What does the Pharmaceutical industry have in common with the Big Bang theory of the Universe?

Medicinal Products…. Counterfeits…. Patient Safety:

Is increased dialogue between the Pharmaceutical Industry and Healthcare Professionals the answer?

Q:What does the Pharmaceutical industry have in common with the Big Bang theory of the Universe? A: Explosive expansion. In the case of the Pharma Industry, expansion caused by Market Forces and the need to be competitive.

Just three decades ago, the Pharma company was a self-contained nucleus, creating Medical Drugs and devices from raw ingredients and transporting them to the end user, often within the Local Market. Today, each stage of manufacture for one product is dispersed throughout the infinite corners of the globe.  As the dust settles, the problematic consequences of the elongated supply chain arise. Counterfeiting and Falsified Medicines are on the increase, and pose a huge risk to patient safety.

New combative Pharmaceutical Good Manufacturing and Good Distribution Practice (GMP and GDP) legislation have been introduced. This covers the supply chain from Raw Materials through to Medicinal Product delivered to hospitals and pharmacies. At this point however, there is a handover – to the Healthcare sector. Does the highly regulated culture of ensuring Product Quality, Safety and Efficacy survive the transition from Pharma supply chain through to the Healthcare sector? What are the responsibilities of pharmacists and hospitals in ensuring the authenticity of medicinal Products until consumed by the end user?

Anti-counterfeiting measures

In 2006 the World Health Organisation launched the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) aimed at protecting the manufacturing and supply chain of medicinal products and halting counterfeiting activities. This group is a partnership comprising international organisations, non-governmental organisations, enforcement agencies, pharmaceutical manufacturers associations and drug regulatory authorities.

Pharmaceutical companies have adopted measures to reduce the risk of counterfeiting; for example tamper-evident seals, holograms and serialisation that are applied to the product packaging. . However these come at a cost, at a time when companies are economising.

Falsification of pharmaceutical raw materials

Falsification of medicines can occur throughout the supply chain, even during production of  raw materials. In 2008 a global recall of Heparin was initiated due to serious injury and death associated with the blood-thinning drug that contained a deliberately contaminated active pharmaceutical ingredient (API) from China. This led to tighter controls in the production and sourcing of pharmaceutical raw materials. The Heparin incident was one of the instigators of the publication of the EU Falsified Medicines Directive (FMD) in 2011. All of the controls laid down in the FMD came into force in 2019, with the final mandate for serialisation of POM medicinal products in the EU.

The global impact of legislation

Manufacturers of APIs in India and China had opposed some of the controls laid down in the directives. The heavy investment required to comply with these new laws could cripple their business. In March 2012 The UK's Medicines & Healthcare Products Regulatory Agency expressed its concerns in a letter to the EC stating that countries exporting raw materials may be unwilling to participate in the FMD as it increases their regulatory burden.

Entry of counterfeits during distribution

The distribution supply chain of medicines and devices is also exposed to the risk of counterfeit medicines being inadvertently or deliberately introduced. Many recalls in the US and Europe have been the result of counterfeit medicines entering into the distribution channels. In the UK alone there had been 10 recalls from 2004 till 2009 of counterfeit medicines in the UK supply chain. In the US this figure is far greater. In February 2013, the Food and Drug Administration (FDA) issued an alert on their website about another counterfeit cancer medicine found in the United States. FDA lab tests had confirmed that at least one batch of a counterfeit version of Roche’s Altuzan distributed in the US contained no active ingredient. A lifesaving drug with no active ingredient has serious implications.

The publication of the EU GDP Guidelines (2013/C 343/01) on 7th March 2013, represented tighter controls for distributors and wholesalers. This was published in response to an increasingly complex pharmaceutical distribution chain. These guidelines work in conjunction with the Falsified Medicines Directive to ensure Patient Safety. These EU GDP Guidelines were adopted by the Pharmaceutical Inspection Convention Scheme (PIC/S) in June 2014 and now 49+ participating health authority members are supposed to follow these guidelines in their Country. It is certainly becoming more evident over recent years as global supply chain, including freight forwarders, are showing an interest to learn about the requirements of Healthcare supply chain quality.

Pharma ↔ Healthcare sector: abdication of responsibility v. dialogue?

Having manufactured and supplied Medicinal Products through a regulated, tightly- controlled, secure and integrated supply chain, what happens next? What are the responsibilities of the pharmacists and hospitals in ensuring the authenticity and Quality for the end user? Are pharmacies, hospitals and clinical trial investigator sites performing the right checks on the products they receive; storing them under the appropriate conditions? Are pharmaceutical companies ensuring that healthcare professionals are aware of the specific requirements of their Product? All parties involved in manufacturing, distributing and administering the product have a responsibility towards Patient Safety. Is there a continued dialogue?

To conclude, the pharmaceutical industry has its operations dispersed across many countries in an initiative to become more competitive in response to market needs. This in turn has increased the risks of substandard products entering the market place. The regulators and law enforcers have identified the risks, issuing directives and guidelines to tighten the controls on the entire supply chain. Everyone involved in the safe delivery of the medicinal products to the patient has a responsibility in ensuring (to the best of their ability) that the Product is of the right Identity, Quality, Safety and Efficacy.

 A Product that we would be happy to take.

Written by: Sanjay Nadarajah