Review of Use of Drugs for Conditions Not Included in Product Characteristics

García-Sabina, A.; Rey, Ramón Rabuñal; Martínez‐Pacheco, Ramón

doi:10.1016/j.farmae.2010.06.006

Cited by 3 publications

(1 citation statement)

References 91 publications

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“…These arguments are not unanimously accepted, as on the contrary some authors recommend that the doctrine of informed consent should be strictly adhered to . The general consensus in Europe is that information and consent are necessary . There is, however, an inherent obstacle to obtaining consent: In psychiatry, although the need for consent is clearly stated , obtaining it may be problematic as the implications of off‐label prescribing are difficult to explain to some patients with cognitive disorders, and also because such explanations modify compliance with the treatment .…”

Section: Discussionmentioning

confidence: 99%

Off‐Label Prescribing by Psychiatrists: What is the Practitioner's Liability?

Bartoli

Berland-Benhaïm

Sastre

et al. 2015

Journal of Forensic Sciences

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In psychiatry, the molecules available and the dosages recommended when a drug receives marketing authorization are not always adequate to treat patients with major behavioral disturbances. Off-label prescribing is frequent in this context, with regard to the indications and the dosages given as well as to the drug combinations used. However, if complications or death occur, the practitioner's liability may be engaged. The authors report three deaths attributed to off-label prescribing in psychiatry and which led to charges against the physicians. They review the precautions to be taken when prescribing in such conditions (no other possible treatment, existence of sound scientific evidence, consent obtained from the patient, or their legal representatives except in cases of force majeure) and the physician's liability if adverse events occur that could be attributed to off-label prescribing.

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Section: Discussionmentioning

confidence: 99%

Off‐Label Prescribing by Psychiatrists: What is the Practitioner's Liability?

Bartoli

Berland-Benhaïm

Sastre

et al. 2015

Journal of Forensic Sciences

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Regulation of Drug Prescribing Information in Latin America and the Caribbean

Ramírez-Telles

Argotti-Rodríguez²

2022

Ther Innov Regul Sci

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Objective To describe the status of drug regulations in Latin America and the Caribbean, in force as of May 2021, and assess through a comparative exercise the differences between the countries under scope on prescribing information of drugs for human use. Materials and Methods A narrative review allowed the identification of the regulations concerning the prescribing information of drugs in 25 countries in Latin America and the Caribbean for the registration of prescription medications. On this basis, terms and concepts regarding this topic, the general provisions by the regulatory authorities for these products, applications for health registration and further amendments were identified for each country. Results The Latin American and the Caribbean countries included, manage and regulate drug prescribing information differently in terms of concepts, information publishing, structure for product information, among other criteria. Few health authorities publish product information on their website. Additionally, the patient information leaflet is not requested for prescription drugs in most of the studied countries. There is no standardized structure for drug product information within the region. Conclusions A poor level of harmonization among the regulations from these countries regarding the content and management (e.g. if physical package insert is required or not, if it is subject to notification or approval) of the prescribing information of human use drugs became evident. Also, there is a visible lack of standardization of concepts for referring to a specific document (e.g., package insert for healthcare professionals, patient information leaflet and technical information for the drug product) and in the content itself.

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Physician-pharmacist agreement about off-label use of medications in private clinical settings in Baghdad, Iraq

Hussain¹,

Abbas²,

Alhadad³

et al. 2017

Pharm Pract (Granada)

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Objective:1) To evaluate the relationship between physician-pharmacist agreement about the off-label drug use and 2) and to identify the most common off-label medication category/indications and prescriber clinical disciplines in private settings in Baghdad area, IraqMethods:This study evaluated 980 off-label use requests in the private clinical settings within Baghdad area, Iraq from October 2013 to September 2015. The efficacy, safety, and convenience of each drug request and its alternative options were evaluated according to the patient health and demographic characteristics and standard guidelines.Results:Of the 980 physician off-label requests, only 22.7% were approved by the pharmacists. Rheumatology and Nephrology accounted for the highest ratio of off-label use requests for adults (30.3% and 26.3%). The pharmacist rejection ratio of off-label use was comparable between the two groups (p>0.05). Most of the issued requests were attributed either to unapproved indication or to combination of more than one drug (38% and 35.3%). A low acceptance rate was reported in the requests issued for treatment in different clinical lines to the authorized one (11.9%). The lowest rate of acceptance was reported in the requests that had very low evidence level (9.1%). The mostly prescribed medications were musculoskeletal agents (28.9%). Finally, 78.2% of the requests came from clinical branches for adults. Although the agreement rate for requests in adults was higher than that in pediatrics, the two rates were not significantly different.Conclusion:Community pharmacists should effectively take responsibility for assessing off-label drug requests in Iraqi private settings. The quality of evidence does not represent the major factor influencing the approval rate of off-label drug use. The availability of safer and/or affordable alternatives and prescribing for a different patient age category highly impacted the pharmacists’ approval rate.

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Review of Use of Drugs for Conditions Not Included in Product Characteristics

Cited by 3 publications

References 91 publications

Off‐Label Prescribing by Psychiatrists: What is the Practitioner's Liability?

Off‐Label Prescribing by Psychiatrists: What is the Practitioner's Liability?

Regulation of Drug Prescribing Information in Latin America and the Caribbean

Physician-pharmacist agreement about off-label use of medications in private clinical settings in Baghdad, Iraq

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