With supply chain problems affecting many industries in recent years, including the pharmaceutical industry, developing ways to combat supply chain issues is essential. The pharmaceutical supply chain is a critical component of patient care. Problems with this process can have a negative impact on patient safety and the healthcare industry as a whole. Understanding the key steps involved in the end-to-end supply chain can help pharma companies in the United States (U.S.) produce effective solutions.
Pharmaceutical Supply Chain: An Overview
The pharmaceutical supply chain begins with the manufacturing process and ends with medication dispensing to consumers. Drug manufacturers, packaging companies, wholesale distributors, healthcare providers, and pharmacists are all key parts of the pharma supply chain in the U.S. The supply chain process contains several steps that are ultimately aimed at ensuring patient safety. For example, pharmaceutical manufacturers must have approval from federal agencies, such as the Food and Drug Administration (FDA), before they are allowed to manufacture over-the-counter or prescription drugs for consumers and patients.
Key Steps Within the Pharmaceutical Supply Chain
The supply chain in the pharmaceutical industry is a complex process due to regulations, safety, and high costs. Overall, each step in the process works to provide individuals access to safe pharmaceutical products, including generic drugs and prescription drugs.
Pharmaceutical manufacturing is the first major step in the pharmaceutical supply chain. This process involves having medications produced in a manufacturing facility. According to the International Finance Corporation (IFC), the industrial-scale production process can be broken down into two main stages including primary processing (the production of the active ingredient) and secondary processing (the “conversion of the drugs into products suitable for administration”).
Whether developing prescription-only medicines (POM) or over-the-counter (OTC) products, pharmaceutical manufacturers utilize raw materials, innovative technology, equipment, and supplies to produce different forms of medications. This includes tablets, capsules, liquids, creams, ointments, and aerosols. The materials, technology, and equipment are what make this complex process possible, and any delay, shortage, or complication with obtaining items or keeping the process functioning will negatively affect the rest of the supply chain.
Wholesale Distributors & Repackagers
Wholesale distributors or repackagers receive pharmaceutical products from drug manufacturing companies. Wholesale distributors will purchase drugs from manufacturers to store and distribute to healthcare markets. According to the Common Wealth Fund, about 92% of prescription drugs in the US are distributed through wholesalers. A repackager will purchase large amounts of generic drugs and repackage the product into smaller quantities before reselling it in healthcare markets.
Problems with this part of the supply chain, from staffing to equipment to materials can result in delays in pharmacies being able to obtain the medications they need to stock.
Pharmacies are typically one of the last steps before the drug reaches the consumer. The specific process of distribution will differ depending on the type of pharmacy and healthcare market the pharmacy operates in.
Whether in hospitals, acute care facilities, integrated delivery networks, long-term care facilities, or specialty markets, it is essential that pharmacies get the right medication to the right patient at the right time.
Dispensed to Consumers
The last part of the supply chain is having medications dispensed to consumers. This might involve having consumers purchase prescription medications from healthcare providers or pharmacies. In other cases, consumers are able to purchase over-the-counter medications from drugstores, supermarkets, department stores, and other retail businesses.
Packaging is a key step throughout the pharmaceutical process. Pharmaceutical packaging refers to the materials, designs, and systems that package, store, label, and help distribute the medications to their next destination. Medications must be placed in packaging that meets strict regulations including those set by the Food and Drug Administration (FDA). Packaging must also protect products from damage, such as exposure to extreme temperatures. Effective systems and materials can provide real benefits to each key stakeholder in pharmaceutical supply chain management including:
- Reduction of medication errors
- Protection of valuable product
- Compliance with regulatory authorities
- Cost Reduction
Addressing Key Challenges in the Pharmaceutical Supply Chain
The pharmaceutical supply chain faces several challenges, from drug shortages to increased drug costs. Taking a closer look at a few of the key challenges in the supply chain can help pharmaceutical manufacturers, packaging companies, distributors, and pharmacies determine where efficient, cost-effective solutions might help.
The pharmaceutical supply chain can impact the cost of pharmaceutical products. Complexities within the supply chain can lead to higher costs for every stakeholder, including consumers. Finding cost-effective solutions and innovative technology are a few ways to simplify the supply chain and improve operational efficiency to help reduce the cost of medications and drug production.
Companies and organizations that are part of the pharmaceutical supply chain often have multiple regulations to meet for safety purposes. Although these regulations are an important part of patient safety in the U.S., complying with them can result in delays or other issues that disrupt the supply chain. Utilizing systems and partnerships that provide speed-to-market regulatory and technical support is one way to speed up the process. Another area to address is finding ways for the FDA and other federal agencies to streamline the regulatory process as a whole.
Safety is the most important element of the supply chain. Drug manufacturing companies are required to ensure product safety and quality during the manufacturing process. Packaging solutions play a vital role in health systems to ensure that medications avoid contamination or medication errors. Utilizing effective packaging and labeling solutions is key for manufacturers, repackagers, wholesalers, and pharmacies to provide safe and traceable medications.
Drug shortages are among the biggest supply chain challenges. Without adequate amounts of certain medications to meet customer and patient demands, consumers face difficulties in treating health issues. From reducing fevers to managing chronic conditions, drug shortages can have a wide range of negative effects on public health. Pharma companies that are able to find effective solutions to these shortages, as well as ways to prevent them from happening, can end up having a distinct competitive advantage over other drug manufacturers. Pharmacies and wholesale distributors can also ensure that they have enough medications available to meet customer and patient demand when drug shortages are reduced or prevented.
Why Drug Shortages Happen
Drug shortages in the U.S. or the global supply chain can occur for many reasons. Problems with manufacturing quality for pharmaceutical products are among the top reasons that shortages happen, possibly compromising patient safety. In some cases, pharmaceutical manufacturers experience problems obtaining the raw materials needed to manufacture medications. For example, a pharmaceutical company may need to delay production if it is unable to obtain the active pharmaceutical ingredient for a medication. Other reasons for drug shortages include drug discontinuations and limited production capacity for some pharmaceutical products.
Preventing Drug Shortages
Federal agencies, including the FDA, take steps to prevent potential drug shortages before they occur. Depending on the cause, this might include addressing issues that affect the manufacturing quality or approving new sources for raw materials that pharma companies need. Drug manufacturers, distributors, and pharmacies can also take steps to lower the risk of drug shortages. Technology has been a huge part of efficiency throughout the supply chain and finding innovative solutions throughout the process is essential.
Promoting Efficiency Within the Pharmaceutical Supply Chain
Although some supply chain disruptions are difficult to prevent, working toward greater efficiency overall can help minimize their negative impact. Pharmaceutical supply chain management involves multiple steps that can be adjusted as needed in order to address potential or actual supply chain problems. Promoting efficiency along the supply chain can help offset any delays or other disruptions that occur.
Packaging: A Key Step Within the Pharmaceutical Supply Chain
As mentioned before, packaging is a crucial component of the pharmaceutical supply chain. Pharmaceutical products require quality packaging with accurate labels to ensure patient safety and reduce the risk of medication errors. The packaging used for these products must meet regulations issued by federal agencies in the U.S. Optimizing the packaging process helps ensure that products meet these regulations, while also improving safety and reducing costs. From primary packaging, such as blister packs and prefilled syringes, to shipping containers used as tertiary packaging, the packaging process provides many opportunities to improve efficiency.
Unit Dose Medication Packaging Solutions
Medical Packaging Inc., LLC (MPI) offers effective, unit dose packaging solutions for key stakeholders in the pharmaceutical industry. These solutions include different types of packaging systems and materials that are designed to improve safety, promote efficiency, and reduce costs in pharmaceutical supply chain management.
Our completion of a Type III Drug Master File (DMF) submission to the U.S. Food & Drug Administration (FDA) allows us to rapidly support customers’ compliance and filing needs within the pharmaceutical industry. It also helps us meet the needs of pharmaceutical drug manufacturers and contract drug manufacturing organizations (CDMOs) for FDA-compliant liquid cup packaging capabilities.
For more information on MPI’s packaging solutions, please contact us.
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 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.
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
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.
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.
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.
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
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.
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.
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.
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.
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.
Hospital Inventory Items and Considerations for Each
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.
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.
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
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. 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)?
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.
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?
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
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.
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:
- Meets the requirements of the Food and Drug Administration regulation 21 CFR 177.1520
- Meets USP UV light resistance (Stock colors: Red and Amber)
- 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.