Over-the-counter drug

A counter drug or non-prescription product (due to the English name over-the-counter drug and OTC drug called) is a drug that is not available on prescription is; so it can be purchased without a doctor's prescription. These can be both pharmacy-only and non-pharmacy-only preparations.

It is characteristic of over-the-counter drugs that their use in the population is considered effective and safe even if no treatment is sought by a health professional.

Situation in Germany

meaning

Over-the-counter drugs play a major role in self-medication . For the statutory health insurance they are of little importance due to the extensive exclusion of the assumption of costs. Their share of sales in the entire SHI pharmaceutical market is only around 3 percent. In private health insurance, over-the-counter drugs account for 14.1 percent of all sales and 35.8 percent of all prescriptions (as of 2009).

According to Section 48 of the German Medicines Act , the Federal Ministry of Health can classify medicines as not requiring a prescription if, when used as intended, they do not endanger the health of the user, even if they are used without medical supervision. An expert committee of the Federal Institute for Drugs and Medical Devices works out proposals as to which substances can be released from the prescription requirement or are to be subject to it.

As OTX drugs are called non-prescription medicines that are prescribed by a doctor. The prescription can be based on a private prescription, statutory health insurance prescription or a “green prescription” , regardless of the possibility of reimbursement. OTX is made up of OTC and RX .

Over-the-counter drugs make up about half of the sales (in packaging units) in pharmacies. By far the largest share of sales, however, is accounted for by the dispensing of prescription drugs.

Pharmaceutical market in Germany: sales in million packaging units (PU)
Area	2010	2011	2012	2013	2014	2015	2016	2017
Self-medication	566	559	556	588	583	613	619	619
OTX	121	120	116	121	117	122	122	120
OTC, total (total self-medication + OTX)	689	679	672	709	700	735	741	739
Rx ⁽¹⁾	690	692	692	710	727	734	741	738
Pharmacy market, total	1379	1371	1364	1419	1427	1469	1481	1478
Outside the pharmacy ⁽²⁾	69	66	62	60	59	62	62	59

⁽¹⁾ Figures 2010–2013 without, from 2014 including mail order business, ⁽²⁾ Figures 2010–2011 without, from 2012 including discounters

Pharmaceutical market in Germany: sales in billions of euros
Area	2010	2011	2012	2013	2014	2015	2016	2017
Self-medication	4.42	4.39	4.44	4.73	4.83	5.16	5.32	5.45
OTX	1.23	1.21	1.19	1.23	1.20	1.25	1.26	1.28
OTC, total (total self-medication + OTX)	5.66	5.61	5.63	5.98	6.03	6.41	6.58	6.23
Rx ⁽¹⁾	33.31	33.53	34.02	35.97	41.85	43.81	45.08	46.82
Pharmacy market, total	38.97	39.14	39.65	41.95	47.87	50.22	51.66	53.55
Outside the pharmacy ⁽²⁾	0.22	0.21	0.19	0.19	0.19	0.20	0.21	0.19

⁽¹⁾ Figures 2010–2013 without, from 2014 including mail order business, ⁽²⁾ Figures 2010–2011 without, from 2012 including discounters

Reimbursement of costs in statutory health insurance

Since the Statutory Health Insurance Modernization Act in 2004, the costs of non-prescription drugs are in principle no longer covered by the statutory health insurance . In accordance with the exception regulations in Section 34 of Book Five of the Social Security Code , costs will continue to be reimbursed for children up to the age of 12 and for adolescents up to the age of 18 if they have developmental disorders. In addition, the Federal Joint Committee can put non-prescription drugs, which are considered the standard therapy for the treatment of serious illnesses, on an exception list. Since 2012, statutory health insurances have also been able to offer their insured persons non-prescription drugs as part of statutory benefits. However, a medical prescription is required. About 70 health insurances currently make use of this.

Reimbursement in private health insurance

The private health insurance (PHI) provides its insured the cost of drugs, by the evidence-based medicine have been recognized or posing as an alternative medicine have been proven in practice. This also covers the cost of non-prescription drugs. The prerequisite is that the submission to the insurance company is accompanied by a corresponding medical prescription and the reimbursement has been contractually agreed.

Data from pharmacoepidemiological studies

Extensive data on the type and extent of the use of non-prescription drugs in Germany were presented by the Robert Koch Institute from pharmacoepidemiological studies representative of the population .

Web links

Wiktionary: prescription-free - explanations of meanings, word origins, synonyms, translations

Federal Joint Committee: Questions and answers on the OTC overview of prescribable, non-prescription drugs. August 6, 2010, accessed August 18, 2010 .

Individual evidence

↑ BfArM: OTC glossary. August 13, 2013, accessed May 18, 2015 .
^ US Food & Drug Administration (FDA): Drug Applications for Over-the-Counter (OTC) Drugs. Retrieved February 23, 2018 .
^ F. Wild: drug supply for privately insured persons 2009: figures, analyzes, private health insurance comparison. ( Memento from April 19, 2011 in the Internet Archive ). (PDF; 783 kB).
↑ BAH glossary index , accessed on March 11, 2019.
↑ ^a ^b BAH figures brochures 2010 to 2017
↑ Federal Joint Committee: Federal Joint Committee adopts an exception list. March 16, 2004, archived from the original on January 23, 2011 ; Retrieved August 18, 2010 .
^ OTC medication as a statutory service. In: Doctors newspaper. March 17, 2015, accessed May 18, 2015 .
^ R. Beitz, M. Dören, H. Knopf, HU Melchert: Self-medication with over-the-counter (OTC) preparations in Germany. In: Federal Health Gazette Health Research Health Protection. 47 (11), Nov 2004, pp. 1043-1050. PMID 15549197 .
↑ HU Melchert, H. Knopf, E. Pabel, M. Braemer-Hauth, Y. Du: Co- and multimedication in users of ASA and vitamin E drugs in the Federal Republic of Germany. Results of the Federal Health Surveys 1984-1999. In: Int J Clin Pharmacol Ther. 39 (11), Nov 2001, pp. 488-491, PMID 11727969 .

[1] BfArM: OTC glossary. August 13, 2013, accessed May 18, 2015 .

[2] US Food & Drug Administration (FDA): Drug Applications for Over-the-Counter (OTC) Drugs. Retrieved February 23, 2018 .

[3] F. Wild: drug supply for privately insured persons 2009: figures, analyzes, private health insurance comparison. ( Memento from April 19, 2011 in the Internet Archive ). (PDF; 783 kB).

[4] BAH glossary index , accessed on March 11, 2019.

[BAH-ZB-5] BAH figures brochures 2010 to 2017

[6] Federal Joint Committee: Federal Joint Committee adopts an exception list. March 16, 2004, archived from the original on January 23, 2011 ; Retrieved August 18, 2010 .

[7] OTC medication as a statutory service. In: Doctors newspaper. March 17, 2015, accessed May 18, 2015 .

[8] R. Beitz, M. Dören, H. Knopf, HU Melchert: Self-medication with over-the-counter (OTC) preparations in Germany. In: Federal Health Gazette Health Research Health Protection. 47 (11), Nov 2004, pp. 1043-1050. PMID 15549197 .

[9] HU Melchert, H. Knopf, E. Pabel, M. Braemer-Hauth, Y. Du: Co- and multimedication in users of ASA and vitamin E drugs in the Federal Republic of Germany. Results of the Federal Health Surveys 1984-1999. In: Int J Clin Pharmacol Ther. 39 (11), Nov 2001, pp. 488-491, PMID 11727969 .