Alcohol-related family violence in Australia: Secondary data analysis of the National Drug Strategy Household Survey

Aims: Alcohol is a risk factor for family violence that affects partners, parents, children and other relatives. This study aims to provide estimates of the prevalence of alcohol-related family violence reported in 2016 in Australia across numerous socio-demographic groups. Methods: This paper presents secondary data analysis of 23,749 respondents (10,840 men, 12,909 women) from the Australian Institute of Health and Welfare’s 2016 National Drug Strategy Household Survey (NDSHS). Alcohol-related family violence was measured by self-report as being physically or verbally abused or put in fear from a family member or partner deemed by the victim as under the influence of alcohol. Logistic regression was used to analyse which factors were associated with alcohol-related family violence. Findings: Analysis revealed that 5.9% of respondents (7.7% of women and 4.0% of men) reported alcohol-related family violence in the past year from either a partner or another family member. Respondents who were women (vs men), within less advantaged (vs more advantaged) socio-economic groups, risky drinkers (vs non-risky drinkers), residing in outer regional areas (vs major cities), holding a diploma (vs high school education) and single with dependents, reported higher overall rates of alcohol-related family violence. In contrast, respondents aged 55+ had significantly lower odds of experiencing alcohol-related family violence than all other age groups. Conclusions: Alcohol-related family violence was significantly more prevalent amongst respondents in a range of socio-demographic categories. Identification of these groups which are adversely affected by the drinking of family and partners can aid in informing current policy to protect those more vulnerable.

Compliance to GMP guidelines for Herbal Manufacturers in East Africa: A Position Paper

With the global increase in the use of traditional and complementary remedies for the prevention and treatment of illness, the quality and safety of these medicines have become a significant concern for all regulatory authorities. Herbal medicines are the most commonly used form of traditional and complementary medicines in the world and the efficacy and safety of herbal medicines, like conventional medicines, largely depends on their quality from planting to harvesting, preprocessing and final processing. Due to the inherent complexity of herbal medicines, often containing an array of active compounds, the primary processing of herbal medicines has a direct influence on their quality. Quality concerns are the reason why the medicines regulatory agencies insist that manufacturers of medicines strictly follow Good Manufacturing Practices since it is an essential tool to prevent instances of contamination, mix-ups, deviations, failures and errors. However, a strict application of GMP requirements is expensive and would drive the prices of the manufactured products up. As a result, a maturity level grading of facilities is proposed as a way of justifying the costs incurred for manufacturers desiring to reach a broader market and investing in continuous improvement. 36 Good Manufacturing Practice (GMP) inspection reports of local herbal manufacturers conducted by National Drug Authority were analyzed to establish the type and extent of deficiencies to GMP requirements for local herbal manufacturers in Uganda. The different GMP chapters and related sub-parameters constituted the variables used for the analysis of conformity to requirements. The primary outcome variable was the conclusion regarding compliance or noncompliance of the inspected local herbal manufacturing facility. GMP parameters that were frequently defaulted by local herbal manufacturers and the corresponding frequencies were identified. The Pearson Chi-square test was applied independently on each category to find the association that existed between conformity and the questions in each category. Only 22% (8) of the 30 inspected facilities were found to comply with GMP requirements, as per National Drug Authority (NDA) guidelines; while the majority of the facilities, 28 (78%), were found not to comply. Of the facilities inspected, 25 were undergoing GMP inspection for the first time. A total of 1,236 deficiency observations were made in the 36 inspection reports reviewed for the study. The mean for all deficiencies was 34.3, and the standard deviation was 15.829. 91.5% of the facilities did not have mechanisms for a record of market complaints; 80.9% did not meet documentation requirements; 78.9% did not have quality control measures in place, and 65.7% did not meet stores requirements. By encouraging a culture of self/voluntary improvement through the introduction of listing of manufacturers based on a maturity level grading, the National Drug Authority will improve the Herbal Medicines sector as per the mandate of improving the herbal medicine industry. Also, increased sensitization of all relevant stakeholders regarding the requirements for GMP should be intensified.

Ukrainian experience in implementation of the flexible provisions of the TRIPS Agreement in the context of European integration and the pandemic

Keywords: intellectual property, human rights, patients' rights, pharmaceutical nationalism,protectionism, vaccines, generics, COVID-19 The article concerns the analysis of global trends in theparadigm of intellectual property rights on the objects used in the diagnosis, preventionand treatment of COVID-19. The experience of the implementation of pharmaceuticalnationalism policies provided by the EU, Canada and Israel are presented in the article.The authors provide the legal backgrounds of the need for Ukraine to be a co-sponsor ofthe IP waivers proposals, which are submitted to the TRIPS Council by some membersof the WTO. The authors stress the need for Ukraine to use the historic opportunity forthe development of the national pharmaceutical industry, which would contribute tothe interests of the domestic patient, and make proposals for the necessary changes tonational legislation.The authors also stressed the position of the governments of Germany and France.Thus, in Germany there is the Law on Governmental Use of Patented Inventions duringa Pandemic. The law provides, inter alia, for amendments to the Patent Law, accordingto which the Federal Ministry of Health has the right to authorize the use of relevantpatents to ensure the production and supply of pharmaceuticals or medical devices.In 2020, France adopted the Emergency Law № 2020-290 to combat theCOVID-19 epidemic, which introduced Article 3131 15 of the French Public HealthCode. This rule authorizes the Prime Minister to issue orders to recover or seize allgoods and services necessary to combat the disaster, to temporarily control the price ofproducts and, if necessary, to take any measures to ensure that patients are providedwith appropriate drugs to deal with the disaster, related to health. It is useful forUkraine to use the experience of Canada in terms of facilitating negotiations with majorvaccine manufacturers to establish national drug production and in terms of developinglegislation in the field of compulsory licensing.It is obviously, voluntary licences from patent owners, which provide for the fulltransfer of technology, and not just patent disclosure, are the most effective tool for thenational production of biosimilars. However, international experience shows that pharmaceuticalcompanies are holding back the issuance of compulsory licences. Therefore,our government's biosecurity portfolio should include an effective tool for compulsory licensingor emergency use of biosimilars and generic drugs by the Government.

Development of the Swiss Database for dosing medicinal products in pediatrics

In daily paediatrics, drugs are commonly used off-label, as they are not approved for children. Approval is lacking because the required clinical studies were limited to adults in the past. Without clinical studies, evidence-based recommendations for drug use in children are limited. Information on off-label drug dosing in children can be found in different handbooks, databases and scientific publications but the dosing recommendations can differ considerably. To improve safety and efficacy of drugs prescribed to children and to assist the prescribers, stakeholders in Swiss paediatrics started a pilot project, supported by the Federal Office of Public Health, with the aim to create a database, providing healthcare professionals with so called “harmonised” dosage recommendations based on the latest available scientific evidence and best clinical practice. A standardised process for dosage harmonisation between paediatric experts was defined, guided and documented in an electronic tool, developed for this purpose. As proof of principle, a total of 102 dosage recommendations for 30 different drugs have been nationally harmonised in the pilot phase considering the current scientific literature and the approval of the most experienced national experts in the field.Conclusion: This approach paved the way for unified national dosage recommendations for children. Reaching the project’s milestones fulfilled the prerequisites for funding and starting regular operation of SwissPedDose in 2018. Since then, the database was extended with recommendations for 100 additional drugs. What is Known:• Prescribing off-label is a common practice among paediatricians, as many drugs are still not authorised for use in children.• Some countries developed national drug formularies providing off-label dosage recommendations. What is New:• Comparison of published dosage recommendations in known drug handbooks and online databases show substantial differences and heterogeneity, revealing the need for harmonisation.• The design of a tool for standardised harmonisation of dosage recommendations, based on information collected on currently applied dosages, latest scientific evidence and the approval of experts.

Strategies for improving the quality of the ground coffee product: a case study at SMEs X Malang, Indonesia

SMEs X is one of the SMEs in Malang City that produces ground coffee. The increasing number of ground coffee producers in Malang City make SMEs X must be able to survive in the competition so that SMEs X needs to improve the quality of ground coffee products. The methods used are Quality Function Deployment (QFD) and Analytical Hierarchy Process (AHP). The results show that five essential attributes for consumers to improve the quality of ground coffee include unique packaging forms, packaging materials that can maintain quality, attractive packaging colours, convenience for consumers to reach sales locations, and convenience for consumers to get products. Strategies that can be used to improve the quality of ground coffee include redesigning the packaging, improving the ground coffee production process, selecting good quality coffee beans, resetting the selling price of the product, increasing marketing effectiveness, and applying for a permit from the national drug and food agency.

Barriers and facilitators to adherence to national drug policies on antibiotic prescribing and dispensing in Bangladesh

Background The National Drug Policy in Bangladesh prohibits the sale and distribution of antibiotics without prescription from a registered physician. Compliance with this policy is poor; prescribing antibiotics by unqualified practitioners is common and over-the-counter dispensing widespread. In Bangladesh, unqualified practitioners such as drug shop operators are a major source of healthcare for the poor and disadvantaged. This paper reports on policy awareness among drug shop operators and their customers and identifies current dispensing practices, barriers and facilitators to policy adherence. Methods We conducted a qualitative study in rural and urban Bangladesh from June 2019 to August 2020. This included co-design workshops (n = 4) and in-depth interviews (n = 24) with drug shop operators and customers/household members, key informant interviews (n = 12) with key personnel involved in aspects of the antibiotic supply chain including pharmaceutical company representatives, and model drug shop operators; and a group discussion with stakeholders representing key actors in informal market systems namely: representatives from the government, private sector, not-for-profit sector and membership organizations. Results Barriers to policy compliance among drug shop operators included limited knowledge of government drug policies, or the government-led Bangladesh Pharmacy Model Initiative (BPMI), a national guideline piloted to regulate drug sales. Drug shop operators had no clear knowledge of different antibiotic generations, how and for what diseases antibiotics work contributing to inappropriate antibiotic dispensing. Nonetheless, drug shop operators wanted the right to prescribe antibiotics based on having completed related training. Drug shop customers cited poor healthcare facilities and inadequate numbers of attending physician as a barrier to obtaining prescriptions and they described difficulties differentiating between qualified and unqualified providers. Conclusion Awareness of the National Drug Policy and the BPMI was limited among urban and rural drug shop operators. Poor antibiotic prescribing practice is additionally hampered by a shortage of qualified physicians; cultural and economic barriers to accessing qualified physicians, and poor implementation of regulations. Increasing qualified physician access and increasing training and certification of drug shop operators could improve the alignment of practices with national policy.

07. Recombinant Zoster Vaccine (RZV) Second-Dose Completion in Adults Age 50‒64 Years in the United States

Background In 2018, CDC recommended a highly efficacious adjuvanted recombinant zoster vaccine (RZV, Shingrix) as a 2-dose series for prevention of herpes zoster (HZ) for immunocompetent persons age ≥50 years, with the 2nd dose recommended 2–6 months after the 1st dose. Among Medicare beneficiaries, 2-dose series completion 6 months and 12 months post initiation was 78% and 86%, respectively. Here we estimate the proportion of adults age 50–64 years who completed the 2-dose RZV series within 6 or 12 months after receiving their 1st dose, by using two administrative claims databases. Methods We used medical and pharmaceutical claims data from October 2017‒March 2020 IQVIA® PharMetrics Plus and October 2017‒October 2020 IBM® MarketScan® databases. RZV vaccination was defined using Current Procedural Terminology and National Drug Codes. We allowed for sufficient follow-up time by examining 1st doses given at least 6 or 12 months prior to the end of the study period in both databases. Place of administration was available in IQVIA data. Results Among persons age 50‒64 years, in IQVIA and MarketScan, 70% and 68% received their 2nd RZV dose within 6 months, respectively, and 79% and 81% received their 2nd dose within 12 months, respectively. The median age of 1st dose of RZV vaccination was 60 years and ~60% were female [Table 1]. When the 2nd dose was administered within 12 months, the median interval between 1st and 2nd doses was 104 and 98 days in the IQVIA and MarketScan databases, respectively. Characteristics by age, sex, or region were similar in persons who received 1 RZV dose vs. 2 RZV doses [Table 1]. Among those who received only 1 RZV dose with at least 12 months of follow-up time, 55% of vaccinations occurred at ambulatory medical provider offices and 40% at pharmacies; among 2 doses recipients, 33% of vaccinations occurred at provider offices and 62% at pharmacies. Conclusion Among 50‒64-year-olds, 2-dose RZV series completion was ~70% within 6 months and 80% within 12 months of initiation. The findings were similar across two administrative claims databases. Availability of RZV at pharmacies has potentially helped to increase RZV 2nd dose completion rates. Disclosures All Authors: No reported disclosures

812. The Impact of Post-Operative Cephalexin on Surgical Site (SSI) Infections During a Cefazolin Shortage

Background Drug shortages directly impact patient care. Rates of drug shortages have declined except for antimicrobials, where shortage rates remain similar each year.1 In November 2018, a national cefazolin shortage occurred driving health systems to implement a therapeutic interchange of cefazolin for cephalexin for post-operative antimicrobial prophylaxis. The objective of this study is to determine whether SSI-rates change when post-operative cephalexin is used in placed of cefazolin. Methods This was a retrospective, observational cohort study of patients receiving post-operative antimicrobial prophylaxis at a community-based health system in Oregon and Washington between May 2018 – August 2019. Participants were divided into 3 periods for SSI-rate trend analysis: pre-shortage (May 2018 – October 2018), shortage (November 2018 – February 2019), and post-shortage (March 2019 – August 2019). The primary outcome was SSI-rates between groups. Results There were 6,378 patients in total (5,840 cefazolin vs. 538 cephalexin). There were no significant differences in baseline characteristics of age, sex, body mass index (BMI), or hospital location. The rate of SSI between pre-shortage and post-shortage cefazolin groups was not statistically different (14 [0.5%] vs. 23 [0.8%]; p=0.16). The primary outcome of SSI in the shortage group who received cephalexin was not statistically different (37 [0.6%] vs. 0 [0%]; p=0.07). Conclusion National drug shortages significantly impact patient care, often leading to seeking evidence-poor alternative medications. These results suggest cephalexin may be an acceptable post-operative prophylaxis antimicrobial if cefazolin is unavailable. Disclosures All Authors: No reported disclosures