Patient compliance electronic monitoring

Advances in measurement have freed the estimation of patient compliance from its long-standing dependence on methods easily manipulated by patients, whose reluctance to acknowledge poor compliance contributes to self-reporting bias, documented in many ways. The years 1986-1987 saw the introduction of chemical marker and electronic monitoring methods, which provide different but complementary estimates of the time history of dosing by ambulatory patients. These advances have been extensively reviewed (Feinstein, 1990 Pullar and Feely, 1990 Urquhart, 1990 Cramer and Spilker, 1991 Bond and Hussar, 1991 Vander Stichele, 1991 Kruse, 1992). The gist of both methods is as follows. 

For the analysis of the observation period, the data saved in the electronic monitors are transferred via a communicator to a personal computer or to a secure website. With few commands, the patient s medication history can be visualized on the PC screen and then printed as a compliance report. 

W. Kruse, P. Koch-Gwinner, T. Nikolaus, P. Oster, G. Schlierf, and E. Weber, Measurement of drug compliance by continuous electronic monitoring a pilot study in elderly patients discharged from hospital. I Am Geriatr Soc 40 1151-1155 (1992). 

Prior to the technical advances described below, patient compliance was vaguely defined. A typical definition might have been, following the instructions of the health care provider (Cramer 1991). With the advent of electronic monitoring methods, it has become practical to use a definition of compliance with pharmacologic and quantitative meaning... 

Whether it is a Phase II study of efficacy or tolerance, one tactic is to use a run-in or preselection period, with the aim of choosing only good compliance patients for the definitive assessment of the study end-points. The criteria for the measurement of compliance with electronic monitors in this case are (a) the ratio of the number of administrations observed to the number of intended doses and (b) the mean intervals between the administrations (e.g. a patient in a trial requiring a dose of a single tablet daily might be considered a good complier if he she took 90% of the total doses with a mean interval between doses of 26 2 hours (h)). 

Data saved in electronic monitors may be transferred and collated in larger computers the data transfer may be hard (cable) or soft (telephonic). Patients medication histories can then easily be charted using software that is not sophisticated by today s standards, and hard copy compliance reports can become part of the patient s clinical chart or case report form. 

Cycler function and patient compliance can be monitored either electronically or with frequent home visits. As previously mentioned, newer cyclers have the ability to record treatment data on flash memory cards, or transmit this information to the center via modem. For the moment, data cards are a... 

Patient data collection is an extremely critical component of a value-added service. The information collected provides pharmacists with important baseline and monitoring parameters for patients. The amount and type of information needed from the patient or other health care providers may differ depending on the service, but nonetheless, this information is the foundation on which the other components of the service are built. Forms can be developed to help pharmacists collect this information (see Figs. 25-2 through 25-4). In addition, some consideration should be given to how this information will be stored (e.g., paper charts or electronic patient database). The information that should be collected from the patient includes demographic information, medical history, family history, and medication history. Since some of the information may need to be collected from other providers and health care institutions, an authorization to release medical information should be signed by the patient and kept as part of the chart (see Fig. 25-5). Lastly, pharmacists should ensure that their site is in compliance with the Health Insurance Portability and Accountability Act (HIPPA) and reinforce to their patients that the information they provide is confidential and secure at the pharmacy. 

The incorporation of breath activation and/or counting mechanisms into the MDI opens the possibility of including other device features, particularly if the above-mentioned two features are achieved via electronic means. MDIs that feature data gathering technology allow the patient or physician to monitor how and when the medicine is being taken (compliance) or to monitor lung function and control the amount of medicine that the patient is taking are distinct possibilities. 

Patients can be asked to keep diary records of PEF and inhaler use. However, such records may be constructed retrospectively by the patient just prior to going to the clinic. As the technology improves and then cost decreases, electronic inhaler and PEF monitoring devices will become more commonly available to assess compliance in the clinical setting. 

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