Assess the frequency and severity of adverse drug reactions due to errors in drug intake at a tertiary care hospital

Background: Drug-related problems are an important cause of morbidity and mortality and a significant burden on healthcare resources. There are few studies to account for errors in drug intake leading to adverse drug reactions (ADRs). This study was pursued with the objective of determining the frequency and severity of the ADRs resulting from erroneous drug intake, the expenses incurred in treating the same.Methods: The study was a prospective, cross-sectional, observational study. The study subjects were patients with ADRs due to errors in drug intake and from self-medication. All the information regarding the ADR were collected as per ADR reporting form issued by Central Drugs Standard Control Organization. Causality was assessed by both Naranjo and the WHO criteria for causality assessment. Direct cost of all the medications, hospital charges (admission, bed charges, consultations paid, treatment charges, investigations, and conveyance charges) were recorded to find the financial burden due to error in drug intake.Results: The study showed that nearly 30% of the ADRs were due to errors in drug intake and the major contributing factor is self-modification either by discontinuation or missed doses. Major drugs that are implicated in these ADRs were that of metformin and insulins among anti-diabetic drugs and amlodipine and atenolol among antihypertensives. These two groups contributed to 18 (62%) of the total 29 ADRs. Organ system commonly involved was central nervous system and that was followed by musculoskeletal system. The average direct cost incurred in the management of these ADRs was Rs. 5773 for non-serious adverse events (SAE’s) and Rs. 11,400 for SAE’s.Conclusion: Proper education about the importance of compliance and damaging consequences of self-modification of drug dosage in patients who are on treatment for chronic disorders like diabetes and hypertension will be an effective strategy to prevent many of these ADRs

Equipping providers to offer novel MPTs: Developing counseling messages for the Dual Prevention Pill in clinical studies and beyond

IntroductionThe pipeline for multi-purpose prevention technologies includes products that simultaneously prevent HIV, pregnancy and/or other sexually transmitted infections. Among these, the Dual Prevention Pill (DPP) is a daily pill co-formulating oral pre-exposure prophylaxis (PrEP), and combined oral contraception (COC). Clinical cross-over acceptability studies for the DPP require training providers to counsel on a combined product. From February 2021–April 2022, a working group of eight HIV and FP experts with clinical and implementation expertise developed counseling recommendations for the DPP based on existing PrEP/COC guidance.Assessment of policy/guidelines options and implicationsThe working group conducted a mapping of counseling messages from COC and oral PrEP guidance and provider training materials. Six topics were prioritized: uptake, missed pills, side effects, discontinuation and switching, drug interactions and monitoring. Additional evidence and experts were consulted to answer outstanding questions and counseling recommendations for the DPP were developed. Missed pills was the topic with the most complexity, raising questions about whether women could “double up” on missed pills or skip the last week of the pack to recover protection faster. Uptake required aligning the time to reach protective levels for both DPP components and explaining the need to take DPP pills during week 4 of the pack. The potential intensity of DPP side effects, given the combination of oral PrEP with COC, was an important consideration. Discontinuation and switching looked at managing risk of HIV and unintended pregnancy when stopping or switching from the DPP. Guidance on drug interactions contended with differing contraindications for COC and PrEP. Monitoring required balancing clinical requirements with potential user burden.Actionable recommendationsThe working group developed counseling recommendations for the DPP to be tested in clinical acceptability studies. Uptake: Take one pill every day for the DPP until the pack is empty. Days 1–21 contain COC and oral PrEP. Days 22–28 do not contain COC to allow for monthly bleeding, but do contain oral PrEP and pills should be taken to maintain HIV protection. Take the DPP for 7 consecutive days to reach protective levels against pregnancy and HIV. Missed pills: If you miss 1 pill multiple times in a month or 2+ consecutive pills, take the DPP as soon as you remember. Do not take more than 2 pills in a day. If 2+ consecutive pills are missed, only take the last missed pill and discard the other missed pills. Side effects: You may experience side effects when you start using the DPP, including changes to monthly bleeding. Side effects are typically mild and go away without treatment. Discontinuation/switching: If you decide to discontinue use of the DPP, but want to be protected from HIV and/or unintended pregnancy, in most cases, you can begin using PrEP or another contraceptive method right away. Drug interactions: There are no drug-drug interactions from combining oral PrEP and COC in the DPP. Certain medications are not recommended due to their contraindication with oral PrEP or COC. Monitoring: You will need to get an HIV test prior to initiating or restarting the DPP, and every 3 months during DPP use. Your provider may recommend other screening or testing.DiscussionDeveloping recommendations for the DPP as a novel MPT posed unique challenges, with implications for efficacy, cost, and user and provider comprehension and burden. Incorporating counseling recommendations into clinical cross-over acceptability studies allows for real-time feedback from providers and users. Supporting women with information to use the DPP correctly and confidently is critically important for eventual scale and commercialization

Reply letter to “Immunogenicity and safety of a quadrivalent high-dose inactivated influenza vaccine compared with a standard-dose quadrivalent influenza vaccine in healthy people aged 60 years or older: a randomized Phase III trial”

A recent study reported that the high-dose quadrivalent influenza vaccine provided superior immunogenicity and efficacy versus the standard-dose quadrivalent vaccine in the elderly. However, we need to view these results in terms of public health benefits as well. The Number Needed to Vaccinate (NNV) is an important tool to measure the benefit of a given vaccine. Further, NNV evaluates the benefits of a vaccine in preventing and controlling communicable diseases. Considering the target of vaccination and coverage of 75% not met in the elderly in Europe, it is important not to prioritize one vaccine over the other, but rather to increase the vaccine coverage with all the available vaccines

Reply letter to “Vaccine effectiveness of recombinant and standard dose influenza vaccines against outpatient illness during 2018–2019 and 2019–2020 calculated using a retrospective test-negative design”

A recent study by Zimmerman et al. (2023) reported non-significant higher relative vaccine effectiveness of recombinant (RIV4) over the standard-dose influenza vaccines (SDIV) against outpatient illness during the 2018–19 and 2019–20 vaccination seasons. We agree with the authors’ conclusions and would like to emphasize minimal difference between RIV4 and SDIV using Number Needed to Vaccinate (NNV). The NNV analysis showed 8.9 for the RIV4 and 10 for the SDIV in the 50–64 age group. In the 65+ age group, the NNV was 10.6 for the RIV4 and 11.4 for the SDIV. This indicates a minimal difference between both vaccines and hence they both can be used in immunization programs to improve vaccine coverage

Assess the frequency and severity of adverse drug reactions due to errors in drug intake at a tertiary care hospital

Background: Drug-related problems are an important cause of morbidity and mortality and a significant burden on healthcare resources. There are few studies to account for errors in drug intake leading to adverse drug reactions (ADRs). This study was pursued with the objective of determining the frequency and severity of the ADRs resulting from erroneous drug intake, the expenses incurred in treating the same.Methods: The study was a prospective, cross-sectional, observational study. The study subjects were patients with ADRs due to errors in drug intake and from self-medication. All the information regarding the ADR were collected as per ADR reporting form issued by Central Drugs Standard Control Organization. Causality was assessed by both Naranjo and the WHO criteria for causality assessment. Direct cost of all the medications, hospital charges (admission, bed charges, consultations paid, treatment charges, investigations, and conveyance charges) were recorded to find the financial burden due to error in drug intake.Results: The study showed that nearly 30% of the ADRs were due to errors in drug intake and the major contributing factor is self-modification either by discontinuation or missed doses. Major drugs that are implicated in these ADRs were that of metformin and insulins among anti-diabetic drugs and amlodipine and atenolol among antihypertensives. These two groups contributed to 18 (62%) of the total 29 ADRs. Organ system commonly involved was central nervous system and that was followed by musculoskeletal system. The average direct cost incurred in the management of these ADRs was Rs. 5773 for non-serious adverse events (SAE’s) and Rs. 11,400 for SAE’s.Conclusion: Proper education about the importance of compliance and damaging consequences of self-modification of drug dosage in patients who are on treatment for chronic disorders like diabetes and hypertension will be an effective strategy to prevent many of these ADRs

Influvac Tetra: clinical experience on safety, efficacy, and immunogenicity

ABSTRACTIntroduction This paper summarizes the safety and immunogenicity data of Influvac Tetra across all age groups starting from 6 months of age, obtained during its clinical development program.Areas covered The article covers the clinical development program of Influvac Tetra based on five registration studies that included different age groups, different comparators, and participants from Europe and Asia. Safety and immunogenicity were assessed in all studies and in one study, the efficacy of Influvac Tetra was assessed.Expert opinion Seasonal influenza is a vaccine-preventable disease that can cause serious complications. Several types of influenza vaccines are available, including egg-based (standard dose, high dose, and adjuvanted), cell-based, and recombinant. The COVID-19 pandemic has stimulated innovation in the development such as mRNA vaccines. However, these vaccines are still in development and the true value still has to be proven. Regardless of the type of vaccine, it is also important to increase overall vaccination coverage. ECDC recommends that EU Member States implement action plans and policies aimed at reaching 75% coverage in at-risk groups and healthcare workers. Even so, vaccine coverage is still far from recommended