Table S1 Allocation of prescription to non-prescription switches into progressive or nonprogressive
Medicine
United Kingdom
Omeprazole
Hyoscine (transdermal)
Year Progressive? Reasoning
2003 Yes
2004 Yes
More effective than H
2
antagonists [1]
One patch lasts 3 days rather than dosing 2-
Simvastatin
Chloramphenicol (eye drops)
2004
2005
Yes
Yes
Alclometasone diproprionate (dermal)
2005 No
Amorolfine (nail lacquer) 2006 Yes
3 times daily
First statin to switch
First antibacterial eye drop
Clobetasone butyrate previously switched
Sumatriptan
Penciclovir (dermal)
Naproxen
2006
2006
2008
Yes
No
Yes
Low efficacy [1], but no other nail antifungals
OTC [2,3]
Triptans used in migraines non-responsive to simple analgesics [1]
Aciclovir previously switched
Maximum daily dose 750 mg [2]. Longer
Azithromycin
Diclofenac
Tamsulosin
Pantoprazole
Orlistat
Tranexamic acid
Domperidone
2008
2008
2009
2009
2009
2010
2010
Yes
No
Yes
No
Yes
Yes
Yes acting and higher relative dosing (to prescription) compared with ibuprofen [1].
First non-prescription antibacterial for
Chlamydia
Maximum daily dose 75 mg [2] similar relative dosing (to prescription) compared with non-prescription ibuprofen [1].
First licensed medicine switched for benign prostatic hypertrophy
Omeprazole already switched
First licensed medicine for weight loss switched
No previous non-prescription treatment for menorrhagia
Extended indication. No previous nonprescription nausea and vomiting treatment
Diclofenac (patch)
Ibuprofen (dermal)
Rabeprazole
Esomeprazole
United States
Omeprazole
Loratadine
Ecamsule (dermal)
Emergency hormonal contraceptive
Terbinafine (dermal)
Ketotifen (ocular)
2011
2012
2012
2013 No
2003 Yes
2003
2006
2006
2006
2006
No
No
No
Yes
No
Yes
No
No
(except for in migraine) [2].
The patch (for local pain) unlikely to have substantially greater benefit than existing non-prescription oral and topical antiinflammatories
For sunburn. Other non-prescription sunburn products are available
Omeprazole switched previously
Omeprazole switched previously
More effective than H
2
antagonists [1].
Extended indication. First non-sedating antihistamine for hives
Previous sunscreens available
First emergency contraception switched
Polyethylene glycol 2250 2006 No
Orlistat
Cetirizine
Lansoprazole
Fexofenadine
2007
2007
2009
Yes
No
No
2011 No
Oxybutynin (transdermal) 2013 Yes
Previous dermal antifungals
Other topical antihistamines or mast cell stabilisers available
Other laxatives available
First such licensed weight loss remedy
Loratadine already switched
Omeprazole already switched
Loratadine already switched
Triamcinolone (nasal)
Japan
Ketotifen (nasal)
Roxatidine
Nizatidine
Minoxidil (scalp)
Azelastine
Ketotifen
Tiquizium bromide
Lanoconazole (dermal)
Triamcinolone (mouth)
Aciclovir (dermal)
Ketotifen (ocular)
Ambroxol
Flavoxate
Tranexamic acid
Isoconazole (vaginal)
Miconazole (vaginal)
Nicotine (transdermal)
Emedastine
Minoxidil (five times strength)
Diclofenac (dermal)
Vidarabine (dermal)
Troxipide (combination)
Epinastine
Loxoprofen
2013 Yes
2004 No
2004 No
2004 No
2004 Yes
2005 No
2006 No
2006 No
2006 No
2006 Yes
2007 Yes
2007 No
2007 No
2007 Yes
2007 Yes
2007 Yes
2008 No
2008 Yes
2008 No
2008 Yes
2009 No
2009 No
2009 No
2009 No
2009 Yes
Clotrimazole (vaginal)
Oxyconazole (vaginal)
Beclometasone (nasal)
Oxymetazoline (nasal)
Acitazanolast (ocular)
Pemirolast
Mequitazine
Ibuprofen
Fexofenadine
Neticonazole vaginal
Eicosapentaenoic acid
Cetirizine hydrochloride
Tranilast (eye drops)
Trimebutine
Ebastine
2010 No
2010 No
2010 Yes
2010 No
2011 No
2011 No
2011 No
2012 No
2012 No
2012 No
2012 Yes
2012 No
2013 No
2013 No
2013 No
Sodium cromoglycate previously switched
[4]
H
2
-antagonist previously switched [4]
H
2
-antagonist previously switched [4]
Extension of indication to women
Other oral non-sedating antihistamine already available [4]
Other oral antihistamines already available
[4]
Scopolamine already switched for stomach cramps in 1987 [4]
Other topical antifungals already available
[4]
Sodium cromoglycate previously switched
[4]
Bromhexine already non-prescription [5]
First medicine for urinary incontinence switched
Unique medicine for liver spots
First vaginal antifungal switched
Isoconazole already switched
Gum switched [4], but patch provides even nicotine levels and is not addictive [6]
Other oral antihistamines
Stronger than previous formulation
Topical anti-inflammatories previously switched
Other antivirals already switched
Teprenone previously switched for gastritis
[4]
Similar to azelastine
Non-prescription dose same as prescription dose. Oral ibuprofen previously switched, but in lower dose than prescription [4,7,8,9]
Other vaginal antifungals already switched
Other vaginal antifungals already switched
First nasal corticosteroid
Other vasoconstrictors already available [5]
Leukotriene inhibitor but no evidence of improvement over alternatives b
Similar to ketotifen [1]
Increased dose; others non-prescription have comparable dosing
Increased dose, but loxoprofen already available at same as prescription dose
Other antihistamines available
Other vaginal antifungals switched
This appears to be the first switch for hypertriglyceridaemia
Other allergic conjunctivitis preparations already available
Other antispasmodics already available
Other antihistamines already available
The Netherlands
Terbinafine (topical)
Ambroxol (lozenge)
EHC
Docosanol (dermal)
Fexofenadine
Omeprazole
Ipratropium (nasal)
Orlistat
Pantoprazole
Flurbiprofen (lozenge)
Clotrimazole (vaginal)
2004
2004
2005
2008
2008
No
No
Yes
No
No
2008 Yes
2009 Yes
2009 Yes
2009 No
2010 No
2011 Yes
Other topical antifungals previously switched
Other throat lozenges previously switched with similar properties
Other dermal antivirals for herpes labialis switched
Other non-prescription non-sedating antihistamines
First proton pump inhibitor
First nasal anticholinergic
Omeprazole already switched
Benzydamine lozenges switched previously
First vaginal antifungal
Medicines listed are oral unless otherwise stated.
Combination medicines and nutritionals excluded. EHC = emergency hormonal contraception a. As loxoprofen non-prescription is available at prescription strength, it has been deemed innovative.
It is unknown if prescription dosing for ibuprofen and loxoprofen are equivalent. No head-to-head studies in humans arose from a Medline search (12 Nov 2012). b. Acitazanolast has little information in English; topical leukotriene inhibitors do not appear in allergic conjunctivitis in Martindale [1], or in
Medline indexing.
1. Sweetman SC, editor. (2010) Martindale: The Complete Drug Reference. London: The
Pharmaceutical Press.
2. MHRA List C Consolidated list of substances which are present in authorised products which have been reclassified since 1 April 2002. Available from: http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofmedicines/Legalstatusandrecla ssification/Listsofsubstances/index.htm
Accessed: 17 Jan 2014
3. Ryan RSM, editor. (2012) British National Formulary. London: BMJ Group Pharmaceutical Press.
4. Sasaki K, Tomioka M (2003) [Pharmacy newsletter for pharmacy student no. 8].
5. Ministry of Health, Labour and Welfare. (2002) [List of switch OTC in main countries: Japan, US,
UK, Germany, France]. Available from: http://www.mhlw.go.jp/shingi/2002/11/dl/s1108-4e.pdf
Accessed: 12 Nov 2012
6. Shaw JP, Ferry DG, Pethica D, Brenner D, Tucker IG (1998) Usage patterns of transdermal nicotine when purchased as a non-prescription medicine from pharmacies. Tob Control 7:
161-167.
7. Daiichi Sankyo Healthcare Limited [Loxonin-s package insert]. Daiichi Sankyo.
8. Taiyo Pharmaceuticals (2012) [Ibuprofen 200mg datasheet]. Japan Pharmaceutical Information
Centre.
9. Pharmaceutical and Medical Devices Agency (2012) [Information of approved assessment for OTC medicine]. Available from: http://www.info.pmda.go.jp/approvalSrch/OverTheCounterSrchInit?
Accessed 12 Nov 2012