Evaluating real-world data in COVID-19 antigen and PCR testing.

OBJECTIVE: COVID-19 testing is an important pillar in fighting the SARS-CoV-2 pandemic. Even though billions of tests have been conducted, little is known on performance of testing sites. This is a retrospective observational study with real-world data from a pharmacist-led COVID-19 testing center in Germany during the Omicron subvariant BA.4 and BA.5 wave in June 2022. MATERIALS: The rapid antigen tests employed were purchased from Anbio Biotechnology (Xiamen, China). The RT-PCR was performed on Egens YS-qPCR-1 real-time system with Kewei multiple real-time PCR kits for detection of SARS-CoV-2 (Beijing Kewei Clinical Diagnostic Reagent Inc., Beijing, China). METHODS: The study followed the STARD 2015 guideline. In this retrospective cohort study, the performance of testing sites was compared. RESULTS: During the study period, 7,112 patients were tested by rapid antigen tests and 1,025 RT-PCR tests conducted. Included were 233 patients who were referred by other testing sites for confirmation of positive results. A positive predictive value of 99.6% was calculated for the antigen tests in the pharmacist-led testing center. Referred positive patients from non-medical sites were antigen and RT-PCR negative in 16 cases, which led to a positive predictive value of 88.8%. Difference between site performance was statistically significant (p < 0.05). CONCLUSION: Results indicate that nucleic acid amplification confirmation is crucial in the context of the current testing strategy in Germany. Higher standards in antigen-testing, however, can make nucleic acid amplification in active COVID-19 infections unnecessary and testing cost efficient. This study provides the first data in the world on COVID-19 testing performance, and how it can be optimized.

COVID-19 vaccinations in German pharmacies: A survey on patient and provider satisfaction.

BACKGROUND: COVID-19 vaccinations applied in pharmacies can facilitate accessibility and potentially increase the vaccination rate but remain controversial in many countries. This study aimed to explore the patients' motivation to receive their COVID-19 vaccination in a pharmacy and examine patient and provider satisfaction with this novel service. METHODS: The study was designed as an explorative cross-sectional multicenter in-house quantitative survey and was conducted during the first weeks of COVID-19 vaccinations in German pharmacies from February to April 2022. The survey consisted of a paper-based questionnaire with scaling questions, multiple choice questions and open questions. Patients were recruited consecutively before their vaccination and completed the survey directly after the service. Vaccinating pharmacists were also invited to answer a questionnaire on their experiences, motivation and expectations. RESULTS: A total of 427 questionnaires out of 11 pharmacies were be included. The overall patient satisfaction with vaccinations in pharmacies was rated with the highest remarks by 91.5% of the participants, another 7.8% were fairly satisfied. Patient satisfaction with scheduling, waiting time, information, hygiene, vaccination technique and a feeling of safety was very high (96.5-97.9%). Patients' motivation on COVID-19 vaccination was to prevent severe COVID-19 symptoms (88.9%) and to protect others (72.3%). Easy accessibility, low barriers and proximity were other reasons for utilizing this service, mentioned by 61.8% of the patients. Pharmacists were highly motivated and found the task meaningful but experienced considerable personnel shortage. General practitioners rather expressed relief on their workload. CONCLUSIONS: Data of this study strongly supports to include pharmacies as additional providers of COVID-19 vaccinations. Patients stated marked satisfaction with this setting and expressed a feeling of safety and trust. Whereas most patients may have utilized the service for convenience, easy accessibility and low barriers were appreciated and can potentially contribute to higher vaccination rates.

Enhancing medication therapy in Parkinson's disease by establishing an interprofessional network including pharmacists.

Background Optimizing therapy regimens through collaboration and combination of available resources is a promising approach to improve quality of life for patients with Parkinson's disease (PD). Aim The aim of this project was to enhance patient-oriented therapy and interprofessional collaboration by establishing a regional PD network. Setting The network is located in a rural area in Germany. It covers primary, secondary and tertiary care facilities across professional boundaries. Development Recruitment of PD specialists and patient support groups was done by the local newspaper to spread the word. The network was initially open to all healthcare professionals, who stated a focus or special interest in PD. A working group for medication was founded within the network by asking for interested participants. Problems in the medication process were discussed within the group. As a consequence, therapy recommendations (quickcards) and a specific medication plan were developed and a certified education curriculum for pharmacists was developed. Implementation The network grew to > 150 participants across all disciplines and sectors. Quickcards were adjusted, approved and implemented by the network during interquartile meetings. Certified education was implemented and became a requirement for participating pharmacists. Evaluation The quickcards on medication plan and drug-drug-interactions were approved to be useful and feasible by the network by unanimous assent. Overall satisfaction with certified education was high (mean of 1.4 on a scale between 1 = high and 6 = low). Conclusion A regional interprofessional PD network with pharmacists was established and new standards were established. Future research needs to measure the effects on patient outcomes.

An Algorithm for Comprehensive Medication Management in Nursing Homes: Results of the AMBER Project.

INTRODUCTION: There are several barriers to conducting medication management in nursing homes. Our project aimed to develop an algorithm that guides and supports pharmacists to perform this clinical service. METHODS: Phase I of the project examined the practitioner and patient perspectives on the medication process in nursing homes. The mixed methods approach consisted of interviews with qualitative content analysis and a quantitative questionnaire. Phase IIa scoped existing research and comprised a three-stepped systematic review. It was registered in the International Prospective Register of Systematic Reviews (CRD42017065002). Results of the first two steps were assessed for quality. Phase IIb was performed as a Delphi survey. The developed algorithm was tested in nursing homes. The primary endpoint was the number and type of detected drug-related problems. The study was conducted between June 2016 and December 2018 (Deutsches-Register-Klinischer-Studien-ID: DRKS00010995). RESULTS: Interviews were held with 21 healthcare practitioners and six patients. Frequent and relevant aspects of the medication process in nursing homes were identified. The systematic reviews included 28 reviews, 12 interventional studies and 1450 non-interventional studies. As a result of the Delphi survey, two new aspects were added. Testing of the drafted algorithm was done in 73 nursing home residents. A mean of 6.3 drug-related problems were detected. Sample cases were executed in a mean time of 21 min by community pharmacists. CONCLUSIONS: The developed and consented algorithm can guide pharmacists in conducting medication management in a timely and effective manner. It might serve as a facilitator to improve collaboration and quality of medication in nursing home residents.

Effects of generic exchange of solid oral dosage forms in neurological disorders: a systematic review.

Background Generic drug exchange is common practice in most healthcare systems. While generics certainly contribute to economic savings, the altered drug formulation might be associated with potential therapeutic problems. Given the narrow therapeutic windows in neurologic indications, any detrimental effect on the therapy can lead to significant consequences. Aim of the review This review aims to investigate potential problems related to a switch from brand-name to generic or from generic to generic drug products in patients with neurologic diseases. Method The review was conducted following the PICO framework and the PRISMA guidelines. MEDLINE and Scopus databases were searched for articles published in English and German language between January 1, 1995 and October 17, 2018. Studies included in this review were randomized controlled studies, reviews, systematic reviews, overviews, cohort studies and case-control studies. Studies excluded were letters, comments, authors view, congress or seminar papers and studies with a focus on economic impact or costs. Results were synthesized qualitatively. The primary outcomes were pharmacokinetic parameters such as the area under the curve (AUC), the peak serum concentration (cmax) or the time at which cmax is observed (tmax). Results The search identified 67 studies with a great variety of endpoints and study designs. The leading indication was epilepsy. Two small RCTs were found on lamotrigine switch. Analysis of the other studies found no significant differences in pharmacokinetic parameters when switching to generic drugs. A more heterogeneous picture was revealed regarding hospitalizations, breakthrough seizures, failure of therapy, adherence and patient concerns. Conclusion While most reports were of poor quality, lamotrigine was the drug with the best available data. Summarizing the results of the available studies, pharmacokinetic parameters of antiepileptic drugs show low deviation. In contrast, data on clinical parameters are less consistent. Some studies found increased seizure frequencies and adverse-drug events, while others showed no complications. Adherence and patient satisfaction seemed to be impaired. In daily practice, generic exchange in epilepsy should be a carefully balanced decision, conducted with great caution. Further research is needed, especially regarding neurologic indications other than epilepsy.

Development of clinical pharmacy services in Australia, Austria, Belgium, Bosnia-Herzegovina, Canada, Germany, Japan, Kosovo, Switzerland, the Netherlands, Thailand, USA and correlation with educational standards, level of research, and implemen.

OBJECTIVE: This study aimed to compare determinants of professional development between different countries to identify barriers and facilitators of development towards clinical pharmacy services and stimulate discussion of under-used potential and opportunities. MATERIALS: The study was conceived as a survey. The questionnaire was administered to a group of experts. METHODS: The survey was conducted as a cross-sectional study with descriptive and correlation analysis. A questionnaire was developed and adjusted to the study focus, covering aspects on general regulations for community pharmacies, professional education, implementation of clinical pharmacy services, and research in patient care. Results were compared for analyses. RESULTS: A total of twelve countries were included in this survey. Pharmacy studies took between 4 and 6 years plus residency in most countries. Curricula remained drug-oriented only in Austria, Bosnia-Herzegovina, and Germany; these three countries had the least pharmacotherapy content in their curricula. Canada, the USA, and Australia have established clinical pharmacy services in almost all fields of practice. Most other countries have implemented at least some clinical services, with the exception of Bosnia-Herzegovina, Germany, and Kosovo. The correlation coefficient between education, research, and implementation was 0.91. CONCLUSION: The results of the survey show that clinical pharmacy services are established to very different extents among the participating countries. The strong correlation suggests that achieving a successful transition in professional practice needs to address several aspects of education and research to reach progress. The collected data might help to identify potential areas of improvement to foster implementation of clinical pharmacy services.
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Development and evaluation of an algorithm-based tool for Medication Management in nursing homes: the AMBER study protocol.

BACKGROUND: Residents of nursing homes are susceptible to risks from medication. Medication Reviews (MR) can increase clinical outcomes and the quality of medication therapy. Limited resources and barriers between healthcare practitioners are potential obstructions to performing MR in nursing homes. Focusing on frequent and relevant problems can support pharmacists in the provision of pharmaceutical care services. This study aims to develop and evaluate an algorithm-based tool that facilitates the provision of Medication Management in clinical practice. METHODS AND ANALYSIS: This study is subdivided into three phases. In phase I, semistructured interviews with healthcare practitioners and patients will be performed, and a mixed methods approach will be chosen. Qualitative content analysis and the rating of the aspects concerning the frequency and relevance of problems in the medication process in nursing homes will be performed. In phase II, a systematic review of the current literature on problems and interventions will be conducted. The findings will be narratively presented. The results of both phases will be combined to develop an algorithm for MRs. For further refinement of the aspects detected, a Delphi survey will be conducted. In conclusion, a tool for clinical practice will be created. In phase III, the tool will be tested on MRs in nursing homes. In addition, effectiveness, acceptance, feasibility and reproducibility will be assessed. The primary outcome of phase III will be the reduction of drug-related problems (DRPs), which will be detected using the tool. The secondary outcomes will be the proportion of DRPs, the acceptance of pharmaceutical recommendations and the expenditure of time using the tool and inter-rater reliability. ETHICS AND DISSEMINATION: This study intervention is approved by the local Ethics Committee. The findings of the study will be presented at national and international scientific conferences and will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: DRKS00010995.