MEXICO

On September 30, the Ministry of Health (Ssa, in Spanish) published a modification to the Official Standard NOM-220-SSA1-2016 which concerns the installation and operation of pharmacovigilance systems. The idea is for all Suspected Adverse Drug Reactions (SARM), Adverse Events (AE), Adverse Drug Reactions (ADR), Events Supposedly Associated with Vaccination or Immunization (ESAVI), and clinical manifestations caused by other problems related to the use of drugs and vaccines, to be notified to the National Center for Pharmacovigilance (CNFV, for its acronym in Spanish). The regulations came into force on October 1. 

The corresponding advisories by EA, SRAM and RAM are classified according to severity criteria. There are four possible scenarios: two severe cases or more; serious; notification of scientific literature; and not serious. The deadlines for reporting, depending on the situation that arises, are a maximum of 48 hours, 7 business days, 30 business days or 90 business days respectively. Likewise, in the event of serious side effects, the notification period is extended to 15 business days, but only if the holder of the health register, distributors, clinical studies or the pharmacovigilance program is involved.

These same categories apply to ESAVI, although non-serious cases must be reported within a maximum period of 7 to 30 calendar days (depending on the type of notification and with the exception of clinical trials, which must present their report when it is complete). In addition, serious cases in the National Health System must be made known within 48 hours. At all events, if there are two or more serious cases, notice must be given using the mechanisms established by the CNFV and detailed in the Pharmacovigilance Guide and all the deadlines indicated run as from the moment when the person responsible for notifying is made aware of what is happening.

In addition, on October 5, the General Health Council published a update to the National Compendium of Health Supplies in the Official Gazette, including a series of drugs in the therapeutic group of palliative care. The authorities have incorporated a number of drugs for cancer treatment, such as Hydromorphone, Megestrol, Morphine (used in terminal phases), Oxycodone, and Tramadol. The regulations, which are already in force, detail the adverse effects and contraindications for each of these prescriptions.