Adherence to Eye Drops Usage in Dry Eye Patients and Reasons for Non-Compliance: A Web-Based Survey

This study aimed to investigate the actual use of eye drops for dry eye disease (DED), the reasons for instillation behavior, and the relationship between instillation behavior and subjective symptoms. This web-based cross-sectional study collected data on instillation behavior, medication instruction, reasons for instillation behavior, and subjective symptoms. In total, 2645 participants were enrolled. The proportion of participants who instilled at the frequency specified in the package insert (the specified frequency) was 10.2%. The most common reason for not instilling at the prescribed frequency was as-needed instillation to alleviate subjective symptoms, and 61.3% of participants instilled when feeling symptoms. The improvement in the subjective symptoms score was significantly greater in the group that regularly instilled at the specified frequency than the other group (p = 0.0027), and patients in the other group were younger and had a higher rate of contact lens use and over-the-counter eye drops use. In conclusion, most participants did not instill the DED eye drops at the specified frequency to alleviate symptoms. In order to obtain the appropriate effect of eye drops, ophthalmologists need to impress upon patients the importance of regular instillation at the frequency specified in the package insert, while taking into account patient characteristics.

Status of Medications Prescribed for Psychiatric Disorders in Korean Pediatric and Adolescent Patients

While mental health services for children are increasing, few psychiatric drugs have been approved for such use. We analyzed claim data from 19,557 South Korean pediatric and adolescent patients (<20 years) who were diagnosed with schizophrenia, bipolar disorder, major depressive disorder, anxiety disorder, attention deficit-hyperactivity disorder (ADHD), or a tic disorder. Among these diseases, depressive episodes were the most common, followed by an anxiety disorder, ADHD, bipolar disorder, tic disorder, and schizophrenia. For each disease, prescriptions were categorized as full-label (approved indication with pediatric dosing in the package insert (PI)), partial-label (approved indication without pediatric dosing in the PI), and contraindication (contraindicated for the specific pediatric age in the PI). For schizophrenia, major depressive disorder, and anxiety disorder, more than 50% of the patients were prescribed partial-labeled medications. Additionally, more than 5% of patients with major depressive disorder were prescribed medications that were contraindicated for their age group. Our findings reveal that children with full-labeled psychiatric conditions are commonly administered drugs that are not explicitly approved for either their disease state or age, including off-label and unlicensed drugs. To use pharmaceuticals more safely, expanding drug indications using real-world data are needed.

Practice of Vaccination

Vaccines are extremely effective public health tools which can dramatically improve the health of populations and individuals. Physicians who administer vaccines should familiarize themselves with the indications and contraindications of the specific product they use as well as its licensed and recommended dosing and schedules. Informed consent must be obtained according to local rules and regulations. Manufacturer requirements for shipping, handling, and storage should be followed to assure that the vaccine remains effective and safe for use. Different vaccines are administered by different routes – whether ID, SC, IM, or orally. The appropriate route should always be used as per the package insert. Vaccines do have side effects; most common are fever and reactions (pain, swelling, tenderness) at the injection site. These are usually mild, transient, and easily treated symptomatically. Providers should counsel vaccine recipients to anticipate such events. Care should be taken not to inappropriately attribute adverse events following immunization (AEFIs) to the respective vaccine as AEFIs can occur by chance (without immunization) as well. Anaphylaxis can be caused by all vaccines, but it is very rare. However, since it can be rapidly life-threatening, vaccinators must be prepared to treat this emergency.

COVID cure or perpetual vaccination?: 30 cheap effective treatments of COVID-19 & variants, like ivermectin, or never-ending compulsory injection, with unsafe, genotoxic, infertilizing, injuring, crippling, handicapping, lethal, inefficient, ineffective, abortion-tainted, abortive, unethical, experimental genetic-hacks, deceivingly called vaccines instead of haccines? Scientific proof of the COVID PLANdemic with 1000 peer reviewed published references.

What is 10x more lethal than COVID-19? Viral covidiocy. 9 out of 10 COVID deaths were vaccinated in Argentina, where case fatality rate was 1300% higher for the vaccinated than for the unvaccinated, plus a higher 40% contagion rate (5% if unvaccinated): the opposite of the narrative. Though not as drastic, Israel, UK, Chile, Uruguay and the USA, also showed worse outcomes for the vaccinated than the unvaxxed, because of different natural evolution of variant waves, periods, treatments and vaccine brands. COVID waves seem to have receded due to the increase of herd immunity of the recovered, both vaccinated and unvaccinated.In the USA and Europe, 5 million adverse reactions and 70 thousand deaths were reported linked to COVID vaccines. Informed consent forms can’t protect COVID-19 vaccine manufacturers against legal actions, even under immunity by law, not only because they are not really “vaccines” but gene hacks to produce the S1 spike protein (or parts), nor because some or all the elements are secret, un-disclosed or hidden, but especially, because the cure had been found, voiding Emergency Use Authorization (EUA): if you get COVID, especially if vaccinated, follow this successful evidence-based treatment: https://covid19criticalcare.com/covid-19-protocols/ ( translations: https://covid19criticalcare.com/covid-19-protocols/translations/ ). Yet, there are many other options in this document.This research is not “anti-vaccine”, but pro-sane-vaccines. Unlike insane vaccines, it stands for evidence based medicine, i.e. scientifically proven safe and effective treatments. 500 scientific citations prove a systemic bias against cheap effective cures and towards unethical, ineffective and/or unsafe vaccines.Among dozens of effective treatments here reviewed, ivermectin is the best mass cure for COVID-19 variants. It had been scientifically proven beyond any reasonable doubt by May 2020, yet, instead of informing the public about the amazing results and going back to normal, there was a global scheme to block lifesaving information and promote lock downs, masks, restrictions, experimental vaccines and passports.1 million dollars of ivermectin would end the pandemic compared to 160 thousand million dollars PER YEAR to keep a perpetual endemic disease, with vaccines always chasing new variants in a never ending lucrative arms race. It is not a matter of unsettled science: there are more RCT studies than for any other standard-of-care treatment. An insane “war on bugs” by legal drug cartels?With COVID vaccines, Governments have turned a medical act into an administrative mandate. Yet, not a single medical association protested against this violation of the right of the physician to practice medicine, i.e. a customized treatment according to the best knowledge/possibilities?Human rights continue to be systematically violated: to life, to informed consent, to fertility, to ethical treatments (where benefits are higher than harms), to healthcare (instead of sickening-care), to treatments for vaccine injuries, to compensation for injuries and death, to privacy (passes), to freedom (to work, move, assemble, worship), etc.This research presents scientific evidence for a planned global genocide: COVID lab creation, vital information cover-up, deadly recommendations, COVID cure censorship and lethal disinformation to promote dangerous vaccines, which are the worst medical and epidemiological solution to the plandemic:MAY A PERSON :WITHCOVIDVACCINATIONWITHEFFECTIVETREATMENTAVOID GETTING SICK FROM COVID?🗴 No✓ YesAVOID INFECTING OTHERS?🗴 No✓ YesAVOID HOSPITALIZATION?🗴 No✓ YesAVOID DYING FROM COVID?🗴 No✓ YesAVOID SIDE-EFFECTS LIKE INFERTILITY, MISCARRIAGE, DISABILITY OR DEATH?🗴 No✓ YesGET HEALTHCARE OR MANUFACTURER LIABILITY FOR INJURIES, DEATH OR NEGLIGENCE?🗴 No✓ YesHELP PROTECT OTHERS?🗴 No✓ YesHELP REDUCE THE SATURATION OF THE HEALTH SYSTEM?🗴 No✓ YesGENERATE HERD IMMUNITY?🗴 No✓ YesHELP TO END THE PANDEMIC?🗴 No✓ YesREDUCE THE GENERATION AND SPREAD OF VARIANTS?🗴 No✓ YesAVOID COOPERATION WITH VACCINES PRODUCED WITH ABORTION CELL LINES?🗴 No✓ YesGIVE INFORMED CONSENT WITH A PACKAGE INSERT LISTING ALL THE INGREDIENTS?🗴 No✓ YesAVOID UNDISCLOSED GENE-HACKING, NANO-TAMPERING AND BLUETOOTH CHIP?🗴 No✓ YesFrom the systematic genocide of abortion, they moved on to the COVID genocide of the elderly blocking effective treatment, and then, to the mass genocide with experimental vaccines, starting with the elderly and ending with the babies, even the unborn (vaccinating the pregnants). The genocidal trend didn’t change, only the target population. Same serial killers, different weapons.Hosea 4:6 “My people are dying for lack of knowledge...”

Characteristics of Daratumumab Reactions in Patients Who Transitioned from Intravenous Daratumumab to Subcutaneous Daratumumab

Introduction Daratumumab based therapy has become standard of care in the treatment of Multiple Myeloma and Systemic Light chain Amyloidosis. The intravenous (IV) infusion of daratumumab is associated with a high rate of infusion-related reactions necessitating use of rescue medications and prolonged chair time. The Phase 3 COLUMBA trial reported non-inferiority of the subcutaneous (SC) daratumumab as compared to IV formulation with significantly reduced rates of daratumumab reactions for new-start patients. However, there is limited data on the characteristics of reactions in patients transitioning between formulations. Methods This single center retrospective chart review was performed on consecutive patients who previously received IV daratumumab but subsequently converted to SC daratumumab between June 2020 and June 2021. In this study, severity of allergic reactions and potential predictors of SC daratumumab reaction were assessed. Results Of the 45 patients who received SC daratumumab during the study period, a total of 13 patients had previously received IV daratumumab. All patients were premedicated per package insert guidelines and institutional standard of care. Patients were predominately Caucasian (77%), Male (84.6%), and undergoing therapy for Multiple myeloma (69%) and AL Amyloidosis (31%). A mean of 19 doses of IV daratumumab were administered prior to transition to SC formulation. The majority of patients (53.8%) transitioned to SC daratumumab had previously reacted to IV daratumumab. All IV daratumumab reactions occurred during the first infusion. Two patients had experienced Grade 3 reactions to IV daratumumab, requiring inpatient observation to complete the initial infusion but tolerated subsequent doses. Of the 13 patients transitioned to SC daratumumab, two patients (15.4%) experienced daratumumab reactions. Patient 1 had a history of grade 3 IV daratumumab reaction to the first infusion and experienced a Grade 2 reaction at 3 hour 50 minutes with symptoms of cough, shortness of breath, palpitations, itching, and myalgia to the first SC daratumumab dose. Subsequent SC daratumumab doses were tolerated without adverse reactions. The other patient had a history of grade 2 IV daratumumab reaction who noted worsening weakness and diarrhea in the first several days post-injection with the new formulation, and ultimately transitioned back to the IV formulation. Conclusion Although SC daratumumab is well tolerated in patients previously treated with IV daratumumab, patients with history of prior first IV daratumumab infusion reactions are still at increased risk of early or delayed daratumumab related reactions with first time exposure to SC daratumumab. Disclosures Gupta: Deva Oncology: Consultancy. Raza: Amgen: Honoraria, Speakers Bureau; drrx, acasti, amicus, abbot: Other: previous stock holder (currently does not hold these stocks); Gilead: Current holder of individual stocks in a privately-held company; Janseen: Honoraria, Speakers Bureau; Takeda: Speakers Bureau; Incyte: Honoraria, Membership on an entity's Board of Directors or advisory committees; Kite: Honoraria, Membership on an entity's Board of Directors or advisory committees; Moderna , Biontec, Stryker: Current holder of individual stocks in a privately-held company; novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees; Celgene: Consultancy, Honoraria, Speakers Bureau.

Assessment of TRM-201 (Rofecoxib) Efficacy and Safety for Chronic Pain in Hemophilic Arthropathy: The Rofecoxib Efficacy and Safety Evaluation Trial in Hemophilic Arthropathy (RESET-HA), a Randomized, Double-Blind Placebo-Controlled Phase III Clinical Trial

Background: Intra-articular bleeding (hemarthrosis) accounts for 80-90% (Roosendaal, et. al. Semin Thromb Hemost . 2003;29:37) of all bleeds and more than 90% of serious bleeding events in patients with severe hemophilia (Valentino. J Thromb Haemost . 2010;8:1895). Recurrent hemarthroses result in progressive joint damage and the development of hemophilic arthropathy (HA) in up to 50% of adults with hemophilia (Forsyth, et al. Haemophilia . 2014;20:44). Acetaminophen is commonly prescribed for pain due to HA yet has limited efficacy at therapeutic doses (Rodriguez-Merchan. Blood Rev. 2018;32:116). Traditional non-steroidal anti-inflammatory drugs (tNSAIDs) inhibit platelet function and cause gastrointestinal (GI) complications including bleeding, both of which can be harmful in patients with hemophilia (Rodriguez-Merchan. Blood Rev. 2018;32:116; Brooks, et al. Rheumatology . 1999;38(8):779). Opioids are prescribed in over 60% of patients with HA(Witkop, et al. Haemophilia. 2012;18:e115) despite dependence, potential for abuse, and an increased risk of falls and other opioid-related injury (Rodriguez-Merchan. Blood Rev. 2018;32:116). Given an unmet need in pain management for HA, alternate approaches are needed. TRM-201 (rofecoxib) is a cyclooxygenase-2 (COX-2) selective NSAID with no impact on platelet function and a lower GI risk than tNSAIDs (Vioxx (rofecoxib) package insert. Merck & Co. I, ed. Whitehouse Station, NJ, 2004). The RESET-HA study is designed to evaluate the efficacy and safety of rofecoxib for HA pain management. Methods/Design: RESET-HA is a multi-national, randomized, double-blind study to evaluate the efficacy and safety of rofecoxib in hemophilia A or B patients with diagnosed HA, aged 12 to 75 years and is based on a previous pilot study (Tsoukas, et al. Blood, 2006;107:1785). Patients must have a history of joint bleeding, and chronic symptomatic pain in one or more joint(s) on 20 of the 30 days prior to screening. Exclusion criteria include use of opioids for greater than 4 days/week, or opioid transdermal patches in the 30 days prior to screening, history of GI perforation, ulcer or bleeding, peptic ulcer disease and major cardiac ischemic symptoms or events. Randomized patients (n=80 per arm) are washed out of analgesics prior to daily administration of TRM-201 (17.5 mg/day) or placebo for 12 weeks (Part I) during which acetaminophen (Stage-1) and acetaminophen plus codeine (Stage-2) are available as rescue medication (where available and acceptable to the patient and study doctor). The patient assessment of hemophilic arthropathy pain, a 0- to 10-point numeric rating scale validated for the assessment of pain across many disease states, is recorded daily. The primary endpoint is the placebo adjusted change from baseline in weekly average of patient assessment of daily HA pain score at Week 12. Key secondary endpoints include patient assessments using the PROMIS physical function instrument and pain interference from the Brief Pain Inventory. Sleep disturbance is also measured using the PROMIS instrument. The study explores the efficacy of rofecoxib on the number of suspected joint bleeds and on the amount of rescue medication used. Following Part I, all study patients (regardless of original randomization arm) receive rofecoxib 17.5 mg once daily for up to 12 additional months (Part II). During Part II of the study, only acetaminophen will be provided as rescue medication. Discussion: The RESET-HA study is intended to evaluate the efficacy and safety of TRM-201 in patients with HA and is the first Phase III trial ever conducted to assess a treatment for HA pain. Pain management in HA requires analgesic anti-inflammatory treatment that does not exacerbate bleeding. Rofecoxib has been shown to have no effect on platelet function, even at supratherapeutic doses(Vioxx (rofecoxib) package insert. Merck & Co. Whitehouse Station, NJ, 2004), a decreased risk of GI side effects, including GI bleeding compared with tNSAIDs, and no greater cardiovascular risk than equipotent doses of COX-2 selective and tNSAIDs (U.S. Food and Drug Administration. J Pain Palliat Care Pharmacother. 2005;19:83). TRM-201 is anticipated to provide analgesic efficacy, with an acceptable tolerability and safety profile, and could become a new treatment option that may possibly facilitate the avoidance of opioid use in patients with HA. (NCT04684511) Disclosures Boice: Tremeau Pharmaceuticals Inc.: Current Employment, Current holder of individual stocks in a privately-held company, Current holder of stock options in a privately-held company. Buckner: Novo Nordisk: Honoraria; American Thrombosis: Membership on an entity's Board of Directors or advisory committees; CSL Behring: Honoraria; Genetech: Honoraria; Spark: Honoraria; Sanofi: Honoraria; Bayer: Honoraria; Pfizer: Honoraria; Takeda: Honoraria; Tremeau Pharmaceuticals: Consultancy, Honoraria; uniQure: Consultancy, Honoraria; BioMarin: Consultancy, Honoraria; Hemostasis Network: Membership on an entity's Board of Directors or advisory committees. Croteau: Tremeau Pharmaceuticals,Inc: Consultancy. Katz: Tremeau Pharmaceuticals,Inc: Consultancy. Sidonio: Takeda: Consultancy, Research Funding; Octapharma: Consultancy, Research Funding; Catalyst: Consultancy; Guardian Therapeutics: Consultancy; Bayer: Consultancy; Novo Nordisk: Consultancy; Biomarin: Consultancy; Pfizer: Consultancy; Genentech: Consultancy, Research Funding. Bolognese: Tremeau Pharmaceuticals,Inc: Consultancy. Garfield: Tremeau Pharmaceuticals,Inc: Current Employment, Current holder of individual stocks in a privately-held company, Current holder of stock options in a privately-held company. Corrigon: Tremeau Pharmaceuticals,Inc: Current Employment, Current holder of individual stocks in a privately-held company, Current holder of stock options in a privately-held company. Walsh: Genentech: Consultancy; Biomarin: Consultancy; Takeda: Consultancy; Novo Nordisk: Consultancy; Tremeau: Consultancy.

1056. Safety and Tolerability of Dalbavancin in Vancomycin Allergic Patients – A Case Series

Background VVancomycin and dalbavancin, both in the glycopeptide class of antibiotics, are used in the treatment of Gram-positive infections, including methicillin-resistant Staphylococcus aureus. Antibiotics in this class contain a heptapeptide core that has potential for cross-sensitivity. Due to this risk, dalbavancin carries a warning in the package insert for use in patients with a glycopeptide allergy. Dalbavancin, a semi-synthetic derivative of vancomycin, has lipophilic side chains which reduce the risk of cross-sensitivity to vancomycin. This case series evaluated patients with a listed vancomycin allergy in their electronic health record who received dalbavancin as an outpatient infusion. Methods This study was a non-randomized, retrospective chart review of adult patients who had a documented vancomycin allergy and received dalbavancin between February 2016 and February 2021 for any indication in the outpatient setting. The primary objective was to evaluate dalbavancin tolerability in patients allergic to vancomycin. Patient characteristics and the specifics of dalbavancin infusion – dose, volume, infusion rate, intravenous line access, and receipt of premedication before infusion – were collected on each patient. Results 559 unique patients received dalbavancin over the time frame. Of these, ten had a documented, subjective vancomycin allergy. Patient-reported allergic reactions were rash (4), hives (3), anaphylaxis (2), red man syndrome (2), renal failure (2), and general malaise (1). Six patients had at least 1 additional subjective drug allergy. The various infections treated included cellulitis/abscess (8), osteomyelitis (1), and bacteremia (2). Most patients received 1500mg (2 received 1125mg) of dalbavancin in 300-500mL of dextrose 5% in water infused at either 600 or 1000mL/hr via a peripheral (6) or central (4) intravenous line. All patients tolerated the infusion with no adverse events reported and no receipt of premedication before administration. Conclusion Dalbavancin may be a reasonable treatment option in vancomycin allergic patients, despite possible cross-sensitivity. Further investigation into cross-sensitivity between vancomycin, dalbavancin, and other glycopeptide class agents is warranted. Disclosures Kerry O. Cleveland, M.D., AbbVie (Speaker’s Bureau)Merck (Speaker’s Bureau)Pfizer (Speaker’s Bureau) Bruce M. Jones, PharmD, BCPS, Abbvie (Consultant, Advisor or Review Panel member, Speaker’s Bureau)La Jolla (Speaker’s Bureau)Melinta (Consultant)Merck (Consultant)Paratek (Consultant, Speaker’s Bureau)

Kijksluiters: kijken naar gesprekken tussen apotheker en patiënt

Kijksluiters: watching conversations between pharmacists and patients As of 1975, Dutch patients receive a package insert with their medication. Due to extensive national and EU legal regulation efforts, the insert developed into a mandatory genre par excellence. However, its communicative functionality remained doubtful: the patient information leaflet has always been regarded as lengthy, complex and user-unfriendly. Recently, the Dutch Medicine Board has introduced a new, audiovisual medication instruction, the so-called Kijksluiter, that shows a video animation of a conversation about the medicine between a pharmacist and a patient. After a historical introduction, the second section of the paper surveys empirical studies that shed light on the main design parameters of the new genre: spoken instead of written information, animated speakers, dialogue instead of monologue. In the third part, we report on an observation study in which 16 users answer 9 scenario questions using a Kijksluiter video. The results indicate that Kijksluiters are not without user problems. Overall, two-thirds of the answers are more or less correct. Half of the participants first watched the video in its entirety before attending to the questions. The main problem this group encountered is: insufficient recollection of the relevant information. The other half of the participants navigated the Kijksluiter for each question, using the menu offering twelve small chapters. The main problems in this group was not finding the question-relevant chapter; but even after listening to the relevant information, some answers are incorrect. We conclude that, although Kijksluiter does not immediately solve all medication communication problems, its concise audiovisual format broadens the range of media available for medicine users.

The Effect of Label and Medication Package Insert Reading Habits of Parents on their Children’s Oral Dental Health

Objective: The aim of this study is to evaluate the relationship between packaged product label and medication package insert reading habits of parents and their children’s oral/dental health. Study design: A questionnaire including demographic characteristics and label/insert reading habits was filled by parents of 301 children who referred to the Pediatric Dentistry Department. The children were examined intraorally and dmft/DMFT and ICDAS II scores were recorded. The data were evaluated statistically. Results: Label and medication package insert reading were found in 71.4% and 88.4% of the parents, respectively. Label reading increased as the age of the child and the number of children in the family increased. Medical package insert reading increased as the mother’s education and SLS/paraben knowledge increased. Decrease of 1 point in ICDAS II resulted in the 1.410 times increase in the rate of medical package insert reading of the parents. Conclusion: It is concluded that improving the label and medical insert reading rate of the parents would be effective for providing better oral and dental health for their children.