https://mhrainspectorate.blog.gov.uk/2016/06/03/qualification-of-customers-what-wholesalers-need-to-know/

Qualification of customers, what wholesalers need to know

In my last post I talked about the importance of ensuring medicines are only obtained from qualified suppliers. Equally important is the obligation distributors have in ensuring that only wholesalers or persons entitled to supply or administer medicines receive medicinal products. Wholesalers have a key role in guaranteeing medicines are only supplied to authorised organisations and qualified prescribers. This role is particularly important when supplying medicines with a potential for misuse.

Counterfeit-medicines

The MHRA has become aware that certain medicines subject to abuse, commonly diazepam, nitrazepam, zopiclone, tramadol and zolipdem have been leaking from the regulated supply chain and made available for sale in the black market and on illegal websites. These products are Schedule 4 controlled drugs under the Misuse of Drugs Act. Significant amounts of genuine licensed packs of these products from various manufacturers have been seized and recovered throughout the UK and Ireland.

Wholesalers are reminded that they have an obligation in GDP to monitor their transactions and investigate any irregularity in the sales patterns of narcotics, psychotropic or other dangerous substances. Unusual sales patterns that may constitute diversion or misuse of medicinal product should be investigated and reported to competent authorities where necessary.

In relation to wholesale distribution of scheduled controlled medicines to other wholesalers, companies must check their customers hold both a wholesale dealer’s licence and a Home Office controlled drugs licence of the appropriate schedule.

For distribution to a wholesale customer, the checks that should be made are similar to the qualification of suppliers outlined in my previous blog. A hard copy of the CD licence must be obtained from your customers prior to any supply being made.

For supplies to pharmacies, hospitals and clinics these organisations are not required to have a Home Office licence as their supplies are for patients. It is particularly important that the usage pattern is considered when fulfilling orders. We have seen pharmacies ordering up to a 2000 packs of these products monthly. That size of order is highly unusual for a retail pharmacy that does not hold a Home Office Licence. There should be procedure in place that sets defined limits to the size of routine orders that can be placed by customers that alert the company Responsible Person to investigate if excessive amounts are ordered.

If you have concerns about your customers ordering of controlled or other drugs, in the first instance email the GDP Inspectorate. Please include details of the company and the name and quantities of products that have been ordered in the last 6 months. This will be dealt with in confidence.

Other issues that arise in relation to customer supplies include medical practitioners who request supplies to their home address. The GMC medical register does not include the address of registered doctors so companies should avoid sending products to home addresses. Doctors operating in the independent sector will be working from clinics registered with the CQC in EnglandHealthcare Inspectorate in Wales, Healthcare Improvement in Scotland  and The Regulation and Quality Improvement Authority in Northern Ireland. Medicines should usually be dispatched to these verifiable addresses rather than residential properties. For example in one case ex-employees of a slimming clinic used a doctor's GMC registration, without their knowledge to set up accounts with deliveries to their home address.

For wholesale distributors exporting medicinal products to persons in third countries, they must ensure that such supplies are only made to persons who are authorised or entitled to receive medicinal products for wholesale distribution or supply to the public in accordance with the applicable legal and administrative provisions of the country concerned. As an example we see companies attempting to export products such as Botox to doctors and clinics in the USA. The U.S. FDA only permits health care providers to obtain and use only FDA approved medications purchased directly from the manufacturer or from wholesale distributors licensed in the U.S. In certain circumstances, the FDA may authorize limited importation of medications that are in short supply. Such medications are imported from approved international sources and distributed in the U.S. through a controlled network, and would not be sold in direct-to-clinic solicitations. UK licensed versions of FDA approved drugs are not treated by FDA as equivalent and must not be sold into the U.S. to doctors or clinics.

Finally, please be aware of any unusual orders that may come in from an export customer. Recently reported was an attempted large order of diazepam placed from a pharmacy in Africa. The purchase order was paid by a UK company purportedly acting on behalf of the pharmacy. They sent an individual in a van to the supplier, but with no paperwork to collect the products. The distributor was rightly suspicious and refused to hand over the products and reported the matter to us.

Like the qualification of suppliers it is important that there is periodic rechecking of the authority to receive medicines for your customers and such checks must be documented.

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Check out our guidance on good practice for information on the inspection process and staying compliant.

7 comments

  1. Stefan

    Hello Tony and thank you for the great blog. When a wholesaler dealer's licence lists more than 1 site, shouldn't there be a GDP certificate for each of them, too? There have been instances, where companies present a valid GDP certificate based on an on-site audit of let's say Site 1, whereas for Site 2&3 that are listed in the WDA, there has been no GDP certificates provided.

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    • Mark Birse

      Every site named on a wholesale dealers licence will be inspected and will generate a GDP certificate. As we have yet to complete a full inspection cycle since the introduction of GDP certificates there remain gaps, particularly for multiple site distributors. If they have a GDP certificate for one site, then that can be considered a good indication of the suppliers compliance with the principles of GDP.

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  2. Senthil Kumar

    Hello Tony, Thank you for this informative blog. Can you please advise on the requirements for qualification of customers with regards to supply of GSL products to wholesaler's within UK by manufacturer's/MAHs? Further will it be mandatory to check the availability of valid WDA-H licence, as a part of supply qualification of super market chains handling GSL products?

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    • Beverley Malin-Smith

      There are several points to consider when qualifying customers who are buying GSL medicinal products from a wholesaler, manufacturer or marketing authorisation holder. GSL medicines can be supplied to any person who may lawfully retail them, so it should be established if the customer is a retailer or a wholesaler when opening the account. If they are a retailer there are no registration checks required, but it is worth viewing any website they may have and if they are selling medicines on line that they are displaying the EU Common logo https://www.gov.uk/guidance/register-for-the-eu-common-logo . In cases where they are selling on line but not displaying the logo please report this using the online reporting tool http://medicine-seller-register.mhra.gov.uk/report/
      If qualification checks establish the customer is a wholesaler then they must hold a WDA(H) prior to placing any orders with the supplier.
      For supermarket chains deliveries of GSL medicinal products in to their distribution hubs is not wholesale distribution and a WDA(H) is not required to be held by them. If distribution for the supermarket chain is contracted out to a third party provider then those third party sites should have a WDA(H) naming the site where GSL medicines will be held.
      On behalf of Tony Orme

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  3. ade

    How much of a space per square foot is required by law to obtain a pharmaceutical wholesaler's licence?

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    • Mark Birse

      There is no minimum requirement for size of premises, given that different organisation do a variety of activities and scale of operations.

      All sites must comply with Good Distribution Practice

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