Pharmacists be prepared.
Since 1st November 2015, everyone dispensing prescription medicine in the US must comply with the Drug Supply Chain Security Act (DSCSA). That means every pharmacy, and every clinic, hospital, care facility and physician involved in the dispensing of any prescription medicine. DSCSA casts its net wide.
Where there is compliance there is enforcement. Where there is enforcement there is inspection and verification. So what must the pharmacist – every pharmacist – be prepared for? And what can happen if they are not?
“The purpose of DSCSA is to provide a “track and trace” system that allows every drug in the USA to be traced from the moment of manufacture to the moment it is dispensed.”
Let’s begin by addressing what DSCSA is for. If the FDA believed that:
- No drug was ever incorrectly manufactured
- No drug drug manufacturer ever subcontracted drug manufacture to an unapproved source
- All warehouses and all containers and trucks were entirely secure against theft
- No logistics contractor ever succumbed to the temptation to buy counterfeit drugs
- Every every pharmacist insisted on buying only drugs that could be proved to be correctly manufactured and that, as with logistics contractors, no pharmacist ever fell prey to the temptation to buy counterfeit drugs
… then there would be no need for a Drug Supply Chain Security Act.
But DSCSA exists and we must therefore assume that the FDA does not believe the statements listed above to be true.
The purpose of DSCSA is to provide a “track and trace” system that allows every drug in the USA to be traced from the moment of manufacture to the moment it is dispensed. When the act is fully in force, every package of every drug will bear a unique identifying code or number allowing it to be traced all the way through the supply chain. If there is ever a need to retrace every step of the route the drug took from manufacture to pharmacist’s customer, DSCSA will meet that need.
Nature Of Tracking
Tracking earlier in the chain will be part substantive and part transactional – that is, making sure the product was correctly manufactured and is what it is supposed to be as well as following the path it takes. As far as pharmacists are concerned, tracking is entirely a transactional matter. It must be possible to check every single transaction the pharmacist is involved in, from acquisition of a drug package to dispensing of the drug.
Inspections
The purpose of an inspection is simple: to verify that rules laid down by the FDA under DSCSA have been complied with. Because checking of pharmacists is transactional (see above), what all pharmacists have to ensure is that every single transaction they enter into is documentedand recorded.
The inspection may be carried out by the FDA, or – when a product has been recalled, or when there is suspicion that products in the supply chain may be suspect or illegitimate – by federal or state officials.
Necessary Documentation
The most important document that must be available at all times is the T3 – the DSCSA Transaction History, Information and Statement. Whether an inspection is random or motivated by suspicion, inspectors may choose any product or products and ask to see the relevant T3. Pharmacist should ensure that every T3 they have:
- is the correct T3 for the product to which they attach it;and
- contains the required data elements and meets the DSCSA requirements as to format.
For point (a) above, it is not enough for the pharmacist to know that the T3 they have is the right one for the product to which they have attached it; they must be able to prove that – to demonstrate beyond doubt that product and T3 match up.
An inspection is also likely to require the pharmacist to demonstrate the process by which the pharmacist meets the requirements of the Act in relation to archival and retrieval of T3 documents. The wise pharmacist will anticipate spot checks to show that this process does what it is supposed to do: that it allows documents to be retrieved quickly and efficiently.
Verification
There will be times when an inspection takes place because the inspectors believe that a particular product in the pharmacist’s possession may be suspect. Various factors may amount to suspicion: belief that the product may have been counterfeited, or that it may have been stolen, adulterated or otherwise made unfit for final use. The pharmacist may not be party to this suspicion and the inspector will have no duty to inform the pharmacist that suspicion exists.
It follows that the nature of the information and documentation the pharmacist will be asked to produce may not be straightforward. Although the Act does not specify everything that might be asked for, the wise pharmacist to whom we have already referred will wish to be sure of the ability to produce supporting evidence for every step and every date set out in the T3. It follows that T3s should be carefully checked at the time the goods they relate to are received – more on this below.
Penalties
A pharmacist unable to produce the required T3 documentation, or who produces inaccurate or inadequate documentation, may face a number of penalties. DSCSA envisions the fining of pharmacists in the circumstances; the product may also be quarantined.
There is also to be considered the fact that not all drugs received by a pharmacist are delivered to the end consumer. Pharmacists also on occasion lend, swap or resell drugs and when they do so they must ensure that they complete a T3 to mark the transaction; if this T3 contains inaccurate data, action may be taken against the pharmacist by the FDA or by state officials.
Finally, we have said that DSCSA exists to provide a “track and trace” system, but that is not its only objective. It also places on all elements in the supply chain – and that does include pharmacists – a responsibility to identify suspect drug products and report related issues. As well as implementing a recording, archival and recovery system allowing T3s to be produced at any point, pharmacists must also develop the habit of closely examining all T3s coming into their possession to ensure:
- that they accurately report the transaction that terminated with the receipt by the pharmacist of the drug batch named in the T3;and
- that nothing in the T3 would give an observant, informed and cautious recipient any reason to question the authenticity of the chain of transactions mentioned in the T3 or of the legitimacy of the drug itself.
This may be summarized as: “Don’t just receive and file the T3; read it carefully, too.”
