Ophthalmic & Physiological Optics ISSN 0275-5408
TECHNICAL NOTE
Impact of supply problems of preservative-free glaucoma medications on patients and hospital staff Shima Shah1, Julia Theodossiades1, Kristin Chapman1 and Ian Murdoch1,2 1
Moorfields Eye Hospital, London, and 2Institute of Ophthalmology, London, UK
Citation information: Shah S, Theodossiades J, Chapman K, Murdoch I. Impact of supply problems of preservative-free glaucoma medications on patients and hospital staff. Ophthalmic Physiol Opt 2015; 35: 236–241. doi: 10.1111/opo.12180
Keywords: dorzolamide, drug supply, eye, glaucoma, medicines supply, preservative-free drops, timolol Correspondence: Shima Shah E-mail address: [email protected] Received: 27 July 2014; Accepted: 3 November 2014
Abstract Purpose: Glaucoma is a chronic ocular disease, which is usually managed with long-term daily medical therapy, in the form of eye drops. Patients who are intolerant to preservatives in topical medicines require preservative-free versions. From early 2011 patients attending Moorfields Eye Hospital, London, UK, started to report recurring problems with the supply of the following preservative-free glaucoma medications: Timolol 0.25% (Timoptol 0.25%, MSD UK); Dorzolamide (Trusopt, MSD UK); Dorzolamide and Timolol 0.5% (Cosopt, MSD UK). This study investigates the impact of the supply problems of these medications at Moorfields Eye Hospital from a patient, administrative and clinical perspective. Methods: Information was sought by interviewing both patients and hospital staff, and by a retrospective case note review between April 2010 and May 2013. Results: Many hospital roles, both administrative and clinical, were involved in attempting to resolve the impact of the supply problems. All staff reported a considerable increase in their workload. At the peak of the problem, the glaucoma secretaries received about 150 enquiries per week. A review of 83 sets of patient notes, retrieved from a random sample of 125 patients, showed that 22% encountered a supply problem. Of these, more than one-third attended Moorfields Eye Hospital Accident & Emergency (A&E) for repeat supplies and 89% eventually had their medication changed. In telephone interviews with 39 of a random sample of 50 patients (a subset of the 83 notes retrieved), 59% of the interviewees reported a supply problem. Of these, one-third attended Moorfields Eye Hospital A&E for repeat supplies and half eventually required an alternative medication. Some patients reported going to considerable lengths to obtain ongoing supplies in the community. Conclusions: This study shows that medication supply problems can have a major impact on patients and hospital services. Supply problems occur across many fields of medicine and with increasing frequency. The findings of this study highlight the importance of early communication of impending shortages between manufacturers and the Department of Health, as recommended in the best practice guidelines. In order to minimise the impact of medicine shortages on patients, clinicians and administrative staff, hospitals need immediate notification of potential supply problems and clear updates on supply resolution. In addition, hospitals should consider nominating an individual as a contact point for patient enquiries regarding medicine supply problems.
Introduction Glaucoma is a chronic ocular disease, which is usually managed with long-term medical therapy in the form of 236
eye drops. The majority of glaucoma eye drops contain preservatives which maintain the sterility of the medication and aid penetration of the active agents into the anterior chamber. Unfortunately the antimicrobial effects
© 2014 The Authors Ophthalmic & Physiological Optics © 2014 The College of Optometrists Ophthalmic & Physiological Optics 35 (2015) 236–241
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of the preservatives can also be toxic to ocular tissue leading to adverse effects and reduced quality of life.1 Pisella et al.2 found that the prevalence of ocular side effects in patients using anti glaucoma medications was related to the number of preserved eye drops used. Additionally, Nordmann et al.3 reported that a high proportion of glaucoma patients complained of significant ocular surface side effects related to their glaucoma eye drops. For those patients intolerant to preservatives, there are preservative-free (PF) alternatives. There have been several studies which have demonstrated comparable efficacy between preserved and their preservative-free equivalents.1 Improved tolerability has also been reported for some PF preparations,1 however they are more expensive.4 For several years there have been discontinuations and interruptions in the supply of topical glaucoma medications in the UK, such as Pilocarpine 4% (Pilogel, Alcon www.uk.alcon.com) and Timolol 0.1% (Nyogel, Novartis www.novartis.co.uk). From early 2011, patients attending Moorfields Eye Hospital (MEH), City Road, London, started to report recurring problems with the supply of PF Timolol 0.25% (Timoptol, MSD, UK www.msd-uk.com) and PF Dorzolamide (Trusopt, MSD UK). From March 2012 patients also began reporting difficulties obtaining steady supplies of PF Dorzolamide and Timolol 0.5% (Cosopt, MSD, UK). MSD (MSD or Merck Sharp & Dohme outside the USA and Canada, where the company is known as Merck & Co) reported that these supply problems arose as a result of a global increase in demand for preservative-free ophthalmic medicines coupled with manufacturing problems and capacity constraints. Erratic drug supply persisted until July 2013. This study investigates the impact of the supply problems of the above PF glaucoma medications at MEH from a patient, administrative and clinical perspective.
Impact of supply problem of preservative-free drops
Patient notes assessments The patient ID numbers of new adult prescriptions of PF Timolol 0.25% (Timoptol 0.25%, MSD UK), PF Dorzolamide (Trusopt, MSD UK) and PF Dorzolamide and Timolol 0.5% (Cosopt, MSD UK) were determined from the Moorfields Eye Hospital (MEH) pharmaceutical database for the year April 2010 to March 2011. Each patient was assigned a random number using the random number generator function in Excel. These numbers were then arranged in ascending order, from which the first 125 patients were selected. Their notes were reviewed from April 2010 to May 2013 (encompassing the period of maximum drug supply disruption) using a standardised proforma. This data collection period predated the start of the supply problems. Thus patients on these drops at the time of the supply problems were maximally targeted for this study. Data were collected concerning evidence of supply problems. For those with supply problems, further data were collected regarding management change, increased hospital visits and additional correspondence. Patient interviews Following the patient notes assessment, the first 50 patients covered by this review were then contacted by telephone and asked to describe their experience concerning ongoing and regular drug supply. If the patient reported difficulties in obtaining supplies, further questions were asked regarding attempts to overcome the problem and consequences. A supply problem was defined as an inability to obtain drops, or having to wait more than 2 weeks to receive the drops. Where necessary, telephone calls were repeated to increase response rate.
Methods
Results
Three sources of information were sought to assess the impact of supply problems.
Anecdotal staff reports Many hospital employees (including glaucoma clerks, glaucoma secretaries, patient advice and liaison officers, Moorfields Direct and pharmacists) were involved in attempting to resolve the supply difficulties encountered by patients. Although the number of enquiries varied by role, all staff noted a considerable impact on their workload (see Table 1). The largest load fell upon the glaucoma clerks and the secretaries who, at the peak of the problem, received about 200 and 150 enquiries a week respectively. Typically the secretaries had to request patient notes from medical records and seek a medical opinion, which in turn generated correspondence with the GP and the patient. Seven of the 10 MEH pharmacists responded. Of these, five reported receiving up to five enquiries per week, one received 15 a
Anecdotal staff reports Glaucoma consultants, Accident and Emergency (A&E) consultants, glaucoma secretaries, glaucoma clerks, patient advice and liaison officers, Moorfields Direct (telephone help line for patients) and pharmacists (medicines information service and dispensary) were interviewed. Interviewees were asked to estimate the peak number of enquiries received per week regarding this problem and describe the consequences of supply problems. Multiple attempts were made to contact staff who did not initially respond.
© 2014 The Authors Ophthalmic & Physiological Optics © 2014 The College of Optometrists Ophthalmic & Physiological Optics 35 (2015) 236–241
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Table 1. Enquiries received by staff at Moorfields Eye Hospital regarding supply problems of preservative-free glaucoma medications
Staff report Secretaries Patient advice and liaison officers Moorfields direct Glaucoma clerks Pharmacists Consultants Total
Sample
Responded (%)
Total enquiries per week
4 2
4 (100) 2 (100)
150 15
2 13 10 22
2 (100) 9 (69) 7 (70) 19 (82)
20 200 85 50 520
week, and one in Medicines Information (telephone advisory service) reported up to 50 a week. The pharmacists then sought medical advice from the glaucoma service. MEH Pharmacists also reported that patients were confused, distressed, frustrated and angry about the situation and anxious about reactions to alternative drops. Consultants reported a lower peak in enquiries, potentially reflecting the resolution of a proportion of the enquiries by other medical staff (fellows and registrars), who were not sampled in the study. Patient notes assessments During the year April 2010 to March 2011, 328 new prescriptions were issued to 301 patients. Some received two of these PF medications within this time period. One hundred and ninety-one received PF Dorzolamide and Timolol 0.5% (Cosopt, MSD UK), 63 PF Dorzolamide (Trusopt, MSD UK), 73 PF Timolol 0.25% (Timoptol 0.25%, MSD UK) and one PF Timolol 0.5% (Timoptol 0.5%, MSD UK). Notes were retrieved for 83 (66%) of the random sample of 125 patients. Where notes were unobtainable (either because they were in use by other ophthalmic specialties, at offsite storage or missing), repeated attempts were made to locate these notes. Supply problems where unambiguously stated in the notes for 18 of the 83 (22%) patients. 89% (16/18) of patients with supply problems recorded in their notes required a management change; 15 had a topical therapy change and one was listed for trabeculectomy surgery. All alternative medications had already been exhausted for this patient. The remaining two patients had obtained repeat supplies from the hospital (A&E). More than one-third (39%) of those with supply problems had attended A&E for repeat supplies and/or advice, some on multiple occasions. Seven of the 18 patients with supply problems made 10 additional visits to hospital. Nine of these visits were to A&E and one was to the glaucoma clinic (Figure 1, Table 2). 238
Patient Interviews Interviews were conducted with 39 of the 50 patients telephoned. Supply problems were reported by 23 of the 39 (59%) patients. 52% (12/23) of patients reporting supply problems in the interviews required a change in topical therapy. Nearly a third (30%) of those patients who reported supply problems attended A&E for repeat supplies and/or advice, some on multiple occasions. Thirteen of 23 reporting supply problems contacted the hospital on 22 occasions. These comprised of 10 visits (seven patients) to A&E, six visits (four patients) to pharmacy and six telephone calls (six patients) to MEH. These patient groups overlapped; for example, a patient telephoned MEH and then attended pharmacy (Figure 2, Table 2). Patient Interview Anecdotes Some patients reported travelling long distances to obtain supplies and community pharmacists reported having to telephone colleagues in the area to seek out supplies. Here is a sample of the anecdotes collected: • ‘I was really anxious. The patients should have had some warning.’ • ‘I couldn’t get my drops from my local pharmacy. My husband contacted MEH pharmacy and came up and collected a supply. I had problems when this ran out so my husband then contacted the manufacturer who then contacted the wholesaler. The wholesaler arranged for supplies to be sent to my local pharmacist, who now orders well in advance.’ • ‘My local pharmacy can’t get my drop so I have to take a long bus ride to one that’s quite far away.’ • ‘I called all my local pharmacies. I found one-five miles away with a one month supply. When this ran out I attended A&E’ • ‘My pharmacist obtained supplies from pharmacists in the area. When he eventually couldn’t get any more I came into A&E and “they” changed my drop to Betagan.’ Discussion To our knowledge, this study represents the first report of the impact of supply problems of topical medication in the field of glaucoma. The study found these problems had a considerable impact on patients both in terms of seeking ongoing supplies and requiring changes in management. This study also shows how erratic supply of medication increased the workload of all patient contact points in the hospital. The study only sampled patients receiving new prescriptions of the PF medications and only those patients identified in the year April 2010 to March 2011. The total
© 2014 The Authors Ophthalmic & Physiological Optics © 2014 The College of Optometrists Ophthalmic & Physiological Optics 35 (2015) 236–241
S Shah et al.
Impact of supply problem of preservative-free drops
New therapy PF drops = 328
Random sample = 125
Notes retrieved = 83
Supply problems = 18 (22%) Extra hospital contact = 7 patients No change = 2
Management change = 16
A&E = 9 visits Clinic = 1 visit
Figure 1. Summary of patient notes assessments.
Telephoned = 50
Interviewed = 39
Supply problems = 23 (59%) Extra hospital contact = 13 patients No change = 11
Management change = 12
A&E = 10 visits Pharmacy = 6 visits Telephone = 6 calls
Figure 2. Summary of patient interview.
Table 2. Summary of supply problems and their consequence, as stated in patients’ notes and patient interview
Patient notes assessment Patient interview
Sample
Reviewed (%)
Supply problems (%)
A&E (%)
Management change (%)
125
83 (66)
18 (22)
7/18 (39)
16/18 (89)
50
39 (78)
23 (59)
7/23 (30)
12/23 (52)
number of patients using these PF medications, including long standing users, during this period, would have been considerably larger. This study may, therefore, underestimate the impact of the erratic drug supply on patients and hospital services. Assessment of patient notes suggests that 22% of patients had supply problems, whereas 59% of those patients interviewed reported supply problems. The disparity may partly
be explained by the fact that a patient answering specific questions about their eye medications in an interview is more likely to raise the issue of supply problems, than a patient attending a clinic appointment, where supply problems may be overshadowed by other issues. Furthermore, some clinicians may have omitted to record the supply problems reported by a patient in the clinic notes. Of those notes in which supply problems were recorded, a high
© 2014 The Authors Ophthalmic & Physiological Optics © 2014 The College of Optometrists Ophthalmic & Physiological Optics 35 (2015) 236–241
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proportion – 89% – also recorded a management change. By contrast, of those patients reporting supply problems at interview (23/39, 59%), only 52% reported a management change. This disparity may reflect the fact that clinicians that record supply problems in the patient notes are then likely to instigate a management change. In other cases (for example where the patient had recalled the supply problems at interview, but forgotten to mention it to the clinician at their clinic appointment), the clinician may not have been aware of the supply problems and therefore would be unlikely to instigate a management change. Those who had no supply problems were generally either only on the drug for a short period of time, regularly visited the hospital and obtained repeat drug supplies from the hospital, or managed to get supplies locally. Assessment of both patients’ notes and interviews revealed that approximately one-third of those with supply problems attended A&E, some on multiple occasions, to obtain further supplies or an alternative medical solution. This is likely to be an underestimate, as not all A&E entries are filed in patient records. These extra visits to A&E would have been inconvenient and time consuming for patients and staff respectively. Moorfields Eye Hospital pharmacists gave regular updates to MEH clinical staff on the status of supply problems and provided advice on alternative preservative-free agents such as Timolol 0.1% (Tiopex, Spectrum Thea, UK www. spectrum-thea.co.uk) and Tafluprost (Saflutan, MSD, UK). Medicine shortages have become increasingly common in recent years and are not limited to ophthalmology. The reasons for shortages may include manufacturing problems, supply/demand imbalance, raw material problems and regulatory problems. In order to reduce the impact of these shortages on patient care, there is statutory legislation (1) and voluntary best practice guidance (2) in place. (1). Article 81 of the European Directive of 2001 was implemented to ensure the appropriate and continued supply of medicines and require marketing authorisation holders, within the limits of their responsibilities, to maintain appropriate and continued supplies of their products, and to notify the Licensing Authority if a product is not going to be available, either temporarily or permanently; both manufacturers and wholesalers licensed to trade in the UK have a legal duty to ensure that UK patient needs are met.5 (2). The voluntary joint Department of Health Guidance with both the Association of the British Pharmaceutical Industry and the British Generic Manufacturers Association entitled ‘Notification and management of medicines shortages’ outlines best practice to minimise the impact of any medicine shortage. It recommends that companies communicate with the Department of Health as soon as possible about 240
impending shortages that are likely to have an impact on patient care, so that the Department of Health and industry can investigate options for managing the shortage and make contingency arrangements.6,7 The supply shortage of PF timolol (Timptol, MSD UK) was announced in a letter circulated by MSD UK to healthcare providers in February 2010, providing early warning of shortages. Moorfields Pharmaceuticals was approached by the NHS Purchasing and Supply Agency and asked about the possibility of making an unlicensed special product to fill the market gap for preservative-free Timolol. As Moorfields Pharmaceuticals had a formulation available, it was able to introduce two multi dose bottle packs of Timolol 0.25% preservative-free and Timolol 0.5% preservative-free. These became available from the end of December 2011. Teva launched a generic preservative-free Dorzolamide and Timolol 0.5% eye drop in April 2013, a year after supply problems began with PF Dorzolamide and Timolol 0.5% (Cosopt, MSD UK). When the Department of Health was contacted and asked what measures had been taken to manage the situation, the following response was received from the Principal Pharmacist, ‘I can confirm that we worked closely with MSD throughout this period to make sure that everything possible was being done to ensure availability of these products for the patients that needed them.’ Conclusions Glaucoma is a chronic disease that requires long-term, daily medical therapy. Our results show that medicine supply problems have a major impact on patients and hospital services. The findings of this study highlight the importance of early communication of impending shortages between manufacturers and the Department of Health, to allow for contingency planning as recommended in the best practice guidelines.6,7 In order to minimise the impact of medicine shortages on patients, clinicians and administrative staff, hospitals need immediate notification of potential supply problems and clear updates on supply resolution. In addition, hospitals should consider nominating an individual as a contact point for patient enquiries regarding medicine supply problems. Acknowledgement This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. Disclosure The authors report no conflicts of interest and have no proprietary interest in any of the materials mentioned in this article.
© 2014 The Authors Ophthalmic & Physiological Optics © 2014 The College of Optometrists Ophthalmic & Physiological Optics 35 (2015) 236–241
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References 1. Hopes M & Broadway D. Preservative-free treatment in glaucoma is a sensible and realistic aim for the future. Eur Ophthal Rev 2010; 4(1): 23–28. 2. Pisella PF, Pouliquen P & Baudouin C. Prevelance of ocular symptoms and signs with preserved and preservative-free glaucoma medication. Br J Ophthalmol 2002; 86: 418–423. 3. Nordmann JP, Auzanneau N, Ricard S & Berdeaux G. Vision related quality of life and topical glaucoma treatment side effects. Health Qual Life Outcomes 2003; 10: 1–75. 4. BNF, www.bnf.org.uk, accessed 18/09/14. 5. Directive 2001/83/EC of the European Parliament, http://ec.europa.eu/health/files/eudralex/vol-1/dir_2001_ 83_cons/dir2001_83_cons_20081230_en.pdf, accessed 27/4/13.
Impact of supply problem of preservative-free drops
6. Joint Department of Health and Association of the British Pharmaceutical Industry Guidance. Notification and management of medicines shortages, Best Practice Guidelines. (Dec 2006), https://www.gov.uk/government/uploads/system/ uploads/attachment_data/file/237064/dh_063441.pdf, accessed 19/06/14. 7. Joint Department of Health and British Generic Manufacturers Association Guidance. Notification and management of medicines shortages, Best Practice Guidelines. (Dec 2006), https://www.gov.uk/government/uploads/system/ uploads/attachment_data/file/237071/dh_063440_1_.pdf, accessed 19/06/14.
© 2014 The Authors Ophthalmic & Physiological Optics © 2014 The College of Optometrists Ophthalmic & Physiological Optics 35 (2015) 236–241
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TECHNICAL NOTE
Impact of supply problems of preservative-free glaucoma medications on patients and hospital staff Shima Shah1, Julia Theodossiades1, Kristin Chapman1 and Ian Murdoch1,2 1
Moorfields Eye Hospital, London, and 2Institute of Ophthalmology, London, UK
Citation information: Shah S, Theodossiades J, Chapman K, Murdoch I. Impact of supply problems of preservative-free glaucoma medications on patients and hospital staff. Ophthalmic Physiol Opt 2015; 35: 236–241. doi: 10.1111/opo.12180
Keywords: dorzolamide, drug supply, eye, glaucoma, medicines supply, preservative-free drops, timolol Correspondence: Shima Shah E-mail address: [email protected] Received: 27 July 2014; Accepted: 3 November 2014
Abstract Purpose: Glaucoma is a chronic ocular disease, which is usually managed with long-term daily medical therapy, in the form of eye drops. Patients who are intolerant to preservatives in topical medicines require preservative-free versions. From early 2011 patients attending Moorfields Eye Hospital, London, UK, started to report recurring problems with the supply of the following preservative-free glaucoma medications: Timolol 0.25% (Timoptol 0.25%, MSD UK); Dorzolamide (Trusopt, MSD UK); Dorzolamide and Timolol 0.5% (Cosopt, MSD UK). This study investigates the impact of the supply problems of these medications at Moorfields Eye Hospital from a patient, administrative and clinical perspective. Methods: Information was sought by interviewing both patients and hospital staff, and by a retrospective case note review between April 2010 and May 2013. Results: Many hospital roles, both administrative and clinical, were involved in attempting to resolve the impact of the supply problems. All staff reported a considerable increase in their workload. At the peak of the problem, the glaucoma secretaries received about 150 enquiries per week. A review of 83 sets of patient notes, retrieved from a random sample of 125 patients, showed that 22% encountered a supply problem. Of these, more than one-third attended Moorfields Eye Hospital Accident & Emergency (A&E) for repeat supplies and 89% eventually had their medication changed. In telephone interviews with 39 of a random sample of 50 patients (a subset of the 83 notes retrieved), 59% of the interviewees reported a supply problem. Of these, one-third attended Moorfields Eye Hospital A&E for repeat supplies and half eventually required an alternative medication. Some patients reported going to considerable lengths to obtain ongoing supplies in the community. Conclusions: This study shows that medication supply problems can have a major impact on patients and hospital services. Supply problems occur across many fields of medicine and with increasing frequency. The findings of this study highlight the importance of early communication of impending shortages between manufacturers and the Department of Health, as recommended in the best practice guidelines. In order to minimise the impact of medicine shortages on patients, clinicians and administrative staff, hospitals need immediate notification of potential supply problems and clear updates on supply resolution. In addition, hospitals should consider nominating an individual as a contact point for patient enquiries regarding medicine supply problems.
Introduction Glaucoma is a chronic ocular disease, which is usually managed with long-term medical therapy in the form of 236
eye drops. The majority of glaucoma eye drops contain preservatives which maintain the sterility of the medication and aid penetration of the active agents into the anterior chamber. Unfortunately the antimicrobial effects
© 2014 The Authors Ophthalmic & Physiological Optics © 2014 The College of Optometrists Ophthalmic & Physiological Optics 35 (2015) 236–241
S Shah et al.
of the preservatives can also be toxic to ocular tissue leading to adverse effects and reduced quality of life.1 Pisella et al.2 found that the prevalence of ocular side effects in patients using anti glaucoma medications was related to the number of preserved eye drops used. Additionally, Nordmann et al.3 reported that a high proportion of glaucoma patients complained of significant ocular surface side effects related to their glaucoma eye drops. For those patients intolerant to preservatives, there are preservative-free (PF) alternatives. There have been several studies which have demonstrated comparable efficacy between preserved and their preservative-free equivalents.1 Improved tolerability has also been reported for some PF preparations,1 however they are more expensive.4 For several years there have been discontinuations and interruptions in the supply of topical glaucoma medications in the UK, such as Pilocarpine 4% (Pilogel, Alcon www.uk.alcon.com) and Timolol 0.1% (Nyogel, Novartis www.novartis.co.uk). From early 2011, patients attending Moorfields Eye Hospital (MEH), City Road, London, started to report recurring problems with the supply of PF Timolol 0.25% (Timoptol, MSD, UK www.msd-uk.com) and PF Dorzolamide (Trusopt, MSD UK). From March 2012 patients also began reporting difficulties obtaining steady supplies of PF Dorzolamide and Timolol 0.5% (Cosopt, MSD, UK). MSD (MSD or Merck Sharp & Dohme outside the USA and Canada, where the company is known as Merck & Co) reported that these supply problems arose as a result of a global increase in demand for preservative-free ophthalmic medicines coupled with manufacturing problems and capacity constraints. Erratic drug supply persisted until July 2013. This study investigates the impact of the supply problems of the above PF glaucoma medications at MEH from a patient, administrative and clinical perspective.
Impact of supply problem of preservative-free drops
Patient notes assessments The patient ID numbers of new adult prescriptions of PF Timolol 0.25% (Timoptol 0.25%, MSD UK), PF Dorzolamide (Trusopt, MSD UK) and PF Dorzolamide and Timolol 0.5% (Cosopt, MSD UK) were determined from the Moorfields Eye Hospital (MEH) pharmaceutical database for the year April 2010 to March 2011. Each patient was assigned a random number using the random number generator function in Excel. These numbers were then arranged in ascending order, from which the first 125 patients were selected. Their notes were reviewed from April 2010 to May 2013 (encompassing the period of maximum drug supply disruption) using a standardised proforma. This data collection period predated the start of the supply problems. Thus patients on these drops at the time of the supply problems were maximally targeted for this study. Data were collected concerning evidence of supply problems. For those with supply problems, further data were collected regarding management change, increased hospital visits and additional correspondence. Patient interviews Following the patient notes assessment, the first 50 patients covered by this review were then contacted by telephone and asked to describe their experience concerning ongoing and regular drug supply. If the patient reported difficulties in obtaining supplies, further questions were asked regarding attempts to overcome the problem and consequences. A supply problem was defined as an inability to obtain drops, or having to wait more than 2 weeks to receive the drops. Where necessary, telephone calls were repeated to increase response rate.
Methods
Results
Three sources of information were sought to assess the impact of supply problems.
Anecdotal staff reports Many hospital employees (including glaucoma clerks, glaucoma secretaries, patient advice and liaison officers, Moorfields Direct and pharmacists) were involved in attempting to resolve the supply difficulties encountered by patients. Although the number of enquiries varied by role, all staff noted a considerable impact on their workload (see Table 1). The largest load fell upon the glaucoma clerks and the secretaries who, at the peak of the problem, received about 200 and 150 enquiries a week respectively. Typically the secretaries had to request patient notes from medical records and seek a medical opinion, which in turn generated correspondence with the GP and the patient. Seven of the 10 MEH pharmacists responded. Of these, five reported receiving up to five enquiries per week, one received 15 a
Anecdotal staff reports Glaucoma consultants, Accident and Emergency (A&E) consultants, glaucoma secretaries, glaucoma clerks, patient advice and liaison officers, Moorfields Direct (telephone help line for patients) and pharmacists (medicines information service and dispensary) were interviewed. Interviewees were asked to estimate the peak number of enquiries received per week regarding this problem and describe the consequences of supply problems. Multiple attempts were made to contact staff who did not initially respond.
© 2014 The Authors Ophthalmic & Physiological Optics © 2014 The College of Optometrists Ophthalmic & Physiological Optics 35 (2015) 236–241
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Table 1. Enquiries received by staff at Moorfields Eye Hospital regarding supply problems of preservative-free glaucoma medications
Staff report Secretaries Patient advice and liaison officers Moorfields direct Glaucoma clerks Pharmacists Consultants Total
Sample
Responded (%)
Total enquiries per week
4 2
4 (100) 2 (100)
150 15
2 13 10 22
2 (100) 9 (69) 7 (70) 19 (82)
20 200 85 50 520
week, and one in Medicines Information (telephone advisory service) reported up to 50 a week. The pharmacists then sought medical advice from the glaucoma service. MEH Pharmacists also reported that patients were confused, distressed, frustrated and angry about the situation and anxious about reactions to alternative drops. Consultants reported a lower peak in enquiries, potentially reflecting the resolution of a proportion of the enquiries by other medical staff (fellows and registrars), who were not sampled in the study. Patient notes assessments During the year April 2010 to March 2011, 328 new prescriptions were issued to 301 patients. Some received two of these PF medications within this time period. One hundred and ninety-one received PF Dorzolamide and Timolol 0.5% (Cosopt, MSD UK), 63 PF Dorzolamide (Trusopt, MSD UK), 73 PF Timolol 0.25% (Timoptol 0.25%, MSD UK) and one PF Timolol 0.5% (Timoptol 0.5%, MSD UK). Notes were retrieved for 83 (66%) of the random sample of 125 patients. Where notes were unobtainable (either because they were in use by other ophthalmic specialties, at offsite storage or missing), repeated attempts were made to locate these notes. Supply problems where unambiguously stated in the notes for 18 of the 83 (22%) patients. 89% (16/18) of patients with supply problems recorded in their notes required a management change; 15 had a topical therapy change and one was listed for trabeculectomy surgery. All alternative medications had already been exhausted for this patient. The remaining two patients had obtained repeat supplies from the hospital (A&E). More than one-third (39%) of those with supply problems had attended A&E for repeat supplies and/or advice, some on multiple occasions. Seven of the 18 patients with supply problems made 10 additional visits to hospital. Nine of these visits were to A&E and one was to the glaucoma clinic (Figure 1, Table 2). 238
Patient Interviews Interviews were conducted with 39 of the 50 patients telephoned. Supply problems were reported by 23 of the 39 (59%) patients. 52% (12/23) of patients reporting supply problems in the interviews required a change in topical therapy. Nearly a third (30%) of those patients who reported supply problems attended A&E for repeat supplies and/or advice, some on multiple occasions. Thirteen of 23 reporting supply problems contacted the hospital on 22 occasions. These comprised of 10 visits (seven patients) to A&E, six visits (four patients) to pharmacy and six telephone calls (six patients) to MEH. These patient groups overlapped; for example, a patient telephoned MEH and then attended pharmacy (Figure 2, Table 2). Patient Interview Anecdotes Some patients reported travelling long distances to obtain supplies and community pharmacists reported having to telephone colleagues in the area to seek out supplies. Here is a sample of the anecdotes collected: • ‘I was really anxious. The patients should have had some warning.’ • ‘I couldn’t get my drops from my local pharmacy. My husband contacted MEH pharmacy and came up and collected a supply. I had problems when this ran out so my husband then contacted the manufacturer who then contacted the wholesaler. The wholesaler arranged for supplies to be sent to my local pharmacist, who now orders well in advance.’ • ‘My local pharmacy can’t get my drop so I have to take a long bus ride to one that’s quite far away.’ • ‘I called all my local pharmacies. I found one-five miles away with a one month supply. When this ran out I attended A&E’ • ‘My pharmacist obtained supplies from pharmacists in the area. When he eventually couldn’t get any more I came into A&E and “they” changed my drop to Betagan.’ Discussion To our knowledge, this study represents the first report of the impact of supply problems of topical medication in the field of glaucoma. The study found these problems had a considerable impact on patients both in terms of seeking ongoing supplies and requiring changes in management. This study also shows how erratic supply of medication increased the workload of all patient contact points in the hospital. The study only sampled patients receiving new prescriptions of the PF medications and only those patients identified in the year April 2010 to March 2011. The total
© 2014 The Authors Ophthalmic & Physiological Optics © 2014 The College of Optometrists Ophthalmic & Physiological Optics 35 (2015) 236–241
S Shah et al.
Impact of supply problem of preservative-free drops
New therapy PF drops = 328
Random sample = 125
Notes retrieved = 83
Supply problems = 18 (22%) Extra hospital contact = 7 patients No change = 2
Management change = 16
A&E = 9 visits Clinic = 1 visit
Figure 1. Summary of patient notes assessments.
Telephoned = 50
Interviewed = 39
Supply problems = 23 (59%) Extra hospital contact = 13 patients No change = 11
Management change = 12
A&E = 10 visits Pharmacy = 6 visits Telephone = 6 calls
Figure 2. Summary of patient interview.
Table 2. Summary of supply problems and their consequence, as stated in patients’ notes and patient interview
Patient notes assessment Patient interview
Sample
Reviewed (%)
Supply problems (%)
A&E (%)
Management change (%)
125
83 (66)
18 (22)
7/18 (39)
16/18 (89)
50
39 (78)
23 (59)
7/23 (30)
12/23 (52)
number of patients using these PF medications, including long standing users, during this period, would have been considerably larger. This study may, therefore, underestimate the impact of the erratic drug supply on patients and hospital services. Assessment of patient notes suggests that 22% of patients had supply problems, whereas 59% of those patients interviewed reported supply problems. The disparity may partly
be explained by the fact that a patient answering specific questions about their eye medications in an interview is more likely to raise the issue of supply problems, than a patient attending a clinic appointment, where supply problems may be overshadowed by other issues. Furthermore, some clinicians may have omitted to record the supply problems reported by a patient in the clinic notes. Of those notes in which supply problems were recorded, a high
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proportion – 89% – also recorded a management change. By contrast, of those patients reporting supply problems at interview (23/39, 59%), only 52% reported a management change. This disparity may reflect the fact that clinicians that record supply problems in the patient notes are then likely to instigate a management change. In other cases (for example where the patient had recalled the supply problems at interview, but forgotten to mention it to the clinician at their clinic appointment), the clinician may not have been aware of the supply problems and therefore would be unlikely to instigate a management change. Those who had no supply problems were generally either only on the drug for a short period of time, regularly visited the hospital and obtained repeat drug supplies from the hospital, or managed to get supplies locally. Assessment of both patients’ notes and interviews revealed that approximately one-third of those with supply problems attended A&E, some on multiple occasions, to obtain further supplies or an alternative medical solution. This is likely to be an underestimate, as not all A&E entries are filed in patient records. These extra visits to A&E would have been inconvenient and time consuming for patients and staff respectively. Moorfields Eye Hospital pharmacists gave regular updates to MEH clinical staff on the status of supply problems and provided advice on alternative preservative-free agents such as Timolol 0.1% (Tiopex, Spectrum Thea, UK www. spectrum-thea.co.uk) and Tafluprost (Saflutan, MSD, UK). Medicine shortages have become increasingly common in recent years and are not limited to ophthalmology. The reasons for shortages may include manufacturing problems, supply/demand imbalance, raw material problems and regulatory problems. In order to reduce the impact of these shortages on patient care, there is statutory legislation (1) and voluntary best practice guidance (2) in place. (1). Article 81 of the European Directive of 2001 was implemented to ensure the appropriate and continued supply of medicines and require marketing authorisation holders, within the limits of their responsibilities, to maintain appropriate and continued supplies of their products, and to notify the Licensing Authority if a product is not going to be available, either temporarily or permanently; both manufacturers and wholesalers licensed to trade in the UK have a legal duty to ensure that UK patient needs are met.5 (2). The voluntary joint Department of Health Guidance with both the Association of the British Pharmaceutical Industry and the British Generic Manufacturers Association entitled ‘Notification and management of medicines shortages’ outlines best practice to minimise the impact of any medicine shortage. It recommends that companies communicate with the Department of Health as soon as possible about 240
impending shortages that are likely to have an impact on patient care, so that the Department of Health and industry can investigate options for managing the shortage and make contingency arrangements.6,7 The supply shortage of PF timolol (Timptol, MSD UK) was announced in a letter circulated by MSD UK to healthcare providers in February 2010, providing early warning of shortages. Moorfields Pharmaceuticals was approached by the NHS Purchasing and Supply Agency and asked about the possibility of making an unlicensed special product to fill the market gap for preservative-free Timolol. As Moorfields Pharmaceuticals had a formulation available, it was able to introduce two multi dose bottle packs of Timolol 0.25% preservative-free and Timolol 0.5% preservative-free. These became available from the end of December 2011. Teva launched a generic preservative-free Dorzolamide and Timolol 0.5% eye drop in April 2013, a year after supply problems began with PF Dorzolamide and Timolol 0.5% (Cosopt, MSD UK). When the Department of Health was contacted and asked what measures had been taken to manage the situation, the following response was received from the Principal Pharmacist, ‘I can confirm that we worked closely with MSD throughout this period to make sure that everything possible was being done to ensure availability of these products for the patients that needed them.’ Conclusions Glaucoma is a chronic disease that requires long-term, daily medical therapy. Our results show that medicine supply problems have a major impact on patients and hospital services. The findings of this study highlight the importance of early communication of impending shortages between manufacturers and the Department of Health, to allow for contingency planning as recommended in the best practice guidelines.6,7 In order to minimise the impact of medicine shortages on patients, clinicians and administrative staff, hospitals need immediate notification of potential supply problems and clear updates on supply resolution. In addition, hospitals should consider nominating an individual as a contact point for patient enquiries regarding medicine supply problems. Acknowledgement This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. Disclosure The authors report no conflicts of interest and have no proprietary interest in any of the materials mentioned in this article.
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References 1. Hopes M & Broadway D. Preservative-free treatment in glaucoma is a sensible and realistic aim for the future. Eur Ophthal Rev 2010; 4(1): 23–28. 2. Pisella PF, Pouliquen P & Baudouin C. Prevelance of ocular symptoms and signs with preserved and preservative-free glaucoma medication. Br J Ophthalmol 2002; 86: 418–423. 3. Nordmann JP, Auzanneau N, Ricard S & Berdeaux G. Vision related quality of life and topical glaucoma treatment side effects. Health Qual Life Outcomes 2003; 10: 1–75. 4. BNF, www.bnf.org.uk, accessed 18/09/14. 5. Directive 2001/83/EC of the European Parliament, http://ec.europa.eu/health/files/eudralex/vol-1/dir_2001_ 83_cons/dir2001_83_cons_20081230_en.pdf, accessed 27/4/13.
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6. Joint Department of Health and Association of the British Pharmaceutical Industry Guidance. Notification and management of medicines shortages, Best Practice Guidelines. (Dec 2006), https://www.gov.uk/government/uploads/system/ uploads/attachment_data/file/237064/dh_063441.pdf, accessed 19/06/14. 7. Joint Department of Health and British Generic Manufacturers Association Guidance. Notification and management of medicines shortages, Best Practice Guidelines. (Dec 2006), https://www.gov.uk/government/uploads/system/ uploads/attachment_data/file/237071/dh_063440_1_.pdf, accessed 19/06/14.
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