Measured Movement: Pharmaceuticals & Control
Written by Shukti Sarma
Probably in no other sector is the function of a moderator more important than in healthcare. The pharmaceutical industry is heavily regulated by several organizations and authorities, which ensure that all health and safety standards are met. It is as important to ensure safety and efficiency in the supply chain; it’s vital for maintaining the quality of drugs. When it comes to life and death; we can never be too careful.
Keeping Up With The Flow
The importance of an efficient supply chain cannot be overstated, but in case of healthcare, it is a crucial point. Imagine a hospital that is unable to provide someone with a life-saving drug. Ensuring a smooth flow is a responsibility that is shared by all stakeholders - the company, the hospital, the doctor and the government.
It is evident that the doctors and the hospitals ensure that they have the requisite stock and have their suppliers in order in order to ensure that their patients get the service and drugs they deserve. But it is also equally important for the pharmaceutical company to keep a close eye on their supply chain, because it is not just a matter of brand reputation and business. There are other dangers that pose a serious threat.
Steering Clear Of Harm
According to a recent Forbes report, the Food and Drugs Authority (FDA) has seen an alarming spike in number of cases involving counterfeit prescription drugs. The report says that FDA’s Office of Criminal Investigation opened 72 new cases in 2010, up from just six a decade earlier. FDA’s documents reveal that thousands of American customers have been sold fake drugs like Viagra, Xanax, Vicodin, flu medications and even cancer drugs.
This instance alone is enough to set alarm bells ringing. When the supply chain is compromised, not only are the goodwill and the business of the company at risk, but also countless lives are affected.
It is thus, important for the company to be vigilant, and more important for the government and the authorities to monitor the supply chain. Various illegal drug traders and manufacturers, who inject harmful and lethal medicines into the system, target the national and international supply chain. There is also ample scope for drug theft; which opens the doors for black marketers.
Lack of security and efficiency in the pharmaceutical supply chain has the worst effects in developing and poor countries, where drug smuggling and counterfeit selling is rampant. Despite the best efforts of government and public bodies, banned, harmful and fake drugs are sold to millions of patients in developing countries. This is most rampant in areas where literacy rates are low and poverty rates are high. Many hospitals and service providers willingly participate in these illegal operations, while lack of knowledge or adequate surveillance on part of government authorities allow this harmful trade to flourish. Many multi national companies have been accused of dumping their rejected, defective or banned drugs in developing countries.
In 2012, the Central Drugs Standard Control Organisation of India detected numerous drugs which were being sold and prescribed by Indian doctors; but which were banned in many other countries. Following the startling revelation, the government has reportedly decided that such drugs; which are banned in US, UK, Canada, Japan, European Union or Australia, will not be sold in India as well.
Obstacles & Roadblocks
It is sad indeed that despite our best efforts, counterfeits keep on slipping into the system. It is not that there are any dearth of laws to regulate the flow of drugs within a state or internationally, but lack of uniformity and the contradictory nature of these legislations provide enough loopholes for illegal traders to infect the system. This is an issue that needs to be solved through mutual understanding and cooperation between states and countries.
On the other hand, ensuring security and efficiency in the supply chain is an extremely difficult task, and it is next to keep track of all medicines being sold in retail or wholesale form. The pharmaceutical industry supports the development of track-and-trace systems; which use encoded data to quickly provide a drug product’s vital information. These systems can trace drugs through product information such as the drug’s strength and expiration date, lot number, and serial number.
While the technology may be available, but most government bodies; including the FDA in US; does not have the authority to implement such systems. It is also a Herculean task, and requires considerable financial and skilled resources; and small businesses will suffer the most to bear the burden of compliance and tracking system.
However, it is encouraging that governments are waking up and taking notice of the matter. Companies too, recognize the perils of maintaining a supply chain that is lax in security and efficiency, and are now more stringent and alert. With some thought and understanding, an effective monitoring system can be designed, which takes into account all the stakeholders. When the responsibility is shared in a way that leaves the smaller stakeholders unburdened, proper service can be ensured for the public; and keeps the evil elements out.
A guide to labelling compliance for medical devices
Small medical device manufacturers often find themselves scrambling to achieve the necessary compliance and validation, risking costly mistakes.
Validating systems and processes including labelling, to ensure they are compliant with stringent regulatory standards is tough and can be expensive. Indeed, compliance with the EU’s Medical Device Regulation (MDR) will cost more than 5% of annual sales, according to 48% of 101 companies polled by the German company Climedo Health, in July and August 2020 about their MDR-readiness.
But if companies bungle the software validation process or put incorrect and uncompliant data on the labels themselves, the penalties are likely to be more severe than just making corrections. Health and safety may be put at risk and fines imposed for failing to comply. When it comes to compliance, they may become overwhelmed with regulations in other geographic regions that focus on device traceability, each with a unique device identifier (UDI-like) component to it.
On the validation front, companies may not be familiar with the software validation process and the multiple tests and documentation necessary for validation are demanding if companies only have a small IT team that is very busy.
Putting a plan in place
MDR-compliant labelling, however, brings with it certain requirements which differ from what is demanded under the FDA’s Unique Device Identification (UDI) system rules. Under MDR, for example, manufacturers must ensure the label specifically states the device is a medical one using an MD symbol in a box. This is only one of many stipulations that usually require redesigned labels.
Small medical device manufacturers who rely on time-consuming and error-prone manual or legacy labelling processes to facilitate these label updates run the risk of mislabelling which can lead to non-compliance. They may have limited staff and no structured processes around roles and responsibilities when it comes to label design, changes and approval. As project leads work toward a compliant labelling process, it is therefore important to establish defined roles and access for each stage of the process.
When dealing with a compliance initiative, up to date, correct and compliant labelling is imperative. This involves having all the relevant label design elements in place to comply with the EU MDR or FDA regulations. Many times, label templates are hard coded, meaning IT must be involved in making changes. And with IT staff often being tasked with multiple mission-critical projects in the organisation, labelling projects can be delayed. For many small medical device manufacturers who have limited resources, finding a solution can be a challenge.
Why labelling in the cloud offers a roadmap forward
Validation-ready cloud labelling solutions have now emerged to ease compliance with regulations and time-consuming validation requirements. These solutions, built with the needs of regulated companies in mind, digitise the quality control processes and facilitate compliant labelling with role-based access, approval workflows and electronic signatures. Outside of compliance, carrying out labelling in the cloud drives scalability and productivity for small medical device manufacturers and boosts overall efficiency.
The latest cloud labelling solutions integrate with other cloud solutions, allowing for seamless functionality and minimising the need for local infrastructure resources and cost.
When it comes to validation, as with many labelling systems, those hosted in the cloud have vendor-supplied documentation that streamlines the process and significantly eases the burden when it comes to installation qualification (IQ). The manufacturer itself has a much lighter burden and a streamlined path to a validated system and process.
A more relaxed software release schedule eases the validation burden on life sciences companies because the software is updated once a year rather than multiple times. This gives them a continuously updated and maintained labelling solution without increasing the validation workload on their IT staff.
The manufacturer would of course need to work closely alongside the vendor and review the documentation, but, if needed, the vendor is able to do much of the work for them, providing not only the full validation acceleration pack but also professional services to assist with the validation process.
While some medical device manufacturers choose to tackle validation on their own, the vendor supplied validation acceleration pack or documentation helps to simplify the process. Consultancy and advice around validation is usually available from the vendor, tailored to the business’s specific needs.
Given the immense hassles of compliance for small device manufacturers, cloud-based labelling systems offer the benefits of a full label management system while easing compliance and validation. This is a future-proof technology. With a cloud-based labelling system, medical device manufacturers can be confident that they are running the most up-to-date software, enabling them to address the fast-changing new regulations and cope with whatever comes their way. And especially in the current pandemic, when face-to-face meetings are still problematic, it is a perfect way to keep labelling operations moving forward.