Compliance

the public are asked to deliver the drugs to their local pharmacies. In one UK city (600 000 population) 500 000 'solid dose units' (tablets, capsules, etc.) were handed in (see Opportunity cost); such quantities have even caused local problems for safe waste disposal.

Factors that are insignificant for compliance are: age49 (except at extremes), gender, intelligence (except at extreme deficiency) and education level (probably).

Overcompliance. Patients (up to 20%) may take more drug than is prescribed, even increasing the dose by 50%. In diseases where precise compliance with frequent or complex regimens is important, e.g. in glaucoma where sight is at risk, there have been instances of obsessional patients responding to their doctors' overemphatic instructions by clock-watching in a state of anxiety to avoid the slightest deviance from timed administration of the correct dose, to the extent that their daily (and nightly) life becomes dominated by this single purpose.

Evaluation of patient compliance. Merely asking patients whether they have taken the drug as directed is not likely to provide reliable evidence;50 and it can be assumed that anything that can happen to impair compliance, will happen sometimes. Estimations of compliance are based on studies using a variety of measures.

47 After Drug and Therapeutics Bulletin 198119: 73.

Patient information leaflets. In economically privileged countries original or patient-pack dispensing is becoming the norm, i.e. patients receive an unopened pack just as it left the manufacturer. The pack contains a Patient Information Leaflet (PIL) (which is therefore supplied with each repeat prescription). Its content is increasingly determined by regulatory authority. The requirements to be comprehensive and, in this litigous age, to protect both manufacturer and regulatory authority, to some extent impair the patient-friendliness of PILs. But studies have shown that patients who receive leaflets are more satisfied than those who do not. Doctors need to have copies of these leaflets so that they can discuss with their patients what they are (or are not) reading.

48 Smith S E et al 1974 Lancet 1: 937.

49 But the elderly are commonly taking several drugs — a major factor in noncompliance — and monitoring compliance in this age group becomes particularly important. The over-60s (UK) are, on average, each receiving two or three medications.

Requiring patients to produce containers when they attend the doctor, who counts the tablets, seems to do little more than show the patient that the doctor cares about the matter (which is useful); and a tablet absent from a container has not necessarily entered the patient's body. On the other hand, although patients are known to practise deliberate deception, to maintain effective deception successfully over long periods requires more effort than most patients are likely to make. The same applies to the use of monitored-dosage systems (e.g. compartmented boxes) as memory aids and to electronic containers that record times of opening.

Some pharmacodynamic effects, e.g. heart rate with beta-adrenoceptor blocker, provide a physiological marker as an indication of the presence of drug in the body.

Compliance in new drug development

Noncompliance, discovered or undiscovered, can invalidate therapeutic trials (in which it should always be monitored). In new drug development trials the diluting effect of undetected noncompliance (prescribed doses are increased) can result in unduly high doses being initially recommended (licensed) (with toxicity in good compilers after marketing), so that the standard dose has soon to be urgently reduced (this has probably occurred with some new nonsteroidal anti-inflammatory drugs).

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