- Email: [email protected]
For recordkeeping under HR 2… A specialized ledger
for recordkeeping under HR 2 •••
a specialized ledger by C. Eugene Watkins
1888
s
FEBRUARY
1966
MTWTFS
02 3 4 5 6 1 8 9 10 1112 13 14 15 16 11 18 19 20212223242526 2128
P
rior to the February 1 effective date for the Drug Abuse Control Amendments of 1965, pharmacists must decide whether they will utilize existing records to comply with the law or develop some alternative method of recordkeeping. There are no alternatives to initial inventory requirements and the restrictions of five renewals and a six-month time limit. A study of the law indicates that there are at least three primary means of complying with the recordkeeping clause which may be used individually or in combination-
no change in the existing prescription order filing system, is the least involved method. This alternative, however, will be the least desirable system if the pharmacist prefers to restrict access to his files. Although the law indicates that the inspection of files will be limited to those prescription orders which were written for drugs covered by the law and will not be excursions conducted to determine other violations, the unlimited access to the files may be considered undesirable by some pharmacists. Also the occasional sale of the restricted
1. make no change in the existing prescription order filing system 2. establish a separate numbering and filing system for prescription orders and other transactions pertaining to the drugs covered under the law 3. utilize a specialized ledger to record transactions which involve the restricted drugs.
In deciding which system to employ in complying with the Drug Abuse Control Amendments, the pharmacist should give careful consideration to the advantages and disadvantages that are inherent in the alternative methods. Careful thought given to the selection of the most useful system prior to its institution can save time, confusion and effort in the future. Noone method will suffice for all pharmacists, but consideration given to the merits of each system will be of benefit. The first alternative, which suggested 10
Journal of the AMERICAN PHARMACEUTICAL ASSOCIATION
drugs to another pharmacist in the outof-stock situation; to a physician, to a dentist, to another health practitioner for office use; or the return of these drugs to a supplier for credit must be recorded in some fashion. The notation of such sale or other action would have to be included in the prescription order file. The establishment of a separate numbering and filing system, the second alternative, will eliminate several disadvantages in that inspections will be limited to those prescription orders
REGISTRATION PRESCRIPTION
17
17i
FDA drug abuse regulations ( continued fro m page 11 )
and address of the person t o whom such drug was sold or delivered; the identity of any common carrier or t ransport ation fir m u sed in effecting such delivery; the registration number, if any ; the dat e su ch sale, delivery, or other disposit ion t ook place ; t he est ablish ed trade n ames for drugs containing a single active ingredient and " for those drugs (for which there is no established n ame) containing more tha n one active component, the established and t rade name for each active component." T he term "qu antity" means t he number of individual packages or containersand a st atement of a single u nit within the individual package resulting in the fo llowing t y pe of designation ("50 100-mg t ablets" or " 3 dozen 25-tablet bottles of lO-mg t ablets"). All such records are t o be readily available. According t o the proposed regulation s, records "will be considered inadequate or incomplete if such records are so intermingled with the records of products not covered by the Drug Abuse Control Amendments of 1965 that inspection of these records is impossible, impracticable or requires an unreasonable length of time. " D rugs covered by the act and regulations, u nless exempted, include any amount of t he following substances1. barbituric acid or any salt of barbituric acid 2. derivatives of barbituric acid which have been designated
as habit formin g 3. dextroamphetamine, levoamphetamine or amphetamine (racemic) or any salts of these The fo llowing is an exact listing published in the December 18 regulations which h as been ident ified as "a partial list of am phet amine product s. " (Since this was received as we were going to press, we have had no opportunity to verify it as to accuracy of spelling of trade names or categories.)Amphetamine phosphate-Actemin , Aktedron, Amphate, Mono· phos, Profetamine Phosphate , Racephen, Raphetamine Phosphate Amphetamine salts or optical isomers of amphetamine salts Amphetamine sulfate-Alentol, Amphoids-S, Benzedrine Sulfate, Linampheta , Psychoton, Simpamina Amphedrine Sulfate Dextroamphetamine carboxymethylcellulose salt Dextroamphetamine hyd rochloride Dextroamphetamine phosphate-Dextro-Profetamine Dextroamphetamine sulfate-Adrizine, Am-Dex, D-Amfetasul, Amitrene, Amphedrine , Ampheres, Amphex , Amsustain, D-Ate Ph. 747 , Betafedrine , d-Betaphedrine, Cendex Cenules, D-Citramine, Cradex, Dadex, D.A.S., Dexalone, Dexamphetam ine, Dexedrine, Dex-OB, Dex-Sule, Dexten, Dextrosule, Diocurb, Domafate, Evrodex, Hetamine, Lowedex, Maxiton, Medex, Nilox, Obesedrin, Obesonil, Pellcaps, Pomadex, Simpamina-D, Sympamin, Tydex, Zamitan Plateau Dextroamphetamine tannate-Tanphetamin, Synatan Dibasic amphetamine phosphate-Bar-Dex Dibasic dextroamphetamine phosphate Levoamphetamine-Ad-Nil, Amphedrine-M, Levabo, Levam · phetamine , Levonor Levoamphetamine succinate-Cydi'il Controls m ay also be est ablished for other drugs wit h a pot ential for abuse; these may include LSD -25 and other hallucinogenic drugs, certain t ran quilizers an d depressant drugs and other stimulants . In determining whether a drug has stimulant effect , the FDA commissioner will reportedly consider , among other relevant fact ors, whether there is subst antial evidence that the drug m ay produce any of the following1. Extended wakefulness 2. Elation, exhilaration or euphoria (exaggerated sense of
well-being)
3. Alleviation of fatigue 4. Insomnia, irritability or agitation 5. Apprehension or anxiety 6. Flight of ideas, loquacity, hypomania or transient deliria In deter mining wheth er a drug has depressant effect on the central nervous system, t he commissioner will, according to the regulations, consider, among other relevant fact ors, whether the substance may produce any of th e following1. Calming effect or relief of emotional tension or anxiety 2. Drowsiness, sedation , sleep, stupor, coma or general anesthesia 3. Increase of pain threshold 4. Mood depression or apathy 5. Disorientation, confusion or loss of mental acuity
In determining wh ether a drug is h abit-forming, the commissioner will consider whether t here is substantial eviden ce that t he drug may produce any of t he following1. A psychological or phys ical dependence on the drug (compulsive use) 2. Euphoria (exaggerated sense of well-being) 3. Personality changes 4. Transient psychoses, deliria , twilight state or hallucinoses 5. Chronic brain syndrome 6. Increased tolerance or a need or desire to increase the drug dosage 7. Physical dependence or a psychic dependence evidenced by a de sire to continue taking the drug for the sense of improved well-being that it engenders 8. Pharmacological activity sim ilar or identical to that of drugs previously designated as habit-forming To det ermine whet her or not a drug may h ave hallucinogenic effect , the commissioner will consider if there is substantial evidence that it may produce h allucinations, illusions. delusions or alterations of any of t he fo llowing1. Orientation with respect to time or place 2. Consciousness , as evidenced by confused states, dreamlike revivals of past traumatic events or childhood
memories 3. Sensory perception, as evidenced by visual illusions,
syn esthesia , distortion of space and perspective 4. Motor coordination 5. Mood and affectivity, as evidenced by anxiety, euphoria, hypomania, ecstasy, autistic withdrawal 6. Ideation, as evidenced by flight of ideas, ideas of reference, impairment of concentration and intelligence 7. Personality, as evidenced by depersonalization and derealization , impairment of conscience and of acquired social and cultural customs To determine which drugs, in addi t ion t o barbiturates and am ph etamines, should be covered under the act , FDA has n amed an advisory committee on abuse of depressant and stimulant drugs, consisting of Frederick E. Shideman, University of M innesot a school of medicine; H enry Brill, MD, Pilgrim Stat e H ospital, New York; J ohn A. Clau sen , Universit y of Californi a; Harris Isbell, M D , University of K entucky medical center ; Walter M odell , M D , Cornell Universit y medical college; E liot Herman Rodnick, University of California, Los Angeles; Klaus R. Unna, M D , University of Illinois college of medicine, and Cy rus B . M axwell, MD , FDA Bureau of Medicine, executive secretary of the committee. Interested part ies are invited t o submit information on over-the-counter drugs and combinations containing stimulant or depressant drugs which should be exem pted because they do not have a pot ential fo r abuse. Comment h as also been invited on whether or not a symbol (recommended by APHA) should be required on the labels of drugs subject t o control. Comment must be submitted in writing by J anuary 18, 1966. t o the H earing Clerk, D epartment of H ealt h, E ducation and Welfare, R oom 5440,330 Independence Avenue N .W., Washingt on , D.C. 20201. Comments concerning any addition al trade names that m ay be list ed are part icularly desired . • Vol . NS6, No . 1,
January 1966
37
a specialized ledger by C. Eugene Watkins
1888
s
FEBRUARY
1966
MTWTFS
02 3 4 5 6 1 8 9 10 1112 13 14 15 16 11 18 19 20212223242526 2128
P
rior to the February 1 effective date for the Drug Abuse Control Amendments of 1965, pharmacists must decide whether they will utilize existing records to comply with the law or develop some alternative method of recordkeeping. There are no alternatives to initial inventory requirements and the restrictions of five renewals and a six-month time limit. A study of the law indicates that there are at least three primary means of complying with the recordkeeping clause which may be used individually or in combination-
no change in the existing prescription order filing system, is the least involved method. This alternative, however, will be the least desirable system if the pharmacist prefers to restrict access to his files. Although the law indicates that the inspection of files will be limited to those prescription orders which were written for drugs covered by the law and will not be excursions conducted to determine other violations, the unlimited access to the files may be considered undesirable by some pharmacists. Also the occasional sale of the restricted
1. make no change in the existing prescription order filing system 2. establish a separate numbering and filing system for prescription orders and other transactions pertaining to the drugs covered under the law 3. utilize a specialized ledger to record transactions which involve the restricted drugs.
In deciding which system to employ in complying with the Drug Abuse Control Amendments, the pharmacist should give careful consideration to the advantages and disadvantages that are inherent in the alternative methods. Careful thought given to the selection of the most useful system prior to its institution can save time, confusion and effort in the future. Noone method will suffice for all pharmacists, but consideration given to the merits of each system will be of benefit. The first alternative, which suggested 10
Journal of the AMERICAN PHARMACEUTICAL ASSOCIATION
drugs to another pharmacist in the outof-stock situation; to a physician, to a dentist, to another health practitioner for office use; or the return of these drugs to a supplier for credit must be recorded in some fashion. The notation of such sale or other action would have to be included in the prescription order file. The establishment of a separate numbering and filing system, the second alternative, will eliminate several disadvantages in that inspections will be limited to those prescription orders
REGISTRATION PRESCRIPTION
17
17i
FDA drug abuse regulations ( continued fro m page 11 )
and address of the person t o whom such drug was sold or delivered; the identity of any common carrier or t ransport ation fir m u sed in effecting such delivery; the registration number, if any ; the dat e su ch sale, delivery, or other disposit ion t ook place ; t he est ablish ed trade n ames for drugs containing a single active ingredient and " for those drugs (for which there is no established n ame) containing more tha n one active component, the established and t rade name for each active component." T he term "qu antity" means t he number of individual packages or containersand a st atement of a single u nit within the individual package resulting in the fo llowing t y pe of designation ("50 100-mg t ablets" or " 3 dozen 25-tablet bottles of lO-mg t ablets"). All such records are t o be readily available. According t o the proposed regulation s, records "will be considered inadequate or incomplete if such records are so intermingled with the records of products not covered by the Drug Abuse Control Amendments of 1965 that inspection of these records is impossible, impracticable or requires an unreasonable length of time. " D rugs covered by the act and regulations, u nless exempted, include any amount of t he following substances1. barbituric acid or any salt of barbituric acid 2. derivatives of barbituric acid which have been designated
as habit formin g 3. dextroamphetamine, levoamphetamine or amphetamine (racemic) or any salts of these The fo llowing is an exact listing published in the December 18 regulations which h as been ident ified as "a partial list of am phet amine product s. " (Since this was received as we were going to press, we have had no opportunity to verify it as to accuracy of spelling of trade names or categories.)Amphetamine phosphate-Actemin , Aktedron, Amphate, Mono· phos, Profetamine Phosphate , Racephen, Raphetamine Phosphate Amphetamine salts or optical isomers of amphetamine salts Amphetamine sulfate-Alentol, Amphoids-S, Benzedrine Sulfate, Linampheta , Psychoton, Simpamina Amphedrine Sulfate Dextroamphetamine carboxymethylcellulose salt Dextroamphetamine hyd rochloride Dextroamphetamine phosphate-Dextro-Profetamine Dextroamphetamine sulfate-Adrizine, Am-Dex, D-Amfetasul, Amitrene, Amphedrine , Ampheres, Amphex , Amsustain, D-Ate Ph. 747 , Betafedrine , d-Betaphedrine, Cendex Cenules, D-Citramine, Cradex, Dadex, D.A.S., Dexalone, Dexamphetam ine, Dexedrine, Dex-OB, Dex-Sule, Dexten, Dextrosule, Diocurb, Domafate, Evrodex, Hetamine, Lowedex, Maxiton, Medex, Nilox, Obesedrin, Obesonil, Pellcaps, Pomadex, Simpamina-D, Sympamin, Tydex, Zamitan Plateau Dextroamphetamine tannate-Tanphetamin, Synatan Dibasic amphetamine phosphate-Bar-Dex Dibasic dextroamphetamine phosphate Levoamphetamine-Ad-Nil, Amphedrine-M, Levabo, Levam · phetamine , Levonor Levoamphetamine succinate-Cydi'il Controls m ay also be est ablished for other drugs wit h a pot ential for abuse; these may include LSD -25 and other hallucinogenic drugs, certain t ran quilizers an d depressant drugs and other stimulants . In determining whether a drug has stimulant effect , the FDA commissioner will reportedly consider , among other relevant fact ors, whether there is subst antial evidence that the drug m ay produce any of the following1. Extended wakefulness 2. Elation, exhilaration or euphoria (exaggerated sense of
well-being)
3. Alleviation of fatigue 4. Insomnia, irritability or agitation 5. Apprehension or anxiety 6. Flight of ideas, loquacity, hypomania or transient deliria In deter mining wheth er a drug has depressant effect on the central nervous system, t he commissioner will, according to the regulations, consider, among other relevant fact ors, whether the substance may produce any of th e following1. Calming effect or relief of emotional tension or anxiety 2. Drowsiness, sedation , sleep, stupor, coma or general anesthesia 3. Increase of pain threshold 4. Mood depression or apathy 5. Disorientation, confusion or loss of mental acuity
In determining wh ether a drug is h abit-forming, the commissioner will consider whether t here is substantial eviden ce that t he drug may produce any of t he following1. A psychological or phys ical dependence on the drug (compulsive use) 2. Euphoria (exaggerated sense of well-being) 3. Personality changes 4. Transient psychoses, deliria , twilight state or hallucinoses 5. Chronic brain syndrome 6. Increased tolerance or a need or desire to increase the drug dosage 7. Physical dependence or a psychic dependence evidenced by a de sire to continue taking the drug for the sense of improved well-being that it engenders 8. Pharmacological activity sim ilar or identical to that of drugs previously designated as habit-forming To det ermine whet her or not a drug may h ave hallucinogenic effect , the commissioner will consider if there is substantial evidence that it may produce h allucinations, illusions. delusions or alterations of any of t he fo llowing1. Orientation with respect to time or place 2. Consciousness , as evidenced by confused states, dreamlike revivals of past traumatic events or childhood
memories 3. Sensory perception, as evidenced by visual illusions,
syn esthesia , distortion of space and perspective 4. Motor coordination 5. Mood and affectivity, as evidenced by anxiety, euphoria, hypomania, ecstasy, autistic withdrawal 6. Ideation, as evidenced by flight of ideas, ideas of reference, impairment of concentration and intelligence 7. Personality, as evidenced by depersonalization and derealization , impairment of conscience and of acquired social and cultural customs To determine which drugs, in addi t ion t o barbiturates and am ph etamines, should be covered under the act , FDA has n amed an advisory committee on abuse of depressant and stimulant drugs, consisting of Frederick E. Shideman, University of M innesot a school of medicine; H enry Brill, MD, Pilgrim Stat e H ospital, New York; J ohn A. Clau sen , Universit y of Californi a; Harris Isbell, M D , University of K entucky medical center ; Walter M odell , M D , Cornell Universit y medical college; E liot Herman Rodnick, University of California, Los Angeles; Klaus R. Unna, M D , University of Illinois college of medicine, and Cy rus B . M axwell, MD , FDA Bureau of Medicine, executive secretary of the committee. Interested part ies are invited t o submit information on over-the-counter drugs and combinations containing stimulant or depressant drugs which should be exem pted because they do not have a pot ential fo r abuse. Comment h as also been invited on whether or not a symbol (recommended by APHA) should be required on the labels of drugs subject t o control. Comment must be submitted in writing by J anuary 18, 1966. t o the H earing Clerk, D epartment of H ealt h, E ducation and Welfare, R oom 5440,330 Independence Avenue N .W., Washingt on , D.C. 20201. Comments concerning any addition al trade names that m ay be list ed are part icularly desired . • Vol . NS6, No . 1,
January 1966
37