| 1. |
- COMPAGNO STRANDBERG, MARIA, et al.
(author)
-
Evidence-based Anti-seizure Monotherapy in Newly Diagnosed Epilepsy: a New Approach
- 2020
-
In: Acta Neurologica Scandinavica. - : Hindawi Limited. - 1600-0404 .- 0001-6314. ; 142:4, s. 323-332
-
Journal article (peer-reviewed)abstract
- ObjectivesTo describe the process and results of the updated Swedish practice guidelines for monotherapy in epilepsy.Materials and MethodsThe Swedish Medical Products Agency led the process together with medical experts. Evidence rating in accordance with the International League Against Epilepsy (ILAE) template was linked to the Cochrane group's GRADE system. Evidence from recently published trials and meta‐analyses was added. A national expert panel participated in the project and contributed their clinical experience.ResultsIn seizures with focal onset, carbamazepine, lamotrigine, or levetiracetam is recommended for children and adults (ILAE level A‐C for adults/Cochrane level strong for children and adults). Oxcarbazepine is an alternative for children, although its level A evidence, in a single class I trial, could relate to poor phenytoin tolerability. Eslicarbazepine acetate, lacosamide, and zonisamide are alternatives for adults and gabapentin for the elderly (ILAE level A). Carbamazepine is not a first choice for the elderly due to its high potential for interactions. In generalized epilepsy with tonic‐clonic seizures (GTC), lamotrigine, levetiracetam, and sodium valproate are recommended for children and adults (ILAE level C‐D/Cochrane level moderate‐strong) although sodium valproate is contraindicated in girls and women of childbearing age unless special considerations are met. Ethosuximide is the first choice in absence epilepsy without GTC (ILAE level A).ConclusionsLamotrigine and levetiracetam can be used as first choice for focal seizures and generalized epilepsy with GTC, suitable in all age‐groups and for both men and women. Recommendations for GTC seizures have lower evidence than those for focal seizures.
|
|
| 2. |
- Kimland, Elin
(author)
-
Drug treatment in children with focus on off-label drug use
- 2010
-
Doctoral thesis (other academic/artistic)abstract
- There is a lack of paediatric documentation concerning efficacy and safety of many drugs, which contribute to drug use outside the terms of the product license (off-label). In the present thesis, four studies (I-IV), using different settings and design to evaluate pharmacological treatment in children, with focus on off-label drug use, is presented. Outpatient records of purchased prescriptions were retrieved to investigate the frequency and characteristics of paediatric off-label prescribing (I). In Stockholm, 1.8 prescribed drugs per child were purchased in the year 2000. Every fifth drug was classified as an off-label prescription. The proportion of off-label prescriptions was highest for topical drugs, due to lack of paediatric information. A survey of all adverse drug reaction reports to the Medical Products Agency concerning paediatric outpatients in the year 2000 was performed, to investigate the frequency of off-label drug prescribing (II). One hundred and twelve paediatric cases, corresponding to 158 adverse reactions were reported. One third of the reports were regarded as serious, and these were more often associated with off-label drug prescribing. Antiasthmatic drugs were most commonly reported. Psychiatric symptoms were the most commonly reported adverse drug reactions. Paediatric questions and answers to a Drug Information Centre in Stockholm were retrieved and analysed regarding off-label drug use and paediatric literature information adding to the labelling of the drug (III). During a 10-year period, 249 paediatric questions were handled. Every third question concerned off-label treatment, often concerning psychotropic drugs. In every other response to off-label questions, additional paediatric documentation concerning the drug was found in the literature. In a prospective, nation-wide, cross-sectional study, paediatric prescriptions and offlabel drug use to children at hospitals in Sweden were analysed (IV). Enrolment of more than 200 hospital departments resulted in data from 2947 paediatric patients, that received altogether11294 prescriptions within two two-day-periods in 2008. Half of all administered prescriptions concerned either off-label drug use or unlicensed or extemporaneously prepared drugs. Paracetamol was the most common drug used both on- and off-label. Absence of paediatric information was the main reason for the large proportion of off-label prescribing of carbohydrates and electrolytes in hospitals. This thesis has demonstrated substantial off-label prescribing to children in both primary and hospital health care. A common reason for this is the lack of paediatric documentation. Children have the same right as adults to well documented and safe drug therapy. Therefore, it is necessary to improve paediatric documentation through harmonization of existing scientific knowledge and clinical experience, improved structure of SPC information, and more appropriate administration forms. Furthermore, the documentation of drug treatment and its outcomes, including the reporting of adverse drug reactions, need to be improved.
|
|
| 3. |
|
|
| 4. |
- Kimland, Elin
(author)
-
Off-label drug treatment and related problems in children : a register-based investigation
- 2006
-
Licentiate thesis (other academic/artistic)abstract
- Introduction: There is a lack of pediatric documentation concerning efficacy and safety of many drugs, which may contribute to off-label drug treatment and increase the risk for adverse drug reactions (ADRs). Aims: To; (I) analyse the frequency and characteristics of pediatric off-label prescribing; (II) investigate frequency of off-label drug prescribing in pediatric ADR reports; (III) analyse drug related problems, the extent of off-label drug treatment in pediatric questions to a Drug Information Centre (DIC) and pediatric literature information adding to the labelling of the drug in DIC answers. Methods: Three retrospective register based investigations on drug treatment of children less than 16 years of age were performed. In study I, outpatient records of purchased prescriptions were retrieved and analysed. The analysis was restricted to the drugs that account for 90% of the total use (DU90%). In study II, a nation-wide survey of ADR reports to the Medical Products Agency in relation to prescriptions among suspected drugs in outpatients was performed. In study III, questions and answers (Q&A) to a DIC in Stockholm (1995-2004) were characterised and analysed. Results: In Stockholm 1.8 prescribed drugs per pediatric outpatient were purchased in the year 2000. Every fifth drug was classified as an off-label prescription. The proportion of off-label prescription was highest for topical drugs, followed by psychotropic drugs. In the year 2000, 112 pediatric ADR reports corresponding to 158 ADRs in outpatients were reported. The off-label proportion in ADR reports was more than 40%. One third of the reports was regarded as serious and these were more often associated with off-label drug prescribing. Antiasthmatic drugs were most commonly reported. Psychiatric symptoms were the most commonly reported ADRs. During a 10-year period DIC in Stockholm handled 249 pediatric questions and each question addressed on average 1.5 drugs. The questions mainly concerned drugs licensed in Sweden. Adverse drug reactions (ADRs), drug choice or dosing were the most common drug related problems. Every third question was off-label and among these the most common therapeutic group was psychotropic drugs. In every other response to offlabel questions, pediatric documentation concerning drug efficacy and safety was found. The most common reason for a drug to be classified as off-label was lack of pediatric labelling in the Swedish catalogue of medical products. Conclusion: This thesis has demonstrated substantial off-label prescribing in primary health care. Off-label prescribing were common in pediatric ADR reports from primary care. We also found literature information adding to the labelling of the drug. There is a great need for evidence based pediatric drug information, which can be retrieved from a DIC. A future challenge is to further diffuse this knowledge to pediatric prescribers through Internet, expert committees and medical journal databases.
|
|
