Pharmacists' warning systems on medicines shortages - Sonia Ruiz Morán General Pharmaceutical Council of Spain FIP-TPA Conference for the European ...
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Pharmacists’ warning systems on medicines shortages Sonia Ruiz Morán General Pharmaceutical Council of Spain FIP-TPA Conference for the European Region Ankara, 24th October 2019
01 Medicines shortages
Why?
Public health problem
Effects on patients, the system and pharmacists
Global
Medicines shortages
All kinds of medicines are affected
Multiple causes
Notification and detection mechanisms
3
What do we need?
A system on detection and notification of medicines shortages
• Detect patient needs
• Reliable and agile information
• Early detection
• Cross border
4
02 CISMED
Based on unmet pharmacy orders
CISMED is based on a communication infrastructure of pharmacies -
provincial chambers- General Pharmaceutical Council of Spain
General
Chambers KNOWLEDGE
Pharmaceutical
Pharmacies send consolidate
Council
to Chambers of information and
consolidates at
medicines NOT send to national
national level and
supplied repository
analysis 6
Simplicity Type of information transmitted -ID pharmacy -National code -Date of the unmet order -Number of units not served Easy adherence of pharmacies to the system: consent form or web adherence Automatic reporting
Effectiveness
> 8 500 pharmacies > 10 000 notified Since 2016, 663
(1 out 3) medicines /week medicines with problems
1 municipality out of 2
> 230,000 Now, 320 medicines have
1 out of 3 is a rural
shortages/day(2019) been classified as such
pharmacy.
Given the potential impact on patients, it is important to collect all medicines shortages
reported by pharmacies, even if not all of them represent a supply problem
8Analysis
• No definition of shortage at European level in quantitative terms
• In Belgium, a medicine is considered unavailable when the
companies responsible for its marketing cannot deliver that
medicine for an uninterrupted period of four days to pharmacies or
distributors.
• In France they describe as interruption of the supply of medicines
when a pharmacy cannot dispense a drug to a patient within 72
hours or within a shorter time, depending on the treatment
• Statistical analysis, comprising two dimensions
• Provincial
• National
• Categorisation of medicinesExamples of analysis
• Procedure at provincial level
Number of reporting pharmacies = 157 → Critical value= 72 (data week 4-10 March 2019)
TRANKIMAZIN RETARD 0.5 MG 30
COMPRIMIDOS LIBERACION PROLONGADA
DAY Pharmacies State Supuesto escenario sin Supuesto escenario con
with short problemas de problemas de
supplies suministro suministro
LUNES 81 ALERT
MARTES 82 ALERT
MIÉRCOLES 76 ALERT
JUEVES 76 ALERT
VIERNES 80 ALERT
SÁBADO 66 NO ALERT
DOMINGO 3 NO ALERT α=Error tipo I. Probabilidad de concluir incorrectamente la existencia de
problemas de suministro. Poder estadístico 1 – β = Probabilidad de
ESTADO FINAL POSSIBLE SHORTAGE concluir correctamente la existencia de problemas de suministro
PROBLEM
A statistical power analysis is used. Critical values may vary depending on the parameters used.Examples of analysis
• Procedure at National level
PROSCAR 5 MG 28 COMPRIMIDOS RECUBIERTOS. DATA UNTIL 10 MARCH 2019
19 February date
CHANGE DETECTION MODEL February 10TH, estimated of detection
Sequential non-parametric model date as beginning of trend
in which each data is evaluated change
deciding if it constitutes a
significant increase with respect to
the previous situation
Medicines
Agency
communicates
11 MarchIt cannot be deduced from the application of these criteria that all
identified medicines have supply problems. These criteria an initial
Results starting point that allows us to limit the problem. This information
should be used in addition to others for validation and assesment
• Categorisation of medicines (cont.)
• M. with possible shortage problems: medicines with alerts in at least one province during >=3
days during the week observed
• M. under monitoring: medicines with alerts < 3 days in different provinces during the week
observed, or nationwide, if in their historical evolution it has been detected recent significant
increases in the number of pharmacies with short supplies
• M. not in shortage
• Example medicines in shortage identified by CISMED before being notified by
Medicines Agency: o VITAMIN RHINOCUSI 12500 UI/G NASAL OINTMENT o VARIARGIL 40 MG/ML ORAL DROPS
o CLEXANE 40 MG (4000 UI) 10 PRE-FILLED SYRINGES o TERBASMIN TURBUHALER 500
o FEBRECTAL INFANTS o DAILY LOETTE 100/20 MCG..
o APOCARD 100MG 60COMP o TEVETENS PLUS 600/12.5 MGAccess to information
• Reports
• Include: n. of pharmacies with shortages per medicine, provinces, medicine
description, whether shortage reported by AEMPS or not, type of medicine:
substitutable or non-substitutable, active ingredients of the medicine, therapeutic
group, prices etc. Usuarios
• + 1,000 monthly reports (pharmacists chambers, Ministry of Health and Medicines
Agency and other NCAs)
• Shortages published weekly on the General Council website
120
NÚMERO DE MEDICAMENTOS CON POSIBLES PROBLEMAS DE SUMINISTRO
% medicines with shortages by therapeutic group TOTAL SUBASTA DESABASTECIMIENTO OFICIAL OTROS
• , B - SANGRE Y ORGANOS
HEMATOPOYETICOS
3%
L - AGENTES ANTINEOPLASICOS E
INMUNOMODULADORES
3%
S - ORGANOS DE LOS
SENTIDOS
7%
R - SISTEMA J - ANTIINFECCIOSOS
RESPIRATORIO
3%
PARA USO
SISTÉMICO
1%
C - SISTEMA
CARDIOVASCULAR
33%
100
A - TRACTO
ALIMENTARIO Y
METABOLISMO
10%
80
G - SISTEMA
GENITOURINARIO Y
HORMONAS
SEXUALES
13%
M - SISTEMA
N - SISTEMA MUSCULOESQUELETI
NERVIOSO CO
12% 15%
60
40
20
0
10/01/2016
31/01/2016
21/02/2016
13/03/2016
03/04/2016
24/04/2016
15/05/2016
05/06/2016
26/06/2016
17/07/2016
11/09/2016
23/10/2016
13/11/2016
04/12/2016
25/12/2016
15/01/2017
12/02/2017
05/03/2017
26/03/2017
16/04/2017
07/05/2017
28/05/2017
18/06/2017
09/07/2017
30/07/2017
20/08/2017
10/09/2017
01/10/2017
22/10/2017
12/11/2017
03/12/2017
24/12/2017
14/01/2018
04/02/2018
25/02/2018
18/03/2018
08/04/2018
29/04/2018
20/05/2018
10/06/2018
01/07/2018
22/07/2018
12/08/2018
02/09/2018
23/09/2018
14/10/2018
04/11/2018
25/11/2018
16/12/2018
06/01/2019
27/01/2019
17/02/2019
10/03/2019
31/03/2019
21/04/2019
12/05/2019
02/06/2019
23/06/2019Access to information
• Portal web
Users
Health professionals and
patients
Usuarios
Pharmacist Chambers
Medicines Agency, Ministry,
NCAs
¿What would it allow?
Make queries
Generate and download
yparameterizable reports
Access to information
customised by users profile
1203 Next steps
Next steps
• Improve early detection tools (machine learning, etc)
• Collaboration with Spanish Medicines Agency
Usuarios
• Collaboration with other stakeholders
• Scaling up at EU level: European Project
o France, Italy, Portugal and Spain
o in collaboration with the Medicines Agency of Spain
o Application for EU funding in August -> Project selectedCONCLUSIONS
• Pharmacists are key to notify shortages and can help risk mitigation
management through an early detection
• For this, we need systems where information is reliable, in real time,
and allows for efficient management
• The system should incorporate predictive tools to allow for preventive
measures
• In collaboration with authorities and rest of supply chain stakeholders
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