The
Exceptional Medicinal Treatment (EMT) Unit is responsible for processing
requests for exceptional medicinal treatment, which is defined as a medicinal
treatment which is not covered by an existing policy on the Government Formulary List.
In brief, an EMT
Request Form endorsed by a medical consultant is submitted for an
individual patient. The request is reviewed by the pharmacists within the EMT unit
and a technical case report is presented to the Exceptional Medicinal Treatment
Committee (EMTC). The EMTC was set up in line with the L.N. 58 of 2018: Health
Act (Cap. 528): Exceptional Medicinal Treatment Committee Regulations, with the
objective of evaluating the submitted applications and decide whether an EMT
request should be approved or rejected as per Exceptional Medicinal Treatment Policy.
The EMT unit finally co-ordinates the supply of approved items with the Central
Procurement and Supplied Unit (CPSU) and Pharmacy of your Choice (POYC) scheme
by providing the necessary information to:
I.
Initiate the procurement process and, once stock
availability is confirmed for a particular patient,
II. Ensure the necessary entitlement documents are in
place for the medication to be collected.
The process is illustrated here.
Frequently Asked Questions
- Who
can apply for exceptional medicinal treatment?
EMT applications need to be
submitted to the Directorate for Pharmaceutical Affairs (DPA) by a medical
consultant.
I. In case of an application for a drug/indication
which has never been approved in the past, counter endorsement by the
respective clinical chair is also required.
II. EMT which has previously been approved through
the EMTC for the same requested indication, also require counter endorsement by
the respective clinical chair, however the clinical chair can delegate
authority to endorse requests to respective lead clinicians.
III. No counter-endorsement is required for renewal
or change in dose of previously approved treatment.
IV. A critical request is defined as a submission
for medicinal treatment which, if not administered immediately, can result in
life-threatening consequences for the patient and thus needs to be initiated
with immediate effect. In this scenario, the medical doctor can endorse the
request on behalf of the clinical chair/lead clinician/consultant in order for
an emergency supply to be provided until the next working day of the respective
department, after which the normal submission procedures are to be carried out.
- Which
forms needs to be submitted in order for an EMT request to be evaluated?
An EMT request form is
required both for new requests and renewal of previously approved treatment.
Information submitted on the form needs to be fully legible and contain all relevant
information as to enable the compilation of a holistic review of the requested
drug for the specific indication.An ADR report needs to be
submitted together with the EMT form in case of requests for specifically
branded medicines.
- How is the EMT request form
submitted?
Applications
for new treatments, any renewals or change in dose can only be processed if
submitted electronically via email address: dpa.emt@gov.mt. No hard copies will be accepted.
- How
long do EMT requests take to be processed?
The EMTC generally convenes every
4 weeks in order to discuss submitted EMT and make the necessary approvals or
rejections. In some cases, further information is requested from the consultant
which would then need to be resubmitted to the EMTC.
Urgent requests, which are
defined as an EMT request which needs to be assessed before the next scheduled
EMTC meeting, are generally submitted to the EMTC within the first working day
following submission of application to DPA.
- Is
EMT stock readily available?
No. Approvals for non-formulary
items are procured on a named-patient basis. This means that stocks for each
approved patient is bought separately as per dose and quantity specified on the
EMT form. Hence, before a new patient is
started on treatment adequate stocks needs to be ensured so that treatment of
previously approved patients is not compromised. Once stock availability is
confirmed through CPSU, POYC are notified to issue out-patient entitlement
documents.
Renewals of exceptionally approved medicines
should be made at least 2 months in advance of their expiry in order to allow adequate time for processing
and for additional stock to be purchased. Any increase in dose requires
DPA approval before being
implemented.
- Is
the EMTC decision final?
Decisions taken by the EMTC are
final unless there is new evidence which was not previously available or
considered. In such cases, the request can be re-submitted for re-consideration
by the consultant through the EMT unit.