Switzerland’s Narcotics Regulation Jungle: Off-Label Use, Counterfoil Prescriptions, and Opioid Agonist Therapy in the French-Speaking Cantons
Abstract
:1. Introduction
- Receive notifications of CM prescriptions for indications other than those for which they were authorized (so-called off-label use; Art. 11 para. 1bis BetmG);
- Provide counterfoil prescription blocks to physicians intending to prescribe specific CM (Art. 47, para 5 BetmKV);
- Grant prior authorization for prescribing, dispensing, and administering CM to treat persons “dependent on narcotics” (i.e., authorization of opioid agonist treatments (OAT); Art. 3e BetmG).
- 1.
- A medicine is used off-label in Switzerland when the physician prescribes it in a manner not foreseen by the professional product information approved by Swissmedic. Off-label use is not prohibited as such and is common and routine in many medical sectors (e.g., oncology and pediatric medicine) [15,16,17]. Physicians must be sure to obtain the treated person’s prior free and informed consent. In other words, individuals treated must know that they are receiving an off-label treatment and that the latter may carry certain increased risks [18,19]. Generally, off-label use of medicines does not require any notifications.However, this is different for CM, for which prescription for non-approved indications must be reported to the relevant cantonal authorities within 30 days (Art. 11 para. 1bis BetmG). As this applies to all CM (e.g., benzodiazepines), we expect the cantons to receive many off-label notifications.The number of notifications would depend, in part, on whether a narrow or broad interpretation of off-label use is retained. Narrow off-label use relates only to the therapeutic indication (i.e., a medicine used for a medical condition that has not been approved). Broad off-label use includes all deviation from the approved notice of use (professional information), such as use at a greater or lower dosage, for a longer or shorter period than authorized, or in other patient populations [18,20].It is not clear whether Art. 11 para. 1bis BetmG requires notification only for narrow off-label use or also for broad off-label use. During a consultation of the initial article, which spelled out a broad definition, a majority of cantons were critical of the initial version [21,22,23]. They drew attention to the additional work for physicians, questioned the benefit of the article, and stated the unclear consequences for cantonal and federal administrations [22]. Yet, the current ordinance would support a broad interpretation since notification must include the name of the CM, quantity, strength, and indication [24]. Hence, we expect cantons to use different definitions.
- 2.
- One measure specified in the BetmKV to control the CM market is the requirement imposed on physicians to prescribe Schedule A and D substances only on triplicate counterfoil prescriptions [25]. In contrast, regular prescriptions are sufficient for Schedule B CM [26]. Swissmedic supplies the cantons with the trilingual counterfoil prescription block (CPB; French, German, and Italian) [27]. Each CPB consists of 25 counterfoil prescriptions featuring a copy protection safety mark and a unique prescription number. Cantons give or sell CPB to physicians. Hence, cantons may track stolen or lost CPB. Each counterfoil prescription consists of one original and two copies (counterfoils). The original (white) is redeemed at the pharmacy, while the physician must keep the blue foil, and the red foil is destined for the insurance company [28]. This counterfoil system creates a paper trail of dispensed CM. We would expect similar cantonal administrative procedures regarding the provision and use of CPB.
- 3.
- Opioid agonist treatment (OAT) is the standard treatment for opioid dependence syndrome. Its efficacy has been proven in multiple studies [29,30,31]. Opioid agonists, such as methadone, create a state of protective tolerance, which allows the person in OAT to reduce or stop taking heroin and initiate other medical and psychosocial care in parallel [32]. According to Art. 8 BetmSV, OAT aims to create distance from the “drug scene,” prevent procurement crime, decrease high-risk forms of consumption, reduce substance use and initiate abstinence.In Switzerland, all OAT treatments must be authorized by the cantons [33]. The BetmSV further specifies that only qualified persons can provide OAT [34], but only physicians can ask for authorization [35]. Apart from their profession, the type of qualification is not further specified in the federal legislation and is absent in most cantonal regulations. We would expect that all physicians with a license to practice (according to Art. 9 BetmG) are considered to have the qualifications necessary to provide OAT. Based on the supposedly exhaustive nature of federal legislation, we hypothesize that there are only minor variations in the conditions for OAT authorization.We selected physicians’ training and written commitments to comply with specific modalities by a person in OAT (so-called “treatment contracts”) since an all-encompassing analysis of OAT authorizations, in general, would have extended beyond the limits of this article.
2. Materials and Methods
3. Results
3.1. Off-Label Notification
3.2. Counterfoil Prescription Blocks
3.3. Opioid Agonist Treatments: Physician Training and “Treatment Contracts”
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Canton | Providing CPB | Price per CPB |
---|---|---|
Fribourg | CPA | CHF 7.80 ** |
Geneva | CPY | CHF 30.30 * |
Jura | CPY | free |
Neuchatel | CPY | free |
Valais | CPA | CHF 10.00 ** |
Vaud | CPA | free |
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Schmitt-Koopmann, C.; Baud, C.-A.; Junod, V.; Simon, O. Switzerland’s Narcotics Regulation Jungle: Off-Label Use, Counterfoil Prescriptions, and Opioid Agonist Therapy in the French-Speaking Cantons. Int. J. Environ. Res. Public Health 2021, 18, 13164. https://doi.org/10.3390/ijerph182413164
Schmitt-Koopmann C, Baud C-A, Junod V, Simon O. Switzerland’s Narcotics Regulation Jungle: Off-Label Use, Counterfoil Prescriptions, and Opioid Agonist Therapy in the French-Speaking Cantons. International Journal of Environmental Research and Public Health. 2021; 18(24):13164. https://doi.org/10.3390/ijerph182413164
Chicago/Turabian StyleSchmitt-Koopmann, Caroline, Carole-Anne Baud, Valérie Junod, and Olivier Simon. 2021. "Switzerland’s Narcotics Regulation Jungle: Off-Label Use, Counterfoil Prescriptions, and Opioid Agonist Therapy in the French-Speaking Cantons" International Journal of Environmental Research and Public Health 18, no. 24: 13164. https://doi.org/10.3390/ijerph182413164