[Analgesic use in Germany : Survey of the years 2008 to 2019]. / Schmerzmittelgebrauch in Deutschland : Eine Erhebung über die Jahre 2008 bis 2019.

BACKGROUND: There are previously published data on the per capita use of analgesics in Germany, but only to 2005. In the present analysis, data for the years 2008-2019 were evaluated. The use of prescription and nonprescription analgesics was investigated and possible influencing factors were discussed. MATERIALS AND METHODS: The per capita use of prescription and nonprescription analgesics was determined based on data on prescriptions and cash purchases in pharmacies (IMS Pharmascope®, Wiener Neudorf, Austria). Moreover, an evaluation according to active substances was performed for nonprescription drugs. In addition, pharmaceutical manufacturers' advertising expenditures and changes in distribution channels were analyzed as possible influencing factors. RESULTS: During the observation period 2008-2019, the use of prescription analgesics in Germany increased, while the use of nonprescription analgesics decreased. Single-agent drugs constitute the majority of sales of nonprescription analgesics. The share of combination drugs has decreased in recent years. CONCLUSION: The use of nonprescription analgesics in Germany decreased between 2008 and 2019. The trend as of 1995, which was observed in a previous investigation, is therefore continuing. External factors, such as the increase in advertising expenses or easier access via mail-order pharmacies, do not appear to influence use.

Lack of Evidence for Blood Pressure Effects of Caffeine Added to Ibuprofen.

BACKGROUND: Caffeine enhances the efficacy of non-opioid analgesics. Data on the cardiovascular health effects of caffeine intake are controversial, and studies on the cardiovascular effects of medical caffeine use are lacking. OBJECTIVE: The study aims to explore the cardiovascular effects of an ibuprofen/caffeine combination in comparison to ibuprofen alone. METHODS: Secondary analysis of a previously reported bioequivalence study of a single dose of a fixed dose ibuprofen/caffeine combination (400/100 mg) vs. ibuprofen alone in a randomized, cross-over design in 36 healthy volunteers. Plasma catecholamines were analyzed to enhance mechanistic interpretation of the data. RESULTS: After exclusion of 10 protocol violators (pre-dosing intake of caffeine), vital signs were comparable over a 24-h period in the absence and presence of caffeine. Plasma catecholamine levels were also comparable. CONCLUSION: These data do not support the hypothesis that occasional intake of a small dose of caffeine as part of pain medication imposes a health risk due to vital sign changes. Based on the proven increase in efficacy, the addition of caffeine to non-opioid analgesics such as IBU has a favorable risk/benefit profile for occasional use.

Development of an Electronic Tool to Assess Patient Preferences in Geriatric Polypharmacy (PolyPref).

Purpose: Medical decision-making in older adults with multiple chronic conditions and polypharmacy should include the individual patient's treatment preferences. We developed and pilot-tested an electronic instrument (PolyPref) to elicit patient preferences in geriatric polypharmacy. Patients and Methods: PolyPref follows a two-stage direct approach to preference assessment. Stage 1 generates an individual preselection of relevant health outcomes and medication regimen characteristics, followed by stage 2, in which their importance is assessed using the Q-sort methodology. The feasibility of the instrument was tested in adults aged ≥70 years with ≥2 chronic conditions and regular intake of ≥5 medicines. After the assessment with PolyPref, the patients rated the tool with regard to its comprehensibility and usability and assessed the accuracy of the personal result. Evaluators rated the patients' understanding of the task. Results: Eighteen short-term health outcomes, 3 long-term health outcomes, and 8 medication regimen characteristics were included in the instrument. The final population for the pilot study comprised 15 inpatients at a clinic for geriatric rehabilitation with a mean age of 80.6 (± 6.0) years, a median score of 28 (range 25-30) points on the Mini-Mental State Examination, and a mean of 11.6 (± 3.6) regularly taken medicines. Feedback by the patients and the evaluators revealed ratings in favor of understanding and comprehensibility of 86.7% to 100%. The majority of the patients stated that their final result summarized the most important aspects of their pharmacotherapy (93.3%) and that its ranking order reflected their personal opinion (100%). Preference assessment took an average of 35 (± 8.5) min, with the instrument being handled by the evaluator in 14 of the 15 participants. Conclusion: Preference assessment with PolyPref was feasible in older adults with multiple chronic conditions and polypharmacy, offering a new strategy for the standardized evaluation of patient priorities in geriatric pharmacotherapy.

Impact of the Neck and/or Shoulder Pain on Self-reported Headache Treatment Responses - Results From a Pharmacy-Based Patient Survey.

Neck and/or shoulder pain (NSP) frequently occurs together with headache. Therefore, we explored how patients with and without concomitant NSP differ in their baseline characteristics and in perceived treatment responses to an analgesic. An anonymous survey was performed among 895 patients with headache (735 self-reported tension-type headache [TTH]) who used an analgesic fixed-dose combination containing 400 mg ibuprofen and 100 mg caffeine as a non-prescription treatment. NSP was abundant among patients in our survey (60%) and was associated with >1 additional day of headache per month. Patients with NSP reported predominantly sedentary work more frequently than those without (40 vs. 29%); they also reported physical tension/poor posture as a perceived trigger factor more frequently (70 vs. 16%). The reported pain reduction was comparable in those with and without concomitant NSP regardless of whether assessed as mean pain rating (from about 6 to 1.5 on a 10-point rating scale), patients experiencing a ≥50% in pain reduction (89.6 vs. 88.8%) or becoming pain-free within 2 h (57 vs. 64%). However, recurrence of pain and use of another dose within the same day were more frequent with than without NSP. We conclude that concomitant NSP is frequent in patients with headache but does not substantially alter responses to a non-prescription medication.

HIOPP-6 - a pilot study on the evaluation of an electronic tool to assess and reduce the complexity of drug treatment considering patients' views.

BACKGROUND: A complex drug treatment might pose a barrier to safe and reliable drug administration for patients. Therefore, a novel tool automatically analyzes structured medication data for factors possibly contributing to complexity and subsequently personalizes the results by evaluating the relevance of each identified factor for the patient by means of key questions. Hence, tailor-made optimization measures can be proposed. METHODS: In this controlled, prospective, exploratory trial the tool was evaluated with nine general practitioners (GP) in three study groups: In the two intervention groups the tool was applied in a version with (GI_with) and a version without (GI_without) integrated key questions for the personalization of the analysis, while the control group (GC) did not use any tools (routine care). Four to eight weeks after application of the tool, the benefits of the optimization measures to reduce or mitigate complexity of drug treatment were evaluated from the patient perspective. RESULTS: A total of 126 patients regularly using more than five drugs could be included for analysis. GP suggested 117 optimization measures in GI_with, 83 in GI_without, and 2 in GC. Patients in GI_with were more likely to rate an optimization measure as helpful than patients in GI_without (IRR: 3.5; 95% CI: 1.2-10.3). Thereby, the number of optimization measures recommended by the GP had no significant influence (P = 0.167). CONCLUSIONS: The study suggests that an automated analysis considering patient perspectives results in more helpful optimization measures than an automated analysis alone - a result which should be further assessed in confirmatory studies. TRIAL REGISTRATION: The trial was registered retrospectively at the German Clinical Trials register under DRKS-ID DRKS00025257 (17/05/2021).

Prevalence and patient-rated relevance of complexity factors in medication regimens of community-dwelling patients with polypharmacy.

PURPOSE: To describe the prevalence of complexity factors in the medication regimens of community-dwelling patients with more than five drugs and to evaluate the relevance of these factors for individual patients. METHODS: Data were derived from the HIOPP-6 trial, a controlled study conducted in 9 general practices which evaluated an electronic tool to detect and reduce complexity of drug treatment. The prevalence of complexity factors was based on the results of the automated analysis of 139 patients' medication data. The relevance assessment was based on the patients' rating of each factor in an interview (48 patients included for analysis). RESULTS: A median of 5 (range 0-21) complexity factors per medication regimen were detected and at least one factor was observed in 131 of 139 patients. Almost half of these patients found no complexity factor in their medication regimen relevant. CONCLUSION: In most medication regimens, complexity factors could be identified automatically, yet less than 15% of factors were indeed relevant for patients as judged by themselves. When assessing complexity of medication regimens, one should especially consider factors that are both particularly frequent and often challenging for patients, such as use of inhalers or tablet splitting. TRIAL REGISTRATION: The HIOPP-6 trial was registered retrospectively on May 17, 2021, in the German Clinical Trials register under DRKS-ID DRKS00025257.

Patients' perception on generating medication plans in an interprofessional medication management program: a mixed-methods study.

A medication plan (MP) provides an overview of a patient's entire medication. In the interprofessional medication management program ARMIN (ARzneiMittelINitiative Sachsen-Thueringen), MPs are jointly generated by general practitioners (GPs) and community pharmacists (CPs). We aimed to assess patients' initial acceptance of the service, how they use the printed MP, and whether they perceived a benefit from it. This was evaluated with mixed-methods: a cross sectional written (quantitative) survey followed by semi-structured (qualitative) interviews. The data were analysed separately and compared. Qualitative data were analysed by thematic analysis. For the survey, 103 patients (mean 73 years) were involved. Benefits indicated were: improved communication between GPs and CPs, safer handling of the medication, and increased knowledge on dosages and indications. Ninety-six percent of the patients used their MP, 51% regularly. Regular use was significantly associated with older age, higher number of drugs, and need for assistance with the medication. Ten patients were interviewed. Results from interviews agreed with the results from the survey but revealed some additional aspects (e.g., patients reported an increased feeling of safety). Health-care professionals should consider providing MPs for their patients. This interprofessional cooperation also meets patient's need for safety in health issues.

Changing the medication documentation process for discharge: impact on clinical routine and documentation quality-a process analysis.

OBJECTIVES: In 2017, an in-house best-practice process for medication documentation was developed and implemented to meet the new German legal requirements concerning the management of patient discharge from the hospital. Because this law regulates the common steps of good discharge practices (eg, specification of discharge mediation documentation), we used its implementation to assess the impact of such a measure on the quality of medication documentation and related workflows in clinical routine. METHODS: By observing workflows and interviewing the affected employees, we analysed the medication workflow processes from admission to discharge of seven representative departments of a large university hospital before and early after implementation of a newly defined best-practice process. To investigate the implementation impact, following measures were determined overall and for five key process steps: quality of medication documentation as measured by predefined criteria, the adherence to the best-practice process (range 0%-100%), workload and potential shifts in responsibilities. RESULTS: Already early after implementation, all departments met the legal requirements and the quality of the medication documentation increased from low to high quality in most departments. Mean adherence to the best-practice process was 77% (range 60%-100%) with strictest adherence of 100% in one department. Thereby, the number of process steps and hence, likely also the workload increased in all departments. New tasks were mainly performed by physicians and in one department by pharmacists. CONCLUSIONS: The new lawful best-practice process led to a higher quality in medication documentation at the cost of a higher workload for physicians, potentially limiting time for other care tasks. Therefore, it could be important to define areas of the medication documentation process in which physicians could be supported by other professions or new tools facilitating accurate medication documentation as the basis of continuity of care.

Development and Pilot-Testing of Key Questions to Identify Patients' Difficulties in Medication Administration.

PURPOSE: The development and testing of key questions suitable to identify patients' difficulties with medication administration. MATERIALS AND METHODS: We used a consecutive five-step process to draft key questions regarding 43 aspects of medication administration that can be difficult for patients who manage a complex drug treatment: Step 1) Identification of potentially error-prone characteristics of drug treatment (such as certain dosage forms) and initial draft of key questions. Step 2) Assessment of how comprehensible the questions are for patients. Step 3) Pre-testing of exemplary key questions with patients and monitoring of patient's actual medication administration behavior. Step 4) Evaluation by general practitioners of how well the questions may be integrated into actual patient visits. Step 5) Final approval of the questions in an expert panel. Thereafter, we pilot-tested exemplary questions with 36 patients (43 tests). In the course of this pilot-testing, the patients' answers to the key questions were tested against both their actual behavior during medication administration and against their answers to more general questions regarding potential difficulties with medication administration. RESULTS: More than half of the key questions (N = 24/43) were revised at least once during the development process. During the pilot-testing, 55.8% of the pilot-tests (N = 24/43) revealed medication administration difficulties. It was observed that the key questions identified significantly more difficulties (N = 17) than the general questions (N = 8; P = 0.021, positive predictive value = 94.4% vs 88.9%). In one case, both a key question and a general question identified difficulties, which, however, was not confirmed during the drug administration demonstration, indicating a false positive rate of 5.3% in both cases. CONCLUSION: We developed key questions aimed at detecting administration errors with a high specificity and a significantly higher sensitivity than general questions, suggesting that the resource-intensive demonstration of medication administration can be reserved for the detection of rarer and uncommon administration errors.

Development of an algorithm to detect and reduce complexity of drug treatment and its technical realisation.

BACKGROUND: The increasing complexity of current drug therapies jeopardizes patient adherence. While individual needs to simplify a medication regimen vary from patient to patient, a straightforward approach to integrate the patients' perspective into decision making for complexity reduction is still lacking. We therefore aimed to develop an electronic, algorithm-based tool that analyses complexity of drug treatment and supports the assessment and consideration of patient preferences and needs regarding the reduction of complexity of drug treatment. METHODS: Complexity factors were selected based on literature and expert rating and specified for integration in the automated assessment. Subsequently, distinct key questions were phrased and allocated to each complexity factor to guide conversation with the patient and personalize the results of the automated assessment. Furthermore, each complexity factor was complemented with a potential optimisation measure to facilitate drug treatment (e.g. a patient leaflet). Complexity factors, key questions, and optimisation strategies were technically realized as tablet computer-based application, tested, and adapted iteratively until no further technical or content-related errors occurred. RESULTS: In total, 61 complexity factors referring to the dosage form, the dosage scheme, additional instructions, the patient, the product, and the process were considered relevant for inclusion in the tool; 38 of them allowed for automated detection. In total, 52 complexity factors were complemented with at least one key question for preference assessment and at least one optimisation measure. These measures included 29 recommendations for action for the health care provider (e.g. to suggest a dosage aid), 27 training videos, 44 patient leaflets, and 5 algorithms to select and suggest alternative drugs. CONCLUSIONS: Both the set-up of an algorithm and its technical realisation as computer-based app was successful. The electronic tool covers a wide range of different factors that potentially increase the complexity of drug treatment. For the majority of factors, simple key questions could be phrased to include the patients' perspective, and, even more important, for each complexity factor, specific measures to mitigate or reduce complexity could be defined.

The Impact of Baseline Pain Intensity on the Analgesic Efficacy of Ibuprofen/Caffeine in Patients with Acute Postoperative Dental Pain: Post Hoc Subgroup Analysis of a Randomised Controlled Trial.

INTRODUCTION: A fixed dose combination (FDC) of ibuprofen 400 mg and caffeine 100 mg has been shown to be more effective than ibuprofen 400 mg alone for the treatment of acute postoperative dental pain in a phase III randomised controlled trial. A post hoc subgroup analysis of the primary data from an active-/placebo-controlled, double-blind, single-centre, parallel-group study was conducted in patients with moderate or severe baseline pain. METHODS: After dental surgery, patients with moderate or severe pain, which was determined on a 4-point verbal rating scale ('no pain' to 'severe pain'), received a single dose of ibuprofen 400 mg/caffeine 100 mg FDC, ibuprofen 400 mg, caffeine 100 mg or placebo. Pain relief (PAR) and pain intensity were assessed 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7 and 8 h after administration of study medication. The primary study endpoint was the time-weighted sum of PAR and pain intensity difference (PID) from pre-dose baseline, summed for all post-dose assessment times from 0 to 8 h (SPRID0-8h). RESULTS: There were 237 patients with moderate pain and 325 with severe pain at baseline. SPRID0-8h was significantly improved with the FDC versus ibuprofen, caffeine and placebo in the moderate and severe pain subgroups. Adjusted mean SPRID0-8h difference for the FDC versus ibuprofen was 18.19 (p < 0.0001) for patients with moderate pain and 7.70 (p = 0.0409) for patients with severe pain. With the exception of the 7-h measurement in patients with moderate pain, PID was significantly improved with the FDC versus ibuprofen at all measured time points from 0.5 to 8 h. In the severe pain subgroup, PID was significantly improved for the FDC versus ibuprofen from 0.5 to 3 h post-dose, but was not significantly different thereafter. CONCLUSION: The enhanced analgesic efficacy of ibuprofen/caffeine FDC versus ibuprofen is most pronounced in patients with moderate intensity pain at baseline, and also evident in patients with severe baseline pain. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT01929031.

The non-steroidal anti-inflammatory drug (NSAID) ibuprofen is commonly used to relieve mild to moderate pain. Research suggests that combining ibuprofen with caffeine can increase the analgesic efficacy. Previously, a randomised, double-blind, placebo-controlled study showed that this ibuprofen/caffeine combination was significantly more effective than ibuprofen alone for relieving pain after dental surgery (wisdom tooth removal). Patients in that study had moderate or severe pain, so the researchers conducted another analysis of the study data to investigate how well the ibuprofen/caffeine combination worked in patients with moderate pain and in patients with severe pain. The study found that a single dose of ibuprofen/caffeine was significantly more effective than ibuprofen alone in patients with moderate pain and in those with severe pain. The analgesic effects of ibuprofen/caffeine were more marked in patients with moderate pain than in those with severe pain. This indicates that ibuprofen/caffeine is an effective pain reliever for patients with moderate pain, and to a lesser extent in patients with severe pain.

Individual factors increasing complexity of drug treatment-a narrative review.

PURPOSE: Complexity of drug treatment is known to be a risk factor for administration errors and nonadherence promoting higher healthcare costs, hospital admissions and increased mortality. Number of drugs and dose frequency are parameters often used to assess complexity related to the medication regimen. However, factors resulting from complex processes of care or arising from patient characteristics are only sporadically analyzed. Hence, the objective of this review is to give a comprehensive overview of relevant, patient-centered factors influencing complexity of drug treatment. METHODS: A purposeful literature search was performed in MEDLINE to identify potential complexity factors relating to the prescribed drug (i.e. dosage forms or other product characteristics), the specific medication regimen (i.e. dosage schemes or additional instructions), specific patient characteristics and process characteristics. Factors were included if they were associated to administration errors, nonadherence and related adverse drug events detected in community dwelling adult patients. RESULTS: Ninety-one influencing factors were identified: fourteen in "dosage forms", five in "product characteristics", twelve in "dosage schemes", nine in "additional instructions", thirty-one in "patient characteristics" and twenty in "process characteristics". CONCLUSIONS: Although the findings are limited by the non-systematic search process and the heterogeneous results, the search shows the influence of many factors on the complexity of drug treatment. However, to evaluate their relevance for individual patients, prospective studies are necessary.

A Randomized, Double-Blind, Placebo-Controlled Trial of Ibuprofen Lysinate in Comparison to Ibuprofen Acid for Acute Postoperative Dental Pain.

INTRODUCTION: Ibuprofen acid is poorly soluble in the stomach, thus reaching maximum plasma levels at approximately 90 min post-dose. Ibuprofen lysinate has been developed to accelerate absorption of ibuprofen to shorten the time to analgesic efficacy. This study compared analgesic efficacy and onset of effect of a single dose of ibuprofen lysinate or ibuprofen acid in patients undergoing third molar extraction. METHODS: Randomized, double-blind, placebo-controlled, multi-center, parallel-group single-dose study. Adults (18-60 years) undergoing extraction of ≥ 1 third molar were randomized 2:2:1 to ibuprofen lysinate, ibuprofen acid, or placebo postoperatively. Pain relief (PAR, 5-point scale, 0 = none to 4 = complete pain relief) and pain intensity (PI, 100 mm visual analog scale) were assessed between 15 and 360 min post-dose. The primary endpoint was the weighted sum of PAR scores at 6 h (TOTPAR). Time to onset of effect, global assessment of efficacy, and adverse events were also assessed. RESULTS: Overall, 351 patients received ibuprofen lysinate (N = 141), ibuprofen acid (N = 139), or placebo (N = 71). Both active treatments significantly reduced pain compared with placebo, from 15 min post-dose to 6 h (TOTPAR: ibuprofen lysinate: 19.57; ibuprofen acid: 19.96; placebo: 8.27). Ibuprofen lysinate was significantly more effective than placebo, but non-inferior to ibuprofen acid, at providing pain relief over 6 h. There was no significant difference between ibuprofen lysinate and ibuprofen acid for onset of analgesia. Both ibuprofen formulations were well tolerated; all adverse events were mild to moderate and considered unrelated to treatment. CONCLUSIONS: A single dose of ibuprofen lysinate is non-inferior to ibuprofen acid in terms of analgesic efficacy, onset of action, and tolerability in patients who have recently undergone dental surgery. TRIAL REGISTRATION: EudraCT No. 2006-006942-33. Plain language summary available for this article.

Reasons for Drug Administration Problems and Perceived Needs for Assistance of Patients, Family Caregivers, and Nurses: A Qualitative Study.

OBJECTIVE: Investigation of drug administration problems, respective causes, and needs for assistance. METHODS: Focus group discussions with patients, family caregivers, and nurses were conducted using a semi-structured interview guideline for a focused exploration of the participants' drug administration experiences and perceived needs for assistance. All discussions were audio-recorded and video-recorded, verbatim transcribed, and analyzed according to Mayring's qualitative content analysis. RESULTS: In total, 6 focus group discussions were conducted. The qualitative content analysis revealed that patients and family caregivers frequently trivialized drug administration, were unaware of errors, and primarily blamed the dosage form of causing administration problems. Nurses also considered health-care system-related conditions and patient factors as potential causes of administration problems. CONCLUSIONS: The administration problems and perceived causes were multifaceted and often directed toward inappropriate dosage forms or health-care system-related conditions rather than critically questioning the medicine user's administration skills. To increase medicine users' motivation to scrutinize wrong administration practices, health-care professionals should consider individual perspectives on administration problems and perceived causes, assist medicine users' to identify the true cause of a distinct problem, and provide individualized support.

[The PRIMA Project - Electronically-Supported Physician-Pharmacist Cooperation to Generate and Update Medication Plans in Germany]. / Das Projekt PRIMA ­ Elektronische Erstellung und Aktualisierung von Medikationsplänen als gemeinsame Aufgabe von Ärzten und Apothekern.

BACKGROUND: A complete overview on the patient's medication is one precondition for medication safety. For this, a complete and current medication plan (MP) is an appropriate instrument. We aimed to develop and implement software to evaluate and exchange medication plans in local software systems of general practitioners (GPs) and community pharmacies (CPs). Furthermore, it was the aim to evaluate feasibility and acceptance of the defined processes. METHODS: CPs and GPs were involved to pilot the software in several steps. Additionally, they generated and updated MP according to pre-defined processes and responsibilities. Feasibility and acceptance were evaluated in a survey and a workshop. RESULTS: For the first time in Germany, the technical requirements were established to generate and exchange MP electronically. Four software systems of CPs and one software system of GPs were involved. Solved Problems were technical errors, errors relevant for medication safety, differences in display of the medication data, and limited capacity of the barcode on the MP printout. Eleven GP and CP teams recruited 196 patients. 60 % were satisfied with the defined processes. 80 % of the GPs and 63 % of CPs agreed with the defined responsibilities. GPs considered the initial compilation on patient's medication in the CP as useful. The professional exchange between GPs and CPs improved: 70 % of GPs referred to increased knowledge on medication and 88 % of CPs received more information on patients' health conditions. The structured collaboration between GPs and CPs was considered to be important (25 %) or very important (75 %) for the quality of medication plans. DISCUSSION: An electronic MP was successfully implemented for the first time in local software systems. Processes and responsibilities were accepted by both professions. These are important prerequisites for sustainably implementing the MP in daily practice.

[Information Gaps in Package Inserts Cause Insufficient Patient Information on Correct Handling of Transdermal Patches]. / Informationslücken in Packungsbeilagen: fehlende Hinweise zum richtigen Umgang mit Transdermalen Therapeutischen Systemen.

BACKGROUND: The multi-step administration process of transdermal patches requires sufficient knowledge and skills of patients to prevent administration errors. The package insert is an easily accessible information source that reaches the patient automatically with drug dispensing. However, information gaps potentially limit their suitability as appropriate patient information material. METHODS: Package inserts of all transdermal patches available on the German drug market were analyzed for medication administration recommendations. RESULTS: In total, 81 package inserts were analyzed including buprenorphine (N = 13), fentanyl (N = 33), granisetron (N = 1), glyceroltrinitrate (N = 2), nicotin (N = 4), oxybutynin (N = 1), rivastigmin (N = 10), rotigotin (N = 2), scopolamin (N = 1), and hormone preparations with estradiol, estradiol hemihydrate, ethinyl estradiol, gestodene, levonorgestrel, norelgestromin, and norethindrone acetate (N = 14). None of the package inserts included all 28 administration recommendations that were previously identified as relevant through a systematic literature search. In particular, information was lacking on transdermal patch-specific characteristics such as mechanism of drug absorption, monitoring, storage, and disposal. DISCUSSION: The package inserts insufficiently inform patients on correct transdermal patch administration and thus, comprehensive patient education by healthcare professionals is required. In the long-term, regulatory requirements for package inserts should include standardized and dosage form-specific recommendations for correct medication administration.

Improving eye-drop administration skills of patients - A multicenter parallel-group cluster-randomized controlled trial.

BACKGROUND: Eye-drop administration errors occur in the majority of patients and increase the risk for treatment failure or systemic adverse events. While lacking knowledge is the principal error cause, most patients overestimate their skills and are unaware of often substantial knowledge gaps. Therefore, the impact of including motivational patient education on long-term eye-drop administration skills of patients was investigated. METHODS: This is a cluster-randomized controlled trial in German community pharmacies. Patient education in both groups comprised observation of the patient during eye-drop administration to identify individual errors, pharmaceutical counseling, and teach-back evaluation of the training. In the intervention group, motivational communication techniques were included to increase error awareness and readiness for patient education. In addition, intervention patients were trained on repeated errors until administration was performed correctly. In contrast, patients in the control group only received feedback on erroneous administration steps without another assessment and reinforced training. RESULTS: In total, 152 adult patients were eligible to the study and 91 patients (intervention group N = 46) agreed to participate in a 1-month, 6-month, and 12-month follow-up. Patient education significantly increased the proportion of patients correctly administering eye-drops from 6% (7 out of 56 intervention patients, 1 out of 82 control patients) at baseline to 35% (12 out of 30 intervention patients, 12 out of 39 control patients, p ≤ 0.001) at the 1-month follow-up, and 64% (11 out of 15 intervention patients, 17 out of 29 control patients, p ≤ 0.001) at the 6-month follow-up irrespective of group allocation. In some patients previously resolved errors recurred during follow-up visits. This emphasizes the need for periodical reevaluation of patient administration skills and the provision of prevention strategies besides education. CONCLUSION: Patient education that included demonstration of administration skills and verbal and written counseling on observed errors improved eye-drop administration skills irrespective of the communication technique applied. Whereof, high drop-out rates limited the power to detect a difference between groups. In particular, periodic demonstration of administration skills seemed important for sustainable improvement of administration skills. However, further error prevention strategies such as additional education materials or support by a caregiver may be necessary in some patients.

Patient Experiences With Handling of Analgesic Transdermal Patches and Challenges in Correct Drug Administration: A Pilot Study on Patient Education.

BACKGROUND: Although problems during transdermal patch administration are primarily caused by insufficient knowledge, patient education programs are lacking. We compared patient education by a clinical pharmacist on knowledge on correct patch administration with routine counseling during patient-physician consultation in a pilot study. METHODS: After baseline assessment of knowledge and difficulties with patch administration, patients in the outpatient pain clinic of Heidelberg University Hospital were allocated to intervention (n = 12) or control group (n = 11). In both groups, identical information leaflets on transdermal patch use were dispensed. Intervention patients additionally received verbal counseling on correct patch administration by a clinical pharmacist. After 4 weeks, patients were called for a follow-up assessment on knowledge and perspective on administration difficulties. RESULTS: Patients reported several difficulties with transdermal patch administration, such as local skin reaction, difficulties with opening the packaging, and poor adhesion. Although patient education increased the ratio of correct answers in the intervention group twice as much than in the control group, overall knowledge was comparable between groups after education (P = 0.602). CONCLUSIONS: Patients encountered numerous problems with transdermal patch administration although on long-term use. Patient education can improve knowledge on correct patch administration. However, the pilot study demonstrated the need for further efforts to improve ease of use of transdermal patch, such as patch adhesion.