- Email: [email protected]
PMA's Concerns About Therapeutic Substitutions
COUNTERPOINT
rn t ub tit ti n Because important differences exist among drugs in the same therapeutic class, it is unwise to dispense another chemical for the medicine prescribed. by Robert F. Allnutt harmacists, with their expert knowledge, can answer many P questions about drugs and help patients better understand their medicines. It is, nevertheless, unwise - and indeed unlawful in virtually every state - to dispense another chemical unilaterally instead of the medicine prescribed by a physician in an outpatient setting. Despite the pharmacist's expertise, the physician understands the patient's diagnosis and medical history - which is important when considering the many serious questions raised regarding the safety and efficacy of therapeutic interchange or substitution. Some hold the mistaken beliefthat many drugs within a given therapeutic category are similar enough to be used interchangeably (i.e., have the same therapeutic effect). Unfortunately, this erroneous idea has been used to justify sharply restrictive drug formularies in some state Medicaid programs. Sen. David Pryor (D-Ark.) is using the concept of "therapeutic equivalence" as a key support for legislation that is intended to lower the cost of the Medicaid drug benefit. Leading physicians and pharmacists know better, however. Important differences exist among drugs in the same therapeutic class. Different pharmaceuticals in the same pharmacologic and therapeutic class frequently differ substantially in many ways: • Effectiveness • Required dosage
• The rate and extent to which medicines are absorbed and distributed in the body • Pathways of the body taken by a therapy's action mechanism • Side effects. As a result, when one medicine is interchanged with another, serious therapeutic consequences may occur. For example, generally, beta blockers are a safe and effective therapeutic class for the treatment of many cardiovascular conditions, as well as some noncardiac disorders, including migraine headaches and glaucoma. But the wrong beta blocker in the wrong patient can fail to be effective
Restrictive formularies can cause ad ional phYSician visits and more hospitalization. and may cause serious problems. Beta blockers have distinct differences and individual advantages (see table, p. 42). Nonsteroidal anti-inflammatory drugs (NSAIDs) are another therapeutic class with important clinical differences among individual drugs. Patients often have quite different responses to different NSAIDs. Some 'Cost-containment advocates, nevertheless, continue to insist that only a few of the 15 NSAIDs available in . the United States for arthritis are actually needed because all the
American Pharmacy, Vol. NS30, No. 10 October 1990/599
therapies have the same effect on all arthritis sufferers. However, many patients with arthritis could not disagree more strongly.
Increased Medical Costs I am particularly concerned about the ramifications of the therapeutic equivalence fallacy perpetuated in 19 states that have sharply restrictive drug formularies for Medicaid programs. In those states, government bureaucrats decide which drugs are to be kept from Medicaid patients. The Pharmaceutical Manufacturers Association (PMA) recently commissioned an economic analysis of Medicaid programs in 47 states. The authors, Louisiana State University economists William J. Moore, PhD, and Robert J. Newman, PhD, found that restricted formularies, by removing the method of preferred treatment, tend to increase rather than decrease the level of total Medicaid expenditures. We find no evidence to support the hypothesis that restricted formularies reduce drug expenditures. In fact, our evidence directly contradicts (in a statistical way) claims that restrictive formularies reduce Medicaid expenditures.
Overall, Moore and Newman found that states with sharply restricted formularies probably had total Medicaid expenditures between 4% and 15% higher than states without restrictive formularies. Counterpoint (continued on p. 42)
39
Point (continued from p. 38)
Part of the reason for the prescription manufacturers' pricing strategy is to offset the negative impact that generic substitution of off-patent medications has had on drug companies' revenues. For instance, in 1987 the total number of prescription orders processed in this country was unchanged from 1986, but sales for brand-name drugs dropped by 6% to 7% (as measured by number of prescription orders).9 Two cost-effective pharmacist interventions are possible to help control drug prices: generic drug product selection and therapeutic interchange (Figure 2). Although the first intervention is gaining wide acceptance, the second is virtually never used.
Generic Substitution Approximately 50% of the prescription orders written in the outpatient setting are for multisource products that are eligible for generic drug product selection. Cost savings yielded through this intervention are reported to be as much as 50%, when comparing the generic drug price with the brand-name drug price. For example, the 1985 New Jersey Medicaid program attributed savings of $7 million, or 46% of the costs of single-source products, to generic drug product selection. In 1986 the New Jersey Pharmaceutical Assistance to the Aged and Disabled (PAAD) program saved $6.7 million, or 53%.10,11
Therapeutic Interchange There are two types of therapeutic interchange: therapeutic alternates and pharmaceutical alternates (Figure 2). Selecting therapeutic alternates (sometimes called therapeutic substitution) is the process of changing the drug that the physician orders to a different drug from within the same therapeutic class, i.e., one diuretic for another. Therapeutic substitution can work only if substantive interaction occurs between the physician and pharmacist. Within the hospital setting, formulary-based therapeutic substitution has been practiced for many years, with no indication that the practice has contributed to a lack of 40
..
-------
Prescription Interventions
"'-
Generic Substitution
Therapeutic Interchange
(Multisource drug entitles)
(Sing le-source drug entitles)
/
Pharmaceutical Alternates (e.g. , different dosage forms)
Therapeutic Alternates (e.g., different drug, same class)
Figure 2. Interventions to Control Prescription Drug Prices quality. In the community setting, the pharmacist has little incentive to attempt therapeutic substitution, and the lack of an organizational structure facilitating physicianpharmacist communication hampers its implementation. At present, the process is disruptive, requires immediate access to the physician, and requires "diplomatic assertiveness" (the pharmacist may be perceived to be questioning the physician's drug choice).
Implementing interchange of pharmaceutical alternates is no more than asking the question: Is this 'prescribed medication available in a less costly dosage form? However, the second type of therapeutic interchange - pharmaceutical alternates - is, or could be, an option for pharmacists to embrace in the community setting. Implementing interchange of pharmaceutical alternates is no more than asking the question: Is this prescribed medication available, as the same drug, in a less costly dosage form? The appropriateness of this question emerges from the economic impact of what has been termed the "evergreening" trend. Typically, when the patent nears expiration for an original short-acting version of a drug, some manufacturers will
introduce a "new" single-source entity - the same drug in a different dosage form such as a patch or long acting tablet, thus extending its life (i.e., evergreening). The "new" dosage form then will be marketed to the prescribers, in lieu of the traditional dosage form. When addressing this issue, Sen. David Pryor (D-Ark.) remarked that some drug companies spend "almost half of their research and development budget on the 'me-too' drugs. We don't want to pay new drug prices for old, repackaged drug therapies."12 An analysis of New Jersey Medicaid data for 1987 demonstrated potential savings of up to 53% if the pharmaceutical alternate were dispensed in some drug classes (see table). The time has come for policymakers and practicing pharmacists to address this issue.
Barriers to Alternates Offering the patient a choice once daily or thrice daily, patch or earring - brings forth issues such as marketing strategies and compliance. Arguments for using the newer dosage forms focus on ease of administration and enhanced compliance - rarely on increased effectiveness. Ignored are issues of equivalence between the sustained release form and the original dosage form (an issue analogous to the bioequi valence argument so often used by some to discourage generic interchange). Also neglected are psychological motivators for adherence to a regimen, e.g., the Health Belief Model - does the patient ''buy into"
American Pharmacy, Vol. NS30, No. 10 October 1990/600
Selected Brand-Name vs. a Pharmaceutical Alternate Using 1987 New Jersey Medicaid Prescription Data
Po:~htial
Expended $* Darvocet N J.OO ".,'.'_, w') Calan SR 240 Hydergine Caps Indocln SR 75 Inderal LA 80 Vibra-Tab 100 Isoptin SR 240 Keftab 250 Norpace CR 150
Totals
$315 ,~Q4
.lternate1Drug
Equivalent
'~Ir oxpq~,! !llCI/~lfAP
Savings Differential $16~J38
186,1!32
Verapa'rtlill 80 (~3*)
1
1
50,521
149,855 133,397 89,597 80,398 64,001 24,503 16,654
Ergoloicj 1 mg Indomethacin 2'5 (x3*) Propranolol 40 (x2*) Doxycycline 100 Capg Verapamil 80 (x3*) Cephalex in 250 Caps Disopyramid e 150
4~~ ,5 1 6
33,709 17,919 ' 6,842 46,629 13,494 6,741
9~l.903 99';696 71,678 73,555 17,37 1 11,008 9,913
$468,859
$644,328
$1,1 13,187
* Excludes any pharmacists' fees.
Source: N.J . Department of Health. 1988 Redbook, Medical Economics Company, Ordell , N.J. Reported as average wholesale price of brand-name drug or Goldline generic drug .
the therapy?13 For the patient who believes that a regimen is important to follow, is it the number of doses per day or the number of drugs per day that predicts potential noncompliance? For the patient who does not buy into the therapy, does either the number of doses per day or the number of different medications make any difference? What effect does pharmacists' counseling have on ensuring compliance, regardless of dosages? Clearly, every patient need not use the newer dosage forms (patches, long-acting tablets, etc.) to facilitate compliance.
Uninformed Consent We know that generic drug product selection works. Despite the recent generic drug scandals, the Food and Drug Administration has ensured generic drug safety, and patients have the opportunity to select their drug preference on the basis of cost and other personal and medical criteria. Interchange ofpharmaceutical alternatives could work also. Yet, because of the way policymakers have structured pharmacy laws and practice regulations, the informed patient is not permitted to behave as a key decision maker in the drug selection process. This leads to at least two problems.
First, there is the issue of informed consent and the patient's ethical right to autonomy. Prescription drugs are no longer a mystery of life - there are a finite number of drug classes and a limited array of drugs under each class. Dosage form options are even less of a mystery. Patients ought to be informed and active participants in the predispensing decision process. Patients should have a right to participate in the selection of drug entity and dosage form. Under the present system, patients are rarely informed or offered choices, thus, they have little opportunity to consent or dissent. Second, patients ought to be part of the prescription drug selection process because, in whole or in part, they are paying the bill. As long as cost-sharing exists in the prescription arena, interest in price will exist. (The repealed Medicare Catastrophic Coverage Act was designed to ensure end-user price sensitivity by mandating a percentage of total prescription price insurance, rather than a fixeddollar copayment.) As many practitioners can attest, patients without price sensitivity (those with a fixed copayment) have little incentive or interest in generic substitution and, presumably, would have little in- . terest in pharmaceutical alternates. However, even in these instances of
American Pharmacy, Vol. NS30, No. 10 October 1990/601
patient-price insensitivity, the patient's chosen payer (e.g., third party) ought to be able to exercise vicarious judgment.
Pharmacy Care The community pharmacist has a unique opportunity to discuss medication options with the patient - one on one - before preparing the prescription product for dispensing. In the generic drug product selection realm, some patients choose the brand name, others the generic. In the pharmaceutical alternate realm, some patients will opt for the newer, more convenient dosage form, others will choose the less expensive traditional dosage form. Whether it is the quantity of medication purchased at anyone time or the dosage of the drug, the fundamental question we must consider is: whose choice is it? Should it be left to the research and development division of a pharmaceutical manufacturer, to pharmaceutical marketers, to the policymakers, to the prescriber, to the pharmacist, or to the patient? Our vote is for the informed patient - and the pharmacist ought to be the informer! Acknowledgment: The authors acknow ledge the assistance of Sanford Lugar, chief pharmacy consultant, New Jersey Department of Health, in providing the New Jersey Medicaid and PAAD database. Calvin H. Knowlton, MDiv, is associate fellow, Center on Drugs & Public Policy, University of Maryland at Baltimore. David A. Knapp, PhD, is director of the center.
References 1. Letsch SW, Levit KR, Waldo DR. National health expenditures, 1987. Health Care Financing Review. Winter 1988;10:109-21. 2. Lipton HL. Drug economics and the elderly: prescriptions for change. Business Health. March 1988; 5(5):8. 3. Pharmacy newswire. NARD J. May 1988;110(5):12. 4. Pharmacy newswire. NARD J. April 1988; 110(4):10 5. Lilly Digest. 1983-88. Eli Lilly and Company, Pharmaceutical Division, Indianapolis, IN.
41
6. Pryor D. Prescription Drug Prices: Are We Getting Our Money's Worth? US Senate Special Committee on Aging Hearing, Opening statement, July 18,1989, Washington, DC. 7. Pollard M. Executive Director, American Pharmaceutical Institute. Letter to David Schulke, Senate Special Committee on Aging, Feb. 29, 1988. 8. Waxman HA. The politics of the
Counterpoint (continued from p. 39)
Restrictive formularies can cause additional physician visits and more hospitalization because the state sometimes pays only for suboptimal therapy. More visits to the hospital may also be necessary because the hospital often becomes the only place a Medicaid patient can obtain the safest, most effective medicines for particular circumstances. The PMA has a long-term goal of removing unwise restrictions from Medicaid formularies in states such as California and hopes to prevent
new drug economics. Business Health. March 1988;5(5):21. 9. Shah H. Financial view: brand name/generic consolidation - each enters the other's territory. Nomura Securities Analyst, speech at conference, Pharmaceutic Update, 1988, Food and Drug Law Institute. May 24,1988, Washington, DC. 10. Culkin T. Executive Director, Drug Utilization Review Council, N.J. Dept. of Health. Personal Communication, Feb. 26, 1988.
11. Culkin T, Mendell S. Generic substitution in New Jersey, 1979-87. Am Plwrm. 1989;NS29:109-14. 12. Pryor D. Skyrocketing Prescription Drug Prices: Turning a Bad Deal into a Fair Deal. US Senate Special Committee on Aging Hearing, opening statement, Nov. 16, 1989, Washington, DC. 13. Becker MH, ed. Health BeliefModel and Personal Health Belwvior. Thorofare, NJ: Charles B Slack Inc; 1974.
similar restrictions from becoming federal law. The PMA welcomes the assistance of pharmacists in the fight against misguided restrictive formulary programs, which clearly deprive patients of appropriate medicines while costing taxpayers money.
cist and the doctor. Pharmacists are experts who can answer many important questions about drugs. They should routinely provide patients with a better understanding of their medicines. The PMA believes that most pharmacists do not support the flawed therapeutic equivalence concept, and will continue to oppose therapeutic substitution.
Appropriate Medical Collaboration There is a time-honored tradition in outpatient settings involving collaboration between the pharma-
Robert F. Allnutt is executive vice-president, Plwrmaceutical Manufacturers Association, Washington, D.C.
Selected Advantages of the Marketed Oral Beta Blockers Advantage
Acebutolol Alternolol Labetalol Metoprolol Nadolol Pindolol Propranolol Timolol
x
Preserves renal blood flow Once-a-day dosing
x
x2
x
x
selectivity
Vasod ilation 1=
x
x
x x
x
Equal effectiveness in blacks and whites
Very low eNS penetration
x1
X
x
No change in serum lipid levels
Intrinsic sympathomimetic activity
x
x
Reduces mortality after heart attacks
B1
x
x x
x x
x x
x x
for controlled-release preparation only for hypertension
2 = once-a-day
Source: Frishman WHo Clinical differences between beta-adrenerg ic blocking agents . Implications for therapeutic substitution . Am Heart J. 1987 ;113(5) :1190-8.
42
American Pharmacy, Vol. NS30, No. 10 October 1990/602
rn t ub tit ti n Because important differences exist among drugs in the same therapeutic class, it is unwise to dispense another chemical for the medicine prescribed. by Robert F. Allnutt harmacists, with their expert knowledge, can answer many P questions about drugs and help patients better understand their medicines. It is, nevertheless, unwise - and indeed unlawful in virtually every state - to dispense another chemical unilaterally instead of the medicine prescribed by a physician in an outpatient setting. Despite the pharmacist's expertise, the physician understands the patient's diagnosis and medical history - which is important when considering the many serious questions raised regarding the safety and efficacy of therapeutic interchange or substitution. Some hold the mistaken beliefthat many drugs within a given therapeutic category are similar enough to be used interchangeably (i.e., have the same therapeutic effect). Unfortunately, this erroneous idea has been used to justify sharply restrictive drug formularies in some state Medicaid programs. Sen. David Pryor (D-Ark.) is using the concept of "therapeutic equivalence" as a key support for legislation that is intended to lower the cost of the Medicaid drug benefit. Leading physicians and pharmacists know better, however. Important differences exist among drugs in the same therapeutic class. Different pharmaceuticals in the same pharmacologic and therapeutic class frequently differ substantially in many ways: • Effectiveness • Required dosage
• The rate and extent to which medicines are absorbed and distributed in the body • Pathways of the body taken by a therapy's action mechanism • Side effects. As a result, when one medicine is interchanged with another, serious therapeutic consequences may occur. For example, generally, beta blockers are a safe and effective therapeutic class for the treatment of many cardiovascular conditions, as well as some noncardiac disorders, including migraine headaches and glaucoma. But the wrong beta blocker in the wrong patient can fail to be effective
Restrictive formularies can cause ad ional phYSician visits and more hospitalization. and may cause serious problems. Beta blockers have distinct differences and individual advantages (see table, p. 42). Nonsteroidal anti-inflammatory drugs (NSAIDs) are another therapeutic class with important clinical differences among individual drugs. Patients often have quite different responses to different NSAIDs. Some 'Cost-containment advocates, nevertheless, continue to insist that only a few of the 15 NSAIDs available in . the United States for arthritis are actually needed because all the
American Pharmacy, Vol. NS30, No. 10 October 1990/599
therapies have the same effect on all arthritis sufferers. However, many patients with arthritis could not disagree more strongly.
Increased Medical Costs I am particularly concerned about the ramifications of the therapeutic equivalence fallacy perpetuated in 19 states that have sharply restrictive drug formularies for Medicaid programs. In those states, government bureaucrats decide which drugs are to be kept from Medicaid patients. The Pharmaceutical Manufacturers Association (PMA) recently commissioned an economic analysis of Medicaid programs in 47 states. The authors, Louisiana State University economists William J. Moore, PhD, and Robert J. Newman, PhD, found that restricted formularies, by removing the method of preferred treatment, tend to increase rather than decrease the level of total Medicaid expenditures. We find no evidence to support the hypothesis that restricted formularies reduce drug expenditures. In fact, our evidence directly contradicts (in a statistical way) claims that restrictive formularies reduce Medicaid expenditures.
Overall, Moore and Newman found that states with sharply restricted formularies probably had total Medicaid expenditures between 4% and 15% higher than states without restrictive formularies. Counterpoint (continued on p. 42)
39
Point (continued from p. 38)
Part of the reason for the prescription manufacturers' pricing strategy is to offset the negative impact that generic substitution of off-patent medications has had on drug companies' revenues. For instance, in 1987 the total number of prescription orders processed in this country was unchanged from 1986, but sales for brand-name drugs dropped by 6% to 7% (as measured by number of prescription orders).9 Two cost-effective pharmacist interventions are possible to help control drug prices: generic drug product selection and therapeutic interchange (Figure 2). Although the first intervention is gaining wide acceptance, the second is virtually never used.
Generic Substitution Approximately 50% of the prescription orders written in the outpatient setting are for multisource products that are eligible for generic drug product selection. Cost savings yielded through this intervention are reported to be as much as 50%, when comparing the generic drug price with the brand-name drug price. For example, the 1985 New Jersey Medicaid program attributed savings of $7 million, or 46% of the costs of single-source products, to generic drug product selection. In 1986 the New Jersey Pharmaceutical Assistance to the Aged and Disabled (PAAD) program saved $6.7 million, or 53%.10,11
Therapeutic Interchange There are two types of therapeutic interchange: therapeutic alternates and pharmaceutical alternates (Figure 2). Selecting therapeutic alternates (sometimes called therapeutic substitution) is the process of changing the drug that the physician orders to a different drug from within the same therapeutic class, i.e., one diuretic for another. Therapeutic substitution can work only if substantive interaction occurs between the physician and pharmacist. Within the hospital setting, formulary-based therapeutic substitution has been practiced for many years, with no indication that the practice has contributed to a lack of 40
..
-------
Prescription Interventions
"'-
Generic Substitution
Therapeutic Interchange
(Multisource drug entitles)
(Sing le-source drug entitles)
/
Pharmaceutical Alternates (e.g. , different dosage forms)
Therapeutic Alternates (e.g., different drug, same class)
Figure 2. Interventions to Control Prescription Drug Prices quality. In the community setting, the pharmacist has little incentive to attempt therapeutic substitution, and the lack of an organizational structure facilitating physicianpharmacist communication hampers its implementation. At present, the process is disruptive, requires immediate access to the physician, and requires "diplomatic assertiveness" (the pharmacist may be perceived to be questioning the physician's drug choice).
Implementing interchange of pharmaceutical alternates is no more than asking the question: Is this 'prescribed medication available in a less costly dosage form? However, the second type of therapeutic interchange - pharmaceutical alternates - is, or could be, an option for pharmacists to embrace in the community setting. Implementing interchange of pharmaceutical alternates is no more than asking the question: Is this prescribed medication available, as the same drug, in a less costly dosage form? The appropriateness of this question emerges from the economic impact of what has been termed the "evergreening" trend. Typically, when the patent nears expiration for an original short-acting version of a drug, some manufacturers will
introduce a "new" single-source entity - the same drug in a different dosage form such as a patch or long acting tablet, thus extending its life (i.e., evergreening). The "new" dosage form then will be marketed to the prescribers, in lieu of the traditional dosage form. When addressing this issue, Sen. David Pryor (D-Ark.) remarked that some drug companies spend "almost half of their research and development budget on the 'me-too' drugs. We don't want to pay new drug prices for old, repackaged drug therapies."12 An analysis of New Jersey Medicaid data for 1987 demonstrated potential savings of up to 53% if the pharmaceutical alternate were dispensed in some drug classes (see table). The time has come for policymakers and practicing pharmacists to address this issue.
Barriers to Alternates Offering the patient a choice once daily or thrice daily, patch or earring - brings forth issues such as marketing strategies and compliance. Arguments for using the newer dosage forms focus on ease of administration and enhanced compliance - rarely on increased effectiveness. Ignored are issues of equivalence between the sustained release form and the original dosage form (an issue analogous to the bioequi valence argument so often used by some to discourage generic interchange). Also neglected are psychological motivators for adherence to a regimen, e.g., the Health Belief Model - does the patient ''buy into"
American Pharmacy, Vol. NS30, No. 10 October 1990/600
Selected Brand-Name vs. a Pharmaceutical Alternate Using 1987 New Jersey Medicaid Prescription Data
Po:~htial
Expended $* Darvocet N J.OO ".,'.'_, w') Calan SR 240 Hydergine Caps Indocln SR 75 Inderal LA 80 Vibra-Tab 100 Isoptin SR 240 Keftab 250 Norpace CR 150
Totals
$315 ,~Q4
.lternate1Drug
Equivalent
'~Ir oxpq~,! !llCI/~lfAP
Savings Differential $16~J38
186,1!32
Verapa'rtlill 80 (~3*)
1
1
50,521
149,855 133,397 89,597 80,398 64,001 24,503 16,654
Ergoloicj 1 mg Indomethacin 2'5 (x3*) Propranolol 40 (x2*) Doxycycline 100 Capg Verapamil 80 (x3*) Cephalex in 250 Caps Disopyramid e 150
4~~ ,5 1 6
33,709 17,919 ' 6,842 46,629 13,494 6,741
9~l.903 99';696 71,678 73,555 17,37 1 11,008 9,913
$468,859
$644,328
$1,1 13,187
* Excludes any pharmacists' fees.
Source: N.J . Department of Health. 1988 Redbook, Medical Economics Company, Ordell , N.J. Reported as average wholesale price of brand-name drug or Goldline generic drug .
the therapy?13 For the patient who believes that a regimen is important to follow, is it the number of doses per day or the number of drugs per day that predicts potential noncompliance? For the patient who does not buy into the therapy, does either the number of doses per day or the number of different medications make any difference? What effect does pharmacists' counseling have on ensuring compliance, regardless of dosages? Clearly, every patient need not use the newer dosage forms (patches, long-acting tablets, etc.) to facilitate compliance.
Uninformed Consent We know that generic drug product selection works. Despite the recent generic drug scandals, the Food and Drug Administration has ensured generic drug safety, and patients have the opportunity to select their drug preference on the basis of cost and other personal and medical criteria. Interchange ofpharmaceutical alternatives could work also. Yet, because of the way policymakers have structured pharmacy laws and practice regulations, the informed patient is not permitted to behave as a key decision maker in the drug selection process. This leads to at least two problems.
First, there is the issue of informed consent and the patient's ethical right to autonomy. Prescription drugs are no longer a mystery of life - there are a finite number of drug classes and a limited array of drugs under each class. Dosage form options are even less of a mystery. Patients ought to be informed and active participants in the predispensing decision process. Patients should have a right to participate in the selection of drug entity and dosage form. Under the present system, patients are rarely informed or offered choices, thus, they have little opportunity to consent or dissent. Second, patients ought to be part of the prescription drug selection process because, in whole or in part, they are paying the bill. As long as cost-sharing exists in the prescription arena, interest in price will exist. (The repealed Medicare Catastrophic Coverage Act was designed to ensure end-user price sensitivity by mandating a percentage of total prescription price insurance, rather than a fixeddollar copayment.) As many practitioners can attest, patients without price sensitivity (those with a fixed copayment) have little incentive or interest in generic substitution and, presumably, would have little in- . terest in pharmaceutical alternates. However, even in these instances of
American Pharmacy, Vol. NS30, No. 10 October 1990/601
patient-price insensitivity, the patient's chosen payer (e.g., third party) ought to be able to exercise vicarious judgment.
Pharmacy Care The community pharmacist has a unique opportunity to discuss medication options with the patient - one on one - before preparing the prescription product for dispensing. In the generic drug product selection realm, some patients choose the brand name, others the generic. In the pharmaceutical alternate realm, some patients will opt for the newer, more convenient dosage form, others will choose the less expensive traditional dosage form. Whether it is the quantity of medication purchased at anyone time or the dosage of the drug, the fundamental question we must consider is: whose choice is it? Should it be left to the research and development division of a pharmaceutical manufacturer, to pharmaceutical marketers, to the policymakers, to the prescriber, to the pharmacist, or to the patient? Our vote is for the informed patient - and the pharmacist ought to be the informer! Acknowledgment: The authors acknow ledge the assistance of Sanford Lugar, chief pharmacy consultant, New Jersey Department of Health, in providing the New Jersey Medicaid and PAAD database. Calvin H. Knowlton, MDiv, is associate fellow, Center on Drugs & Public Policy, University of Maryland at Baltimore. David A. Knapp, PhD, is director of the center.
References 1. Letsch SW, Levit KR, Waldo DR. National health expenditures, 1987. Health Care Financing Review. Winter 1988;10:109-21. 2. Lipton HL. Drug economics and the elderly: prescriptions for change. Business Health. March 1988; 5(5):8. 3. Pharmacy newswire. NARD J. May 1988;110(5):12. 4. Pharmacy newswire. NARD J. April 1988; 110(4):10 5. Lilly Digest. 1983-88. Eli Lilly and Company, Pharmaceutical Division, Indianapolis, IN.
41
6. Pryor D. Prescription Drug Prices: Are We Getting Our Money's Worth? US Senate Special Committee on Aging Hearing, Opening statement, July 18,1989, Washington, DC. 7. Pollard M. Executive Director, American Pharmaceutical Institute. Letter to David Schulke, Senate Special Committee on Aging, Feb. 29, 1988. 8. Waxman HA. The politics of the
Counterpoint (continued from p. 39)
Restrictive formularies can cause additional physician visits and more hospitalization because the state sometimes pays only for suboptimal therapy. More visits to the hospital may also be necessary because the hospital often becomes the only place a Medicaid patient can obtain the safest, most effective medicines for particular circumstances. The PMA has a long-term goal of removing unwise restrictions from Medicaid formularies in states such as California and hopes to prevent
new drug economics. Business Health. March 1988;5(5):21. 9. Shah H. Financial view: brand name/generic consolidation - each enters the other's territory. Nomura Securities Analyst, speech at conference, Pharmaceutic Update, 1988, Food and Drug Law Institute. May 24,1988, Washington, DC. 10. Culkin T. Executive Director, Drug Utilization Review Council, N.J. Dept. of Health. Personal Communication, Feb. 26, 1988.
11. Culkin T, Mendell S. Generic substitution in New Jersey, 1979-87. Am Plwrm. 1989;NS29:109-14. 12. Pryor D. Skyrocketing Prescription Drug Prices: Turning a Bad Deal into a Fair Deal. US Senate Special Committee on Aging Hearing, opening statement, Nov. 16, 1989, Washington, DC. 13. Becker MH, ed. Health BeliefModel and Personal Health Belwvior. Thorofare, NJ: Charles B Slack Inc; 1974.
similar restrictions from becoming federal law. The PMA welcomes the assistance of pharmacists in the fight against misguided restrictive formulary programs, which clearly deprive patients of appropriate medicines while costing taxpayers money.
cist and the doctor. Pharmacists are experts who can answer many important questions about drugs. They should routinely provide patients with a better understanding of their medicines. The PMA believes that most pharmacists do not support the flawed therapeutic equivalence concept, and will continue to oppose therapeutic substitution.
Appropriate Medical Collaboration There is a time-honored tradition in outpatient settings involving collaboration between the pharma-
Robert F. Allnutt is executive vice-president, Plwrmaceutical Manufacturers Association, Washington, D.C.
Selected Advantages of the Marketed Oral Beta Blockers Advantage
Acebutolol Alternolol Labetalol Metoprolol Nadolol Pindolol Propranolol Timolol
x
Preserves renal blood flow Once-a-day dosing
x
x2
x
x
selectivity
Vasod ilation 1=
x
x
x x
x
Equal effectiveness in blacks and whites
Very low eNS penetration
x1
X
x
No change in serum lipid levels
Intrinsic sympathomimetic activity
x
x
Reduces mortality after heart attacks
B1
x
x x
x x
x x
x x
for controlled-release preparation only for hypertension
2 = once-a-day
Source: Frishman WHo Clinical differences between beta-adrenerg ic blocking agents . Implications for therapeutic substitution . Am Heart J. 1987 ;113(5) :1190-8.
42
American Pharmacy, Vol. NS30, No. 10 October 1990/602