Reissuing pharmaceuticals in the NHS: Challenging the chain of trust
The UK Department of Health (DoH) has introduced a key policy concerning the reissuing of patients' own pharmaceuticals on admission into hospital, determining that this will save money and improve quality of care.
This report examines and questions the introduced DoH policy to show how it may represent a significant challenge to the integrity of the Chain of Trust, which offers protection to both manufacturers and patients.
Introduction
The long-term viability of every pharmaceutical manufacturer depends upon a reputation for always delivering products that combine efficacy with safety. Reliable combination of efficacy with safety secures the confidence and trust of consumers (patients) and of the health care practitioners (HCPs) responsible for prescribing and issuing medicines. Manufacturers must therefore take every reasonable measure to reduce the risk of any divergence from the expected (registered) benchmarks of efficacy and safety for each individual medicine.
Securing the combination of safety and efficacy is however not a simple task - because the majority of medicines delivered to the market combine beneficial biological activity with potential toxicity in formulations that can both heal and harm the human "consumer". There is always a need to establish and maintain the desired balance between heal and harm, and to minimize the inherent risks. It is thus essential for manufacturers to establish and maintain the most stringent standards of monitoring to ensure that they always deliver to the consumer's products of the highest possible safety and efficacy.
In practice the only way that manufacturers are able to monitor the efficacy and safety of each individual product is through constant monitoring of the physical composition (and packaging) of the product, and through monitoring of the pharmacological potency of the key constituent(s).
The formulation and packaging of individual medicines are defined in the registration and licensing documentation. Formulation defines the accepted limits of the chemical composition of each product - this can be precisely measured by appropriate laboratory analysis. Similarly, the pharmacological potency of the key constituent(s) can be precisely measured by appropriate laboratory testing. The packaging used to contain and protect each medicine is also strictly specified and subjected to prescribed laboratory testing of the stability of the contained medicine under specified time-related environmental challenges. Using these stringent laboratory-based assessments of the manufacture of each batch of a product a manufacturer constructs an evidence-based certification of the quality of a medicine.
This stringently evidence-based quality assurance (QA) certification not only serves as a guarantee of the quality of any medicine released by a manufacturer, it also infers an equal guarantee of the efficacy and safety of the medicines, because...
(i) The required efficacy of an individual medicine is defined by the registration and licensing documentation for each formulation. If the defined formulation is guaranteed by appropriate QA certification then the required efficacy is presumed to be equally guaranteed.
(ii) The safety of an individual medicine is maintained within acceptable limits, which are defined in the registration and licensing documentation (monitored and adjusted where necessary on the basis of on-going pharmaco-vigilance during marketing). The limits are laid down for each specific formulation - hence if the formulation is guaranteed by appropriate QA certification then the required margins of safety are presumed to be equally guaranteed by the QA certification.
Thus, the qualitative assessment of any sample of a medicine provides a practical evidence-based indicator of the quality, safety, and efficacy of any medicine.
The manufacturer generates the evidence-based guarantee of the quality, safety and efficacy of a product as a liability protection for the duration of the projected shelf-life of the product. However, once the product has been purchased and delivered into the supply chain for ultimate issue to the patient, responsibility for maintaining this guarantee is taken on (and shared) by the other licensed partners in the supply chain. Each partner in the supply chain takes on a requisite share of the responsibility for maintaining the quality (and inferred efficacy and safety) of an individual product produced and QA certificated by the manufacturer. Each partner in the supply chain has to trust the professional competence of the other partner individuals and organizations. This trust is secured through to the issue of a medicine to the patient by a regulatory framework (pharmaceutical regulation) which defines the "permitted" practices of all partners in a strictly licensed supply chain.
Hence, from the manufacturer through to the patient/consumer, the pharmaceutical supply chain constitutes a Chain of Trust.
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