- Email: [email protected]
Legislation & Regulation
to get more questions about homeopathy from their patients. "More people are asking, 'What is this stuff? Does it work, and can it help me? '" Borneman says. Jerry Danoff, owner of the Medicine Chest phannacy in Mclean, Va., sells homeopathic remedies because his
patients want them. The affluent neighborhood he serves includes a large percentage of Europeans who work at embassies and international organizations in Washington, D.C. "Homeopathy is much bigger in their COlmtries than it is here, " Danoff says. "I don't
A Sampling of NIH-Funded Studies of Alternative Treatments Modality
Institution
Acupuncture to treat unipolar depression
University of Arizona
Massage therapy for HIV infection
Morse Physical Health Research Center
Electrochemical current to shrink tumors
City of Hope National Medical Center
Hypnosis for chronic pain
Virginia Polytechnic Institute
Massage therapy and postsurgical outcomes
University of Virginia
Music therapy's effects on brain injury
Pennsylvania State University College of Medicine
Hypnosis for healing bone fractures
McLean Hospital
Homeopathy's effects on health
University of California
Dance movement to treat cystic fi brosis
Hahnemann University
Guided imagery for asthma
Lenox Hill Hospital
Macrobiotics and cancer
University of Minnesota
Biofeedback and diabetes
Medical College of Ohio
Massage effects on the development of HIVexposed babies
University of Miami
Yoga and obsessivecompulsive disorder
Khalsa Foundation for Medical Science
Acupuncture and attention-deficit! hyperactivity disorder
Virginia Commonwealth University
HIV = human immunodeficiency syndrome; NIH Institutes of Health.
Vol. NS34, No.8
August 1994
= National
have a lot of knowledge about it, but my customers tell me it works." He sometimes recommends homeopathic products-such as cold remedies-to patients with high blood pressure or another underlying condition that makes him reluctant to recommend decongestants or standard over-the-counter (OTC) treatments. Martha Oelman of the National Center for Homeopathy, a membership organization that promotes the study of homeopathy, says that sales to pharmacies seem to be growing, although statistics are "hard to come by. " Carmen Fuentes of Humphreys Pharmacal, a homeopathic manufacturer established in 1840, says sales are increasing because homeopathic products are "not expensive and you can buy them over the counter."
Homeopathic remedies are regulated by the Food and Drug Administration (FDA) and must follow the same approval process used for any OTC drug. Another nontraditional medical treatment increasingly attracting attention in the United States is acupuncture. FDA recently met with acupuncturists and representatives from the National Institutes of Health to examine data about the safety and efficacy of acupuncture. According to Sharon Snider, an FDA representative, the agency classifies acupuncture needles as "investigational" devices but is considering reclassifying them as "generally regarded as safe and effective. " Whether the switch will occur, and when, is anybody's guess, Snyder says. "We're still looking at the data. "
LEGISLATION & REGULATION Schedule II Faxes AllolNed by DEA Rule The Drug Enforcement Administration (DEA) has issued a rule that allows prescription orders for Schedule II controlled substances to be transmitted from a prescriber to a dispensing pharmacy by facsimile. This rule will facilitate delivery of these prescription orders in situations where medication needs change quickly and prescribers' orders must be communicated rapidly.
The rule specifies that faxed prescription orders must contain all information required on written prescription orders, except the prescriber's signature. It "requires that the original written prescription be presented and verified against the facsimile when the prescription is dispensed, and that the original document be properly annotated and retained for filing." The rule gives the pharmacist additional responsibilities to ensure the authenticity of a facsimile and prevent AMERICAN PHARMACY
PHARMACY NEWS
forgery. The phannacist must check that each faxed prescription order has been issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. To prevent diversion of controlled substances through forgeries , DEA suggests that each phannacy maintain a fIle of practitioners' fax numbers, verify the originating fax number when a prescription order is received, and phone the practitioner's office to double-check that the prescription order was both written and transmitted from there. DEA specifIed two exceptions to this rule: • In cases of intravenous pain therapy or of home or hospice infusion, the original prescription order need not be sent to the phannacy either before or after the medication is delivered to a patient's home. The home infusion phannacy must retain the faxed prescription order as the original document. This exception only applies to prescription orders for patients who require frequent dosage modifIcations of parenteral, controlled-release narcotic substances; it does not apply to dispensing of oral dosage units of controlled substances. • A faxed prescription order for a Schedule II medication that is written for a patient in a long-tenn-care facility is considered the original written prescription order and must contain all required infonnation. The AMERICAN PHARMACY
dispensing phannacy must retain the facsimile copy as the original document.
Pryor Bill Would Pay Pharmacists for Services Sen. David Pryor CD-Ark.), along with Sen. Jim Sasser CD-Tenn.), introduced a Senate bill (S.2239) on June 24 that contains several signifIcant provisions for phannacists. The Phannaceutical Marketplace Refonn Act of 1994 would require phannacists to provide dnlg use review CDUR) and other services under Part B of the Medicare program and under state Medicaid plans. The Secretary of Health and Human Services would be required to establish a method to pay phannacists for these services. The legislation, which seeks to implement safe and cost-effective outpatient drug benefIts, "recognizes the expanded role that pharmacists should have in any refonned health care system, " Pryor said. "Phannacists are the most underused health professionals in our nation .... This bill would provide that all health care planS-including Medicare-make patient counseling and other phannacy services an integral part of the benefIts that they offer," he said. Pryor has long supported an expanded role for phannacists as health care providers. "Pryor's bill is particularly important because it may be
the basis for any amendments Pryor offers to the Senate Finance Committee as it debates its version of a health care refonn bill, " said William M. Hennelin, director of government affairs at the American Phannaceutical Association (APhA). Pryor serves on the Finance Committee, the key congressional committee addressing health care refonn, and is chairman of the Senate Aging Committee. In addition to paving the way for reimbursement for phannaceutical care services, Pryor's bill also includes an "equal access to discounts" provision that would ensure that all pharmacies can purchase drugs on equal tenns. Under Pryor's bill, the Secretary of Health and Human Services would be required to establish, within 180 days of the bill's enactment, a system for paying phannacists a "drug use review allowance" for prospective dnlg review and phannaceutical care activities. SpecifIcally, compensation would cover phannacists' services for the following activities: • Prospective DUR that includes reviewing drug therapy before dispensing medication, as well as patient counseling. (The bill uses language adopted in the Omnibus Budget Reconciliation Act of 1990 [OBRA '90]). • Retrospective DUR, as defmed by OBRA '90. • Case management of drug therapy for patients
II
with high risk of medicationrelated problems. • Therapeutic interchange. • Management of incentive programs for patient compliance. • Other services consistent with standards of phannaceutical care. The Pryor bill also calls for amending the Medicaid prescription dnlg program by requiring that all state Medicaid plans include: (1) either a phannacy and therapeutics committee or DUR board, (2) a therapeutic formulary, (3) a phannaceutical care services program covering the same activities described above for Medicare, and (4) a payment system for phannacists who provide these services. The provision requiring equal access to prescription drug prices, Pryor said, "will put all purchasers of prescription medications on an equal footing." Under this provision, manufacturers of single-source and innovator multiple-source drugs would be required to "offer such phannaceuticals for sale to every purchaser on equal tenns and conditions, including any rebates, free merchandise, discounts, and similar adjustments." Such special conditions and adjustments "may only be offered if the manufacturer experiences savings as a result of efficiencies in purchasing, such as volume buying (including programs to increase volume buying through influencing physician prescribing practices or by making an agreement to August
1994 Vol. NS34, No.8
place drugs on a formulary), prompt delivery, single-site delivery, and prompt payment." Other bill provisions would encourage use of generic drugs in the Medicaid and Medicare programs
and would establish a ninemember Pharmaceutical Marketplace Price Information Commission that would provide information to prescription medication purchasers but would not regulate or control drug prices.
STATE NEWS
Discriminatory Pricing Bills in Ohio and Pa. Bills in the Ohio and Pennsylvania legislatures would require pharmaceutical manufacturers to offer their customers equal access to drug prices. In Ohio, a health care reform bill would prohibit manufacturers from offering discounts not based on volume purchases. The state's House of Representatives passed the measure in March. The state senate held hearings in May and is expected to vote on the bill before year-end. The Ohio bill requires a manufacturer or distributor to extend to all buyers the same rights and privileges given to those most favored, including the same purchase price for similar volume purchases. Nothing, however, would prohibit a company from giving a discount "that is based on economies or efficiencies realized by a manufacturer as a result of volume sales," the bill says. In Pennsylvania, similar legislation has been introduced in the legislature. A draft of the state senate bill, Vol. NS34, No.8
August 1994
companion to a bill introduced in the state House on April 11 , has been under study this spring. The senate version would require both manufacturers and wholesalers to extend the same rights and privileges equally to all buyers and customers. The House bill refers only to sales by manufacturers to wholesalers and purchasers. The Pennsylvania senate bill would also allow manufacturers and wholesalers to change their prices with 30 days' notice. The provision would allow drug suppliers maximum flexibility in their pricing policies, while ensuring that sales made within a certain time period would be regulated by the bill's pricing provisions. Currently, more than 20 states have passed antidiscriminatory pricing laws.
Texas Association Sues Insurance Company The Texas Pharmaceutical Association (TPA) flIed suit in district court in Austin against Prudential Insurance
Company of America, charging that the company violated the "willing provider" law passed by the Texas legislature in 1991. TPA claimed in a press release that "the insurance company has steadfastly refused to permit community pharmacies to participate in its insurance programs, effectively locking them out and denying them the ability to continue to provide service to their patients. " TPA also charged that the Texas Department of Insurance has refused to enforce the law, even after acknowledging that the violations were occurring. The law requires that insurance companies allow any pharmacy that meets the terms and conditions of a closed network to participate in its prescription drug plans. The association seeks judgment against Prudential for having knowingly violated the state statute. Texas pharmacists in community, independent, chain, and institutional settings have been adversely affected by actions of both the Department of Insurance and Prudential, TPA said.
patient whose case was reviewed by the Iowa Medicaid Commission, which administers the program. The commission "continues to believe in the importance of drug utilization review as an informational and educational component of health care for providers with the state that provide care for recipients in the Medicaid program, " according to an article in the June 1994 issue of Iowa Pharmacist. The increase in the number of participating providers (from 35.1 % of state providers in 1991 to 45.1% in 1992) has contributed to the program's success, the article noted. Iowa's Medicaid program has also grown since 1991, with 8.5% more filled prescriptions and 6.1% more Medicaid beneflciaries. In its review of the DUR program, the commission reviewed more than 6,400 medication regimens in 1992. The commission funds several DUR research projects and is developing an educational outreach program, with pharmacy organizations and other groups, to help providers enhance quality of care for their Medicaid patients.
IOllVa Medicaid DUR Saves Money During flscal year 1992, the drug use review (DUR) program in Iowa saved the state $2,254,703 in drug costs. This represents an average yearly savings of $582 for each Medicaid AMERICANPHARMACY
patients want them. The affluent neighborhood he serves includes a large percentage of Europeans who work at embassies and international organizations in Washington, D.C. "Homeopathy is much bigger in their COlmtries than it is here, " Danoff says. "I don't
A Sampling of NIH-Funded Studies of Alternative Treatments Modality
Institution
Acupuncture to treat unipolar depression
University of Arizona
Massage therapy for HIV infection
Morse Physical Health Research Center
Electrochemical current to shrink tumors
City of Hope National Medical Center
Hypnosis for chronic pain
Virginia Polytechnic Institute
Massage therapy and postsurgical outcomes
University of Virginia
Music therapy's effects on brain injury
Pennsylvania State University College of Medicine
Hypnosis for healing bone fractures
McLean Hospital
Homeopathy's effects on health
University of California
Dance movement to treat cystic fi brosis
Hahnemann University
Guided imagery for asthma
Lenox Hill Hospital
Macrobiotics and cancer
University of Minnesota
Biofeedback and diabetes
Medical College of Ohio
Massage effects on the development of HIVexposed babies
University of Miami
Yoga and obsessivecompulsive disorder
Khalsa Foundation for Medical Science
Acupuncture and attention-deficit! hyperactivity disorder
Virginia Commonwealth University
HIV = human immunodeficiency syndrome; NIH Institutes of Health.
Vol. NS34, No.8
August 1994
= National
have a lot of knowledge about it, but my customers tell me it works." He sometimes recommends homeopathic products-such as cold remedies-to patients with high blood pressure or another underlying condition that makes him reluctant to recommend decongestants or standard over-the-counter (OTC) treatments. Martha Oelman of the National Center for Homeopathy, a membership organization that promotes the study of homeopathy, says that sales to pharmacies seem to be growing, although statistics are "hard to come by. " Carmen Fuentes of Humphreys Pharmacal, a homeopathic manufacturer established in 1840, says sales are increasing because homeopathic products are "not expensive and you can buy them over the counter."
Homeopathic remedies are regulated by the Food and Drug Administration (FDA) and must follow the same approval process used for any OTC drug. Another nontraditional medical treatment increasingly attracting attention in the United States is acupuncture. FDA recently met with acupuncturists and representatives from the National Institutes of Health to examine data about the safety and efficacy of acupuncture. According to Sharon Snider, an FDA representative, the agency classifies acupuncture needles as "investigational" devices but is considering reclassifying them as "generally regarded as safe and effective. " Whether the switch will occur, and when, is anybody's guess, Snyder says. "We're still looking at the data. "
LEGISLATION & REGULATION Schedule II Faxes AllolNed by DEA Rule The Drug Enforcement Administration (DEA) has issued a rule that allows prescription orders for Schedule II controlled substances to be transmitted from a prescriber to a dispensing pharmacy by facsimile. This rule will facilitate delivery of these prescription orders in situations where medication needs change quickly and prescribers' orders must be communicated rapidly.
The rule specifies that faxed prescription orders must contain all information required on written prescription orders, except the prescriber's signature. It "requires that the original written prescription be presented and verified against the facsimile when the prescription is dispensed, and that the original document be properly annotated and retained for filing." The rule gives the pharmacist additional responsibilities to ensure the authenticity of a facsimile and prevent AMERICAN PHARMACY
PHARMACY NEWS
forgery. The phannacist must check that each faxed prescription order has been issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. To prevent diversion of controlled substances through forgeries , DEA suggests that each phannacy maintain a fIle of practitioners' fax numbers, verify the originating fax number when a prescription order is received, and phone the practitioner's office to double-check that the prescription order was both written and transmitted from there. DEA specifIed two exceptions to this rule: • In cases of intravenous pain therapy or of home or hospice infusion, the original prescription order need not be sent to the phannacy either before or after the medication is delivered to a patient's home. The home infusion phannacy must retain the faxed prescription order as the original document. This exception only applies to prescription orders for patients who require frequent dosage modifIcations of parenteral, controlled-release narcotic substances; it does not apply to dispensing of oral dosage units of controlled substances. • A faxed prescription order for a Schedule II medication that is written for a patient in a long-tenn-care facility is considered the original written prescription order and must contain all required infonnation. The AMERICAN PHARMACY
dispensing phannacy must retain the facsimile copy as the original document.
Pryor Bill Would Pay Pharmacists for Services Sen. David Pryor CD-Ark.), along with Sen. Jim Sasser CD-Tenn.), introduced a Senate bill (S.2239) on June 24 that contains several signifIcant provisions for phannacists. The Phannaceutical Marketplace Refonn Act of 1994 would require phannacists to provide dnlg use review CDUR) and other services under Part B of the Medicare program and under state Medicaid plans. The Secretary of Health and Human Services would be required to establish a method to pay phannacists for these services. The legislation, which seeks to implement safe and cost-effective outpatient drug benefIts, "recognizes the expanded role that pharmacists should have in any refonned health care system, " Pryor said. "Phannacists are the most underused health professionals in our nation .... This bill would provide that all health care planS-including Medicare-make patient counseling and other phannacy services an integral part of the benefIts that they offer," he said. Pryor has long supported an expanded role for phannacists as health care providers. "Pryor's bill is particularly important because it may be
the basis for any amendments Pryor offers to the Senate Finance Committee as it debates its version of a health care refonn bill, " said William M. Hennelin, director of government affairs at the American Phannaceutical Association (APhA). Pryor serves on the Finance Committee, the key congressional committee addressing health care refonn, and is chairman of the Senate Aging Committee. In addition to paving the way for reimbursement for phannaceutical care services, Pryor's bill also includes an "equal access to discounts" provision that would ensure that all pharmacies can purchase drugs on equal tenns. Under Pryor's bill, the Secretary of Health and Human Services would be required to establish, within 180 days of the bill's enactment, a system for paying phannacists a "drug use review allowance" for prospective dnlg review and phannaceutical care activities. SpecifIcally, compensation would cover phannacists' services for the following activities: • Prospective DUR that includes reviewing drug therapy before dispensing medication, as well as patient counseling. (The bill uses language adopted in the Omnibus Budget Reconciliation Act of 1990 [OBRA '90]). • Retrospective DUR, as defmed by OBRA '90. • Case management of drug therapy for patients
II
with high risk of medicationrelated problems. • Therapeutic interchange. • Management of incentive programs for patient compliance. • Other services consistent with standards of phannaceutical care. The Pryor bill also calls for amending the Medicaid prescription dnlg program by requiring that all state Medicaid plans include: (1) either a phannacy and therapeutics committee or DUR board, (2) a therapeutic formulary, (3) a phannaceutical care services program covering the same activities described above for Medicare, and (4) a payment system for phannacists who provide these services. The provision requiring equal access to prescription drug prices, Pryor said, "will put all purchasers of prescription medications on an equal footing." Under this provision, manufacturers of single-source and innovator multiple-source drugs would be required to "offer such phannaceuticals for sale to every purchaser on equal tenns and conditions, including any rebates, free merchandise, discounts, and similar adjustments." Such special conditions and adjustments "may only be offered if the manufacturer experiences savings as a result of efficiencies in purchasing, such as volume buying (including programs to increase volume buying through influencing physician prescribing practices or by making an agreement to August
1994 Vol. NS34, No.8
place drugs on a formulary), prompt delivery, single-site delivery, and prompt payment." Other bill provisions would encourage use of generic drugs in the Medicaid and Medicare programs
and would establish a ninemember Pharmaceutical Marketplace Price Information Commission that would provide information to prescription medication purchasers but would not regulate or control drug prices.
STATE NEWS
Discriminatory Pricing Bills in Ohio and Pa. Bills in the Ohio and Pennsylvania legislatures would require pharmaceutical manufacturers to offer their customers equal access to drug prices. In Ohio, a health care reform bill would prohibit manufacturers from offering discounts not based on volume purchases. The state's House of Representatives passed the measure in March. The state senate held hearings in May and is expected to vote on the bill before year-end. The Ohio bill requires a manufacturer or distributor to extend to all buyers the same rights and privileges given to those most favored, including the same purchase price for similar volume purchases. Nothing, however, would prohibit a company from giving a discount "that is based on economies or efficiencies realized by a manufacturer as a result of volume sales," the bill says. In Pennsylvania, similar legislation has been introduced in the legislature. A draft of the state senate bill, Vol. NS34, No.8
August 1994
companion to a bill introduced in the state House on April 11 , has been under study this spring. The senate version would require both manufacturers and wholesalers to extend the same rights and privileges equally to all buyers and customers. The House bill refers only to sales by manufacturers to wholesalers and purchasers. The Pennsylvania senate bill would also allow manufacturers and wholesalers to change their prices with 30 days' notice. The provision would allow drug suppliers maximum flexibility in their pricing policies, while ensuring that sales made within a certain time period would be regulated by the bill's pricing provisions. Currently, more than 20 states have passed antidiscriminatory pricing laws.
Texas Association Sues Insurance Company The Texas Pharmaceutical Association (TPA) flIed suit in district court in Austin against Prudential Insurance
Company of America, charging that the company violated the "willing provider" law passed by the Texas legislature in 1991. TPA claimed in a press release that "the insurance company has steadfastly refused to permit community pharmacies to participate in its insurance programs, effectively locking them out and denying them the ability to continue to provide service to their patients. " TPA also charged that the Texas Department of Insurance has refused to enforce the law, even after acknowledging that the violations were occurring. The law requires that insurance companies allow any pharmacy that meets the terms and conditions of a closed network to participate in its prescription drug plans. The association seeks judgment against Prudential for having knowingly violated the state statute. Texas pharmacists in community, independent, chain, and institutional settings have been adversely affected by actions of both the Department of Insurance and Prudential, TPA said.
patient whose case was reviewed by the Iowa Medicaid Commission, which administers the program. The commission "continues to believe in the importance of drug utilization review as an informational and educational component of health care for providers with the state that provide care for recipients in the Medicaid program, " according to an article in the June 1994 issue of Iowa Pharmacist. The increase in the number of participating providers (from 35.1 % of state providers in 1991 to 45.1% in 1992) has contributed to the program's success, the article noted. Iowa's Medicaid program has also grown since 1991, with 8.5% more filled prescriptions and 6.1% more Medicaid beneflciaries. In its review of the DUR program, the commission reviewed more than 6,400 medication regimens in 1992. The commission funds several DUR research projects and is developing an educational outreach program, with pharmacy organizations and other groups, to help providers enhance quality of care for their Medicaid patients.
IOllVa Medicaid DUR Saves Money During flscal year 1992, the drug use review (DUR) program in Iowa saved the state $2,254,703 in drug costs. This represents an average yearly savings of $582 for each Medicaid AMERICANPHARMACY