Consumer Processing and Use of Supplementary Drug Label Information

F. Robert Dwyer, University of Arizona
ABSTRACT - Right to know arguments, comprehension effects on compliance and shortcomings of verbal communications from medical staff have fostered increased interest in written patient-oriented information on drugs. This paper presents an experimental approach for the evaluation of cognitive and behavioral impacts of alternative communication designs.
[ to cite ]:
F. Robert Dwyer (1978) ,"Consumer Processing and Use of Supplementary Drug Label Information", in NA - Advances in Consumer Research Volume 05, eds. Kent Hunt, Ann Abor, MI : Association for Consumer Research, Pages: 220-226.

Advances in Consumer Research Volume 5, 1978      Pages 220-226

CONSUMER PROCESSING AND USE OF SUPPLEMENTARY DRUG LABEL INFORMATION

F. Robert Dwyer, University of Arizona

ABSTRACT -

Right to know arguments, comprehension effects on compliance and shortcomings of verbal communications from medical staff have fostered increased interest in written patient-oriented information on drugs. This paper presents an experimental approach for the evaluation of cognitive and behavioral impacts of alternative communication designs.

INTRODUCTION

The extent of patient non-compliance with prescription drug therapy has been measured at rates ranging from 4 to 90%, with the average near 35 to 45% (Boyd et al, 1974). The consequences of patient overdosages, omissions, and improper mixing include deprived therapeutic benefits and distorted evaluation of therapy in addition to economic wastage.

Studies of the causes of patient non-compliance have identified several patient and treatment factors--perceived seriousness of the illness, side effects from the medication, confidence in the physician. Blackwell (1973) has reviewed the literature on compliance and concludes, however, that beyond patient and treatment factors ....

The most important contribution to compliance is the understanding a patient has of the illness, the need for treatment and the likely consequences of both. (p. 252)

Moreover, this point of view has been supported by recent research (Clinite and Kabat, 1976; Cole and Emmanuel, 1971; and Madden, 1973). The issue is not so clear-cut, though, as Malahy (1966) and Sackett et al (1975) failed to find compliance effects from increased comprehension of treatment and illness.

Nevertheless, educating patients about their prescription drugs is becoming an important component in health care. Fueled by this trend has been a growing interest in the subject of patient package inserts (PPI's)--written patient-oriented information on drugs. Recently a measure (HR 14289) was introduced before the House that would require PPI's be distributed with all prescription drugs. Another, S-1282, requiring PPI's for drugs undergoing the final phases of clinical evaluation was proposed by Kennedy in the Senate. Not unexpectedly, a good deal of political controversy accompanying the PPI interest hinges on the patient's right to know about his or her condition and treatment, versus the physician's responsibility to create a favorable clinical milieu, which is sometimes assumed to require the withholding of information on medication side effects and interactions.

Beyond the "right-to-know" stance, additional arguments advanced by PPI proponents include the shortcomings of the physician's verbal counseling of the patient: (1) verbal counseling is often forgotten, (2) the physician may be too busy to counsel, and (3) the patient's perception of his or her doctor's time-press may discourage patient questioning. Verbal counseling by the pharmacist has similar problems. In addition, the prescription may be dispensed to a third party (a person sent to the pharmacy by the patient), and the pharmacist who prepares the prescription may not be the person who physically distributes the medication.

PPI opponents counter with arguments that inserts will lead to dangerous attempts of patients to self medicate. Also, the provision of cautions and enumeration of even rare side effects may foster undue anxieties in patients. Obviously, cost and distribution problems are also raised.

Fortunately, at a recent symposium in Washington, D.C., PPI proponents and opponents recognized the inadequacies of current research and agreed on the importance of addressing the following key questions:

1. What ought patients to know about the medicines prescribed for them?

2. What effect will such information have on patients and on the practice of medicine?

3. How can the information be best communicated?

4. What is the best delivery method? (Schmidt, 1976)

The purpose of this article is to address the above questions by highlighting significant findings and shortcomings of previous research in the area. Moreover, the literature review leads to a set of hypotheses that were tested in a factorial field experiment run on consumers of anti-hypertensive diuretics.

PREVIOUS RESEARCH AND EXPERIENCE

Several studies have examined the question of what information should be provided to patients. Smith (1975) and Hussar (1975) recommend patients be informed of the (1) purpose of the medication, (2) proper times and methods of administration, and (3) special precautions to be observed while taking the medication. Joubert and Lasagna (1975) assessed the information needs of consumers via telephone survey and found the name of the drug, its purpose, and adverse effects and cautions in normal use desired by 97, 93, and 89%, respectively. Similar percentages were obtained in a Food and Drug Administration survey of oral contraceptive users (FDA, 1975).

A recent study by Katz and Rose (1976) suggests that a reliance on survey data for assessing consumer information needs can be misleading. A majority of their respondents wanted additional information on light bulbs that, in fact, had been heretofore provided for several years. In proper perspective, it seems that asking consumers if they would like to know more about the drugs they take may be equivalent to asking them if steps should be taken to lower property taxes.

The research on the effect of amount of information on decision making may have PPI significance. As a source of health education information, PPI's should help consumers make several kinds of decisions--the decision to initiate, alter, or discontinue drug therapy or contact with the medical staff, and the "implicit" decision a patient makes every time he or she remembers or forgets to take a prescribed drug (Morris, 1977).

In simulated war games and lesser developed country economy management games, Suedfeld and Streufert (1966) and Schroder, Driver, and Streufert (1967) consistently discovered an inverted U-shaped relationship between optimal decision making and amount of input information. Recently Jacoby and associates (1974; 1974b) have found evidence of possible overload effects in a simulated purchase situation. Although several scholars have challenged their interpretations (Summers, 1974; Wilkie, 1974a), and the external validity of the brand X attribute matrix is suspect, the overload phenomenon is nevertheless intriguing.

Indeed, the PPI concept is just one significant dimension of the accelerating interest in consumer information disclosure in a number of product categories (Wilkie, 1974b; Day, 1976). Therefore, a good deal may be learned by examining previous experiences in disclosure measures.

Field experience in non-drug information disclosure has shown little evidence of overload ("confused, dysfunctional'') behavior, rather, minimal to nonuse of the policy-provided information. The interpretation of these results has primarily occupied two dimensions: (1) the compatibility of the newly disclosed information with the abilities of consumers to process (attend, comprehend, believe, and retain) this information, and to a lesser extent, consumer motivation to use the information. A brief examination of the performance of recent disclosure laws will serve to highlight these points.

The results of unit pricing experiences have shown consumer awareness to vary between 50 and 82% (Monroe and LaPlaca, 1972; Carman, 1972-73). While 5 to 38% claimed they had used the information to switch package sizes or change brands, warehouse movements reflected no such shifts. Houston (1972) bypassed the possibility that price is often a nondeterminant factor by instructing his subjects to shop for the most economical brand and size. Here, when consumers were motivated to shop "economically'' unit price savings were achieved.

Before leaving the topic of unit pricing, it is worthwhile to note that a portion of the variance in consumer-reported familiarity and use of unit price information can be explained by the differences in the manner in which the information was presented. Formats have included shelf tags, computer print-outs, and display signs. Following several laboratory studies of decision making, Russo et al (1975) hypothesized that a single list of all brand/sizes and their unit prices is an effective presentation of unit price information. In a five-week sales test on three products there was a significant shift in sales from higher to lower priced brands within each brand subgroup (local/national).

In another area, Day (1976) argues that truth-in-lending (TIL) requirements suffer from design problems. While finding just 10% of credit buyers of durables claiming use of the TIL information, he suggests the buyer does not get the correct information when it is needed, prior to the point of decision, but after the effective oral agreement has been concluded.

Finally, an experiment by Asam and Bucklin (1973) is of considerable significance because it not only shows that attention varies by format but that consumers make product inferences that vary with the amount of detail or preciseness of (nutritional) information.

While these brief reviews of non-drug disclosure laws have served well to illustrate the importance of presenting the "right" information, in the "right" format, at the "right" level of detail, at the "right" time, perhaps even greater insights can be gleaned from the lone PPI evaluation.

Since 1970 the FDA has required that basic warnings and instructions be distributed with birth control pills. In addition, two brochures, one prepared by the American Medical Association and the other by drug manufacturers, providing a fuller discussion of risks and benefits were distributed by the physician upon the patient's request. In 1975 the FDA contracted for a nationwide survey of former and current oral contraceptive (OC) users to collect information about distribution, readership, comprehension and reported behavioral changes induced by the inserts.

The results of this study (FDA, 1975) have been recently summarized by Morris et al (1977). The survey disclosed that 93% reported receipt of the PPI and 94% of those read it. Only 54% knew that OC's could cause blood clots, in spite of the fact that the inserts stated that blood clots were the most serious side effect of the pill. Also, only one-third of the OC users who reported having never received an insert were "concerned" about not getting one. The non-readers most frequently said they "always ask (their) doctor such questions."

The AMA and manufacturers' brochures were reported less widely distributed. Yet, among those who received the brochure, an equally high (95%) level of readership was reported. Interestingly, more women retained the often more detailed manufacturer-prepared brochure (50%) than the AMA brochure (16%). Only 11% report consulting either PPI or brochure on occasions subsequent to the initial prescription receipt. The brochure and insert were consulted upon instances of side effects, missed pills, or when the physician was unavailable.

Twelve percent of the current users who had read the insert reported that it had raised questions that caused them to contact their physicians. About one in seven insert readers report the insert causing either increased or decreased visits or calls to the doctor. Two-thirds of these decreased physician contacts. Among the brochure readers about the same proportion report physician contact changes. In four-fifths of the cases here, however, the action was toward reduced physician contact.

At least two policy implications from this research have been identified by the FDA. First, since patients tended to physically retain the more detailed brochures, it has been proposed that the brochure be expanded to include more detailed information related to pill use. Secondly, since the insert had nearly three times the distribution level of the physician-distributed brochure, the FDA has proposed the pharmacist directly distribute the pills and insert.

While the oral contraceptive insert/brochure experience has provided a great number of insights for the development of a full-scale PPI program, . . .

OC users are not typical of the general patient population and survey research cannot answer all critical questions. Studies of patients undergoing treatment for disease are also needed to help determine the best methods of communicating important patient information (Morris et al, 1977, p. 25).

Hence, Morris et al complete the rationale for the study described below.

METHODOLOGY

An input-output approach was employed on newly diagnosed hypertensive patients in a 32 factorial design, in a clinical setting, to determine what presentation format and what level of detail in the information contained in the insert were optimal in terms of:

1. Enhancing compliance and clinical outcome

2. Facilitating patient "processing" of the information

3. Fostering optimal levels of anxiety

Specifically, the design was employed to test the following set of hypotheses:

1. Form of presentation and level of detail of PPI information have no effect on patient compliance and clinical outcome.

2. Form of presentation and level of detail of PPI information have no effect on patient perceived experiences with side effects.

3. Form of presentation and level of detail of PPI information have no effect on patient treatment-related anxiety.

4. Form of presentation and level of detail of PPI information have no effect on patient information processing (attention, yielding, comprehension) of drug information.

5. Form of presentation and level of detail of PPI information have no effect on patient physical retention of the insert.

6. The coefficients of the likely covariates of compliance, experience with side effects, information processing, and physical retention of the PPI are all zero. These covariates include:

a. Attitude toward physician

b. Concern for health

c. Perceived seriousness of condition

d. Sex

e. Education, occupation, etc.

f. Health Locus of Control score

Treatments

Russo and company's (1975) unit pricing experiment proves the importance of the form of presentation in consumer information disclosure programs. Also, by following Bettman's (1975) line of thought in information environment design, it should be kept in mind that consumption of medication over time means possible adverse reactions or complications over time, requiring recollection of information from the medical staff or PPI. Unless the patient tape records conversations with medical personnel, the feature of external information storage is unique to the PPI. It seems desirable, then, to attempt to develop a PPI that would facilitate a patient's physical retention of it.

It is possible, however, that the creation of a widely retained insert is an insurmountable (patients misplace or dispose of a designed-to-be-retained insert) or unnecessary task (patients hold on to almost anything). If the former is the case, the focus of PPI design efforts should be on gaining and holding the patient's initial attention and interest in its contents.

In the event that neither a designed-to-be-retained insert nor the designed-to-be-attractive insert offer significant improvements in patient comprehension, retention and compliance, or if patients are motivated to attend to nearly any format, the design focus should be on minimizing the cost of the PPI.

It follows, then, that the form of presentation of drug information, henceforth designated factor A, should be tested at a minimum of three levels. The specific factor A levels are summarized in Table 1.

The information categories appropriate for patient package inserts, the literature suggests, are essentially settled. Yet to be determined, however, is the relative amount of detail an insert should provide in each of the categories.

TABLE 1

FACTOR A: FORM OF PRESENTATION

"Amount of detail" is a versatile phrase that can encompass a number of dimensions. Amount of detail on side effects, for example, could include gradations within the areas of (1) descriptive information, (2) remedies, or (3) causes. In this study, gradations in amount of detail have been made across the areas enumerated above. Specifically, the levels progress from "what can happen," to "what to do if it does," to "why it happens." This sequence is best defended by paraphrasing McGuire (1976): People already know side effects, risks, and medication errors are bad; people must be taught how they can cope with and avoid them.

The "whys" of side effects and precautions may have one or more of the following effects: (1) enhance/hinder the believability of the PPI, (2) soothe anxieties accompanying the medication program, or (3) foster anxiety through confusion. Therefore, their inclusion or exclusion from the PPI is a significant policy issue.

The amount of detail, henceforth designated factor B, was examined at the levels summarized in Table 2.

TABLE 2

FACTOR B: AMOUNT OF DETAIL

The design of the test inserts was facilitated by the information presented in the Physician's Desk Reference and Govoni and Hays (1971). Insert prototypes were reviewed by the head pharmacist and three doctors on staff at the supporting medical center. Inserts were modified in light of their remarks.

Type size was held constant across all treatments, while a graphics consultant was employed in the design of the front cover of the brochure insert, A2. Sixty-pound green construction paper was the vehicle for A2 and A3 was bound in a green Duo Tang notebook. The amount of detail, factor B, levels are depicted in the Appendix.

Experimental Design

The experimental design employed in this study provided for replicates of a 32. Experimental subjects in this design were newly diagnosed hypertensive patients at the St. Louis Park Medical Center in the Minneapolis suburb. Furthermore, to facilitate cost control and minimize variance in the treatment regimen, the population of eligible subjects was limited to essential hypertensives prescribed diuretics. Finally, due to limitations of experimenter control, only patients receiving their prescriptions at the Medical Center Pharmacy were eligible for study. The director of the Medical Center had estimated that 30% of the center-prescribed medications were dispensed at the Medcenter Pharmacy. There was no evidence indicating that those not dispensing there were different in regards to the outcome measures to be discussed below.

Inserts in coded bags were dispensed at the pharmacy by a double blind procedure. Two weeks after the receipt of the medication and insert, the patient received a letter from the pharmacist. The letter stated that unless the patient called to state otherwise a researcher from the University of Minnesota would soon call to set up a half-hour interview dealing with his or her opinions on medications, health, and health care in general. About one in six patients did not wish to be called.

The patient interview was completed approximately one month after medication and insert receipt. Patient comprehension of the insert information was assessed in Section 1, a set of 20 true-false, yes-no, and multiple choice questions. Two of the 20 questions were dummy items on topics not discussed in any insert but included to confound yea-saying.

Section 2 of the questionnaire explored the patient's recollection of receipt of the insert (aided and unaided). In addition, physical retention and recalled use of the insert were examined. Insert believability or patient yielding was measured with an itemized rating scale nested among measures of PPI complexity and completeness. Also, patients' valuations of other sources of drug information were obtained.

Patient recollection of side effects was solicited with an open ended question. The interviewer probed for the frequency of occurrence of each experienced side effect and whether or not the patient took special actions--such as calling the medical staff, ceasing medication, etc.

Section 3 employed a lead-in and probing to assess patient compliance with medication directions. This section also obtained patients' prior familiarity with the drug and family experience with hypertension.

Section 4 measured several suggested covariates of compliance and was completed by respondents by hand. Importance and belief scores were obtained on five attributes of physicians in general and the prescribing physician. These attributes, identified in patient focus groups, were: (1) knows his/her business, (2) is friendly, (3) communicates in patient terms, (4) charges reasonable rates, and (5) shows real concern for the patient.

A second portion of Section 4 consisted of items from the A-State anxiety measure developed by Spielberger et al (1970). This scale has been used to measure the level of anxiety raised by a situation, as opposed to the A-Trait measure which seeks to assess the anxious tendencies of individuals. The instrument has never been used to measure the anxiety caused by a communication message and should be interpreted with caution; it is possible that the interview itself fosters anxiety in individuals. Also, since it was felt that the original 20-item instrument was too threatening and fatiguing for the study purpose, a random selection of 10 items yielded a more workable instrument. Nested among the 10 items were three similar statements designed to assess subjects' degree of concern for their health.

The third portion of Section 4 was a health locus of control measure developed by Wallston et al (1975). This scale has been used to examine an individual's belief in internal control of physical health or well being. In their validation efforts, the developers of this scale noted some evidence of greater information seeking among subjects classified as internals.

Finally, respondents indicated their occupation, level of education, marital status, and number of children (under 18 years) living at home.

In addition to the data obtained from patient interviews, subject deviations from the prescription refill date and changes in blood pressure readings were obtained from Medical Center and Pharmacy archive data. Blood pressure readings used were those taken closest to one month after the initial diuretic prescription was dispensed.

RESULTS

At this point in time, data has been obtained on 30 subjects--providing approximately three replicates. This apparently small sample size is characteristic of previous research in patient education and is indicative of the difficulties encountered in such field research. Nevertheless, the data contain a number of interesting facets and are presented as preliminary in light of continuing data collection.

First, to briefly contrast this experiment with the previously reported OC experience, 100% reported receipt of the PPI on diuretics. Physical retention of the insert by hypertensives was higher (67% vs. 50%) but the OC retention rate was measured much later from the time of initial receipt. Forty-eight percent of the hypertensives (vs. 11% of the OC users) reported looking back at the insert. Most common reasons for subsequent insert consultations were to recall special cautions and side effects.

Subjects scored an average of 69% on the measure of comprehension; the most commonly missed items dealt with the drug's effects on pregnant and breast-feeding women. Overall, the inserts were rated clear and helpful. In addition, subjects rated the inserts on a par with the prescribing physician in terms of contribution to their understanding the nature of the drug.

A two-factor fixed effects analysis of variance/covariance model was examined for each of the dependent variables enumerated in hypotheses 1-6. Since there were unequal cell sizes the dummy variable regression approach was employed as covariate coefficients, interactions and main effects were tested at a = .1. The results of these tests are addressed in the following paragraphs and are summarized in Table 3.

Two dependent variables were employed in testing hypothesis 1, which dealt with treatment effects on compliance. The number of days delinquent (early) from the compliant refill date is the variable labeled "Refill deviance" in the first row of Table 3. While there are no main effects on this measure of compliance, patients who received minimum information on onion skin were significantly more deviant.

Hypothesis 1 was also tested on a dichotomous criterion, patient self report of compliance. Here the hypothesis is rejected on the basis of significant factor B effects. In examining the coefficients from Table 3 two items deserve special notice. First, among factor levels, the largest increment in compliance comes in B2, in which remedies and strategies for coping are provided. Interestingly, this information was also included in B3, which did not foster increased compliance. Second, and related to hypothesis 6, education beyond high school is positively associated with compliance. No treatment effects on clinical outcome were uncovered.

TABLE 3

SUMMARY OF SIGNIFICANT STANDARDIZED REGRESSION COEFFICIENTS FOR THE TESTED HYPOTHESES

The presence of both A and B factor effects on whether subjects experienced side effects requires the rejection of hypothesis 2. Patients receiving the onion skin and/ or strategies for dealing with difficulties are more likely to notice side effects. This pattern does not seem to be related to any anxiety-inducing treatment effects as hypothesis 3 is accepted.

Hypotheses 4 and 5, dealing with treatment effects on patient information processing, are accepted in their null form. There were several occasions when, as the only model elements, main effects on insert believability, comprehension, and physical retention were significant. However, this significance disappeared as other, more powerful variables were introduced.

As attention shifts to hypothesis 6 dealing with the impact of the covariates of these processing criteria, a number of interesting relationships are revealed. First, since all experimental subjects recall getting an insert, no significant covariates were expected. However, both aided and unaided measures of insert believability (coded in terms of unbelievability) are inversely correlated with patients' attitudes toward their prescribing physician. In the aided measure, inserts prove less credible to females and patients highly concerned about their health.

Comprehension of the purpose and nature of the drug is positively correlated with patients' attitude toward their doctor and their concern for health. This latter variable is also significant in explaining 18% of the variation in physical retention rates.

CONCLUSIONS

The focus of this research has been on the measurement of end-states as they have been effected by the insert stimuli. The information processes themselves were never explicitly measured. However, the alternative approaches, direct monitoring and decision net, become unworkable in field evaluations.

Furthermore, the study does not pretend to have explored all possible vehicles of written drug information. However, the chosen factor levels were of such a diverse nature that if form of presentation effects do exist, they would have been identified in this design. Level of detail effects would seem to be easily manufacturable--technical names for side effects and precautions would be nearly impossible for patients to understand. The examined range of this factor was deliberately restricted to what are currently considered realistic levels from a judgmental perspective.

Also, the generalizability of these findings is limited to disease categories similar in nature and consequences to hypertension. It is likely that a patient with an acute condition requires a different insert than the chronic subjects of this study. Further research is required with patients with a variety of acute conditions.

In spite of these limitations, however, several important conclusions seem inescapable. First, on a descriptive level, several insights have been gained into patient use of supplementary drug information. These findings complement the earlier study of OC users. Moreover, the demonstrated effects of form of presentation and level of detail on patient compliance, anxiety, and understanding provide evidence for PPI program and vehicle design.

Regardless of which compliance measure is used, the data suggest that patients need information beyond the basic purpose, side effects, do's, and don'ts. Looking at patient self-reports of compliance, it is clear that strategies for coping with the possible treatment remedies are required. This information may make patients more likely to notice side effects, as does the onion skin format, but no measurable increase in anxiety is fostered by these treatments. It is also worthwhile to note that the provision of B3 information, the why's, does not enhance compliance,-affect experiences with side effects, nor foster insert credibility.

Patient information processing of the inserts is explained primarily by motivational factors--not the communication stimuli themselves. It should be noted, however, that after the motivational covariates, in several instances, factor main effects were only "marginally" insignificant. They may enter the model as the power of the tests increase with continuing data collection.

APPENDIX

B1 LEVEL OF INFORMATION

YOU AND YOUR MEDICATIONS

YOUR DOCTOR HAS PRESCRIBE/) A DIURETIC (DI-YU-RET-IK) DRUG, DIURETIC DRUGS ARE MADE BY SEVERAL- DRUG COMPANIES, EACH COMPANY HAS ITS OWN NAME FOR THE DRUG IT MANUFACTURES, IT IS IMPORTANT TO KNOW THE NAME OF THE DRUG YOU ARE TAKING, READ CAREFULLY THE INSTRUCTIONS ON THE LABEL, FOLLOW THOSE INSTRUCTIONS.

IT IS IMPORTANT THAT YOU TELL YOUR DOCTOR IF YOU HAVE DIABETES, LIVER OR KIDNEY PROBLEMS, ALLERGY OR BRONCHIAL ASTHMA. ALSO, TELL YOUR DOCTOR IF YOU ARE PREGNANT OR BREAST FEEDING.

THE PURPOSE OF THIS DRUG IS TO REMOVE YOUR BODY'S EXCESS SALTS AND WATER. SOME OF THE DIRECT EFFECTS OF THIS MEDICATION ARE MORE FREQUENT URINATION, OCCASIONAL DIZZINESS, LIGHT-HEADEDNESS OR HEADACHE, AND SOMETIMES DRY MOUTH, THIRST, OR CRAMPS IN MUSCLES.

RARELY, SIDE EFFECTS SUCH AS PERSISTENT FATIGUE OR NAUSEA, STOMACH CRAMPS OR RASH OCCUR. THESE SHOULD BE REPORTED TO YOUR DOCTOR.

FINALLY, YOUR DOCTOR MAY WANT TO SEE YOU AFTER A MONTH OR MORE TO CHECK ON TREATMENT EFFECTIVENESS. CONTACT YOUR DOCTOR SOONER IF YOU HAVE ANY OF THE PROBLEMS MENTIONED ABOVE.

ANY QUESTIONS CAN BE DIRECTED TO THE PHARMACY STAFF BY CALLING:

926-5522

B2 LEVEL OF INFORMATION

YOU AND YOUR MEDICATIONS

YOUR DOCTOR HAS PRESCRIBED A DIURETIC (DI-YU-RET-IK) DRUG, DIURETIC DRUGS ARE MADE BY SEVERAL DRUG COMPANIES, EACH COMPANY HAS ITS OWN NAME FOR THE DRUG IT MANUFACTURES, IT IS IMPORTANT TO KNOW THE NAME OF THE DRUG YOU ARE TAKING. READ CAREFULLY THE INSTRUCTIONS ON THE LABEL. FOLLOW THOSE INSTRUCTIONS,

IT IS IMPORTANT THAT YOU TELL YOUR DOCTOR IF YOU HAVE DIABETES, LIVER OR KIDNEY PROBLEMS, ALLERGY OR BRONCHIAL ASTHMA ALSO, TELL YOUR DOCTOR IF YOU ARE PREGNANT OR BREAST FEEDING.

THE PURPOSE OF THIS DRUG IS TO REMOVE YOUR BODY'S EXCESS SALTS AND WATER. A DIRECT EFFECT OF THIS DRUG IS MORE FREQUENT URINATION. UNLESS OTHERWISE DIRECTED, TO AVOID GETTING UP IN THE NIGHT, TAKE MEDICATION BEFORE NOON.

YOU MAY OCCASIONALLY EXPERIENCE DIZZINESS, LIGHT-HEADEDNESS OR HEADACHE. WHEN THESE OCCUR, REST A WHILE. DO NOT GET UP AND DOWN SUDDENLY. MOVE MORE SLOWLY. YOU MAY GET VERY THIRSTY AND HAVE A VERY DRY MOUTH. FRUITS AND FRUIT JUICES AND FRESH VEGETABLES ARE THE BEST REMEDY FOR THIS DISCOMFORT.

RARELY, SUCH SIDE EFFECTS AS PERSISTENT FATIGUE, NAUSEA, STOMACH CRAMPS OR RASH OCCUR. THESE SHOULD BE REPORTED TO YOUR DOCTOR. REMEMBER, THOUGH, THESE PROBLEMS OCCUR NATURALLY FROM TIME TO TIME EVEN WHEN YOU'RE NOT TAKING ANY MEDICATION. UNLESS THEY OCCUR FREQUENTLY, FOLLOW YOUR USUAL PROCEDURES OF TREATMENT. TAKING THE DRUG WITH MEALS MAY PREVENT STOMACH IRRITATIONS.

FINALLY, YOUR DOCTOR MAY WANT TO SEE YOU AFTER A MONTH OR MORE

TO CHECK ON TREATMENT EFFECTIVENESS. CONTACT YOUR DOCTOR SOONER IF YOU HAVE ANY OF THE PROBLEMS MENTIONED ABOVE.

ANY QUESTIONS CAN BE DIRECTED TO THE PHARMACY STAFF BY CALLING:

926-5522

B3 LEVEL OF INFORMATION

YOU AND YOUR MEDICATIONS

YOUR DOCTOR HAS PRESCRIBE]) A DIURETIC (DI-YU-RET-IK) DRUG. DIURETIC DRUGS ARE MADE BY SEVERAL DRUG COMPANIES, EACH COMPANY HAS ITS OWN NAME FOR THE DRUG IT MANUFACTURES, IT IS IMPORTANT TO KNOW THE NAME OF THE DRUG YOU ARE TAKING. READ CAREFULLY THE INSTRUCTIONS ON THE LABEL. FOLLOW THOSE INSTRUCTIONS,

IT IS IMPORTANT THAT YOU TELL YOUR DOCTOR IF YOU HAVE DIABETES, LIVER OR KIDNEY PROBLEMS, ALLERGY OR BRONCHIAL ASTHMA -- AS THOSE CONDITIONS CAN BE AGGRAVATED BY THIS DRUG. ALSO, TELL YOUR DOCTOR IF YOU ARE PREGNANT OR BREAST FEEDING BECAUSE THE DRUG CAN BE PASSED TO THE FETUS OR CHILD.

THE AIM OF THE TREATMENT IS TO REMOVE YOUR BODY'S EXCESS SALTS AND WATER. A DIRECT EFFECT OF THE DRUG, THEN, IS MORE FREQUENT URINATION. UNLESS OTHERWISE DIRECTED, TO AVOID GETTING UP IN THE NIGHT, TAKE YOUR MEDICATION BEFORE NOON. DUE TO THE ELIMINATION OF SOME WATER AND SALTS IN YOUR BLOOD, YOU MAY OCCASIONALLY EXPERIENCE DIZZINESS, LIGHT-HEADEDNESS OR HEADACHE. WHEN THESE OCCUR, REST FOR A WHILE. DO NOT GET UP AND DOWN SUDDENLY. MOVE MORE SLOWLY.

YOU MAY GET VERY THIRSTY AND HAVE A DRY MOUTH. THIS IS BECAUSE YOUR BODY NEEDS SOME SPECIAL SALTS. FRUITS AND FRUIT JUICES AND FRESH VEGETABLES ARE THE BEST REMEDY FOR THIS DISCOMFORT.

RARELY, SUCH SIDE EFFECTS AS PERSISTENT FATIGUE, NAUSEA, OR STOMACH CRAMPS OCCUR. THESE MAY BE CAUSED BY AN OVERDOSAGE AND SHOULD BE REPORTED TO YOUR DOCTOR. REMEMBER, THOUGH, THESE PROBLEMS OCCUR NATURALLY FROM TIME TO TIME EVEN WHEN YOU'RE NOT TAKING ANY MEDICATION. UNLESS THEY OCCUR FREQUENTLY, FOLLOW YOUR USUAL PROCEDURES OF TREATMENT. TAKING THE DRUG WITH MEALS MAY PREVENT STOMACH IRRITATIONS. IF A RASH APPEARS, IT MAY MEAN YOU ARE ALLERGIC TO THE MEDICATION. TELL YOUR DOCTOR RIGHT AWAY.

FINALLY, YOUR DOCTOR MAY WANT TO SEE YOU AFTER A MONTH OR MORE TO CHECK ON TREATMENT EFFECTIVENESS. CONTACT YOUR DOCTOR SOONER IF YOU HAVE ANY OF THE PROBLEMS MENTIONED ABOVE.

ANY QUESTIONS CAN BE DIRECTED TO THE PHARMACY STAFF BY CALLING:

926-5522

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Edward H. Asam and Louis P. Bucklin, "Nutritional Labeling for Canned Goods: A Study of Consumer Response," Journal of Marketing, (April 1973), 32-37.

James R. Bettman, "Issues in Designing Consumer Information Environments," Journal of Consumer Research, 2 (December 1975), 169-177.

Barry Blackwell, "Patient Compliance," The New England Journal of Medicine (August 2, 1973), 249-252.

James R. Boyd, Tim R. Covington, Walter F. Stanaszek, and R. Timothy Coussons, "Drug Defaulting. Part I: Determinants of Compliance," American Journal of Pharmacy, 31 (April 1974), 486-491.

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Phillip Cole and Sister Emmanuel, "Drug Consultation: Its Significance to the Discharged Hospital Patient and its Relevance as a Role for the Pharmacist," American Journal of Hospital Pharmacy (December 1971), 954-960.

George S. Day, "Assessing the Effects of Information Disclosure Requirements," Journal of Marketing (April 1976), 42-52.

Food and Drug Administration, Survey of Consumer's Perceptions of Patient Package Inserts for Oral Contraceptives (Springfield, Virginia: National Technical Information Service, 1975).

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