Editor: What To Know
- Using a digital quality system for record keeping enables the pharmacy to have everything available at the click of a button, removing the need to go through a multitude of binders filled with printed documents.
- Beyond the operational and regulatory benefits, having a unified system in place will aid pharmacies when they need to look into potential incidents, such as if a medicine arrives to the patient damaged.
- In addition to creating a unique depth of transparency, digital QMS solutions also provide pharmacies with a level of scalability if they were to expand their geographic footprint, for example, to other states while addressing any licensing requirements.
“There’s no doubt – consumer preferences are shifting.”
They are changing. Since the pandemic, there has been a rise in ordering everything to the home – from vitamins to prescription drugs – and the days of venturing to a brick-and-mortar store are declining. The pharmaceutical industry is no different. It too is evolving, and pharmacy-focused businesses must make sure their systems are updated to keep up with the changing times.
The proof is in the data. For instance, in 2021, mail-order, compounding and online pharmacies in the United States accounted for less than 10% of total US prescriptions. Since then and for a variety of reasons, a major shift in consumer adoption has been taking place. This segment of the market received more than $3 billion in funding by the end of 2022, reflecting a rise in pharmacies that mail medications. To make prescription ordering safer, easier and more effective for patients, pharmaceutical companies are turning to cloud-based, streamlined quality management systems (QMS).
With the focus on delivering the best possible patient outcomes, collaborative QMS allows for companies to have a clear line of sight into every aspect of their business. As more consumers start to order their medications directly, pharmaceutical companies must re-evaluate their legacy systems, and ensure they are robust enough to keep up with the evolving demand the industry is seeing.
Providing business support
The benefits of a streamlined QMS system are multifold. One of the strengths is the ability to support the business processes of a pharmacy today and extensible as continually grow and evolve. For example, many pharmacies are still reliant on manual practices and having prescriptions and other important documents stored in physical files and binders. Accessing this information is a labor-intensive process that takes attention away from the pharmacy’s primary purpose – providing patients with medicine.
The most effective QMS implementations can automate back-end processes and transform paper records into a reliable digital environment, turning pharmacies into data-driven businesses. And as such, help ensure that the pharmacy’s digital environment is compliant, and that data is stored securely.
Patient security must be top of mind as pharmacies transition their data from paper processes to digital environments. Gone are the days of storing files in a cabinet. Secure, cloud-based systems provide pharmacies with peace of mind that their patient data will be safe.
Always be audit-ready for inspections
Undergoing inspections and audits from regulatory bodies can be stressful and complex when working with a paper-based audit trail. Using a digital quality system for record keeping enables the pharmacy to have everything available at the click of a button, removing the need to go through a multitude of binders filled with printed documents. With a cloud-based system, clean annotated data is immediately available at any time for review.
This is especially helpful when inspectors initiate real-time, unannounced reviews. The right QMS system allows pharmacies to remain audit ready. Digital records can provide inspectors with the data they need as well as full traceability if/when corrections must be made. Moreover, they have a fully trackable history and record of related events.
For example, pharmacies can quickly access reference and training information such as when employees read materials. All this contributes to pharmacies having an unprecedented level of preparedness. Their ability to deliver accurate product records and change processes throughout the product life cycle is a game changer.
Regulatory processes are of utmost importance for pharmacies. In addition to creating a unique depth of transparency, digital QMS solutions also provide pharmacies with a level of scalability if they were to expand their geographic footprint, for example, to other states while addressing any licensing requirements.
Access to quality and management reports while having the ability to document everything becomes a significant competitive advantage in the marketplace.
Transforming customer experience
Beyond the operational and regulatory benefits, having a unified system in place will aid pharmacies when they need to look into potential incidents, such as if a medicine arrives to the patient damaged. With a unified system, a patient can issue a report, often with a photo of the product. With an entire view of the product lifecycle, the pharmacy can pinpoint where the issue likely arose. They will be able to understand the root cause and identify, and ultimately predict, the likelihood of similar issues arising. This leads to shorter incident to resolution times, reducing escaped quality issues and improving customer satisfaction.
Whether it’s a packaging malfunction, a courier company mistake, or an error in medication transport at altitude, numerous factors can have an impact. A proper QMS can prepare an action plan to minimize risk should any kind of unintended event happen.
QMS is a profound way to connect events, garner insights, and implement needed modifications at any point in the supply chain.
Ensuring safety and ease for patients
A unified quality system can also be easily updated to reflect changing pharmacy requirements. For example, a system that can monitor all regulatory aspects – including employee training – will help better serve patients by making sure those who are handling the product are up to speed on necessary training and learnings.
Looking forward, companies that implement a streamlined QMS system will be on the right path to succeed. They will be able to gain quicker access to documentation that can help correct situations at the root cause, saving time and money, as well as ensuring safety from a patient perspective.
About Chuck Serrin, VP of MedTech & Life Sciences Industry Marketing
Chuck is the VP of MedTech and Life Sciences Industry Marketing at Propel. Formerly, as a Solution Architect and Program Manager at Stryker Corporation, he implemented and supported global PLM, QMS, and digitalization projects. Chuck has deep domain expertise on the development, compliance, and commercialization of medical device products, along with providing high-quality support in launching new products. Over 20 years of experience across senior positions in enterprise software solutions with companies such as Agile Software, Oracle, and PTC.
