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Legislation & Regulation
Hydrogels: A Flexible Delivery System Purdue University researchers have developed a new hydrogel-based drugdelivery system that can take its cues from the body, releasing drugs only in certain locations or only when the body needs them. Based on a special group of hydrogels, called ionic networks, the new system could help the body use and absorb drugs more effectively and alleviate side effects, such as the stomach irritation that can occur when certain drugs are released in an acidic environment. Chemical engineering professor Nikolaos Peppas and his research team developed new polymers capable of responding to physiological changes in the body, such as temperature, pH levels of surrounding tissues, or salt concentrations in the blood. The development was reported during a recent meeting of the American Chemical Society. Hydrogels developed from these polymers respond to their environment by changing their density: swelling to release their contents, or contracting to allow little or none of their contents to escape, said Peppas. One new hydrogel, for example, will expand only in areas where the pH level is neutral or slightly alkaline, such as the small intestines.
Vol. NS33, No. 10
October 1993
Such a hydrogel could be used to coat medications that cause stomach irritation. Peppas reported great success with laboratory tests using solutions designed to mimic the body's fluids. "[The success rate] was almost 100%. That is to say, the systems responded to the change of pH without any problem. They responded very quickly, contracting or expanding within a minute," he said. Peppas described the new system as superior to the conventional gelatin capsules and enteric coatings that operate by delay mechanisms. "The problem with these methods is that there is no flexibility," he said. "Capsules can easily pass through the small intestines before a sufficient amount of medication is absorbed." One of the new hydrogels is activated by increased salt concentrations in the blood and, thus, could be used to deliver medications for high blood pressure. For diabetics, insulin could be released when needed after a meal by hydrogels sensitive to acid. With continued funding from the National Institutes of Health, the Purdue team expects to conduct animal trials beginning in late 1993 and continuing through early 1994. The researchers then hope to collaborate with a pharmaceutical company to develop the system for use in human drug delivery.
LEGISLATION & REGULATION Separate DEA Registrations for Midleve. Practitioners A new Drug Enforcement Administration (DEA) rule has established a separate registration category for midlevel practitioners (MLPs) who can prescribe drugs. The rule, which went into effect July 1, 1993, includes health care providers such as nurse practitioners and physician assistants. In some states, it may also apply to pharmacists. DEA numbers issued to MLPs will begin with the letter M rather than the letters A or B, which appear in the registration numbers held by traditional practitioners. When pharmacists see an M registration, they should know that the practitioner's authority to dispense drugs is subject to specific state restrictions, and pharmacists are responsible for contacting the appropriate state officials, such as the state board of pharmacy, to verify what authority the state has granted the practitioner. In states where pharmacists have some sort of dependent prescriptive authority, the DEA rule could apply to them as well. These states include California, Florida, Indiana, Mississippi, Missouri, New Mexico, North Dakota, Oregon, South Dakota, and Washington. The American Pharmaceutical Association (APhA)
has sent letters to DEA and the boards of pharmacy in those states asking whether or not pharmacists are considered MLPs and whether they are required to register withDEA. APhA and other organizations have objected to the possibility of DEA' s issuing registrations to nurse practitioners and other MLPs who do not have the education, training, or experience necessary to allow them to dispense controlled substances properly. APhA also has questioned the variation in the authority granted to MLPs by the different states and the lack of assurance that consistent standards exist regarding education, training, and experience. Responding to APhA concerns, DEA plans to work with the appropriate state authorities, the National Association of Boards of Pharmacy, and the professions to encourage consistency and clarity in the standards for education and training of MLPs, and the scope of their authority to prescribe controlled substances.
New FDA Guideline for Women in Drug Studies The Food and Drug Administration (FDA) has proposed a new guideline AMERICAN PHARMACY
PHARMACY NEWS
Lt:(; I S L \ T I () N & RE(a L \ T I () N
Continued from previous page
encouraging researchers to include more women in clinical drug studies and to report on significant differences in the way men and women respond to medications. The FDA guideline also changes a 1977 policy banning women of childbearing age from participating in the early trials of most drugs. According to the FDA announcement in the July 22 Federal Register, companies conducting drug studies should look for significant gender differences in response to medications. These include the effects of
drugs on women during phases of the menstrual cycle, during menopause, and when taking oral contraceptives or estrogens. FDA will review all new drug applications to ensure that they include appropriate analyses by sex. Without these analyses, FDA said it may not proceed with its review. The new policy encourages the collection of better information about the effects of drugs in women and provides women with greater opportunities to participate in drug development and research, said an article in The New England Journal of Medicine on the new guideline.
STATE NEWS
Anti-Mail Order Kit for California Pharmacists The California Pharmacists Association (CPhA) has designed an "anti-mail order kit" pharmacists can use to educate their patients to the possible dangers of buying medications through a mail order pharmacy. "It seems counterproductive that the very laws instituted to ensure public safety are waived for mail order drug suppliers," said CPhA Chief Executive Officer Bob Marshall. The whole point of the requirements of the AMERICAN PHARMACY
Omnibus Budget Reconciliation Act of 1990 (OBRA '90) and the regulation by the 1992 California Board of Pharmacy directing pharmacists to provide oral consultation to patients for every new or changed prescription "is to ensure that the public receives proper, professional, face-to-face consultation from a licensed pharmacist. Given that point, mail order ftrms could pose a serious threat to the very health of their users," Marshall said. The kit was developed in response to a growing concern about mail order com-
panies. Many of the companies are located outside California and are exempt from state laws, Marshall said. The flfffis can undercut prices of drugs sold in local pharmacies partly because they do not incur costs related to counseling. Sometimes community pharmacists take on a surrogate counseling role, answering questions from patients who receive their medications through the mail, he said. Not only is this inappropriate because they are not the drug dispensers, but it also creates a situation fraught with legal liability, Marshall added. Some of these concerns would be addressed if a bill pending in the state legislature is passed. This bill requires mail order flfffis doing business in California to counsel patients just as local pharmacists are required to do. As part of its grass-roots educational campaign, CPhA has sent out more than 200 anti-mail order kits, free to CPhA members and for $45 to non-association members, according to Sue Navest, CPhA vice president of marketing and public affairs. The kits include informational brochures about what patients should know about mail order companies; a window poster ("Don't Let Your Postman Be Your Pharmacist! "); lapel buttons for pharmacists to wear on the job; a newspaper advertisement; and sample letters for patients and pharmacists to send to employers, employee beneftts managers, and legislators about the prob-
lems of mail order. "We want to let people know there are options [other than] mail order, and other things should be considered besides the cost of the drug," Navest said. "There's a discrepancy in care and everyone should be aware of it.
Pharmacists in S.C. Fill Free Prescriptions for the Needy South Carolina pharmacists are participating in a new state initiative to help provide health care to needy residents. The initiative, Commtm-I-Care, is a coalition of pharmacists, doctors, and state agencies that serve South Carolina residents who cannot afford health insurance, are not covered by a government insurance program such as Medicare or Medicaid, and are referred by a local Department of Social Services. Under the program, Commun-I-Care refers patients who call a statewide toll-free telephone line to one of 600 voltmteer physicians. Prescriptions written by Commun-I-Care physicians are filled at no cost by volunteer pharmacists. Pftzer Pharmaceuticals, Johnson and Johnson, and their subsidiaries provide their complete lines of pharmaceuticals free of charge. Supported by the South Carolina Pharmacists Association (SCPhA), Commun-ICare has enlisted 60-70% of the state's independent October 1993
Vol. NS33, No. 10
Vol. NS33, No. 10
October 1993
Such a hydrogel could be used to coat medications that cause stomach irritation. Peppas reported great success with laboratory tests using solutions designed to mimic the body's fluids. "[The success rate] was almost 100%. That is to say, the systems responded to the change of pH without any problem. They responded very quickly, contracting or expanding within a minute," he said. Peppas described the new system as superior to the conventional gelatin capsules and enteric coatings that operate by delay mechanisms. "The problem with these methods is that there is no flexibility," he said. "Capsules can easily pass through the small intestines before a sufficient amount of medication is absorbed." One of the new hydrogels is activated by increased salt concentrations in the blood and, thus, could be used to deliver medications for high blood pressure. For diabetics, insulin could be released when needed after a meal by hydrogels sensitive to acid. With continued funding from the National Institutes of Health, the Purdue team expects to conduct animal trials beginning in late 1993 and continuing through early 1994. The researchers then hope to collaborate with a pharmaceutical company to develop the system for use in human drug delivery.
LEGISLATION & REGULATION Separate DEA Registrations for Midleve. Practitioners A new Drug Enforcement Administration (DEA) rule has established a separate registration category for midlevel practitioners (MLPs) who can prescribe drugs. The rule, which went into effect July 1, 1993, includes health care providers such as nurse practitioners and physician assistants. In some states, it may also apply to pharmacists. DEA numbers issued to MLPs will begin with the letter M rather than the letters A or B, which appear in the registration numbers held by traditional practitioners. When pharmacists see an M registration, they should know that the practitioner's authority to dispense drugs is subject to specific state restrictions, and pharmacists are responsible for contacting the appropriate state officials, such as the state board of pharmacy, to verify what authority the state has granted the practitioner. In states where pharmacists have some sort of dependent prescriptive authority, the DEA rule could apply to them as well. These states include California, Florida, Indiana, Mississippi, Missouri, New Mexico, North Dakota, Oregon, South Dakota, and Washington. The American Pharmaceutical Association (APhA)
has sent letters to DEA and the boards of pharmacy in those states asking whether or not pharmacists are considered MLPs and whether they are required to register withDEA. APhA and other organizations have objected to the possibility of DEA' s issuing registrations to nurse practitioners and other MLPs who do not have the education, training, or experience necessary to allow them to dispense controlled substances properly. APhA also has questioned the variation in the authority granted to MLPs by the different states and the lack of assurance that consistent standards exist regarding education, training, and experience. Responding to APhA concerns, DEA plans to work with the appropriate state authorities, the National Association of Boards of Pharmacy, and the professions to encourage consistency and clarity in the standards for education and training of MLPs, and the scope of their authority to prescribe controlled substances.
New FDA Guideline for Women in Drug Studies The Food and Drug Administration (FDA) has proposed a new guideline AMERICAN PHARMACY
PHARMACY NEWS
Lt:(; I S L \ T I () N & RE(a L \ T I () N
Continued from previous page
encouraging researchers to include more women in clinical drug studies and to report on significant differences in the way men and women respond to medications. The FDA guideline also changes a 1977 policy banning women of childbearing age from participating in the early trials of most drugs. According to the FDA announcement in the July 22 Federal Register, companies conducting drug studies should look for significant gender differences in response to medications. These include the effects of
drugs on women during phases of the menstrual cycle, during menopause, and when taking oral contraceptives or estrogens. FDA will review all new drug applications to ensure that they include appropriate analyses by sex. Without these analyses, FDA said it may not proceed with its review. The new policy encourages the collection of better information about the effects of drugs in women and provides women with greater opportunities to participate in drug development and research, said an article in The New England Journal of Medicine on the new guideline.
STATE NEWS
Anti-Mail Order Kit for California Pharmacists The California Pharmacists Association (CPhA) has designed an "anti-mail order kit" pharmacists can use to educate their patients to the possible dangers of buying medications through a mail order pharmacy. "It seems counterproductive that the very laws instituted to ensure public safety are waived for mail order drug suppliers," said CPhA Chief Executive Officer Bob Marshall. The whole point of the requirements of the AMERICAN PHARMACY
Omnibus Budget Reconciliation Act of 1990 (OBRA '90) and the regulation by the 1992 California Board of Pharmacy directing pharmacists to provide oral consultation to patients for every new or changed prescription "is to ensure that the public receives proper, professional, face-to-face consultation from a licensed pharmacist. Given that point, mail order ftrms could pose a serious threat to the very health of their users," Marshall said. The kit was developed in response to a growing concern about mail order com-
panies. Many of the companies are located outside California and are exempt from state laws, Marshall said. The flfffis can undercut prices of drugs sold in local pharmacies partly because they do not incur costs related to counseling. Sometimes community pharmacists take on a surrogate counseling role, answering questions from patients who receive their medications through the mail, he said. Not only is this inappropriate because they are not the drug dispensers, but it also creates a situation fraught with legal liability, Marshall added. Some of these concerns would be addressed if a bill pending in the state legislature is passed. This bill requires mail order flfffis doing business in California to counsel patients just as local pharmacists are required to do. As part of its grass-roots educational campaign, CPhA has sent out more than 200 anti-mail order kits, free to CPhA members and for $45 to non-association members, according to Sue Navest, CPhA vice president of marketing and public affairs. The kits include informational brochures about what patients should know about mail order companies; a window poster ("Don't Let Your Postman Be Your Pharmacist! "); lapel buttons for pharmacists to wear on the job; a newspaper advertisement; and sample letters for patients and pharmacists to send to employers, employee beneftts managers, and legislators about the prob-
lems of mail order. "We want to let people know there are options [other than] mail order, and other things should be considered besides the cost of the drug," Navest said. "There's a discrepancy in care and everyone should be aware of it.
Pharmacists in S.C. Fill Free Prescriptions for the Needy South Carolina pharmacists are participating in a new state initiative to help provide health care to needy residents. The initiative, Commtm-I-Care, is a coalition of pharmacists, doctors, and state agencies that serve South Carolina residents who cannot afford health insurance, are not covered by a government insurance program such as Medicare or Medicaid, and are referred by a local Department of Social Services. Under the program, Commun-I-Care refers patients who call a statewide toll-free telephone line to one of 600 voltmteer physicians. Prescriptions written by Commun-I-Care physicians are filled at no cost by volunteer pharmacists. Pftzer Pharmaceuticals, Johnson and Johnson, and their subsidiaries provide their complete lines of pharmaceuticals free of charge. Supported by the South Carolina Pharmacists Association (SCPhA), Commun-ICare has enlisted 60-70% of the state's independent October 1993
Vol. NS33, No. 10