Active search about latex in injectable drugs for patient’s safety in medical therapy

Objectives: To classify injectable drugs used in a general hospital inventory according to latex presence or absence in vials with rubber stoppers, antibiotics, and electrolytes bags. Methods: The information about latex content has been collected from medicine industries, after identification of authorized manufacturers in Brazil, through the National Health Surveillance Agency (ANVISA) medicine search database. Medicines have been grouped per pharmaceutical manufacturers, and data were collected through telephone or e-mail. Only written information from pharmaceutical companies were considered. Results: Among 161 medicines used in the hospital packaged in vials with rubber stoppers, antibiotics, and electrolytes bags, 123 (76.4%) medicine-related responses were received, covering 540 (82.2%) different presentations. For this, from 87 contacts, 70 (80.5%) companies responded and 65 (74.7%) provided information related to the presence or absence of the allergen. Among the medicine list, 8 (6.5%) were identified as containing latex (in 12 different presentations – 2.2%) and 101 medications (82.1%) in 507 presentations (93.9%) do not contain latex. The manufacturers responded that the medicine was latex-free, but could not confirm for raw materials (6 medicines – 4.9% - in 6 different presentations – 1.1%) and that they were unable to ensure there was no contact with latex during manipulation (4 medicines – 3.3% - in 8 different presentations – 1.5%). For 4 medicines (3.3%) in 7 different presentations (1.3%), the companies were inconclusive, as they could not confirm whether they were latex-free or not. Conclusion: Although latex is a known allergen, information about the presence of latex components in pharmaceutical packaging and package inserts needs improvement, since the active search identified 161 medicines packaged in vials with rubber stoppers, antibiotics, and electrolytes bags that failed to depict this information. The results of this survey endorse the Importance of displaying this information on medicines label or packaging in order to ensure healthcare professionals easy access and prompt consultation.

An Evaluation of Information Sources Regarding Drug Use and/or Poisoning Cases of Community Pharmacists in Ankara, Turkey

Objective: Exploring and categorizing the drug and/or poisoning information resources available in community pharmacies in Ankara according to some variables, and revealing common opinions regarding the future of the profession and information resources. Materials and Methods: This study was conducted as an online questionnaire for community pharmacists in Ankara. It had four headings on the pharmacists’ demographics, their general information resources, specific resources in specific topics, and 4 suggestions regarding the future of pharmacy and drug information resources. Results: The number of participants was 134 as 17.9% of 746 e-mail addresses. Mean ages±standart deviation were 40.9±12.0 years. The top 3 information sources on poisonings were the internet, colleagues, and physicians with 74.6%, 43.3%, and 30.6%, respectively. Participants in the “colleagues” group in terms of poisoning preferences had a shorter period after graduation (p=0.001). In the drug information inquiries package inserts, internet and colleagues were preferred mostly, with 69.4%, 63.4%, and 35.8%, respectively. Age groups and graduation years were statistically different regarding the “package inserts” and “colleagues” groups (p=0.012 and p=0.001, and p=0.019 and p<0.001, respectively). The most “totally agreed” suggestion was accepting the pharmacies’ being important drug and/or poison information resources for consumers with 68.7%. Conclusion: The pharmacists have been fulfilling their duty of “being an information resource” through rather limited resources. To equip community pharmacists properly, authorities, professional institutions, and universities need to contribute to the process in different ways together with pharmacists being aware of their responsibilities.

Pharmacotherapy for nontuberculous mycobacterial pulmonary disease

Disclaimer In an effort to expedite the publication of articles , AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. Purpose To provide an updated review of the diagnosis and pharmacotherapy of nontuberculous mycobacteria pulmonary disease (NTM-PD) and summarize guideline recommendations for an interdisciplinary treatment approach. Summary A systemic approach was taken in which all articles in English in MEDLINE and PubMed were reviewed. DAILYMED was used to assess drug package inserts. Analysis of NTM treatment guidelines is summarized in the article with a focus on medications, dosing, interactions, and medication monitoring. Conclusion It is critical to manage patients with NTM with a multidisciplinary team approach. Treatment is prolonged and expensive, and the potential for drug toxicity, adverse effects, and drug interactions requires monitoring. Clinical pharmacists play a role in the management of NTM.

Analysis of medication-induced xerostomia in elderly Japanese patients

Objectives To determine the general condition of elderly xerostomia patients, we collected their background and medication data in order to potentially treat their xerostomia. It is critical to identify the drugs causing xerostomia in elderly patients. A total of 521 patients who were examined at the Xerostomia Clinic of Osaka University Dental Hospital were included in the study. We obtained patients’ data on age, sex, number of primary illnesses, Saxon test scores, oral moisture test, subjective symptoms, and drug types from their clinical records. Results The mean age of the patients was 65.2 ± 13.3 years. Although all patients exhibited xerostomia symptoms, there were a lot of patients without hyposalivation. With respect to medication, each elderly xerostomia patient took an average of 6.8 ± 4.4 medicines. A total of 26.1% of patients in their 70 s took more than ten number of drugs. In addition, the number of frequently used medication medicine was different between elderly and young patients. Most of the medicines had xerostomia as a side effect in medical package inserts. Moreover, the quantity of salivation significantly decreased in patients who took more than seven drugs in comparison with the patients who did not take medicine. Conclusions As patients age, the number of medications they take tends to increase, subsequently increasing their risk of xerostomia. For the health of the patients, it is critical that an accurate diagnosis is made. Clinical relevance To establish therapeutic strategies for treatment of xerostomia, this study provides new and important information that will help in the development of xerostomia medical treatment.

Adr In Journals: Are They Translated Into Regulatory Frameworks?

Introduction: An adverse drug reaction case report refers to a scientific publication that is written by a health care professional who suspects a causal relationship between a drug and an adverse drug reaction (ADR). ADR case reports help to identify potential risks associated with the use of the drug. Most of the case reports do not mention reporting the ADR to regulatory authorities. With this objective, the aim of this study was to analyze the number of Adverse Drug Reaction (ADR) published as case reports (PubMed indexed journals) from January 2018 to June 2019 and observe if they are translated into a regulatory framework like Vigibase and package inserts. Materials And Methods: 321 ADRs were obtained with the keywords “Adverse Drug Reaction.” Out of those, 158 were independently extracted by two investigators, observed and categorized according to classes of the drugs, geographic location, severity, hospitalization, completeness of ADR, and whether they were reported to the regulatory authority (VigiBase) or listed in the package insert. Literature review articles were excluded. Results: Out of the 158 ADRs, antibiotics accounted for 12.65%, CNS drugs and monoclonal antibodies accounted for 11.39%, anticancer drugs for 9.49%, CVS drugs for 4.43%, anti-virals for 3.79%, and the others for 45.56%. According to geographic region, 26 ADRs published were from USA, 4 from Australia, 3 from Italy, 17 from India, 9 from Turkey, 1 from Singapore and the UK, 20 from China, 2 from Denmark and Canada, 10 from Japan, 9 from France, 1 from Austria, 5 from Korea, 3 from South America, and 2 from Switzerland. Depending upon the severity, causality assessment was performed for 45 ADRs only; it was not performed for 113 ADRs. 41.13% of patients (from 65 case reports) were hospitalized. Among the 158 ADRs, 14 ADRs were not found in VigiBase. 32 ADRs were not mentioned in the drug package inserts. When categorized according to the completeness of case reports, weight accounted for 1.89%, lab values and procedure for diagnosis accounted for 96.8%, risk factors for 95.56%, prior exposure for 88.60%, post ADR status for 60.12%, and the start-stop medication, route of administration, first dose, last dose, and the duration of illness accounted for 100%. Conclusion: Depending upon our observation, we have noticed that there is a deficiency in reporting of suspected ADR to the regulatory authorities. Reporting can be included as mandatory criteria for ADR case reports. Also, there is an increased need for various healthcare workers to be aware about reporting ADR.

Assessment of SARS-CoV-2 rapid antigen tests

Objectives Point-of-care antigen tests (PoC-AgTs) for the rapid detection of SARS-CoV-2 infection enable screening of additional populations with less effort, independent of laboratories and at a low cost. PoC-AgTs have therefore been included in national testing strategies with additional quality requirements to address limitations in specificity and sensitivity. Information given in the package inserts of the test providers should enable the user to evaluate the performance of a PoC-AgT in advance. The quality of this information has been independently assessed since the Corona Test Ordinance came into force in Germany in October 2020. Methods The completeness of analytical and diagnostic performance specifications was assessed for all package inserts publicly available via the Paul Ehrlich Institute (PEI). It was ascertained whether the minimum criteria, recommendations, and extended criteria of the PEI were comprehensibly fulfilled. The number of tests removed from the list by March 2021 was determined. Results By the closing date of the survey (17.11.2020), the PEI had listed 165 PoC-AgTs that formally fulfilled the minimum criteria and were thus reimbursed. A total of 78 identical systems were identified. Almost all providers were found to have gaps in the information on the validation results of their tests, meaning that an evaluation of performance is only possible to a limited extent. Until March 2021, 25 non-identical PoC-AgTs have been removed from the list. Conclusions Many PoC-AgTs could not be comprehensively evaluated based on the information provided by the provider. Users are therefore dependent on provider-independent sources of information.

ASSESSMENT OF KNOWLEDGE, ATTITUDE, AND PRACTICE ABOUT PACKAGE INSERTS AMONG MEDICAL UNDERGRADUATE STUDENTS: A CROSS-SECTIONAL QUESTIONNAIRE-BASED STUDY

Objective: The objective of our study was to assess knowledge, attitude, and practice regarding package inserts (PIs) among medical undergraduates of a Government Medical College in Kerala, India Methods: A cross-sectional, questionnaire-based study was carried out on 100 medical students. It was conducted with the consent of all participants and after the approval of Institutional Review Board and Ethics Committee. Pre-validated 15 items questionnaire was used to elicit responses about knowledge, attitude, and practice with a scoring scheme of +1 for “yes”/positive response and 0 for “no/I don’t know”/negative response. Data analyzed using “SPSS” and responses were expressed as mean scores and percentages. Results: Statistical analysis (response rate 98%) revealed that 88.2% have seen PIs but only 18.4% had the knowledge of drug acts governing the information to be provided on PIs in India. About 78.6% agreed PIs are necessary add-on to drug information. About 62.2% opined that PIs must be in regional language along with English. About 100% agreed that written information in PIs is difficult to read and understand. About 66.3% feel that doctors must instruct patients to read PIs thoroughly. About 71.4% have referred PIs as a source of knowledge for Indication/Contraindication/ Adverse Effects/Drug interaction. About 95.9% would like to refer PIs in future while prescribing as physician. Conclusion: We conclude that participants have positive attitude toward PIs but have less knowledge as compared with developed countries. Results suggest the need for escalating knowledge and awareness among medical students about PIs which, in turn, help to minimize medication errors.

Deprescribing benzodiazepines: Do Brazilian package inserts address this issue?

OBJECTIVE: To analyze the presence and quality of content on drug deprescribing in Brazilian package inserts for benzodiazepine drugs. METHODS: Documentary study where we analyzed data on deprescribing extracted from electronic package inserts of drugs containing benzodiazepines; these documents were available at the Brazilian Health Surveillance Agency website. Our search was performed independently by 2 researchers who used the following keywords: “deprescription,” “withdrawal,” and “tapering.” The deprescribing plan, when presented by the package insert, was compared to deprescribing protocols for benzodiazepines found in the literature. Moreover, we assessed the presence of guidance on the maximum length of treatment and risks of long-term use. RESULTS: We found 12 package inserts for benzodiazepines and 100% of them suggested gradual withdrawal; only 1 (8.33%) suggested a systematized deprescribing plan. One document (8.33%) did not offer guidance on maximum treatment duration. Eleven (91.67%) had the information on long-term use possibly causing dependence or tolerance, and 1 (8.33%) did not describe the risks of continuous use. CONCLUSIONS: It is known that benzodiazepines should be withdrawn in a gradual and schematized manner, but package inserts do not currently bring this information in detail. It is of utmost importance that health professionals be educated on their conduct, hence the necessity for updating medication package inserts.