The Legal Supply Chain – How can we protect Patients?

How do we protect the Legal Supply Chain?

Answer: by increasing the number of referrals to the MHRA

The legal supply chain of medicinal products is a big factor is protecting the products and the patients (end users) who take them.

Sadly, many wholesalers are scared of the regulator but it should be noted that there is a legal requirement under section 43 of the Human Medicines Regulations for the licence holder to advise the competent authority of the purchase or offer of any medicines that are falsified, or suspected to be falsified. If you are approached by a trader that is involved with falsified medicines or suspected falsified medicines, you must also refer them.

This requirement also includes stolen and diverted products that may be offered or supplied; and at the time of update of this blog (May 2020) fake PPE equipment, Covid-19 test kits or devices.

The base inclination when receiving a call from a suspicious individual is to back away, reject the contact and move on.

Sadly, this allows the rogue trader to move on to the next and less diligent individual, who may buy/sell/discuss the products and think “it’s probably OK” or “there’s a profit” or learn from the experience to hone and refine their con.

What should you do if you are contacted by someone suspicious and/or you think a product has left the legal supply chain?

• Be friendly.
• Be polite.
• Be interested.
• Collect more information on what is for sale, how much, where was it from.
• Get telephone number and email.
• Ask how they will pay and where can it be collected, or how will they deliver it.

Collate all of this information, and supply it to the case referrals team at MHRA or your inspector (the most recent inspector that visited you for GDP).

 

Remember that if you are implicated in illegally trading in controlled substances or illegally buy or sell medicines, you face an unlimited fine, and between 2 years (Human Medicines Regulations 2012) and 14 years (UK law, supply of controlled drugs) in prison. Counterfeit medicines can attract a 14 year sentence for violation of intellectual property rights.

Both you and your staff should be trained in Falsified Medicines, and should know the definition of a falsified medicine. Your SOP on falsified medicines must give this definition. There must be procedures for receipt, checking and (where safety features are in place) scanning of the products.

Even if you are buying from nominated wholesalers and manufacturers within the legal supply chain, how do you know if a product is falsified? You need to be registered with SecurMed and you need to be aware of your obligations.

Are you?

Medicines enforcement

Enquiries about potential illegal dealings with medicines

Telephone (weekdays 9:00-17:00): 020 3080 6330

Telephone (out-of-hours emergency): 020 3080 6701

Email: casereferrals@mhra.gov.uk

Report suspected counterfeit/falsified medicines via the Yellow Card Scheme.

Telephone: 020 3080 6330

Email: counterfeit@mhra.gov.uk

 

The watchlist of substances of abuse is continually growing and so is the misuse of items on this list.

Many drug users have “turned to Diazepam”. Diazepam, formerly known as Valium, is prescribed for insomnia and anxiety and is increasing in popularity with drug users.

Diazepam has been used as a heroin substitute, and often taken alongside alcohol and methadone to ease the comedown from crack cocaine. This, combined, with other drugs can lead to high risk of overdose.

With increasing headlines and press coverage, pharmacists and wholesalers are on the front line, and are in a good position to help reduce risks around Z drugs and Pam drugs.

 

Sadly, and in many cases, pharmacists and wholesalers have been part of the cause and continuation of the problem. From the misuse of Diazepam  Valium/blues, Z drugs (Zopiclone and Zoplidem) and Pregabalin bought online, these illegal sales are causing fatalities and the misuse of these “sleeping pills” is destroying lives.

Changes in regulation (Pregabalin and Zopiclone becoming controlled drugs), and enhanced action from CQC and  …it doesn’t stop there!

At least 60 UK drug deaths in the first 8 months of 2017 were linked to Fentanyl.

TV shows on Netflix like Drugs Inc and Dope show both sides of the story, with law enforcement and dealers, and how Fentanyl powder is being added at production with opium gum to enhance the high of the heroid, which is now reaching Europe.

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What are the issues?

The threat to the legal supply chain is not only falsified or defective medicinal products….

The threat is also with the GENUINE licensed products intended for supply within the United Kingdom. Unlawfully diverted from the legitimate supply chain, the genuine products were being prescribed online with little oversight, and from non-CQC registered premises, and brought with the intent to supply on streets as a substitute heroin or for cocaine/crack users to aid in combating their “comedown.”

These were not stolen or counterfeit/falsified products. These were genuine products that were being personally misused by patients or purchased to resell on the streets of the UK.

Some wholesale dealers have been willfully neglectful or are completing weak or no due diligence checks and allowing excessive purchases by pharmacies or other wholesale distributors with increasing number of deaths and addictions.

 

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