2015 02 11 vulto drug keynote shortages oman conference vs15b10agv
TRANSCRIPT
Drug Shortages, an emerging crisis in patient care How business interest and regulations compromise patient care
Arnold G. Vulto PharmD, FCP, Ph.D.
Professor of Hospital Pharmacy & Practical Therapeutics
Dr. Jorie Versmissen MD, Zita Vermijs
Hospital Pharmacy, Section Clinical Pharmacology
Erasmus University Medical Center, Rotterdam, The Netherlands
Oman Pharmaceutical Care
11th February 2015
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How low can you go?
NaCl 0,9% injection bags
in short supply
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Conflict of interest statement
I have a serious conflict of interest with drug suppliers that do not fullfill their
obligations: deliver the drugs for which they have the privilege of a marketing
authorisation.
I perceive a serious conflict of interest between shareholders value of these
companies and patients interests, that are my responsibility
I do not have any personal business interest in any pharmaceutical company
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Reference: Vulto, A. (2011): No stakeholders, no solution.
Eur J Hosp Pharmacy Practice 17, no.5, 7
Who cares? Pharmacists do!
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Agenda
1. Drug shortages: a multi-factorial problem
2. My hospital
3. Drug shortages in my hospital 2011 – 2013
4. Dutch National Working Party on Drug Shortages
Analysis of the problem
Selected recommendations
Impact study
5. Supply Chain Partnership: the better alternative? 6
1. Drug shortages are a multi-factorial problem
The supply chain for medicines has
become so complicated, that it
threatens to succumb due to its
vulnerability
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Gupta & Huang, editorial Drug Shortages
Clin Pharm Ther 93(2013)133
2. Erasmus University Medical Center
Total no. of acute care beds (incl. ICU): 1.320
42.000 admissions (2012), 285.000 bed-days
9.500 fte (11.500 persons; 750 medical specialists)
Total turnover of medicines (2013, incl. orphan drugs): 150 M€
Total no. of drug orders from external suppliers (2013): 95.500 lines
Total no. of drug orders supplied (2013): 257.000 lines
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How we track drug shortages
Each week we count the no. of products from our regular stock that are not
available
(wholesaler report + additional sources)
Non-availability means proces interruption, extra work
Then we look at the product involved
Each drug / dosage form / strength is counted as unique product
We have around 3.500 unique products in stock
Inclusion of all products from external suppliers
Raw materials and “home made” products excluded
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Drug shortages 2011 - 2013
Year No. Of
Reports
No. Of Unique
Products
Total No. Of
products
% non-
availability
2011 2483 366 3500 10
2012 3101 374 3500 11
2013 2885 331 3500 9
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Drug shortages (2011 – 2013) by
No. of reports and No. of products involved
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Jul
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2011 2012 2013
Reeks1
Reeks2
Lineair (Reeks1)
Lineair (Reeks2)
Which products are involved?
Top 15 drug shortage reports 2011 - 2013
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Top 15 Product Company
No. of
Reports
Incidental /
long-term
1 RABIES IMMUNOGLOBULINE INJE 300IE=2ML Pasteur 135 long-term
2 LORAZEPAM INJE 4MG=1ML Pfizer 103 long-term
3 ACETYLCHOLINE PDR V INSTVL INTRA-OC 20MG Thea Farma 98 long-term
4 MITOXANTRON INFCONC 20MG=10ML Sandoz 90 long-term
5 BLEOMYCINE INJE 15.000 IE(=15USP-E) TEVA 83 incidental
6 MEGESTROL TABL 160MG TEVA 82 long-term
7 POLIBAR ACB SUSP 965 MG/G Bracco 77 long-term
8 CHLOORHEXIDINE SCRUB 4% 250ML Regent 72 incidental
9 BETAMETHASON INJE 4MG=1ML MSD 69 long-term
10 PENFLURIDOL TABL 20MG (SEMAP) Janssen-Cilag 65 long-term
11 DOXORUBICINE LIPOSOM. INFC 20MG=10ML Janssen-Cilag 63 long-term
12 CYTARABINE INFCONC 2000MG=20ML Hospira 63 long-term
13 DIMETHYLAMINOFENOL, 4- INJE 250MG=5ML Kohler 61 long-term
14 CEFOTAXIM INJE 500MG TEVA 61 incidental
15 CHORIONGONADOTROFINE INJE 5000IE + SOLV Organon 59 incidental
By therapeutical class
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1 CNS (psychiatry)
2 CNS (neurology)
3 Anaesthetics / muscle relax.
4 Blood formation / coagulation
5 Cardiovascular system
6 Alimentary tract
7 Respiratory system
8 Urogenital system
9 Female genital system
10 Dermal preparations
11 Ear / Nose / Throat
12 Ophthalmic preps
13 Anti-infectives
14 Hormones
15 Analgesics
16 Vitamins / minerals
17 Oncolytic drugs
18 Anti-allergy preps
19 Miscelaneous
20 Dental products
Consequences for patient care: unique products
Bleomycine injection (single supplier)
Megestrolacetate tablets 160 mg
Caelyx (liposomal doxorubicine) (global shortage)
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Companies involved: 50 / 50 innovator / generic
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Year Supplier No.of Reports
No. of unique
products
No. of products
from that supplier
% not
available
Type of
Company
2011 Company A 591 75 339 22% generic
Company B1 (merger) 189 14 65 22% Innovator
Company C 141 24 110 22% Innovator
Company D 113 13 40 33% generic
Company E 111 12 114 11% generic
Company F 53 16 157 10% Innovator
2012 Company A 718 78 353 22% generic
Company C 211 31 119 26% Innovator
Company B2 (merger) 178 15 67 22% Innovator
Company D 105 12 29 41% generic
Company B1 (merger) 100 7 64 11% Innovator
Company G 94 6 11 55% generic
2013 Company A 655 69 307 22% generic
Company E 166 15 152 10% generic
Company H 116 11 118 9% Innovator
Company I 87 17 162 10% Innovator
Company J 80 9 15 60% generic
Company K 79 8 113 7% generic
Consequences
Each week we have to find alternative suppliers
To many ad-hoc decisions
Sometimes “panic”
Usually at a higher cost
Or buy from abroad: typical 5 times more expensive
Communication internally, to nursing staff, doctors, patients
This requires some 0,5 fte pharmacy staff
Pharmacy-clients blame the pharmacy
Reputation-damage for the pharmacy
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Analysis Dutch National Working Party on Drug Shortages
Report December 2012
Reasons shortages multifactorial
Technical, economical, legislation, regulatory
interventions, quality issues
These factors may work in synergy
New rules, Higher quality increased costs
Lower prices less investment in quality
Producers withdraw from the market
Increased vulnerability
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www.medicijngebruik.nl
Selection of recommendations Working Party
Ministry of Health
Clarify and quantify the problem
Stimulate collaboration private and public organisations
Try to learn from experience how to tackle shortages
Get insight in production capacity national / Europe
New legislation may disturb the market: make risk assessment in advance
Adaptation of laws and regulations
Marketing authorisation = duty to deliver, with sanctions
(this is already part of the law, but not sanctioned)
Allow GMP-certified pharmacies to fill supply gaps
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Adaptation of laws and regulations (cont’d)
Allow forced marketing authorisations in case of non-supply
Facilitate importation of drugs in short supply, but licensed elsewhere
Insurance companies
More prudent preference-policy to sustain continuity and availability
Pharmaceutical industry
Define list of critical drugs with critical stock levels
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Selection of recommendations Working Party
Source: Drug Shortages, December 2012
Dutch Institute of Responsible Drug Use
Follow up report: what was the impact?
It was difficult to pin down specific health
damage due to drug shortages
Pharmacists were able in most instances to
find some sort of alternative to limit damage
The organisational damage was
considerable
For the pharmacy
For doctors and nursing staff
For patients
Risky situations could occur
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Dutch Association of Hospital Pharmacists
Currently making inventory of the damage to the pharmacy-system
Calculation mode financial damages:
Market research to find alternative
Higher cost alternative
Additional shipping charges
Extra labour cost for stocking / dispensing
Extra administrative costs for duties like drug accountability
Extra cost for (permanent) changes in logistic system
Information / education prescribers and users
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Industry initiative for faster communication
(but as yet not very concrete)
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A daring suggestion
Change purchase policy from discount buying to
supply chain partnership
Make drug supplier partner in the supply chain
Develop performance parameters as partner
Show commitment
Reward good suppliers with more sales
Based on such performance monitoring we have shifted
purchases to more reliable suppliers (at a modest higher cost)
The first results look promising 24
Take home message
Due to a combination of – synergistic – factors, drug shortages increase
Intuitive actions – buy what you can – worsens the situation
Plan ahead (learning organisation), avoid opportunism and panic
Strategic actions on a higher level then a single hospital are needed
Enter in supply chain partnership with your critical suppliers
More in detail in tomorrow’s workshop
(13:30 – 15:30)
Questions ?
Contact: [email protected]
Acknowledgement:
Many thanks to my colleagues Melissa Bujens and Jeroen Hassink for their
invaluable contributions and discussions 26
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