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Medicine shortages – A study of community pharmacies in Finland
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Medicine shortages – A study of community pharmacies in Finland K. Heiskanen a , R. Ahonen a , P. Karttunen b , R. Kanerva c , J. Timonen a,∗ a b c
School of Pharmacy/Social Pharmacy, Faculty of Health Sciences, Kuopio Campus, University of Eastern Finland, Kuopio, Finland Siilinjärvi Pharmacy, Siilinjärvi, Finland VI Pharmacy of Turku, Humalisto Pharmacy, Turku, Finland
a r t i c l e
i n f o
Article history: Received 21 June 2014 Received in revised form 29 October 2014 Accepted 3 November 2014 Keywords: Medicine shortages Community pharmacy Finland
a b s t r a c t Objectives: To explore the frequency, the reasons behind, and the consequences of medicine shortages in Finnish community pharmacies. Methods: During the 27-day study period in the autumn of 2013, randomly selected pharmacies reported on medicines that were in short supply from orders made to wholesalers. Results: Altogether 129 (66%, n = 195) pharmacies participated in the study, and the study material consisted of 3311 report forms. Of the study pharmacies, 79.8% had medicine shortages daily or almost daily. Medicines in short supply were most commonly medicines that affect the nervous system (30.8%) and the cardiovascular system (17.5%). The reason behind the shortage was reported to the pharmacies in 11.2% of the shortage cases. The medicine shortages caused problems for the pharmacies in 33.0% of the cases. In most cases (67.0%) the medicine shortages did not cause problems for the pharmacies, usually because a substitutable product was available (48.5%). Conclusions: Medicine shortages are common in Finnish community pharmacies. Medicines in short supply were commonly used medicines. The reason behind the shortage was rarely told to the pharmacies. Medicine shortages caused problems for the pharmacies in onethird of all the shortage cases. These shortages may be significant for the customers or the pharmacies, as they cause customer dissatisfaction and increase the workload of the pharmacy staff. © 2014 Elsevier Ireland Ltd. All rights reserved.
1. Introduction Good availability of medicines has been stated as a political goal internationally [1]. Regardless, medicines are not always readily available and medicine shortages occur. A medicine shortage can be defined as “a drug supply issue requiring a change that impacts patient care
∗ Corresponding author at: School of Pharmacy/Social Pharmacy, Faculty of Health Sciences, Kuopio Campus, University of Eastern Finland, P.O. Box 1627, FI-70211 Kuopio, Finland. Tel.: +358 40 355 3881. E-mail address: johanna.timonen@uef.fi (J. Timonen).
and requires the use of an alternative agent” [2]. Several reasons related to demand or supply causes may be behind medicine shortages [2,3]. For example, demandrelated factors include changes in demand like increased demand and non-traditional demands like parallel trade [2]. Medicine supply problems may be related to raw and bulk material issues (e.g., raw material shortage), manufacturing issues (e.g., limited manufacturing capacity or changes/problems in the production process or business-related decisions to cease production due to poor demand and profit), wholesale and distribution issues (e.g., inventory management practices or delays in the distribution chain), market structure issues (e.g., single- or
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limited-source products due to mergers and consolidations or the generic medicines market), regulatory issues (e.g., batch recall or stringent regulatory requirements that delay production), and communication issues (e.g., lack of information or reluctance to share details of shortages) [2,3]. There may also be multiple simultaneous reasons behind a shortage. A shortage can emerge at any stage in the life cycle of a medicine and in any part of the pharmaceutical distribution chain (pharmacy, pharmaceutical company, or wholesaler) [2]. There are a limited number of research publications dealing with medicine shortages. In addition, the studies have primarily been conducted in hospitals. Some studies have reported the impact of medicine shortages on patient safety and patient care [4–11]. Medicine shortages may cause several issues related to patient care, such as medication errors, inefficient medical care, and side effects or allergies when the medicine is changed due to the shortage. In addition, due to medicine shortages, the patient’s care may be delayed and in some cases the patient may not receive recommended treatment at all [8–10]. Furthermore, sometimes due to shortages the treatment may be more expensive than the originally selected treatment [8–11]. Patients may also experience stress or frustration when shortages occur [11]. Moreover, medicine shortages may also cause significant harm to health care professionals, as shortages increase the workload of physicians and pharmacists [8–10,12,13]. A few studies have reported the frequency of medicine shortages. According to a study conducted in hospitals in the United States, nearly all the hospitals suffered from medicine shortages at least once within the last 6 months [6]. Of these hospitals, 44% reported 21 or more shortages within the last 6 months. According to a Canadian study conducted in pharmacies, medicine shortages were even more common, as almost 94% of respondents reported shortages during the last week and 81% during their last shift [11]. The shortages had complicated dispensing of an average of ten prescriptions during the last week. Of the respondents, 89% agreed that the number of medicine shortages had increased notably during the last year. Medicine shortages have been an internationally recognized current topic lately [2,3,14–17], and have also been addressed in an international summit [2]. According to the report of the international summit on medicine shortages, medicine shortages have become a growing global issue, and in some countries the number of shortages has tripled between 2005 and 2010. However, medicine shortages are still a rarely investigated subject and the information currently available is insufficient for assessing the extent and characteristics of medicine shortages at a country-specific and international level. 1.1. Study context In Finland, the pharmaceutical market is small [18]. In 2013, total sales of pharmaceuticals at wholesale prices were approximately D 2 billion, which was divided into sales to pharmacies (72%), sales to hospitals (26%), and sales to retailers and others (2%) [19]. Most pharmacy sales (87%) consisted of sales of prescription medicines, of which
a majority (78%) were reimbursed medicines [19,20]. The share of the global pharmaceutical market is approximately 0.3%, and of the European pharmaceutical market, approximately 1.3%. The majority of medicines sold in Finland come from abroad, mostly from EU countries [18]. Community pharmacies have the sole right to sell prescription and over-the-counter (OTC) medicines (excluding nicotine replacement therapy) to the public in Finland. There is a privately owned pharmacy system, with 615 pharmacies and 185 subsidiary pharmacies in 2013 [21]. Subsidiary pharmacies are privately owned, small pharmacy outlets that the pharmacy owner possesses along with the main community pharmacy. Subsidiary pharmacies are placed in areas where pharmaceutical service is needed but there is no need for an independent main community pharmacy. In addition, there are two community pharmacies owned by two universities: the University Pharmacy of Helsinki, with 16 subsidiary pharmacies, and the University Pharmacy of Eastern Finland. The university pharmacies operate like the privately owned community pharmacies. The staff in pharmacies consists of the pharmacy owner (M.Sc. in pharmacy), pharmacists (M.Sc. in pharmacy), prescriptionists (B.Sc. in pharmacy), and, for example, pharmacy technicians. Furthermore, 59% of the staff has a pharmaceutical education. A pharmacist is a person with 5-year education and a prescriptionist is a person with 3-year education at the university. Both pharmacist and prescriptionist dispense medicines independently and ensure their safe and proper use among the public by patient counseling, but pharmacists also act as manager. The average pharmacy in Finland delivered about 72,000 prescriptions in 2013 [22]. The pharmacy business is strictly regulated in Finland. The Finnish Medicines Agency (FIMEA) controls the location, number, and ownership of pharmacies [23]. The pharmaceutical network in Finland is comprehensive, as there is at least one pharmacy in almost every municipality [24]. There is one pharmacy per 6000 inhabitants. The prices of medicines are the same in all pharmacies [23]. Sales of medicines constitute 94% of the turnover of pharmacies [25]. In Finland, there are two pharmaceutical wholesalers with a distribution system that covers the whole country. Finnish wholesale distribution of medicines is based on a single-channel system [26]. This means the pharmaceutical manufacturer makes a sole-distribution contract covering all its products with a wholesaler, and pharmacies or hospitals can acquire a certain pharmaceutical product though that wholesaler only. Generic substitution (GS) and a reference price system (RPS) are in use in Finland [27,28]. According to the Medicine Act 80/2003, pharmacists are obligated to substitute the prescribed product with the cheapest or close to the cheapest interchangeable product if the price of the product is higher than the reference price. If the customer objects to the substitution, the customer has to pay the price difference between the reference price and the chosen medicine out of pocket. The reference price is determined quarterly by the least expensive medicine in every reference price group. The reference price is the price of the cheapest product +D 1.50 if the price is under D 40, and
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the price of the cheapest product +D 2.00 if the price is D 40 or more. However, pharmaceutical companies may revise their prices every 2 weeks. 2. Aim The aim of this study was to assess medicine shortages in Finnish community pharmacies. Further objectives were to explore how frequently medicine shortages occur, the reasons behind medicine shortages, and the problems medicine shortages cause for Finnish community pharmacies. 3. Material and methods A study was conducted in Finnish community pharmacies in the autumn of 2013. A random sample of 194 privately owned community pharmacies was selected from a total of 583 pharmacies that were listed in the affiliate register of the Association of Finnish Pharmacies. One of the 18 University Pharmacy outlets also took part. During the 27-day study period (September 27, 2013 to October 23, 2013) pharmacies reported medicines in short supply from orders made to wholesalers. The study period was scheduled to cover the change in the reference price (October 1, 2013). Prescription medicines (human and veterinary), non-prescription medicines (human and veterinary), and reimbursable emollient creams were reported. Nonmedical products and food, dietary, or other supplements were excluded from the study. Each study pharmacy received 40 forms for reporting medicines in short supply from the medicine orders of the pharmacy. In addition, each pharmacy received one background form (location of the pharmacy, the number of prescriptions per year, and the number of returned forms) and instructions for filling in the forms. The report form (appendix, online only) was developed mainly on the basis of our own experiences, a pharmacy’s experiences from a piloting period, and also earlier literature [2] concerning reasons behind medicine shortages. The report form consisted of 21 questions related to information on the medicines in short supply (e.g., trade name, package size, and whether the medicine was a prescription or OTC medicine), the reasons behind the medicine shortages that were reported to the pharmacy, the consequences of the medicine shortages at the pharmacy, and whether the pharmacy received the medicine during the study period. Furthermore, the person who filled in the form (e.g., pharmacy owner, pharmacist, prescriptionist) and the date when the form was filled in were also asked. The questions related to the product were open-ended questions and the questions related to the reasons behind the shortages and the consequences of the medicine shortages were structured questions, some with open-ended choices added. For example, the question related to the reasons behind the shortages had 12 fixed answers to choose from and also space for open answers. The report form was piloted at a local pharmacy with over 100,000 prescriptions per year. Six forms were filled in during the 1-week piloting period. As a result, the total number of forms sent per study pharmacy (n = 40 forms) was stated.
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In addition, some minor adjustments were made to the form. Each trade name, the amount of the active ingredient(s), and package size were reported separately. In addition, the forms were to be filled by a person or a work pair that handled the medicine orders at the pharmacy on a daily basis. The study in the pharmacies was finished when all 40 forms were filled in or the study period ended. In cases where two or more forms were filled in by the study pharmacy for the same medicine on the same day and they contained the same information, only one was included in the study. Missing information (e.g., a holder of marketing authorization) was added to the forms by the research group, if possible. The medicines were classified according to the 5th level of the Anatomic Therapeutic Chemical (ATC) classification [29]. The frequency of medicine shortages at the pharmacies was calculated based on the dates when the forms were filled in during the weeks of the study period. The data were analyzed with IBM SPSS 21.0 for Windows using frequencies and cross-tabulations for descriptive analysis and Fisher’s exact and Pearson’s 2 tests for group comparison. A significance level of 0.05 was used. The study setting and research process were in accordance with the local and national ethical instructions for research (Finnish Advisory Board on Research Integrity: http://www.tenk.fi/en/ethical-review-humansciences). According to the instructions, this study did not require ethical approval. 4. Results The study flow is shown in Fig. 1. Altogether 129 (66%) community pharmacies participated in the study, returning a total of 3472 report forms. However, 161 forms were removed from the final study material because the forms were filled in with information about non-medical products and food, dietary, or other supplements (n = 95) or because two or more forms were filled in for the same product on the same day, thus containing identical information (n = 66). Consequently, the final study material consisted of 3311 forms. A summary of the study pharmacies and the forms for reporting medicines in short supply are shown in Table 1. Of the study pharmacies, 79.8% had medicine shortages daily or almost daily (three or more times per week), 17.1% weekly (one to two times per week), and 3.1% less frequently than weekly during the study period. Pharmacies with over 100,000 prescriptions per year had shortages more frequently than pharmacies with 30,001–60,000 prescriptions per year (p = 0.022). There was no statistically significant difference in how frequently shortages occurred and the location of the pharmacy. Most of the medicines in short supply were human medicines (97.7%) and prescription medicines (79.9%) (Table 2). Medicines in short supply were most commonly medicines that affect the nervous system (30.8%) and cardiovascular system (17.5%). The most common active ingredients in short supply were (n = 3311) paracetamol (7.1%), atorvastatin (4.2%), temazepam (2.7%), and doxepin
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Table 1 Summary of the study pharmacies and forms for reporting medicines in short supply (number of prescriptions per year and the location of the study pharmacies in comparison to Finnish community pharmacies). In this study a
In Finland b
Number of prescriptions per year in the pharmacy (n = 125) ≤30,000 11.2 (14) 16.7 (98)c 30,001–60,000 32.8 (41) 32.0 (188)c 60,001–100,000 32.8 (41) 32.0 (188)c ≥100,001 23.2 (29) 19.3 (113)c Location of the pharmacy (n = 125)b The county of Western 36.0 (45) 39.4 (250)d Finland The county of Southern 32.8 (41) 34.0 (216)d Finland 16.8 (21) The county of Eastern 14.0 (89)d Finland The county of Northern 8.8 (11) 9.0 (57)d Finland The county of Lapland 5.6 (7) 3.6 (23)d Number of report forms returned per pharmacy (n = 129) 1–10 8.5 (11) 11–20 24.0 (31) 21–30 31.0 (40) 36.4 (47) 31–40 The person or work pair who filled in the form (n = 3309)e Pharmacy technician 45.6 (1509) 25.5 (845) Pharmacist (M.Sc.) Prescriptionist (B.Sc.) 10.0 (332) Pharmacist (M.Sc.) and 7.0 (231) pharmacy technician together Pharmacy owner 6.6 (217) Other work pairf 3.4 (113) g Other 1.9 (62)
Fig. 1. Study flow.
(2.3%). Of all the medicines, 44.8% were cheaper than the reference price and of those medicines, most (39.3%) were the cheapest alternatives. The information about the medicine shortage usually (98.4%, n = 3224) came from the wholesaler. The reason behind the medicine shortage was reported to the pharmacy in 11.2% (n = 3147) of the shortage cases. The most common reason behind the medicine shortages was that the product had run out in Finland or at the supplier (49.3%) (Table 3). In 64.1% (n = 2053) of the shortage cases, the pharmacy did not receive information on when the medicine would be available again. In 58.6% (n = 1838) of the shortage cases, the pharmacy received the medicine in short supply during the study period. The medicine shortages caused problems for the pharmacies in 33% of the shortage cases (n = 3044). Most often these problems were that the customers were unsatisfied (54.1%) or that serving the customers was more timeconsuming (52.9%) (Table 3). In most cases (67.0%) the medicine shortages did not cause problems for the pharmacy, mostly because a substitutable product was available (48.5%). There were no statistically significant differences in whether the medicine shortages caused problems for the pharmacies and the number of prescriptions per year of the pharmacies or the location of the pharmacies.
a In this study, the pharmacies reported the number of prescriptions per year from 2012. b Of the study pharmacies, four did not report the number of prescriptions per year or the location of the pharmacy. c Information based on Ref. [35] with the total number of pharmacies being 587. d Information based on Refs. [36,37] with the total number of pharmacies being 635. e Of the report forms, two did not include the information on the person or work pair who filled in the form. f For example, prescriptionist (B.Sc.) and pharmacy technician. g For example, pharmacy student.
5. Discussion According to this study, medicine shortages were very common in Finnish community pharmacies, as a great majority of the study pharmacies suffered from medicine shortages daily or almost daily. The result is consistent with a Canadian study conducted in pharmacies [11]. We also found that medicines in short supply also included medicine groups that are commonly used in Finland [30]. In addition, medicines in short supply were more common especially in big pharmacies than in small ones. This might be because big pharmacies may have a larger assortment of products in their stock than small ones and therefore, shortages may occur more often. In addition, big pharmacies sell a larger volume of products and may also have a larger frequency of medicine orders than small pharmacies. Our results showed that the reasons behind the shortages were rarely reported to the pharmacies. Furthermore, in most of the shortage cases, the pharmacies did not
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Table 2 Background characteristics of medicines in short supply. Medicines in short supply
% (n)
All Human medicine Veterinary medicine Prescription medicine Over-the-counter (OTC) medicine Parallel trade medicine Anatomical therapeutic chemical (ATC) classificationa Medicines that affect the nervous system (N) Psycholeptics (N05) Analgesics (N02) Psychoanaleptics (N06) Cardiovascular medicines (C) Lipid modifying agents (C10) Beta-blocking agents (C07) Agents that act on the renin-angiotensin system (C09) Medicines that affect the alimentary tract and metabolism (A) Medicines used in diabetes (A10) Antidiarrheals, intestinal anti-inflammatory/anti-infective agents (A07) Medicines for functional gastrointestinal disorders (A03) Medicines that affect the genitourinary system and sex hormones (G) Medicines that affect the respiratory system (R) Anti-infectives for systemic use (J) Dermatologicals (D) Other Included in the reference price? (n = 3190)b No Yes Position in the reference price (n = 1339)b , c The cheapest Between the cheapest and the most expensive The most expensive Otherd
100 (3311) 97.7 (3236) 2.3 (75) 79.9 (2645) 20.1 (666) 4.0 (131) 30.8 (1021) 9.7 (321) 8.4 (279) 7.8 (260) 17.5 (581) 6.8 (224) 4.7 (156) 3.2 (105) 10.1 (335) 2.4 (80) 1.8 (58)
1.4 (48) 9.6 (319) 8.7 (287) 5.8 (191) 5.3 (175) 12.1 (402) 55.2 (1760) 44.8 (1430) 39.3 (527) 28.3 (379) 28.1 (377) 4.2 (56)
a The three most common subgroups are presented from the three most common main groups. b All forms did not include information on whether the medicine was included in the reference price. c Contains medicines that were included in the reference price. d For example, all the medicines in the reference price had exactly the same price.
receive information on when the medicine in short supply would be available again. Similar results have been reported earlier in Canadian studies [11,31]. The lack of information may complicate not only customer service, but also time management at the pharmacies as the pharmacy staff tries to find the missing information. The most common reason behind the medicine shortages was that the product had run out in Finland or at the supplier. However, it should be noted that the number of cases where the reason behind the shortage was known was small with respect to the whole study material. In addition, in the reasons behind the medicine shortages (Table 3) we addressed the shortage cases, not different medicines in short supply. Accordingly, the same medicine may appear multiple times, affecting the commonness of a certain reason, and the reason behind the shortage may appear more
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Table 3 Reasons behind the medicine shortages and consequences of the shortages for the pharmacies. Reasons behind the medicine shortages (n = 353)a The product had run out in Finland/the product had run out at the supplier Problem at the manufacturing site Wholesaler The owner of the trading license changed Raw material shortage Otherb Problems that the shortages caused for the pharmacies (n = 1005)c The customers were unsatisfied Serving the customer was more time-consuming Storage management required additional work The working environment was experienced as more hasty The medicine had to be borrowed from another pharmacy The physician had to be contacted Other products were sold instead The customer was left with no suitable medicine Reasons why the shortages did not cause problems for the pharmacies (n = 2039)d A substitutable product was available The product in short supply was in stock and there was a sufficient amount of the product during the shortage period The product was not sold during the shortage period The shortage was only temporary
49.3 (174)
12.7 (45) 9.1 (32) 5.7 (20) 4.5 (16) 18.7 (66)
54.1 (544) 52.9 (532) 21.8 (219) 12.3 (124)
8.5 (85)
2.4 (24) 2.3 (23) 1.2 (12)
48.5 (988) 27.5 (561)
14.7 (300) 3.7 (76)
a Only shortage cases where the reason behind the shortage was reported to the pharmacy. Multiple responses could be reported. b For example, the product had exited from the market or the product required a special permit. c Only shortage cases where the pharmacy reported that the medicine shortage caused problems for the pharmacy. Multiple responses could be reported. d Only shortage cases where the pharmacy reported that the medicine shortage did not cause problems for the pharmacy. Multiple responses could be reported.
often. Therefore, this result should be interpreted with caution. The earlier literature has reported that common reasons for medicine shortages relate to manufacturing issues, raw material shortages, single- or limited-source products, inventory management practices, and the size of the market in an otherwise small country with a limited market [2,11,32]. However, more research on this topic is needed in the future. In most cases the medicine shortages did not cause problems for the pharmacies because of the possibility
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of GS and because a substitutable product was available. This finding is in line with an earlier Finnish study dealing with GS [28]. Our result meant that in most cases the customer received the medicine and in only 12 cases the customer was left with no suitable medicine. Even though the number of cases in which the customer was left with no medicine is relatively small, the effect of the shortage on patients may still be significant, as reported in the earlier studies [4–11]. However, the earlier studies have primarily been conducted in hospitals, and more research on outpatient treatment is needed. Medicine shortages caused problems for the pharmacies in every third shortage case. Those shortages may be significant for the pharmacy or customer. According to this study, medicine shortages can increase the workload of health care professionals and cause customer dissatisfaction. The results are consistent with earlier studies exploring medicine shortages [8–10,12,13]. The study pharmacies were randomly selected from the affiliate register that covers almost all Finnish pharmacies. Of these pharmacies, 66% participated in the study. This is comparable with or higher than in some earlier studies of pharmacies related to medicine shortages [12,13] or Finnish surveys of pharmacy staff [33,34], in which the response rate has varied between 13% and 67%. In addition, the study pharmacies represented Finnish pharmacies well in terms of location and the number of prescriptions per year. Thus, we suggest that the results of this study may be generalized to Finnish community pharmacies. This study also has some limitations. It should be noted that the results of this study are based on self-reports from the staffs of community pharmacies. Consequently, it is possible that all shortages might not have been reported in this study, and in bigger pharmacies the number of forms might not have been sufficient to cover all medicine shortages during the study period. Therefore, medicine shortages may occur even more frequently than suggested by this study. Furthermore, we explored the shortage cases, not different medicines (e.g. active ingredient, amount of active ingredient, package size) in short supply. That information would provide a wider view of the matter studied. Besides, the study was limited to experiences in Finland, and there are country-specific differences, such as variation in the size of the pharmaceutical market and the operating environment. Thus, the results of this study should be compared with other countries with caution. According to the report of the International Pharmaceutical Federation (FIP), country-specific research is needed to provide a general view of medicine shortages and to determine the actual extent of medicine shortages [2]. Therefore, this study provides much needed information about the subject from community pharmacies in Finland. However, similar studies from other countries are needed in the future. In addition, the subject should be examined from different perspectives, such as patients, pharmaceutical companies, and wholesalers. 6. Conclusions This study suggests that medicine shortages are common in Finnish community pharmacies. Besides, medicines
in short supply were very commonly used medicines. The reasons behind the medicine shortages were rarely reported to the pharmacies. In most cases the medicine shortages did not cause problems for the pharmacies and the customers received medicine, mostly because a substitutable product was available. However, in every third case, the medicine shortage did cause problems for the pharmacy. These shortages may be significant for the customer or the pharmacy, as they can cause customer dissatisfaction and increase the workload of the pharmacy staff. Acknowledgement This study was conducted in the School of Pharmacy at the University of Eastern Finland. Appendix A. Supplementary data Supplementary data associated with this article can be found, in the online version, at http://dx.doi.org/10.1016/ j.healthpol.2014.11.001. References [1] European Medicines Agency. Road map to 2015 – The European Medicines Agency’s contribution to science, medicines and health. London; 2011. [2] Besancon L, Chaar B. Report of the international summit on medicines shortage. Toronto: International Pharmaceutical Federation (FIP); http://www.fip.org/files/fip/publications/FIP Summit On 2013. Medicines Shortage.pdf [3] Morrison A. Drug supply disruptions [environmental scan issue 17]. Ottawa: Canadian Agency for Drugs and Technologies in Health; 2011. [4] McLaughlin M, Kotis D, Thomson K. Effects on patient care caused by drug shortages: a survey. Journal of Managed Care Pharmacy 2013;19:783–8. [5] Baumer AM, Clark AM, Witmer DR. National survey of the impact of drug shortages in acute care hospitals. American Journal of HealthSystem Pharmacy 2004;61:2015–22. [6] American Hospital Association. Survey on drug shortages; 2011. July 12. http://www.aha.org/content/11/drugshortagesurvey.pdf [7] Institute for Safe Medication Practices (ISMP). National survey on drug shortages/ISMP survey on drug shortages. ISMP Medication Safety Alert 2010;15:4. [8] Becker DJ, Talwar S, Levy BP. Impact of oncology drug shortages on patient therapy: unplanned treatment changes. Journal of Oncology Practice 2013;9:122–8. [9] Gundlapalli AV, Beekmann SE, Graham DR. Perspectives and concerns regarding antimicrobial agent shortages among infectious disease specialists. Diagnostic Microbiology and Infectious Disease 2013;75:256–9. [10] McBride A, Holle LM, Westendorf C. National survey on the effect of oncology drug shortages on cancer care. American Journal of HealthSystem Pharmacy 2013;70:609–17. [11] Canadian Pharmacists Association. Canadian drug shortages survey: final report, Ottawa; 2010. www.pharmacists.ca/cpha-ca/assets/ file/cpha-on-the-issues/drugshortagesreport.pdf [12] Kaakeh R, Sweet BV, Reilly C. Impact of drug shortages on U.S. health systems. American Journal of Health-System Pharmacy 2011;68:1811–9. [13] Hunnisett-Dritz D. Successful importation of cytarabine into the United States during a critical national drug shortage. American Journal of Health-System Pharmacy 2012;69:1416–21. [14] Dolgin E. NIH faces marching orders on orphan drug shortage. Nature Medicine 2011;17:522. [15] Kaiser J. Medicine. Shortages of cancer drugs put patients, trials at risk. Science 2011;332:523. [16] Mitka M. FDA, US hospital and pharmacy groups report drug shortages a growing problem. The Journal of the American Medical Association 2011;306:1069–70.
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[17] Roehr B. FDA is to hold public meeting to discuss reasons for drug shortages. British Medical Journal 2011;343:5650. [18] EFPIA (European Federation of Pharmaceutical Industries and Associations). The pharmaceutical industry in figures, 2013 edition. Brussels; 2013. http://www.efpia.eu/uploads/Figures Key Data 2013.pdf [19] Pharma Industry Finland, Pharmaceutical Sales in Finland in 2013 http://www.pif.fi/Tiedostot/11%20wholesales%20year.pdf [20] Pharma Industry Finland, Wholesale to pharmacies http://www. pif.fi/Tiedostot/13%20wholesales%20to%20pharmacies.pdf [21] Association of Finnish Pharmacies, Apteekit numeroina. [Pharmacies in numbers] http://www.apteekkariliitto.fi/fi/apteekkitieto/ apteekit-numeroina.html [22] Association of Finnish Pharmacies, Annual review 2013 http://www. apteekkariliitto.fi/media/pdf/afp annual review 2013 web.pdf [23] Finnish Medicines Agency, About us. http://www.fimea.fi/about us [24] Peura S, Rajamäki S, Kurkijärvi U. PPRI-pharma profile Finland. The pharmaceutical pricing and reimbursement information project, Vienna; 2007. [25] Pharma Industry Finland, Breakdown of pharmacy sales in 2012. http://www.pif.fi/Tiedostot/18%20pharmacy%20sales.pdf [26] Pelkonen E. Ajankohtaista Suomen lääkejakelusta [Current Topics in Finnish Pharmaceutical Distribution]. Helsinki: Toim. Hanhela, Lääketietokeskus; 2010. p. s. 28–30. Kirjassa: Lääkkeistä terveyttä? [27] Ministry of Social Affairs and Health, Viitehintaryhmät ja viitehinnat. [Reference pricing system] http://www.stm.fi/stm/ neuvottelukunnat/hila/viitehinta/viitehintaryhmat [28] Timonen J, Heikkilä R, Ahonen R. Generic substitution in Finland: lessons learned during 2003–2008. Journal of Pharmacy and Health Research 2013;4:165–72.
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[29] WHO Collaborating Centre for Drug Statistics Methodology, ATC – structure and principles. http://www.whocc.no/atc/structure and principles/ [30] Finnish medicines agency, FIMEA and social insurance institution. Helsinki: Finnish Statistics on Medicines 2012; 2013. [31] Joubert RJ. Analysis of survey of community pharmacy managers on disruptions in supply and/or shortages of prescription drugs. Saskatoon: Saskatchewan College of Pharmacists; 2010. http://napra.ca/Content Files/Files/Saskatchewan/Analysisof SurveyofCommunityPharmacyManagers.pdf [32] Woodend KA, Poston J, Weir K. Drug shortages – risk or reality? Canadian Pharmacists Journal/Revue des Pharmaciens du Canada 2005;138:27. [33] Hartikainen-Herranen K, Ahonen R. Lääkevaihdon vaikutukset apteekkien talouteen ja toimintaan [The impact of generic substitution on the finances and activities of pharmacies]. Helsinki: Toim. Ahonen ja Martikainen, Edita Prima Oy; 2005. p. s.69–78. Kirjassa: Lääkevaihdon ensimmäinen vuosi. [34] Tiihonen M, Norlund S, Nousiainen S. Apteekkifarmaseuttien käsitykset unettomuuden hoidosta ja unilääkkeiden käytöstä Suomessa [Pharmacists’ Perceptions of Treating Insomnia and the Utilization of Hypnotics in Finland]. Dosis 2013;29:75–83. [35] Data of Association of Finnish Pharmacies; 2012. [36] Tamro Suomi. Apteekit ja apteekkarit Suomessa 2013 [Finnish Pharmacies and Pharmacy Owners in 2013, Helsinki]; 2013. [37] Statistics Finland, Counties and municipalities http://www. tilastokeskus.fi/meta/luokitukset/laani/001-2009/luokitusavain. html
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Medicine shortages – A study of community pharmacies in Finland K. Heiskanen a , R. Ahonen a , P. Karttunen b , R. Kanerva c , J. Timonen a,∗ a b c
School of Pharmacy/Social Pharmacy, Faculty of Health Sciences, Kuopio Campus, University of Eastern Finland, Kuopio, Finland Siilinjärvi Pharmacy, Siilinjärvi, Finland VI Pharmacy of Turku, Humalisto Pharmacy, Turku, Finland
a r t i c l e
i n f o
Article history: Received 21 June 2014 Received in revised form 29 October 2014 Accepted 3 November 2014 Keywords: Medicine shortages Community pharmacy Finland
a b s t r a c t Objectives: To explore the frequency, the reasons behind, and the consequences of medicine shortages in Finnish community pharmacies. Methods: During the 27-day study period in the autumn of 2013, randomly selected pharmacies reported on medicines that were in short supply from orders made to wholesalers. Results: Altogether 129 (66%, n = 195) pharmacies participated in the study, and the study material consisted of 3311 report forms. Of the study pharmacies, 79.8% had medicine shortages daily or almost daily. Medicines in short supply were most commonly medicines that affect the nervous system (30.8%) and the cardiovascular system (17.5%). The reason behind the shortage was reported to the pharmacies in 11.2% of the shortage cases. The medicine shortages caused problems for the pharmacies in 33.0% of the cases. In most cases (67.0%) the medicine shortages did not cause problems for the pharmacies, usually because a substitutable product was available (48.5%). Conclusions: Medicine shortages are common in Finnish community pharmacies. Medicines in short supply were commonly used medicines. The reason behind the shortage was rarely told to the pharmacies. Medicine shortages caused problems for the pharmacies in onethird of all the shortage cases. These shortages may be significant for the customers or the pharmacies, as they cause customer dissatisfaction and increase the workload of the pharmacy staff. © 2014 Elsevier Ireland Ltd. All rights reserved.
1. Introduction Good availability of medicines has been stated as a political goal internationally [1]. Regardless, medicines are not always readily available and medicine shortages occur. A medicine shortage can be defined as “a drug supply issue requiring a change that impacts patient care
∗ Corresponding author at: School of Pharmacy/Social Pharmacy, Faculty of Health Sciences, Kuopio Campus, University of Eastern Finland, P.O. Box 1627, FI-70211 Kuopio, Finland. Tel.: +358 40 355 3881. E-mail address: johanna.timonen@uef.fi (J. Timonen).
and requires the use of an alternative agent” [2]. Several reasons related to demand or supply causes may be behind medicine shortages [2,3]. For example, demandrelated factors include changes in demand like increased demand and non-traditional demands like parallel trade [2]. Medicine supply problems may be related to raw and bulk material issues (e.g., raw material shortage), manufacturing issues (e.g., limited manufacturing capacity or changes/problems in the production process or business-related decisions to cease production due to poor demand and profit), wholesale and distribution issues (e.g., inventory management practices or delays in the distribution chain), market structure issues (e.g., single- or
http://dx.doi.org/10.1016/j.healthpol.2014.11.001 0168-8510/© 2014 Elsevier Ireland Ltd. All rights reserved.
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limited-source products due to mergers and consolidations or the generic medicines market), regulatory issues (e.g., batch recall or stringent regulatory requirements that delay production), and communication issues (e.g., lack of information or reluctance to share details of shortages) [2,3]. There may also be multiple simultaneous reasons behind a shortage. A shortage can emerge at any stage in the life cycle of a medicine and in any part of the pharmaceutical distribution chain (pharmacy, pharmaceutical company, or wholesaler) [2]. There are a limited number of research publications dealing with medicine shortages. In addition, the studies have primarily been conducted in hospitals. Some studies have reported the impact of medicine shortages on patient safety and patient care [4–11]. Medicine shortages may cause several issues related to patient care, such as medication errors, inefficient medical care, and side effects or allergies when the medicine is changed due to the shortage. In addition, due to medicine shortages, the patient’s care may be delayed and in some cases the patient may not receive recommended treatment at all [8–10]. Furthermore, sometimes due to shortages the treatment may be more expensive than the originally selected treatment [8–11]. Patients may also experience stress or frustration when shortages occur [11]. Moreover, medicine shortages may also cause significant harm to health care professionals, as shortages increase the workload of physicians and pharmacists [8–10,12,13]. A few studies have reported the frequency of medicine shortages. According to a study conducted in hospitals in the United States, nearly all the hospitals suffered from medicine shortages at least once within the last 6 months [6]. Of these hospitals, 44% reported 21 or more shortages within the last 6 months. According to a Canadian study conducted in pharmacies, medicine shortages were even more common, as almost 94% of respondents reported shortages during the last week and 81% during their last shift [11]. The shortages had complicated dispensing of an average of ten prescriptions during the last week. Of the respondents, 89% agreed that the number of medicine shortages had increased notably during the last year. Medicine shortages have been an internationally recognized current topic lately [2,3,14–17], and have also been addressed in an international summit [2]. According to the report of the international summit on medicine shortages, medicine shortages have become a growing global issue, and in some countries the number of shortages has tripled between 2005 and 2010. However, medicine shortages are still a rarely investigated subject and the information currently available is insufficient for assessing the extent and characteristics of medicine shortages at a country-specific and international level. 1.1. Study context In Finland, the pharmaceutical market is small [18]. In 2013, total sales of pharmaceuticals at wholesale prices were approximately D 2 billion, which was divided into sales to pharmacies (72%), sales to hospitals (26%), and sales to retailers and others (2%) [19]. Most pharmacy sales (87%) consisted of sales of prescription medicines, of which
a majority (78%) were reimbursed medicines [19,20]. The share of the global pharmaceutical market is approximately 0.3%, and of the European pharmaceutical market, approximately 1.3%. The majority of medicines sold in Finland come from abroad, mostly from EU countries [18]. Community pharmacies have the sole right to sell prescription and over-the-counter (OTC) medicines (excluding nicotine replacement therapy) to the public in Finland. There is a privately owned pharmacy system, with 615 pharmacies and 185 subsidiary pharmacies in 2013 [21]. Subsidiary pharmacies are privately owned, small pharmacy outlets that the pharmacy owner possesses along with the main community pharmacy. Subsidiary pharmacies are placed in areas where pharmaceutical service is needed but there is no need for an independent main community pharmacy. In addition, there are two community pharmacies owned by two universities: the University Pharmacy of Helsinki, with 16 subsidiary pharmacies, and the University Pharmacy of Eastern Finland. The university pharmacies operate like the privately owned community pharmacies. The staff in pharmacies consists of the pharmacy owner (M.Sc. in pharmacy), pharmacists (M.Sc. in pharmacy), prescriptionists (B.Sc. in pharmacy), and, for example, pharmacy technicians. Furthermore, 59% of the staff has a pharmaceutical education. A pharmacist is a person with 5-year education and a prescriptionist is a person with 3-year education at the university. Both pharmacist and prescriptionist dispense medicines independently and ensure their safe and proper use among the public by patient counseling, but pharmacists also act as manager. The average pharmacy in Finland delivered about 72,000 prescriptions in 2013 [22]. The pharmacy business is strictly regulated in Finland. The Finnish Medicines Agency (FIMEA) controls the location, number, and ownership of pharmacies [23]. The pharmaceutical network in Finland is comprehensive, as there is at least one pharmacy in almost every municipality [24]. There is one pharmacy per 6000 inhabitants. The prices of medicines are the same in all pharmacies [23]. Sales of medicines constitute 94% of the turnover of pharmacies [25]. In Finland, there are two pharmaceutical wholesalers with a distribution system that covers the whole country. Finnish wholesale distribution of medicines is based on a single-channel system [26]. This means the pharmaceutical manufacturer makes a sole-distribution contract covering all its products with a wholesaler, and pharmacies or hospitals can acquire a certain pharmaceutical product though that wholesaler only. Generic substitution (GS) and a reference price system (RPS) are in use in Finland [27,28]. According to the Medicine Act 80/2003, pharmacists are obligated to substitute the prescribed product with the cheapest or close to the cheapest interchangeable product if the price of the product is higher than the reference price. If the customer objects to the substitution, the customer has to pay the price difference between the reference price and the chosen medicine out of pocket. The reference price is determined quarterly by the least expensive medicine in every reference price group. The reference price is the price of the cheapest product +D 1.50 if the price is under D 40, and
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the price of the cheapest product +D 2.00 if the price is D 40 or more. However, pharmaceutical companies may revise their prices every 2 weeks. 2. Aim The aim of this study was to assess medicine shortages in Finnish community pharmacies. Further objectives were to explore how frequently medicine shortages occur, the reasons behind medicine shortages, and the problems medicine shortages cause for Finnish community pharmacies. 3. Material and methods A study was conducted in Finnish community pharmacies in the autumn of 2013. A random sample of 194 privately owned community pharmacies was selected from a total of 583 pharmacies that were listed in the affiliate register of the Association of Finnish Pharmacies. One of the 18 University Pharmacy outlets also took part. During the 27-day study period (September 27, 2013 to October 23, 2013) pharmacies reported medicines in short supply from orders made to wholesalers. The study period was scheduled to cover the change in the reference price (October 1, 2013). Prescription medicines (human and veterinary), non-prescription medicines (human and veterinary), and reimbursable emollient creams were reported. Nonmedical products and food, dietary, or other supplements were excluded from the study. Each study pharmacy received 40 forms for reporting medicines in short supply from the medicine orders of the pharmacy. In addition, each pharmacy received one background form (location of the pharmacy, the number of prescriptions per year, and the number of returned forms) and instructions for filling in the forms. The report form (appendix, online only) was developed mainly on the basis of our own experiences, a pharmacy’s experiences from a piloting period, and also earlier literature [2] concerning reasons behind medicine shortages. The report form consisted of 21 questions related to information on the medicines in short supply (e.g., trade name, package size, and whether the medicine was a prescription or OTC medicine), the reasons behind the medicine shortages that were reported to the pharmacy, the consequences of the medicine shortages at the pharmacy, and whether the pharmacy received the medicine during the study period. Furthermore, the person who filled in the form (e.g., pharmacy owner, pharmacist, prescriptionist) and the date when the form was filled in were also asked. The questions related to the product were open-ended questions and the questions related to the reasons behind the shortages and the consequences of the medicine shortages were structured questions, some with open-ended choices added. For example, the question related to the reasons behind the shortages had 12 fixed answers to choose from and also space for open answers. The report form was piloted at a local pharmacy with over 100,000 prescriptions per year. Six forms were filled in during the 1-week piloting period. As a result, the total number of forms sent per study pharmacy (n = 40 forms) was stated.
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In addition, some minor adjustments were made to the form. Each trade name, the amount of the active ingredient(s), and package size were reported separately. In addition, the forms were to be filled by a person or a work pair that handled the medicine orders at the pharmacy on a daily basis. The study in the pharmacies was finished when all 40 forms were filled in or the study period ended. In cases where two or more forms were filled in by the study pharmacy for the same medicine on the same day and they contained the same information, only one was included in the study. Missing information (e.g., a holder of marketing authorization) was added to the forms by the research group, if possible. The medicines were classified according to the 5th level of the Anatomic Therapeutic Chemical (ATC) classification [29]. The frequency of medicine shortages at the pharmacies was calculated based on the dates when the forms were filled in during the weeks of the study period. The data were analyzed with IBM SPSS 21.0 for Windows using frequencies and cross-tabulations for descriptive analysis and Fisher’s exact and Pearson’s 2 tests for group comparison. A significance level of 0.05 was used. The study setting and research process were in accordance with the local and national ethical instructions for research (Finnish Advisory Board on Research Integrity: http://www.tenk.fi/en/ethical-review-humansciences). According to the instructions, this study did not require ethical approval. 4. Results The study flow is shown in Fig. 1. Altogether 129 (66%) community pharmacies participated in the study, returning a total of 3472 report forms. However, 161 forms were removed from the final study material because the forms were filled in with information about non-medical products and food, dietary, or other supplements (n = 95) or because two or more forms were filled in for the same product on the same day, thus containing identical information (n = 66). Consequently, the final study material consisted of 3311 forms. A summary of the study pharmacies and the forms for reporting medicines in short supply are shown in Table 1. Of the study pharmacies, 79.8% had medicine shortages daily or almost daily (three or more times per week), 17.1% weekly (one to two times per week), and 3.1% less frequently than weekly during the study period. Pharmacies with over 100,000 prescriptions per year had shortages more frequently than pharmacies with 30,001–60,000 prescriptions per year (p = 0.022). There was no statistically significant difference in how frequently shortages occurred and the location of the pharmacy. Most of the medicines in short supply were human medicines (97.7%) and prescription medicines (79.9%) (Table 2). Medicines in short supply were most commonly medicines that affect the nervous system (30.8%) and cardiovascular system (17.5%). The most common active ingredients in short supply were (n = 3311) paracetamol (7.1%), atorvastatin (4.2%), temazepam (2.7%), and doxepin
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Table 1 Summary of the study pharmacies and forms for reporting medicines in short supply (number of prescriptions per year and the location of the study pharmacies in comparison to Finnish community pharmacies). In this study a
In Finland b
Number of prescriptions per year in the pharmacy (n = 125) ≤30,000 11.2 (14) 16.7 (98)c 30,001–60,000 32.8 (41) 32.0 (188)c 60,001–100,000 32.8 (41) 32.0 (188)c ≥100,001 23.2 (29) 19.3 (113)c Location of the pharmacy (n = 125)b The county of Western 36.0 (45) 39.4 (250)d Finland The county of Southern 32.8 (41) 34.0 (216)d Finland 16.8 (21) The county of Eastern 14.0 (89)d Finland The county of Northern 8.8 (11) 9.0 (57)d Finland The county of Lapland 5.6 (7) 3.6 (23)d Number of report forms returned per pharmacy (n = 129) 1–10 8.5 (11) 11–20 24.0 (31) 21–30 31.0 (40) 36.4 (47) 31–40 The person or work pair who filled in the form (n = 3309)e Pharmacy technician 45.6 (1509) 25.5 (845) Pharmacist (M.Sc.) Prescriptionist (B.Sc.) 10.0 (332) Pharmacist (M.Sc.) and 7.0 (231) pharmacy technician together Pharmacy owner 6.6 (217) Other work pairf 3.4 (113) g Other 1.9 (62)
Fig. 1. Study flow.
(2.3%). Of all the medicines, 44.8% were cheaper than the reference price and of those medicines, most (39.3%) were the cheapest alternatives. The information about the medicine shortage usually (98.4%, n = 3224) came from the wholesaler. The reason behind the medicine shortage was reported to the pharmacy in 11.2% (n = 3147) of the shortage cases. The most common reason behind the medicine shortages was that the product had run out in Finland or at the supplier (49.3%) (Table 3). In 64.1% (n = 2053) of the shortage cases, the pharmacy did not receive information on when the medicine would be available again. In 58.6% (n = 1838) of the shortage cases, the pharmacy received the medicine in short supply during the study period. The medicine shortages caused problems for the pharmacies in 33% of the shortage cases (n = 3044). Most often these problems were that the customers were unsatisfied (54.1%) or that serving the customers was more timeconsuming (52.9%) (Table 3). In most cases (67.0%) the medicine shortages did not cause problems for the pharmacy, mostly because a substitutable product was available (48.5%). There were no statistically significant differences in whether the medicine shortages caused problems for the pharmacies and the number of prescriptions per year of the pharmacies or the location of the pharmacies.
a In this study, the pharmacies reported the number of prescriptions per year from 2012. b Of the study pharmacies, four did not report the number of prescriptions per year or the location of the pharmacy. c Information based on Ref. [35] with the total number of pharmacies being 587. d Information based on Refs. [36,37] with the total number of pharmacies being 635. e Of the report forms, two did not include the information on the person or work pair who filled in the form. f For example, prescriptionist (B.Sc.) and pharmacy technician. g For example, pharmacy student.
5. Discussion According to this study, medicine shortages were very common in Finnish community pharmacies, as a great majority of the study pharmacies suffered from medicine shortages daily or almost daily. The result is consistent with a Canadian study conducted in pharmacies [11]. We also found that medicines in short supply also included medicine groups that are commonly used in Finland [30]. In addition, medicines in short supply were more common especially in big pharmacies than in small ones. This might be because big pharmacies may have a larger assortment of products in their stock than small ones and therefore, shortages may occur more often. In addition, big pharmacies sell a larger volume of products and may also have a larger frequency of medicine orders than small pharmacies. Our results showed that the reasons behind the shortages were rarely reported to the pharmacies. Furthermore, in most of the shortage cases, the pharmacies did not
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Table 2 Background characteristics of medicines in short supply. Medicines in short supply
% (n)
All Human medicine Veterinary medicine Prescription medicine Over-the-counter (OTC) medicine Parallel trade medicine Anatomical therapeutic chemical (ATC) classificationa Medicines that affect the nervous system (N) Psycholeptics (N05) Analgesics (N02) Psychoanaleptics (N06) Cardiovascular medicines (C) Lipid modifying agents (C10) Beta-blocking agents (C07) Agents that act on the renin-angiotensin system (C09) Medicines that affect the alimentary tract and metabolism (A) Medicines used in diabetes (A10) Antidiarrheals, intestinal anti-inflammatory/anti-infective agents (A07) Medicines for functional gastrointestinal disorders (A03) Medicines that affect the genitourinary system and sex hormones (G) Medicines that affect the respiratory system (R) Anti-infectives for systemic use (J) Dermatologicals (D) Other Included in the reference price? (n = 3190)b No Yes Position in the reference price (n = 1339)b , c The cheapest Between the cheapest and the most expensive The most expensive Otherd
100 (3311) 97.7 (3236) 2.3 (75) 79.9 (2645) 20.1 (666) 4.0 (131) 30.8 (1021) 9.7 (321) 8.4 (279) 7.8 (260) 17.5 (581) 6.8 (224) 4.7 (156) 3.2 (105) 10.1 (335) 2.4 (80) 1.8 (58)
1.4 (48) 9.6 (319) 8.7 (287) 5.8 (191) 5.3 (175) 12.1 (402) 55.2 (1760) 44.8 (1430) 39.3 (527) 28.3 (379) 28.1 (377) 4.2 (56)
a The three most common subgroups are presented from the three most common main groups. b All forms did not include information on whether the medicine was included in the reference price. c Contains medicines that were included in the reference price. d For example, all the medicines in the reference price had exactly the same price.
receive information on when the medicine in short supply would be available again. Similar results have been reported earlier in Canadian studies [11,31]. The lack of information may complicate not only customer service, but also time management at the pharmacies as the pharmacy staff tries to find the missing information. The most common reason behind the medicine shortages was that the product had run out in Finland or at the supplier. However, it should be noted that the number of cases where the reason behind the shortage was known was small with respect to the whole study material. In addition, in the reasons behind the medicine shortages (Table 3) we addressed the shortage cases, not different medicines in short supply. Accordingly, the same medicine may appear multiple times, affecting the commonness of a certain reason, and the reason behind the shortage may appear more
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Table 3 Reasons behind the medicine shortages and consequences of the shortages for the pharmacies. Reasons behind the medicine shortages (n = 353)a The product had run out in Finland/the product had run out at the supplier Problem at the manufacturing site Wholesaler The owner of the trading license changed Raw material shortage Otherb Problems that the shortages caused for the pharmacies (n = 1005)c The customers were unsatisfied Serving the customer was more time-consuming Storage management required additional work The working environment was experienced as more hasty The medicine had to be borrowed from another pharmacy The physician had to be contacted Other products were sold instead The customer was left with no suitable medicine Reasons why the shortages did not cause problems for the pharmacies (n = 2039)d A substitutable product was available The product in short supply was in stock and there was a sufficient amount of the product during the shortage period The product was not sold during the shortage period The shortage was only temporary
49.3 (174)
12.7 (45) 9.1 (32) 5.7 (20) 4.5 (16) 18.7 (66)
54.1 (544) 52.9 (532) 21.8 (219) 12.3 (124)
8.5 (85)
2.4 (24) 2.3 (23) 1.2 (12)
48.5 (988) 27.5 (561)
14.7 (300) 3.7 (76)
a Only shortage cases where the reason behind the shortage was reported to the pharmacy. Multiple responses could be reported. b For example, the product had exited from the market or the product required a special permit. c Only shortage cases where the pharmacy reported that the medicine shortage caused problems for the pharmacy. Multiple responses could be reported. d Only shortage cases where the pharmacy reported that the medicine shortage did not cause problems for the pharmacy. Multiple responses could be reported.
often. Therefore, this result should be interpreted with caution. The earlier literature has reported that common reasons for medicine shortages relate to manufacturing issues, raw material shortages, single- or limited-source products, inventory management practices, and the size of the market in an otherwise small country with a limited market [2,11,32]. However, more research on this topic is needed in the future. In most cases the medicine shortages did not cause problems for the pharmacies because of the possibility
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of GS and because a substitutable product was available. This finding is in line with an earlier Finnish study dealing with GS [28]. Our result meant that in most cases the customer received the medicine and in only 12 cases the customer was left with no suitable medicine. Even though the number of cases in which the customer was left with no medicine is relatively small, the effect of the shortage on patients may still be significant, as reported in the earlier studies [4–11]. However, the earlier studies have primarily been conducted in hospitals, and more research on outpatient treatment is needed. Medicine shortages caused problems for the pharmacies in every third shortage case. Those shortages may be significant for the pharmacy or customer. According to this study, medicine shortages can increase the workload of health care professionals and cause customer dissatisfaction. The results are consistent with earlier studies exploring medicine shortages [8–10,12,13]. The study pharmacies were randomly selected from the affiliate register that covers almost all Finnish pharmacies. Of these pharmacies, 66% participated in the study. This is comparable with or higher than in some earlier studies of pharmacies related to medicine shortages [12,13] or Finnish surveys of pharmacy staff [33,34], in which the response rate has varied between 13% and 67%. In addition, the study pharmacies represented Finnish pharmacies well in terms of location and the number of prescriptions per year. Thus, we suggest that the results of this study may be generalized to Finnish community pharmacies. This study also has some limitations. It should be noted that the results of this study are based on self-reports from the staffs of community pharmacies. Consequently, it is possible that all shortages might not have been reported in this study, and in bigger pharmacies the number of forms might not have been sufficient to cover all medicine shortages during the study period. Therefore, medicine shortages may occur even more frequently than suggested by this study. Furthermore, we explored the shortage cases, not different medicines (e.g. active ingredient, amount of active ingredient, package size) in short supply. That information would provide a wider view of the matter studied. Besides, the study was limited to experiences in Finland, and there are country-specific differences, such as variation in the size of the pharmaceutical market and the operating environment. Thus, the results of this study should be compared with other countries with caution. According to the report of the International Pharmaceutical Federation (FIP), country-specific research is needed to provide a general view of medicine shortages and to determine the actual extent of medicine shortages [2]. Therefore, this study provides much needed information about the subject from community pharmacies in Finland. However, similar studies from other countries are needed in the future. In addition, the subject should be examined from different perspectives, such as patients, pharmaceutical companies, and wholesalers. 6. Conclusions This study suggests that medicine shortages are common in Finnish community pharmacies. Besides, medicines
in short supply were very commonly used medicines. The reasons behind the medicine shortages were rarely reported to the pharmacies. In most cases the medicine shortages did not cause problems for the pharmacies and the customers received medicine, mostly because a substitutable product was available. However, in every third case, the medicine shortage did cause problems for the pharmacy. These shortages may be significant for the customer or the pharmacy, as they can cause customer dissatisfaction and increase the workload of the pharmacy staff. Acknowledgement This study was conducted in the School of Pharmacy at the University of Eastern Finland. Appendix A. Supplementary data Supplementary data associated with this article can be found, in the online version, at http://dx.doi.org/10.1016/ j.healthpol.2014.11.001. References [1] European Medicines Agency. Road map to 2015 – The European Medicines Agency’s contribution to science, medicines and health. London; 2011. [2] Besancon L, Chaar B. Report of the international summit on medicines shortage. Toronto: International Pharmaceutical Federation (FIP); http://www.fip.org/files/fip/publications/FIP Summit On 2013. Medicines Shortage.pdf [3] Morrison A. Drug supply disruptions [environmental scan issue 17]. Ottawa: Canadian Agency for Drugs and Technologies in Health; 2011. [4] McLaughlin M, Kotis D, Thomson K. Effects on patient care caused by drug shortages: a survey. Journal of Managed Care Pharmacy 2013;19:783–8. [5] Baumer AM, Clark AM, Witmer DR. National survey of the impact of drug shortages in acute care hospitals. American Journal of HealthSystem Pharmacy 2004;61:2015–22. [6] American Hospital Association. Survey on drug shortages; 2011. July 12. http://www.aha.org/content/11/drugshortagesurvey.pdf [7] Institute for Safe Medication Practices (ISMP). National survey on drug shortages/ISMP survey on drug shortages. ISMP Medication Safety Alert 2010;15:4. [8] Becker DJ, Talwar S, Levy BP. Impact of oncology drug shortages on patient therapy: unplanned treatment changes. Journal of Oncology Practice 2013;9:122–8. [9] Gundlapalli AV, Beekmann SE, Graham DR. Perspectives and concerns regarding antimicrobial agent shortages among infectious disease specialists. Diagnostic Microbiology and Infectious Disease 2013;75:256–9. [10] McBride A, Holle LM, Westendorf C. National survey on the effect of oncology drug shortages on cancer care. American Journal of HealthSystem Pharmacy 2013;70:609–17. [11] Canadian Pharmacists Association. Canadian drug shortages survey: final report, Ottawa; 2010. www.pharmacists.ca/cpha-ca/assets/ file/cpha-on-the-issues/drugshortagesreport.pdf [12] Kaakeh R, Sweet BV, Reilly C. Impact of drug shortages on U.S. health systems. American Journal of Health-System Pharmacy 2011;68:1811–9. [13] Hunnisett-Dritz D. Successful importation of cytarabine into the United States during a critical national drug shortage. American Journal of Health-System Pharmacy 2012;69:1416–21. [14] Dolgin E. NIH faces marching orders on orphan drug shortage. Nature Medicine 2011;17:522. [15] Kaiser J. Medicine. Shortages of cancer drugs put patients, trials at risk. Science 2011;332:523. [16] Mitka M. FDA, US hospital and pharmacy groups report drug shortages a growing problem. The Journal of the American Medical Association 2011;306:1069–70.
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Please cite this article in press as: Heiskanen K, et al. Medicine shortages – A study of community pharmacies in Finland. Health Policy (2014), http://dx.doi.org/10.1016/j.healthpol.2014.11.001