Horology: time measuring systems or devices – Combined with disparate device
Patent
1990-09-21
1991-12-10
Miska, Vit W.
Horology: time measuring systems or devices
Combined with disparate device
206534, 221 3, G04B 4700, B65D 8304
Patent
active
050724304
DESCRIPTION:
BRIEF SUMMARY
When evaluating the usefulness of drugs, it is necessary to carry out lengthy and costly trials to establish their effectiveness and also to establish any side-effects that they might have. In fact, it is not possible to register new drugs and medicaments with government authorities unless usefulness and a reasonable absence of side-effects can be shown.
A particular difficulty encountered in trials of this nature derives from the so-called placebo effect, which enables a patient to be helped, both subjectively and even objectively, with the aid of "sugar pills", provided that the patient believes that he has been administered with an effective drug. It is doubtful that drugs can be effectively tested against the effect of placeboes, unless the doctor concerned is also unaware of which tablets contain the placebo and which contain the active drug, since otherwise the doctor may inadvertently divulge to the patient, in some way or another, the fact that a particular tablet is nothing more than a placebo. The practice of double blind trials is therefore widespread and necessary.
An idea of the difficulties encountered when testing drugs is given by the clinical observation that a patient administered with a placebo may also complain of side-effects resulting therefrom. In the case of one reported study in which patients were administered with placeboes, no less than a quarter of the patients concerned discontinued taking the placebo, because of the side-effects felt to be caused thereby (Capel et al, J. Rheumatol. 6 (1979) 584-593).
The standard procedure in clinical drug trials is to supply the patients concerned with blister cards or charts containing the drug in tablet form, together with a prescription as to how many tablets should be taken and at what times. The patient is also instructed to make notes relevant to the treatment. This is particularly important in the case of short-lived drugs, such as pain relieving drugs. One problem with such practices is that the patient may forget to make notes at the times prescribed and attempt to rectify this omission at a later date, for instance immediately prior to seeing his doctor. Cases are also known where a patient who has forgotten to take his tablets, removes a few from the blister chart and throws them away, thus pretending to have taken the tablets and therewith avoiding the doctor's displeasure.
Consequently, it is an object of this invention to provide a compliance meter with which many of the pitfalls experienced in drug trials can be avoided. By compliance is meant here the strict obedience of the patient in following the doctor's instruction as to the times when the drugs (tablets) are to be taken and in what quantities, or, in a relative sense, how the tablets were taken and when, in those cases, for instance, when the patient was told to take a tablet when and if the need was felt.
Known to the art are devices which signal to a patient when a tablet should be taken and which stop signalling when the tablet is removed from the pack, these devices functioning in the manner of an alarm clock.
Some devices of this kind are constructed to receive a blister pack and means are provided for detecting when a blister pad is broken and a tablet is freed therefrom, whereupon the "alarm clock" is switched off and is not restarted until the next time a tablet is to be taken. Examples of such devices are to be found in DE-A-33 35 301 and EP-A-0 191 168.
Although such devices have been found practical from the aspect of patient treatment, thereby overcoming the forgetfullness of old or very sick patients, they are not particularly useful for the purpose of the present invention.
One particularly important advantage afforded by the present invention is that it is thereby made possible to register the time at which a tablet is taken from the blister pack and also the tablet which was taken at that time. This is of particular value when the tablets concerned are a mixture of different tablets and, for instance, comprise placebo tablets. For example, when testing t
REFERENCES:
patent: 4526474 (1985-07-01), Simon
patent: 4660991 (1987-04-01), Simon
patent: 4731765 (1988-03-01), Cole et al.
Dahlstrom Bengt
Eckernas Sven-Ake
Compumed AB
Miska Vit W.
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