sou · H0B375 · 2012-10-31 00:00:00 — Criticism has been directed against the system owing to the fact that for certain patients, mainly the elderly and persons taking several pharmaceuticals, it creates problems when a previously familiar pharmaceutical is replaced by another. This can, in certain cases, lead to medication errors. From the pharmacy side it is argued that the monthly substitu- tions from one to another product of the period drive up handling and logistics costs. The pharmacy sector also maintains that the substitution system lies behind deficiencies in supply/availability for the . Problems with the current model, however, are not, in the opinion of the Inquiry, of such a character as to justify the creation of a new substitution model, particularly bearing in mind that a changed model must be able to guarantee the same price squeeze and savings for the public purse. Instead, the Inquiry proposes changes within the framework of the existing system with the aim of reducing the negative features that have been identified. Repeated substitutions can be problematic, particularly for the elderly and those prescribed several pharmaceuticals. In certain cases it is not appropriate for the prescribed pharmaceutical to be substituted. As things stand at present, the pharmacist has the pos- sibility of going against the substitution for patient safety reasons. It is proposed to regulate in law this exception to when substitu- tion shall take place. The Inquiry proposes also that the pharmacist be given the possibility, where there are special reasons for this, to substitute a pharmaceutical previously issued against prescription for the currently prescribed pharmaceutical. The purpose with the proposal is to allow a patient to stay with the same product in the case of all or certain of the issued pharmaceuticals during the entire validity of the prescription. The proposal means that the pharma- ceutical issued on a previous occasion can also be issued on the following occasion, even if it is neither the product of the period nor the particular pharmaceutical that has been prescribed. It is important that the Dental and () has sufficient supervisory capacity to be able to monitor situations when substitution does not take place. It is therefore proposed that submit information on sub- stitution to the Agency (TLV). It is recommended that the substitution period (sale period) in the substitution system be extended from one to two months. This may mean fewer substitutions for patients who collect their pre- scriptions frequently. The most important consequence, however, is that the pharmacys handling and logistics costs, driven up by a new product being designated as the product of the period, will be lower. The supplier who wishes to have its product designated the product of the period shall apply for this specially, prior to each substitution period. One problem indicated by the pharmacy sector is that shortages occur, i.e. that the wholesale business is unable to deliver the product of the period to the pharmacy. To avoid, as far as possi- ble, this situation arising, the proposal for longer substitution peri- ods also implies that the period from the decision of the Dental and () concerning the prod- uct of the period until the start of the substitution period be ex- The supplier thereby has longer time to build up adequate stocks so that shortages can be avoided. Regardless of how the substitution periods are arranged, the In- quiry considers that a requirement should be introduced for the supplier to actively apply for, or register, in order for a pharmaceu- tical to be designated product of the period. In this way, the situ- ation is avoided where an item is unintentionally designated as product of the period e.g. through competitors having raised the price. In addition, differentiated sales periods are recommended. Un- der the present model, the pharmacy may, during the first 15 days of a period, issue the product of the period from the preceding period at the sale price that applied during that period. The Inquiry proposes that the sale period be differentiated between products with high and low turnover respectively. For products with low volume, 15 days may be an unnecessarily short period, whereas it may be unnecessarily long for products with large volumes. For the pharmacy, the proposal implies enhanced scope for selling off products with low turnover, i.e. it mitigates the effect of change in the product of the period. As shown above, the inquiry has considered introducing a sup- ply obligation for those holding a licence for sale of a pharmaceuti- cal, but it has considered that at the present time it is difficult to justify such an obligation. It is proposed, therefore, that the is entrusted with the task of surveying shortages and backorder list- ings and, where appropriate, recommending appropriate measures. This task also relates to shortages etc. in relation to generic medi- cines. It is therefore essential that the , in its task, consults with the Dental and (). An effective substitution system demands that individual retail pharmacies comply with the regulatory framework. The Inquiry recommends that the Dental and () shall be entitled to levy an administrative fine (penalty fee) on the retail pharmacy which does not comply with the provisions concerning pharmaceutical substitution. A prerequisite for the introduction of provisions on administrative fines is, however, that it is clear and predictable regarding the situations when an admin- istrative fine can be levied and that IT systems are developed with the aim of better supporting the monitoring process in accordance with the applicable regulations. The Dental and () should review the provisions that can bring into effect an administrative fine and ensure that these provisions are clear and predictable. Furthermore, measures to further strengthen patient safety are proposed. It is important that the patient receives information concerning what the generic substitution implies and also the rea- sons behind its introduction. This inquiry therefore recommends intensified information inputs targeted at the patient. Substitution implies that patients handle different packs with different names for the same substance. For those patients with several pharmaceuticals this may mean that a large number of packs are being handled. So as to minimise confusion (mix-ups) and mis- understandings it is desirable that the substance name clearly ap- pears on all packs. This can take place through clear information on the pharmacy label and change in the packaging appearance. The Inquiry proposes that packs should be marked with information on what is prescribed and what is issued, as well as name of the substances on the pharmacy label. In addition, it is recommended that the government continues to work for change in regulatory framework concerning pharmaceutical packaging and investigates the possibilities for a voluntary national agreement. There is a need for developing the IT systems at pharmacies and wholesale businesses as well as at the Dental and () in order to achieve the positive effects which the proposals described are expected to facilitate. It is con- sequently proposed that the Dental and () and are entrusted with the task of specifying how the pharmacies IT systems should be de- signed and how they should be used so that pharmacies shall be able to comply with the applicable regulations. In summary, the Inquiry submits the following proposals: The possibility for pharmacists, out of regard for patient safety, to go against product substitution is regulated. Where special reasons apply, the pharmacist has the possibility of substituting for the prescribed pharmaceutical a pharmaceutical that has pre- viously been issued against the prescription. Extended periods in the substitution system, so that the new product of the period is designated for two months at a time instead of one month as at present. This is then combined with a longer preparation period for the suppliers. Demand that suppliers actively register/apply for their particu- lar product being designated as product of the period. Differentiated sell-off periods, which can lead to longer sell-off periods for low volume products. The survey that the , in consultation with the Dental and , is recom- mended to adopt in respect of backorder listings should form the basis for renewed assessment of a possible supply obligation for pharmaceuticals, including generic ones. Administrative fines for pharmacies that fail to comply with the provisions concerning substitution. Strengthened information efforts concerning generic substitu- tion directed at the patients. Marking of packs with information on what is prescribed and what is issued as well as the name of the substance (ingre- dient). Furthermore, it is proposed that the government contin- ues to work for changes in regulatory framework for pharmaceutical packaging as well as investigating the possi- bilities for a voluntary national agreement. Developed IT systems at pharmacies and wholesalers as well as at the Dental and () in or- der to achieve the positive effects to which the proposals de- scribed are expected to lead. This Inquiry is of the opinion that these changes, taken together, will lead to an improved substitution system with improved access to pharmaceutical products and, most important, enhanced patient safety. Certain other matters (Chapters 15–18) Notification in case of substitution The Inquiry has been commissioned to propose statutory changes in order to facilitate the pharmacys reporting back to the pre- scribing professionals in the case of generic substitution. point for Inquiry deliberations is that the prescribing professionals need information that substitution has occurred. The Inquiry con- siders that, as things stand at present, the most suitable way to frame the provision concerning the retail pharmacys reporting duty to those prescribing is to remove the demand for this being in written form. The pharmacy operator can thereby itself determine in which way they wish to inform the prescriber, e.g. by electronic means. Various projects are under way that may simplify the obli- gation to notify, e.g. the work with the national prescription data- base (NOD). Duty of confidentiality and supervision of personnel at extempore pharmacies Extempore pharmaceutical fulfill an essential function; in certain cases they are the only possible treatment for the patient. Extempore pharmaceuticals can be produced at extempore pharma- cies. This Inquiry has the task of investigating whether there is a need for new provisions concerning the duty of confidentiality and supervision over personnel at extempore pharmacies. At present, it is considered unclear if this is subject to regulation. Through the extempore pharmacy handling prescriptions, information on the individuals state of health is also handled. Personnel at extempore pharmacies should therefore be covered by the duty of confidenti- ality and by supervision of fare (), a similar state of affairs as applied before the re-regulation of the pharmacy market. For this reason, amend- ments should be made to the Patient (2010:659) so that is clear that extempore preparation is part of the Swedish health care system and the personnel are health care personnel also. Information on scope of prescription rights Access to information on the scope of prescription right is neces- sary in the case of the issue of pharmaceuticals by retail pharma- cies. The prescription right may, for example, be withdrawn, lim- ited or relate to the prescription of certain pharmaceuticals only. is doubtful that the current legislation permits the prescription register to contain the relevant data and that may offer this to the retail pharmacies. A registration of the pre- scribing professionals Swedish ID number (personnummer) is necessary for Apotekens Service ABs handling, however the ID number shall not be searchable or accessible for pharmacy person- nel. Regulation of a central register for powers of attorney At present, there is no joint power of attorney register for all retail pharmacies. The Inquiry is therefore entrusted with the task of analysing whether the National Prescription Register should be amended in order to regulate Apotekens Service ABs power of attorney register so that it becomes accessible for all pharmacies. The Inquiry adjudges that a central power of attorney register fa- cilitates matters both for the retail pharmacies and for the custom- ers. No disadvantages with such a register have emerged. already has a power of attorney register, in that connection no new information or costs for Apotekens Ser- vice AB arise. The power of attorney register should therefore be regulated in the National Prescription Register . New rules concerning storage of data stores customer-specific data concerning e.g. prescriptions and the high-cost threshold (högkostnadsskyddet). Such data preservation presupposes consent from the individual. Current provisions entail problems for retail pharmacies, the cus- tomers and for since they require that new consent in respect of storage must be obtained at regular intervals. In practice, the customer-specific data also needs to be saved for a longer time that what is applicable at present. The Inquiry has the task of reviewing the provisions relating to data storage and sub- mitting draft statutes which solve the problems that arise with the present formulation. The question as to how long a consent submitted shall be kept means achieving a balance between the integrity protection interest and the information requirement. The judgement is that consent offered should be respected until further notice. There is also a need to find an appropriate preservation period for data contained in prescriptions, the costs cap database etc. The Inquiry proposes such amendments. Permit for pharmacies and wholesalers to trade narcotics At present no permit is required for pharmacies to prepare narcotic drugs or for retail pharmacies and wholesalers to carry out trade with narcotic drugs. The task of the Inquiry is to analyse how Swe- dens Narcotic Drugs Control Act can be adjusted to the UNs Convention on Narcotic Drugs. The Inquirys proposal means that legislation is formulated in accordance with the wording of the UN Convention. The exemption from the permit requirement is thereby withdrawn. Furthermore, no special treatment of state- owned companies is permitted. However, retail pharmacies do not need to have a separate permit for conducting trade with narcotic pharmaceuticals. Entry into force (Chapter 19) An implementation of the Inquirys proposals requires statutory amendments. The draft statutes are proposed to enter into force on 1 2014. Apart from time for the customary circulation for comment (consultation process) and work on the government bill there will be a requirement for preparatory time so far as the differ- ent stakeholders are concerned e.g. to revise and develop new reg- ulations as well as to develop IT systems. The proposal for a new pricing model for original pharmaceuticals without generic com- petition implies relatively far-reaching changes for the authority concerned (Dental and ) but also for other stakeholders e.g. the county councils. It is of central im- portance that these preparations are allowed sufficient time and that the stakeholders collaborate properly during this period. Some of the preparations may involve contractual adjustments in respect of certain points between the central government and county councils/ Authorities and Regions. The Inquiry proposes that be entrusted with the task of developing a joint search system. The Inquiry has sub- mitted proposals for regulation which is required for a search system to be able to function. has reported on its assignment there may be a need to review the The Inquiry adjudges that all proposals are in accordance with EU laws. The proposal concerning the introduction of permits for trade with narcotic pharmaceuticals must be notified to the EU Commission. lag om ändring i lagen (1992:860) om kontroll av narkotika Härigenom föreskrivs att 4 och 5 §§ lagen (1992:860) om kontroll av narkotika ska ha följande lydelse. Med tillverkning avses i denna lag framställning, omvandling, bearbetning, avvägning, uppräkning, förpackning eller ompackning Tillverkning av narkotika får Tillverkning av narkotika får bedrivas endast av den som har bedrivas endast av den som har tillstånd till det. tillstånd till det. dock inte för att på apotek göra en dock inte för att i vetenskapligt beredning med narkotiskt ämne syfte framställa narkotika vid en som verksam beståndsdel eller för vetenskaplig institution, som ägs att i vetenskapligt syfte fram- eller stöds av staten. ställa narkotika vid en veten- skaplig institution, som ägs eller stöds av staten. 1 Senaste lydelse 2011:114. Handel med narkotika får bedrivas endast av 1.den som med tillstånd antingen har infört varan till riket eller har vidtagit sådan åtgärd med varan som innebär tillverkning, 2.den som enligt 2 kap. 1 § eller 4 kap. 1 § andra stycket lagen (2009:366) om handel med läkemedel får bedriva detalj- handel med läkemedel, eller 3.någon annan som har till- stånd att handla med varan. Handel med narkotika får bedrivas endast av 1.den som med tillstånd antingen har infört varan till riket eller har vidtagit sådan åtgärd med varan som innebär tillverkning, eller 2.den som har tillstånd att handla med varan. Handel med narkotiska läke- medel får bedrivas utan sådant tillstånd som anges i första stycket av den som enligt 2 kap. 1 § lagen (2009:366) om handel med läke- medel får bedriva detaljhandel med läkemedel till konsument. 1.Denna lag träder i kraft . 2.Den rätt att tillverka narkotika som apoteken har enligt den äldre lydelsen ska gälla som tillstånd enligt den nya lydelsen till dess att tillstånd enligt 4 § den nya lydelsen har meddelats, dock längst till och med . 3.Den rätt som den som anges i 2 kap. 1 § eller 4 kap. 1 § andra stycket lagen (2009:366) om handel med läkemedel, har att handla med narkotika enligt den äldre lydelsen ska gälla som tillstånd enligt den nya lydelsen till dess att tillstånd enligt 5 § den nya lydelsen har meddelats, dock längst till och med . 2 Senaste lydelse 2009:369. lag om ändring i lagen (1996:1156) om receptregister Härigenom föreskrivs i fråga om lagen (1996:1156) om recept- register dels att 6, 8, 9, 11, 12, 18 och 19 §§ ska ha följande lydelse, dels att det i lagen närmast före 18 a § ska införas en ny rubrik av följande lydelse, dels att det i lagen ska införas en ny paragraf, 18 a §, av följande lydelse. Personuppgifterna i receptregistret får behandlas om det är nödvändigt för 1. expediering av läkemedel och andra varor som förskrivits, 2. registrering av underlaget för tillämpningen av bestäm- melserna om läkemedelsförmåner vid köp av läkemedel m.m., 3. debiteringen till landstingen, 4. ekonomisk uppföljning och framställning av statistik hos , 5. registrering och redovisning till landstingen av uppgifter för ekonomisk och medicinsk uppföljning samt för framställning av statistik, 6. registrering och redovisning till förskrivare, till verksam- hetschefer enligt hälso- och sjukvårdslagen (1982:763) och till läkemedelskommittéer enligt lagen (1996:1157) om läkemedels- kommittéer av uppgifter för medicinsk uppföljning, utvärdering och kvalitetssäkring i hälso- och sjukvården, 7. registrering och redovisning till av uppgifter för epidemiologiska undersökningar, forskning och framställning av statistik inom hälso- och sjukvårdsområdet, 8. registrering av recept och blanketter som används för flera uttag, samt registrering av dosrecept och elektroniska recept, 1 Senaste lydelse 2010:669. 9. registrering och redovisning 9. registrering och redovisning till av uppgifter om till av uppgifter om förskrivning av narkotiskt läke- förskrivning av narkotiskt läke- medel eller annat särskilt läke- medel eller annat särskilt läke- medel, för styrelsens tillsyn över medel, för styrelsens tillsyn över (2010:659), och (2010:659), 10. registrering och redovis- ning av uppgifter för Tandvårds- ning av uppgifter för Tandvårds- tillsyn över utbyte av läkemedel tillsyn över utbyte av läkemedel enligt 21 § lagen (2002:160) om enligt 21 § lagen (2002:160) om uppgifter för ändamål som avses uppgifter för ändamål som avses i första stycket 2 och 8, med i första stycket 2, 8, med elektroniska recept, och 12 får ske i fråga om den som har lämnat endast ske i fråga om den som har lämnat sitt samtycke till För ändamål som avses i första stycket 3 får uppgifter som kan avses i första stycket 3 får upp- hänföras till en enskild person gifter som kan hänföras till en inte omfatta annat än inköpsdag, enskild person inte omfatta annat än inköpsdag, kostnad, kostnads- reducering och patientens person- För ändamål som avses i första stycket 4, 6 och 10 får inga uppgifter redovisas som kan hänföras till en enskild person. Ändamålen enligt första stycket 5 får inte, med undantag för utlämnande av uppgifter enligt 14 §, omfatta några åtgärder som innebär att uppgifter som kan hänföras till någon enskild patient redovisas. Dock får uppgifter som kan hänföras till en enskild förskrivare ingå i redovisning enligt första stycket 6 till samma förskrivare och till verksamhetschefen vid den enhet vid vilken förskrivaren tjänstgör samt i redovisning enligt första stycket 9 till . Förskrivningsorsak får redovisas endast för de ändamål som avses i första stycket 5 och 6. I den utsträckning det behövs för ändamålen enligt 6 § får receptregistret innehålla följande uppgifter som kan hänföras till enskilda personer: 1.inköpsdag, vara, mängd, dosering, kostnad och kostnadsreducering enligt lagen (2002:160) om läkemedelsförmåner m.m., 3.patientens namn, personnummer och folkbokföringsort samt postnumret i patientens bostadsadress, 4. förskrivarens namn, yrke, 4. förskrivarens namn, person- specialitet, arbetsplats, arbets- nummer, yrke, specialitet, arbets- platskod och förskrivarkod, plats, arbetsplatskod, 5. samtycke enligt 6 § andra 5. samtycke enligt 6 § andra 6. administrativa uppgifter. 6. fullmakt samt 7. omständigheten att farmac- euten har motsatt sig utbyte eller 21 § tredje stycket 3 lagen om skälen för det, och 8. administrativa uppgifter. Förskrivningsorsak ska anges med en kod. 2 Senaste lydelse 2010:411. Patienters identitet får använ- das som sökbegrepp endast för de ändamål som anges i 6 § första stycket 2 och 8. För- skrivares identitet får användas som sökbegrepp endast för de ändamål som anges i 6 § första stycket 6 och 9. Förskrivnings- orsak får inte användas som sökbegrepp. Patienters identitet får använ- das som sökbegrepp endast för de ändamål som anges i 6 § första stycket 2, 8 och 12. För- skrivares identitet får användas som sökbegrepp endast för de ändamål som anges i 6 § första stycket 1, 6 och 9. Fullmakts- tagares identitet får användas som sökbegrepp endast för det ändamål som anges i 6 § första stycket 12. Förskrivningsorsak får inte användas som sökbegrepp. Expedierande personal på ett Expedierande personal på ett öppenvårdsapotek får ha direkt- öppenvårdsapotek får ha direkt- de ändamål som anges i första stycket 1, 2 och 8. första stycket 1, 2, 8 och 12. Expedierande personal på öppen- vårdsapotek får inte ha direkt- åtkomst till uppgifter om för- skrivarens personnummer. Den som har legitimation för yrke inom hälso- och sjukvården får ha direktåtkomst till uppgifter om dosrecept. Den enskilde får ha direktåtkomst till uppgifter om sig själv. 3Senaste lydelse 2009:370. 4Senaste lydelse 2009:370. bolag ska, för de ändamål som bolag ska, för de ändamål som anges i 6 § första stycket 1, 2 anges i 6 § första stycket 1, 2, 8 respektive 8, till öppenvårds- respektive 12, till öppenvårds-