Optimizing the Biopharmaceutical Manufacturing Process

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.

Biopharmaceutical research

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 drugs

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.

Key challenges in biologics

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. 

Pak-EDGE UD Barcode Labeling Software Version 2.0 Is Now Available

Medical Packaging Inc., LLC (MPI) is excited to announce the release of our new Pak-EDGE® UD Barcode Labeling Software Version 2.0. 

The latest edition of our customizable labeling program, which provides user interface for MPI’s packaging solutions, offers simplified access to packaging features, enhanced security options, increased library capabilities and additional design elements to users for their medication labeling needs.

The design enhancements and added improvements to our barcode labeling software support our commitment to hospital pharmacy and pharmaceutical professionals with establishing medication management that increases efficiency and enhances patient safety.

Learn more about barcode labeling software by visiting the product page on our website. Please feel free to contact us to speak with a product expert for additional information, pricing and to order Pak-EDGE® UD Barcode Labeling Software Version 2.0 for your facility.

Hospital Inventory Management Best Practices

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:

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

Worker practicing inventory management


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.

DSCSA Compliance: Is Your Organization Ready?

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. This law provides the Food and Drug Administration (FDA) with greater authority for regulating and tracking compounded drugs. The DSCSA also offers a more secure way to track drugs in the United States pharmaceutical supply chain from start to finish. The main goal of this law is to keep patients safe from harmful drugs, which include counterfeit and other kinds of harmful drugs.  Although the law was enacted in 2013, full DSCSA implementation is set to occur in 2023. This includes the requirements for product tracing at the package level, affecting stops along the drug lifecycle. Knowing more about DSCSA compliance for each part of the drug supply chain is important to ensure that manufacturers, re-packagers, wholesale distributors, pharmacies, and trading partners are prepared. 


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 2023 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 2023 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 2023 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 Development of Pharmaceutical Packaging in Today’s Care Markets

What Is Pharmaceutical Packaging?

Pharmaceutical packaging refers to the process, materials, designs, and systems that package, label, and distribute drugs in a variety of healthcare markets.

With such a highly regulated industry, healthcare organizations and pharmacies must use specific packaging that meets the requirements set by regulatory authorities in the United States, such as the Food and Drug Administration (FDA).

These regulations along with trends and changes in the healthcare industry have led to increasing demand for safe, efficient, and sustainable packaging.

Manufacturers focus on meeting these demands by optimizing the packaging materials and equipment that play a part in the packaging process. Let’s take a closer look at the development of the industry, as well as the solutions pharmaceutical packaging manufacturers bring to the market.


Packaging Technology

Technology plays a key role in the global pharmaceutical packaging market, allowing manufacturers to provide safer and more efficient ways to package medications. Industry leaders like Medical Packaging Inc., LLC (MPI) are constantly leveraging technology to build upon and create solutions for a variety of packaging processes including bagging, labeling, barcoding, and sealing different types of medication.

The use of technology in the current and coming years is expected to result in even more innovative packaging solutions that take efficiency to the next level while ensuring product protection and patient compliance.


How to Optimize the Packaging Process?

Optimizing the packing process involves conducting market research, evaluating case studies, and taking other steps to provide cost-effective packaging methods that support improved patient safety.

In the drug development process, regulatory affairs in a pharmaceutical company must approve products based on strict safety standards. In product development for pharmaceutical packaging, the process is similar. A packaging manufacturer must ensure that their product packaging meets each U.S. regulatory requirement.

Drivers of Development in the Pharmaceutical Packaging Market

Technology advancements and continual optimization efforts result from a variety of wants, needs, and regulations within specific care markets. Let’s look at some of those key drivers of development in pharmaceutical packaging:

  • Cost Reduction: With the responsibility of allocating and managing such important resources, pharmaceutical executives will look to reduce costs wherever possible. Packaging companies are pressed to provide the most efficient equipment and materials that will increase the profitability of their customers.
  • Safety and Sterility: The pharmaceutical market places a high level of importance on safety and sterility. This trickles down to the packaging process and has always been a key component in the industry. In recent years, regulations and standards have led many organizations to focus on utilizing safer, more efficient ways to package medications. These regulations are constantly changing and updating, making it important for pharmacies to use up-to-date methods.
  • Flexibility and Capacity: Having more responsive production processes and delivery systems are necessary to meet unpredictable volumes and maintain efficient operations. The increasing demand for individualized medicine has created methods such as the unit dose supply to reduce any medication mistakes and save valuable time.


How the Unit Dose Supply Method Has Advanced the Industry

While pharmaceutical packaging varies from one care setting to the next, all require a dedication to ensuring compliance for regulatory purposes and patient safety.

The need for customized and efficient solutions is prominent in every care market. Overall, a shift to using unit dose packaging solutions has provided greater efficiency for hospitals, long-term care facilities, and specialty pharmacies.

The Unit Dose Supply Method has been an innovative solution to reduce medication mistakes while also saving time for patient care. The method itself delivers the recommended dose of a given medicine to a specific patient at a particular time.

This can be compared to previous approaches where each dose of prescription medicine is packaged separately in a ready-to-administer form. To read more about the Unit Dose Supply method and the advantages it brings to the industry, check out our blog post, Understanding the Unit Dose Supply Method.


Types of Packages

Pharmaceutical product packaging can be classified under three levels: Primary, secondary, and tertiary. The type of packaging and relevant stakeholders will depend on where in the distribution process you find a specific medication.

Primary Packaging

The main purpose of primary packaging is product protection and safety. This type of packaging must meet each U.S. regulatory requirement to protect the product from tampering or contamination to ensure that it is able to reach its shelf life instead of expiring at an earlier date. For example, primary packaging in North America includes child-resistant packaging for medications in bottles and other types of containers to prevent children from being able to open them.

Labels plat an important role in primary packaging. There are various factors goes into the label of medication, and each label will differ in many ways including the type, dose, patient, etc. Efficiency and accuracy in the labeling process are vital.

Different types of primary packaging include:

  • Blister packs
  • Prefilled syringes
  • Vials
  • Bottles

Blister packaging is commonly used for capsules and tablets, while bottles, syringes, and vials are typically used for liquid medications. These types of packaging are designed to prevent medications from spoiling, harboring bacteria, or developing other problems that affect shelf life and usage. 

Secondary Packaging

Secondary packaging refers to the product packaging that is used for storing or grouping multiple primary packages. This packaging will secure various components and/or units within a facility. Examples of secondary packaging include:

  • Boxes
  • Cartons
  • Injection trays
  • Shipping containers

Secondary packaging can be used to keep primary packages organized and make it easier to store them. This type of packaging can also provide added product protection. A pharmaceutical company might use secondary packaging to group primary packages together before shipping them. Pharmacies and other facilities might store medications in secondary packaging until they are needed.

Tertiary Packaging

Tertiary packaging refers to the packaging that is used to ship products in bulk. This type of packaging is used for shipping and handling to facilities that store or distribute large quantities of medication. Different components of tertiary packaging that are used in the pharma industry include:

  • Large shipping containers
  • Barrels
  • Edge protectors and other packaging that helps cushion packages as needed


MPI’s Packaging Solutions

MPI has been providing top-quality products since 1971, constantly innovating and growing with the pharmaceutical packaging market. As a manufacturer of unit dose medication and pharmaceutical packaging and labeling systems, equipment, barcode labeling software, and MPI-certified consumable materials, our products are categorized as a primary packaging solution for a variety of healthcare markets. These products include:

Oral Solid Packaging Systems

Our oral solid packaging systems include:

  • Auto-Print®: This barcode and packaging system can package at speeds of 60-unit dose packages per minute.
  • Express 90: This packaging system can package at speeds of 90-unit doses of oral solid medications per minute.
  • Oral Solid Feeder Attachment: This is used to load bulk medication into the feeder for improved speed and efficiency.
  • Canister Feeder Attachment: This attachment fills prescription dose medications using canisters.

Oral Liquid Packaging Systems

Our oral liquid packaging systems include:

  • Fluidose®: This unit dose packaging system can fill and seal liquid medication at 22 doses per minute.
  • Auto-Draw®: This oral syringe filling system provides improved accuracy in dose packaging for liquid medications.
  • FD-Pharma®: This oral liquid cup packaging system is designed for managing lower to full production volumes.

Overwrapping Systems

Our overwrapping systems include:

  • Pharmacy Accessory Bagging System: This system handles barcoding for packaging and can seal up to 35 bags in a minute.
  • Auto-Print® Max Bagger: This system can fill 30 bags per minute with the use of automation technology.

Labeling Systems

Our labeling systems include:

  • Auto-Wrap®: This machine can wrap a label around a syringe at the rate of up to 20 syringes in a minute, resulting in greater speed and efficiency.
  • Pharmacy Accessory Label Printer: This system can print barcodes and labels for a wide range of packaging, including vials and ampoules.


Relevant Care Settings

Pharmaceutical packaging is used in a wide range of care markets in the healthcare industry, from hospitals to specialty pharmacies. The development of packaging requires pharmaceutical packaging manufacturers to meet all requirements and regulations for medications that are sent to various care settings.

Hospitals, Acute Care Facilities, & IDNs

You’ll find hospitals, acute care facilities, and IDNs ranging in a variety of sizes and scopes. With more comprehensive healthcare services, we offer a full range of oral solid and liquid medication packaging and materials.

With such large organizations, you can imagine how complex communication can be between departments, and how vital efficiency is to get the proper care to the patients. Pharmaceutical packaging is a prime example of a large-scale process within these facilities. With unique packaging needs and a wide range of requirements, the packaging process is an essential part of operations, getting the right medication to the right individuals.

Long-Term Care and Extended Care Facilities 

Medication is a huge part of treatment for patients within long-term or extended care. These organizations typically require pharmaceutical packaging for smaller or individualized medications for residents. Depending on the size of the facility, packaging needs might be a lower volume compared to large hospital systems.

You’re likely to find pharmacies that specifically serve long-term care facilities. It’s important for these pharmacies to use specific medication packaging and labeling machines and materials to maintain compliance with the CMS-mandated short-cycle dispensing model in LTC/EC pharmacy environments.

Specialty Pharma

Specialty pharma companies or a contract drug manufacturing organization (CDMO) can handle the innovation, development and manufacturing of drugs involved with bringing new products to market.  An example are biotechnology drugs that may require special ordering, handling or distribution.

MPI understands the unique and complex needs of specialty pharmaceutical manufacturers and CDMOs. Our FD Pharma Packaging System is created to specifically meet these needs, as a solution for unit dose oral liquid medication. The system provides liquid cup packaging for multiple modes, addressing clinical trials, small production and validation runs, and full production. FD Pharma is the complete packaging system with barcode labeling software and materials to provide the ultimate efficiency in specialty pharmaceuticals.


Medical Packaging Inc., LLC (MPI)

MPI remains committed to providing pharmaceutical market clients with solutions aimed at improving efficiency and ensuring safety. The U.S. Food and Drug Administration has accepted our Type III Drug Master File (DMF) submittal. Having a DMF allows MPI to meet the filing and compliance needs of our customers in the pharmaceutical industry at a more rapid speed. It also allows us to fulfill the FDA-compliant liquid cup packaging capabilities for contract drug manufacturing organizations and pharmaceutical drug manufacturers.

With a DMF, we can expedite the application process for New Drug Applications or Abbreviated New Drug Filings. We are also able to offer improved support for our customers in terms of technical and regulatory requirement needs.

MPI offers efficient solutions for pharmacies and other medical facilities that rely on safe, high-quality pharmaceutical packaging. Our commitment to technology and efficiency has advanced the market and continues to exceed the needs of medication packagers in different market segments.

If you would like additional information on medication packaging solutions, please contact us today. We offer a full line of medical and pharmaceutical packaging products, including unit dose packaging machines, barcode labelers, and software for label and barcode design. We can assist you in finding the right packaging solutions for your pharmacy or facility.

Increasing Safety & Efficiency in Integrated Delivery Networks

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:

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.

Pharma Tech Trends That Are Changing The Drug Development Process

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.

U.S. News & World Report Issues the Best Hospitals Honor Roll 2022-2023

U.S. News & World Report released their 2022-23 Best Hospitals rankings. The annual rankings acknowledge hospitals for outstanding performance in delivering complex and common care while also helping patients find a hospital with the resources needed for skilled inpatient care, especially those with life-threatening or rare conditions.

Nearly 5,000 hospitals nationwide were evaluated based on analysis gathered on performance in adult and pediatric clinical specialties, procedures and conditions. About 65% of the Top 20 hospitals are Medical Packaging Inc., LLC (MPI) customers and more than ¾ of them are repeat customers with more than one MPI packaging solution being utilized in their facility.

The rankings for the Honor Roll consider 15 areas of complex specialty care and 20 specific procedure and conditions, such as heart bypass and lung cancer surgery.

Please click here to view the complete list of recognized hospitals and the methodology used in the rankings.

MPI’s Drug Master File (DMF) Accepted by the U.S. Food and Drug Administration

Medical Packaging Inc., LLC (MPI) is pleased to announce that the company has completed a Type III Drug Master File (DMF) submittal to the U.S. Food & Drug Administration (FDA). This will enhance MPI’s customer partnerships by providing speed-to-market regulatory and technical support related to our packaging components with our medical and pharmaceutical market clients.

Establishing a DMF enables MPI to rapidly support customers’ compliance and filing needs within the pharmaceutical industry as well as meet the needs of pharmaceutical drug manufacturers and contract drug manufacturing organizations (CDMOs) for FDA-compliant liquid cup packaging capabilities.

“Typically, MPI has relied on our vendors and sub-vendors to obtain all necessary regulatory and technical documents, sometimes adding delays while awaiting critical support files, which could result in delayed FDA Filings by customers. Having a DMF allows us to better support our customers in meeting and exceeding expectations for regulatory and technical requirements, confirming a high-quality, safe product is delivered, and expediting the application process during a New Drug Application (NDA) or Abbreviated New Drug Filing (ANDA),” said John Zripko, President & CEO for MPI.

Guide to Pediatric Medication Safety

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.