- Email: [email protected]
Pharmacy Update
NY Formulary Endorsed by FDA The Food and Drug Administration has endorsed a formulary of equivalent prescription drugs devised by New York state officials in order to cut prescription drug costs without sacrificing quality. The endorsement is the first of its kind from FDA. Announcing the endorsement at a press conference in Washington, DC, January 24, 1978, FDA Commissioner Donald Kennedy said, "As far as FDA is concerned, the drugs listed in the New York formulary meet our requirements for therapeutic equivalence." As of April I, 1978, New York state law will allow physicians to tell pharmacists to fill their prescription orders with a generic product, provided the generic is listed in the state formulary, which was compiled with FDA assistance. All prescription forms used in New York after April 1 will be required by law to carry two signature lines for the physician, who will indicate that substitution is permissible or that the order must be dispensed as written. "FDA concurrence in the New York list reflects the agency's view that there is no consistent difference between drug products sold by large and small firms or between drugs sold under a brand name or 'generic' name," said Kennedy. "We have a single standard for drugs in this country." FDA spokesman Wayne Pines added that" ... New York asked us to check their list for accuracy, and we did. That's it. FDA has no role in matters involving state government." Pines said that the endorsement was not a recommendation to states considering adoption of a form ulary, and tha t FDA would not distribute or reproduce the list of some 2,000 drugs. A spokesman for the Pharmaceutical Manufacturers Association said that FDA's endorsement does not change that organization's position 10
statement on the New York formulary: "That list is merely a compilation of approved new drug applications and abbreviated NDAs, and neither NDAs nor ANDAs are proof that one drug is bioequivalent to another ... FDA hasn't tested for bioequivalence, they've only said that they haven't found evidence of inequivalence. We say, 'If you don't look, you won't find.'"
Liquid Protein Diet Contraindicated With Some Prescriptions Lost in the confusion and furor over the dangers of liquid protein diets has been the fact that patients taking certain prescription medications should forget liquid protein as their last chance at getting thin. The Food and Drug Administration says low-calorie protein regimens such as Dr. Robert Linn's "last chance diet" (from the book by the same name) should not be used by anyone taking any of the following: diuretics; antihypertensive drugs; oral hypoglycemic agents and insulin; and adrenergic medications. Also warned about the liquid protein diet are pa tien ts taking: high doses of corticosteroids; thyroid preparations other than those used in replacement therapy; and lithium therapy. "Use of very low-calorie protein diets by such patients is extremely hazardous," says the FDA, adding that patients taking digitalis must maintain adequate potassium intakes if they go on the liquid protein diet. FDA has proposed a mandatory warning label for all protein products intended for dieters. The warning says that such products should not be used without medical supervision. While FDA says infants, children, pregnant and nursing women should not go on such a diet, the proposed label does not include warnings directed at those taking specific medications. In the wake of some 40 deaths reportedly associated with
very low-calorie protein diets, FDA is looking at ways to ban the products used in such regimens.
FDA Expands Pill Warning The Food and Drug Administration has announced the revision and expansion of patient information requirements for birth control pills. Effective April 3, 1978, both patient and physician labeling of oral contraceptives will be required to contain the warning that women who take the pill should not smoke. Patient packages and brochures distributed by pharmacists at the point of sale will be marked with a box label containing the warning. The brochures, which have been required since 1971, will also contain an expanded list of possible side effects caused by the estrogens and progestogens that are the active components in most birth control pills. In announcing the new program, FDA Commissioner Donald Kennedy said that FDA is completing studies on various categories of drugs that may be required to carry patient package information. According to Kennedy, the studies will be completed by the summer of 1978, when FDA will consider further steps. Said Kennedy: "We want more patients to have more information about their own therapy," adding that he sees no legal reasons why the April 3 start of the program would be .delayed. In his prepared remarks, Kennedy said that birth control piUs have a synergistic effect with smoking, each multiplying the dangers of the other. Asked what he would recommend to his wife or daughter if she were considering birth control pills as a means of contraception, Kennedy replied, "I'm speaking not as a physician, and not as the FDA commissioner, but I would tell someone I love to find another method of birth control." American Pharmacy Vol. NS18, No.3, Mar.1978/114
(Kennedy, who holds a PhD, is the first nonphysician to head FDA since 1965.)
Political Action Group Formed Organizers of a new pharmacy political action group see their organization as an extension on the national level of state political action committees. The National Pharmacy Political Action Committee (PharmPAC) has been organized to support political candidates who are open to the concerns of pharmacists. "You don't buy anything or anybody," said PharmPAC chairman James Powers, who is also secretary of the Florida Pharmaceutical Association. "We want to help select people who will at least listen to us. It's basically a state PharmPAC operating on a national level." Similar groups have worked to represent pharmacists' interests at the state level, and National PharmPAC will follow their cue, supporting
candidates sympathetic to pharmacy and opposing candidates whose records reflect a lack of sympathy for pr acti tioners. In accordance with federal election laws, National PharmPAC will be permitted to accept donations from individuals only. The group will reg~ ister with the Federal Election Commission to obtain authorization for its contributions to candidates for the Senate and House of Representatives.
CPSC Wants Child-Resistant Packaging For Aspirin Substitutes The U.S. Consumer Product Safety Commission will propose child-resistant packaging for acetaminophen. The CPSC will base its proposal on the fact that children under the age of five who take large amounts of the aspirin substitute by mistake may become seriously ill or die. The National Clearinghouse for Poison Control Centers reported 4,819 ingestions of acetaminophen-
containing products by children under five during 1969-1975 (the latest period for which statistics are available). Of these cases, 102 children required hospitalization and two died . The CPSC is proposing that packaging of preparations containing more than one gram of acetaminophen in a single package have childresistant closures. (Tablets of acetaminophen are usually in packages of 325 mg. or 500 mg.) Although acetaminophen is effective when taken in proper dosage, and is valuable for those who need a pain reliever but are allergic to aspirin, ingestion of large amounts of acetaminophen can cause serious health problems, including liver disease. Some people mistakenly believe that acetaminophen is safer than aspirin in overdose situations, according to the CPSC. (For separate article on the CPSC, see page 25, and for an article on poison prevention, see page 3 1.J 0
DISTINCTIVE PHARMACY .S TAMP REPLICAS
Handsome Rug
Stunning Needlepoint
Latch Hook Rug Kit
New! Now Available! A beautiful replica of the Pharmacy postage stamp in a latch hook rug kit. You won't believe how rich and vibrant the finished kit really is. The complete kit contains all necessary materials; precision-screened rug canvas, 100% acrylic precut yarns, latch hook, and complete instructions. The finished rug is 20 X 27 inches. Easy to do, even for beginners. Price: $25;95 per kit.
Needlepoint
Available in a complete kit At a reasonable price the Pharmacy kit successfully captures the beauty and detail of the postage stamp. In vivid colors , it may be used for a beautiful pillow or an attractive wall hanging for home, office, or store. A thoughtful gift or a nice treat for yourself. Kit includes highest quality materials; precis ion-screened 12 mono canvas, finest Persian wool yarns, needle and complete instructions. Order yours today while supply lasts. Price: $15.95 per kit.
Fast delivery via United ParceL Payment by ch eck. money order. or charge it to your credit card. Phone orders accepted. too
American Pharmacy VoI.NS18, No.3, Mar.1978/115
Send Order To: QUALITY TOPICAL SUPPLY P.O. BOX 20208 COLUMBUS, OH 43220
PHONE ORDERS: (614) 451-6114
Ph2
Name _________________________________________ Address ________________________________________ City, State ____________________
Zip _ _ _ __
Please rush the following kits: Pharmacy needlepoint kits @15.95 Pharmacy rug kits @ 25.95 Postage & Handling ($1 .00 per kit) Sales tax (Ohio residents) Total enclosed For credit cards, account· number _ _ _ _ _ _ _ _ _ _ expiration d a t e - - BankAmericard/Vis3--- Mastercharge _ _
11
Last year 500,000 victims were poisoned with such substances as aspirin, sleeping pills, iron preparations and liniments. Most of these victims were young children. The United States has an estimated 15.5 million children under the age of five years. Many of these will become needless victims of poisoning through accidental swallowing of hazardous household substances and overdoses of medicines. To focus attention on preventable household poisonings, March 19-25 has been declared National Poison Prevention Week. President Kennedy launched the idea of a special poison prevention week 17 years ago; since then there has been a 73 percent decline in fatalities among children under the age of five related to accidental swallowing of toxic substances, report federal officials. This year, in cooperation with the Food and Drug Administration (FDA), the U.S. Consumer Product Safety Commission (CPSC) is campaigning to encourage parents to keep 'syrup of ipecac on hand for use when emesis is indicated following ingestion of certain hazardous products. Officials of the CPSC caution that ipecac syrup should not be used if the child is unconscious or having convulsions, or if the poison is a strong corrosive such as acid or lye. Pharmacists can help the national poison prevention effort by stocking syrup of ipecac, making counter displays, and advertising ipecac's availability and use. The American Pharmaceutical Association also has prepared a poster for display.
Questions Patients Ask To help pharmacists anticipate and answer patients' questions about treatment of poisoning, the following "Q and A checklist" has been provided by the CPSC:
Q: What are some first aid rules in the event of accidental ingestion of poisons? A: The first rule is to call for professional medical help; call your doctor, the nearest poison control center, a hospital emergency room, or a rescue squad. All such emergency telephone numbers should be beside your phone. American Pharmacy VoI.NS18 , NO.3 , Mar.1978 / 135 .
Puffind Poisons
Q: What's the best way to induce vomiting? A: For children over the age of one year, a tablespoon of syrup of ipecac, together with at least one cup of water, should be given. If no vomiting occurs after 20 minutes, the dose can be repeated-but only once. After vomiting, the pa tien t should be given more water or milk .
in Ihtir Pla£t
Q: What is syrup of ipecac? A: It is a nonprescription formula, available at pharmacies, that makes people vomit. It should be kept in the home at all times. Q: And what if no syrup of ipecac
is available? A: Give the patient some water, and then induce vomiting by gently pressing the back of the throat with your finger, a spoon or other blunt object. These emergency procedures should be used only in the absence of medical attention. In case of poisoning, the first rule is always to get professional medical help ... as quickly as possible.
Q: Is it necessary to know exactly what poison was swallowed to help the physician determine the proper treatment? A: Yes. For example, if pills were ingested, the container and any remaining contents should be saved for the attending medical authority. Q: What if you don't know, but
suspect poisoning? A: You should make a search for the poison, and in the event that the patient vomits, a specimen should be saved for analysis.
Q: Is vomiting always desirable? A: No. Vomiting should never be induced if the child is unconscious or having convulsions; or if a strong corrosive was swallowed, such as acid or lye, in which case milk or water should be given. Vomiting is not routinely advised if any type of petroleum distillate was swallowed.
Q: Is induced desirable?
vomiting
ever
A: In general induced vomiting is desirable if the ingested poison is not a drain ,cleaner, an oven cleaner, or some other caustic substance. For example, vomiting should be induced if medicines such as aspirins, barbiturates, stimulants, etc., have been swallowed.
State Poison Education Campaigns _ In an effort to reduce the number and severity of childhood poisonings, the Brokaw Hospital Poison Control Center in BloomingtonNormal, Illinois, has developed the "No Siop"program; "NoSiop"(poison spelled backwards) is the center's new symbol for poison. The address is Virginia at Franklin Streets, Normal, Illinois 61761. Another campaign to teach the public about poison prevention has been launched by the American Association of Poison Control Centers (AAPCC), Committee on Educational Activities, in Cleveland, Ohio. AAPCC has made available slides, filmstrips, posters and pamphlets which discuss hazards in the home, safety rules and emergency procedures. The AAPCC may be contacted at 10525 Carnegie Avenue, Cleveland, Ohio 44106. A two-year-old is no judge of what can hurt him, and when it comes to accidental poisoning, household substances aren't child's play. To keep childhood poison~ng statistics spiraling downward, an adult education campaign is needed. -Margaret Rasmussen
31
statement on the New York formulary: "That list is merely a compilation of approved new drug applications and abbreviated NDAs, and neither NDAs nor ANDAs are proof that one drug is bioequivalent to another ... FDA hasn't tested for bioequivalence, they've only said that they haven't found evidence of inequivalence. We say, 'If you don't look, you won't find.'"
Liquid Protein Diet Contraindicated With Some Prescriptions Lost in the confusion and furor over the dangers of liquid protein diets has been the fact that patients taking certain prescription medications should forget liquid protein as their last chance at getting thin. The Food and Drug Administration says low-calorie protein regimens such as Dr. Robert Linn's "last chance diet" (from the book by the same name) should not be used by anyone taking any of the following: diuretics; antihypertensive drugs; oral hypoglycemic agents and insulin; and adrenergic medications. Also warned about the liquid protein diet are pa tien ts taking: high doses of corticosteroids; thyroid preparations other than those used in replacement therapy; and lithium therapy. "Use of very low-calorie protein diets by such patients is extremely hazardous," says the FDA, adding that patients taking digitalis must maintain adequate potassium intakes if they go on the liquid protein diet. FDA has proposed a mandatory warning label for all protein products intended for dieters. The warning says that such products should not be used without medical supervision. While FDA says infants, children, pregnant and nursing women should not go on such a diet, the proposed label does not include warnings directed at those taking specific medications. In the wake of some 40 deaths reportedly associated with
very low-calorie protein diets, FDA is looking at ways to ban the products used in such regimens.
FDA Expands Pill Warning The Food and Drug Administration has announced the revision and expansion of patient information requirements for birth control pills. Effective April 3, 1978, both patient and physician labeling of oral contraceptives will be required to contain the warning that women who take the pill should not smoke. Patient packages and brochures distributed by pharmacists at the point of sale will be marked with a box label containing the warning. The brochures, which have been required since 1971, will also contain an expanded list of possible side effects caused by the estrogens and progestogens that are the active components in most birth control pills. In announcing the new program, FDA Commissioner Donald Kennedy said that FDA is completing studies on various categories of drugs that may be required to carry patient package information. According to Kennedy, the studies will be completed by the summer of 1978, when FDA will consider further steps. Said Kennedy: "We want more patients to have more information about their own therapy," adding that he sees no legal reasons why the April 3 start of the program would be .delayed. In his prepared remarks, Kennedy said that birth control piUs have a synergistic effect with smoking, each multiplying the dangers of the other. Asked what he would recommend to his wife or daughter if she were considering birth control pills as a means of contraception, Kennedy replied, "I'm speaking not as a physician, and not as the FDA commissioner, but I would tell someone I love to find another method of birth control." American Pharmacy Vol. NS18, No.3, Mar.1978/114
(Kennedy, who holds a PhD, is the first nonphysician to head FDA since 1965.)
Political Action Group Formed Organizers of a new pharmacy political action group see their organization as an extension on the national level of state political action committees. The National Pharmacy Political Action Committee (PharmPAC) has been organized to support political candidates who are open to the concerns of pharmacists. "You don't buy anything or anybody," said PharmPAC chairman James Powers, who is also secretary of the Florida Pharmaceutical Association. "We want to help select people who will at least listen to us. It's basically a state PharmPAC operating on a national level." Similar groups have worked to represent pharmacists' interests at the state level, and National PharmPAC will follow their cue, supporting
candidates sympathetic to pharmacy and opposing candidates whose records reflect a lack of sympathy for pr acti tioners. In accordance with federal election laws, National PharmPAC will be permitted to accept donations from individuals only. The group will reg~ ister with the Federal Election Commission to obtain authorization for its contributions to candidates for the Senate and House of Representatives.
CPSC Wants Child-Resistant Packaging For Aspirin Substitutes The U.S. Consumer Product Safety Commission will propose child-resistant packaging for acetaminophen. The CPSC will base its proposal on the fact that children under the age of five who take large amounts of the aspirin substitute by mistake may become seriously ill or die. The National Clearinghouse for Poison Control Centers reported 4,819 ingestions of acetaminophen-
containing products by children under five during 1969-1975 (the latest period for which statistics are available). Of these cases, 102 children required hospitalization and two died . The CPSC is proposing that packaging of preparations containing more than one gram of acetaminophen in a single package have childresistant closures. (Tablets of acetaminophen are usually in packages of 325 mg. or 500 mg.) Although acetaminophen is effective when taken in proper dosage, and is valuable for those who need a pain reliever but are allergic to aspirin, ingestion of large amounts of acetaminophen can cause serious health problems, including liver disease. Some people mistakenly believe that acetaminophen is safer than aspirin in overdose situations, according to the CPSC. (For separate article on the CPSC, see page 25, and for an article on poison prevention, see page 3 1.J 0
DISTINCTIVE PHARMACY .S TAMP REPLICAS
Handsome Rug
Stunning Needlepoint
Latch Hook Rug Kit
New! Now Available! A beautiful replica of the Pharmacy postage stamp in a latch hook rug kit. You won't believe how rich and vibrant the finished kit really is. The complete kit contains all necessary materials; precision-screened rug canvas, 100% acrylic precut yarns, latch hook, and complete instructions. The finished rug is 20 X 27 inches. Easy to do, even for beginners. Price: $25;95 per kit.
Needlepoint
Available in a complete kit At a reasonable price the Pharmacy kit successfully captures the beauty and detail of the postage stamp. In vivid colors , it may be used for a beautiful pillow or an attractive wall hanging for home, office, or store. A thoughtful gift or a nice treat for yourself. Kit includes highest quality materials; precis ion-screened 12 mono canvas, finest Persian wool yarns, needle and complete instructions. Order yours today while supply lasts. Price: $15.95 per kit.
Fast delivery via United ParceL Payment by ch eck. money order. or charge it to your credit card. Phone orders accepted. too
American Pharmacy VoI.NS18, No.3, Mar.1978/115
Send Order To: QUALITY TOPICAL SUPPLY P.O. BOX 20208 COLUMBUS, OH 43220
PHONE ORDERS: (614) 451-6114
Ph2
Name _________________________________________ Address ________________________________________ City, State ____________________
Zip _ _ _ __
Please rush the following kits: Pharmacy needlepoint kits @15.95 Pharmacy rug kits @ 25.95 Postage & Handling ($1 .00 per kit) Sales tax (Ohio residents) Total enclosed For credit cards, account· number _ _ _ _ _ _ _ _ _ _ expiration d a t e - - BankAmericard/Vis3--- Mastercharge _ _
11
Last year 500,000 victims were poisoned with such substances as aspirin, sleeping pills, iron preparations and liniments. Most of these victims were young children. The United States has an estimated 15.5 million children under the age of five years. Many of these will become needless victims of poisoning through accidental swallowing of hazardous household substances and overdoses of medicines. To focus attention on preventable household poisonings, March 19-25 has been declared National Poison Prevention Week. President Kennedy launched the idea of a special poison prevention week 17 years ago; since then there has been a 73 percent decline in fatalities among children under the age of five related to accidental swallowing of toxic substances, report federal officials. This year, in cooperation with the Food and Drug Administration (FDA), the U.S. Consumer Product Safety Commission (CPSC) is campaigning to encourage parents to keep 'syrup of ipecac on hand for use when emesis is indicated following ingestion of certain hazardous products. Officials of the CPSC caution that ipecac syrup should not be used if the child is unconscious or having convulsions, or if the poison is a strong corrosive such as acid or lye. Pharmacists can help the national poison prevention effort by stocking syrup of ipecac, making counter displays, and advertising ipecac's availability and use. The American Pharmaceutical Association also has prepared a poster for display.
Questions Patients Ask To help pharmacists anticipate and answer patients' questions about treatment of poisoning, the following "Q and A checklist" has been provided by the CPSC:
Q: What are some first aid rules in the event of accidental ingestion of poisons? A: The first rule is to call for professional medical help; call your doctor, the nearest poison control center, a hospital emergency room, or a rescue squad. All such emergency telephone numbers should be beside your phone. American Pharmacy VoI.NS18 , NO.3 , Mar.1978 / 135 .
Puffind Poisons
Q: What's the best way to induce vomiting? A: For children over the age of one year, a tablespoon of syrup of ipecac, together with at least one cup of water, should be given. If no vomiting occurs after 20 minutes, the dose can be repeated-but only once. After vomiting, the pa tien t should be given more water or milk .
in Ihtir Pla£t
Q: What is syrup of ipecac? A: It is a nonprescription formula, available at pharmacies, that makes people vomit. It should be kept in the home at all times. Q: And what if no syrup of ipecac
is available? A: Give the patient some water, and then induce vomiting by gently pressing the back of the throat with your finger, a spoon or other blunt object. These emergency procedures should be used only in the absence of medical attention. In case of poisoning, the first rule is always to get professional medical help ... as quickly as possible.
Q: Is it necessary to know exactly what poison was swallowed to help the physician determine the proper treatment? A: Yes. For example, if pills were ingested, the container and any remaining contents should be saved for the attending medical authority. Q: What if you don't know, but
suspect poisoning? A: You should make a search for the poison, and in the event that the patient vomits, a specimen should be saved for analysis.
Q: Is vomiting always desirable? A: No. Vomiting should never be induced if the child is unconscious or having convulsions; or if a strong corrosive was swallowed, such as acid or lye, in which case milk or water should be given. Vomiting is not routinely advised if any type of petroleum distillate was swallowed.
Q: Is induced desirable?
vomiting
ever
A: In general induced vomiting is desirable if the ingested poison is not a drain ,cleaner, an oven cleaner, or some other caustic substance. For example, vomiting should be induced if medicines such as aspirins, barbiturates, stimulants, etc., have been swallowed.
State Poison Education Campaigns _ In an effort to reduce the number and severity of childhood poisonings, the Brokaw Hospital Poison Control Center in BloomingtonNormal, Illinois, has developed the "No Siop"program; "NoSiop"(poison spelled backwards) is the center's new symbol for poison. The address is Virginia at Franklin Streets, Normal, Illinois 61761. Another campaign to teach the public about poison prevention has been launched by the American Association of Poison Control Centers (AAPCC), Committee on Educational Activities, in Cleveland, Ohio. AAPCC has made available slides, filmstrips, posters and pamphlets which discuss hazards in the home, safety rules and emergency procedures. The AAPCC may be contacted at 10525 Carnegie Avenue, Cleveland, Ohio 44106. A two-year-old is no judge of what can hurt him, and when it comes to accidental poisoning, household substances aren't child's play. To keep childhood poison~ng statistics spiraling downward, an adult education campaign is needed. -Margaret Rasmussen
31