Self-management of Low Molecular Weight Heparin Therapy

Self-management of Heparin Therapy - Drug Use Problems and Compliance With Self-injected Low Molecular Weight Heparin in Ambulatory Care

There is very little data available on compliance with self-injected low molecular weight heparins (LMWH), but what there is, definitely shows that compliance represents a significant problem. We therefore aim to a) record drug use problems of patients including compliance, b) develop a "SOP" for first instruction by a pharmacist and for subsequent pharmaceutical care and c) to compare intensive pharmaceutical care (intervention) vs. standard care (control) provided in the pharmacy to patients with a prescription for a LMWH as an outpatient treatment. Hypothesis: Intensive pharmaceutical care in ambulatory patients who self-inject low molecular weight heparins results in improved compliance, more safety and satisfaction as well as in fewer complications.

Patient recruitment in community pharmacies enables the testing of the feasibility of the interventions under daily-practice conditions and facilitates the recruitment of a larger number of patients. Data collection: telephone interviews with structured questionnaires at the beginning and at the end of the therapy monitored self-injection in the study center or at patient's home (direct observation technique [DOT]) compliance measurement: answers from patient interviews, comparing number of used syringes vs. number of prescribed syringes (analogue "pill count"), measuring residual volume in recycled syringes recording of the fine motor skills by the adapted "Disabilities of the Arm, Shoulder and Hand" questionnaire (DASH questionnaire)

Heparin, Low-Molecular-Weight, compliance, drug safety, self-administration, ambulatory Care, Pharmaceutical Services

Recruitment of patients in the hospital into the randomized intervention group. Intervention is done by a trained pharmacist/Doctor of Philosophy-student in the study center (a pharmacy) or at patient's bedside in the hospital. Intervention: patient education

Recruitment of patients in the hospital into the randomized control group (standard care in community pharmacy)

Recruitment of patients in trained community pharmacies into the intervention group. Intervention is done by trained pharmacists. Intervention: patient education

Recruitment of patients in community pharmacies into control group (standard care in community pharmacy)

Possible, individualized interventions: Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes) Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom First self-injection under control of a specially trained pharmacist

During a home visit and at her/his individual injection time, each patient was monitored when self-administering an s.c. injection (directly observed therapy, DOT). Score minimum = -2.00; score maximum = +2.00 for the objective estimation of the application quality. Higher score values represent better outcomes.

objectively determined by syringe count Therapy durations varied individually depending on the indication of the drug therapy (days to weeks).

Inclusion Criteria: Patients are recruited from orthopedic clinics, an emergency department and from community pharmacies with a prescription for a LMWH as an outpatient treatment. self-application of the LMWH german / english speaking -> clinical setting: Dalteparin -> daily life setting: all LMWH (ready-to-use syringes) control group: self-application or application by another person (family member, medical person, etc.) Exclusion Criteria: - patient's home far away from study center

Mengiardi S, Tsakiris DA, Molnar V, et al. Impact of Pharmaceutical Care on Self-Administration of Outpatient Low-Molecular-Weight Heparin Therapy. Pharmacology & Pharmacy 5: 372-385, 2014