION 3. Statutory material to be repealed is bracketed and stricken. New statutory material is underscored.
SECTION 4. This Act shall take effect upon its approval.
West Virginia
HB 4676
Rep. Perdue
(Filed and referred to committee 2/21/06)
Would prohibit any pharmacy benefit manager, insurance company, electronic transmission intermediary, retail, mail order or Internet pharmacy from transferring or selling for any commercial purpose records relative to prescription information containing identifiable patient and prescriber data.4
CHAPTER 30. PROFESSIONS AND OCCUPATIONS.
ARTICLE 5. PHARMACISTS, PHARMACY TECHNICIANS, PHARMACY INTERNS AND PHARMACIES.
§30-5-12c. Prescription information to be kept confidential. Records relative to prescription information containing identifiable patient and prescriber data shall not be transferred or sold by any pharmacy benefit manager, insurance company, electronic transmission intermediary, retail, mail order or Internet pharmacy for any commercial purpose.
In addition to other appropriate remedies under this chapter, a violation of this section is an unfair trade practice within the meaning of article eleven-a, chapter forty-seven of this code. Any right or remedy set forth in article eleven-a, chapter forty-seven may be used to enforce the provisions of this section.
CHAPTER 60A. UNIFORM CONTROLLED SUBSTANCES ACT.
ARTICLE 4. OFFENSES AND PENALTIES.
§60A-4-412. Prohibited acts; prescription information to be held confidential. Pursuant to section twelve-c, article five, chapter thirty of this code, records relative to prescription information containing identifiable patient and prescriber data shall not be transferred or sold by any pharmacy benefit manager, insurance company, electronic transmission intermediary, retail, mail order or Internet pharmacy for any commercial purpose. In addition to other appropriate remedies under this chapter, a violation of this section is an unfair trade practice within the meaning of article eleven-a, chapter forty-seven of this code. Any right or remedy set forth in article eleven-a, chapter forty-seven may be used to enforce the provisions of this section.
NOTE: The purpose of this bill is to ensure the confidentiality of prescription drug information and to prevent the
sale of the information.
New Hampshire
HB 1346
Rep. Rosenwald
(The New Hampshire state Senate unanimously passed legislation May 4 and it has gone to the governor for approval.)
This bill would prohibit prescription information from being transferred or sold for any commercial purpose except for
the limited purpose of reimbursing the pharmacy.4
Records relative to prescription information containing identifiable patient and prescriber data shall not be used transferred, licensed or sold by any pharmacy benefits manager, insurance company, electronic transmission, intermediary retail mail order or Internet pharmacy, or other similar entity for any commercial purpose except for the limited purposes of pharmacy reimbursement care management and utilization review by the patient’s insurance provider or the provider’s agent.
Commercial purpose includes but is not limited to advertising marketing promotion or any other purpose that could be used to influence sales or market share of a pharmaceutical product influence or evaluate the prescribing behavior of an individual healthcare professional except for evaluation by an insurance provider or the provider’s agent for the purpose of compliance with the provider’s formulary or evaluate the effectiveness of a professional detailing sales force.
Has the following scenario ever happened to you?
A pharmaceutical representative comes into your office and asks why you are not prescribing his company’s medication named “Best Moisturizer Ever,” though other dermatologists are. Taken aback, you reply that you do not know that much about the medication named “Best Moisturizer Ever” and do not know anyone prescribing or using it. The representative replies that the dermatologist across the street from you, who trained at the same residency program as you, uses a lot of “Best Moisturizer Ever.” In fact, that dermatologist writes three scripts a day, and his patients seem really happy.
The rep leaves and you go on to see more patients. Then a bit later, you look up and another rep is waiting by the receptionist’s counter. As soon as she sees you she springs toward you. Avoiding pleasantries, she asks you why you write for a medication named “Upstart Brand” 65% of the time and for her medication, “Proven Brand”, only 35% of the time though both medications are chemically similar.
You are surprised because you do not know the ratio for which you write one medication over another and are curious about where she gets her information.
Doctors’ Prescribing Data: Big Business
I’ve had similar scenarios happen to me, and I’ve found them to be quite obtrusive and inappropriate.
Since 1993,2 pharmaceutical companies have had access to all doctors’ prescribing data. According to a New York Times article by Stephanie Saul, “the leading compiler and vendor of prescription data is IMS Health, a publicly traded company based in Fairfield, CT, that had revenue last year of $1.75 billion.1
IMS and its competitors gather the data through contracts with retail pharmacy chains and companies that manage drug plans for insurers, and then sell it to pharmaceutical companies.”
The American Medical Association, makes more than $40 million a year selling physician data to third parties (mostly ultimately used by pharmaceutical companies).2,3 This information allows companies to target doctors who use new medications early and to try to change the minds of doctors who use competing brands.
Some of the numbers surrounding pharmaceutical sales are startling. There are about 100,000 to 115,000 pharmaceutical representatives in the United States. Spending in the United States for prescription drugs was $179.2 billion in 2003 and almost $220 billion in 2005.
Drug manufacturers spent $22 billion on direct marketing to doctors in the United States during 2003.3 Pharm-aceutical companies have paid fines of $3.5 billion since 2001 for wrongful promotions.
No Legal Protection for Physicians’ Activities
Privacy laws protect patients’ data and not physicians’ activities. Several recent articles1,2,3 and pieces of pending state legislation have addressed this issue.
Recently, state legislatures in New Hampshire, Hawaii, West Virginia and Arizona have addressed data tracking issues. Maine lawmakers also considered such legislation but enacted a limited version that focused only patient privacy.
What Else Is Happening?
The state medical association in California, which is opposed to tracking, is beginning its own program. This program will enable doctors who do not opt out under the AMA system to receive comparisons of their prescribing patterns in 17 classes of drugs from the data companies. This pilot program is intended to be extended statewide.1
Perhaps to head off formal regulations and calls by organizations, such as the American College of Physicians, to ban the sale of data, the AMA announced that:
On July 12,3 physicians can begin to restrict access to information about their prescription practices for pharmaceutical company sales representatives. Under this proposed system, doctors listed in an AMA database called Masterfile can signify in a new online registry that pharmaceutical company sales representatives should not have access to such information for 3 years.2,3
Masterfile includes information on about 1 million U.S. medical school graduates and foreign medical school graduates licensed in the United States. This program won’t cover nurse practitioners, physicians assistants or dentists.2,3
The AMA program is not a cure-all. Musacchio and Hunkler2 noted that under the AMA new system: “The Prescribing Data Restriction Program (PDRP) will take data from reps and their direct supervisors, but leave it available to the company for marketing, compensation, and research. The rules allow the industry to retain access to prescribing data for most purposes, but they require companies to police their own sales forces.”
Still Saul1 noted that while “the AMA’s new registry . . . will enable doctors listed in its Masterfile to indicate they do not want their prescribing data shared with pharmaceutical sales representatives, the ‘opt out’ will remain in force for 3 years. But even those doctors’ prescription information will still be collected and transmitted to drug companies . . . .”
Saul1 further noted that “A Gallup Poll commissioned by the American Medical Association in 2004 found that two-thirds of doctors surveyed opposed the release of such data to pharmaceutical representatives but that 77% felt that an opt-out program would alleviate concerns about the release of data.
The survey also found that: Nearly one-quarter of the doctors were not even aware that the pharmaceutical industry had access to such information.”
What Will Change?
If you do not want drug representatives to use your data, you as a dermatologist will have new protections based on laws in some states and self-imposed regulations nationally. Prescription data will still be compiled and analyzed by drug companies.
How these new rules will affect the interaction of dermatologists and detail people remains to be seen.
Details of AMA plan/PDRP Adapted from Musacchio and Hunkler2
• PDRP enrollment will begin on the AMA’s Web site so that the program can take effect on Jul. 1, 2006. Enrolling in the program is sometimes known as “election”.
• Enrollment will remain in effect for 3 years from the date on which the AMA receives the physician’s election.
• Pharmaceutical companies will have ample time (about 90 days from receiving notice that a physician has enrolled) to make the internal system changes needed to suppress data from being released to restricted employees.
• Physicians may revoke the election at any time by notifying the AMA.
• Pharmaceutical employees having direct contact with physicians will be blocked from accessing restricted data on PDRP physicians. The block-outs apply to part-time and temporary sales employees and contractors, as well as full-time sales reps and first-line sales managers.
• Restricted data are defined as any product-level data regarding the prescribing practices of an identifiable physician who has made the PRDP election. This includes measures of prescription volume in absolute and percentage terms, the associated dollar value of a physician’s prescribing, any indicators of change in these measures, as well as any means of ranking, benchmarking, or grouping physicians that may reveal prescribing habits for a particular product. Furthermore, sales representatives must not “reverse engineer” or re-identify any prescribing information of a PDRP physician.
• The restrictions do not apply to:
a. deciles at the market or therapeutic class level
b. segmented data that are not likely to reveal the actual or estimated
activity of an individual physician
c. data on products ordered by physicians from pharmaceutical companies.
• A physician’s participation in the PDRP has no bearing whatsoever on the AMA’s “No Contact List,” which has been in place for more than 20 years to prevent
listed physicians' names from being licensed for marketing purposes.
• Compliance will be gauged by physician complaints to the AMA.
• Isolated and minor infractions will likely result in an investigation, followed by a warning. Those manufacturers who show a disregard for the program’s requirements by maintaining a pattern of abuse may lose access to AMA data, and, if infractions continue, may subsequently lose access to health information organization data.
• The information available to the “home office” will not change, regardless of physician enrollment in PDRP. This program will not affect headquarter business systems. As long as the industry complies with PDRP, the program will
not restrict access to information used in efficient marketing and compensation practices. n
To sign up for the AMA’s Prescribing Data Restriction Program, doctors can link to the Prescribing Data Information Center’s Web site
(www.ama-assn.org/go/prescribingdata ).
To ensure security, doctors must to use their members-only username and password. Non-members must sign up for an AMA Internet ID. For assistance with the online opt-out process, contact the center by phone (800-621-8335) or e-mail (pdrp@ama-assn.org).
STATUS OF STATES’ LEGISLATION ON LIMITING THE USE OF PHYSICIANS’ PRESCRIBING DATA
Arizona
HB 2800
Rep. Cahill.
(Filed and referred to committee 2/6/06)
This legislation would require a licensed pharmacist or pharmacy to keep confidential prescription information containing identifiable patient and prescriber data and would prohibit the release or sale of this information for any commercial purpose. Any such release or sale of confidential prescription information would constitute unprofessional conduct.4
Section 1. Title 32, chapter 18, article 3, Arizona Revised Statutes, is amended by adding section 32-1973, to read:32-1973. Prescription information; sale; prohibition; unprofessional conduct
A. A pharmacist or pharmacy licensed pursuant to this chapter must keep confidential prescription information containing identifiable patient and prescriber data and may not release or sell this information for any commercial purpose.
B. A pharmacist or pharmacy that releases or sells confidential prescription information commits an act of
unprofessional conduct.
Hawaii
HB 1873
Rep. Takumi
(Filed and referred to committee 1/19/06; passed House, 3/7/06)
This legislation would prohibit prescription records containing identifiable patient and prescriber data from
being sold for commercial purposes.4
SECTION 1. Chapter 329, Hawaii Revised Statutes, is amended by adding a new section to be appropriately
designated and to read as follows:
§329- Prescription information; confidentiality; penalty. Records relative to prescription information containing identifiable patient and prescriber data shall not be transferred or sold by any pharmacy benefits manager, insurance company, electronic transmission intermediary, retail, mail order or Internet pharmacy for any commercial purpose. In addition to other appropriate remedies under this chapter, a violation of this section is an unfair or deceptive act or practice within the meaning of section 480-2. Any right or remedy set forth in section 480-13 may be used to enforce the provisions of this section.”
SECTION 2. Section 461-13, Hawaii Revised Statutes, is amended to read as follows:
§461-13 Prescription records; confidentiality. (a) Records relative to prescription information containing identifiable patient and prescriber data shall not be transferred or sold by any pharmacy benefits manager, insurance company, electronic transmission intermediary, retail, mail order or Internet pharmacy for any commercial purpose. In addition to other appropriate remedies under this chapter, a violation of this section is an unfair or deceptive act or practice within the meaning of section 480-2. Any right or remedy set forth in section 480-13 may be used to enforce the provisions of this subsection.
(b) A pharmacy shall keep prescription records of each prescription compounded or dispensed at the pharmacy for a period of not less than 5 years. The prescription records shall at all times be open to inspection by the board of pharmacy and other law enforcement officers.”
SECTION 3. Statutory material to be repealed is bracketed and stricken. New statutory material is underscored.
SECTION 4. This Act shall take effect upon its approval.
West Virginia
HB 4676
Rep. Perdue
(Filed and referred to committee 2/21/06)
Would prohibit any pharmacy benefit manager, insurance company, electronic transmission intermediary, retail, mail order or Internet pharmacy from transferring or selling for any commercial purpose records relative to prescription information containing identifiable patient and prescriber data.4
CHAPTER 30. PROFESSIONS AND OCCUPATIONS.
ARTICLE 5. PHARMACISTS, PHARMACY TECHNICIANS, PHARMACY INTERNS AND PHARMACIES.
§30-5-12c. Prescription information to be kept confidential. Records relative to prescription information containing identifiable patient and prescriber data shall not be transferred or sold by any pharmacy benefit manager, insurance company, electronic transmission intermediary, retail, mail order or Internet pharmacy for any commercial purpose.
In addition to other appropriate remedies under this chapter, a violation of this section is an unfair trade practice within the meaning of article eleven-a, chapter forty-seven of this code. Any right or remedy set forth in article eleven-a, chapter forty-seven may be used to enforce the provisions of this section.
CHAPTER 60A. UNIFORM CONTROLLED SUBSTANCES ACT.
ARTICLE 4. OFFENSES AND PENALTIES.
§60A-4-412. Prohibited acts; prescription information to be held confidential. Pursuant to section twelve-c, article five, chapter thirty of this code, records relative to prescription information containing identifiable patient and prescriber data shall not be transferred or sold by any pharmacy benefit manager, insurance company, electronic transmission intermediary, retail, mail order or Internet pharmacy for any commercial purpose. In addition to other appropriate remedies under this chapter, a violation of this section is an unfair trade practice within the meaning of article eleven-a, chapter forty-seven of this code. Any right or remedy set forth in article eleven-a, chapter forty-seven may be used to enforce the provisions of this section.
NOTE: The purpose of this bill is to ensure the confidentiality of prescription drug information and to prevent the
sale of the information.
New Hampshire
HB 1346
Rep. Rosenwald
(The New Hampshire state Senate unanimously passed legislation May 4 and it has gone to the governor for approval.)
This bill would prohibit prescription information from being transferred or sold for any commercial purpose except for
the limited purpose of reimbursing the pharmacy.4
Records relative to prescription information containing identifiable patient and prescriber data shall not be used transferred, licensed or sold by any pharmacy benefits manager, insurance company, electronic transmission, intermediary retail mail order or Internet pharmacy, or other similar entity for any commercial purpose except for the limited purposes of pharmacy reimbursement care management and utilization review by the patient’s insurance provider or the provider’s agent.
Commercial purpose includes but is not limited to advertising marketing promotion or any other purpose that could be used to influence sales or market share of a pharmaceutical product influence or evaluate the prescribing behavior of an individual healthcare professional except for evaluation by an insurance provider or the provider’s agent for the purpose of compliance with the provider’s formulary or evaluate the effectiveness of a professional detailing sales force.
