1) Hospitals need medications in unit-of-use packaging with barcodes to streamline supply chain processes and safely administer drugs at the bedside. Without barcodes, additional pharmacy steps are required that introduce risks and inefficiencies.
2) Barcoding on individual drug units allows for traceability of each dose, inventory management, and recall of affected drugs. It supports efficiency through automated verification and tracking of medications throughout distribution and administration.
3) International regulations now require serialization and tracing of drug units for safety. Hospitals must track and trace drugs to standards to mitigate medication errors and the nearly 25,000 deaths per year in Canada related to adverse medical events. Barcoding is essential for closed-loop medication
Hospitals need commercial products that better support current clinical practice and safety standards. Many current product offerings fall short by supplying hazardous drugs in formats requiring manipulation or having dosages that do not match patient needs. Hospitals require ready-to-use, unit-dose packaging for hazardous drugs to minimize occupational exposure and cross-contamination. Single-dose vial sizes and a range of strengths are also needed to reduce wastage and support dosing changes. Collaboration between hospitals and suppliers can help transform commercial offerings to meet evolving practice needs.
1) Hospitals have highly automated and tightly controlled supply chains similar to manufacturers, where product specifications are the basis for downstream processes.
2) Any changes to commercial products used by hospitals can cascade throughout the hospital supply chain, requiring disruption of processes to assess and adapt to the change. This introduces risks of medication errors.
3) Advance notification of product changes is needed to allow hospitals time to plan, assess impact, implement changes, and validate processes before the changed product arrives. This minimizes risks to patient care from disruption of established routines and protocols that healthcare professionals rely on.
1. A good allocation strategy by suppliers is needed to avoid drug shortages that negatively impact hospitals, patients, and suppliers.
2. Poor allocation can lead to shortages that increase pharmacy workload, may trigger difficult ethical decisions about patient care, and result in patients receiving suboptimal or delayed treatment.
3. Key aspects of a good allocation strategy include early implementation when shortages are anticipated, equitable distribution, transparency about supply issues and allocation amounts, flexible processes to address special needs, and comprehensive communication with healthcare providers.
Manufacturing Investigational Medicinal Products - Legislative and GMP requir...TGA Australia
Presentation on Legislative requirements, specific risks for IMP manufacturing, manufacturing authorisations, PIC/S Guide to GMP PE009-13 and common issues
Presentation: Pharmacovigilance: The Australian landscapeTGA Australia
Overview of current post-market monitoring regulations and practice in Australia. Focusing on changing trends and the implications for future post-market vigilance practice.
The document provides an overview of common issues seen by regulators in evaluating bioequivalence studies from the perspective of a regulatory evaluator. It discusses key aspects of study design, clinical conduct, analytical methods, pharmacokinetic analysis, and statistical analysis that are evaluated. Examples of specific studies that were not accepted due to issues such as analytical problems, clinical inconsistencies, and use of an inappropriate reference product are also provided. The evaluator emphasizes that justification for exclusion of data and consideration of outliers is important in statistical analysis.
Hospitals need commercial products that better support current clinical practice and safety standards. Many current product offerings fall short by supplying hazardous drugs in formats requiring manipulation or having dosages that do not match patient needs. Hospitals require ready-to-use, unit-dose packaging for hazardous drugs to minimize occupational exposure and cross-contamination. Single-dose vial sizes and a range of strengths are also needed to reduce wastage and support dosing changes. Collaboration between hospitals and suppliers can help transform commercial offerings to meet evolving practice needs.
1) Hospitals have highly automated and tightly controlled supply chains similar to manufacturers, where product specifications are the basis for downstream processes.
2) Any changes to commercial products used by hospitals can cascade throughout the hospital supply chain, requiring disruption of processes to assess and adapt to the change. This introduces risks of medication errors.
3) Advance notification of product changes is needed to allow hospitals time to plan, assess impact, implement changes, and validate processes before the changed product arrives. This minimizes risks to patient care from disruption of established routines and protocols that healthcare professionals rely on.
1. A good allocation strategy by suppliers is needed to avoid drug shortages that negatively impact hospitals, patients, and suppliers.
2. Poor allocation can lead to shortages that increase pharmacy workload, may trigger difficult ethical decisions about patient care, and result in patients receiving suboptimal or delayed treatment.
3. Key aspects of a good allocation strategy include early implementation when shortages are anticipated, equitable distribution, transparency about supply issues and allocation amounts, flexible processes to address special needs, and comprehensive communication with healthcare providers.
Manufacturing Investigational Medicinal Products - Legislative and GMP requir...TGA Australia
Presentation on Legislative requirements, specific risks for IMP manufacturing, manufacturing authorisations, PIC/S Guide to GMP PE009-13 and common issues
Presentation: Pharmacovigilance: The Australian landscapeTGA Australia
Overview of current post-market monitoring regulations and practice in Australia. Focusing on changing trends and the implications for future post-market vigilance practice.
The document provides an overview of common issues seen by regulators in evaluating bioequivalence studies from the perspective of a regulatory evaluator. It discusses key aspects of study design, clinical conduct, analytical methods, pharmacokinetic analysis, and statistical analysis that are evaluated. Examples of specific studies that were not accepted due to issues such as analytical problems, clinical inconsistencies, and use of an inappropriate reference product are also provided. The evaluator emphasizes that justification for exclusion of data and consideration of outliers is important in statistical analysis.
Presentation: The challenges of regulating direct to consumer digital medical...TGA Australia
The document discusses the challenges of regulating direct-to-consumer digital medical devices. It describes what digital medical devices are, including connected devices, telehealth, apps, and wearables. The Therapeutic Goods Administration (TGA) regulates medical devices in Australia to ensure they are safe and effective. However, digital devices pose new challenges as many are software-based and consumers may not understand their intended medical purpose. The TGA must determine how to appropriately apply existing regulations to these new technologies.
Pharmacovigilance and complementary medicines - Regulatory requirementsTGA Australia
Presentation on Pharmacovigilance basics – sponsor obligations, Complementary medicine safety – Regulatory perspective and Special considerations for complementary medicine pharmacovigilance
Presentation: Updates from the Therapeutic Goods Administration - For medicin...TGA Australia
The Therapeutic Goods Administration provides updates on several pathways for new medicine approvals in Australia, including standard, priority, provisional, comparable overseas regulator, and orphan drug pathways. It discusses key issues for the priority and provisional pathways, such as eligibility criteria and timelines. The TGA also provides an overview of its orphan drug program and discusses emerging trends toward more expedited drug approvals globally and in Australia.
Adoption of TGO 91 - Prescription medicine labelling TGA Australia
This document discusses the adoption of Therapeutic Goods Order 91 (TGO 91) for prescription medicine labelling in Australia. It provides an overview of the need for updated medicine labels to improve safety, quality of use, and reduce medication errors. TGO 91 and TGO 92 were created to provide clearer labelling requirements for prescription and non-prescription medicines respectively. Common prescription labelling issues are identified, such as prominence of active ingredients and batch/expiry information. The guidance aims to standardize important health information and its location on labels through TGO 91.
Presentation: Spotlight on complementary medicines MMDR reformsTGA Australia
The document discusses reforms to the regulation of complementary medicines in Australia resulting from a 2015 review. It focuses on 5 streams of work: 1) enhancing the listing framework; 2) improving transparency for consumers; 3) increased flexibility for sponsors and improving the evidence base; 4) increased flexibility and predictability for industry; and 5) enhanced post-market monitoring and compliance actions. Key reforms discussed include establishing a permitted indications list, new pathways for assessing medicines, incentives for innovation, and enhanced post-market monitoring.
TGA presentation: Codeine Industry Forum - Regulatory options for up-schedulingTGA Australia
To provide sponsors of OTC codeine products with information on how to submit an application to change the class of their product from OTC to prescription medicine
This presentation highlights some of the changes in Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019, compared to the previous Order, Therapeutic Goods Order No. 78 – Standard for tablets and capsules.
Presentation: Changes to medicine labelsTGA Australia
This presentation discusses the recent changes to medicines labelling in Australia including the history and consultation as well as the changes and features brought in with Therapeutic Goods Order No. 79.
Improving the Patient Experience Through PharmacyCompleteRx
This document discusses how pharmacy impacts the patient experience through its many roles and interactions across the healthcare system. It touches on key areas like patient safety, medication safety, compliance, and proposed CMS changes. The document notes that pharmacy is involved in selecting, procuring, storing, dispensing, administering, and monitoring medications. It also discusses metrics around measuring medication errors and the case for improving sterile compounding practices.
TGA Presentation: Biologicals framework updatesTGA Australia
The document summarizes recent changes and proposed updates to Australia's regulatory framework for biological products such as human cells and tissues (biologicals). Key points:
- The biologicals framework regulates cell and tissue therapies and was introduced in 2011. It applies different regulation levels based on product risks.
- Recent approvals include various tissue-based products and cell therapies. Challenges include improving product characterization and developing potency assays.
- Proposed changes include updating guidance documents, expanding expedited pathways similar to the US and EU, and allowing some autologous cell/tissue uses to be exempt from regulation.
- The review aims to facilitate earlier patient access to innovative therapies while maintaining safety, efficacy and
TGA Presentation: GMP Clearance Information Session,5-7 September 2017TGA Australia
Provides an overview of the improvements made to the GMP clearance process including the revised guidance, the introduction of an application assistance tool, the redesigned application e-forms and the compliance verification process.
Regulatory Reform - Are we heading in the right direction?TGA Australia
The document summarizes updates from the Therapeutic Goods Administration (TGA) regarding regulatory reform efforts. Key points include: 1) TGA is restructuring to improve processes; 2) The government aims to improve innovation through regulatory reform while ensuring safety; and 3) TGA is working to streamline complementary medicine processes, international cooperation, manufacturing standards, and labelling reviews. The assistant secretary notes reforms are improving processes under the existing framework while further changes may come from ongoing reviews.
The European Commission Health and Consumers Directorate – General has published draft “GUIDELINES ON THE FORMALISED RISK ASSESSMENT FOR ASCERTAINING THE APPROPRIATE GOOD MANUFACTURING PRACTICE FOR EXCIPIENTS OF MEDICINAL PRODUCTS FOR HUMAN USE” for public consultation.
Following presentation has been prepared by " Drug regulations" a not for profit organization which provides free online resources for the Pharmaceutical Professional.
TGA Presentation: TGA focus and wrap up - What we've done, and what we still ...TGA Australia
An overview of the TGA's implementation of the recommendations made in the Review of Medicines and Medical Devices Regulation and other reforms for the IVD framework
The PV audit ensures that a company’s drug safety and pharmacovigilance operations comply with applicable laws, regulations and guidances worldwide, and compare to best practices for organizations of similar size.
HealthPRO provides nutrition and food services contracting for over 800 hospitals across Canada. Their contract approach involves:
1) Planning and developing a strategy based on factors like product complexity and need for innovation.
2) Prequalifying products by having nutrition experts score them on quality specifications.
3) Committing members to contracts in advance of supplier selection to ensure pricing commitments.
4) Issuing requests for proposals to prequalified suppliers and making award recommendations.
5) Providing ongoing support through implementation plans and supplier meetings to ensure benefits of national purchasing power, quality products, and savings.
HealthPRO provides contracting support services to over 250 healthcare members across Canada representing over 800 hospitals. They take a strategic approach to contracting that involves planning, prequalifying products, committing members to contracts, issuing requests for proposals, and awarding and implementing contracts with supplier support. Their national reach and collective purchasing power provides members with significant financial savings, high quality prequalified products, local support teams, and a strong voice on healthcare issues.
Presentation: The challenges of regulating direct to consumer digital medical...TGA Australia
The document discusses the challenges of regulating direct-to-consumer digital medical devices. It describes what digital medical devices are, including connected devices, telehealth, apps, and wearables. The Therapeutic Goods Administration (TGA) regulates medical devices in Australia to ensure they are safe and effective. However, digital devices pose new challenges as many are software-based and consumers may not understand their intended medical purpose. The TGA must determine how to appropriately apply existing regulations to these new technologies.
Pharmacovigilance and complementary medicines - Regulatory requirementsTGA Australia
Presentation on Pharmacovigilance basics – sponsor obligations, Complementary medicine safety – Regulatory perspective and Special considerations for complementary medicine pharmacovigilance
Presentation: Updates from the Therapeutic Goods Administration - For medicin...TGA Australia
The Therapeutic Goods Administration provides updates on several pathways for new medicine approvals in Australia, including standard, priority, provisional, comparable overseas regulator, and orphan drug pathways. It discusses key issues for the priority and provisional pathways, such as eligibility criteria and timelines. The TGA also provides an overview of its orphan drug program and discusses emerging trends toward more expedited drug approvals globally and in Australia.
Adoption of TGO 91 - Prescription medicine labelling TGA Australia
This document discusses the adoption of Therapeutic Goods Order 91 (TGO 91) for prescription medicine labelling in Australia. It provides an overview of the need for updated medicine labels to improve safety, quality of use, and reduce medication errors. TGO 91 and TGO 92 were created to provide clearer labelling requirements for prescription and non-prescription medicines respectively. Common prescription labelling issues are identified, such as prominence of active ingredients and batch/expiry information. The guidance aims to standardize important health information and its location on labels through TGO 91.
Presentation: Spotlight on complementary medicines MMDR reformsTGA Australia
The document discusses reforms to the regulation of complementary medicines in Australia resulting from a 2015 review. It focuses on 5 streams of work: 1) enhancing the listing framework; 2) improving transparency for consumers; 3) increased flexibility for sponsors and improving the evidence base; 4) increased flexibility and predictability for industry; and 5) enhanced post-market monitoring and compliance actions. Key reforms discussed include establishing a permitted indications list, new pathways for assessing medicines, incentives for innovation, and enhanced post-market monitoring.
TGA presentation: Codeine Industry Forum - Regulatory options for up-schedulingTGA Australia
To provide sponsors of OTC codeine products with information on how to submit an application to change the class of their product from OTC to prescription medicine
This presentation highlights some of the changes in Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019, compared to the previous Order, Therapeutic Goods Order No. 78 – Standard for tablets and capsules.
Presentation: Changes to medicine labelsTGA Australia
This presentation discusses the recent changes to medicines labelling in Australia including the history and consultation as well as the changes and features brought in with Therapeutic Goods Order No. 79.
Improving the Patient Experience Through PharmacyCompleteRx
This document discusses how pharmacy impacts the patient experience through its many roles and interactions across the healthcare system. It touches on key areas like patient safety, medication safety, compliance, and proposed CMS changes. The document notes that pharmacy is involved in selecting, procuring, storing, dispensing, administering, and monitoring medications. It also discusses metrics around measuring medication errors and the case for improving sterile compounding practices.
TGA Presentation: Biologicals framework updatesTGA Australia
The document summarizes recent changes and proposed updates to Australia's regulatory framework for biological products such as human cells and tissues (biologicals). Key points:
- The biologicals framework regulates cell and tissue therapies and was introduced in 2011. It applies different regulation levels based on product risks.
- Recent approvals include various tissue-based products and cell therapies. Challenges include improving product characterization and developing potency assays.
- Proposed changes include updating guidance documents, expanding expedited pathways similar to the US and EU, and allowing some autologous cell/tissue uses to be exempt from regulation.
- The review aims to facilitate earlier patient access to innovative therapies while maintaining safety, efficacy and
TGA Presentation: GMP Clearance Information Session,5-7 September 2017TGA Australia
Provides an overview of the improvements made to the GMP clearance process including the revised guidance, the introduction of an application assistance tool, the redesigned application e-forms and the compliance verification process.
Regulatory Reform - Are we heading in the right direction?TGA Australia
The document summarizes updates from the Therapeutic Goods Administration (TGA) regarding regulatory reform efforts. Key points include: 1) TGA is restructuring to improve processes; 2) The government aims to improve innovation through regulatory reform while ensuring safety; and 3) TGA is working to streamline complementary medicine processes, international cooperation, manufacturing standards, and labelling reviews. The assistant secretary notes reforms are improving processes under the existing framework while further changes may come from ongoing reviews.
The European Commission Health and Consumers Directorate – General has published draft “GUIDELINES ON THE FORMALISED RISK ASSESSMENT FOR ASCERTAINING THE APPROPRIATE GOOD MANUFACTURING PRACTICE FOR EXCIPIENTS OF MEDICINAL PRODUCTS FOR HUMAN USE” for public consultation.
Following presentation has been prepared by " Drug regulations" a not for profit organization which provides free online resources for the Pharmaceutical Professional.
TGA Presentation: TGA focus and wrap up - What we've done, and what we still ...TGA Australia
An overview of the TGA's implementation of the recommendations made in the Review of Medicines and Medical Devices Regulation and other reforms for the IVD framework
The PV audit ensures that a company’s drug safety and pharmacovigilance operations comply with applicable laws, regulations and guidances worldwide, and compare to best practices for organizations of similar size.
HealthPRO provides nutrition and food services contracting for over 800 hospitals across Canada. Their contract approach involves:
1) Planning and developing a strategy based on factors like product complexity and need for innovation.
2) Prequalifying products by having nutrition experts score them on quality specifications.
3) Committing members to contracts in advance of supplier selection to ensure pricing commitments.
4) Issuing requests for proposals to prequalified suppliers and making award recommendations.
5) Providing ongoing support through implementation plans and supplier meetings to ensure benefits of national purchasing power, quality products, and savings.
HealthPRO provides contracting support services to over 250 healthcare members across Canada representing over 800 hospitals. They take a strategic approach to contracting that involves planning, prequalifying products, committing members to contracts, issuing requests for proposals, and awarding and implementing contracts with supplier support. Their national reach and collective purchasing power provides members with significant financial savings, high quality prequalified products, local support teams, and a strong voice on healthcare issues.
HealthPRO is a healthcare procurement organization in Canada that aggregates volumes to achieve the greatest value for its members. It represents over 250 members across seven provinces and territories, with purchasing power over 800 hospitals. For clinical contracts involving capital equipment used across departments or clinically complex products with innovation potential, HealthPRO follows a 5-step approach: 1) Develop a strategy with clinical input, 2) Prequalify products against criteria, 3) Commit members in advance to contracts, 4) Issue RFPs and award contracts, 5) Implement and provide ongoing local and national support. This approach delivers the best overall value while meeting members' unique needs.
This document summarizes HealthPRO's contract approach for pharmacy contracts. It discusses HealthPRO's role in aggregating volumes to achieve the greatest value for members. The contract process involves planning strategy, issuing requests for proposals, evaluating products, awarding contracts, and providing ongoing support. Key aspects of the process include separating contracts into packages, evaluating products based on criteria like safety and quality, monitoring vendors, managing drug shortages, and driving policy changes to support members.
Dokumen ini berisi profil seorang mahasiswa bernama M. Agung Firman Sampurna yang berisi identitas diri, riwayat pendidikan, hobi dan minat, sosial media yang dimiliki, serta sebuah anekdot matematika tentang siswa bernama Jenung.
Berikut PPT yang berisikan analisis dari skripsi yang membahas tentang penerapan langkah polya guna meningkatkan keterampilan dalam meyelesaikan soal cerita pokok bahasan SPLDV.
Virsocom is an integrated marketing agency located in Miami, Florida that offers services such as advertising, marketing, 3D and interactive media production, and video production. The agency treats clients' brands as their own and acts as a strategic partner to help clients stand out from competition and drive sales through creative thinking. Key people at Virsocom include CEO Rishi Kapoor, Digital Marketing Director Lucas Sommer, and Creative Directors Andrew Hunt and Christian Cipriani.
The document discusses the characters and plot of a horror film project. The protagonist is weak compared to the dominant antagonist. However, it is revealed that they are the same character. Traditionally, the male is the antagonist but in this film the roles are reversed with a dominant female antagonist. This reversal of gender roles is meant to subvert horror conventions.
A special purpose vehicle (SPV) is a company or legal entity formed to fulfill a specific limited use, such as raising funds for a project. SPVs isolate risk and allow sponsors to achieve specific objectives while separating the activity from other business operations. The Indian government proposes establishing an SPV to fund financially viable but difficult to finance infrastructure projects, especially in roads, ports, airports and tourism. The SPV would directly lend longer term debt to eligible projects appraised by banks and financial institutions, supplementing other loans to help implement necessary infrastructure development.
Cum promovezi cu buget redus un eveniment mare @Lumea SEO PPCRoxana Ivan
Metode de promovare cu buget mic a evenimentelor mari, de la conferinte B2B la workshop-uri si intalniri de nisa. Prezentarea de la Lumea SEO PPC - 27 februarie 2014.
Dokumen tersebut membahas beberapa bangun datar seperti persegi, persegi panjang, segitiga, layang-layang dan lingkaran. Dijelaskan ciri-ciri dan rumus luas serta keliling masing-masing bangun datar.
A quick slideshow to enforce some of the basics of giving good customer service in a call center. I made a few modifications to it so I hope this one is better liked. :)
The document summarizes challenges faced by units in the Santacruz Electronic Export Processing Zone (SEEPZ) in Mumbai, India. It notes that the infrastructure in SEEPZ is dilapidated and in need of repairs, as the buildings are over 30 years old. It also discusses issues like labor unrest encouraging companies to consider relocating, a lack of maintenance from the governing body MIDC, and challenges from the global recession affecting export-dependent businesses.
The document discusses how personalization and dynamic content are becoming increasingly important on websites. It notes that 52% of marketers see content personalization as critical and 75% of consumers like it when brands personalize their content. However, personalization can create issues for search engine optimization as dynamic URLs and content are more difficult for search engines to index than static pages. The document provides tips for SEOs to help address these personalization and SEO challenges, such as using static URLs when possible and submitting accurate sitemaps.
The document discusses technology used to reduce medication errors and ensure patient safety. It begins with objectives to discuss past, present, and future technology used to reduce errors, and describe strategies to prevent patient harm. It then provides examples of technologies like CPOE, barcoding, automated dispensing units, and infusion pumps. It also discusses the importance of training, monitoring, and establishing procedures to safely utilize these technologies and outlines strategies for effective error reduction like competency assessment, validation testing, and performance monitoring.
This document provides a case study on how adopting global standards enabled interoperability and improved patient safety and supply chain efficiency for medication management of hemophilia patients in Ireland. It discusses how GS1 standards were implemented, including barcoding of medications, patients, and locations. This allowed medications to be tracked from manufacturer to patients' homes and improved recall capabilities. Outcomes included validated cold chain delivery, reduced documentation errors, improved stock rotation savings, and the ability to locate all medication during a mock recall. The smartphone app further enabled real-time medication recalls, improved compliance monitoring, and significant early cost savings. The document concludes that standards like those from GS1 are key to improving patient safety and reducing healthcare costs through more efficient supply chain
Background to the Falsified Medicines Directive and the Delegated RegulationGS1 UK
The document discusses the Falsified Medicines Directive and Delegated Regulation, which aim to secure the pharmaceutical supply chain and reduce counterfeit medicines. It outlines key aspects of the new regulations, including unique identifiers and tamper-evident packaging for prescription medicines. Verification of authenticity will occur at wholesale distributors and dispensing points. National repositories will store product information to enable verification. Implementation poses scale and connectivity challenges across the complex supply chain. Wider benefits may include improved patient safety, monitoring, and reducing fraud. Flexibilities allow country-specific requirements and earlier verification in some settings like hospitals.
The document discusses pharmacy automation and computerized provider order entry (CPOE) in healthcare. It describes the large and growing market for pharmacy automation technologies like tablet counters, IV compounders, and automated dispensing machines. It also outlines key terms related to CPOE systems, their importance for improving safety and reducing errors, and factors that can lead to issues like e-iatrogenesis during computer downtimes.
This document discusses pharmacovigilance in clinical trials, which involves monitoring the safety of medicines being tested. It outlines the responsibilities of various stakeholders like sponsors, investigators, and regulators in pharmacovigilance activities like adverse event reporting, risk assessment, and safety monitoring. Key aspects covered are the protocol guidance for safety reporting, use of case report forms and investigator brochures to document adverse drug reactions, and management of safety issues that arise during trials.
Pharmacovigilance is the science of monitoring approved drugs to detect adverse effects. It aims to improve patient safety by understanding drug risks. Clinical trials cannot detect all risks due to limited size and duration. Spontaneous reporting allows healthcare providers to report suspected adverse drug reactions. Limitations of clinical data and withdrawals like thalidomide led to pharmacovigilance programs worldwide including the WHO program and national programs in India, UK, and US. Pharmacovigilance involves collecting, analyzing, and communicating safety information to improve patient therapy and public health.
Vaccine development is just the first step in eradicating the pandemic, the real challenge lies in managing and handling its supply chain. An ERP built specifically for Vaccines can be the way out in efficiently fighting these challenges. Go through the presentation to know how exactly an ERP for vaccines helps.
Nursing professionals have an ethical duty to ensure patient safety. Various safety initiatives and technologies have aimed to promote safety and reduce errors. Informatics tools can integrate into the medication administration cycle through technologies like computerized physician order entry, barcoded medication administration, smart pumps, and clinical decision support. These technologies perform checks, provide alerts, and assist with decisions to help ensure the five rights of medication administration and reduce human errors.
1) The study results differed from randomized controlled trials on some outcomes like mortality and stroke risk.
2) There are differences in warfarin management between clinical trials and real-world settings that could impact results.
3) Excluding many warfarin users from the matched analysis impacts the generalizability of the findings.
4) There may be unmeasured confounding when comparing warfarin to NOACs or different NOACs.
5) The study relies on claims-based outcome algorithms that were not all directly confirmed.
6) Treatment persistence in the study could lead to bias or
This study used Medicare claims data to compare risks of stroke, bleeding, and death between warfarin and four non-vitamin K antagonist oral anticoagulants (NOACs) in older patients with atrial fibrillation. Researchers assembled an inception cohort of over 500,000 patients newly initiating warfarin or a NOAC between 2010-2015. Patients were propensity score matched and weighted to balance characteristics between treatment groups. Outcomes during follow-up were compared between warfarin and individual NOACs using adjusted Cox proportional hazards models, finding lower risks of stroke, bleeding, and death for NOACs versus warfarin.
This study used Medicare claims data to compare risks of stroke, bleeding, and death between warfarin and four non-vitamin K antagonist oral anticoagulants (NOACs) in patients with atrial fibrillation. Researchers assembled an inception cohort of over 500,000 new warfarin users and over 260,000 new NOAC users. They used propensity score matching and weighting to balance patient characteristics between the treatment groups. Outcomes were compared using Cox proportional hazards models, finding lower risks of stroke, bleeding, and death for NOACs compared to warfarin. This provided real-world evidence on effectiveness and safety of NOACs versus warfarin.
Deborah Weinswig's Digital Health Presentation for NACDS Aug. 24, 2015Deborah Weinswig
This document discusses digital health, wearables, and the consumer. It provides background on the author and organization. Key topics covered include digital health trends like big data and machine learning/AI. It then discusses medication adherence and how various apps, devices, and systems can help monitor medication usage. It also covers specialty pharmacy areas like biosimilars. The document discusses the growth of urgent care clinics and telemedicine, noting services available today and barriers to their adoption like physician shortages.
This document summarizes automated drug dispensing systems. It discusses dispensing processes and environments. Outpatient services refer to non-hospitalized patients visiting for consultations, while inpatient services refer to hospitalized patients receiving total pharmaceutical care. Common inpatient drug dispensing methods are individual prescription ordering, complete floor stocking, mobile dispensing, and unit dose dispensing like CUDDS and DUDDS. Automated dispensing involves robotic systems that store and retrieve medications automatically for improved safety, efficiency, and stock control. While advantages include faster filling and less errors, disadvantages include costs and technical skills required.
Medication order entry introduction, Medication order management system, steps involved, clinical decision support system, entering information in computers, drug labels and drug lists
Hans van Bruggen | Semantic interoperability to manage medicinal data and exc...semanticsconference
This document discusses the importance of managing medicinal data within and between the pharmaceutical industry and regulatory agencies. It outlines challenges such as ensuring consistent high-quality drug production, evaluating drug safety and efficacy, and exchanging information accurately. Examples are given where failures in data management led to health issues or drug shortages. The document argues that integrating systems using technical and semantic interoperability standards, and defining a single source of truth for medicinal product data, can help address these challenges by improving information sharing, signal detection, and corrective actions.
Risk management in pharmaceutical supply chainMohammad Fat'hy
In the modern day, a company's competitive advantage in most industries will be determined by maximizing its relationships and the diligent management of its forward and backwards facing supply chains.
The ability to effectively manage risks in a supply chain is an absolute must in the skill set of any current supply chain professional. This course will equip and develop procurement and supply chain professionals to be able to operate diligently and effectively with their supply base, mitigating any risks and maximizing all opportunities to gain competitive advantage in their market place.
The document discusses bar code medication administration (BCMA) quality assurance efforts at the Veterans Health Administration (VHA) over time. It notes that in 2000, VHA implemented BCMA at all medical centers, and since 2004 has developed closed loop verification procedures, established bar code verification labs, and added bar code quality clauses to contracts. Automated data capture of failed scans began in 2009. This has helped increase wristband and medication scan success rates from around 88-96% in 2009 to around 94-98% in 2011, returning over 60 hours of staff time per day to patient care. The document advocates for supply chain standardization and serialization to further improve safety.
Updates from the Pharmacovigilance and Special Access Branch TGA Australia
Presentation on using new sources of data in Pharmacovigilance, Pharmacovigilance Inspection Program (PVIP) update, International collaboration activities, Adverse Event Management System (AEMS)
Q and A
Presentation: Updates from the Pharmacovigilance and Special Access BranchTGA Australia
This presentation covers using new sources of data in Pharmacovigilance, Pharmacovigilance Inspection Program update, international collaboration activities and Adverse Event Management System.
The joint replacement unit at Sahlgrenska University Hospital implemented a value-based healthcare approach. A project team measured outcomes, costs, and processes for hip and knee replacements. After the first year, they found reductions in waiting times, length of stay, costs per patient, and adverse events, along with increases in the number of surgeries and value. The business intelligence software QlikView helped visualize data and support the transition to value-based management.
At Apollo Hospital, Lucknow, U.P., we provide specialized care for children experiencing dehydration and other symptoms. We also offer NICU & PICU Ambulance Facility Services. Consult our expert today for the best pediatric emergency care.
For More Details:
Map: https://cutt.ly/BwCeflYo
Name: Apollo Hospital
Address: Singar Nagar, LDA Colony, Lucknow, Uttar Pradesh 226012
Phone: 08429021957
Opening Hours: 24X7
Can coffee help me lose weight? Yes, 25,422 users in the USA use it for that ...nirahealhty
The South Beach Coffee Java Diet is a variation of the popular South Beach Diet, which was developed by cardiologist Dr. Arthur Agatston. The original South Beach Diet focuses on consuming lean proteins, healthy fats, and low-glycemic index carbohydrates. The South Beach Coffee Java Diet adds the element of coffee, specifically caffeine, to enhance weight loss and improve energy levels.
Can Allopathy and Homeopathy Be Used Together in India.pdfDharma Homoeopathy
This article explores the potential for combining allopathy and homeopathy in India, examining the benefits, challenges, and the emerging field of integrative medicine.
Healthy Eating Habits:
Understanding Nutrition Labels: Teaches how to read and interpret food labels, focusing on serving sizes, calorie intake, and nutrients to limit or include.
Tips for Healthy Eating: Offers practical advice such as incorporating a variety of foods, practicing moderation, staying hydrated, and eating mindfully.
Benefits of Regular Exercise:
Physical Benefits: Discusses how exercise aids in weight management, muscle and bone health, cardiovascular health, and flexibility.
Mental Benefits: Explains the psychological advantages, including stress reduction, improved mood, and better sleep.
Tips for Staying Active:
Encourages consistency, variety in exercises, setting realistic goals, and finding enjoyable activities to maintain motivation.
Maintaining a Balanced Lifestyle:
Integrating Nutrition and Exercise: Suggests meal planning and incorporating physical activity into daily routines.
Monitoring Progress: Recommends tracking food intake and exercise, regular health check-ups, and provides tips for achieving balance, such as getting sufficient sleep, managing stress, and staying socially active.
The best massage spa Ajman is Chandrima Spa Ajman, which was founded in 2023 and is exclusively for men 24 hours a day. As of right now, our parent firm has been providing massage services to over 50,000+ clients in Ajman for the past 10 years. It has about 8+ branches. This demonstrates that Chandrima Spa Ajman is among the most reasonably priced spas in Ajman and the ideal place to unwind and rejuvenate. We provide a wide range of Spa massage treatments, including Indian, Pakistani, Kerala, Malayali, and body-to-body massages. Numerous massage techniques are available, including deep tissue, Swedish, Thai, Russian, and hot stone massages. Our massage therapists produce genuinely unique treatments that generate a revitalized sense of inner serenely by fusing modern techniques, the cleanest natural substances, and traditional holistic therapists.
International Cancer Survivors Day is celebrated during June, placing the spotlight not only on cancer survivors, but also their caregivers.
CANSA has compiled a list of tips and guidelines of support:
https://cansa.org.za/who-cares-for-cancer-patients-caregivers/
R3 Stem Cell Therapy: A New Hope for Women with Ovarian FailureR3 Stem Cell
Discover the groundbreaking advancements in stem cell therapy by R3 Stem Cell, offering new hope for women with ovarian failure. This innovative treatment aims to restore ovarian function, improve fertility, and enhance overall well-being, revolutionizing reproductive health for women worldwide.
TEST BANK For Accounting Information Systems, 3rd Edition by Vernon Richardso...rightmanforbloodline
TEST BANK For Accounting Information Systems, 3rd Edition by Vernon Richardson, Verified Chapters 1 - 18, Complete Newest Version
TEST BANK For Accounting Information Systems, 3rd Edition by Vernon Richardson, Verified Chapters 1 - 18, Complete Newest Version
TEST BANK For Accounting Information Systems, 3rd Edition by Vernon Richardson, Verified Chapters 1 - 18, Complete Newest Version
MBC Support Group for Black Women – Insights in Genetic Testing.pdfbkling
Christina Spears, breast cancer genetic counselor at the Ohio State University Comprehensive Cancer Center, joined us for the MBC Support Group for Black Women to discuss the importance of genetic testing in communities of color and answer pressing questions.
DECODING THE RISKS - ALCOHOL, TOBACCO & DRUGS.pdfDr Rachana Gujar
Introduction: Substance use education is crucial due to its prevalence and societal impact.
Alcohol Use: Immediate and long-term risks include impaired judgment, health issues, and social consequences.
Tobacco Use: Immediate effects include increased heart rate, while long-term risks encompass cancer and heart disease.
Drug Use: Risks vary depending on the drug type, including health and psychological implications.
Prevention Strategies: Education, healthy coping mechanisms, community support, and policies are vital in preventing substance use.
Harm Reduction Strategies: Safe use practices, medication-assisted treatment, and naloxone availability aim to reduce harm.
Seeking Help for Addiction: Recognizing signs, available treatments, support systems, and resources are essential for recovery.
Personal Stories: Real stories of recovery emphasize hope and resilience.
Interactive Q&A: Engage the audience and encourage discussion.
Conclusion: Recap key points and emphasize the importance of awareness, prevention, and seeking help.
Resources: Provide contact information and links for further support.
Unlocking the Secrets to Safe Patient Handling.pdfLift Ability
Furthermore, the time constraints and workload in healthcare settings can make it challenging for caregivers to prioritise safe patient handling Australia practices, leading to shortcuts and increased risks.
This particular slides consist of- what is Pneumothorax,what are it's causes and it's effect on body, risk factors, symptoms,complications, diagnosis and role of physiotherapy in it.
This slide is very helpful for physiotherapy students and also for other medical and healthcare students.
Here is a summary of Pneumothorax:
Pneumothorax, also known as a collapsed lung, is a condition that occurs when air leaks into the space between the lung and chest wall. This air buildup puts pressure on the lung, preventing it from expanding fully when you breathe. A pneumothorax can cause a complete or partial collapse of the lung.
3. If not, must go through additional pharmacy
processes and manipulated for use
Compounding Reconstitution Repackaging
What hospitals need
Ready-to-Administer
3
4. End-point of medication supply chain is the
direct administration of a single dose by a nurse
to the patient at the bedside
What hospitals need
In Unit-of-Use
4
5. Unique identifier that ensures
What hospitals need
With Barcode
efficiency of
distribution and
inventory
management
verification of
correct
medication for
patient
administration
tracking and
traceability of
each dose to
the patient in
the event of an
issue
5
6. What is a good barcode?
Machine readable, every time
Has clear, crisp print with good
contrast
Can be scanned in any
direction
Is on opaque, non-reflective
background
Is not placed on a curved
surface
Is unique – GS1 compliant
6
7. GS1 compliant barcode includes
• Drug identifier (GTIN)
• Variable data – lot number
and expiry date
• Application Indicators (AI)
to separate different data
code functions
What is a good barcode?
1D Linear
Datamatrix
7
10. 10
Needed to
Receive
product from
suppliers
Do our job
efficiently and
safely
Locate drugs
in event of a
recall
Track
inventory
Move inventory
throughout the
hospital
Reconcile controlled
substances
(enable auditing and
prevent diversion)
Supply Chain Efficiency
11. • Medication should be
received from manufacturer
ready-to-go directly to patient
• Lack of barcoded unit-of-use
products has been identified
as a factor in not being able to
achieve greater verification of
medications prior to
administration
Hospitals are under
pressure to do
more with less
Supply Chain Efficiency
11
12. Moved to
active stock
Segregated
from active
stock
Moved to
reprocessing
area
Barcodes
generated on
labeler; applied
by technician
Must be
verified for
accuracy
Product
with
barcode on
unit of use
Product
without
barcode on
unit of use
Supply Chain Efficiency
12
13. Diverts staff from
direct patient care
activities
Impact of additional steps
Introduces risk
and
inefficiencies
Supply Chain Efficiency
13
14. Supply Chain Efficiency
A 350 bed hospital must
add barcodes to:
30%
of products
200,000 doses
per year
200+ FTEs
required across Canada
14
15. 15
Supply Chain Efficiency
• Injectables
(have come a long way)
• Inhalers
• Topical administration
Ophthalmic
Transdermal patches
Cream and ointment
tubes
• Suppositories
Barcode on box but
not on unit of
administration
15
16. 16
• Ampoule or vial is not
the final product
Ready-to-administer
16
Supply Chain Efficiency
17. Supply Chain Efficiency
Not machine
readable, every
time
Consequences
- If barcode quality does not
meet hospital needs, they
will seek an alternative
supplier
- Hospitals may require
certificate of readability
Challenges
- Multiple barcodes on
product, causes disruption in
system
- Barcode positioning on
curved surface impedes
scanner read
17
18. • Each dose includes all
appropriate label
information, but no
barcode
• If enough room for
barcode, hospital staff
will add
• Otherwise need to
repackage
Supply Chain Efficiency
Oral Solids – Unit
Dose Pack
18
19. • Significant improvement required – currently of no value
• Hospital staff must remove tablets from blister and then
repackage, similar to bulk
• NEED – unit dose packaging with barcode on each unit of
administration
Supply Chain Efficiency
Oral Solids – Patient Compliance Packs
19
20. • Availability of high-tech
packaging machines in
hospitals allows bulk
oral solids to be
repackaged into unit
dose format with a
barcode
• NEED – ensure a
readable barcode on
the bottle
Supply Chain Efficiency
Oral Solids – Bulk
20
22. • National Institute of Occupational Safety
and Health (US) has identified list of
antineoplastics and other hazardous
substances that require special handling to
limit exposure to healthcare workers
• The University of Utah Drug Information
Service has published an expanded list of
drugs* (hazardous or allergenic) that should
not be put in automated machines
• Drugs packaged in automated machines
may also lead to cross-contamination risk
to patients
Supply Chain Efficiency
*Oral Medications that Should Not be Packaged in the Prepackage Machine and Oral
Medications that Require Special Handling Precautions
Oral
Medications
that require
special
handling
22
Cytotoxic Hazardous
Drugs
23. • Colleges of Pharmacy in Canada
moving to enforce that these
products not be processed in
automated packaging machines
(retail + hospital)
• Hospitals must package manually
to meet regulatory requirements
• Very labour intensive and must don
Personal Protective Equipment
(PPE) to mitigate exposure
• Best suited for a supplier
manufacturing and packaging
facility
Supply Chain Efficiency
Oral Medications
that require
special handling
23
24. • Standards for handling of hazardous
products created through
NIOSH/The University of Utah Drug
Information Service
• Regulators enforcing standards
(Colleges across Canada)
• FDA issued the Bar Code Final Rule
in February 2004 requiring bar
codes on the labels of all human
prescription drug products,
biological products, and OTC drug
products that are commonly used in
hospitals and dispensed pursuant to
an order
Supply Chain Efficiency
External Forces Driving
Transformation
24
25. • commercially available unit dose
package
• drugs on NIOSH list packaged in
unit dose packages with barcode
on each dose
Supply Chain Efficiency
25
What we need
27. Supply Chain Traceability
27
Suppliers need to Track
and Trace
US Federal Drug Quality and Security Act H.R. 3204
(aka Drug Supply Chain Security Act)
• Securing the drug supply chain against
counterfeit drugs through tracking and
tracing of every transaction –
enabler: barcode or product identifier
• Sunset date for manufacturers –
complete supply chain by 2023
Product
Identifier
- National Drug
Code
- Serial Number
- Lot Number
- Expiration
Date
28. Supply Chain Traceability
28
Suppliers need to Track
and Trace
• European Union Falsified Medicines Directive –
need for security of supply chain based on
serialization, product verification at each
transaction and compliance reporting;
• Sunset February 9, 2019
• Expectations expanding throughout the global
supply chain
29. Supply Chain Traceability
29
Counterfeit Version of Drugs
Discovered
UK and EU: 2007
• Casodex (for prostate cancer)
• Plavix (for heart disease)
• Zyprexa (for schizophrenia)
US: 2012
• Avastin (for various types of cancer)
Canada (2005)
• Norvasc (for hypertension and angina)
30. Supply Chain Traceability
• Safeguard “authenticity of health products as they
move through the medication use system” — Health
Canada
• Based on product verification, product traceability,
and automated verification systems
30
This is a goal for suppliers and
all healthcare providers
31. Supply Chain Traceability
Hospitals also need to Track and Trace
• National Association of Pharmacy Regulatory Authorities
(NAPRA) standards of practice – ability to immediately
determine which patients received a given drug product
• Addresses specific public safety issues to trace drugs to
rapidly determine which drugs had been dispensed to
which patients by:
• product identifier
• lot or batch number
• expiry date
• Serialization is a future need to combat counterfeit drugs
31
32. Supply Chain Traceability
32
Ideal automated identifier
Product
Identifier
Variable
Data
Serialization
Yesterday Today Tomorrow
e.g. GTIN Lot or batch
# and expiry
date
Serial
number
34. Supply Chain Traceability
Ability to “Track and Trace”
• Ready to use product with
barcode with variable data and
serialization (tomorrow)
• Motives are different
• Enablers are the same
What we need
34
36. Evidence shows that
medication errors lead
to negative patient
outcomes, including
death.
In Canada, 24,000 adults die every year
from adverse events in acute care settings.1
Medication errors
account for almost half of these.
1Canadian Adverse Events Study: The incidence of Adverse Events Among Hospital Patients in Canada
Safe Medication Management
36
37. Safe Medication Management
Evidence shows barcoding/computerization helps
mitigate these occurrences
• Scan verification of medication at the bedside can help reduce
patient error in hospitals by up to 41%1
• Implementing BCMA in the ED was associated with significant
reductions in medication error rate (80% relative rate reduction)
• A study using direct-observation methodology to monitor
medication administration before and after the deployment of
the EMAR and BCMA systems demonstrated a 54% reduction in
medication administration errors following implementation of a
multidisciplinary, collaborative approach to medication safety. 3
1. Poon EG et al. Effect of Bar Code Technology on the Safety of Medication Administration. N Eng J Med 2010; 362:1698-1707)
2. Bonkowski J et al. Effect of barcode-assisted medication administration on emergency department medication errors. Acad Emerg Med. 2013
Aug;20(8):801-6.
3. Paoletti RD et al. Using bar-code technology and medication observation methodology for safer medication administration. Am J Health Syst Pharm.
2007;64(5):536-543.
37
38. Safe Medication Management
Evidence
CLMM requires barcoding on unit of administration
11% occur at
the point of
dispensing
(barcoding can
help)
39% of errors
occur at the
point of
prescribing
(CPOE* can help)
38% occur at
the point of
administration
(barcoding can
help)
12% occur at the
point of
transcription
(CPOE can help)
Leape, LL, Bates DW, Cullen DJ, et al. Systems Analysis of Adverse Drug Events. JAMA. 1995; 274:35-43
*Computerized Prescriber Order Entry
38
40. Safe Medication Management
• Computerized Prescriber Order Entry (CPOE) and Closed
Loop Medication Management (CLMM) Systems are
fundamental to achieving a high EMRAM score
• Electronic Medical Record Adoption Model (EMRAM) is
internationally recognized benchmarking tool which
helps improve the quality and safety of patient care
• Is an indicator of the healthcare system’s integration and
connectivity
• Highly adopted in U.S., Ontario and British Columbia and
increasingly across other provinces in Canada
40
41. Safe Medication Management
Adapted from
https://www.oha.com/CurrentIssues/keyinitiatives/eHealth/Pages/eHealthAdoptionFindingsandComparisons.aspx
EMRAM Adoption
41
42. Safe Medication Management
Medication bar coding practices significantly
reduce serious errors and patient harm, while
improving both the patient care environment
and electronic health record documentation.
ISMP Canada Safety Bulletin – Volume 13 • Issue 13 • December 19, 2013
Advocacy for the use of
automated barcode technology
42
43. Safe Medication Management
Accreditation Canada standards
• Standard 18.0 – automated barcode verification help
avoid look-alike errors at all points of the medication
chain
Canadian Society of Hospital Pharmacists (CSHP) 2015
Targeting Excellence in Pharmacy Practice
• Objective 5.1 Hospitals will use machine readable
coding to verify medications before dispensing
• Objective 5.2 Hospitals will use machine readable
coding to verify medications before administration to
a patient
Other standards of practice recommendations to
improve patient safety
43
44. Safe Medication Management
• With automated tracking of
inventory, facilitated by a
barcode on unit of use,
all doses anywhere in the
hospital can be retrieved and
accounted for
• Reduce risk that a recalled
product is administered to a
patient
Hospitals are under
pressure to reduce the
risk of patient harm
44
45. “In the U.S., we could not
scan drugs at the point of
care until individual
packages arrived from the
manufacturer with
barcodes.”
– Mark Neuenschwander,
“Guru of Barcoding”
45
46. We are facing external and internal pressures
Barcoding and complete labelling on a
ready-to-administer unit dose format is a global need
and a necessary state for:
We can’t get there without you
46
47. We Can Get
to a Better State
Let’s Transform,
Together
Editor's Notes
The widespread use of automation throughout our hospital supply chain is dependent on a readable barcode on the unit of use.
Products can be tracked more efficiently with the use of automation, and most importantly, they safeguard against errors at the most vulnerable stage of the medication use process – during medication administration.
But hospitals in Canada need your help to achieve this goal.
[Read Slide]
A product that is received from you in a ready-to-administer format with a barcode can go right into the hospital supply chain.
Otherwise, it has to be segregated from active stock and go through a separate hospital pharmacy production process before getting to the patient.
There is a fundamental difference between hospital pharmacy and community pharmacy.
In community practice – a package of medication is dispensed to a patient pursuant to a prescription and generally for self-administration. However, in hospital practice, the end point of the medication supply chain is the direct administration of one single dose of drug by a nurse to the patient at the bedside.
Products in a ready to administer format with a barcode on the unit of use are needed to support:
Efficiency in distribution of medications within the hospital internal supply chain (from cases to boxes to individual units of use)
Verification of the right medicines at all points of the medication supply chain, but particularly at the patient administration step
Traceability of all medicines administered to patients, particularly if they have been altered by a pharmacy production process and are no longer in their original manufacturer’s format. This is a need in retail pharmacy as well as hospitals.
It’s not enough to put a barcode on a product. It has to be readable each and every time it is scanned throughout the hospital supply chain, but especially at the point of administration to the patient.
There are a number of points to consider to ensure your barcode is a GOOD barcode.
The Global Trade Identification Number is a critical unique identifier of the product but it is important to also have the lot number and expiry date embedded into the barcode to allow for tracking and traceability.
Not all hospitals are able to use this information yet but this is the evolving need going forward.
With properly embedded application indicators, scanners can parse the information in the barcode and capture the information they can use.
The two dimensional datamatrix barcode is ideal for small ampoules, vials, unit dose blisters and ophthalmic dropper bottles.
In the future, as in other countries, we will need to also have serialization embedded in the barcode to ensure the authenticity of the products we administer to our patients and prevent diversion.
The most fundamental use of the barcode is for supply chain efficiency. We need to track inventory so we can move it throughout the hospital, know where every dose is in the event of a recall and be able to reconcile narcotics and controlled substances.
Lack of barcoded unit of use products has been identified as a factor in not being able to achieve greater verification of medications prior to administration.
We need the pharmaceutical industry to provide barcoded products and your production facilities are the appropriate place for this to happen since following Good Manufacturing Practices, or GMP standards, you have better control systems.
Hospital production facilities are not up to GMP standards and risk can be introduced when we have to repackage and relabel products. Hospitals do not have the sophistication of systems available to the pharmaceutical industry.
The healthcare system is under pressure to implement systems to detect and prevent errors. To do this efficiently, we need products barcoded to the unit of use.
This is a simple depiction of the additional steps required at the hospital pharmacy level when a product is received without a barcode on the unit of use.
Like your facilities, hospitals have to develop Standard Operating Procedures to ensure consistent and accurate packaging and labeling, documentation and verification steps as part of our quality assurance.
In addition to the inefficiency and introduction of risk associated with the additional steps required for reprocessing, hospital staff is diverted from important patient care activities.
The Pharmacy Department must operate with its allotted Full Time Equivalent, or FTE, complement.
One or two FTEs to perform these extra steps may not seem like much, but when you take this example from one hospital and extrapolate it across the country, more than 200 FTEs are diverted from patient care activities.
This is likely a conservative estimate since smaller hospitals would not have the same economies of scale as a 350 bed hospital but would still require the resources.
The good news is that there has been good improvement in the availability of injectables drugs with a barcode on the unit of use. We do, however, continue to have some issues with the readability of some barcodes which will be addressed shortly.
Categories of products where there is a lot of room for improvement are listed on this slide, but especially inhalation products such as drugs in nebules, Metered Dose Inhalers, topical products and suppositories. Ideally, we would have injectable drugs available in barcoded ready-to‐administer formats, such as prefilled syringes or premixed bags.
As I have acknowledged, when it comes to injectables, manufacturers have come a long way in including barcodes on ampoules and vials. However, the amp or vial is not the final product – a syringe full of the drug is.
We’ve seen workarounds such as nurses taking the broken amps along with the syringe to
the bedside for scanning – so a move toward prefilled syringes is really necessary.
Changing practice requires positive user experience, so when nurses have difficulty determining which barcode they are supposed to scan, get frequent error messages or have to manually key in the GTIN, the task of ensuring compliance becomes more difficult.
A certificate of readability is often useful to identify if there is a particular scanner that does not capture your barcode accurately, rather than simply stating that “the barcode doesn’t work!”
Whereas unit‐dose packages are helpful to decrease the need to repackage oral solids, if your product does not have a barcode on each unit, the pharmacy will have to add one.
Sometimes, if there is enough white space on the blister unit, the staff can simply print and affix a barcode (with all associated documentation and QA checks).
In other situations, they will actually have to remove the product from your unit dose package and repackage it with complete labeling including a hospital generated barcode.
So the bottom line is we NEED a readable barcode on each unit of administration.
Blister packages, often called compliance packs, are one type of product that creates significant workload for pharmacy technicians.
Each dose has to be removed from the blister and then either added to a cassette for automated packaging or manually packaged.
Antineoplastic drugs and other hazardous products have additional steps associated with repackaging due to the need to reduce occupational exposure.
Narcotic, controlled drugs and targeted substances also have additional documentation, tracking and reporting requirements.
Most oral solids are best packaged in bulk bottles so they can be processed through high speed automated packaging machines.
However, if you distribute your product in an outer box, it is important that the barcode be on the bottle as well as the box.
An exception to this, is for narcotic, controlled and targeted substances.
As mentioned previously, because of the controls, necessary documentation and reporting requirements, it would be better to be able to purchase these products in properly labelled and barcoded unit dose packages.
A number of medications require special handling to protect both hospital staff from occupational exposure and patients from cross-contamination.
Antineoplastic drugs, hormonal drugs and allergenic drugs such as antibiotics are not to be packaged using the automated packaging machines because the stresses exerted by the machine can generate particles or can cause breakage. The pharmaceutical dust that is generated contaminates both the air hospital staff inhale, as well as other tablets and capsules that are being packaged which patients will ingest.
In addition to Occupational Health and Safety Boards, the Colleges of Pharmacy across Canada are also mandating that these products not be processed in the automated packaging machines. This is confirmed during onsite inspections.
This applies to both the hospital and retail market.
As you saw in the video, pharmacy staff must don personal protective equipment and perform the packaging function manually in a segregated area.
Some sites have also purchased compounding aseptic containment isolators (CACI) for this function, as recommended in USP Chapter 800 guidelines for handling hazardous products.
So as you can see, this is a function that is best suited to be done in your facilities.
There are multiple external forces driving our appeal.
Since 2006, all manufacturers selling products to hospitals in the U.S. have had to comply with the barcode rule. The FDA published the Bar Code Final Rule in 2004 but allowed for a two year implementation period.
This requirement has advanced the availability of pharmaceutical products with barcodes in the U.S.
It is not sustainable for our hospitals to continue to take on this additional workload.
We need your help.
With the many pressures coming from regulators and legislators, we need commercially available products with a barcode on the unit of use.
Our appeal to include barcoding on the unit of use is not a Canadian anomaly.
Global regulations for Track and Trace, including the US Drug Quality and Security Act and the European Union Falsified Medicines Directive, support this request.
By 2023, the US Drug Supply Chain Security Act will require a unique product identifier that includes the NDC, the lot number and expiry date, as well as a serial number on your product to track and trace products through the complete supply chain.
The barcode is the answer.
The European Union, also driven by fraudulent activity in various countries, has published a Directive requiring compliance with product verification at each transaction by early 2019.
There are similar mandates globally, with over 40 countries, including China, India, Saudi Arabia, and Brazil covered by track and trace regulations.
Ultimately, scanning the barcode will facilitate verifying that the drug is genuine.
UK and EU:
In 2007, according to a report from the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK, 2.1m doses of falsified medicines labelled for the treatment of prostate cancer, heart disease and schizophrenia were imported into the country and entered the regulated supply chain, purporting to be parallel traded products.
700,000 doses reached pharmacies and patients; the remainder were traced and seized by the MHRA or recalled from the market. The case ended in a conviction.
US:
In 2010, the FDA's Office of Criminal Investigation opened 72 new cases of counterfeit drugs in 2010, up from just six a decade earlier.
In February 2012, counterfeit versions of Roche's cancer drug Avastin found its way into hospitals and patients' groups, prompting an FDA investigation.
In the US, patients can buy drugs online from some Verified Internet Pharmacy Practice Sites (VIPPS). These sites are often mimicked by criminals, who create counterfeit sites that claim to be accredited when they are not. Although, people can buy drugs online in the EU also, there are no verified sites and doctors always advise against this.
Counterfeit drugs are not only dangerous to patients, but they lose the pharmaceutical industry billions of dollars every year.
Here’s one close to home from 2005:
For the first time in Canada -- according to police -- a pharmacist has been charged with dispensing counterfeit medical drugs to patients. RCMP charged a Hamilton, Ont., druggist with dispensing fake Norvasc -- a medication used to treat high blood pressure and angina.
http://www.cbc.ca/news/canada/hamilton-pharmacist-charged-with-handing-out-counterfeit-drugs-1.568647
http://www.theglobeandmail.com/news/national/college-of-pharmacists-trying-to-shut-hamilton-drug-store/article24357177/
Although Canada does not currently have legislation or regulations enacted, Health Canada does require the safeguarding of the authenticity of health products throughout the medication use system.
Beyond legislation, there are also professional standards to be met.
The National Association of Pharmacy Regulatory Authorities supplemental document to the Pharmacy Practice Management Systems to support standards of practice1, addresses the need for traceability of drug products. They define ‘traceability’ as the capacity to immediately determine which patients received a given drug product.
Traceability is a major concern from both a safety and a risk management perspective. The need for traceability extends to all dispensed drugs, including those dispensed in the retail market.
1Approved April 2016 and effective January 1, 2019
Our barcode needs have evolved.
In 2009, through the Canadian Pharmaceutical Bar Coding Project, the Institute for Safe Medication Practices-Canada and the Canadian Patient Safety Institute endorsed adoption of the GS1 global standard for Automated Identification of pharmaceuticals in Canada – a GS1 complaint barcode containing the global trade identification number.
Milestones were established for inclusion of the variable data to support traceability. Inclusion of the lot number and expiry date within a barcode were recommended in Canada by December 2017.
The future use and application of medication product serial numbers was considered by the project, but deferred in order to allow time to harmonize with global requirements.
A ready to use product with variable data within the barcode will help both suppliers and hospitals comply with Track and Trace requirements.
The landmark Canadian Adverse Events Study, commonly referred to as the Baker Norton Study, published in 2004 followed on the heels of similar studies in the US, Britain, New Zealand and Australia.
By extrapolation, the results of this study suggested that, in 2000, between 141 and 232 thousand of 2.5 million similar admissions to acute care hospitals in Canada were associated with an adverse event, and that between 9,000 and 24,000 deaths from adverse events could have been prevented.
The most common types of adverse events were related to surgical procedures, and the next most common were associated with drug or fluid related events.
This was the impetus for the many patient safety initiatives that followed to reduce risks to patients – including verification of barcoded medications to safeguard against errors at the most vulnerable stage of the medication use process – medication administration.
There have been several studies which have shown that barcode scanning against an electronic medical record reduces errors and harm to patients.
The evidence shows that almost 50 per cent of medication errors can be mitigated by the use of barcode scanning. The other 50 per cent can be reduced through automation.
Really, what we’re talking about is Closed Loop Medication Management, or CLMM, which takes advantage of all the available automation to reduce patient risk and improve health outcomes.
It requires an active medication order, electronic verification of the provider, usually the nurse, electronic verification of the patient and a bar coded drug to make sure that the right patient gets the right dose of the right medication, at the right time and by the right route. For example, intravenous and oral medications. Scanning the bar codes also result in the right documentation entered into the patient record.
Standards of practice are evolving, including the need for paperless electronic medical records across the continuum of healthcare. As hospitals track their progress and benchmark against the EMR Adoption Model (EMRAM), an important indicator of the healthcare system’s integration and connectivity, the implementation of CLMM will continue to increase.
The goal is to achieve Stage 7 of EMR adoption.
Stage 7 healthcare organizations demonstrate superior implementation and utilization of health IT systems. Their achievement has resulted in the true sharing, information exchange and immediate availability of patient data to improve process performance, quality of care and safety.
Having a fully integrated EMR ensures that everyone involved in the patient’s care has real time information and can make appropriate decisions to ensure positive health outcomes.
As you can see from this graph, US hospitals, shown in red, are mostly at stage 5 or 6. Canadian hospitals are sitting at stage 2 or 3.
We need your help to progress along this journey.
The evidence for full implementation of medication barcoding practices exists and is supported by important patient safety advocates in Canada.
Accreditation Canada Medication Management Standards (Standard 18.0) point to automated barcode verification systems to help avoid errors at all points of the medication chain.
The Canadian Society of Hospital Pharmacists’ 2015 objectives include routine use of machine readable bar codes to verify medications before dispensing, as well as before administration to the patient.
In Ontario, the OCP inspection criteria recognize the importance of barcoding, and require hospitals to have policies and procedures to ensure appropriate barcoding throughout the medication use process, as well as to ensure a safe and consistent process for the application of barcoding technology.
[Category A6:73, Category C:149, 150]
No presentation on the use of barcodes in the healthcare system is complete without a quote from Mark Neuenschwander.
“In the U.S., we could not scan drugs at the point of care until individual packages arrived from the manufacturer with barcodes.”
With the help and cooperation of manufacturers, US hospitals have been able to move much farther along in implementing Closed Loop Medication Management.
With YOUR help, we can do the same in Canada.
We can get to a better state. Let’s transform, together.