Koshi, Blerina and Zisovska, Elizabeta and Nica, Vasilka and Simonovska Crcarevska, Maja and Glavas Dodov, Marija and Slaveska-Raicki, Renata (2016) Model framework for off label use of medicines. Macedonian Pharmaceutical Bulletin, 62 (1). pp. 607-608. ISSN 1409-8695
Preview |
Text
Volume_62_supp.pdf Download (1MB) | Preview |
Abstract
Background
The drug licensing regulatory system ensures that marketed
drugs to be used, meet the high standards and requirements
for quality, efficacy and safety. Unfortunately,
in practice, prescribers are often obliged to deviate from
granted medicine marketing authorisation, due to the lack
of availability of appropriate medicines for patient’s therapeutic
needs and progress. This concept of medicines use
not mentioned in the approved labelling (FDA Modernization
Act) or outside of the terms of Summary of Product
Characteristics regarding indication, age, dosage, pharmaceutical
form and route of administration (British NHS
Guideline) is defined as off-label use of licensed medicines.
On the global level, many supportive evidence and
health care needs confirm that off-label medicines use
occurs in every country and each level or specialty area
of healthcare (Conroy, 2003). Moreover, it is an integral
part of Good Medical Practice and may provide the best
available option or even the standard of care in a particular
health condition (Dresser and Frader, 2009). In general,
this concept is legal and may be appropriate, but it can be
associated with safety, clinical and ethical concerns, emphasizing
the increased incidence of adverse events associated
with off-label medicines uses in particularly vulnerable
patient groups (Gazarian and Kelly, 2006).
A concerning issue is that the majority of all off-label
uses have limited to no scientific support (Radley et al.,
2006) and a considerable number of prescribers have no or
limited knowledge about off-label medicine use or do not
meet regulations regarding off-label use, if they exist. (Piñeiro
Pérez et al., 2014).
Experience shows that to ensure the quality of off-label
use of medicines, there should be a formal mechanism
to assess the feasibility, monitoring the safety and efficiency
of medication used based on this concept.Thus, in continuum,
the off-label use of medicines has been an essential
part of the ethical and legal considerations as well as,
many regulatory initiatives.
The overall objective is to present a model regulatory
framework setting out guidelines and recommendations for
quality use of off-label medicines within the national profile
of health care policy.
A literature search was undertaken to identify the issues
and challenges related to off-label medicines use including
clinical, safety and ethical concerns.
Recommendations for model framework
Principles of good practice for off-label use of medicines
should include the following elements: identifying
the medical needs; compilation of a consensus list of accepted,
scientific based off-label uses; creating an official
expert group for the evaluation and approval of specific offlabel
uses; and, providing a safe and effective supply. The
main guiding principles and developed activities to support
a responsible decision-making with regard to off-label
medicines include: 1) the medical need- the best avail-
S7 OP 290
608
Maced. pharm. bull., 62 (suppl) 607 - 608 (2016)
Oral presentations
Continuing professional development
able treatment in cases of specific characteristics when authorized
medicines cannot meet the patients’ need; 2) sufficient
scientific basis and/or clinical practice experience
to justify their action. Distinguish the routine off-label use,
which is the use of these medicines based on “high quality”
evidence and the use in specific exceptional circumstances;
3) information duty and a high degree of respect
for patient rights, involving the patient/carer in decisionmaking
process; 4) monitoring and reporting the outcomes,
efficiency and adverse reactions; 5) considering self-monitoring
of prescribing practices, liability and accountability.
An additional special responsibility which among others
falls on pharmacists should be to ensure that the prescriber
is conscious for off-label prescribing and the reasons for
that 6) production of compendia of certain medicines, enlisting
those off-label uses judged to be legitimate.7) financial
sustainability of an off-label use in medical practice.
Before deciding to compound a patient-specific preparation,
a step by step evaluation of alternatives should be
made. These alternatives include a therapeutic alternative,
dose rounding or manipulation of licensed dosage forms
(splitting tablets, crushing tablets/opening capsules, dispersing
their content in water or food, splitting suppositories,
the use of a preparation designed for another route of
administration).
Conclusion
Prescription, compounding, dispensing and administration
of off label use of medicines should be regulated
within the national profile of health care policy.
The regulation regarding the practice of off-label medicine
use differs between countries. Some countries have
this practice regulated by law, while in others it is covered
by good practice regulations or general professional
recommendations and ethical standards. Assuming that
there is no any general rule to regulate the “accurate” offlabel
use of medicines it is of paramount importance for
the countries to find a national solution to fulfil the ethical
and legal demand, especially in the areas of pharmaceutical
law and health insurance law. The common elements of
these regulatory frameworks are the physicians’ freedom to
prescribe off-label medicines if the scientific evidence exists
and the need to inform patients when making this decision.
Making policy efforts, by adopting appropriate guidelines
for off-label medicines use, based on scientific evidence,
with specifications of healthcare professionals’ responsibilities
and a registry of off-label drug use in every
day practice, would make possible a valuable approach towards
ensuring a quality use of these medicines. Recommended
solutions, as practiced in some countries, would
support prescribes in more direct and active approach to
handle the ethical and legal phenomenon associated with
the off-label use of medicines.
| Item Type: | Article |
|---|---|
| Subjects: | Medical and Health Sciences > Clinical medicine |
| Divisions: | Faculty of Medical Science |
| Depositing User: | Elizabeta Zisovska |
| Date Deposited: | 18 Oct 2017 11:40 |
| Last Modified: | 18 Oct 2017 11:40 |
| URI: | https://eprints.ugd.edu.mk/id/eprint/18333 |
Actions (login required)
 |
View Item |