Key-words: Child-resistance packaging; Elderly; Openability
This Research Database has been developed by HCPC Europe to create an overview of the available research in the field of patient-friendly and adherence packaging. The database is for all members of HCPC Europe. Members can register as a user to get access to the database. Is your organisation not a member yet? Then please register your organisation as a member or contact our Executive Director Ger Standhardt for more information.
Poison exposures in the elderly are largely unintentional and, therefore, amenable to prevention techniques. Based on an analysis of the major causes of unintentional exposures in persons age 60 years and older, injury control strategies are applied to poisoning. These strategies address pre-event, event, and post-event phases. Ideas for specific changes to protect the elderly, especially in the areas of labeling and packaging, are presented.
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.
A study examined the extent and correlates of noncompliance in 155 predominantly elderly public housing tenants. Data were gathered through in-home interviews; only data from tenants taking prescribed medications on a regularly scheduled basis (n= 140) were analyzed. Noncompliance was significantly (p<0.05) associated with taking more than five prescribed medications, an inability to read prescription and auxiliary labels, and difficulty opening flip-off type medication container lids.
The results indicate that attempts to reduce the total number of prescription drug products used in these elderly residents by carefully scrutinizing the need for each prescription drug may enhance compliance. Pharmacists could assist in the detection of elderly patients at risk for medication noncompliance (five or more total prescription medications) by assessing the patients’ ability to read labels on prescription containers for all new drug additions and refills, and by having them try to open a flip-off container lid.
Manufacturers of Over-the-Counter (OTC) drugs and some consumer products are in a quandary. On the other hand, they must make packaging, containers, and closures secure enough to be tamper-resistant and child safe. At the same time, the Consumer Product Safety Commission has challenged them to create packaging that is easy for the elderly and handicapped to open. Tampering indications based on sight, sound and smell are the latest developments.
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.
In connection with self-administration of medicine for patients with rheumatoid arthritis, patients with weak hands and elderly patients in general, the design of many medicine containers makes them awkward to handle for the patients. In this investigation 12 different medicine containers were tested. The 12 containers represent the antirheumatic medicine containers available on the market in Denmark in 1988. Sixty patients participated in the investigation. Thirty had rheumatoid arthritis and 30 had normal hand function. The age range was 40-85 years The patients had the choice between five possible answers concerning each container. In all patients, grip strength was measured. The patients with rheumatoid arthritis were classified in four functional classes, and pulpa-vola distance end thumb–5th MCP point distance were measured. The opening mechanisms of 29% of the antirheumatic medicine containers are unacceptable; these are plastic containers with a “push-off” top and suppository packs. 46%–(containers with screw cap or pressure dispensing) are considered acceptable. For 25% (tablet and capsule blister packs) the patients’ estimate varied. It is important that medicine containers can be opened by the patients without difficulty, so that they do not present a hindrance to a correct intake of medicine or result in an unnecessary admission to hospital. The results of this investigation show that it is of continuous importance to encourage the production of medicine containers that comply with the requirements of the patients.
A controlled trial of the effect of a unit dose system of tablet/capsule calendar packaging (Webster-Pak) on the rate of successful self medication both in hospital and after discharge to the community has been completed in a geriatric assessment and rehabilitation unit. Eighty-four elderly patients, 45 using calendar packs (study), and 39 using conventional bottles or packs (control), were followed for three months after discharge. There was a significant improvement in patient compliance in the study group over controls on discharge (86.7% vs 66.7%), 10 days (68.8% vs 41.0%), one month (64.4% vs 38.5%) and three months (48.9% vs 23.1%) after discharge. Unit dose packaging is a cost effective method of improving the delivery of medicine in elderly patients, and should be available as part of the health budget.
The decision to use a compliance aid will depend on the motivation of the patient, their specific medication regimen, and their physical and cognitive ability. The administration of oral medicines may be facilitated through the appropriate use of ‘organisers’ which act as aides memoire. ‘Medidos’ and ‘Dosett’ are the most frequently studied compliance aids and both have been shown to be beneficial to the elderly and to community-based psychiatric patients. Adherence to a medication regimen may be improved without the use of proprietary compliance aids by ensuring that the most appropriate traditional container is used and by paying attention to the highest standard of labelling on the medicine container. Gadgets that are designed to improve physical dexterity can be useful when applying topical preparations, administering insulin injections, operating pressurised inhalers or administering eyedrops. The accurate administration of eyedrops is particularly important when treating glaucoma and may be facilitated by using devices that are designed to help with aiming of the eyedrops (‘Easidrop’, ‘Mumford Auto-drop’, ‘Opticare’). If squeezing the eyedrop container is a problem the ‘Opticare’ device may be particularly suitable.
There may be value in the use of the compliance aids to provide assistance to carers who become involved with preparing medication for patients. Selection of an appropriate compliance aid is not likely to be the total solution to inadequate adherence and most patients will require a combination of strategies to facilitate adherence to treatment with medicines.