With more than $200 billion lost to substandard drugs annually, the unholy grand cabal of fakers with an international network does not seem to be abating. The intensified efforts of both NAFDAC and the NDLEA are yet to cage the monstrous activities of the dare devil merchants of death i.e. fake and adulterated drug peddlers. PharmaTimes Editor, MORGAN NWANGUMA examines the latest technology that is hoped will bring about a lasting solution. Experts say Blockchain has the potential to transform healthcare in general and the pharmacy supply chain in particular.
In his resounding lecture at the 90th Annual National Conference of the Pharmaceutical Society of Nigeria (PSN) in Umuahia (Abia 2017), Dr. S. Nevin, Ph.D – the Keynote Address Speaker emphatically stated that Blockchain technology holds the key to checking the menace of fake and adulterated medicines.
The menace of fakery
Substandard or fake drug is medicament made in imitation of something else with intent to deceive the unwary buyer or consumer; it is indeed a forged product. On the other hand, an adulterated medicine implies that there is an intent to corrupt, debase, or make impure by the addition of a foreign or inferior substance or element; especially: to prepare for sale by replacing more valuable with less valuable or inert ingredient. This is according to experts, one of the major causes of adverse drug reactions aside medication errors, and the inherent chemical toxicity of the drug itself.
On various occasions both the National Food Drug Administration and Control (NAFDAC) as well other individual and corporate stakeholders in the health and pharmaceutical industry have called for legislations advocating stiffer penalties for offenders if that is the only way to curb the evil practice. According to a publication in the British Colombia Drug and Poison Information Centre, the issue of drug faking and adulteration is not a new phenomenon, and the form of deterrent to be enforced has always been an issue as well.
The publication states that in 9th century Arabia an official, the Mutsahib, was given authority to supervise the makers of drug products: “make them fearful, try them, and warn them against imprisonment.” Even penalties in olden times were quite harsh; in Salerno, Italy in the 10th century, the penalty for adulteration of a drug included: “whoever shall have or sell any noxious drug or poison not useful or necessary to his art, let him be hanged.” Concerns over quality control continued and eventually led to the creation of pharmacopoeias in the 19th century with their defined standards for drug purity.
This phenomenon as a matter of fact is indeed a global problem. But now, it is time to cage the beast. In Nigeria, notwithstanding the foot dragging on policy formulations and implementation, it seems that all over the world policy has not been able to effectively check the drug faking menace and cage the adulteration monster. But instead what we observe is the ever increasing latitude of the drug peddlers as the fake and substandard medicine market continues to thrive unabatedly, even to an assuming global epidemic.
Enter Blockchain technology
Blockchain is a decentralised platform that distributes and verifies shared data with trusted partners in secure, tamper-proof environment. This technology is the underlying distributed ledger system that enables peer-to-peer transactions of information in a secure manner.
A number of recent studies have been examining the obstacles and benefits of adopting blockchain technology for securing and optimising the pharmaceutical supply chain. According to Maria Palombini, Director, Initiative and Community Development, Global Business and Strategic Initiatives for IEEE Standards Association (IEEE-SA), “Global pharmaceutical supply chains are complex, siloed, and operate with legacy platforms that do not easily enable collaboration amongst the many partners, compliance with regulatory guidance, and cannot guarantee the security of the distribution of medicine.”
Even the World Health Organisation (WHO) has not found it funny in trying to input strategies to combat the growing phenomenon. It says that an estimated 10% to 30% of drugs are fakes even in the entire worldwide market; most of the quantum of the products in this category is circulating within developing countries. And this is also where the pharmacists should come into their own to play the role of expert druggists as well as community watchdog for the health of its populace.
Palombini said, “Community pharmacists play a vital role in the health care system and the pharmaceutical supply chain operation through the medicine and information they provide. They are the forward-facing touch point with a patient.” For the effective application of the blockchain tool, it will be vital to put in place the requisite information as would be required especially for the Community Pharmacist to effectively fulfill his/ her role in the scheme of things.
First of all, data must be put in proper perspective. In advanced climes this is not a problem, but in a society such as ours it leaves much to be desired. The key ingredients here are the patients, the prescription and then the drug data. There must be a policy on data collection; the pharmacist must have to run a data base around his/ her patients and the prescriptions. This automatically enables medicine tracking and traceability to its final destination – the patient. However, all three partners in the network are needed for effective monitoring of drug dissemination; the manufacturer, wholesaler as well as the pharmacy are all needed here.
And as things are, manufacturers may also become responsible in the tracing and tracking chain of medicines that eventually get to the consumer. What a big relief blockchain is going to bring to bear on the entire system: Fake and adulterated drugs make up a whopping $35 billion dollar global industry, and accounting for about more than 45% of all drugs sold in Africa and Asia, experts say.
Also the drug data held in their repository is compulsory if the blockchain technology is to pan out for our expected desire. Thus the drug expert holds a vital part in the whole scheme of things in this case because eventually, blockchain will make it possible for that data sharing capability without sacrificing privacy while offering pharmacists the ability to verify the source of a medicine.
Today the pharmacy practice is tended more towards patient centeredness and Blockchain Technology will be able to offer community pharmacists the opportunity to improve on patient safety by authenticating the source of drugs. It will as well enable the pharmacist to more effectively handle inventory to forestall the backlash resulting from shortages of medicines, and also enhance their involvement in a better organised drug recall process if it happens to arise.
With the use of Blockchain technology, pharmacists working in the communities will greatly benefit from its capacity to distribute, validate, safeguard, and handle data transactions on a system that is not centralised. Apart from these, it will in a nutshell aid the pharmaceutical supply chain in the following ways:
Facilitate cooperation with trading associates by sharing and authenticating data transactions with anonymity in a tamper-proof environment
Facilitate conformity with NAFDAC regulations and the National Drug Distribution Guidelines
Eradicate opportunistic gaps that encourage the propagation of the nuisance posed by fake drug merchants
Check and properly regulate the new phenomenon of online pharmacies
Better record keeping and control which makes for a better approach in curtailing shortage of medicines
Facilitate an organised process for recalling drug
Make all partners visible to verify the source of a drug by accessing one original source record that is time-stamped and unchangeable, with each new transaction attached to the original source
The workability of the Blockchain technology is that it will align completely with the overall motives and activities of regulatory as well as law enforcement agencies like NAFDAC and NDLEA – further enabling medication track-and-trace, product verification and notification of stakeholders about illegitimate drugs. A shared ledger of information to facilitate every of the above steps is a basic feature of blockchain technology.
According to Kevin Clauson, Associate Professor in the College of Pharmacy and Health Sciences at Lipscomb University, “One of the most promising benefits of blockchain from a patient safety perspective is to help stem the tide of the so-called SSFFC medicines – substandard, spurious, falsely labelled, falsified and counterfeit – that continue to plague the pharmaceutical supply chain.”
Due to the huge quantum of loss in the pharmaceutical and health care both to the patient and the drug industry, pharmaceutical supply chain integrity automatically becomes one of the most appropriate and challenging use-cases for blockchain. In the words of Tapan Mehta, a market development executive, healthcare and life sciences services practice, at DMI, a mobile technology and services company, “A blockchain-based system could ensure a chain-of-custody log, tracking each step of the supply chain at the individual drug or product level.”
In certain parts the potential applications for blockchain in the pharmaceutical industry are already being explored. An example of this is the BlockRX initiative, which has been set up to deal with the drug supply chain integrity problem by taking advantage of the distributed digital ledger to support and manage the drug development lifecycle. This is the world’s first blockchain initiative for the pharmaceutical industry. According to experts, transparency and traceability are critical to blockchain in the pharmacy supply chain.
And of course not being able to guarantee the integrity of your data comes at a huge cost. For instance GlaxoSmithKline had to pay as much as $3 billion in fines for promoting an antidepressant for unapproved uses and failing to report safety data about its top diabetes drug. So far this singular case has remained the largest settlement having to do with a pharmaceutical company.
According to Meta, “In the event that a drug shipment is disrupted or goes missing, the data stored on the common ledger provides a rapid way for all parties to trace it, and determine who handled the shipment last,” Mehta explained. “The public availability of the ledger would make it possible to trace every drug product all the way back to the origin of the raw material used to make it.” At the end of the day the pertinent thing about this technology is that it affords you the user real-time, actionable intelligence, without any of the data that isn’t actually useful to you. The reason is that it’s not just about you outperforming your competitors – it’s about using solutions that enable you work smart.
Blockchain application development for the pharma industry eliminates the question of verifiable data for the reason that the data in the chain cannot be falsified once entered. And since anyone with access can see the chain, there can be no question of a lack of data at any point in the process. You don’t need to trust blockchain because it isn’t necessary. The technology ensures data integrity in every transaction, and because every transaction in the chain is linked, the historicity and traceability of the data can be seamlessly followed; every transaction is linked and time stamped.