The Spanish medicines regulatory authority (AEMPS) recently issued recommendations to help distributors detect, audit and report unusual sales patterns of human medicinal products suspected of being misused or diverted into unlawful trade (Recommendations). The Recommendations supplement (i) the Spanish decree on the distribution of human medicines, which requires distributors to report any conduct or suspicion of undue consumption or of diversion into unlawful trade, as well as (ii) AEMPS procedural guidance on reporting diversions, thefts and loss of medicines (including a reporting template).

According to the AEMPS, unusual orders may take place in particular when (i) there is a substantial increase in orders within a given period of time (generally more than a 20% monthly increase) that is unjustified or disproportionate according to market shares or usual patients’ needs, or (ii) there are suspicions of misuse of certain medicines which features entail a higher risk of diversion or abuse, such as hormonal derivatives that could be used for doping.

In that respect, the Recommendations require distributors to implement a procedure to detect, audit and report suspected unusual sales patterns to pharmacies (and certain clients under surveillance). The procedure shall apply adequate criteria in order to detect such patterns by considering elements such as product type (e.g, seasonal product) and sales history, type of pharmacy (touristic, rural), and any previous irregularities. The pharmaceutical technical director – or the person acting on his behalf – shall conduct a monthly audit of sales made to pharmacies (and certain clients subject to monitoring) in order to assess whether any unusual sales increase is justified. The audit should prioritise two groups of medicines included in the Annex to the Recommendations, and namely:

  • Certain medicines prone to diversion for misuse or unlawful trade, including: (i) those containing active substances used off-label in sports (anabolic steroid metenolone, androgens testosterone and esters and mesterolone, clenbuterol, insulin, etc.), (ii) psychotropics (e.g., certain benzodiazepine derivatives), and (iii) other medicines (such as codeine, oxicodone and ketamine). This is a non-exhaustive list that may be updated where appropriate.
  • Medicines under potential supply shortage that are included in a list published in the AEMPS website. These medicines are regulated under the AEMPS instruction no 2/2012 on prior notification of deliveries of medicines to other member states, which requires distributors – as well as marketing authorisation holders and other pharmaceutical companies at the AEMPS’ request – to notify any planned deliveries of these medicines to another EU member state to the AEMPS (e-notification). The AEMPS may refuse delivery on public health grounds in the event of supply concerns.

The distributor can also audit other medicines if it deems so appropriate and must do so at the authorities’ request. The distributor must keep evidence of the audits and submit it to the health authorities if so requested.

When the audit detects irregularities or diversions, the pharmaceutical technical director – or the person acting on his behalf – must draft a report indicating at least the distributor’s contact details, date, reported period, pharmacy (or client’s) contact details, details of the medicine (name, national code, ordered and sold quantities, sales history), as well as the reasons that raised suspicions and the conclusions resulting from applying the procedure.

The distributor must promptly send the report to the inspection services of the autonomous community where the warehouse concerned is located (or to the AEMPS department for medicinal product inspection and surveillance if the marketing authorisation holder is the notifying party). Notification of the report can be done by email under the recommended heading “Reporting of unusual sales patterns of medicines” together with other relevant information.

The Recommendations apply without prejudice to distributors’ compliance with regulations applicable to specific types of medicines (in particular, narcotic, psychotropic, immunological, radiopharmaceuticals and blood products) and with the European Commission guidelines on good distribution practice of human medicines.