title: Managing the risks of off-licence prescribing in pregnancy.
abstract: The dearth of randomised controlled trials confirming the efficacy, quality and safety of drugs used in pregnant women means that off-licence prescribing in this vulnerable patient population is commonplace. If a licenced drug harms a patient, the responsibility lies with the manufacturer. When an off-licence drug causes harm, the responsibility lies with the doctor. In theory, a doctor could be exposed to a claim of negligence solely for using an off-licence drug if harm was caused and if a licenced alternative was available. However, it is more likely that a failure to provide adequate information on which a patient can give informed consent will result in litigation. Off-licence prescribing is an important aspect of patient care. However, the doctor must ensure that the patient fully understands the relative risks and benefits of the treatment, what is meant by off-licence drug use, that a licenced alternative is available and the reasons why the particular course of action was chosen. The entire consenting process must be fully documented. Off-licence drugs are frequently given on grounds of cost, but cost constraints are not a defence to a claim of negligence. Sensible prescribing is key to managing the risks of using off-licence drugs. Whenever possible, licenced drugs supported by extensive clinical trial programs undertaken for regulatory approval should be used in preference to off-licence, unproven alternatives, particularly when both are equivalent in efficacy and no additional benefits are associated with use of the off-licence drug. Absence of evidence of harm is not the same as evidence of absence of harm.
authors.affiliation: Bevan Brittan Solicitors LLP, Fleet Place House, 2 Fleet Place, Holborn Viaduct, London EC4M 7RF, UK. saj.shah@bevanbrittan.com
authors.forename: Saj
authors.initials: S
authors.lastname: Shah
authors.forename: Herman
authors.initials: H
authors.lastname: van Geijn
mesh_terms: D002983:Clinical Competence; D017277:Drug Approval; D011307:Drug Prescriptions; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D008318:Malpractice; D010817:Physician-Patient Relations; D010818:Practice Patterns, Physicians'; D011247:Pregnancy; D011248:Pregnancy Complications / Q000175:diagnosis*; D012307:Risk Factors