gms | German Medical Science

Background: Improved medical technology has resulted in a huge increase in lifespan in general, and in patients with chronic, life-shortening diseases in particular. Most experience time-related increases in the number of incurable co-morbidities, disability, and suffering for increasingly prolonged periods before death. This situation makes models of “one disease – one therapy/guideline” an unrealistic approach to good care. However, older patients and those with co-morbidity are usually excluded from evidence-generating controlled studies (EBM). Therefore, most indications for medication use and Clinical Practice Guidelines (CPGs) are based on EBM stemming from a single disease model studies, performed in young or middle age adults without significant co-morbidity who have a life expectancy of several decades. Family physicians usually extrapolate from these CPGs to include elders in whom research evidence underpinning guidelines does not exist. However, for most drugs, applying the results and/or CPGs developed from these studies to elderly patients is inappropriate because this subpopulation is much more vulnerable to drug adverse effects; there is a higher risk to benefit ratios with increased age, co-morbidity, disability and cognitive decline. Furthermore, the extent and severity of polypharmacy and inappropriate medicine use also increases with age, co-morbidity and disability thus creating a vicious circle leading to significant health risks for an increasing number of elderly people. Nevertheless, a scheduled, formal drug reevaluation may never be performed, neither in hospitals or long-term care setting nor in the community.

A completely new approach is presented combining the ancient "primum non nocere" notion with evidence based medicine and clinical judgment; it involves rethinking and re-evaluation for each and every drug in the elderly in an attempt to achieve individualization of drug therapy.

Hypotheses:

1.

Polypharmacy itself should be perceived as “a disease,” with potentially more serious complications than those of the diseases these different drugs have been prescribed for.

2.

Rethinking and re-evaluation is needed for each and every drug in the elderly

3.

Simultaneous discontinuation of many drugs is not associated with significant risks and usually improves quality of life.

4.

Supervised reduction of medications, based on a person’s individual status, can significantly benefit patients’ health.

Methods: The Garfinkel GPGP method involves meeting of no less than one hour with the patient and/or guardian/family (PGF) in the privacy of their own home, devoted to comprehensive geriatric assessment; it includes a thorough discussion of the pros and cons (benefit/risk ratio) of every medication consumed by the patient, based on EBM knowledge (if available) and clinical judgment. An agreed upon comprehensive “tailor-made” therapeutic treatment plan is drawn up, taking into account patient’s age, co-existing conditions, functional, mental and cognitive status as well as individual PGF'S requirements and preferences. With their consent, a detailed report with recommendations and clarifications is sent to the family physician. Then, based on the Garfinkel's algorithm, as many “non-life saving” medications as possible are discontinued simultaneously for a trial period of three months at least. Obviously, during the home visit, new problems may be found and new diagnoses made (mainly depression); therefore, in some elders the intervention is not limited to drug discontinuation, but involves drug readjustments and renewal of the entire therapeutic regimen. Follow-up is an integral component of the method allowing PGF to report any adverse effects to the physician and allowing the physician to monitor any change in the patient’s quality of life, as well as PGF satisfaction.

Results: In the first study Drug Discontinuation (DD) has been applied to 119 disabled patients in 6 geriatric nursing departments; the control group included 71 comparable patients in the same wards. A total of 332 different drugs were discontinued in 119 patients (average of 2.8 drugs per patient) and was not associated with significant adverse effects. The overall rate of DD failure was 18% of all patients and 10% of all drugs. The 1 year mortality rate was 45% in the control group but only 21% in the study group (P < 0.001, chi-square test). The patients’ annual referral rate to acute care facilities was 30% in the control group but only 11.8% in the study group (P < 0.002). The intervention was associated with a substantial decrease in the cost of drugs.

The second study tested the method in community dwelling elders. 70 elders age 82.8 ± 6.9 were evaluated using the GPGP DD approach. 83% were frail or independent, 61% had ≥3, 26% ≥5 co-morbidities, 71% suffered from ≥3 geriatric syndromes. Counting co-morbidities & syndromes together, 94% suffered from ≥3, 51% >6 different health problems. The mean follow up was 19.2±11.4 months. Participants used 7.73±3.7 medications (range 0-16). DD was recommended for 57.5% of these drugs (mean 4.4±2.5 drugs/participant). After further consultation with PGF and family physicians 47% (3.7±2.5 drugs/patient) were actually stopped. Only 5/256 discontinued drugs had to be restarted (DD failure 2%), successful DD eventually achieved in 80.7%. DD was not associated with significant adverse effects. 80% of PGFs reported medical functional - mental -cognitive improvements defined as significant in 37%, outstanding in 29%. 10 elders died after follow up of a mean of 13 months, mean age at death 88.

Conclusions & Health Policy Implications: Many elders suffer from ill effects of polypharmacy. Both studies have proven that the sum total of the negative effects of a variety of drug combinations outweighs the sum total of beneficial effects of the specific drugs. The Garfinkel method for a controlled, rational drug discontinuation is feasible and highly beneficial in both long term care facilities and community dwelling elders and has no significant risks. It represents an appropriate approach both clinically and ethically, allowing for the flexibility to restart medicinal therapies. Applying this method worldwide may significantly decrease medication burden in elderly people, improve their quality of life, with an associated