With a deadline looming to meet a new EU Falsification Medicines Directive (FMD) by 2019, there is no shortage of challenges for packaging experts.
Besides satisfying EU requirements, drug manufacturers must meet different countries’ standards and keep packaging patient-friendly, while at the same time deter counterfeiters or those who might want to tamper with drugs.
Under the terms of the directive, packaging of the majority of prescription drugs must have a unique identifier (UI) and an anti-tampering device (ATD) or tampering verification feature (TVF) by Feb. 9, 2019. Included in the UI is a product code, an up to 20-character alphanumeric serial number, a batch number and an expiration date. In some cases a national reimbursement number or identification number also will be required. The information must be in a “human readable format” and appear as a bar code on the outside packaging.
The exceptions to the regulations are drug makers in Belgium, Italy and Greece who are already working on similar requirements, and will have until Feb. 9, 2025, to meet the serialization mandate.
When it comes to anti-tampering devices, the FMD is far less specific. The directive states that “a device allowing verification of whether the outer packaging has been tampered with” has to be added. The choice of the most appropriate device allowing the verification of whether a pack has been opened/tampered with is left to the manufacturer.
This will cost a lot of money
What the directive means for the drug industry in the EU is that approx. 12,000 packaging lines will have to be equipped to apply TVFs to approximately 10.5 billion drug packages per year in the EU/EEA, according to Dieter Moessner, working at Edelmann GmbH in Germany and being the Convenor of working group 15 at the Technical Committee 122 Packaging of the International Organization for Standardization (ISO). This working group creates an International Standard on Tamper Verification Features for medicinal product packaging. The FMD involves between 28 and 32 countries and about 2,500 pharmaceutical companies and 150,000 pharmacies, he added. Wholesalers and packaging producers also will be affected.
“This will cost a lot of money and involve investments, qualification and validation, and require changes to the packaging, such as text and graphics, as well as changes to the production scenario at the pharmaceutical manufacturers,” said Moessner in explaining the potential impact. “They (also) will need new die-cutting tools at the folding box producer.”
Maintaining container integrity
Among the approaches pharmaceutical manufacturers can take to develop their anti-tampering strategies is to rank some proposals according to criteria such as ease of opening, technical feasibility and occupational safety and see which ones work best, based on the needs of the product and the market, noted Moessner. “Usually, there is not a single solution for all products. We want to introduce something that maintains container integrity.”
The majority of pharmaceutical products are sold in a folding box, and gluing the box and applying certain labels are two of the most frequently-employed tamper-verification features, particularly by companies that already have devised TVFs for their packaging, he added. But new solutions, such as folding boxes with integrated TVFs are on the horizon. “There is a chance to optimize packaging and production in order to regain some of the productivity losses or to add value to the packaging, say by integrating the package leaflet or an opening aid,” added Moessner. Besides securing the packaging, products will have to carry a TVF, but if there is a secondary pack, that also has to carry a TVF.
Companies are trying to look into as many standards as possible
Packaging experts have been attending conferences on the directive, including several this past summer, and are working to develop standards for anti-tampering features to try to avoid each country adopting its own schemes, according to Moessner. In the past, companies sometimes have been hampered in complying with some EU requirements by a lack of details, he said.
“In the absence of specifications (from the EU), then national regulatory authorities could require different anti-tampering devices for the same box for the same product,” Moessner said. “This could waste a lot of time, money and resources.” Companies are trying to look into as many standards as possible, taking into account requirements for the next three years. “A lot of companies already have secured boxes,” he added. The EU requires tamper verification features on the outer packaging of a finished medicinal product – in addition to the already existing TVF for the primary container.
Up until the FMD was adopted in 2011 and had been specified by its implementing delegated regulation in 2016, tamper-evident packaging or tamper-verification features were not required globally on a large scale for prescription drug medicines. But tamper verification devices have a natural connection with the new identification procedures for drugs, noted Moessner. “With international serialization requirements coming up, it is clear that it does not make sense to serialize each individual box, if it can then still be opened by anybody without leaving a trace,” he said. “It is not logical to have an individually marked pack that everyone can open.”