As you might expect in a ‘life and death’ sector, this industry has extensive, stringent local and global Information Governance requirements. A new drug costs millions to develop and can take many years to get FDA approval. Compliance is key to the success of large Pharmaceutical companies.
But, it isn’t difficult to undermine all of this good work. A vulnerable global Pharmaceutical supply chain can result in patients not receiving the drugs they require. Information Governance can help control and manage the flow of information across the supply chain to increase its integrity.
The scale of the problem is immense. The World Health Organisation (WHO) estimates that up to 25% of drugs consumed in developing countries is counterfeit or sub-standard. Worse, Transparency International estimates that globally – including developed countries like the US – two thirds of medicine supplies in hospitals are lost to corruption and fraud.
Not only does this put the health of patients at risk, it puts the development of the next medical breakthrough at risk. No Pharmaceutical company can afford to invest billions into medicine development and then lose as much as 66% of its revenue.
The challenge is that the Pharmaceutical supply chain is both extended and opaque. There is little end-to-end visibility and a multitude of points where the supply chain can be open to attack. Information Governance can help by setting policies and procedures for managing and sharing information across the supply chain:
Manufacturers must operate their business in a way that mitigates risk and ensures regulatory compliance. The organisation has to create an environment where the appropriate information can be shared with others in the supply chain, especially local governments and distributors. As much of the supply chain monitoring may take place on mobile devices, policies need to be in place for the capture and management of information on those devices.
Transparent, effective and uniform laws and standards need to be established for drug registration by local authorities to assure drug quality control. These requirements need to be communicated to manufacturers and relevant information on new drugs supplied to the relevant systems. It is the responsibility of the registrar to conduct market surveillance and sampling, with subsequent information delivered to the relevant drugs company. Policies and procedures are also required, so that different elements in the registration process don’t become silos of vital information.
Procurement bodies such as health organisations and hospitals must assure transparent procurement procedures with written tenders and explicit criteria for contract awards. Information Governance is required to ensure information management around supplier selection with information held on bids received, reasons for bidder success and up-to-date information on products and services procured. This information should be securely available to manufacturers and distributors to measure the amount of legitimate drug that arrives from production to point of consumption.
Much of the onus for supply chain integrity will fall to distributors. At a minimum, the distributor needs information systems to ensure drugs are allocated, transported and stored securely. The systems must be communicated to all levels of the supply chain to control inventory and delivery. Stock has to be electronically monitored as it passes through the supply chain and information delivered to both the manufacturer and customer.
For a large global distributor, this will require an enormous amount of structured and unstructured information and a product deviation can be achieved just through a single email giving a change of delivery address. It also has to be securely managed to ensure it can be fully analysed in the event of a breach of supply chain integrity.
Pharmaceutical Prescribing and Dispensing
To prevent fraud at the point of consumption, information systems are required to monitor physician prescription patterns. In many countries, increased regulation is setting out how prescribers must operate and these systems must be able to show compliance. The systems also need to communicate with the manufacturers and distributors, both to facilitate automatic re-order where appropriate, and to ensure that the supply chain can be audited to determine that it was a legitimate drug that was prescribed.
While is it essential to regulate the development of new drugs, it is no less important to safeguard the integrity of the Pharmaceutical supply chain. This can only occur through end-to-end supply chain visibility based on safe and secure information sharing between organisations involved. Information Governance is required to establish the centralised information management policies and procedures to make this happen.