4.5. Definitions

Age and sex. As far as age was concerned, the population was either considered as a whole, i.e. including all persons aged 64 year old or over, or stratified into groups aged 64–74 and 75+ years, 64–74, 75–84, and 85+ years, or 64–69, 70–74, 75–79, 80–84, and 85+ years. The young elderly were defined to consist of 64- to 71-year-old persons, who were different persons in the two cross-sectional assessments.

Marital status and living alone. Marital status was divided as follows: married/cohabiting, widowed, unmarried, and other or married/cohabiting, widowed, and other. Persons living alone were differentiated from those living with someone.

Basic education. Basic education was defined as under basic compulsory, basic compulsory, and over basic compulsory.

Previous occupation. Previous occupations were in service, industry, agriculture, or family.

Chronic morbidity. The diseases recorded by Social Insurance Institution as entitling the patients to special refunds of medication costs were counted as chronic morbidity (ranging from 0 to 5 diseases) in 1998–99.

A single question about self-perceived health and life satisfaction. The persons with poor self-perceived health or poor life satisfaction had chosen the alternatives “quite or very poor situation” compared to those reporting a “good situation” (alternatives “moderate, quite or very good”) in 1998–99.

Smoking and alcohol consumption. Smoking history was asked, and the subjects were classified as non-smokers, ex-smokers, or current smokers. If a person had smoked at least one cigarette per day (or one cigar per week or 28 g of tobacco per month) for at least a year and had not smoked for the previous 6 months or more, he/she was defined as an ex-smoker. In 1998–99, the frequency of alcohol consumption (beer, wine, or spirit) per month as 0, 1–4, or > 5 times was recorded.

Home nursing. The persons receiving supervised home nursing services were counted and included into the studies.

Drug use and polypharmacy. Both regular and irregular prescription drug use during seven days prior to the interview were defined as use of medication. Medication was defined as regular if it was taken daily or at regular intervals, e.g., once a week or month, as is the case with, for instance, vitamin B12 or long-acting antipsychotics injected intramuscularly once a month or at other regular intervals. If the person used a drug once a month or at other regular intervals, but had not had an intramuscular injection, for example, during the previous week, his/her drug use was recorded as regular use. Irregular medication was taken when needed. Polypharmacy was defined as concomitant use of more than five prescription medications. WHO defines polypharmacy as the concominant use of five or more drugs (WHO 1985), and Finnish studies follow the same principle (Klaukka et al. 1993, Klaukka & Rajaniemi 1998).

Psychotropics. Psychotropics had ATC codes of N05-6. Psychotropics were divided into hypnotics/sedatives (N05B-C), including anxiolytics (e.g., diazepam, alprazolam, chlordiazepoxide) (N05B) and hypnotics (e.g., temazepam, nitrazepam, zopiclone, zolpidem) (N05C), as well as antipsychotics, including lithium (N05A), antidepressants (N06A), and antidepressants, including other psychotropics (benzodiazepines or antipsychotics) (N06C). Antidepressants and combination preparations were mostly included in the same category (N06A, N06C) in this study. Neuroleptics are called antipsychotics in the ATC system. None of the study subjects used anti-dementia drugs (N06D) in 1990–91, and only three persons used them in 1998–99. Hypnotics/sedatives were divided into short-acting benzodiazepines, such as midazolam and triazolam, medium-acting ones, such as lorazepam, oxazepam, and temazepam, and long-acting ones, such as diazepam, flunitrazepam, chlordiazepoxide, chlorazepate, medazepam, nitrazepam, and alprazolam (Pelkonen 1998), and non-benzodiazepine sleeping pills, such as zopiclone and zolpidem. In clinical practice, many benzodiazepines are used either as anxiolytics or hypnotics, including oxazepam. They were therefore mostly analyzed together as hypnotics/sedatives for the purposes of this thesis. Any use of two or more psychotropics was defined as concominant use.

Classification of drugs by their sedative properties. Summaries of the product characteristics of the drugs approved for prescription in Finland in 1998–2001 were checked for the key words “sedating, sedative, drowsiness, sleepiness, lassitude, exhaustion, tiresome and fatigability”. The source of information was Pharmaca Fennica, the Finnish drug compendium. In addition, updated online product information was reviewed in autumn 2001, when nearly 900 different compounds were available in Finland. A psychogeriatrician, a geriatrician, and a physician specialized in drug epidemiology provided expert knowledge about the categorization of drugs, particularly concerning the elderly. Mainly the official summaries of the product characteristics of drugs were used, but in uncertain cases, if for example, a synonymous preparation containing the same ingredients had a sedative effect, leading manuals, textbooks, and the Medline database were consulted. The drug was classified into the group with least sedation if its sedative quality was uncertain or undocumented.

The drugs were divided into 4 groups based on the ATC system: 1. primary sedatives with the aim to sedate (conventional psychotropics), 2. drugs with sedation as a prominent side/adverse effect or preparations with a sedating component, 3. drugs with sedation as a potential adverse effect, and 4. drugs with no known sedative effect (Paper III, Table 1). Drugs injurious in traffic were placed into group 1 or 2, which included all known sedative drugs (proper sedatives). Almost all drugs in group 2 were said to be “injurious in traffic”, but other sedating drugs prescribed to the elderly, such as metoclopramide (Wynne et al. 1993) and second-generation psychotropics, were also included. Group 2 drugs further included psychotropics in combinations indicated for somatic disorders. Drugs of the groups 3 and 4 were not reported to be injurious in traffic.

Sedation may be a desirable side effect (strong analgesic) or an undesirable adverse effect (old antihistamines in the daytime). The effect may be expected and connected with the pharmacological properties of the drugs, or it may be unexpected. If the effect is not associated with pharmacological properties, it may be a partly subjective feeling (drugs in group 3) or mixed with symptoms of diseases or their other treatments.

Sedation score, sedation sum score, and polysedation. In this study, proper sedatives were rated numerically to calculate the sedative drug load per drug user. Each drug in group 1 was rated as having a sedation score of 2, and each drug in group 2 was rated as having a sedation score of 1. The sedation scores were added up, and this sum score ranged within 0–9 in the study series. A total sedation sum score of 3 or more was defined as polysedation, and to have polysedation, one was to have at least two proper sedatives.

Physical functional abilities. The questions about physical functional abilities included four items about ADL (getting in and out of bed, using the lavatory, dressing and undressing, washing and bathing), four items about mobility (walking between rooms, using stairs, moving outdoors, walking at least 400m), and four (1990–91) (light housekeeping tasks, heavy housekeeping tasks, carrying a heavy load, cutting one`s toe nails) or eight (1998–99) (light housekeeping tasks, heavy housekeeping tasks, carrying a heavy load, cutting one`s toe nails, handling finances, use of public transportation, taking care of one’s medication, ability to use the phone) items about IADL. The following reply alternatives were available in most cases: 1. cannot do the activity in question, 2. can do the activity if someone helps, 3. can do the activity with difficulties, but without help, 4. can do the activity without difficulties and without help. For the purposes of this study, all items were dichotomized, with the values 1–3 indicating “difficulties or dependence” in the activity.