Professionals from the remember very well the year 1982. That was the year when seven people died in the Chicago area as a result of taking Tylenol capsules that had been laced with cyanide. Johnson & Johnson (the owners of the Tylenol brand) had to take extraordinary measures to respond to the crisis. In addition, the incident led the pharmaceutical industry to develop tamper-resistant packaging.
Fast-forward to 2015, when Turing Pharmaceuticals attracted massive negative attention for having raised the price of Daraprim, an antiparasitic drug, by over 5,000% (from $13.5 to $750 per tablet). The controversy highlighted for pharmaceutical companies the importance of protecting and enhancing their public reputation.
These two very different cases spread over 33 years, and a number of other incidents during the same timeframe, illustrate the difficult environment in which Pharmaceutical firms must operate. This operating environment also includes a number of EHS and Product Stewardship challenges that must be addressed. Let’s look at four of them.
1) Centralize Product Stewardship to Ensure Compliance
Pharmaceutical companies must make sure that their products are compliant with chemical regulations around the world (e.g. REACH in the EU, TSCA and FDA regulations in U.S.), and do not harm the environment or human health. The compliance status of a final product is a direct result of the compliance status of individual ingredients. Therefore, there must be full visibility over classifications and physical-chemical properties of chemical products. This is obtained through data and content from regulatory lists (for substances) and Safety Data Sheets (for substances or mixtures), as well as lab tests performed by the company itself. The information needs to be accessible throughout the enterprise to ensure that everybody is working with the same information. The data on ingredients must be used to assess their compliance, and to analyze impacts on the compliance of final products by rolling-up classifications. This allows firms to minimize risks of non-compliance throughout all business units and sites, and make sure that products are not harmful to the environment or human health.
2) Obtain Safety Data Sheets and Information from Suppliers
Pharmaceutical firms are part of chemical supply chains. Information about the properties of a substance or mixture, its hazards, instructions for handling, disposal and transport, as well as first-aid and exposure control measures are communicated through the Safety Data Sheet (SDS). Pharmaceutical companies need the SDSs of purchased chemical products and ingredients for three reasons: 1) Ensure the compliance of ingredients that will go in the final product, to make sure that the final product itself is compliant; 2) Ensure the safe handling and use of chemicals; and 3) Create compliant SDSs for some of their own products. In addition, pharmaceutical firms may require information on chemicals from suppliers that is not provided on an SDS. Given the multitude of suppliers and purchased materials, and the fact that SDSs can change, companies need to find an efficient, automated and cost-effective way to obtain information from upstream suppliers, including SDSs, material disclosures and product declarations.
3) Create Compliant Safety Data Sheets
Pharmaceutical products sold to the general public do not require SDSs. When you buy over-the-counter or prescription drugs, you do not receive a 16-section SDS compliant with HazCom 2012 in the US, or the EU CLP Regulation. However, pharmaceutical firms may need to create compliant SDSs under two scenarios: 1) When they sell or ship pharmaceutical products, especially intermediates, to other pharmaceutical firms; and 2) When they move substances or mixtures from one site or plant, to another. Creating SDSs is a daunting task. First, SDSs need to be compliant with the local jurisdiction. If a Pharmaceutical firm has a plant in Switzerland, and is going to ship chemicals to its plant in Germany, the SDS needs to be compliant with German laws. Countries have their own local regulations affecting SDSs, even if they are part of the EU and follow EU regulations (e.g. WGK in Germany, Maladies Professionelles in France). Second, SDSs must be translated in the local language. The EU is a good example. There may be a single CLP Regulation for SDSs, but SDSs must be translated in all local languages. In summary, SDSs need to be created in an automated way, with access to regulatory data and content, and translated in all applicable languages.
4) Ensure a Compliant Packaging, Not Just a Compliant Product
In the Pharmaceutical industry, compliance is not only about the drugs made available to the public. It is also about the whole product, including the packaging. The packaging of pharmaceutical products marketed to consumers also carries its own set of stringent regulations, in addition to the drug itself. For example, the Falsified Medicines Directive (Directive 2011/62/EU) in the EU requires mandatory safety features on the outer packaging of medicines, such as a unique identifier and an anti-tampering device, to allow the verification of the authenticity of medicinal products subject to prescription, and protect patients and companies. The unique identifier is placed in a 2D barcode and contains the product code, a serial number, the national reimbursement number, the batch number and the expiry date. As part of their product stewardship efforts, pharmaceutical companies must have complete oversight over all compliance requirements associated to packaging. The same diligence applied to ensuring the compliance of the drug itself must also be applied to ensuring the compliance of the product packaging.
If you want to learn more about how to successfully address those challenges, and others, affecting the Pharmaceutical industry, register for the webinar Pharmaceutical Spotlight: EHS Compliance Landscape & Effects on Products and Intermediates. The webinar will take place July 12 at 11am CDT / 12pm EDT / 17:00 BST / 18:00 CEST. Speakers include Peter Franke from ERM, James Lee from 3E Company, and Pam Bobbitt from Enablon. The recording of the webinar will be made available afterwards. During this webinar, you will learn more about:
- Business trends and challenges affecting the Pharmaceutical industry.
- Product Compliance issues to keep an eye on.
- How to ensure product compliance by leveraging chemical regulatory content and substance data.
- The benefits of a single, centralized, and integrated system for product stewardship and chemical compliance.