ABSTRACT
BACKGROUND: A graded therapeutic concept for the treatment of chronic pain patients in Germany is only available to a limited extent. Following the onset of coronavirus disease (COVID-19), care for these patients has become even worse. AIM: To develop and establish a cross-sector therapeutic concept for chronic pain patients as part of a selective contract. METHODS: Embedded in existing therapeutic procedures, we define seven clinical pathways (CPs) into which patients are directed, after an interdisciplinary assessment according to refined criteria. ORGANIZATION: In CP I, patients remain in standard therapy. In CP II, patients have the opportunity to participate in an additional inter-profession education program. In CP III, patients get a specialized outpatient treatment. CP IV is a partial inpatient treatment, where multiple inpatient attendance days are replaced by tele-medical treatment, via a rehabilitation app. CP V and VI are inpatient treatments over 8 and 15 days each. If patients need further psychotherapeutic support after an inpatient treatment, they can be treated by clinical psychotherapists for another six months in CP VII. EVALUATION: The evaluation takes place 3, 6 and 12 months after initial assessment and includes the German Pain Questionnaire with different psychometric tests.
Subject(s)
COVID-19 , Chronic Pain , Chronic Pain/therapy , Germany , Hospitalization , Humans , Pain ManagementABSTRACT
BACKGROUND: Despite the high prevalence of headache and migraine in the general population, many people do not receive adequate medical attention and treatment. OBJECTIVE: To evaluate the effects of pharmaceutical care (defined as intensified structured counseling between patient and pharmacist, including the use of drug databases), for patients with headache or migraine, on both clinical and psychological endpoints. METHODS: A prospective, randomized, controlled intervention study was conducted using pharmacies in Northern Germany. A total of 112 pharmacies (26% of all pharmacies in the study region) recruited 410 patients with headaches. Pharmacies were randomly assigned to an intervention or control group. Patients were interviewed by telephone prior to the intervention and again after 4 months. Primary endpoints were number of days with headache, number and severity of headaches, self-efficacy, and the patients' perceptions of their health-related quality of life. RESULTS: Each pharmacy treated an average of 4.6 patients (total time effort 9 h). The intervention group consisted of 201 patients who received pharmaceutical care, whereas the control group comprised 209 patients who received standard counseling. In both groups, the number of headache attacks and intensity of pain in treated headache attacks did not change significantly between the first and second interviews. However, a statistically significant improvement in mental health and self-efficacy was shown in the intervention group. Intensity of pain in untreated headache attacks and the number of days with headache decreased in both groups. Most participants described this intervention as helpful and effective and 90% reported that they would recommend pharmaceutical care to other patients with headache. CONCLUSIONS: A short-term pharmaceutical care intervention improved patients' mental health and self-efficacy, although it did not significantly change the number and severity of headaches. The increase in self-efficacy and mental health associated with pharmaceutical care may be instrumental in improving long-term pharmacotherapy of patients with migraine and headache. To fully assess the effects of pharmaceutical care, a longer study may be required.
Subject(s)
Community Pharmacy Services/standards , Directive Counseling/methods , Headache Disorders/drug therapy , Migraine Disorders/drug therapy , Adult , Data Collection , Databases, Factual , Directive Counseling/standards , Female , Follow-Up Studies , Germany/epidemiology , Headache Disorders/psychology , Humans , Male , Middle Aged , Migraine Disorders/psychology , Patient Education as Topic/methods , Patient Education as Topic/standards , Patient Satisfaction/statistics & numerical data , Pharmacists/organization & administration , Pharmacists/standards , Professional Role , Quality of Life , Self Efficacy , Severity of Illness IndexABSTRACT
BACKGROUND: Transdermal buprenorphine is available in Europe for the treatment of moderate to severe chronic pain. It has been evaluated at doses of 35, 52.5, and 70 microg/h for the management of moderate to severe chronic cancer and noncancer pain in 3 randomized, double-blind, placebo-controlled trials, each of limited duration (approximately 14 days each). Long-term data are essential to determining the performance of an analgesic in the management of chronic pain. OBJECTIVE: The purpose of this follow-up study was to obtain data on the efficacy and tolerability of long-term treatment with transdermal buprenorphine in cancer and noncancer patients with chronic persistent pain of moderate to severe intensity. METHODS: This was an open-label, uncontrolled, follow-up study in patients from the 3 previous clinical trials who elected to continue treatment with transdermal buprenorphine 35 microg/h and sublingual buprenorphine tablets (0.2 mg) as needed for breakthrough pain. The patch was to be changed every 72 hours throughout the patient's course of pain therapy. At visits every 2 weeks for the first 4 weeks and every 4 weeks for the remainder of study participation, patients evaluated their pain relief retrospectively on a 4-point verbal rating scale. They also rated the ease of patch handling using a 3-point verbal rating scale. Patterns of dose escalation and dose stability were monitored over time. Adherence to therapy was determined based on the number of patients who complied with the dosing schedule. Adverse events were documented by type, intensity, location (systemic or local), and relationship to study medication. RESULTS: Two hundred thirty-nine patients were included in this follow-up study (120 women, 119 men; 100% white; mean [SD] age, 58 [11.3] years; mean weight, 70.8 [14.7] kg). One hundred thirty-four had cancer-related pain and 105 had pain of noncancerous origin. The mean duration of participation was 7.5 months, and 37 (15.5%) patients participated for >12 months. Maximum study participation was 3.4 years in cancer patients and 5.7 years in noncancer patients. One hundred eighty-eight (78.7%) patients were considered adherent to therapy. The majority (65.9%) of patients managed their pain with the patchalone or took no more than 1 additional sublingual tablet daily for breakthrough pain. At least satisfactory pain relief was reported by 215 (90.0%) patients, and the buprenorphine patch was generally well tolerated. The most common systemic adverse drug reactions were nausea (9.2%), dizziness (4.6%), vomiting (4.2%), constipation (3.8%), and tiredness (2.9%), whereas the most common local adverse drug reactions were erythema (12.1%), pruritus (10.5%), and exanthema (8.8%). CONCLUSION: Transdermal buprenorphine was generally well tolerated and effective for the long-term treatment of chronic cancer or noncancer pain in these patients who had previously received buprenorphine in 3 short-term clinical trials.
