Patient safety
Ensuring patient safety is one of the most important commitments a pharmaceutical company makes in the delivery of its products and devices. It is also an aspect of company activities which is highly regulated. Failure to meet regulatory requirements can have negative consequences not only for patients but for a company’s reputation and licence to operate.
Several high-profile cases in recent years of prescription medicines being withdrawn from the market due to safety concerns have sharpened demands from authorities and other stakeholders for companies to be even more vigilant in ensuring the safety of products, both during clinical trials and after they are marketed. Companies are expected to take a strong risk management approach to patient safety issues, and new guidelines and requirements are emerging within this area.
As one example, in 2006, the Institute of Medicine of the National Academies in the US published the results of a comprehensive review of the safety of prescription drugs, on behalf of the US Food and Drug Adminstration (FDA). The review emphasised the need for the FDA to improve safety monitoring of drugs after they have been approved and introduced into the marketplace, and made several recommendations now under consideration.
Novo Nordisk's approach
This atmosphere of heightened attention to patient safety underscores the central importance of ensuring the safety of Novo Nordisk products and devices.
Novo Nordisk has long had policies and processes and a comprehensive Quality system in place to minimise any safety risks connected with the use of its products and devices. It is our policy to take early contact with authorities and to be proactive in addressing any safety issues that arise. We strive to be open and transparent in our communication about the safety of our products. In adhering to high standards in both the manufacturing of products and their safe use by patients, Novo Nordisk is overall in high compliance with regulatory demands, as reflected by the outcomes of recent inspections.
Our obligations to the authorities
As a pharmaceutical company, Novo Nordisk is obliged by authorities to collect, investigate and evaluate information relating to side effects of medicines in order to protect patient health and advise authorities on drug safety. We are also legally bound to report individual adverse reactions related to the use of a product. Any potential safety issues are promptly reported to regulators. Following an evaluation together with regulators, a decision is made about action to be taken.
Monitoring safety at Novo Nordisk
Novo Nordisk has procedures, systems and processes in place to ensure that safety information on all serious adverse events is entered into a global Novo Nordisk safety database. This activity comes under the broad heading of pharmacovigilance.
Pharmacovigilance is the science and activities relating to detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. At Novo Nordisk, the chief responsibility for pharmacovigilance within the company is undertaken by International Product Safety (IPS), whose responsibilities include involvement in any emerging drug safety-related concern; provision to authorities of safety information which may influence the benefit-risk ratio evaluation of a product; and review of safety reports, new safety information and complaints.
This work is supported by hundreds of people throughout the Novo Nordisk organisation. Subsidiaries in the local markets are required to report serious adverse events within 48 hours and non-serious adverse events on a weekly basis, unless otherwise agreed.
IPS is organised according to three key processes:
- Customer complaint handling
- Safety case handling
- Safety surveillance
The vice president of IPS reports to the senior vice president of Quality.
Information about adverse events can come from a range of sources, including spontaneous reports from healthcare professionals and patients; post-marketing or observational studies; investigators who submit reports about ongoing clinical studies; regulatory authorities; medical and scientific literature; and the media. All such information is entered into the Novo Nordisk global safety database. The information is used to analyse, monitor and report on the safety of all our products to regulatory authorities.
Safety Committees
In order to be in compliance with procedures for handling adverse events and safety information, Novo Nordisk has several Safety Committees that review safety of specific products. For marketed products, members consist of representatives from the relevant safety surveillance department, global development, marketing and regulatory affairs, with ad hoc attendance from other relevant areas.
These are responsible for reviewing:
- The results of non-clinical studies in pre-clinical development
- The results of ongoing safety surveillance managed by IPS on Novo Nordisk’s products and devices
- Any safety concern that has come to the attention of any Novo Nordisk employee and which has been reported to IPS
The Safety Committee is the sole Novo Nordisk body responsible for initiating appropriate actions in the event of a safety signal or alert.
Datamonitoring committees
In order to protect the safety of clinical trial participants, Novo Nordisk may initiate external independent Data Monitoring Committees. These are formed to independently review and evaluate accumulating safety data from an ongoing clinical trial. Such committees may be warranted in clinical trials investigating high morbidity and/or high mortality trial populations, particularly in vulnerable populations or in long-term exposure clinical trials. Such committees are used, for instance, in the ongoing phase 3 trials of new indications for NovoSeven® such as intracerebral haemorrhage.
Clinical risk management plans
Another important feature of the Novo Nordisk system for ensuring safety of our products for patients is the Clinical Risk Management Plan. This plan identifies the potential risks associated with a medical product, methods to further clarify the safety profile of a product, and ways to minimise risk and achieve an improved benefit-risk ratio for individual patients in clinical use.
To enhance transparency of information to physicians and patients about the safety profile of products in clinical trials as well as marketed products, data from Novo Nordisk clinical trials is reported in a public database on the internet.
Continuous improvement
The robust quality system at Novo Nordisk has resulted in a consistently high level of performance regarding the safety of our products and devices as well as the manufacturing of products. Serious adverse events are reported in a timely fashion, and customer surveys indicate an improvement in the level of customer satisfaction.
These results are made possible through an efficient safety surveillance system. While Novo Nordisk makes every effort to continuously improve processes for ensuring patient safety, no medicine – nor any human activity – can be described as completely without risk. Safety is not the absence of risk. Regulatory authorities define a medicine as safe when its benefits outweigh risk. Novo Nordisk will continue to improve its pharmacovigilance approach in line with its own high standards, the requirements of regulatory authorities, and the expectations of society in order to earn the trust of its stakeholders.
This page has been assessed by PricewaterhouseCoopers as part of its assessment of Novo Nordisk’s statement that it reports ‘in accordance’ with GRI. Please refer to Audit and assurance for a full description of the nature of assurance offered.
