Child-Resistant Containers—Effects on Patient Care

AGP questionnaire reveals lack of patient knowledge, acceptance

Child-Resistant ContainersEffects on Patient Care

The Polson Prevention Packaging Act of 1970 (Public Law 91 -601) was enacted by the U.S. Congress "to provide for special packaging to protect children from serious personal injury or serious illness resulting from handling, using, or ingesting household sUbstances. " As the result of a series of regulations promulgated by the Food and Drug Administration and by the Consumer Product Safety Commission (responsibility for administration ' of the Act was transferred to CPSC in 1973), all prescription drugs in oral dosage forms now require child-resistant packaging, except a few products that have been granted specific exemptions . The American Pharmaceutical Association has always supported wholeheartedly the primary objective of the Poison Prevention Packaging Act of 1970, namely, a reduction in the incidence of accidental child poisoning, and has had official policy supporting the use of child-resistant containers since 1968. Since passage of the Act, APhA has played an important role in keeping its members informed of the provisions of the Act and of the various regulations that have been promulgated during its implementation. Likewise, the Association has consistently cooperated with the Consumer Product Safety Commission indiother pharmacy organizations in seeking ways to assure that implementation of the Act would be effectively accomplished. The first drug products to be made subject to the provisions of the Act were aspirin and aspirin-containing products, for which special packaging has been required since August 14, 1972. The rate of accidental child ingestion of aspirin products has therefore been considered as the first reliable indicator of the effectiveness of the Act. Based upon this parameter the Act appears to be achieving its desired effect, for 1975 injury data released by the Consumer Product Safety Commission indicate a 20 percent decline in the number of aspirin ingestions since the safety packaging requirements went into effect. Although encouraged by these results , APhA has at the same time become increasingly concerned about the growing number of patient care problems related to the use of child-resistant containers. Although these reports have been reaching the Association with greater frequency and from widely varying quarters, it nonetheless has been difficult to document whether or not such problems were being experienced with regularity by a significant number of practitioners and patients on a national basis. Therefore, it was decided that

a study should be conducted to determine to what extent health care problems were occurring that could be related to the use of child-resistant containers. It was hoped that through such a survey specific problems could be identified and solutions then sought, thereby allowing implementation of the Act to proceed more smoothly.

502

Table I

Estim ate of Frequ ency (% o f total respondents)

Methodology

In February 1975, a questionnaire, designated as a " Child-Resistant Container Experience Report Form," was mailed to 2,000 randomly selected members of the Academy of General Practice of Pharmacy of the American Pharmaceutical Association , a population selected because Academy members are pharmacy practitioners and thus would have firsthand experience in the use of child-resistant containers. The questionnaire consisted of 10 questions permitting the respondent to assess the acceptance of child-resistant containers by patients in his own practice; to estimate the extent of exemption requests by patients and prescribers; to judge knowledge of the Poison Prevention Packaging Act and its provisions on the part of physicians and patients; and to indicate the frequency of occurrence in his practice of seven specific patient care problems that are related to the use of child-resistant containers. An open-ended question permitted the respondent to report other problems encountered in his practice that were not among the seven included on the questionnaire. Another open-ended question asked the respondent to suggest changes that would " minimize the poisoning hazard for children while facilitating patient compliance in drug use and storage." Finally, the respondent was asked to supply individual reports of specific cases encountered in which the use of child-resistant containers had had an adverse effect on patient care. Response Of the 2,000 questionnaires mailed, 1,027 were returned for a response rate of 51.4 percent. Of those returned, 950 were from community pharmaCists, 60 from hospital pharmacists and 17 from pharmacists practicing in other environments such as clinics and health maintenance organizations. An additional 12 uncompleted forms were returned by pharmaCists no longer in active practice.

Results and Discussion

Patient Acceptance - Respondents were asked to judge acceptance by their patients of child-resistant packaging used

Frequency of Occurrence of Specific Problems Related to the Use of Child-Resistant Containers

Problem Encountered

Seldo m Occaor sionVery Often Often Never ally 14.4

44.4

40.2

Contain er and/ or 3.9 cap purp osely or acciden tally broken in o rder to remove medica ti on

37.7

40.5

17.5

Patient unable to 4 .1 op en co ntain er without assistance

44 .4

35 .8

15.7

Con tain er 5.8 routin ely left open or with safety fea ture d isengaged

32.5

43 .6

17 .8

36 .2 Properly cl osed co nta iner eas ily opened by children

39 .6

17.4

6.6

Medica tio n trans- 4.4 ferred to ano ther co ntainer without safety fea ture

31.9

38.7

24 .3

48 1

26 .5

10. 1

Container opened by patient wit h grea t difficulty

Spill age or loss o f medica tion while opening co n ta iner

1.0

14.4

for prescription medication. An overwhelming majority of the respondents-80.1 percent- rated patient acceptance as either " fair " or " poor, " while only two percent indicated that it is " excellent." If the Poison Prevention Packaging Act is to ever achieve its intended results, it is obvious that a great deal more must be done to create a much higher degree of acceptance by the general public. Extent of Exemption Requests-Since the Act permits the utilization of conventional packaging upon the request of the patient or prescriber, the respondents were asked to estimate the percentage of prescriptions that they dispensed in conventional packaging in compliance with such requests. The results indicate that the use of the exemption is relatively low, with 41.77 percent of the respondents indicat-

Journal of the American Pharmaceutical Association

ing that they dispense 10 percent or fewer of their prescriptions in non safety packaging. Well over half of the pharmacists replying-63.2 percent-package over 70 percent of the prescriptions they dispense in child-resistant containers. According to the survey results, the vast majority of requests for conventional containers come from patients rather than physicians. As these and the following results confirm, it is likely that the relatively low use of the exemptions permitted by the Act is to some degree due to the general 'unawareness on the part of both patients and physicians that conventional packaging may be requested. Moreover, the data should lay to rest the charge occasionally heard that pharmacists abuse the exemption provision by using it as a loophole to utilize only conventional packaging for dispensing prescription medication. The results show clearly that the large majority of pharmacists surveyed are complying well with the provisions of the Poison Prevention Packaging Act and are routinely using safety packaging for prescription medications. Patient A wareness of Rights-Respondents were asked whether or not most of their patients are aware of the option available to them to request conventional packaging for their prescription medication; 76.9 ' percent of the pharmacists replying feel that most of their patients are unaware of this right. Prescriber Knowledge of the ActSince many aspects of the Act are relevant to the prescriber as well as to the pharmacist and the patient, respondents were asked to assess, on the basis of their experience with prescribers in their areas, prescriber knowledge and understanding of the requirements of the Poison Prevention Packaging Act and the regulations pertaining to the use of child-resistant containers. Only three percent of the pharmacists replying felt that prescriber knowledge and understanding is "excellent," while 76.5 percent assessed prescriber knowledge and understanding as "fair" or "poor." Frequency of Occurrence of Specific Problems-Seven problems were selected for inclusion on the questionnaire-those that had been most often reported to APhA and the Academy in the period between the time implementation of the Act was begun and the time the survey was conducted. Respondents were asked to estimate the frequency of occurrence of each in his own practice indicating whether it occurs (a) "seldom or never," (b) "occasionally," (c) "often" or (d) "very often." The results, expressed in percentages of the

Vol. NS 15, No. 9, September 1975

total number of respondents, appear in Table I (page 502). As expected, difficulty encountered by patients in opening child-resistant containers was the problem most frequently observed by respondents, with 84.6 percent indicating that it occurs "often" or "very often." Over half felt that it is "often" or "very often" that patients are unable to open safety containers without assistance., Fifty-eight percent of the respondents indicated that frequently the ultimate result of the difficulty in opening is breakage of the container and/or the cap, either purposely or aCcidentally. Over 60 percent of the respondents felt that it is "often" or "very often" that patients leave the containers open or with the safety feature disengaged, and 63 percent observed that patients frequently transfer medication to another container. Pharmacists also observed a fair amount of spillage or loss of medication by patients while opening childresistant containers, with 36.6 percent indicating this occurs "often" or "very often." The story has been often told about the ease with which children open safety containers that have successfully foiled the efforts of their parents, and indeed, many pharmacists related such incidents in their survey responses. However, the results indicate that this aspect of the problem may be somewhat over-emphasized, since only 24 percent of the respondents indicated that easy child access occurred "often" or "very often." Even so, this is a high enough response to indicate that further investigation is warranted. It is more than possible that as the number of child-resistant containers in the home increases, the probability of children becoming familiar with the way they operate might also increase. Other PrOblems-Many of the pharmacists responding to the open-ended question on other problems they have encountered used the opportunity to expand on the problems included on the questionnaire. For example, many pOinted out that it was not only patients who have difficulty opening child-resistant containers-so do many pharmacists; some complained of callouses, sprains and other InJunes caused by manipulation of closures. A number of pharmacists cited liquids packaged in child-proof containers as the source of an inordinate number of problems, especially those products such as syrups and suspensions which tend to "gum up" the safety closure mechanism. A number of pharmacists cited specific problems related to patients transferring

medication to other nonsafety containers. Not only is the pOison prevention protection of safety packaging lost in such cases, but the containers to which they are transferred are either unlabeled or may be labeled for a completely different drug product also taken by the patient or for the same drug product with different directions for use. Many also pointed out that containers used for this purpose often provide no protection for the drug product against moisture, light and atmospheric contaminants. Many pharmacists cited container design as a major problem, and some observed that the effectiveness of the safety feature deteriorated after a period of use. Although it is impossible to quantify through these data the relative occurrence of problems with specific brands or types of childresistant containers, a significant number of pharmacists reported that many prob~ lems were related to closures which require the patient to properly align the container and the cap before the con~ainer can be opened, for example, by matching arrows on cap and vial or aligning a tab on the cap with a recess in the cap lip. /:.. few pharmacists noted that child-re-

503

Child-Resistant ContainersEffects on Patient Care

sistant containers are a special problem to non-English-speaking patients since they are unable to read the directions for opening which appear on the containers. Case Study Reports-Because most of the questions on the survey form were directed toward general problems related to the use of child-resistant containers, respondents were also asked to provide reports of specific cases in which the use of child-resistant containers had had an adverse effect on patient care. Pharmacists were asked to describe the patient, the container involved and the incident that occurred. Although specific problems had been identified earlier in the questionnaire, there was no mechanism whereby it could be determined what effect the problem actually had on patient care, so respondents were also asked to describe the outcome. Pharmacist-respondents provided 145 individual case reports, significantly more than had been anticipated. It is, of course, impossible to report verbatim the contents of all reports, but the cases did fall into some general categories. The largest number of cases reported were of situations in which patients had extreme difficulty before finally getting the containers opened, often resulting in extreme mental upset and anguish. Patient solutions to the problem were varied, and in some cases, imaginative. Some resorted to help by outsiders-"the gas station attendant across the street" or the " policeman down at the precinct. " Many pharmacists reported that they had to send pharmacy personnel to the patient's home to open the container. Destruction of the closure or the entire container was a commonly reported remedy; in most cases, this resulted in improper storage of the medication, and in a few cases, patient injury resulted. Although transfer to another container is always undesirable, in some cases reported the practice had potentially serious consequences. As one pharmacist reportedPatient was intelligent 65-year old female. She was on both Lanoxin and Lasix. Because of trouble opening child-resistant containers, she changed them to "old botties" she had around the house. As a result, she was taking the Lanoxin for "water" and the Lasix for "heart. " This was recognized during a refill procedure when she did not get the medication she was expecting to. Luckily, in this case the directions were the same for both, but the potential for a very serious problem existed.

504

The possible consequences of the following case reported by a pharmacist could be numerousMrs. J., an elderly epileptic and highly nervous patient, takes many chronic medications. She was in the habit of opening the plastic (child-resistant) vials with a hammer and pouring all her pills in one bottle. There were many reports of patients failing to take medications as directed by the physiCian solely because of difficulties in opening child-resistant containers, but there was also a disturbing number of cases in which the patient took absolutely no medication because of the inability to get the container open. It would seem that in such cases patients would get help, but as one pharmacist pointed out, many are too proud and independent to seek assistance from others, and in other cases, assistance is not readily available. In many cases reported, the period of time without medication was not critical and the consequences were not serious, but there were too many reports of patients who did not take essential medication for long periods of time. In four such cases, the outcome was hospitalization of the patient. In another case, the pharmacist suspected that the failure to take prescribed medication due to the inability to gain access to it had contributed to the death of a patient. One pharmacist reported such a case resulting in hospitalizationA 60-year old woman was admitted with diagnosis of digitalis toxicity and hypokalemia. Patient was not receiving adequate potassium because she was unable to open the container of KayCiel Elixir. After treatment, she was discharged with K-Lyte tablets, which are not safety-packaged.

It was expected that most of the case reports received would involve elderly or handicapped patients, but there was a surprising number of cases in which noncompliance by pediatric patients resulted from the inability of the patients' parents to open the medication. The following is a typical case report of this typeIn December of 1974, I had a call in the early hours of the morning by a woman who was almost hysterical. It seems she had purchased a bottle of children's aspirin which had a lock cap, as the one she had at home was about empty. She did not try to open it until after store hours. After repeated attempts, she resorted to cold cloths to try to reduce the fever of the child, which was around 104. The child did

fall asleep, but woke up again in a few hours burning up with a fever. The mother went back to the bottle of aspirin and once again tried with no luck. She finally resorted to a hammer and pliers, which resulted in a broken bottle, but then she was afraid to give the aspirin as there was broken glass all over the tablets. By this time she was beside herself and cold compresses did not help. She called me at home, this being 3:00 a.m. I did get her a new bottle and opened it for her, but with great difficulty. Why this child had not gone into convulsions is a miracle, and serious side effects could easily have occurred, to say nothing of the nervous state of the mother. Had this mother had any sort of heart condition, I am sure there would have been two in the hospital-the mother and the child. A Virginia pharmacist reported a similar case involving a six-year-old childA very upset mother of the child brought the unopened container into my pharmacy. She had purchased the prescription in North Carolina and had driven to Richmond with the child and the medication. All the way she and others had tried numerous ways to open the bottle but with no success. By the time she arrived at my pharmacy, she was extremely upset because she had been unable to give the sick child any medication for several hours. Her request was, " Would you please open this bottle for me? I've tried everything but breaking it." With the use of a screw driver to pry up the striped flange, I finally did get the bottle open without breaking it, but this child had been a long time without needed medication. Respondents' Suggested Solutions

Although one of the primary objectives of the study was to identify and measure the extent of occurrence of specific problems related to the use of child-resistant packaging for prescription medications, the ultimate objective is to find suitable solutions to those problems. Therefore, respondents were provided the opportunity, via open-ended question, to suggest changes which would "minimize the poisoning hazard for children while facilitating patient compliance in drug use and storage. " Considerable care was taken in structuring the question so that respondents would not be led into limiting their suggestions to those pertaining to changes in the poison Prevention Packaging Act or related regulations. The effort was obviously successful, for nearly 45 percent of the 701 phar-

Journal of the American Pharmaceutical Association

macists responding to the question felt that patient education would be the most effective approach to reducing the incidence of accidental child poisoning. A large number indicated that educational campaigns should be directed at adults and should emphasize the safe handling and storing of medicines, but most also felt that such programs should also be directed toward young children in order to instill in them a respect for medicines and a knowledge and understanding of their proper use. A few pharmacists, 3.1 percent of those responding to the question, felt that the thrust of a patient education program should be advising patients of their option to request conventional packaging. Almost as many respondents, 300 or 42.8 percent, did suggest changes related to the Poison Prevention Packaging Act. By far the largest number, 201 or 28.7 percent of those responding to the question, felt that the Act should be amended to make the use of child;.resistant containers voluntary rather than mandatory; that is, those patients who have a need for safety packaging, such as those residing in homes with small children, should have the option of requesting that their medications be packaged in child-resistant containers. Respondents felt that this approach would eliminate most of the problems encountered in their practices since patients not wanting or requiring special packaging would not be forced to take special action in order to receive conventional packaging. Fifty-eight pharmacists (8.3 percent) suggested that the pharmacist be given the authority to determine those cases in which special packaging is neither needed nor desired, an authority presently vested in only the pat·ient or the prescriber. Only 41 of those responding (less than six percent) suggested that the Poison Prevention Packaging Act should be repealed. These data indicate clearly that the vast majority of pharmacists strongly support the basic objectives of the Act. Eighty-seven suggestions were related to changes in the packages themselves. Sixty-nine respondents (9.8 percent) felt that improved design of child-resistant containers would significantly improve the situation, and 18 (2.6 percent) suggested that unit dose packaging should be considered. Summary and Conclusions

A survey of 2,000 randomly selected pharmacist-members of the APhA Academy of General Practice of Pharmacy confirmed that a number of specific patient care problems related to the use of child-

Vol. NS 15, No. 9, September 1975

resistant containers occur frequently and that patient acceptance of safety packaging is relatively poor. Respondents felt that patient knowledge and understanding of the Poison Prevention Packaging Act and related regulations are low, specifically of that provision of the Act which permits the patient to request nonsafety packaging for his prescription medication if child access is unlikely or the patient experiences undue difficulty in manipulating safety packaging. Physicians appear to be equally uninformed on the subject. If the Poison Prevention Packaging Act is to achieve' its ultimate objective-a significant reduction or elimination of accidental child poisonings-it is obvious that greater ,public support than is indicated by the survey must be achieved. A continuing public education program, both in regard to the need for safety packaging and other measures necessary to protect children

against poisoning must be a part of the total effort. Additionally, the factor currently proving to be the greatest deterrent to the success of the Act must be overcome, i.e., those patients who for various reasons cannot or will not properly utilize safety packaging must be given free and easy access to use of nonsafety packaging. FinalIy, all concerned with implementation of the Act must be constantly alert that efforts to reduce the incidence of accidental child poisoning do not at the same time create other extensive and serious health care problems. As is always the prudent course, zeal must be tempered with reason . •

505