Drug shortages are serious global problem in delivering healthcare. This presentation was delivered at the 5th Pharmaceutical care Conference in Oman (February 11, 2015)

1. 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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4. 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

5. Who cares? Pharmacists do!
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6. 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?
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7. 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
7
Gupta & Huang, editorial Drug Shortages
Clin Pharm Ther 93(2013)133

8. 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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9. 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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10. 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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11. Drug shortages (2011 – 2013) by
No. of reports and No. of products involved
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0
50
100
150
200
250
300
350
400
Jan
Feb
Mrt
Apr
Mei
Jun
Jul
Aug
Sept
Okt
Nov
Dec
Jan
Feb
Mrt
Apr
Mei
Jun
Jul
Aug
Sept
Okt
Nov
Dec
Jan
Feb
Mrt
Apr
Mei
Jun
Jul
Aug
Sept
Okt
Nov
Dec
2011 2012 2013
Reeks1
Reeks2
Lineair (Reeks1)
Lineair (Reeks2)

12. 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

13. By therapeutical class
13
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

14. Consequences for patient care: unique products
 Bleomycine injection (single supplier)
 Megestrolacetate tablets 160 mg
 Caelyx (liposomal doxorubicine) (global shortage)
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15. Companies involved: 50 / 50 innovator / generic
15
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

16. 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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18. 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

19. 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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20.  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

21. 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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22. 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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23. Industry initiative for faster communication
(but as yet not very concrete)
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24. 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

25. 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

26. More in detail in tomorrow’s workshop
(13:30 – 15:30)
Questions ?
Contact: a.vulto@erasmusmc.nl
Acknowledgement:
Many thanks to my colleagues Melissa Bujens and Jeroen Hassink for their
invaluable contributions and discussions 26

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