New Labeling Laws Encouraging Innovative Ways to Update Rx Drug Info

Structured product labeling--along with more formalized methods of tracking changes--seek to improve patient safety


The implementation of new labeling laws is challenging pharmaceutical companies to put in systems and processes to ensure compliance. But the task is easier said than done, industry members say, as product labeling content is often duplicated in multiple documents for various product strengths, dosage forms and presentations, resulting in a large set of data difficult to manage and synchronize.

“The more regulated label practices get, the more important it is that vendor and client work closely together on finding the ideal customized solution,” says Gene Dul, president of Schreiner MediPharm U.S. (Blauvelt, NY), a specialist pharmaceutical label company. “Though the label has to carry a lot of information and combine user friendliness with patient safety—which demands a high level of sophistication—it still has to be easily integrated into the production processes at the pharmaceutical manufacturer and run smoothly on the dispensing machines.”

The labeling laws, implemented the past four years by FDA, aimed at forcing pharma companies to capture a physician’s attention to the most important pieces of drug information before a product is prescribed. Among the most significant changes was requiring drug makers, for the first time, to submit prescribing and product information to FDA in an electronic Structured Product Labeling (SPL) format and update package inserts (PIs) annually. SPL is designed to provide accurate, updated information using standardized medical terminology in a readable, accessible format while PIs provide important information for the safe and effective use of the Rx drug.

“Before the implementation of SPL, labeling updates were literally at the mercy of the supply chain,” notes a senior labeling specialist at a major pharma company who declined to be identified for this story. “Even a safety update acted upon immediately, and getting pushed through artwork creation, printing, and manufacturing in as little as two to four months, may sit six months to a year in distribution centers and on retail shelves before reaching a customer.”

With SPL, new labeling information—such as updated warnings and precautions—can be published literally overnight. The SPL system works through an electronic gateway that feeds directly into the U.S. National Laboratory of Medicine’s (NLM; Bethesda, MD) DailyMed Web site. Earlier this year, FDA launched the FDA Online Label Repository, which also contains SPL data, providing another source for updated information. “This additional SPL repository ensures that the public has yet another resource to be utilized to access the up-to-date safety information available in SPL format,” says Karen Mahoney, an FDA spokesperson.

According to Mahoney, NLM recently informed FDA that the DailyMed website receives 10 million visits per month. “This number of visits is indicative that the public not only has access to, but is viewing the up-to-date safety information included in many of the tens of thousands of unique SPL files posted on DailyMed,” she says. “In addition, NLM has added a feature which will allow consumers/patients to more easily print the medication guide as a separate document.”

Pharma companies have reportedly invested a significant amount of time managing product labeling documents such as PIs, Summaries of Product Characteristics (SmPCs), and Core Data Sheets (CDSs). FDA recommends SPL document authors select specific codes (Logical Observation Identifiers Names and Codes, or LOINCs) to identify the medication guides and patient package inserts (PPIs) in SPL files. “Inclusion of the LOINC codes specific to medication guides and PPIs presents the opportunity for consumers/patients to rapidly navigate the SPL file to locate the medication guide or PPI, if present in an SPL file posted in one of the publicly available SPL repositories,” Mahoney says.

Greater Access to Updated Reporting Data
The SPL initiative has reportedly led pharma companies to leverage modern information technology to provide better reporting data to consumers and healthcare providers while enhancing patient safety. For example, a smartphone can be used to access the DailyMed Web site, even while at the doctor’s office or waiting in line at the pharmacy. “A patient is given the increased ability to be aware of side effects, contraindications, and drug-drug interactions,” the pharma company source says.

 Smartphone applications have demonstrated new ways to improve effectiveness and efficiency of established approaches to managing chronic diseases by helping patients record and manage their medication in real time. A case in point is the National Centre for Hereditary Coagulation Disorders (NCHCD), based at St. James Hospital (Dublin, Ireland), where more than 2,000 patients have bleeding disorders. There hemophlia patients are utilizing a user-friendly application from Crimson Tide which is fully compliant with the GS1 bar code track-and-trace system and extends the management of bar-coded medication into the patient’s home, according to a published report.

Studies show patient outcomes improve when they actively participate in their own care. Many tend to think of SPL solely as a means of communicating the prescribing information, or product use information. While a valuable communication tool, SPL impacts the safe use of drugs in many more ways. “SPL includes all of the active and inactive ingredients, places of manufacture or processing for each major step, including API manufacturing, importer information, and several other data elements,” the pharma company source says. “All this information is set up in a standardized process which enables automatic and robust processing into databases for further use.”

FDA wants to ensure meaningful information is included on PIs for healthcare professionals and patients while pharma companies are being more careful in providing details on Rx drug benefits/risks so they are better protected against potential liability. “There is a tendency to include more information with the help of extended content labels that contain all crucial information to help improve patient safety,” Schreiner MediPharm’s Dul says.

To that end, FDA, NLM, the National Institutes of Health, drugmakers, and drug information companies are collaborating to improve the safe use of drugs by increasing access to updated data. Drug product information is now required to be uploaded as SPL files for use on Web sites, computer systems and other processes to make it accessible to healthcare providers, patients and the public. Prescribing and product information in the SPL format can be electronically managed, allowing users to search for specific data, such as indications, dosage and administration, and warnings.

“Since 2005, FDA has responded as soon as possible to requests related to the improvement of the content of labeling in SPL format to ensure that the labeling is clearer and more user friendly,” Mahoney says. “For example, to ensure that computer screen readers utilized by visually impaired persons are able to ‘read’ the information about images, FDA requires that SPL document authors include descriptive text which will permit the computer screen reader to provide a description of the content of the image file to visually impaired persons.”

There are solutions providers who specialize in enabling pharma companies to create and manage their labeling and drug listing information, NDC Labeler Code Requests, and Establishment Registrations in an SPL format. For instance, Glemser Technologies (Bethlehem, PA), a designer, developer and implementer of content management solutions for life sciences companies, offers xmLabeling for SPL which enables clients to do just. Glemser reports that its OnDemand Conversion Services allow companies to author MS Word-based product information documents and utilize Glemser products and services to convert these documents for submission to health authorities.

Nosco (Waukegan, IL) offers a system which allows pharma manufacturers to provide prescribing and product information directly to the company. “Nosco works directly with them to design the copy to fit their and the FDA’s needs,” explains Kregg Albrecht, VP, solutions engineering. “Since Nosco is providing all of the printing and converting of the packaging and labeling materials, coming directly to Nosco reduces cost and complexity for the pharmaceutical manufacturers.”

Life-saving innovations
The latest products from carton and label providers have enough space to accommodate more useful information while removing any obstacles additional components would have on packaging line efficiencies. Methods of artwork layout, including color schema and visual structure, are being targeted to help reduce medication errors, observers say.

Problems with medication errors are well documented and estimated to cause 100,000 deaths annually in the United States, according to the Institute of Medicine of the National Academies (IOM; Washington). Mistakes occur at different points of transition in care, ranging from admission to a hospital, transfer from one department to the next (such as from critical to general care), and at discharge from home to another facility. Further compounding matters are patient challenges in self-administration, which are numerous and include complex regiments, poor patient education and literacy.

Rx drug labels are now clearer, more user friendly and designed to improve patient safety. For example, Nosco’s Lit-a-Sure is a product that allows for the combination of customer’s FDA required literature to be attached to the pharmaceutical manufacturer’s cartons by Nosco. ”Lit-a-Sure can be designed in such a way that it will present itself to the customer when the package is opened, making it accessible, and compliance friendly,” Albrecht says. “The literature can be designed with a combination of PI and/or PPI and include other compliance prompting features such as calendarization or patient recording features.” Up to 130 panels in a single style format can be designed, or Nosco can attach multiple folded pieces into one compact literature pack.

Fix-a-Form (FaF) multi-panel labels are another form of labeling from Nosco that addresses the needs of the consumer for improved clarity and ease of information access. The labels provide multiple pages of copy, which are attached directly to the product or carton in an easy-to-read format. “Fix-a-Form labels keep the information at the fingertips of the consumer,” Albrecht says. “Multiple languages can also be printed on the same FaF, making access to many cultures using one label a reality.”

A technology which holds the promise of driving life-saving innovation to drug labeling is barcode-enabled medication administration (BCMA). BCMA is used to verify all medications electronically before they are administered to patients. Healthcare providers who implemented barcoding solutions found improved patient safety through the reduction of preventable medication errors, according to published reports.

“Barcoding is getting more and more important and there is an increasing use of 2-D barcodes which contain much more information,” Schreiner MediPharm’s Dul says. “However, there still seems to be some reluctance in implementing this widely within healthcare practice.” Industry members attribute part of the slow market acceptance to barcoding to lagging adoption of computerized physician order entry (CPOE); both the barcoding point of contact (BPOC) and CPOE are pieces of the closed-loop medication administration process.

Two-dimensional barcode systems – which have found greater adoption in the semiconductor and aviation industries – are also being used in the healthcare industry, observers say. The issue of software is critical, due to the fact that healthcare instructions generally have outdated software systems and the fact that these systems must comply with healthcare auditing and patient privacy regulations.

One more system also put into action in the past few years is the barcode requirement for the NDC number. This system, though at different stages of use at the dispensing level, was developed so one dispensing the drug can scan the barcode to ensure correct medication and dosage is administered. “One of the largest forms of medication error is a medication ‘mix up’—either with strength, form, drug, or timing,” the pharma company source observes. “A robust dispensing system tied into a database could not only warn the dispenser of a potential medication error, it could also be used to reduce or eliminate misadministration by warning about things such as drug-drug interactions.”

Further developments designed to minimize the risks of medication errors involve the use of peel-off labels (POLs), an application utilized prominently in Europe. POLs provide a clear identification of the drug or vaccine and variable data pertinent to the product. These labels are said to offer a competitive advantage to manufacturers who make use of the technology, and based on market surveys, are preferred by end users and much needed in both acute and alternate settings.

“Peel-off labels are a very useful tool as well,” Dul says, “especially when these are sophisticated solutions which combine ease of use with reliable documentation and safe tracking of the administered drug.”

Schreiner MediPharm offers a broad portfolio of labels with peel-off parts. These labels contain all necessary product information and have one or more detachable parts which help to clearly identify the drug, all the way from dispensing to patient administration. A recent development is the Pharma-Comb SL label with self-lifting parts for multi-dose medications.

“Due to its special construction, the detachable parts automatically rise after opening the outer label and can be easily and quickly applied to filled disposable syringes after drawing a dose from the vial,” Dul explains. “The peel-off parts contain all crucial information and can even be printed with a bar code on the backside.” POLs serve a dual purpose in providing a major barrier against counterfeiters because of the label’s complex build-up and manufacturing process.

By providing accurate and readable information, pharma companies can help educate and involve patients in their care. Industry members say they have been working together more than ever in finding solutions to meet the needs of the customers and the changing regulatory requirements and expectations. PC