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Title: Pharmacotherapy of diseases from the spectrum of eczema – an analysis of the concordance between recent expert guidelines, official drug licenses, and evidence for efficacy of recommended drugs

Abstract:

Physician's and Dentist's Profession Act (PDPA) imposes an obligation on Polish physicians to prescribe only drugs licensed for trade in the Republic of Poland. The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products authorizes the introduction of drugs to Polish market based upon the Summary of Product Characteristic (SPC) that - among others - defines the official indications for the use of a drug. According to the Polish Act on Pharmaceutical Law and the PDPA, prescribing a drug for treating diseases that are not among official indications listed in the SPC ('off-label' use) could be interpreted as a ‘medical experiment’, leading to a range of legal and financial consequences for the doctor. Moreover, the ‘off-label’ prescription results as a rule in the denial of drug reimbursement. The aim of this study was to analyze the concordance between official indications as determined in the SPC of drugs registered in Poland for treating diseases from the spectrum of eczema with up-to-date expert guidelines and the scientific evidence for the efficacy of recommended and registered of recommended and registered drugs. The policy of drug reimbursement was also analysed with this regard. ; Material and methods: The analysis included Polish and international expert guidelines for the treatment of diseases from the spectrum of eczema that were published within the last ten years. These recommendations were confronted with SPC of recommended drugs in order to select those which were officially licensed for the treatment of a given type of eczema. A systematic review of clinical trials of recommended or registered drugs was carried out with the quality of published results assessed according to the GRADE scale. Attention was paid to the discrepancies between expert recommendations and official indications as determined in the SPC. An additional analysis was done of regulations concerning reimbursement of drugs recommended or registered for the treatment of diseases from the spectrum of eczema. Results: The analysis included 20 recommendations by experts bodies, 565 SPC, 90 published results of clinical trials of drugs both recommended by expert bodies and registered in Poland for treating diseases from the spectrum of eczema, results of 85 trials of drugs that were recommended by experts, but not licensed in Poland for the treatment of eczema, as well as 3 trial results of drugs that were not recommended by experts, yet still licensed in Poland for treating certain types of eczema. From the list of drugs recommended by expert bodies for the treatment of atopic eczema (AE), 387 medicinal products containing altogether 38 pharmacological substances, as well as 20 emollients and 77 vaccines for allergen-specific immunotherapy were licensed for the use in Poland. Among theme, there were 84 medicinal products containing 25 active substances, and 5 emollients with official indication for the treatment of AE. Among the medicinal products both recommended by expert bodies and registered in Poland for the treatment of AE, clinical trials of high- or moderate quality have confirmed the efficacy of active components of 36 medicinal products, including 2 topical calcineurin inhibitors (pimecrolimus – 3 products, tacrolimus – 2 products), oral ciclosporin (12 medicinal products), and 19 out of 45 topical ; preparations of glucocorticoids (tGCS) registered for the treatment of AE containing five active substances (betamethasone dipropionate, mometasone furoate, hydrocortisone butyrate, fluticasone propionate, clobetasol propionate). Thirty medicinal products (containing 11 active substances) registered for AE treatment were covered by the reimbursement scheme, among them 19 medicinal products contained any of 5 active substances, whose effectiveness in the treatment of AE was proven by high- or moderate quality clinical trials (mometasone furoate, hydrocortisone butyrate, fluticasone propionate, clobetasol propionate, ciclosporin). Put together, there were 19 medicinal products available in Poland for the treatment of atopic eczema that were both recommended by expert bodies, officially licensed for the treatment of AE, with effectiveness proven by high- or moderate quality scientific studies, and reimbursed. Among medicinal products licensed for use in Poland, yet in diseases other than atopic eczema, there were 51 preparations of 7 active substances (betamethasone dipropionate, mometasone furoate, hydrocortisone butyrate, clobetasol propionate, azathioprine, loratadine, fexofenadine), and 24 house dust mite allergy vaccines for immunotherapy with efficacy in the treatment of AE proven in high- or moderate quality clinical trials. Among drugs recommended by expert bodies for the treatment of allergic contact dermatitis (ACD), 148 medicinal products with 26 active substances, and 20 emollients were licensed for use in Poland. Forty preparations containing 12 active substances, as well as 3 emollients were officially registered for treating this condition. None of the drugs which were both recommended by experts for treating ACD and licensed to Polish market contained active substances, whose effectiveness has been proven in high- or moderate quality clinical trials. Consequently, none of the 11 drugs reimbursed in the indication "allergic contact dermatitis" (4 active substances) contained a substance with efficacy confirmed in clinical studies of at least moderate quality. Among medicinal products available in Poland, but not registered for the treatment of ACD, there were 5 medicinal products ; containing one active substance (tacrolimus) with efficacy in ACD proven in moderate quality trials. Among drugs recommended by experts for seborrhoeic dermatitis (SD), there were 185 medicinal products registered in Poland with 27 active substances, including 68 preparations of 19 active substances with the official indication for the treatment of SD. Among drugs both recommended and registered in Poland for the SD treatment, there were 18 medicinal products containing active substances with efficacy proven in high- or moderate quality clinical trials, including 11 topical preparations of ketoconazole, 3 topical ciclopirox olamine preparations, as well as 4 out of 32 glucocorticoid (GCS) preparations registered for this indication (1 active substance – fluocinolone acetonide). Among recommended medicinal products available in Poland, but not registered for the treatment of seborrhoeic dermatitis, there were 24 medicinal products containing 3 active substances (cicropilox olamine, pimecrolimus, oral terbinafine) with efficacy proven in high- or moderate quality clinical trials. The reimbursement scheme for the indication “seborrhoeic dermatitis” covered six topical GCS preparations (4 active substances, none with efficacy confirmed in high or moderate quality trials) and 9 oral GCS preparations (4 active substances, none with confirmed effectiveness). Among drugs recommended by expert bodies for the treatment of hand eczema (HE), 382 medicinal products with 41 active substances, and 21 emollients were licensed to the Polish market. Out of these, only 6 local GCS preparations with 2 active substances (betamethasone, diflucortolone valerate), one oral preparation of the retinoid alitretinoin (9-cis-retinoic acid), and one emollient had the official indication for the treatment of this condition. Only one medicinal product registered for treating hand eczema contained an active substance with effectiveness confirmed in high- or moderate quality clinical studies (oral alitretinoin, high quality evidence). No medicinal products were placed on the reimbursement list with the indication "hand eczema". Among medicinal products available in Poland but not registered for the ; treatment of hand eczema, none contained active substances with effectiveness in HE treatment confirmed in high- or moderate quality clinical trials. The present analysis has also demonstrated that for some of the diseases from the spectrum of eczema, neither expert guidelines, nor drugs licensed for the given indication were available.Conclusions: There are considerable discrepancies between expert recommendations for pharmacotherapy of diseases from the spectrum of eczema, the scientific evidence for the effectiveness of recommended drugs, and the acceptable use of the drugs as determined by the Summaries of Product Characteristics (SPC) that are in force in Poland. The SPC do not reflect the current state of medical knowledge. Therefore, for the sake of patients, it is necessary to elaborate protocols of treatment routines acceptable to all stakeholders in the health system which would be based on scientific evidence for effectiveness and safety of the drugs, as well as their cost-effectiveness.

Place of publishing:

Kraków

Level of degree:

2 - studia doktoranckie

Degree discipline:

farmacja ; farmakologia

Degree grantor:

Uniwersytet Jagielloński. Collegium Medicum. Wydział Farmaceutyczny.

Promoter:

Radosław Śpiewak

Date issued:

2013

Format:

application/pdf

Identifier:

oai:dl.cm-uj.krakow.pl:3664

Call number:

ZB-120302

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Language:

pol

Access rights:

tylko w bibliotece

Location of original object:

Biblioteka Medyczna Uniwersytetu Jagiellońskiego- Collegium Medicum

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Last modified:

Jun 26, 2019

In our library since:

Mar 18, 2014

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ZB-120302 Jun 26, 2019
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