Administration & observation room
Number of rooms eligible for treatment
Is the site ready for SPRAVATO® (esketamine)?
What is the SPRAVATO® (TRD*) treatment and visit pathway?
*SPRAVATO®, in combination with a SSRI or SNRI, is indicated for adults with treatment-resistant Major Depressive Disorder, who have not responded to at least two different treatments with antidepressants in the current moderate to severe depressive episode1
Induction phase
Two sessions per week
Maintenance phase
One session per week
One session per week or every two weeks
9+ weeks
Standard session pathway
Arrive at site
Waiting room
Consultation
Administration
The patient self administers SPRAVATO® under the supervision of an HCP.
Post administration observation
Patient is monitored by an HCP until clinically stable and deemed ready to leave.
Leave site
What is needed for administering SPRAVATO® ?
Chair
Total number of chairs in these rooms
Blood pressure monitor
Is there enough blood pressure monitoring equipment?
Healthcare professional time
Physician(s) to be involved
Nurse(s) to be involved
Safe storage
Is there storage available to safely store the SPRAVATO® nasal sprays?
What are options for improving the pathway?
Results:
Patient "carer" involved in pathway
Allow for the patient to be accompanied by a ‘carer’ (e.g. spouse, family member, friend), who could be with the patient during the post-administration observation, and help the patient throughout the journey.
Simplified administration system
Implement a simplified administration system, as often used for indications with frequent hospital visits, for decreasing the administrative burden for the patient (e.g. no registration at a desk and use of ID card), allowing for easier access to the observation room and faster treatment start.
Patient profile tracking
Make notes of individual patient experience on treatment so it can be used for subsequent treatment sessions to optimise their experience.
Site of care layout
Optimised location and layout of Site of Care while considering the flow of patients and considering specific needs, e.g. disabled people. Improve traffic flow (e.g. observation rooms close to admission desk or secondary entrance) and eliminate redundancy (e.g. avoid 2 steps admissions).
Storage location optimisation
Set-up a (dedicated) storage location close to the treatment location(s).
End-of-day treatment
Set-up of an end-of-day treatment schedule for allowing patients to keep their day scheduled unaltered, e.g. allowing to drive or use machinery during the morning and early afternoon.
How to best organise the practice?
How much time is spent with the patient?
Standard session pathway
min
week(s)
min
min
Standard duration & frequency of treatment
Treatment duration in weeks
Number of weeks between sessions during maintenance
How many patients can be taken care of on site?
Room(s)
Room(s)
Hour(s)/week
Chair(s)
Nurse(s)
Nurse(s)
Hour(s)/week
Dedicated observation time
%
Physician(s)
Physician(s)
Hour(s)/week
Aspiration of patients treated in a year
Theoretical maximum number of patients per year:
Number of patients seen (sessions) in a week:
Number of patients ramp-up
Impact of adding:
- h/w for room(s):
- h/w for nurse(s):
- h/w for physician(s):
07:00
08:00
09:00
10:00
11:00
12:00
13:00
14:00
15:00
16:00
17:00
18:00
19:00
20:00
21:00
22:00
Mon.
Tue.
Wed.
Thu.
Fri.
Sat.
Sun.
Monday
Tuesday
Wednesday
Thursday
Friday
Saturday
Sunday
07:00
08:00
09:00
10:00
11:00
12:00
13:00
14:00
15:00
16:00
17:00
18:00
19:00
20:00
21:00
22:00
23:00
C
N
P
S
C
N
P
S
C
N
P
S
C
N
P
S
C
N
P
S
C
N
P
S
C
N
P
S
1
2
3
4
5
Number of HCP's/rooms
Number of sessions
C Chairs
N Nurses
P Physicians
S Sessions
What are options for organising the site most efficiently?
Results: 11
Optimised staffing approach
Change the staffing mix to decrease overall cost of effort for taking care of patients (e.g. leverage junior nurses for post-administration observation of known patients, optimised frequency of physician consultations).
Efficient observation time planning
In a prolonged observation phase, the available free time can efficiently be used by the nurse to do additional work. E.g. administrative work …
Joint patient observation
For the maintenance phase of the treatment, set-up a dedicated room with the necessary equipment for administration and post- …
Low-utilisation infrastructure
The use of under-utilised infrastructure (e.g. specific times) of neighbouring departments (e.g. oncology).
Site of Care partnerships
Set-up of partnerships with other Sites of Care. E.g. for allowing treatment during non-induction phases, with Sites of Care within the responsibility of the hospital pharmacy.
Low-peak timeslot treatment
Set-up of a dedicated timeslot for treatment that is currently known to be underutilised by the nurses (i.e. because inpatients are in treatment/therapy, sleeping, less patients on Monday and Friday, …).
Neighbouring rooms
Organise administration & post-administration observation in rooms next to / close to each other, potentially allowing a nurse to observe multiple patients at the same time.
Part-time nurse practitioner
Utilise flexible staff planning (e.g. part time nurses) in order to schedule more patients on some part of the days / some day, and leverage infrastructure availability.
Optimised discharge
Organise HCP time to allow for smooth discharge of patients by leveraging the discharge readiness checklist, e.g. ensuring availability of a physician at scheduled treatment end (and therefore avoiding to keep patients in the Site of Care while post-administration observation is complete).
Remote observation
Support and increase efficiency of the observation phase using tele-observation (i.e. the observation of a patient within the hospital using dedicated equipment like beepers or camera supervision) of multiple patients by a single nurse.
ECT reconversion
Reconvert (part of) ECT rooms and reallocate ECT staff for product use.
What is the value for the site?
What are the priority drivers in site of care decision making?
What is the budget impact of implementing SPRAVATO® ?
Opportunity cost
Physician time dedicated to SPRAVATO®
hour(s)
Weekly working time
hour(s)
%
Nurse time dedicated to SPRAVATO®
hour(s)
Weekly working time
hour(s)
%
Room time dedicated to SPRAVATO®
hour(s)
Weekly available time
hour(s)
%
Out of pocket costs
| Total | Fixed costs 0€ |
Variable costs 0€ |
|
|---|---|---|---|
| € | € | ||
| € | € | ||
| € | € | ||
| € | € | ||
What are the options for funding SPRAVATO® ?
Reimbursement product
SPRAVATO® readiness
Dear Sir/Madam, please find below the minutes of our discussion.
Actions
Pathway
Resource utilisation & capacity
Value
Privacy policy and legal disclaimer
This Application processes data that may include but is not limited to data on equipment / infrastructure / HCP volume vs. requirements (e.g. number of rooms, chairs, existence of blood pressure monitoring equipment, existence of safe storage space, number of physicians and nurses within the team); opening hours of site; volume of available hours for rooms, physicians and nurses; estimation of time spent on consultation, administration and monitoring for SPRAVATO®; ‘expected number of patients’ to be treated with SPRAVATO®; costs estimates (fixed and variable) of possible investment; working time estimate of physicians & nurses; status on recommendations, with possible answers being: already in place, to be done, not relevant; and an option to add own recommendation for improvement on infrastructure/capacity/value creation. Non-personal data collected for the provision of services are solely for the purposes of internal reporting and targeting.
In some cases, we may also collect data obtained directly from you when you decide to communicate such data to us (e.g., your professional email address for us to send you the minutes of the discussion, or through open fields ‘notes’ and ‘actions to be taken’ per module). By using this application, you acknowledge that Johnson & Johnson will process the personal data you provide for the purpose of internal anonymized reporting and targeting. In such case, Johnson & Johnson will retain your data for as long as necessary for the provision of SoC Activation Tool services (e.g. email address is deleted after sending you the minutes by email). For more information, please read our Privacy Policy.
If you provide personal data concerning other individuals than yourselves you acknowledge that you have the right to provide such personal data, and that such individuals have been informed about, and agree to the processing of their personal data as per requirements in applicable data protection law. No data regarding personal patient information should be recorded via this tool.
Disclaimer
By using this Application, you are agreeing to be bound by the following terms and conditions.
The information on this Application is intended to furnish users with general information on matters that they may find to be of interest.
While every effort has been made to offer current and accurate information, errors can occur.
Furthermore, this Application may contain references to certain laws and regulations. Laws and regulations will change over time and should be interpreted only in light of particular circumstances.
JOHNSON & JOHNSON DISCLAIMS ALL LIABILITY AND RESPONSIBILITY FOR ANY ERRORS OR OMISSIONS IN THE CONTENT CONTAINED ON THIS APPLICATION.
All content on the Application and all services provided through it are provided “as is”, with no guarantees of completeness, accuracy or timeliness, and without representations, warranties or other contractual terms of any kind, express or implied.
Johnson & Johnson does not represent or warrant that this Application, the various services provided through this Application, and / or any information, software or other material downloaded from this Application, will be accurate, current, uninterrupted, error-free, omission-free or free of viruses or other harmful components.
References
- 1. Spravato SPC
- 2. Popova V et al. Am J Psychiatry. 2019; 176(6): 428-438
- 3. RMP material, checklist
- (Pligttekst)
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Pathway
What is the SPRAVATO® (TRD*) treatment and visit pathway?
What is needed for administering SPRAVATO® ?
Administration and observation room
Chair
Blood pressure monitoring
HCP time
Safe storage
What are the options for improving the pathway?
Show
Hide
Resource utilisation & capacity
How much time is spent with the patient?
How many patients can be taken care of on site?
What are the options for organising the site most efficiently?
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Summary setup
Actionables
Notes on pathway
Notes on resource utilisation & capacity
Notes on impact & performance
Privacy Policy
This tool does not collect any personal data from its users. Non-personal data collected for the provision of services are solely for the purposes of internal reporting and targeting. Non-personal data which is being collected may include but is not limited to data on equipment / infrastructure / HCP volume vs. requirements (e.g. number of rooms, chairs, existence of blood pressure monitoring equipment, existence of safe storage space, number of physicians and nurses within the team); opening hours of site; volume of available hours for rooms, physicians and nurses; estimation of time spent on consultation, administration and monitoring for SPRAVATO® ; ‘expected number of patients’ to be treated with SPRAVATO® ; costs estimates (fixed and variable) of possible investment; working time estimate of physicians & nurses; status on recommendations, with possible answers being: already in place, to be done, not relevant; and an option to add own recommendation for improvement on infrastructure/capacity/value creation.
In some cases, we may also collect data obtained directly from you when you decide to communicate such data to us (e.g., your professional email address for us to send you the minutes of the discussion, or through open fields ‘notes’ and ‘actions to be taken’ per module). By using this application, you acknowledge that Johnson & Johnson will process the personal data you provide for the purpose of internal anonymized reporting and targeting. In such case, Johnson & Johnson will retain your data for as long as necessary for the provision of SoC Activation Tool services (e.g. email address is deleted after sending you the minutes by email). For more information, please read our Privacy Policy.
If you provide personal data concerning other individuals than yourselves you acknowledge that you have the right to provide such personal data, and that such individuals have been informed about, and agree to the processing of their personal data as per requirements in applicable data protection law. No data regarding personal patient information should be recorded via this tool.
Disclaimer
By using this Application, you are agreeing to be bound by the following terms and conditions.
The information on this Application is intended to furnish users with general information on matters that they may find to be of interest.
While every effort has been made to offer current and accurate information, errors can occur.
Furthermore, this Application may contain references to certain laws and regulations. Laws and regulations will change over time and should be interpreted only in light of particular circumstances.
JOHNSON & JOHNSON DISCLAIMS ALL LIABILITY AND RESPONSIBILITY FOR ANY ERRORS OR OMISSIONS IN THE CONTENT CONTAINED ON THIS APPLICATION.
All content on the Application and all services provided through it are provided “as is”, with no guarantees of completeness, accuracy or timeliness, and without representations, warranties or other contractual terms of any kind, express or implied.
Johnson & Johnson does not represent or warrant that this Application, the various services provided through this Application, and / or any information, software or other material downloaded from this Application, will be accurate, current, uninterrupted, error-free, omission-free or free of viruses or other harmful components.
TO THE FULLEST EXTENT PERMISSIBLE PURSUANT TO APPLICABLE LAW, JOHNSON & JOHNSON DISCLAIMS ALL LIABILITY TO YOU AND EVERYONE ELSE IN RESPECT OF THE CONTENT ON THIS APPLICATION AND ALL SERVICES PROVIDED THROUGH IT, WHETHER UNDER ANY THEORY OF TORT, CONTRACT, WARRANTY, STRICT LIABILITY OR NEGLIGENCE OR OTHERWISE, AND WHETHER IN RESPECT OF DIRECT, INDIRECT, CONSEQUENTIAL, SPECIAL, PUNITIVE OR SIMILAR DAMAGES, EVEN IF JOHNSON & JOHNSON WAS ADVISED, KNEW OR SHOULD HAVE KNOWN OF THE POSSIBILITY OF SUCH DAMAGES.
Johnson & Johnson reserves the right to alter or delete material from the application at any time, and Johnson & Johnson may, at any time, revise the terms and conditions, the legal disclaimer or other policies set forth in this application by updating it. Such modifications shall be deemed effective immediately upon posting on Johnson & Johnson’s application. Any continued use of the application shall be deemed conclusive of your acceptance of the modified terms and conditions, the legal disclaimer of Johnson & Johnson and other policies.
Privacy statement and legal disclaimer
This Application processes data that may include but is not limited to data on equipment / infrastructure / HCP volume vs. requirements (e.g. number of rooms, chairs, existence of blood pressure monitoring equipment, existence of safe storage space, number of physicians and nurses within the team); opening hours of site; volume of available hours for rooms, physicians and nurses; estimation of time spent on consultation, administration and monitoring for SPRAVATO®; ‘expected number of patients’ to be treated with SPRAVATO®; costs estimates (fixed and variable) of possible investment; working time estimate of physicians & nurses; status on recommendations, with possible answers being: already in place, to be done, not relevant; and an option to add own recommendation for improvement on infrastructure/capacity/value creation. Non-personal data collected for the provision of services are solely for the purposes of internal reporting and targeting.
In some cases, we may also collect data obtained directly from you when you decide to communicate such data to us (e.g., your professional email address for us to send you the minutes of the discussion, or through open fields ‘notes’ and ‘actions to be taken’ per module). By using this application, you acknowledge that Johnson & Johnson will process the personal data you provide for the purpose of internal anonymized reporting and targeting. In such case, Johnson & Johnson will retain your data for as long as necessary for the provision of SoC Activation Tool services (e.g. email address is deleted after sending you the minutes by email). For more information, please read our Privacy Policy.
If you provide personal data concerning other individuals than yourselves you acknowledge that you have the right to provide such personal data, and that such individuals have been informed about, and agree to the processing of their personal data as per requirements in applicable data protection law. No data regarding personal patient information should be recorded via this tool.
Disclaimer
By using this Application, you are agreeing to be bound by the following terms and conditions.
The information on this Application is intended to furnish users with general information on matters that they may find to be of interest.
While every effort has been made to offer current and accurate information, errors can occur.
Furthermore, this Application may contain references to certain laws and regulations. Laws and regulations will change over time and should be interpreted only in light of particular circumstances.
JOHNSON & JOHNSON DISCLAIMS ALL LIABILITY AND RESPONSIBILITY FOR ANY ERRORS OR OMISSIONS IN THE CONTENT CONTAINED ON THIS APPLICATION.
All content on the Application and all services provided through it are provided “as is”, with no guarantees of completeness, accuracy or timeliness, and without representations, warranties or other contractual terms of any kind, express or implied.
Johnson & Johnson does not represent or warrant that this Application, the various services provided through this Application, and / or any information, software or other material downloaded from this Application, will be accurate, current, uninterrupted, error-free, omission-free or free of viruses or other harmful components.
Disclaimer
version:
GDPR privatlivspolitik
Janssen-Cilag A/S går op i emner omkring privatliv og ønsker, at du skal være klar over, hvordan vi indsamler, anvender og videregiver information. Denne privatlivspolitik beskriver vores fremgangsmåder i forbindelse med information, som vi eller vores serviceydere indsamler via webstedet eller applikationen (herefter ”tjenesten”), som drives og kontrolleres af os, og fra hvilken du har adgang til denne privatlivspolitik. Du anerkender, at du har læst og er indforstået med denne privatlivspolitik, når du afgiver personlig informationer til os eller ved at anvende denne service.
MINDREÅRIGES ANVENDELSE
Denne tjeneste er ikke rettet mod personer, som er mindreårige, under 18 år, og vi anmoder om, at disse personer ikke afgiver personlige oplysninger via tjenesten. Hvis dit barn har indsendt personlige oplysninger, og du gerne vil anmode om at disse personlige oplysninger bliver slettet, så kontakt os som omtalt nedenfor under ”kontakt os”.
INFORMATIONSINDSAMLING
Vi kan anmode dig om at sende personlige oplysninger, for at du kan gøre brug af bestemte funktioner (såsom abonnement på nyhedsbrev, ideer/gode råd eller ordrebehandling) eller for at deltage i en særlig aktivitet (såsom sweepstakes eller andre reklamekampagner). Du vil blive informeret om, hvilken information der er nødvendig, og hvilken information der er valgfri.
Vi kan kombinere informationen, som du indsender, med anden information, som vi har indsamlet fra dig, hvad end det er online eller offline, f.eks. indbefattet din købshistorik. Vi kan også kombinere det med information, som vi modtager om dig fra de følgende andre kilder: iQVIA OneKey database.
Hvis du sender os personlige oplysninger i relation til andre personer end dig selv, bekræfter du, at du har ret til at gøre det og tillader os at bruge disse oplysninger i overensstemmelse med denne privatlivspolitik.
FØLSOMME OPLYSNINGER
Vi anmoder dig om, at du ikke sender eller videregiver nogen følsomme oplysninger til os med mindre vi specifikt anmoder om dette (f.eks. CPR-numre, information i relation til race, etnisk oprindelse, politiske holdninger, religion eller filosofiske overbevisninger, sundhed, sexliv eller seksuel orientering, kriminel baggrund eller medlemskab af fagforening eller biometrisk eller genetiske data med det formål at kunne identificere en person helt specifikt), på eller via tjenesten eller på anden måde til os.
AUTOMATISK INFORMATIONSINDSAMLING OG ANVENDELSE
Vi og vores serviceudbydere kan automatisk indsamle bestemte informationer, når du navigerer rundt i tjenesten. Læs venligst vores cookie-politik for yderligere informationer om cookies og andre sporings-teknologier der bliver anvendt på denne tjeneste. Vores cookie-politik inkluderer informationer om, hvordan du kan deaktivere disse teknologier. Hvis du ikke deaktiverer dem, og fortsætter med at bruge vores tjeneste, vil vi betragte det som dit samtykke til anvendelsen.
Vi og vores serviceudbydere kan også automatisk indsamle og bruge informationer på følgende måder:
- Gennem din browser: De fleste browsere indsamler bestemte informationer, såsom din Media Access Control (medieadgangskontrol (MAC)) adresse, computertype (Windows eller Mac), skærmopløsning, operativsystemets navn og version samt internetbrowsertype og -version. Tilgår du tjenesten via en mobilenhed kan vi indsamle lignende informationer, såsom typen og identifikatoren af din enhed. Vi bruger disse informationer til at sikre, at tjenesten fungerer ordentligt.
- IP-adresse: Din IP-adresse er et nummer, som automatisk tildeles din computer af din internetserviceudbyder. En IP-adresse identificeres og logges automatisk i vores serverlogfiler, når en bruger besøger tjenesten sammen med tidspunktet for besøget og de besøgte sider. Indsamling af IP-adresser er standard praksis, og udføres automatisk af mange online-tjenester. Vi bruger IP-adresser til formål såsom beregning af servicebrugsniveauer, diagnosticering af serverproblemer og administration af tjenesten. Vi kan også udlede din omtrentlige placering fra din IP-adresse.
- Information om din enhed: Vi kan indsamle informationer om din mobilenhed, såsom en unik enhedsidentifikator, for at forstå hvordan du bruger tjenesten.
HVORDAN VI BRUGER OG VIDEREGIVER INFORMATION
Vi bruger og videregiver informationer, som du giver os, som beskrevet for dig ved indsamlingen. Se venligst afsnittet med titlen ”Valg og adgang” nedenfor, for at få mere at vide om hvordan du kan framelde dig visse af vores funktioner og videregivelser.
Vi vil indhente din tilladelse til brug af dine personlige oplysninger i forbindelse med indsamling af information, når det kræves af gældende lov. Vi kan også støtte os til andre juridiske grundlag, i særdeleshed for:
-
At levere tjenestens funktioner og opfylde dine anmodninger.
- At levere tjenestens funktioner til dig og forsyne dig med relateret kundeservice;
- At besvare dine spørgsmål og opfylde dine anmodninger, såsom at sende dokumenter du anmoder om eller e-mailpåmindelser til dig;
- At sende dig vigtige oplysninger vedrørende vores relation til dig eller angående tjenesten, ændringer af vores vilkår, betingelser og politikker og/eller andre administrative informationer.
-
Gennemførelse af vores forretningsformål.
- Til dataanalyse, for eksempel, for at forbedre tjenestens effektivitet;
- Til revisioner, for at verificere, at vores interne processer fungerer efter hensigten og er i overensstemmelse med juridiske, regulatoriske eller kontraktuelle krav;
- Til at overvåge svindel og sikkerhed, for eksempel for at opdage og forhindre cyberangreb eller forsøg på at begå identitetstyveri;
- Til udvikling af nye produkter og tjenester;
- Til at forbedre eller ændre vores hjemmeside eller produkter og tjenester;
- Til at identificere tendenser i brugen af tjenesten, for eksempel for at forstå hvilke dele af vores tjeneste, der er af størst interesse for brugere; og
- Til at bestemme vores markedsføringskampagners effektivitet, så vi kan tilpasse vores kampagner til vores brugeres behov og interesser.
-
Analyse af personoplysninger for at levere individuelle tjenester.
- For bedre at forstå dig, så vi kan individualisere vores kommunikation med dig og give dig oplysninger og/eller tilbud, der er tilpasset dine interesser;
- For bedre at forstå dine præferencer, så vi kan levere indhold via tjenesten, som vi tror vil være relevant og interessant for dig.
Vi vil indgå i disse aktiviteter for at administrere vores kontraktforbindelse med dig og/eller for at efterleve en juridisk forpligtelse
Vi vil indgå i disse aktiviteter for at administrere vores kontraktforbindelse med dig, for at efterleve en juridisk forpligtelse, og/eller fordi vi har en legitim interesse.
Vi vil levere individualiserede tjenester enten med dit samtykke, eller fordi vi har en legitim interesse.
Vi videregiver også informationer indsamlet via tjenesten:
- Til vores datterselskaber til de formål, der er beskrevet i denne privatlivspolitik. Der findes en liste over vores datterselskaber på http://www.investor.jnj.com/governance/sec-filings.cfm (klik på linket for ”Form 10K” , bevis 21, under “SEC-dokumentation”). Janssen-Cilag A/S er den part, som er ansvarlig for ledelsen af de fælles anvendte personlige oplysninger;
- til vores tredjeparts partnere med hvem vi tilbyder et fælles brand eller et fælles markedsført tilbud;
- Til vores tredjeparts serviceudbydere, som sørger for tjenester, såsom hosting og redigering af websites, hosting af mobilapplikation, dataanalyse, behandling af betaling, ordreopfyldelse, provision for infrastruktur, it-tjenester, kundeservice, e-mail- og direkte post-leveringstjenester, revision og andre tjenester for at gøre det muligt for dem at levere ydelser; og
- som tilladt ved gældende lov, at en tredjepart i tilfælde af enhver omorganisering, sammenlægning, salg, joint venture, opgave, overførsel eller anden bestemmelse af hele eller en del af vores forretning, aktiver eller aktier (herunder i forbindelse med konkurs eller lignende sager).
Yderligere kan vi bruge og videregive dine informationer, når vi anser det for at være nødvendigt eller passende: (a) overholdelse af juridisk proces eller gældende lov, som kan omfatte love uden for dit opholdsland; (b) som tilladt ifølge gældende lov, at besvare anmodninger fra offentligheden og myndigheder, som kan omfatte myndigheder uden for dit opholdsland; (c) at håndhæve vores vilkår og betingelser; og (d) beskytte vores rettigheder, privatliv, sikkerhed eller ejendom og/eller herunder vores datterselskabers, dit eller andres. Vi kan også bruge og videregive dine informationer på andre måder, efter at have indhentet dit samtykke.
Vi kan vælge at anvende og videregive informationer, vi automatisk indsamler, som beskrevet ovenfor under ”automatisk informationsindsamling og anvendelse.”
Yderligere kan vi anvende og videregive informationer i overensstemmelse med gældende lov, som ikke findes i en personlig identificerbar form til ethvert formål. Hvis vi kombinerer oplysninger, som ikke er i en personlig identificerbar form med de informationer, som er identificerbare (såsom kombination af dit navn med den geografiske placering), så vil vi behandle de kombinerede informationer som personlige oplysninger, så længe de er kombineret.
VALGMULIGHEDER OG ADGANG
Vi giver dig mulighed for at vælge med hensyn til vores brug og videregivelse af dine personlige oplysninger
Vi giver dig mulighed for at vælge vedrørende vores anvendelse og videregivelse af dine personlige oplysninger i forbindelse med salgsfremmende formål. Følgende kan fravælges:
- Modtagelse af salgsfremmende materialer fra os: Hvis du ikke længere ønsker at modtage salgsfremmende materialer fra os, kan du afmelde dette ved at kontakte os på e-mail: jacdk@its.jnj.com. I din anmodning til os bedes du oplyse dit navn, angiv de(n) form(er) for salgsfremmende materiale(r), som du ikke længere ønsker at modtage og inkluder adresserne til hvilke den/de er sendt. Hvis du for eksempel ikke længere ønsker at modtage salgsfremmende e-mails eller direkte post fra os, så fortæl os det og oplys dit navn og e-mail- eller postadresse. Du kan også afmelde modtagelsen af salgsfremmende materialer ved at besøge tjenesten og opdatere din profil online. Yderligere kan du afmelde modtagelsen af salgsfremmende e-mails fra os ved at følge afmeld-vejledningen i vores kommunikationer.
- Modtagelse af påmindelser fra os: Hvis du ikke længere ønsker at modtage medicinske påmindelser fra os, kan du afmelde disse ved at kontakte os på e-mail: jacdk@its.jnj.com. Oplys venligst dit navn og e-mailadressen eller telefonnummeret, som du modtager påmindelser fra os på, i dit svar til os.
- Vores deling af dine personlige oplysninger med datterselskaber og tredjeparts-partnere: Hvis du tidligere har tilmeldt dig modtagelsen af salgsfremmende materialer fra vores datterselskaber eller tredjeparts partnere, kan du afmelde dig vores deling af dine personlige oplysninger med disse parter i forhold til deres direkte salgsfremmende formål i fremtiden ved at kontakte os via e-mail: jacdk@its.jnj.com. Hvis du henvender dig til os, så oplys venligst at vi ikke længere skal dele dine personlige oplysninger med vores datterselskaber og/eller tredjeparts-partnere til deres salgsfremmende formål og inkluder dit navn og e-mailadresse.
Vi vil søge at opfylde din(e) anmodning(er) så snart, som det er praktisk muligt. Bemærk at vi, hvis du afmelder dig som beskrevet ovenfor, vil vi ikke vil være i stand til at fjerne dine personlige oplysninger fra databaserne, som tilhører vores datterselskaber, med hvem vi allerede har udvekslet dine oplysninger (f.eks. fra den dato hvor vi implementerede din anmodning om frameldelse). Bemærk også, at hvis du afmelder dig modtagelsen af salgsfremmende materialer fra os, kan vi fortsat sende dig vigtige transaktionsrelaterede og administrative beskeder, som du ikke kan framelde dig.
Hvordan du kan tilgå, ændre eller slette dine personlige oplysninger
Hvis du gerne vil gennemgå, redigere, opdatere, begrænse eller slette dine personlige oplysninger eller hvis du gerne vil anmode om at modtage en elektronisk kopi af dine personlige oplysninger med det formål at overføre dem til en anden virksomhed (i det omfang disse rettigheder gives dig under gældende lov), så kontakt os venligst via e-mail: jacdk@its.jnj.com. Vi vil besvare din anmodning, så hurtigt som det er praktisk muligt og ikke senere end en måned efter modtagelsen. Hvis omstændighederne medfører en forsinkelse af vores besvarelse, vil du med det samme blive underrettet, og få oplyst en dato for vores besvarelse. Du kan også besøge tjenesten for at opdatere din online-profil.
OVERFØRSEL PÅ TVÆRS AF LANDEGRÆNSER
Dine personlige oplysninger kan blive gemt og behandlet i ethvert land, hvor vi driver virksomhed eller har serviceudbydere, og når du bruger vores tjeneste eller giver os samtykke (når det er krævet ved lov), godkender du at en overførsel af information til lande udenfor dit opholdsland, inklusive USA, som kan have andre databeskyttelsesregler end dit eget land, kan finde sted. Passende kontraktmæssige eller andre standarder er på plads for at beskytte personlige oplysninger, når de overføres til vores datterselskaber eller tredjeparter i andre lande.
Nogle lande udenfor Det Europæiske Økonomiske Samarbejdsområde (EØS) er anerkendt af Den Europæiske Kommission i forhold til at have et tilstrækkeligt niveau af databeskyttelse i overensstemmelse med EØS-standarder (en komplet liste over disse lande findes her: http://ec.europa.eu/justice/data-protection/international-transfers/adequacy/index_en.htm I forbindelse med overførsler fra EØS til lande som ikke anses for at være tilfredsstillende af Den Europæiske Kommission, har vi sikret at tilfredsstillende metoder er på plads, inklusive sikring af at modtageren er bundet af [EU standard kontraktbestemmelser, EU-US Privacy Shield certificering eller et EU-godkendt adfærdskodeks eller certificering], for at beskytte dine personlige oplysninger. Du kan rekvirere en kopi af disse standarder ved at kontakte vores databeskyttelsesmedarbejder (jf. instruktioner i ”kontakt os”-afsnittet nedenfor).
SIKKERHED
Vi søger at bruge passende organisatoriske, tekniske og administrative metoder udformet til at beskytte personlige informationer, som er under vores kontrol. Desværre kan intet system til overførsel af data over internettet eller lagringssystem garanteres at være helt sikkert. Hvis du har grund til at tro, at din interaktion med os ikke længere er sikker (hvis du for eksempel føler at sikkerheden vedrørende en konto, du har hos os, er blevet kompromitteret), så giv os straks besked ifølge ”kontakt os” -afsnittet nedenfor.
BIBEHOLDELSESPERIODE
Vi vil bibeholde dine personlige oplysninger, så lang tid der er behov for det eller det er tilladt i forhold til formålet(ene) hvormed de blev indsamlet. Kriterierne brugt for at afgøre vores bibeholdelsesperiode omfatter: (i) tidsrummet vi har haft en relation med dig og ydet tjenesten til dig; (ii) hvorvidt der er en juridisk forpligtelse vi er underlagt; (iii) hvorvidt bibeholdelse er tilrådelig set i lyset af vores juridiske stilling (såsom i forhold til gældende forældelsesfrister, retssager eller reguleringsmæssige undersøgelser).
Hvis vi for eksempel indsamler dine personlige oplysninger da vi indgår et kontraktforhold, vil vi gemme dem i en periode på 15 år fra kontraktens udløbsdato. Har vi indsamlet dine personlige oplysninger I forbindelse med indsamling af dit samtykke for at kunne sende dig salgsfremmende materialer vil vi opbevare dette indtil du trækker dit samtykke tilbage og i en periode på 5 år.
Men vær opmærksom på, at dette ikke er en komplet liste over bibeholdelsesperioder. Dine personlige oplysninger kan blive gemt i en længere periode ved brug af kriteriet i det første afsnit i denne del, særligt punkterne (ii) og (iii).
TREDJEPARTS-SITES OG -TJENESTER
Denne privatlivspolitik adresserer ikke, og vi er ikke ansvarlige for beskyttelsen af dine personlige oplysninger, informationer eller anden praksis hos tredjeparter, herunder enhver tredjepart, der driver ethvert websted eller online-tjeneste (herunder uden begrænsning, enhver applikation), der er tilgængelig gennem denne tjeneste eller som denne tjeneste indeholder et link til. Tilgængeligheden af eller inkorporeringen af et link til et hvilket som helst sådant websted eller ejendom på tjeneste betyder ikke, at den bifaldes af os eller af vores datterselskaber.
KONTAKT OS
Janssen-Cilag A/S, placeret på Bregnerødvej 133, 3460 Birkerød, er virksomheden, som er ansvarlig for indsamlingen, brugen og videregivelsen af personlige oplysninger i denne privatlivspolitik.
Hvis du har spørgsmål angående denne privatlivspolitik, så kontakt os på e-mail: jacdk@its.jnj.com. eller skriv til os på følgende adresse:
Janssen-Cilag A/S
Bregnerødvej 133
3460 Birkerød
Du kan også kontakte databeskyttelsesrådgiveren, som er ansvarlig for dit land eller region, hvis gældende, på emeaprivacy@its.jnj.com.
INDGIVELSE AF EN KLAGE TIL EN MYNDIGHED
Du kan indgive en klage til en kompetent tilsynsmyndighed i dit land eller region. Kontaktinformation til sådanne myndigheder: http://ec.europa.eu/justice/data-protection/article-29/structure/data-protection-authorities/index_en.htm.
OPDATERINGER AF DENNE PRIVATLIVSPOLITIK
Vi kan ændre denne privatlivspolitik. Eventuelle ændringer af denne privatlivspolitik vil effektueres efter offentliggørelse af den reviderede privatlivspolitik på tjenesten. Din brug af tjenesten efter disse ændringer betyder, at du accepterer den reviderede privatlivspolitik. Vi anbefaler, at du med jævne mellemrum gennemgår denne privatlivspolitik, når du besøger tjenesten. Denne privatlivspolitik blev sidst opdateret den 19.03.2018.
Helpdesk
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Privacy Policy and legal disclaimer
This Application processes data that may include but is not limited to data on equipment / infrastructure / HCP volume vs. requirements (e.g. number of rooms, chairs, existence of blood pressure monitoring equipment, existence of safe storage space, number of physicians and nurses within the team); opening hours of site; volume of available hours for rooms, physicians and nurses; estimation of time spent on consultation, administration and monitoring for SPRAVATO®; ‘expected number of patients’ to be treated with SPRAVATO®; costs estimates (fixed and variable) of possible investment; working time estimate of physicians & nurses; status on recommendations, with possible answers being: already in place, to be done, not relevant; and an option to add own recommendation for improvement on infrastructure/capacity/value creation. Non-personal data collected for the provision of services are solely for the purposes of internal reporting and targeting.
In some cases, we may also collect data obtained directly from you when you decide to communicate such data to us (e.g., your professional email address for us to send you the minutes of the discussion, or through open fields ‘notes’ and ‘actions to be taken’ per module). By using this application, you acknowledge that Johnson & Johnson will process the personal data you provide for the purpose of internal anonymized reporting and targeting. In such case, Johnson & Johnson will retain your data for as long as necessary for the provision of SoC Activation Tool services (e.g. email address is deleted after sending you the minutes by email). For more information, please read our Privacy Policy.
If you provide personal data concerning other individuals than yourselves you acknowledge that you have the right to provide such personal data, and that such individuals have been informed about, and agree to the processing of their personal data as per requirements in applicable data protection law. No data regarding personal patient information should be recorded via this tool.
Disclaimer
By using this Application, you are agreeing to be bound by the following terms and conditions.
The information on this Application is intended to furnish users with general information on matters that they may find to be of interest.
While every effort has been made to offer current and accurate information, errors can occur.
Furthermore, this Application may contain references to certain laws and regulations. Laws and regulations will change over time and should be interpreted only in light of particular circumstances.
JOHNSON & JOHNSON DISCLAIMS ALL LIABILITY AND RESPONSIBILITY FOR ANY ERRORS OR OMISSIONS IN THE CONTENT CONTAINED ON THIS APPLICATION.
All content on the Application and all services provided through it are provided “as is”, with no guarantees of completeness, accuracy or timeliness, and without representations, warranties or other contractual terms of any kind, express or implied.
Johnson & Johnson does not represent or warrant that this Application, the various services provided through this Application, and / or any information, software or other material downloaded from this Application, will be accurate, current, uninterrupted, error-free, omission-free or free of viruses or other harmful components.
Arrival at site
When arriving at the site, the patient registers at the front desk/reception. Afterwards the patient will be directed towards the appropriate room. The patient may or may not be joined by a carer.
Waiting room
The patient waits in the waiting room until they are invited into a consultation room or taken directly for treatment administration.
Consultation
Consultations are key, particularly at the beginning of the journey. After that, consultations are ‘ad hoc’ depending on the patient and the need for a consultation. The physician can discuss the efficacy of the treatment, potential side effects, etc.
How to administer SPRAVATO®1
Pre-administration
- Blood pressure should be measured before SPRAVATO® administration
- If a patient’s blood pressure is elevated (cf. risk minimization guide (for healthcare professionals)), please reconfirm their blood pressure
- If a patient’s blood pressure is still elevated, consider lifestyle or pharmacological intervention to reduce blood pressure prior to starting SPRAVATO® treatment
- Consider the individual patient’s benefit and risk before deciding whether to delay SPRAVATO® treatment
Administration
SPRAVATO® is intended to be self‑administered by the patient under the direct supervision of a healthcare professional. A treatment session consists of nasal administration of SPRAVATO® and a post‑administration observation period in settings where this can be performed. Please refer to the dosing and administration guide or to the summary of product characteristics (SPC) for full details of prescribing information.
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Step 1 Get ready
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Step 2 Prepare device
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Step 3 Prepare patient
It is recommended that healthcare professionals wear protective gloves while assisting patients
At each session, instruct patient to blow nose before first device only
Confirm required number of devices
Check expiration date (’EXP’)
If expired, get a new device
Peel blister and remove device
Do not prime device – this will result in a loss of medication
Check that indicator shows 2 green dots. If not, dispose of device and get a new one
Hand device to patient
Patient should:
Hold device as shown with the thumb gently supporting the plunger
Do not press the plunger
Recline head at about 45 degrees during administration to keep medication inside the nose
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Step 4 Patient sprays once into each nostril
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STEP 5 Confirm delivery
and rest
Patient Should:
Insert tip straight into the first nostril
Nose rest should touch the skin between the nostrils
Patient should:
Breathe in through nose while pushing plunger all the way up until it stops
Sniff gently after spraying to keep medication inside nose
Switch hands to insert tip into the second nostril
Take device from patient
Check that indicator shows no green dots. If you see a green dot, have patient spray again into the second nostril
Check indicator again to confirm device is empty
Patient should:
Rest in a comfortable position (preferably,
semi-reclined) for 5 minutes after each device
Do not blow nose
If liquid drips out, dab nose with a tissue
Ensure that the patient waits 5 minutes after each device to allow medication to absorb
Post administration observation
Patient should be monitored for any transient side effects including dissociation, sedation and increase in blood pressure, until patient is clinically stable based on clinical judgment.1
Leave site
WARNING: Before SPRAVATO® administration, patients should be instructed not to engage in potentially hazardous activities requiring complete mental alertness and motor coordination, such as driving a vehicle or operating machinery, until the next day following a restful sleep (see section 4.4). 1
Readiness-to-leave checklist for healthcare professionals3
Clinical assessment
- Have you confirmed that the patient does not have signs of dissociation or perceptual changes that might impair their functioning?
- Have you confirmed that the patient is not experiencing sedation (i.e. the patient is fully awake and responding to stimuli)?
- Are the patient’s blood pressure values at acceptable levels?
- Have any other adverse events resolved?
- Have you advised the patient that they should not drive or operate machinery until the next day following a restful sleep?
- Has the patient planned to travel home by public transport or arranged for someone else to drive them home?
- Do you, the treating physician, believe the patient is ready to leave the healthcare facility based on your clinical judgement?
Administration & observation room
In order to be able to implement SPRAVATO® within the site of care, eligible rooms need to be available for patients.
The rooms need to be suitable for (1) administration of the product and (2) for post administration observation. These 2 steps do not need to occur in different rooms.
Arrival at site
Time spent in this step is not expected to involve a healthcare professional.
Chair
In order to be able to implement SPRAVATO® within the site of care, chairs need to be in place.
Reclining chairs are not required but may be more comfortable for patients, who need to lean back with an angle of 45° during the administration step.
Waiting room
Time spent in this step is not expected to involve a healthcare professional.
Blood pressure monitor (Sphygmometer)
In order to be able to implement SPRAVATO® within the site of care, blood pressure a monitoring device
needs to be in place to measure the patients’ blood pressure before and after the self-administration. Several
devices might be needed depending on the number of patients.1
Consultation
Evidence of therapeutic benefit should be evaluated at the end of induction phase to determine need for continued treatment. 1
The need for continued treatment should be reexamined periodically. 1
Assessment of contraindications and concomitant medications should take place, plus patient medical history (and assessment of history of substance abuse).
There will be a consultation before the first administration, where the physician will check suitability for treatment (e.g. contra-indications, need for lifestyle or pharmacological intervention prior to starting SPRAVATO® treatment in case of elevated blood pressure...). The decision to prescribe SPRAVATO® should be determined by a psychiatrist.1
At the end of induction period there will be a consultation to check for evidence of therapeutic benefit. Consultations during the maintenance phase will check for dosing frequency and the need for continued treatment.
Healthcare professional time
Implementing SPRAVATO® within the site of care will require healthcare professional(s) to be available for the administration and post administration observation period.
SPRAVATO® is intended to be self-administered by the patient under the direct supervision of a healthcare professional.The patient then needs to observed by a healthcare professional during a post administration observation period.1
Safe storage
The nasal sprays needs to be stored according to local regulation and in a dry, safe compartment preferably close to the location where the SPRAVATO® is being administered. The disposal of the device depends on the local region.1
Administration
Blood pressure should be assessed prior to dosing with SPRAVATO®. In patients whose blood pressure prior to dose administration are judged to be elevated (as a general guide: >140/90 mmHg for patients <65 years of age and >150/90 mmHg for patients ≥65 years of age), it is appropriate to adjust lifestyle and/or pharmacologic therapies to reduce blood pressure before starting treatment with SPRAVATO®. 1
Post administration observation
Patients should be monitored by a healthcare professional after SPRAVATO® administration at each treatment session:
- Measure the patients blood pressure at around 40 minutes after administration of the first dose of SPRAVATO. If their blood pressure is elevated, continue to regularly measure it until it returns to acceptable levels.1
- Regularly monitor the patient for signs of dissociation, sedation and any other adverse events.1
- Approximately half (≥44.3%) of patients are ready to be discharged within 1 hour. 2
- Almost all (93.2%) patients are ready to be discharged within 90 minutes.2
Leave site
Readiness to leave checklist is available to help assess when a patient is ready to leave the site of care.3
Impact on patient
Impact on site of care
Requirements
Impact on patient
Impact on site of care
Requirements
Impact on patient
Impact on site of care
Requirements
Impact on patient
Impact on site of care
Requirements
Add option for priority drivers in site of care decision making
Edit option
Patient "carer" involved in pathway
- ++ Arrive at & leave site
- ++ Administration
- +++ Pos-administration observation
Allow for the patient to be accompanied by a ‘carer’ (e.g. spouse, family member, friend), who could be with the patient during the post-administration observation, and support the patient throughout the journey.
Impact on patient
- Patient supported by a known person
Impact on site of care
- Observation may be done more efficiently with 'carer' support
- Reduction in observation phase HCP effort as emotional and practical support of certain side effects are taken up by ‘carer’ (e.g. anxiety, dissociation)
Requirements
- Ability / capacity for the ‘carer’ to support the patient during clinic appointments and on the way to and from the clinic (can e.g. be combined with other options)
- Willingness from the board/psychiatrist to allow ‘carer’ in administration and post-administration observation environment
Simplified administration system
- ++ Arrive at site
Implement a simplified administration system, as often used for indications with frequent hospital visits, for decreasing the administrative burden for the patient (e.g. no registration at a desk and use of ID card), allowing for easier access to the observation room and faster treatment start.
Impact on patient
- Easier access to treatment
- Less time spent in the site of care
Impact on site of care
- Minimised impact of busy periods at administration desk on the patient arrival pattern (i.e. decrease in people turning up late for treatment)
Requirements
- Infrastructure requirements (patient badges, …)
- Payment and administrative system dapted to such a set-up (e.g. for payment)
Patient profile tracking
- +++ Post-administration observation
Make notes of individual patient experience on treatment so it can be used for subsequent treatment sessions to optimise their experience.
Impact on patient
- Allows for personalised approach of treatment for the patient
Impact on site of care
- Better knowledge and history of patient side effects during observation phase
- Higher administrative requirements for nurses
- Investment in profile template creation required
Requirements
- Deployment of a tool and/or procedures for tracking patient specificities
- When patient information is already in place, this can be leveraged for an holistic patient overview
Hospital layout
- + Total pathway
Optimised location and layout of site of care while considering the flow of patients and considering specific needs, e.g. disabled people. Improve traffic flow (e.g. observation rooms close to admission desk or secondary entrance) and eliminate redundancy (e.g. avoid 2 steps admissions).
Impact on patient
- Less time spent in the site of care
- Easier & smoother journey
Impact on site of care
- Reduction of the idle time of the HCP for moving in the site of care
- Higher administrative requirements for nurses
- Optimised utilisation of HCP and rooms
Requirements
- Can require significant investments
- Can require activities at a broader scale than the practice at stake
- Requires dedicated analysis on the patient flow and physical journey
Optimised staffing approach
- +++ Physician-Time
- +++ Nurse-Time
- +++ Space
Changing the staffing mix to decrease overall cost of effort for taking care of patients (e.g. leverage junior nurses for post-administration observation of known patients, optimised frequency of physician consultations).
Impact on site of care
- Optimisation of staff utilisation & potential for additional capacity creation
Requirements
- Sufficient time-size and critical mass to allow for organisational optimisation
Efficient observation time planning
- +++ Nurse-Time
In a prolonged observation phase, the available free time can efficiently be used by the nurse to do additional work. E.g. administrative work. The nurse can also sit in the same room as the patient(s) - have a desk and just do some paperwork etc.
Impact on patient
- No continuous observation
- Observation based on frequent check-ups
Impact on site of care
- Optimised utilisation of HCP time
Requirements
- Nurse needs to be able to do frequent check-ups on patient
Joint patient observation
- ++ Nurse-Time
- +++ Space
For the maintenance phase of the treatment, set-up a dedicated room with the necessary equipment for administration and post-administration observation of several patients in parallel, in order to reduce the number of required HCP and room(s).
Impact on patient
- Lack of privacy during observation phase
- Potential incompatibility of patients during treatment (i.e. based on reaction to treatment)
- Patient more closely observed during the post-administration observation
Impact on site of care
- Optimised utilisation of HCP time
- Optimised utilisation of available space
- No exclusive observation
Requirements
- Availability of sufficiently large rooms at the site of care
Low-utilisation infrastructure
- ++ Space
The use of under-utilised infrastructure (e.g. specific times) of neighbouring departments (e.g. oncology).
Impact on patient
- Can lead to logistic challenges for patient
Impact on site of care
- Increases in capacity for patient care
- Optimised utilisation of HCP time
- Optimised utilisation of available space
Requirements
- Availability of low-utilisation infrastructure close to the practice
Site of care availability
Monday
Tuesday
Wednesday
Thursday
Friday
Saturday
Sunday
Chairs
Chairs
Start Time
End Time
Room 1
Nurse Timing
Start Time
End Time
Nurse 1
Nurse 2
Nurse 3
Physician Timing
Start Time
End Time
Physician 1
Physician 2
Physician 3
Chairs
Chairs
Start Time
End Time
Room 1
Room 2
Room 3
Nurse Timing
Start Time
End Time
Nurse 1
Nurse 2
Nurse 3
Physician Timing
Start Time
End Time
Physician 1
Physician 2
Physician 3
Chairs
Chairs
Start Time
End Time
Room 1
Room 2
Room 3
Nurse Timing
Start Time
End Time
Nurse 1
Nurse 2
Nurse 3
Physician Timing
Start Time
End Time
Physician 1
Physician 2
Physician 3
Chairs
Chairs
Start Time
End Time
Room 1
Room 2
Room 3
Nurse Timing
Start Time
End Time
Nurse 1
Nurse 2
Nurse 3
Physician Timing
Start Time
End Time
Physician 1
Physician 2
Physician 3
Chairs
Chairs
Start Time
End Time
Room 1
Room 2
Room 3
Nurse Timing
Start Time
End Time
Nurse 1
Nurse 2
Nurse 3
Physician Timing
Start Time
End Time
Physician 1
Physician 2
Physician 3
Chairs
Chairs
Start Time
End Time
Room 1
Room 2
Room 3
Nurse Timing
Start Time
End Time
Nurse 1
Nurse 2
Nurse 3
Physician Timing
Start Time
End Time
Physician 1
Physician 2
Physician 3
Chairs
Chairs
Start Time
End Time
Room 1
Room 2
Room 3
Nurse Timing
Start Time
End Time
Nurse 1
Nurse 2
Nurse 3
Physician Timing
Start Time
End Time
Physician 1
Physician 2
Physician 3
Site of care availability
Monday
Tuesday
Wednesday
Thursday
Friday
Saturday
Sunday
Rooms
Chairs
Room 1
Room 2
Nurses
Nurse 1
Nurse 2
Nurse 3
Physicians
Physician 1
Physician 2
Physician 3
Sessions
Session 1
Session 2
Session 2
SPRAVATO® (Esketamin)
▼ Dette lægemiddel er underlagt supplerende overvågning. Dermed kan nye sikkerhedsoplysninger hurtigt tilvejebringes. Sundhedspersoner anmodes om at indberette alle formodede bivirkninger.
LÆGEMIDDELFORM: Næsespray, opløsning. Indikation: Spravato®, i kombination med en SSRI eller SNRI, er indiceret til voksne med behandlingsresistent moderat til svær depression, som ikke har responderet på mindst to forskellige behandlinger med antidepressiva under den igangværende moderate til svære depressionsepisode. Administration: Spravato® er kun til nasal anvendelse og er beregnet til selvadministration af patienten under direkte supervision af en sundhedsperson. Næsesprayanordningen er en engangsanordning, som afgiver i alt 28 mg esketamin i to pust (ét pust i hver næsebor). Under anvendelse af 1 anordning (til en dosis på 28 mg), 2 anordninger (til en dosis på 56 mg) eller 3 anordninger (til en dosis på 84 mg) er der en hvileperiode på 5 minutter mellem anvendelsen af hver anordning. For at undgå tab af lægemiddel skal anordningen ikke præaktiveres før brug. En behandlingssession består af nasal administration af Spravato® og en observationsperiode efter administrationen. Både administrationen og observationsperioden efter denne skal finde sted i passende kliniske omgivelser. Vurdering inden behandling: Inden dosering med Spravato® skal blodtrykket vurderes. Hvis blodtrykket er forhøjet ved baseline, skal risiciene ved stigningen i blodtrykket på kort sigt overvejes i forhold til fordelen ved behandling med Spravato®. Spravato® må ikke administreres, hvis en stigning i blodtryk eller intrakranielt tryk udgør en alvorlig risiko. Patienter med klinisk signifikante eller ustabile hjerte-kar- eller respirationssygdomme kræver yderligere forholdsregler. Hos disse patienter skal Spravato® administreres under forhold, hvor egnet genoplivningsudstyr og sundhedspersoner med uddannelse i hjerte-lungeredning er til rådighed. Observation efter administration: Efter dosering med Spravato® skal blodtrykket revurderes efter ca. 40 minutter og efterfølgende som det findes klinisk relevant. På grund af muligheden for sedation, dissociation og forhøjet blodtryk skal patienterne overvåges af en sundhedsperson, indtil patienten anses for at være klinisk stabil og parat til at forlade klinikken. Dosering: Hver næsesprayanordning indeholder esketaminhydrochlorid svarende til 28 mg esketamin. Induktionsfase (uge 1-4): Startdag 1 dosis er 28 mg (≥65 år) eller 56 mg (<65 år), og efterfølgende doser er 56 mg eller 84 mg to gange om ugen for voksne <65 år, og 28 mg, 56 mg eller 84 mg to gange om ugen for voksne ≥65 år. Evidensen for terapeutiske fordele skal evalueres ved afslutningen af induktionsfasen for at afgøre behovet for fortsat behandling. Det anbefales at fastholde den dosis, som patienten får ved afslutningen af induktionsfasen, i vedligeholdelsesfasen. Vedligeholdelsesfase (fra uge 5-8): 56 mg eller 84 mg én gang om ugen for voksne <65 år, og 28 mg, 56 mg eller 84 mg én gang om ugen for voksne ≥ 65 år (uge 5-8). Vedligeholdelsesfase (fra uge 9): 56 mg eller 84 mg hver anden uge eller én gang ugentligt for voksne <65 år, og 28 mg, 56 mg eller 84 mg hver anden uge eller én gang ugentligt for voksne ≥ 65 år. Behovet for fortsat behandling skal jænvligt reevalueres. Alle dosisændringer skal foretages i trin af 28 mg, og bør foretages baseret på virkning og tolerabilitet af den tidligere dosis. Det anbefales at fortsætte behandlingen i minimum 6 måneder efter forbedring af de depressive symptomer. Særlige populationer: Nedsat leverfunktion: dosisjusering er ikke nødvendig hos patienter med let nedsat leverfunktion (Child-Pugh klasse A) eller moderat nedsat leverfunktion (Child-Pugh klasse B). Spravato er ikke undersøgt hos patienter med svært nedsat leverfunktion (Child-Pugh C), og frarådes. Nedsat nyrefunktion: Dosisjustering er ikke nødvendig fos patienter med let til svært nedsat nyrefunktion. Patienter i dialyse er ikke blevet undersøgt. Race: hos patienter af japansk afstamning er den indledende dosis af Spravato® 28 mg esketamin (dag 1, startdosis). Efterfølgende doser skal øges i trin på 28 mg op til 56 mg eller 84 mg baseret på virkning og tolerabilitet. Pædiatrisk population: Spravato’s® sikkerhed og virkning hos pædiatriske patienter i alderen 17 år eller yngre er ikke klarlagt. Der foreligger ingen data. Det er ikke relevant at anvende Spravato® til børn under 7 år til indikationen behandlingsresistent depression. Kontraindikationer: Overfølsomhed over for det aktive stof ketamin eller over for et eller flere af hjælpestofferne. Patienter hos hvem en stigning i blodtryk eller interkranielt tryk udgør en alvorlig risiko (patienter med aneurismal karsygdom, patienter der tidligere har haft hjerneblødning og nyelig (inden for 6 uger) kardiovaskulær hændelse, herunder myokardieinfarkt). Særlige advarsler og forsigtighedsregler vedrørende brugen: Det er rapporteret, at Spravato® har forårsaget somnolens, sedation, dissociative symptomer, perceptionsforstyrrelser, svimmelhed, vertigo og angstanfald i de kliniske forsøg. Disse virkninger kan give nedsat opmærksomhed, dømmekraft, tænkeevne, reaktionshastighed og motoriske evner. Der blev ikke observeret nogen tilfælde af respirationsdepression i kliniske forsøg med esketamin næsespray (Spravato®), men der er blevet rapporteret om sjældne tilfælde af dyb sedation. Samtidig brug af Spravato® og CNS-depressiva kan øge risikoen for sedation. Spravato® kan medføre forbigående stigninger i det systoliske og/eller diastoliske blodtryk, som topper cirka 40 minutter efter administration af lægemidlet og varer cirka 1-2 timer. Der kan opstå betydelig stigning i blodtrykket efter enhver behandlingssession. Hos patienter, hvis blodtryk før administration af dosis vurderes til at være forhøjet (som generel retningslinje: > 140/90 mmHg for patienter < 65 år og> 150/90 mmHg for patienter ≥ 65 år), er det relevant at iværksætte livsstilsændringer og/eller farmakologisk behandling med henblik på at reducere blodtrykket før behandling med Spravato®. Hvis blodtrykket er forhøjet før behandlingen med Spravato®, skal en eventuel beslutning om at udsætte behandlingen tage højde for afvejningen af fordele og risici for den enkelte patient. Blodtrykket skal overvåges efter administration af dosis. Hvis blodtrykket forbliver forhøjet igennem længere tid, skal der straks søges hjælp fra en læge, der har erfaring med blodtryksregulering. Patienter, der oplever tegn på hypertensiv krise skal øjeblikkeligt henvises til akutbehandling. Patienter med selvmordsforsøg i anamnesen, og patienter der udviser en høj grad af selvmordstanker før igangsætningen af behandlingen, vides at have større risiko for selvmordstanker og selvmordsforsøg, og skal derfor overvåges tæt under behandlingen. Personer med stofmisbrug eller afhængighed i anamnesen kan have større risiko for misbrug eller forkert brug af Spravato®. Den enkelte patients risiko for misbrug eller forkert brug skal vurderes før ordination af Spravato®, og patienter, som får esketamin, skal overvåges for opståen af adfærd eller forhold, der kan tyde på misbrug eller forkert brug herunder medicinsøgende adfærd, mens behandlingen står på. Ældre patienter, der behandles med Spravato®, kan have større risiko for at falde. Urinvejs- og blæresymptomer er blevet rapporteret ved brug af Spravato® Interaktion med andre lægemidler og andre former for interaktion: Samtidig brug af Spravato® og CNS-depressiva (f.eks. benzodiazepiner, opioider, alkohol) kan øge den sederende effekt. Blodtrykket skal overvåges nøje ved brug af Spravato® sammen med psykostimulantia (f.eks. amfetamin, methylphenidat, modafanil, armodafinil) eller andre lægemidler, der kan øge blodtrykket (f.eks. xanthinderivater, ergometrin, thyreoideahormoner, vasopressin, eller MAO-hæmmere, som f.eks. tranylcypromin, selegitin, phenelzin). Graviditet og amning: Spravato frarådes under graviditet og til kvinder i den fertile alder, som ikke anvender kontraception. Der er ingen eller utilstrækkelig data vedrørende anvendelse af esketamin til gravide kvinder. Det er uvist, om esketamin udskilles i human mælk. En risiko for det ammede barn kan ikke udelukkes. Det skal besluttes, om amning skal ophøre eller behandling med Spravato® skal seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen. Dyreforsøg har vist at esketamin ikke påvirker fertiliteten og reproduktionsevnen negativt. Virkning på evnen til at føre motorkøretøj eller betjene maskiner: Spravato® påvirker i væsentlig grad evnen til at føre motorkøretøj og betjene maskiner. Før administration af Spravato® skal patienten instrueres i ikke at involvere sig i potentielt farlige aktiviteter, der kræver fuld mental årvågenhed og motorisk koordination, som f.eks. at køre bil eller betjene maskiner, indtil næste dag efter en god nats søvn Bivirkninger: De hyppigst observede bivirkninger var svimmelhed (30%), kvalme (27%), dissociation (26%), hovedpine (24%), somnolens (18%), vertigo (18%), dysgeusi (17%), hypæstesi (11%) og opkastning (10%). Følgende er alle bivirkninger, der er blevet indberettet for Spravato®. Meget almindelige (≥ 1/10): dissociation, svimmelhed, hovedpine, dysgeusi, somnolens, hypæstesi, vertigo, kvalme, opkast. Almindelige (≥ 1/100 til < 1/10): euforisk stemning, agitation, angstanfald, illusion, irritabilitet, panikangst, ændret tidsopfattelse, hallucinationer herunder synshallucinationer, derealisation, mental svækkelse, tremor, letargi, dysartri, paræstesi, sedation, sløret syn, hyperakusis, tinnitus, takykardi, hypertension, nasalt ubehag, nasal tørhed herunder nasal skorpedannelse, nasal pruritus, mundtørhed, oral hypæstesi, hyperhidrose, pollaksuri, dysuri, akut vandladningsbehov, følelse af at være unormal, følelse af at være beruset, følelse af ændret kropstemperatur, forhøjet blodtryk. Ukendte: hypersalivation. Indberetning af mistænkte bivirkninger: Når lægemidlet er godkendt, er indberetning af mistænkte bivirkninger vigtig. Det muliggør løbende overvågning af benefit/risk-forholdet for lægemidlet. Sundhedspersonale anmodes om at indberette alle mistænkte bivirkninger via det nationale rapporteringssystem. Overdosering: Symptomer: Sammenlignet med den anbefalede dosis var bivirkningerne i forbindelse med dosen 112 mg esketamin næsespray hyppigere, herunder svimmelhed, hyperhidrose, somnolens, hypoæstesi, unormal følelse, kvalme og opkastning. Behandling: Der findes intet specifikt antidot mod overdosering med esketamin. Behandling af overdosering med Spravato® bør omfatte behandling af de kliniske symptomer og relevant monitorering. Pakninger: Spravato® (esketamin) næsesprayanordning 1x28 mg: (VNR. 499425); Spravato® (esketamin) næsesprayanordning 2x28 mg: (VNR. 546611); Spravato® (esketamin) næsesprayanordning 3x28 mg: (VNR. 484104). Priser: Dagsaktuelle priser kan ses på www.medicinpriser.dk. Udlv.: BEGR Produktinformationen er forkortet i forhold til EMAs produktresumé 18 December 2019. Produktresuméet kan vederlagsfrit rekvireres fra: Janssen-Cilag A/S. Bregnerødvej 133, 3460 Birkerød, Tlf.: 45 94 82 82, Fax: 45 94 82 83. www.janssen.com/denmark/