Research database

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.

Child-resistant containers for the elderly?

With the introduction of child-resistant medication containers, the geriatric patient has suffered another setback in an already poor record of medication compliance. Most physicians, while applauding the remarkable decrease in child poisonings resulting from safety closure devices, are not aware of the burden that child-resistant medication containers has imposed on the elderly. Nor are they aware of methods to correct the problem. Elderly patients, however, are keenly aware of the problems of child-resistant medication containers but are ignorant about methods to overcome the difficulty in opening and closing them.

Adherence of elderly patients to treatment with pentoxifylline

A study of adherence to treatment was conducted by 179 general practitioners in elderly outpatients with geriatric cerebral symptomatology treated with pentoxifylline. The drug was provided in 2 different randomized packages, with or without memory‐aid stickers (also randomized). Compliance was assessed by pill count after 1 mo of treatment. Clinical evolution was assessed by a digit‐span test, and by filling in 9 “relative” visual analogue scales of aggravation—improvement. Side effects were recorded from patient complaints. Leftover drug was brought back by 83.1% of patients, and this proportion was influenced neither by packaging type nor memory‐aid stickers. Compliance was considered good (fewer than 30 tablets returned) in 62% of patients, and was not influenced by either packaging types or stickers. Peaks of pill count were evident at multiples of packaging units (10 or 40 according to type). Compliance was not related to age or sex, but was related to memory score. There was a correlation between compliance and clinical improvement, and a significant inverse correlation between the former and the frequency of side effects.

Poison prevention packaging act, 1970: A human factors standard

This paper, the first of two, gives an account of legislation and regulations made in the USA requiring hazardous pharmaceutical and other household products to be packaged in child-resistant containers. Human factors test procedures and standards, in terms of which child-resistance is defined, are described. An account is given of those hazardous substances which regulations in the USA require should be packed in child-resistant containers. The paper concludes with a description of the effects of the regulations and of child-resistant containers in reducing mortality and morbidity associated with the ingestion of poisonous substances, particularly aspirin, in the USA.

The second paper will briefly describe the effects of legislation made in England and Wales requiring certain pharmaceutical products to be packaged in child-resistant containers. It will also give an account of experiments, carried out in England and Sweden, describing the difficulties and inconvenience which the elderly and disabled experience when they attempt to use such containers.

An ergonomics evaluation of a reclosable pharmaceutical container with special reference to the elderly

The British Standard on reclosable child resistant medicine containers stales that adults should be able to open such containers but fails to consider the special problems of the elderly.

This study compared the ability of 100 elderly people to open a particular child resistant container (CRC) with their ability to open conventional drug containers. Information on drug taking and on contact with children under 5 years was also collected, and indicated that 62% of the subjects were taking prescribed tablets and, of these, 70% came into contact with children under 5 years.

The results showed that, without a demonstration, over 20% of attempts to open the CRCs resulted in failure and even after a demonstration 16 5% of attempts were unsuccessful. Taking the frequency of contact with children into account, it was concluded that the elderly come into contact with young children sufficiently often to justify their tablets being dispensed in CRCs. Consequently it was felt that the special problems of the elderly need consideration in the British Standard and in the design of child resistant containers.

Compliance with prescribed medication by elderly patients

Factors contributing to improper use of medication were examined in 40 patients aged 65 years or more who were in a home care program. They reported taking an average of 3.8 prescription medications and 1.2 nonprescription medications each. Pill counts showed that they were actually taking 57% of the prescribed medications; compliance decreased with the number of medications concurrently prescribed. Poor labelling instructions, difficulty opening childproof containers and misunderstanding of verbal instructions contributed to this problem. The patients tended to rely more on physicians than on pharmacists or visiting nurses for advice problems with medication.

Assessment of a new calendar pack—the ‘C-Pak’

Seventy-eight elderly patients in hospital were studied for up to four weeks to assess drug compliance. Forty patients received medication from individualized calendar packs (‘C-Pak’) and 38 received medication from standard bottles. There was no difference in compliance between the two groups, the percentage error for each group being 26%. This result suggests that C-Pak is unlikely to improve drug compliance in unselected elderly patients.

Testing child resistant packaging for access by infants and the elderly

Accidental poisoning of young children by household products and medicines remains a serious problem in many countries. Child resistant packaging, i.e. packages of which the opening and closing mechanisme requires manipulation and/or forces beyond the limits of children’s exertions, has been developed to counter this problem. It is important to standardise field trials of such packaging to ensure adequate protection for the population at risk (the inquisitive and ingenious youngsters), while permitting access by adults. Testing variables which were studied were the age boundaries of the child panel and of the adult panel. Tests were conducted on four types of child resistant reclosable containers; two of the push-and-turn type, two of the squeeze-and-turn type. Inclusion of children between 24 and 41 months old in the test panel did not significantly affect the proportion of subjects who were able to gain access to the containers. However, the inclusion of adults, in the age-range 60–75 yr, in the test was found to provide the best safeguard against overcomplex and difficult packaging coming on to the market. Any standardised tests need to take into account the finding that in a testing situation most of the children between 42 and 51 months do not use their teeth. In normal situations nevertheless, children of one-two years old, the age group in which most of the poisoning accidents happen, frequently resort to using their teeth when they are unable to open containers by hand.

Drug noncompliance in the elderly

Drug noncompliance is a major therapeutic problem for clinicians who deal with the elderly. This group receives 25% of all prescriptions, although comprising only 11% of the population. Clinicians overestimate their patients’ compliance by 100%. One-third of patients always comply, one-third sometimes comply, and one-third never comply. Noncompliance can be determined by pill counts, timing of refills, blood and urine drug levels, and observation of therapeutic effect. Contributing factors to noncompliance include vision, hearing, and memory impairment, side effects, drug interactions, fear of drug dependency, difficulty in obtaining of taking medication, complicated regimens, and lack of confidence in the clinician. Recommendations are given to aid the clinician in overcoming noncompliance. The elderly benefit from verbal instructions reinforced in writing, frequent visits, simplified regimens, clearly labeled, non-childproof containers, and involvement of family members. An illustrative case study is presented.