Biopharmaceuticals: An Overview

Biological medical products, also known as biologics, or biopharmaceuticals, are being developed at a fast pace due to the consistently increasing demand throughout the healthcare industry. According to The National Center for Biotechnology Information (NCBI), biopharmaceuticals refer to “pharmaceuticals produced in biotechnological processes using molecular biology methods”. This is opposed to the chemical synthesis process that is used in traditional pharmaceutical manufacturing.

Biotech vs Pharma

Biotechnology involves the use of technology and living organisms or other biological systems to create medicines, foods, or other products. Biotech is used for therapeutic proteins, gene therapy, and other types of medicinal products. It’s also used for other purposes, such as agricultural, environmental, and industrial. 

The pharmaceutical industry develops and produces medicines used for disease prevention and treatment, as well as prevention and treatment for other medical conditions. Standard pharmaceutical manufacturing typically uses chemical synthesis to create medicine. 

The NCBI compares the biopharmaceutical manufacturing industry to the synthetic process to outline some key differences between the two. These include “the nature of the product, the source of the active agent, bioequivalence criteria, identity, structure, manufacturing methods, composition, dosing, formulation, handling, intellectual property rights, legal regulations, and marketing”.

Biopharmaceutical Companies 

Biopharmaceutical companies have an increasingly valuable role in the treatment and prevention of diseases in the United States and other countries. The biopharmaceutical processes used for creating protein therapeutics, vaccine manufacturing, monoclonal antibody production, gene therapy, and other products are providing alternative forms of treatment to traditional pharmaceutical products. In recent years, some of these biopharmaceutical products have been used or have been in research and development to treat infectious diseases and potentially life-threatening illnesses, such as cancer. 

With some major distinctions throughout the development process, biopharmaceutical companies face different challenges that pertain specifically to the biopharmaceutical manufacturing process. Solutions to overcome these challenges differ for every step along the drug’s lifecycle, from discovery to clinical research to packaging.

Let’s review some critical considerations for the production of biopharmaceuticals and explore some solutions pertaining to the packaging portion of biopharmaceutical manufacturing.

Important Regulations for Biopharma 

The pharmaceutical industry and the biopharmaceutical industry in the United States are both subject to strict regulations in order to ensure quality and safety. The pharmaceutical industry and biopharmaceutical industry have the same U.S. Food and Drug Administration (FDA) regulations. However, the path to approval for each pharmaceutical product or biopharmaceutical product is different. 

Biopharmaceutical Product Approval 

The approval path for biotech in the United States involves submitting a Biologics License Application (BLA) to the Center for Biologics Evaluations and Research (CBER). The BLA for each biologics product must be approved by the CBER. This regulatory process for biopharmaceuticals is an important part of ensuring that products are safe before entering the market. 

Pharmaceutical Product Approval 

The approval path for traditional pharmaceutical products involves submitting a New Drug Application (NDA) through the FDA’s Center for Drug Evaluation and Research (CDER). The NDA includes test results for the product, manufacturing information, data from clinical trials, and a proposed label with information on the reason for use, how to use it, and potential risks. If the product’s benefits outweigh any known risks, the regulatory agency approves it for commercial manufacturing. 

DSCSA 

Applying to every drug, whether developed synthetically or naturally, the Drug Supply Chain Security Act (DCSCA) was created in the United States to improve traceability in the supply chain for pharmaceutical products. This act has several provisions that are aimed at making it easier to keep track of pharmaceutical products that enter the supply chain. This helps reduce the risk of having patients or consumers end up with counterfeit drugs or medicines. Although the law was enacted in 2013, full DSCSA implementation is set to occur in 2023, causing both pharmaceutical and biopharmaceutical companies to ask the question: Is our organization ready? 

Biopharmaceutical Manufacturing Process

Biopharmaceutical Processing 

The biopharmaceutical manufacturing process is more complex than other processes used to make synthetic or traditional pharmaceutical products. For biologics, process development involves having to obtain, grow, or reproduce living organisms, such as bacteria or cells, in order to create medicinal products. Working with living organisms rather than chemicals or other synthetic materials results in certain challenges in ensuring safety, quality, and efficacy.

Biopharmaceutical Packaging: Optimizing the Process

The packaging process is a significant part of these challenges since biologics need to remain in good condition until they are administered. These types of medicine are usually injected rather than taken in oral form or used in topical form. Unlike traditional pharmaceutical medicines, biopharmaceuticals are much more sensitive to temperature changes and environmental factors. Finding ways to optimize the biopharmaceutical packaging process can help biopharmaceutical companies reduce costs and keep their products in good condition. 

Key Challenges in Manufacturing Biologics 

Manufacturing biopharmaceuticals requires more complicated processes. The living organisms and biotechnology used for these products create challenges that make it difficult to produce, store, package, and transport them. This can lead to biologics that are deemed unsafe, ineffective, or unsuitable for use once they reach healthcare facilities or pharmacies. Knowing more about these challenges can help companies find solutions for handling them and optimizing the biopharmaceutical manufacturing and packaging processes overall. 

Cost

Manufacturing biopharmaceutical products typically has a high cost. When products cannot be used due to contamination, damage from heat, or other causes, this can cost biopharmaceutical companies a considerable amount of money. The companies then have to spend additional money on producing biologics again and run the risk of having the same or similar problems occur. 

Packaging solutions can provide an effective way for biopharmaceutical companies to keep lower costs since they help protect these products from damage, contamination, and other problems. 

Environmental Control

Pharmaceutical products made from chemicals have raw materials that aren’t as susceptible to temperature changes and other environmental factors. This makes it easier to store and transport  products without a high risk of having an active pharmaceutical ingredient become damaged or contaminated. 

With biopharmaceutical products, cells, bacteria, or other living organisms are much more vulnerable to damage or contamination due to environmental factors, such as changes in temperature or moisture exposure. These products tend to be highly sensitive to heat and can become easily contaminated. Ensuring environmental control throughout storage and transportation is essential, yet difficult to achieve. 

Regulations 

The pharmaceutical industry faces a number of regulations that help ensure drug safety. From purification processes to unit operations for drug manufacturing, these regulations are an important part of improving both product and patient safety. With so many pharmaceutical products being developed on a commercial scale and the increasing demand for biologics, companies must keep up with changes and new regulations. This can be a considerable challenge for biopharmaceutical manufacturing.

Innovative Packaging Solutions to Meet Biopharma’s Unique Needs

MPI has years of experience providing high-quality, dependable packaging solutions for pharmaceutical products. This extensive experience has allowed our company to develop effective solutions that help ensure medicinal products maintain their efficacy and are safe to use after being packaged and shipped to healthcare facilities or pharmacies.

This expertise extends to the biopharmaceutical industry with its unique needs and challenges. Our packaging solutions can help ensure that biopharma products avoid contamination and damage during storage and transportation. Our systems also contribute to overall operational efficiency and reduce medication errors. These solutions can help offset the high cost of producing biopharma products while ensuring that these products remain safe for use. 

MPI Products for Biopharma

At MPI, we offer packaging solutions aimed at meeting the challenges of storing and transporting biopharma products. Our oral liquid packaging products provide comprehensive solutions to virtually any liquid biopharmaceutical packaging requirement. Alongside our products, MPI’s Drug Master File (DMF) provides speed-to-market regulatory and technical support, helping our customers through the approval process in a shorter time period. 

The biopharma industry includes many products that are in the early stages of development. These products do not require large-volume manufacturing or packaging. Our cost-effective packaging solutions for specialty pharma manufacturers and repackagers ensure fast and efficient packaging that helps support the development and validation process. 

Liquid Medication Solutions 

FD-Pharma®

MPI offers an innovative solution for liquid medications. Our FD-Pharma Unit Dose Packaging System provides barcode packaging that ensures precise dosing for oral liquid medications. This cost-effective solution is suitable for clinical trials, validation runs, and low-volume production, as well as full production. FD-Pharma is a printing and pumping system for use with our MPI-certified packaging materials that meet FDA regulations. 

Fluidose® Series 6

The Fluidose Series 6 Unit Dose Packaging System from MPI is another barcoding packaging solution for liquid medications. This solution has a built-in syringe pump mechanism and can produce up to 22 doses per minute. Fluidose meets the Joint Commission’s regulations for dispensing liquid medications and includes our Pak-EDGE UD Barcode Labeling Software. 

Contact MPI for More Information on Our Biopharmaceutical Packaging Solutions!

If you are looking for more information on solutions for optimizing biopharmaceutical manufacturing and packaging, please contact MPI. Our team of experts is happy to help you find the best packaging solution for your unique organization and market. 

Hospital inventory management is an essential part of improving patient safety and patient outcomes while also reducing inventory costs. Challenges to the healthcare industry, such as supply shortages and human error, make healthcare inventory management highly important. Following best inventory management practices can help hospital administrators achieve better inventory control while remaining in compliance with regulations and handling difficulties within the industry. 

Importance and Benefits of Inventory Management 

From medical equipment to pharmaceuticals, hospitals are responsible for keeping an inventory count of each item. Doing so helps ensure quality patient care and prevents a healthcare facility from having too much or too little in stock at any given time. The following are some of the challenges that the healthcare sector faces, resulting in a greater need for an inventory management system.

Supply Chain Issues and Unforeseen Circumstances

The hospital supply chain has been experiencing disruptions in recent years. This puts hospitals and other medical facilities at risk of having inadequate medical supplies, which can lead to reduced patient safety and poor outcomes. For example, possible drug shortages can make it difficult to promptly provide patients with the treatment they need. Using best practices for inventory management can help hospitals avoid the direct impact of healthcare supply chain issues, along with unforeseen circumstances.

Budgeting 

Each hospital and medical facility in the healthcare sector operates within a budget for medical instruments, medications, and other inventory. Without effective inventory management techniques, these facilities can end up ordering too much inventory, which then goes to waste. Having better inventory control lowers the risk of hospitals and other facilities going over budget and wasting medical supplies. This helps create room in the budget to purchase other supplies, such as expensive equipment needed for improving patient care. 

Patient Safety 

Having medications and other medical supplies that are past their expiration date can put patients at risk of receiving medication or treatment that has lost its efficacy. Keeping inventory that has been recalled, such as pharmaceuticals, can be dangerous to patients. Each hospital and medical facility should use best practices for inventory management to protect patients from these risks.

Staff Shortages and Improving Efficiency 

Staff shortages in a hospital can lead to patient safety issues, such as treatment delays or medication distribution errors. Hospital inventory management helps improve staff efficiency, even when a staff member or medical personnel shortage occurs. This helps keep patients safe from errors while also ensuring that patients receive timely, high-quality care. 

Unfortunately, staffing storages are expected to continue in the future, making it even more important for hospitals to address ways to improve efficiency and adopt new systems that reduce the negative effects.

Human Error in Manual Processes 

Relying on manual processes for inventory management can lead to human error. Medical personnel might enter the wrong inventory count for some items or fail to update inventory levels for other items. This can lead to inadequate medical supplies or other inventory problems. 

Compliance 

Healthcare providers at hospitals and other medical facilities must follow federal regulations and other regulations in the healthcare industry, such as the following:

• FDA UDI
• DSCSA
• Joint Commission Standards & National Patient Safety Goals 

Having an inventory management system in place can make it much easier for these facilities to always remain in compliance. 

Hospital Inventory Items and Considerations for Each 

Medical Equipment 

From specialty equipment to routine medical equipment, hospitals, and other healthcare facilities must keep close track of inventory. This helps prevent hospitals from having to replace costly pieces of equipment that have been lost. Hanging inventory also helps prevent overspending on equipment that facilities might already have in plentiful supply, while also ensuring that these facilities are not short on medical equipment that medical staff use on a regular basis. 

Pharmaceuticals/Medication

From recalls and expiration dates to drug shortages, using effective inventory management techniques helps hospitals and other facilities reduce the risk of medication distribution errors. These techniques also help these facilities improve patient care, remain in compliance with regulations, and avoid treatment delays due to drug shortages. 

Supplies 

Medical products, such as syringes and other key items used daily, require reliable inventory control to prevent excesses or shortages. Hospital supply chain problems add to the challenge of keeping enough supplies on hand, making inventory management even more essential. 

What to Look for When Implementing a Hospital Supply Management System 

Cloud Supply Chain Strategy 

A cloud-based healthcare supply chain strategy can help hospitals and other medical facilities prevent shortages of medication, medical supplies, and medical equipment. Using a cloud-based strategy helps keep inventory information secure and updated in real-time. 

PAR vs. Perpetual Inventory

Periodic automatic replenishment (PAR) and perpetual inventory are two different approaches to inventory management. PAR involves having updates made to inventory data at regular intervals, such as every week. Perpetual inventory involves using inventory management software to update data in real-time rather than on a periodic basis. PAR can be effective for managing inventory. However, it leaves room for error, making it less efficient for larger hospitals and healthcare facilities. Perpetual inventory often costs more to implement, but it can lead to better accuracy, especially for larger medical facilities. 

When choosing a hospital inventory management software to implement best practices, hospital administrators should look for the following qualities:

• Ease of use 
• Integration with hospital systems 
• Communication capabilities 
• Scalable and customizable
• Comprehensive reporting and data analytics 
  

Hospital Inventory Management Best Practices 

Organize Inventory 

A key practice for managing inventory is keeping it well-organized. A cluttered or disorganized supply space can make it more difficult to have inventory accurately updated. Items can be misplaced, a shortage of items might go unnoticed, or ordering too much of an item when inventory is organized inefficiently. For example, have medical staff put items that are nearing their expiration date at the front of shelves rather than in the back to ensure that they are used before items that have a later expiration date. Store items that are used often and in large quantities near the front of supply rooms. 

Assign Team Responsibilities Clearly 

Hospitals and other medical facilities have several staff members who are part of inventory management. A few may be responsible for going over purchase orders, while others might be expected to place supply orders. Other team members who might be involved with inventory include medical staff who clean and organize supply rooms and other areas. Hospital administrators should assign inventory management roles and ensure that each team member understands their responsibilities clearly. Conduct training sessions to make sure that these responsibilities are carried out efficiently. 

Asset Tags and Barcodes 

Using barcodes and asset tags provides a highly efficient way to manage inventory, including pharmaceuticals and medical equipment. Asset tags and barcodes allow for easy and convenient check-in and check-out processes for medical instruments and equipment. This helps lower the risk of having instruments and equipment go missing or end up misplaced. Using asset tags and barcodes can also help hospitals and healthcare facilities reduce costs. 

The use of barcodes and asset tags is an important part of compliance as well. Having a serial number and lot number on each pharmaceutical, for example, helps hospitals and other facilities meet DSCSA compliance standards for tracking. 

Collect Data and Optimize 

Gathering supply chain data and other data, then optimizing this data can help hospitals and other medical facilities accurately track inventory and prepare for potential shortages or other disruptions that can affect supplies. For example, hospitals might increase purchase orders for supplies that are expected to experience shortages in the near future. 

Collecting data and optimizing it should involve reducing the reliance on manual processes that can increase the risk of errors. These facilities should also analyze the usage vs. order frequency ratio to prevent ordering too many or not enough items. For example, items that are not used frequently should not be ordered on a regular basis compared to items that are used more often. Hospital administrators should also keep track of lifecycle management and equipment maintenance to plan ahead as equipment nears the end of its lifecycle. 

MPI’s Benefits to Hospital Inventory Management

Medical Packaging Inc., LLC (MPI) offers packaging solutions that can help hospitals and other medical facilities manage inventory more accurately and efficiently while remaining in compliance. These solutions can be customized to fit your facility’s needs and requirements. 

MPI’s unit dose medication packaging and labeling systems, and materials are the answer to safe and efficient drug inventory management. Our solutions provide hospital inventory managers with the ease of ordering everything from one place. These systems, materials, and benefits include:

• For use with MPI packaging systems, our Pak-Edge UD Barcode Labeling Software is the key to enhanced tracking and security. Our new Pak-Edge Version 2.0 takes networking capabilities to the next level with advanced barcoding capabilities and configurations.
• Oral solid and liquid packaging systems offer custom packaging for unit dose oral solids and liquids. These systems are easy to use and cost-effective for a variety of healthcare markets.
• Overwrapping systems, equipment, and materials are designed for a variety of medications, ampoules, vials, syringes, and more.
• Medical packaging materials are designed exclusively for our packaging systems, so you are relying on one source for all your medication packaging needs.
• Labeling solutions for customers in a wide range of care settings
• MPI provides the best, high-quality customer assurance and technical support.

Our systems and related materials are designed with efficiency and safety in mind, promoting all the best practices within your hospital inventory management system.

For more information on MPI solutions to help your hospital or healthcare facility implement best practices for inventory management, please contact us.

To improve drug supply security and reduce the risk of having an illegitimate product enter the supply chain, the Drug Supply Chain Security Act (DSCSA) became law in 2013. The DSCSA provides the Food and Drug Administration (FDA) with greater authority for regulating and tracking compounded drugs. 

The main goal of this law is to keep patients safe from harmful drugs, which include counterfeit medicine. This includes the requirements for product tracing at the package level, affecting stops along the drug lifecycle. 

Although enacted in 2013, full DSCSA implementation was set to occur in November 2023. In August of 2023, however, the FDA announced “a 1-year stabilization period to accommodate additional time” needed by pharmaceutical supply chain stakeholders. 

With a new deadline set to November 27th, 2024, manufacturers, wholesale distributors, dispensers, and repackagers are preparing for process and tracking changes.

What Is the Drug Supply Chain Security Act (DSCSA)?

DSCSA Background

The Drug Supply Chain Security Act, enacted in 2013, offers an approach toward improving patient safety and reducing illegitimate products, such as counterfeit prescription drugs, in the pharmaceutical supply chain. 

Why was this law introduced?

DSCSA is part of the Drug Quality and Security Act (DQSA). DQSA includes two components, Title I and Title II. Title I was introduced in response to a meningitis outbreak at the New England Compounding Center in 2012, which resulted in 64 deaths. Title I is also known as the Compounding Quality Act.

Title II was created to make product tracing easier within the drug supply chain. This includes setting DSCSA regulations on transactional documentation, which is made up of a transaction statement, transaction information, and transaction history. Several other requirements of Title II provide additional guidance. 

As part of Phase I of DSCSA implementation, all supply chain entities are required to work with authorized trading partners only. Each authorized trading partner is required to give a transaction history to the drug manufacturer and be able to respond to federal agency, state agency, and other system requests to meet verification requirements for illegitimate products.

COVID-19 Exemptions

When the COVID-19 pandemic began in 2020, the FDA made certain exemptions to DSCSA. These include exempting the distribution of drugs for emergency medical reasons from being considered a “transaction” as defined in DSCSA. These drugs were also excluded from being defined as “wholesale distribution.” The drugs included in this exemption and exclusion are drugs administered under emergency use authorization and products that have been approved for COVID-19, including for diagnosis, prevention, and treatment. 

Main Goals of DSCSA Compliance

The main goals of DSCSA include improving patient safety, securing the drug supply chain, and minimizing the presence of illegitimate or counterfeit drugs in the supply chain. To better understand these goals, it is important to know more about the key parts of traceability requirements. These include the following:

• Transaction information: product name, dosage form and strength, container size, transaction date, lot number, number of containers, National Drug Code, and names and addresses of businesses involved in a transfer of ownership
• Transaction history: electronic statement or paper statement for tracing the transaction information for all previous transactions, including drug manufacturers 
• Transaction statement: electronic statement or paper statement from business that transfers ownership of a drug that includes confirmation that it complies with the Drug Quality and Security Act (DQSA). 

Trading partners are required to provide this documentation under DSCSA regulations. Producing this information provides a more efficient way to track and trace prescription drugs and other products in the pharmaceutical industry. Being able to do this helps lower the risk of having patients take potentially harmful drugs that have entered the drug supply chain. 

Is Your Organization Ready for the DSCSA?

DSCSA Requirements

Under DSCSA, each pharmaceutical manufacturer, re-packager, wholesale distributor, dispenser or pharmacy, and third-party logistics provider is required to provide transaction information every time a change of ownership occurs. When any of these trading partners has knowledge of a counterfeit or illegitimate product or if there is a recall on pharmaceutical drugs, they must follow certain requirements on how to handle it. 

Other requirements of Title II include having the re-packager or drug manufacturer place proper Product Information on every drug package or case, including the Product NDC number, product lot number, product expiration date, and product serialized numerical identifier or serial number. Re-packagers and pharmaceutical companies are only allowed to sell products to authorized trading partners. Trading partners are also required to verify returns before redistributing drugs, and wholesalers and third-party logistics providers must follow national license standards.

Trading partners and other entities involved in the pharma supply chain have been given additional time since the enactment of DSCSA to become compliant. Confusion over DSCSA implementation has resulted in delays with this compliance. As part of Phase II, DSCSA requires an interoperable system of product tracing at the package level. This electronic system requires the following:

• Interoperable exchange: All authorized trading partners must share transaction statements and information electronically in a secure manner. This information must include the product identifier on individual packages. 
• Interoperable verification: Under these verification requirements, trading partners must verify the product identifier at the unit level.
• Interoperable tracing: These serialization requirements call for traceability at the unit level that allows individual products to be tracked and traced at any point in the supply chain. This includes the standardized numerical identifier, lot number, and expiration date. 

DSCSA For Manufacturers

Starting at the top of the drug lifecycle, identification and tracking are essential from the beginning. Requirements for pharmaceutical manufacturers have been pushed back, although manufacturers are expected to meet the 2024 deadline, along with other industry partners.

To move their product into the market, manufacturers must develop the traceability requirements from the start. Along with the tracking requirements, manufacturers must also work with pharmacies, wholesalers, re-packagers, or third-party organizations in cases involving illegitimate or suspect products to ensure patient safety. 

This is the first, but not last stop along the supply chain where Medical Packaging Inc., LLC (MPI)’s Pak-EDGE® UD Barcode Labeling Software solution is key. Additionally, specialty pharmaceutical manufactures will find opportunities in our FD-Pharma® to expand their market base with new capabilities.

DSCSA For Re-packagers

Like manufacturers, re-packaging companies are a key stop in the process and must retain the same DSCSA compliance to maintain relationships with their stakeholders. These organizations must also have a system for identifying and quarantining suspect or illegitimate products, notifying the FDA and other trading partners, and investigating these products. Re-packagers must affix a product identifier on every package or homogenous case.

Many of MPI’s re-packaging customers are utilizing the FD-Pharma® solution along with MPI-certified materials that meet several compliance factors including cups and lidding, which we will discuss in more detail below.

DSCSA for Wholesale Distributors

Wholesale distributors must meet the same 2024 deadline for tracing. They are expected to verify each product at the package level, which includes the standardized numerical identifier. These distributors must also avoid participating in transactions that involve certain prescription drugs unless these products have product identifiers.

DSCSA For Dispensers/Pharmacies

As the last stop before consumers, pharmacies or “dispensers” play a key role in supply chain security, especially under DSCSA regulations. These businesses are expected to confirm that any entities they conduct transactions with are registered or licensed. Pharmacies must also help trace drug movement through the pharmaceutical supply chain. This involves receiving transactional documentation, storing it, and providing it as needed. Pharmacies are also expected to investigate cases of illegitimate drugs. This involves determining if the drugs in question are illegitimate and making sure patients do not receive these drugs. Pharmacies must notify trading partners and the FDA about illegitimate drugs. 

As with the other partners, our Pak-EDGE® software is the solution to complying with DSCSA changes along with our FD-Pharma® for specialty pharmacies.

Compliance Made Easy with MPI

Pak-EDGE® Software

MPI’s Pak-EDGE® software, used with most MPI packaging systems, has a built-in serialization feature that allows customers to print individual packages with a unique serial number and barcode, in compliance with DSCSA. The advanced barcode builder adds fields and delimiters to create complex linear or 2D barcodes. These barcodes may include expiration date and lot numbers or any combination of fields that help an organization comply to tracking regulations. Pak-EDGE® also provides lot traceability for drugs and materials. 

FD-Pharma®

The FD-Pharma® is a cost-effective packaging solution to specialty pharmaceutical manufacturers and CDMO’s seeking to expand their market base with new and expanded packaging capabilities. 

The FD-Pharma® supports clinical trials to early liquid product development and small batch liquid validation runs as well as lower volume full production needs not suited for high-speed packaging lines. 

Materials used with the FD-Pharma® system produce FDA complaint packages and meet several other compliance factors:

Cups

• Meets the requirements of the Food and Drug Administration regulation 21 CFR 177.1520
• Meets USP UV light resistance (Stock colors: Red and Amber)

Lidding

• All lidding is produced in accordance with Good Manufacturing Practices and complies with Applicable FDA regulations for most food, beverage, and pharmaceutical product

MPI’s DMF Helps Assist in Compliance

Relying on vendors and sub-vendors to obtain regulatory and technical documents will lead to waiting weeks and months for these critical documents and in some cases, delaying the FDA Filing by our customer. With our own Drug Master File (DMF), we have better control during the process and can help customers with a “Speed to Market” approach. The DMF will also help to expedite the application process during a New Drug Application (NDA) or Abbreviated New Drug Filing (ANDA). Click here to read more about MPI’s DMF acceptance.

How to Prepare for the DSCSA 2024 Deadline with MPI

At MPI, we provide a simple solution that can help you prepare for the DSCSA compliance deadline. Our Pak-EDGE® barcode labeling software provides accurate and efficient product labeling to help you meet DSCSA requirements at the package level. The latest version of this software includes more design features, as well as an enhanced label template that can be used to clearly label products with all the required information for tracking and tracing. 

If you need more information on how we can help your organization prepare for the upcoming DSCSA compliance deadline, please contact MPI. We can provide you with additional details on our products, including the latest version of our barcode labeling software. 

The rise of integrated delivery networks (IDNs) is contributing to higher-quality patient care, better patient outcomes, and other positive trends in the United States healthcare industry.

These trends reflect how IDNs make it easier for healthcare facilities to provide patients with comprehensive treatment at a lower cost. IDNs provide a variety of services within their network, including treatment of chronic conditions, acute care for injuries and illnesses, and attention to other health issues.

IDNs have been an important contribution to growth and development in the industry, offering important benefits while also facing certain challenges and difficulties. But what exactly is an integrated delivery network? And how can we increase safety and efficiency to truly maximize the benefits?

What Are IDNs?

IDNs are healthcare networks that are made up of a group of healthcare providers. These systems own and operate a network of healthcare facilities, which can include several types of outpatient and inpatient facilities, such as hospitals, health clinics, physician groups and practices, ambulatory surgery centers, imaging centers, and more.

IDNs provide healthcare services in a specific geographic area. For example, Intermountain Healthcare offers services in the Intermountain West region of the U.S., including Utah, Nevada, and Idaho. Partners Healthcare, now known as Mass General Brigham, offers healthcare services in the greater Boston area. And Baylor Scott and White offers health services in Texas. Other, large IDNs can offer healthcare services in a variety of regions. On a larger scale, Kaiser Permanente is able to operate in eight different states while Ascension Health can be found in 19 states. 

Types of Integrated Delivery Networks

Various levels or types of IDNs exist. These organizations are categorized based on factors such as how many healthcare facilities are included, how they make strategic decisions on healthcare costs, care coordination, and other aspects of healthcare delivery. IDNs fall under one of the following categories or levels. 

1. Horizontal Integration

Horizontal integration IDNs, or System II IDNs, typically include multiple hospitals, although some include other kinds of healthcare facilities as well. National or regional hospitals can be part of these healthcare systems. System II networks can also include state, government, and even investor owned IDNs.

2. Vertical Integration

Vertical integration, or System III IDNs, includes a wide range of different healthcare facilities and medical centers. This type of health system focuses on providing a care continuum for a patient population that includes all ages. System III networks offer care that allows patients to stay within the system throughout their lives, from pediatric care to geriatric care. In addition to primary care and specialized care, healthcare services that are often part of these networks include prenatal care, hospice, and assisted living. Community health IDNs typically fall into this, as well as academic health systems and faith-based health systems.

3. Strategic Integration

Strategic integration IDNs, or System IV IDNs, also use vertical integration to share healthcare resources equally among all facilities rather than focusing on one kind of facility. However, System IV networks use a complex approach to managing healthcare delivery and making decisions that involve different aspects of these systems, such as purchasing decisions. 

IDN Benefits

IDNs provide important advantages in terms of patient outcomes and healthcare delivery. These networks can offer the following benefits, whether they are classified as System II, System III, or System IV.

High-Quality Care

IDNs have a distinct advantage over the accountable care organization model when it comes to providing high-quality care. With a wide network that connects valuable resources and specialties, IDNs are in a unique position to offer improved clinical outcomes. They can contribute to improvements in overall population health and quality care in their existing communities.

Communication

Improved communication is another main benefit of IDNs. These networks have shared electronic health records and centralized provider control, which facilitates communication between healthcare providers or physicians and patients, as well as other healthcare industry professionals. Greater communication enhances proper patient care, whether they come in for an annual physical or for a chronic condition, disease, acute illness, or injury.

Access to Medicine and Specialties

Being part of an IDN often means that a healthcare provider does not have to refer patients to out-of-network providers for specialized services. For example, cancer patients can receive all the care they need within an IDN through their health plan, including chemotherapy or other treatments, nutrition services, and care for other health conditions. Access to medicine and specialties can help improve the healthcare ecosystem. 

Market Influence

IDNs have a significant impact on market influence, which can help provide better control over healthcare costs. This can lead to more affordable care for patients to help ensure that they receive the services they need. The strong market influence of IDNs can also result in more efficient healthcare delivery, leading to lower operating costs for hospitals and other healthcare facilities. 

Challenges Facing IDNs

While IDNs offer notable benefits, they also face certain difficulties. Healthcare reform and financial challenges are causing more hospitals and other healthcare facilities to consolidate to form these networks. This growth has led to a variety of challenges within everyday operations.

Let’s look at the problems that IDNs are facing specific to medication distribution, and how these difficulties are affecting the ability to supply adequate healthcare products across their facilities.

Supply-Chain Issues

Supply chain issues have had an impact on many industries, including healthcare. Shortages of healthcare products have a direct effect on the quality of care patients receive, as well as patient outcomes. IDNs can take steps to minimize the risks of supply chain shortages by turning to trusted sources and establishing healthcare product safety nets to alleviate disruptions in the supply chain.

Incompatible Network Communications

The flow of information and data is a critical part of integrated delivery networks. Managing such large-scale and complex information systems comes with an abundance of challenges and potential for problems. When it comes to investing in these systems, there are various considerations to keep in mind to maintain efficiency. A few of those considerations are usability, network capabilities, and data management.

Increase of Burnout and Exhaustion within Hospitals

With fluctuations and recent upticks in hospital occupancy rates, healthcare workers and executives can, directly and indirectly, feel the effects of burnout. From a staffing standpoint, there are plenty of challenges faced within an integrated delivery network, which can trickle down to multiple operations and affect the level of care provided. Medical Packaging Inc., LLC (MPI) sees this problem within the industry and provides a solution to help alleviate some of the challenges that a lack of staffing can reflect on packaging and distribution. Our solutions save time and resources with the ability to efficiently operate and package, even with a reduced staff.

How MPI Improves Efficiency in Integrated Delivery Networks

As a leader in the industry, Medical Packaging Inc., LLC aims to increase safety and efficiency within IDNs while assisting with some of their challenges. When an organization is looking to maximize the process of medical packaging and distribution, MPI products provide an efficient solution with the following benefits:

1. Network Capabilities

With uniform software across facilities, Medpak’s networking capabilities provide an advanced level of consistency, communication, and collaboration across key stakeholders. Our software will meet all industry regulations while connecting your organizations under one centralized system. Staying connected and improving communications can help promote consistency across medication distribution.

2. Avoiding Supply Chain Disruptions

As pharma companies struggle to increase production and overcome supply chain issues, MedPak’s solutions make it possible for IDNs to avoid these disruptions. Taking the packaging process in-house helps ensure that IDNs have access to all the medication needed for patients within the system. Our solutions provide any relevant packaging materials, to reduce the reliance on yet another vendor.

3. Promoting Patient Safety

MedPak helps improve patient safety with the ability to package the proper dosage. These products and services help reduce the risk of patients receiving the wrong medication dosage. The use of barcode scanning and FDB technology helps ensure efficient distribution among healthcare facilities in an IDN.

4. Improving Clinical Efficacy

MedPak uses equipment that helps increase clinical efficacy through different methods and applications. A few of these include:

• Auto-Print for oral medication unit dose packaging, which has lower operating costs, since no print ribbon is needed
• Fluidose oral liquid unit dose packaging solution, which involves the use of high-quality materials to reduce the risk of waste and leaks
• Pak-EDGE UD Barcode Labeling Software Version 2 offers a barcode labeling solution that helps reduce costs

MedPak’s barcode labeling solution includes a serialization feature that makes it possible for customers to print unique serial numbers and barcodes for medications in compliance with the Drug Supply Chain Security Act. Check out more pharmaceutical and medication packaging equipment and materials from MedPak.

Learning more about MedPak’s unit dose medication packaging solutions can help IDNs better understand how these products and services can advance their operations and help them avoid being impacted by a variety of challenges that come with medication distribution. With these solutions, IDNs can focus on continuing to make improvements to patient safety and provide efficient healthcare delivery. 

To learn more about MedPak’s unit dose supply method or specific packaging products and services for IDNs, visit our website. Or contact MedPak today to find the packaging solution that best fits your needs.

In recent years, the pharmaceutical industry has been making use of the latest technology to help improve healthcare and meet regulatory compliance requirements. New technology trends, such as artificial intelligence and 3D printing, have provided innovative ways for the pharmaceutical industry to become more efficient and advance the ways in which medication is developed, packaged, and delivered to patients and consumers. The following are some of the top pharma tech trends that are making a notable impact on healthcare in the United States. 

Digital Technology in the Pharma Industry

1. Artificial Intelligence

Artificial intelligence (AI) trends have led to major improvements in the pharmaceutical manufacturing process and patient identification. AI supports both automation and optimization in drug manufacturing processes. This helps improve efficiency, leading to reduced waste and lower risks of errors during drug manufacturing. AI and machine learning allows manufacturers to automate complicated tasks rather than manual labor, making drug manufacturing more efficient and accurate.

The use of AI has also resulted in improvements in patient identification. Being able to identify patients accurately reduces the risk of errors during drug development. A lower risk of medication errors is important since these errors can lead to serious and even fatal effects. Healthcare professionals in the pharmaceutical industry are turning to the use of AI more because of the added enhancements in patient identification and drug manufacturing processes.

2. Ability to Analyze and Store Large Amounts of Data

Pharma companies require large amounts of data to be analyzed and stored as part of the drug development process. From the discovery and development stage to the pre-clinical and clinical research stages, researchers need an efficient way to have all the data evaluated. Digital transformation is making it possible for substantial amounts of data to be analyzed as part of the drug development process.

The ability to analyze big data efficiently promotes a continuous developmental process in the pharmaceutical industry. This is important due to the rise in precision medicine, which helps provide patients with more effective treatment based on several factors, such as genetics and environment. A continuous developmental process provides pharmaceutical companies with a competitive advantage while also benefiting patients by supplying better care and treatment.

More pharmaceutical companies are depending on the use of advanced technologies that allows larger data amounts to be evaluated and used for continuous improvements. To securely store this large amount of data and sensitive information, organizations are relying heavily on cloud technology. Cloud computing allows for pharmaceutical research teams to collaborate and innovate quickly, utilizing an on-demand IT environment that makes data, like labs and medical imaging, easily accessible. Not only is cloud-based infrastructure highly secure, the scalability and efficiency help pharmaceutical companies get to market faster.

3. Blockchain Technology

With the increase in online transactions and orders for medications, consumers are at risk of ending up with counterfeit medicine or substandard drugs. In some cases, this can lead to serious health consequences. Consumers are also at risk of taking medications that do not provide the effects needed to treat or manage a health condition. The pharmaceutical industry’s technological transformation has led to better ways of protecting consumers from the risk of fake and substandard medications, along with ensuring that patients receive the right medication.

Blockchain technology is providing protection from counterfeit and substandard drugs on the market. This technology uses encryption and a decentralized database to help prevent fraud from occurring. The pharmaceutical industry has been adopting the use of blockchain technology to avoid having data stored in a centralized database, where it can become compromised. The increasing reliance on this technology is expected to lead to a significant reduction in substandard and fake medications purchased online. 

4. Real-World Data

Real-world data from electronic health records, claims data, wearable technology, medical devices, and other sources provides valuable information on the experience of patients as they interact with healthcare providers and systems. This information is leading to improvements in the development of medications. Real-world data supports innovation in the drug development process, while also playing a role in assessing the effectiveness of medications. These sources of data are considered reliable and are used to help make improvements to existing medications or to produce new medications as needed. Researchers have been using this data in designing and conducting clinical trials.

Real-world data is also having an impact on regulatory decision regarding medications. The Food and Drug Administration (FDA) is increasingly relying on the use of real-world data, as well as real-world evidence, to evaluate the safety of medications on the market and monitor adverse events associated with these drug discoveries.

5. Cybersecurity

Cybersecurity in the healthcare and pharmaceutical industry is becoming increasingly important as more complex security risks emerge. Because healthcare organizations possess so much important patient data, they are at an elevated risk for attack. Pharma executives and hospital directors need to be able to protect sensitive data from these attacks, which are on the rise. Improvements in cybersecurity are providing healthcare directors with the ability to keep sensitive data protected. Several security risks are increasing in the pharmaceutical industry, such as the use of third-party vendors, ransomware, phishing attacks, and the Internet of Things (IoT). Pharmacies and hospitals must have the ability to meet these challenges and take steps to prevent cyber-attacks from compromising patient and drug data. 

The development of cybersecurity procedures, controls, and risk management solutions gives hospital and pharmacy directors effective ways to keep sensitive information safe from cyber-attacks. The increased focus on raising security awareness among employees through training is also helping healthcare facilities protect this information. As cyber-attacks increase, pharmacy and hospital directors are taking a more holistic approach to preventing them from occurring, including making use of available security solutions and raising awareness. 

Production Processes

1. Manufacturing to Meet Market Dynamics

The market dynamics of the pharmaceutical industry have been changing in recent years. Tech trends have been providing ways for pharmaceutical companies to keep up with these shifting dynamics. Changes in manufacturing have included the production of smaller batches in response to the trend in personalized medicine. The use of precision medicine or personalized medicine does not require large batches of medication to be produced. Technological trends in manufacturing are making it possible for companies to produce small batches as needed.

Changing market dynamics that reflect the increasing use of targeted therapies require the development of specialized manufacturing facilities. The smaller facilities are needed to manage low volume production rather than high volume production. These manufacturing facilities rely on technological developments to produce high-value, personalized medication instead of mass-producing low-cost medications aimed at a much wider group of consumers. 

2. Continuous Manufacturing Process

Pharmaceutical companies look for ways to improve operational efficiency and productivity during the manufacturing process. Technological trends are promoting a continuous manufacturing process from pharmaceutical research labs to the market. Digital tools are providing pharmaceutical companies with the ability to get drugs to the market faster, reduce their environmental footprints, and provide product quality that is more consistent. The use of these digital tools has been occurring in small molecule drug facilities and bioprocessing. With these tools, companies have been able to reduce operating costs and improve process control during manufacturing. 

Continuous manufacturing processes in the pharmaceutical industry offers notable advantages over batch manufacturing. Instead of having to produce drugs in multiple steps with production pauses in between each step, medications can be manufactured in a nonstop process. With the advantages that continuous manufacturing provides, such as better quality and a lower risk of human error, the use of these digital tools is on the rise. 

3. Advanced 3D Printing of Human Tissue

The use of 3D printing has also been increasing in the healthcare industry. Healthcare research has focused on the use of this technology to print human tissue for patients who need organ transplants. Advances in 3D printing have also been beneficial for the pharmaceutical industry. The ability to use this technology to print human tissue is expected to provide a safer way to conduct clinical trials involving medications. Current methods rely on the use of human volunteers, which includes a risk of having these individuals experience an adverse reaction.

With the use of 3D printing, drug testing facilities might be able to conduct trials involving human tissue rather than using human volunteers. This could lead to significant improvements in the safety of clinical drug trials. More research is needed to reach the point where 3D printing can be relied on for these drug trials, but advancements in this technology show promise.

4. Growth in CDMO Market

The growth in the contract development and manufacturing organization (CDMO) market is expected to continue, making it essential for pharmaceutical companies to meet the challenges that come with it. This market is made up of companies that develop and manufacture drugs rather than manufacturing pre-formulated drugs as contract manufacturing organizations (CMOs) do. The main challenge for CDMOs tends to involve speed, since these companies need to go through a more complex process before heading to the market. Tech trends in the pharmaceutical industry for CDMOs focus on outsourcing product development, clinical testing, and regulatory support. This is done to help medications reach the market more quickly, which helps to make drugs more readily available for consumers. 

MPI Offers State-of-the-Art Solutions for Medication Packaging

Medical Packaging Inc., LLC (MPI) offers solutions for pharmacy and hospital directors to help ensure high-quality unit dose packaging using state-of-the-art technology. Our medication packaging solutions are carefully tailored to each customer’s unique needs, helping keep patients safe by reducing the risk of errors. We serve specialty pharmaceutical manufacturers and contract drug manufacturing organizations with liquid cup unit dose packaging systems that deliver high-quality, FDA-compliant packages at a low price point.  With our Drug Master File, MPI can provide speed-to-market regulatory and technical support to medical and pharmaceutical market clients. Contact us to learn more about how our products and services can help streamline your pharmaceutical packaging processes.

Pediatric medication errors, such as incorrect dosages, can occur in a wide range of healthcare settings, including hospitals, outpatient clinics, emergency departments and at home. Due to certain risk factors in children, such as their size, medication errors can lead to serious and potentially life-threatening adverse reactions. According to The Joint Commission, potential adverse drug events occurred as much as three times more often in pediatric patients than adult patients. 

Administering and dispensing medication to pediatric patients has unique challenges, which raises the risk of medication errors. In many cases, formulating and packaging medications is done for the adult population rather than children. Making these medications safe for children involves carefully determining and adjusting dosages. Other challenges include the fact that children’s immune systems, renal functions, and hepatic functions are still developing, which can make it more difficult for them to tolerate medication errors. They may also have a harder time communicating about any side effects or reactions they are experiencing when taking medication.

Improving administration and dispensing of pediatric medication in medical facilities and in the home can help reduce the risk of pediatric medication errors. Pediatric medication safety training programs for healthcare workers and the use of technology offer important ways to lower the risk of medication inaccuracy. The following information can help pharmacies, hospitals, and other healthcare facilities promote pediatric medication safety. 

Medication Administration and Dispensing

Administering and dispensing medication to pediatric patients entails a higher risk for error when certain factors are not considered. Healthcare workers and pharmacists can lower the risk in the following ways. 

Pediatric Safety or Approval Confirmation

Confirming which drugs are safe or approved for use in children is the first step in promoting medication safety. Pharmacists and other healthcare workers who oversee drug administration and dispensing should ensure that all medications given to pediatric patients are considered safe or have been approved by the FDA for its intended use. Confirming this information can help reduce the risk of having children take medications that are unsafe or not approved.

Dosing Factors

When determining the proper medication dosage for pediatric patients, pharmacists and other healthcare providers should consider the following factors:

• Patient’s weight
• Patient’s age
• Body surface area
• Clinically approved weight-based dosage ranges

When calculating pediatric medication dosages, especially for liquid medicines, weight is often used rather than age. Using weight-based ranges can offer a more accurate way to determine the correct dosage for children instead of basing dosages on age due to variations in body size at different ages. Utilizing body surface area to determine dosage involves considering a patient’s height and weight, which can provide a more accurate drug dosage.

Appropriate Dosage Form

Improving pediatric medication safety involves determining the appropriate dosage form for different prescription medications. Pharmacists and other healthcare workers should determine whether a tablet or liquid form is more appropriate for pediatric patients. Several factors, including age, should be considered. Liquid forms are typically used for infants and younger children, while tablet forms may be appropriate for older children. Regardless of whether tablet or liquid forms, the dosage should be accurate.

Medication Labels

Medication errors can occur due to unclear or incorrect information on labels. When determining the content for pediatric medication labels, pharmacists and other healthcare workers should ensure that the following information is clearly stated:

• Name of medication
• When to take medication
• How much medication to take
• Proper storage instructions
• Possible side effects or reactions of medication
• Warnings about allergic reactions to medication ingredients
• What to do if a patient misses a dosage

Ensuring that all relevant information is included on the label helps decrease the risk of patient harm, due to medication errors or adverse drug reactions.

Medication Error Factors

Hospital and healthcare workers should also be familiar with the factors that may contribute to pediatric medication errors. Recognizing these factors and avoiding them can significantly reduce the risk of patient harm. Examples of these factors include the following:

• Do not abbreviate or shorten the names of medications on labels
• Do not place a zero after a whole number, such as 1.0 or 2.0, since this can cause confusion about dosage amounts
• Place a zero to the left of a decimal point if required, such as 0.1 or 0.2 mg, to avoid confusion over dosage amounts

Side Effects and Adverse Reactions

When determining the content for pediatric medication packaging and labeling, potential side effects and adverse reactions must be clearly communicated. This content should include a list of side effects, both common and rare, that may occur when a medication is consumed. Possible adverse reactions also need to be listed, along with the signs and symptoms associated with the reactions. Pediatric medication labels and packaging should also provide clear instructions on what to do if patients show any signs or symptoms of adverse effects, such as contacting a physician or seeking emergency medical services. This helps to ensure that family members who are administering medication to children know how to handle an adverse event if one occurs. 

Create a Pediatric Medication Safety Training Program

Having a pediatric medication safety training program in place helps to ensure that healthcare staff are prepared to administer or dispense medication orders as safely as possible. Healthcare directors can implement these programs as part of a commitment to improving pediatric medication safety. When creating these programs, healthcare directors consider the following guidelines.

Make the Program Mandatory for New Staff

New staff members should go through the pediatric medication safety training program. Including this training as part of the process for onboarding new staff can help reduce the risk of medical errors among the pediatric population. Once staff have completed this training program, they should be knowledgeable about safely administering and dispensing medication to pediatric patients.

Include Early Exposure to Pediatric Patients in Pharmacist Training Programs

Pharmacist training programs should provide opportunities for trainees to have early exposure to pediatric patients. This allows trainees to gain experience treating young patients and learn more about safety protocols when administering and dispensing pediatric medication.

Develop Pediatric Drug Lists for Specific Facilities

Pharmacists and other healthcare staff should create a list of pediatric drugs that are specific to their facility. For example, an emergency department might have a different list of medications as opposed to an oncology unit in a pediatric hospital. Staff should  evaluate the list developed and focus on determining which medications are considered high-risk for that specific facility. This information can help lower the risk of pediatric medication errors and improve pediatric patient safety.

 Use External Resources

External resources from The Joint Commission, the National Coordinating Council for Medication Error Reporting and Prevention, and other organizations provide valuable information on pediatric medication safety. Utilizing these resources can help to ensure that pharmacists and other healthcare workers are up to date on the latest pediatric advisory recommendations and changes to pediatric medication labeling. This information should be communicated to any staff members that manage pediatric medication at hospitals and other facilities to reduce the risk of errors. 

Technology

The use of technology can significantly improve pediatric patient safety when medications are administered or dispensed. In some cases, technology can reduce the risk of human errors that can lead to incorrect dosages or other pediatric medication errors.

Improve Overall Safety

Pharmacists and healthcare directors should choose software programs and other technology that helps to improve overall safety and reduces the risk of preventable harm in administering and dispensing medication. Smart pumps and similar technological devices for healthcare facilities can help to provide an appropriate dose of medication to pediatric inpatients. However, these devices should not be considered a guarantee that medication errors will not occur. Any technology utilized to improve medical care should be used correctly and checked regularly to make sure errors are not occurring.

Use Automation

Using automation, such as computerized physician order entry, clinical decision support tools, and pharmacy automation, can improve dosage accuracy and other factors that help prevent medication errors. These tools can dispense the correct dose of pediatric medication, sync patient records, automate medication reconciliation, and handle other medication safety tasks. Automation used in a hospital pharmacy should be checked regularly for accuracy to prevent errors.

Reduce Medication Errors

Technology that is used for lowering medication errors is typically designed for adult medication. As with the formulation and packaging of pediatric drugs, this technology needs to be adapted for pediatric medication. Technological advances such as barcoding typically requires careful adjustments for use with pediatric medications.

Medical Packaging Inc., LLC (MPI) is dedicated to helping healthcare professionals reduce the risk of pediatric medication errors. MPI offers high-quality unit dose medication and pharmaceutical packaging and labeling systems, MPI-certified consumable materials, and other products to help pharmacies, hospitals, and other medical facilities ensure pediatric medication safety. Contact MPI to learn more about medical packaging solutions.

Healthcare systems in the United States rely on quality of care and patient outcomes to help meet their long-term goals. Measuring work performance and productivity is far more complex than task tracking. The way healthcare workers interact with patients is just as important as their ability to perform the administrative responsibilities that keep the organization moving efficiently.

Healthcare organizations must maintain the effectiveness of their performance management programs as the sector increasingly incentivizes health outcomes above treatment volume. The industry decision-makers can enhance work performance by concentrating on their strong and weak aspects in each area. The first step is improving employee engagement and internal communication, which will allow for the implementation of positive changes and modern technologies that streamline performance. 

What Affects Work Performance in Healthcare?

Working in a healthcare environment has unique stressors that put employees at elevated risk for burnout. Intensely stressful and emotional situations, along with long hours, unpredictable schedules, physical demands, risk of exposure to infectious diseases, and more can lead to anxiety, insomnia, and a decrease in job satisfaction and overall mental health. These are all issues that can affect work performance and the ability for medical professionals to provide high-quality care, resulting in a risk to patient safety.

A systematic approach to evaluating work performance includes : 

·       Task performance

·       Contextual performance

·       Counterproductive work behavior

Work performance in healthcare encompasses job obligations such as job skills, clinical competence, work quality (task performance), and those that lie outside of job titles (contextual performance). 

How can you address these specific issues to allow for improved work performance? The key might be to break it down into single challenges and determine what might improve efficiency. An excellent example of this is implementing automated systems, like the unit dose supply method, to help provide relief to overworked staff members. 

How to Improve Employee Engagement

Keeping employees engaged is a challenge that every business faces. Building a connection between team members, especially with healthcare workers, can be a powerful tool in improving job satisfaction, which leads to increased productivity. This enhances quality of care and patient outcomes within a healthcare system.

But, how do you increase employee engagement? There are a few steps you can take.

1. Improve internal communication

Effective communication is key for the success of any business. Numerous studies have noted the link between internal communication and having productive employees. Keeping your team members aware of critical information, news, and other happenings within company can increase productivity and morale.

2. Provide better opportunities for mentorship

A mentorship program is a fantastic way for senior employees to show their newer colleagues the ropes. Simply discussing different ways to go about completing daily tasks can help staff members gain the confidence to conduct their work.

3. Invest in your leadership team

The most obvious, but sometimes overlooked, solution for improving employee engagement is having healthcare leaders that empower and inspire their direct reports. Having a leader with poor people skills or is out of touch can create a negative, toxic workplace environment. A leader with effective communication skills who puts in the effort to include and empower their colleagues will see overall healthcare quality improvement.

4. Provide mental health resources

Stress is an issue medical professionals deal with on a regular basis. Investing in mental health programs shows employees that their well-being is also a top priority of their leadership team. Providing free counseling or assistance programs can help healthcare workers deal with the emotional and physical toll that comes with the long hours in high-pressure situations.

Improving employee engagement is an easy, efficient method for boosting work performance and productivity. An empowered, satisfied healthcare organization leads to better outcomes and greater patient care. 

How Automation and Medical Packaging Solutions Can Help Healthcare Facilities Provide High-Quality Care

Automation, electronic health records, and improvements in medical equipment and machinery can all help to relieve some of the stress from healthcare workers and provide a better patient experience. Utilization of the solutions allows more time for nurses, primary care physicians, pharmacists and additional staff to focus on the patient, instead of organizational tasks.

Medical Packaging Inc., LLC is a leading global manufacturer of pharmaceutical packaging and labeling systems that meet the needs of pharmacies, long-term care facilities, hospitals, and more. Our systems help increase efficiency throughout healthcare organizations and improve patient safety.

The Unit Dose Supply Method for Healthcare Improvement

A unit dose, also known as a single dose, is a drug that is packaged individually. Each package contains one dose of medication created by an automated packaging and dispensing system. This packing type makes it easier and safer to administer a required dose of medication to a patient. 

Over the past few decades, research on unit dosage medication delivery methods has shown that these systems are more efficient and a more effective way of employing professional resources when compared to alternative drug delivery techniques.

In fact, a 2013 study conducted at the Barzilai Medical Center found that implementing an individual unit dose system provided:

·       Shorter turnaround times between prescribing the drug and administering it

·       Increased pharmacist’s clinical interventions without adding staff

·       Decrease in costs and patient hospitalization times

Any medication not consumed by patients may be returned to a central storage system if the unit dose package was not opened and no sensitive patient data is included on the package. The major benefit is it decreases the risk of medication errors. 

How Administrators Can Use Single Doses to Improve Efficiency

 One of the many benefits of initiating a unit dose packaging system in a healthcare facility is saves time devoted to medication management. Implementing this system starts with identifying the medications that best fit into this process. 

1. Choosing the Right Medications to Package in the System

The unit dose method is best suited for medications in bulk packaging. However, most other types of medication packaging, such as suppositories, ampoules, transdermal patches, and pre-filled syringes, can be packaged into unit doses. After creating a unit medicine dosage, it may be ordered and delivered for safe medication administration.

The medication is not removed from the package until it reaches the patient, which is a significant advantage of unit doses. In addition, it means no cross-contamination with other drugs or human contact.

Unit dosages can also create a patient-specific therapy that combines multiple medications. Medication is transported to nursing stations in patient-specific treatment carriers. This method dramatically decreases the time nursing staff spends physically storing, organizing, and dispensing medicine. Furthermore, clear labeling of a drug name, dose, batch and expiration date increases safety, especially when dealing with high-risk medication.  The use of barcode technology and scanning procedures can also help with drug identification.

2. Determining the Type of Packaging Desired for Each Medication

After determining which medications are best suited for this dosage supply method and the ideal delivery method for each, the healthcare institution must decide on the appropriate equipment.

When defining equipment needs, for example packaging equipment for the different dosage forms of drugs, such as tablets, capsules, injectables, and liquids, factors to consider include:

·       Floor carts for direct distribution

·       Modular filling stations

·       Patient profile holders

Another critical decision is determining what items should be purchased in unit dose packages and what should be packaged in the pharmacy, and how that is accomplished. This will entail identifying the specific package requirements, what supplies the pharmacy needs and the amount required for each format.

The administration must assess the cost of the equipment and consumable supplies to determine the return on investment when budgeting for the unit dosage supply method. For example, how much would the hospital save by implementing this system?

Consider how the implementation of unit dose packaging would affect staff and patient care workflow. What effect will it have on various wards? For example, the impact will be different in pediatric wards than in areas of a hospital that deal with adult patients, such as acute care centers.

3. Creating Effective Training Strategies

When planning implementation, the administration must also consider training and how to conduct it in a way that does not interfere with patient care.

A few effective training methods include:

·       Rotating pharmacy staff to work on single dose dispensing once a week until everyone has completed the training procedure.

·       Educating the nurses using video presentations or live demonstrations of a new system

·       Distributing information on medication administration adjustments to general staff, such as a newsletter.

Training small groups at a time is the most effective way to avoid interruptions in patient care while still ensuring all employees understand the unit dose supply method.

4. Establishing An Internal Plan for All Unit Dose Packaged Medications

Beyond equipment, supplies, and training, the unit dosage supply system requires careful planning before implementation.  In addition, protocols for dose preparation need to follow safe medication practices and standards closely.

The healthcare institution will also need to have a storage system in place, whether in a bulk storage area or on a cart in the nursing unit.  There must also be plans for internal flow from patient admission to patient medication profile to packaging to filling drug delivery carts.

Common factors include:

·       Establishing the ward stock procedures 

·       Designing stock batch controls

·       Inventory management and monitoring

·       Determine how to manage unutilized medications

It may be necessary to modify existing procedures and integrate current technology to accommodate the new process of ordering and administering medication, along with how to achieve accurate dosing calculations and avoid medication errors.

Finding the Right Equipment and Supply Partners

The unit dose supply method improves the work performance of healthcare professionals. The key is collaborating with the right partners for equipment, supplies and support. Medical Packaging Inc., LLC (MPI) can assist you in achieving your medication management goals with unit dose packaging. 

MPI was established in 1971 and is now one of the world’s leading unit dose packaging and pharmaceutical equipment manufacturers. We take pride in producing high-quality pharmaceutical packaging equipment, MPI-certified consumables, and our own Pak-EDGE^TM UD Barcode Labeling Software. MPI strives to be the premier provider of pharmaceutical packaging solutions that save patients’ lives while increasing productivity and profitability for all clients.

Customer service and technical help is available to all clients in a timely, professional, and courteous manner. We build, maintain, and encourage long-term relationships with our customers, strategic partners, and distributors alike based on professionalism and passion. We assist customers when they are starting or expanding their unit dose packaging program with training, implementation, and technical support if needed. In addition, we are continually improving our pharmacy packaging technologies to ensure that we comply with industry regulations and regulatory requirements for unit dose pharmaceutical packaging. We also promote continual learning and development among all employees to ensure that we remain a market leader in our ever-changing industry.

MPI and the healthcare industry have a common goal – to improve work performance for medical professionals while enhancing the safety of patients.  

 

 

 

In providing patient medication supplies, there is a lot of detail that goes into each and every package. Unit dose medication packaging solutions including materials like labels for single-dose vials and syringes must also comply with federal standards for labeling drugs. This takes a lot of diligent attention and can be a daunting task for healthcare facilities and pharmacies. The evidence suggests that pharmacies are making more critical mistakes with mislabeled or unlabeled syringes, leading to serious medication safety concerns. However, there are guidelines and technologies available to assist pharmacists in providing the most accurate labeling information for every medication syringe. Start by understanding more about the importance of safe and accurate medication labels. 

Importance of Labeling Medication Syringes

The Joint Commission released National Patient Safety Goals, laying out goals for improving medication safety by labeling all medications, medication containers, and other solutions to ensure patients receive the correct medication, whether they are in a perioperative setting, assisted living community, or by themselves at home. According to Federal Survey Manual and F431 §483.60(d) Labeling of Drugs and Biologicals, “Drugs and biologicals used in the facility must be labeled in accordance with currently accepted professional principles, and include the appropriate accessory and cautionary instructions, and the expiration date when applicable.” 

Injectable medications, along with many oral medications, are dispensed as ready-to-use syringes that are either administered by a healthcare professional or by the patient. This is when labeling medications is paramount, since patients have only the information on the syringe label to help guide them. However, even in clinical areas, mistakes can be made when medication vials and syringes are improperly labeled. Hazardous conditions are increased for the patient when high-alert medications are being administered.

Everything the patient requires for proper dose administration must be printed on the label. At a minimum, medication containers and medication syringe labels must include:

• Accurate spelling of medication name  
• Brand name or generic name
• Patient’s name
• Dosing amounts
• Dosing and/or drug administration instructions
• Total medication quantity
• Medication expiration date
• Date of dispensing
• Serial number
• Name of the prescriber
• Name, address, and telephone number of the issuing pharmacy

Each piece of information is there to improve patient safety. Reducing spelling errors, typographical mistakes, or the spacing of the information including label breaks will help prevent patient harm.

Safe Labeling Prevents Medication Errors

A patient error with medication involving a syringe can send a patient straight to the ER or worse. This could be due to an overdose of medication, or not using enough medication because the labeling instructions are inaccurate. Other concerns are using the wrong medication altogether due to a mistake with labeling in the pharmacy.

Keeping patients out of the emergency room is a top priority for the medical industry. Medication is expected to make the patient better, not increase their rate of illness or chance of suffering from an overdose, adverse reaction, or misuse. This is where providing safe labeling will prevent medication errors and save a pharmacy from a lawsuit.

Issues With Mislabeling Vaccinations

Vaccines are one of the most common types of injectable medications, especially since the COVID-19 vaccines became available. Giving the wrong dosage or vaccine can be detrimental to the patient’s health and personal wellness. 

In 2021, there were multiple reports of mix-ups between the Flu and COVID-19 vaccines. With more vaccinations being added to the market all the time, labeling syringes accurately and having procedures in place to reduce errors is the best way to ensure patients are getting the right vaccine at the right dose.

It is important to focus on perfecting a medication syringe labeling process. This typically involves automation equipment as a way to also improve production with fewer labeling mistakes. Along with choosing a new syringe labeling system by MPI, you want to identify elements of syringe labels that must meet federal and industry guidelines. This includes the font type and size, as well as the color of the label and printed information.

Best Practices for Labeling a Medication Syringe

The Institute for Safe Medication Practices (ISMP) reports errors with injectable medications remain a common problem. Along with being more common than other types of medications, such as pills, about 50 percent of harmful errors in injectable medications occur during administration. By eliminating labeling mistakes on injectable medications, you are able to minimize danger to the patient. That is worth the extra effort in best practices for labeling a medication syringe. 

Let’s cover some of the best practices for labeling a medication syringe. The label itself must be:

• Clearly printed
• Provide all of the medication information
• Not reduce the nurse or patient’s ability to administer medication for themselves in a timely and safe manner

There are several ways to ensure this happens when labeling an injectable medication.

Start with the label design and where the information is printed, especially key data like patient name, drug name, dose instructions, dosage amount, and pharmacy contact number. The label must also meet specific industry guidelines for the medication you are labeling.

For example, if you are labeling vaccinations, there will be labeling requirements that differ from the labeling of anesthesia. Determining the correct labeling requirements for the type of medication syringe you are packaging is very important at this stage. 

Watch for how the label breaks when flagging labels. A label break occurs where the end of a label lies on a syringe. If the label break is in an awkward placement, the nurse or patient could miss key information. This could be a number or the inclusion of a few ending letters on an important word.

Covering syringe barrel markings is another critical error that happens with pharmaceutical syringe labeling. If the syringe markings, indicating measurements for dosing, are not visible due to the sticker label, this slows down patient care and may lead to medication dosing errors.

If the pharmacist is adding additional information to a medication syringe label after it is affixed to the unit, there are some ways to do this safely. Use a ballpoint pen or a permanent felt-tipped marker on a label when handwriting instructions to minimize smearing. Patients can’t read a smudged or blurred word very well, which will likely lead to improper medication administration or dosing.

Color blindness and age-related vision loss are concerns for patients self-administering medication. For high-contrast color combinations on labeling for syringes, the American Society of Anesthesiologists (ASA) recommends the following:

• Black text on white background
• Blue text on yellow background
• White text on blue background
• Blue text on white background

Using an optimal color combination for text on the background of a medication syringe is one area where the pharmacist or provider of patient medication supplies can improve patient care. There is also the use of certain color options that are reserved specifically for labeling certain drugs considered more dangerous as classified narcotics, such as benzodiazepines or opioids. For example, the color Salmon 156 is reserved for major tranquilizers and anti-emetics, while beta blockers have two colors–Copper 876U and White.

For more information, check with specific health care industries and providers of safe medical practices. The ASA provides specific guidelines for labeling pharmaceuticals used in anesthesiology. They are responsible for potent medications used for putting patients under general anesthesia for surgery. As a result, the ASA is alert to the importance and patient care associated with medication syringes.

How Medical Packaging Inc., LLC Can Help

Medical Packaging Inc., LLC (MPI) is a leading provider of unit dose and liquid medicine packaging and labeling systems. With MPI’s Auto-Wrap® Syringe Labeling System, you can automate the process of labeling injectable medications and oral syringes. Compact enough to fit in an office, the label printer is capable of printing 20 syringes in 60 seconds. This is the perfect solution for retail pharmacies and hospital pharmacies.

Find out how our medical packaging and labeling units will improve your business and increase productivity. Contact MPI today to request a free quote for your ideal medical packaging equipment.