Key-words: Child-resistance packaging; Elderly; Openability
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A tamper‐resistant package has an indicator or barrier to entry that, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred. Regulations to implement tamper‐resistant packaging on all over‐the‐counter drugs and certain cosmetics began in February 1983. Tamper‐resistant packaging, like child‐resistant packaging, may impede access by the elderly and other adults who have mental, motor, and/or sensory disabilities. This article describes: 1) the reasons for the increasing use of over‐the‐counter medications in the prevention and treatment of the major causes of morbidity and mortality in the elderly; 2) the types of difficulties encountered in opening tamper‐resistant packaging; 3) the causes of these inaccessibility problems; 4) the methods to correct them; and 5) testing procedures to determine whether the existing designs of tamper‐resistant packaging are accessible by the elderly and adults with selected disabilities. Testing of individual types of tamper‐resistant packaging, multiple types of tamper‐resistant packagings on the same container, and combinations of tamper‐resistant packagings and child‐resistant packagings on groups of normal elderly people and those with selected disabilities is necessary to guarantee accessibility to the growing number of therapeutically efficacious nonprescription medications used by these populations.
Evaluation of a novel medication aid, the calendar blister-pak, and its effect on drug compliance in a geriatric outpatient clinic01/01/1987/Journal of the American Geriatrics Society/Scientific Research
A prospective, controlled, crossover study on drug compliance was initiated in 22 elderly patients from a geriatric clinic. Half of the patients received their pills from a commercially prepared calendar mealtime blister‐pak; the remaining patients received their medication from standard pill bottles. At the end of three months the two groups were crossed over. Pill count and issuance of a new drug supply were done monthly to assess compliance. It was found that the average noncompliance index was significantly decreased (9.17 to 2.04) with the blister‐pak packaging system. The relationship of age, Folstein mini‐mental status, over compliance, frequency of dosing interval, and living situation were also explored.
To compare the difficulty experienced by older persons in using various medication containers, 50 noninstitutionalized women and men over 60 years of age were timed while opening 15 containers. Pill and liquid medication bottles with and without child‐resistant closure mechanisms were tested. In addition, other types of medication packaging were evaluated, such as nitroglycerin patches.
All subjects could open each of the non‐child‐resistant containers, though none of the child‐resistant containers could be opened by all participants. For child‐resistant containers, dramatic differences were observed in the proportion of subjects who could open the various designs and in the amount of time required. Subjects’ comments and observations of subjects’ efforts provided possible reasons for some of these differences.
The results suggest that when child‐resistant containers are used, consideration of the type of medication container can significantly reduce inconvenience to older persons. Containers without child‐resistant mechanisms provide the best option for elderly people when access by small children is not an issue.
Older people contribute to a significant portion of all prescription drug use and expenditures in the United States. Despite this, older people are often excluded from clinical trials examining the safety and efficacy of drugs. It is unclear to what extent drugs commonly used in older people contain information about prescribing in older people on their product labeling. The objective of this study was to determine the availability of pharmacokinetic, safety, and dosing information with reference to older people on product labels or package inserts (PIs) for commonly prescribed drugs in patients aged 65 and older. The top 50 oral drugs prescribed at the University of Pittsburgh Medical Center were identified through a computerized search of pharmacy records. PIs for these drugs were evaluated for information on elderly patients. Information on drug use in older people was found in 41 (82%) of the PIs. Drugs marketed after 1990 were more likely to contain information on geriatric use, with pharmacokinetic information being the most common type. Approximately 50% of the PIs contained precautionary statements for older people, but most did not provide any specific problems that might be encountered in this population. Only 28 (56%) PIs had dosing information available, and of these, just eight provided specific milligram recommendations for elderly patients. This analysis provides evidence that more should be done to improve the availability of prescribing information, particularly dosing and safety, on drug labels for older people. Additional regulatory action requiring this information to be included on drug product labels may be warranted.
To identify the practical problems that older people experience with the daily use of their medicines and their management strategies to address these problems and to determine the potential clinical relevance thereof.
Qualitative study with semistructured face‐to‐face interviews.
A community pharmacy and a geriatric outpatient ward.
Community‐dwelling people aged 70 and older (N = 59).
Participants were interviewed at home. Two researchers coded the reported problems and management strategies independently according to a coding scheme. An expert panel classified the potential clinical relevance of every identified practical problem and associated management strategy using a 3‐point scale.
Two hundred eleven practical problems and 184 management strategies were identified. Ninety‐five percent of the participants experienced one or more practical problems with the use of their medicines: problems reading and understanding the instructions for use, handling the outer packaging, handling the immediate packaging, completing preparation before use, and taking the medicine. For 10 participants, at least one of their problems, in combination with the applied management strategy, had potential clinical consequences and 11 cases (5% of the problems) had the potential to cause moderate or severe clinical deterioration.
Older people experience a number of practical problems using their medicines, and their strategies to manage these problems are sometimes suboptimal. These problems can lead to incorrect medication use with clinically relevant consequences. The findings pose a challenge for healthcare professionals, drug developers, and regulators to diminish these problems.