Longitudinal Monitoring

The long period usually taken to achieve a substantial cohort is a disadvantage in terms of producing quick results and is due to the small NZ population (3.8 million) and restrictions on reimbursement for most new medicines, which slows market uptake. However, the necessity to undertake a longitudinal approach to monitoring has advantages as follows: a proportion of patients are monitored for several years and this provides greater opportunity for identifying (a) delayed effects; (b) use in pregnancy or lactation; (c) death rates and causes of death; (d) reasons for cessation of therapy; (e) changed indications (these frequently broaden over time); (f) evidence of tolerance or dependence; (g) changes in prescribing practice which for new medicines takes time to be established; and (h) changes in patient characteristics which in the early post-marketing phase of a drug frequently differ from later use. Patients with severe disease who have failed other therapy are often tried on a new drug as a last resort and in the early months of use, this group is over-represented

Table 27.2. Current monitoring studies.

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