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Improving Compounding Practices
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by Dr. SalDuel W . Goldstein*
BACK in 1885, when standard limits for drugs in addition to those for cinchona bark and opium were being considered for the s~eventh revision of the U. S. P., some pharmaceutical journals declared editorially that ,t he , retail pharmacists could not meet the proposed ,'s tandards. They also stated that the ' standards would force the pharmacists to relinquish their manufacturing to the large drug houses. Those editors were right on both counts, and as a result we have many manufactured pharn~aceuti cals that meet standards of accuracy and elegance that the retail pharmacist could not approach. What has been left to the practicing pharmacist that still allows his claim to professional recognition and demands the educational background and training that is expected of a professional man? It is his co-responsibility with the physician to see that the patient receives the correct dose of the proper medicine in the m.ost suitable dosage form. This is particularly true when the pharmacist must use his knowledge and skill to compound extemporaneous dosage forms. That is what sets the pharmacist apart from the dispensers of other services and commodities. His Presented before the Section ' on Practical Pharm;lcy, A. PH. A. Convention, Buffalo, N. Y., August. 1951. ' Received from Drug Laboratory, Maryland State Health Dept. Present Address: Laboratory of the American Pharmaceutical Association, Washington, D. C.
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120
knowledge of therapeutic actions and dosages of therapeutic and chemical incompatibilities and his compounding art make up his professional contributions in the field of medical care. Having become proficient in his knowledge and skills, as attested by his Pharmacy Board Certificate, the pharmacist should be capable of responsible professional judgment. Most pharmacists are. However, many studies-including one made internationally, show that there is a wide range of error in compounding. Adequate tolerances must be established and maintained in our daily compounding. TEACHING PRECISE COMPOUNDING
How can we reduce the excessive errors in prescription compounding? Our best hope is in the proper training of the next generations of pharmacists. We should improve the method of teaching compounding. Student pharmacists should be taught the most precise techniques th,at can be practically applied i~ extemporaneous compounding. One pharmacy teacher, and apparently a good one, publicly stated that his students could do their compounding within a ±5% . limit of error. That opinion was based upon the fact that 88% of his students could prepare Fowler's solution within the ±5% limit of error. He did not say he would fail the other 12% of the class. - The teacher should be com·
Vol. Xliii No.2
PRACTICAL PHARMACY EDITION
Proper standards in cOD'lpounding are ' iD'lportant froD'l a professional and educational standpoint, not to D'lention their yalue in better, surer, safer D'ledication.
mended-and was-for developing a procedure which enables 88% of his students to compound Fowler's solution with such a degree of precision in a school laboratory. Then, in 1950, the same teacher had two other compounded solutions tested. Results from one were very good. But with the other solution, one involving measuring in a graduate and no weighing, the deviations increased to such an extent that 76%of the students'products exceeded a ± 5% limit of error and 24% of the products exceeded a ± 10% limit of error. The teacher immediately reviewed the procedure for preparing dilute solutions of acetic acid from glacial acetic acid; and I am sure that his future students will compound these solutions more accurately while they are in his classes. But the hundreds of students that were taught by this educator in bygone years did not have ~heir dilute acetic acid solutiuns tested, and only now does their former teacher have some idea of their precision with this type of preparation. Testing several of the products compounded by students is commendable, but it is not enough. Every assayable product that is compounded by students should be tested, and the analytical results should be made available to them. This might force some schools to replace old or inac- ' curate compounding equipment. Under these conditions, the teachers and the students would learn more about the attainable limits of precision when practical compounding procedures are used. A full time analyst, who would also teach quantitative analysis, should be added to
Author's Summary Properly and accurately con1.pound.ed products reflect the pharmacist's knowledge, skill, and professional attitude.
The methods of teaching compounding and dispensing pharmacy should be altered to promote the necessary understanding of the factors affecting accuracy in extemporaneous com pounding.
Establishment of standards for compounded products is essential to the dev~lopment of better teaching procedures.
Reasonable and equitable standards for extemporaneously compounded pharmaceuticals would protect the pharmacists from unqualified criticism, especially from non-pharmacists in offici~1 positions.
(Continued on page 130)
The same standards should be applied to the products compounded by students, State Board candidates, and practicing pharmacists.
Proper regard for his scientific contributions to the medical care \ program \ will inevitably affect the professional a tti tude of the pharmaclst.
February, 1952
121
by Dr. SalDuel W . Goldstein*
BACK in 1885, when standard limits for drugs in addition to those for cinchona bark and opium were being considered for the s~eventh revision of the U. S. P., some pharmaceutical journals declared editorially that ,t he , retail pharmacists could not meet the proposed ,'s tandards. They also stated that the ' standards would force the pharmacists to relinquish their manufacturing to the large drug houses. Those editors were right on both counts, and as a result we have many manufactured pharn~aceuti cals that meet standards of accuracy and elegance that the retail pharmacist could not approach. What has been left to the practicing pharmacist that still allows his claim to professional recognition and demands the educational background and training that is expected of a professional man? It is his co-responsibility with the physician to see that the patient receives the correct dose of the proper medicine in the m.ost suitable dosage form. This is particularly true when the pharmacist must use his knowledge and skill to compound extemporaneous dosage forms. That is what sets the pharmacist apart from the dispensers of other services and commodities. His Presented before the Section ' on Practical Pharm;lcy, A. PH. A. Convention, Buffalo, N. Y., August. 1951. ' Received from Drug Laboratory, Maryland State Health Dept. Present Address: Laboratory of the American Pharmaceutical Association, Washington, D. C.
*
120
knowledge of therapeutic actions and dosages of therapeutic and chemical incompatibilities and his compounding art make up his professional contributions in the field of medical care. Having become proficient in his knowledge and skills, as attested by his Pharmacy Board Certificate, the pharmacist should be capable of responsible professional judgment. Most pharmacists are. However, many studies-including one made internationally, show that there is a wide range of error in compounding. Adequate tolerances must be established and maintained in our daily compounding. TEACHING PRECISE COMPOUNDING
How can we reduce the excessive errors in prescription compounding? Our best hope is in the proper training of the next generations of pharmacists. We should improve the method of teaching compounding. Student pharmacists should be taught the most precise techniques th,at can be practically applied i~ extemporaneous compounding. One pharmacy teacher, and apparently a good one, publicly stated that his students could do their compounding within a ±5% . limit of error. That opinion was based upon the fact that 88% of his students could prepare Fowler's solution within the ±5% limit of error. He did not say he would fail the other 12% of the class. - The teacher should be com·
Vol. Xliii No.2
PRACTICAL PHARMACY EDITION
Proper standards in cOD'lpounding are ' iD'lportant froD'l a professional and educational standpoint, not to D'lention their yalue in better, surer, safer D'ledication.
mended-and was-for developing a procedure which enables 88% of his students to compound Fowler's solution with such a degree of precision in a school laboratory. Then, in 1950, the same teacher had two other compounded solutions tested. Results from one were very good. But with the other solution, one involving measuring in a graduate and no weighing, the deviations increased to such an extent that 76%of the students'products exceeded a ± 5% limit of error and 24% of the products exceeded a ± 10% limit of error. The teacher immediately reviewed the procedure for preparing dilute solutions of acetic acid from glacial acetic acid; and I am sure that his future students will compound these solutions more accurately while they are in his classes. But the hundreds of students that were taught by this educator in bygone years did not have ~heir dilute acetic acid solutiuns tested, and only now does their former teacher have some idea of their precision with this type of preparation. Testing several of the products compounded by students is commendable, but it is not enough. Every assayable product that is compounded by students should be tested, and the analytical results should be made available to them. This might force some schools to replace old or inac- ' curate compounding equipment. Under these conditions, the teachers and the students would learn more about the attainable limits of precision when practical compounding procedures are used. A full time analyst, who would also teach quantitative analysis, should be added to
Author's Summary Properly and accurately con1.pound.ed products reflect the pharmacist's knowledge, skill, and professional attitude.
The methods of teaching compounding and dispensing pharmacy should be altered to promote the necessary understanding of the factors affecting accuracy in extemporaneous com pounding.
Establishment of standards for compounded products is essential to the dev~lopment of better teaching procedures.
Reasonable and equitable standards for extemporaneously compounded pharmaceuticals would protect the pharmacists from unqualified criticism, especially from non-pharmacists in offici~1 positions.
(Continued on page 130)
The same standards should be applied to the products compounded by students, State Board candidates, and practicing pharmacists.
Proper regard for his scientific contributions to the medical care \ program \ will inevitably affect the professional a tti tude of the pharmaclst.
February, 1952
121