- Email: [email protected]
Counseling Patients on OTC Drugs
cals-qualification of the process. Such "qualification" began, as stated before, with consideration of the theoretical capabilities of given pieces of equipment used in the manufacture of the product, aod consideration of the physical and chemical characteristics of the testing or challenge components of each step of the process. This testing and challenge may range from particle size distribution in mixing of powdered ingredients to testing various portions of a mixture to determine the uniformity of the mix. It would, of course, include, in the case of compressed tablets, intensive monitoring of the physical characteristics as well as composition of the individual dosage units. The number of tests to establish adequacy of a process-both in processes and finished product testing-would, of course, be much greater than that routinely used as control procedures once the adequacy of the process is established. In the case of control procedures which
include analytical procedures, the adequacy of such procedures must be established prior to the qualification of any process or product. Needless to say, any change in the manufacturing and control process must oe subject to the same challenge as an entirely new product. In this age of economic difficulty, design is an essential tool in controlling unnecessary expenditure of manpower, materials and capital. Product failure because of lack of attention to these factors can, as we all know, cause recall situations requiring manpower expenditure by both the firm and the agency. Just as important if not more so, defective products can affect the consumer's pocketbook and can result, especially in a difficult economic time, in a lack of confidence in the industry's products. Regulatory agencies such as FDA also have a responsibility in this area. In considering changes in requirements as enunciated in regulations, we must justify to ourselves
as well as to you and the rest of the public any additional requirements which cost money. In closing, I would like to mention the most important quality factor in the manufacture of any product, especially pharmaceuticals. That quality factor applies not only to those who produce pharmaceuticals, but to us in the federal government who have the responsibiUty under the law for assuring that the firms and their products meet the requirements of the law. That quality factor does not depend on chance but, rather, on design. That quality factor is a dedication to the high principles of serving the citizens of this country by assuring that the pharmaceutical supply is of uniform high quality and is produced under uniformly high conditions under the direction of people who make the right decision at the right time. •
A Community Pharmacist's. View
moved to nonprescription status, and recognizing that o-t-c drugs have potential side effects, Pharmacist Riffee states that now more than ever, counseling is needed concerning these products, their potential side effects and interactions with other drugs. In his pharmacy, these o-t-c medications have been placed in one area from which Riffee and Doyle can counsel patients. To supplement the counseling, a patient compliance sheet with do's and don't's concerning the drugs is given to the patient. The important thing, Riffee feels, is to reinforce the instructions so that the patient appreciates the fact that these medications are potent and can have potential side effects with which the patient must be concerned. He states"These are responsibilities practicing pharmacists must accept in this day when prescription strength medication is being moved from legend to over-the- counter status-responsibilities that are vital to maintaining the good health of the people. If we respond as practitioners who are concerned with the health of our patrons, and not with the economics of having these drugs 'all to ourselves' then we can be optimistic that those to whom we provide health care services will respond to us as professionals.
''This is particularly true in our community practice, for the more we communicate our willingness to consult with our patrons about over-the counter drugs and prescription drugs, the more we are called on to do so."
Counseling Patients on OTC Drugs Prompted by the JAPhA September issue on nonprescription drug advertising, Pharmacist Robert Riffee of Blackstone, Virginia, has written to us about what he feels is a very important part of the practicing pharmacist's responsibilities-that of consulting with patients about o-t-c drugs. Because he feels strongly that the pharmacist is the most accessible health professional in the community and the most logical person patients turn to for advice on self-medicating, Riffee has explored ways in which he can best serve the role of consultant. To this end, he has made an effort to make the prescription department in his pharmacy conducive to answering questions his patients ask about o-t-c drugs. During remodeling two years ago, all of the o-t-c medications that Riffee and his colleague, Mills Doyle, would be recommending most often were placed in the prescription area. These included cough and cold preparations, analgesics and vitamins. Thus, these products are not available for self-service and are under the constant scrutiny of the pharmacist. With various prescription drugs being
Vol. NS 16, No. 11, November 1976
607
include analytical procedures, the adequacy of such procedures must be established prior to the qualification of any process or product. Needless to say, any change in the manufacturing and control process must oe subject to the same challenge as an entirely new product. In this age of economic difficulty, design is an essential tool in controlling unnecessary expenditure of manpower, materials and capital. Product failure because of lack of attention to these factors can, as we all know, cause recall situations requiring manpower expenditure by both the firm and the agency. Just as important if not more so, defective products can affect the consumer's pocketbook and can result, especially in a difficult economic time, in a lack of confidence in the industry's products. Regulatory agencies such as FDA also have a responsibility in this area. In considering changes in requirements as enunciated in regulations, we must justify to ourselves
as well as to you and the rest of the public any additional requirements which cost money. In closing, I would like to mention the most important quality factor in the manufacture of any product, especially pharmaceuticals. That quality factor applies not only to those who produce pharmaceuticals, but to us in the federal government who have the responsibiUty under the law for assuring that the firms and their products meet the requirements of the law. That quality factor does not depend on chance but, rather, on design. That quality factor is a dedication to the high principles of serving the citizens of this country by assuring that the pharmaceutical supply is of uniform high quality and is produced under uniformly high conditions under the direction of people who make the right decision at the right time. •
A Community Pharmacist's. View
moved to nonprescription status, and recognizing that o-t-c drugs have potential side effects, Pharmacist Riffee states that now more than ever, counseling is needed concerning these products, their potential side effects and interactions with other drugs. In his pharmacy, these o-t-c medications have been placed in one area from which Riffee and Doyle can counsel patients. To supplement the counseling, a patient compliance sheet with do's and don't's concerning the drugs is given to the patient. The important thing, Riffee feels, is to reinforce the instructions so that the patient appreciates the fact that these medications are potent and can have potential side effects with which the patient must be concerned. He states"These are responsibilities practicing pharmacists must accept in this day when prescription strength medication is being moved from legend to over-the- counter status-responsibilities that are vital to maintaining the good health of the people. If we respond as practitioners who are concerned with the health of our patrons, and not with the economics of having these drugs 'all to ourselves' then we can be optimistic that those to whom we provide health care services will respond to us as professionals.
''This is particularly true in our community practice, for the more we communicate our willingness to consult with our patrons about over-the counter drugs and prescription drugs, the more we are called on to do so."
Counseling Patients on OTC Drugs Prompted by the JAPhA September issue on nonprescription drug advertising, Pharmacist Robert Riffee of Blackstone, Virginia, has written to us about what he feels is a very important part of the practicing pharmacist's responsibilities-that of consulting with patients about o-t-c drugs. Because he feels strongly that the pharmacist is the most accessible health professional in the community and the most logical person patients turn to for advice on self-medicating, Riffee has explored ways in which he can best serve the role of consultant. To this end, he has made an effort to make the prescription department in his pharmacy conducive to answering questions his patients ask about o-t-c drugs. During remodeling two years ago, all of the o-t-c medications that Riffee and his colleague, Mills Doyle, would be recommending most often were placed in the prescription area. These included cough and cold preparations, analgesics and vitamins. Thus, these products are not available for self-service and are under the constant scrutiny of the pharmacist. With various prescription drugs being
Vol. NS 16, No. 11, November 1976
607