Abstract

Over-The-Counter drugs are also known as Non prescription drugs. These are safe drugs and can be sold over the counter, by the chemist without prescription. More products have been deregulated for purchase without a prescription. Increasing availability of non-prescription medicines may encourage patients to believe that there is a drug treatment for every ailment. Furthermore, the use of such products may delay/mask the diagnosis of serious illness, with increased risks of interactions and adverse reactions. There is also the potential for misuse and abuse of such products. In India, the import, manufacture, distribution and sale of drugs and cosmetics are regulated by the Drugs and Cosmetics Act (DCA) and its subordinate legislation, the Drugs and Cosmetics Rules (DCR).This legislation applies to the whole of India and to all sorts of medicines (e.g. allopathic, ayurvedic, homeopathic, etc.) whether imported or made in India. A questionnaire regarding OTC drug was distributed to the 100 persons those coming to the pharmacy for self medication to assess the awareness and attitude towards over-the-counter (OTC) drugs amongst urban population.

Introduction

Over-The-Counter drugs are also known as Non prescription drugs. These are safe drugs and can be sold over the counter, by the chemist without prescription of registered medical practitioner eg. vitamins, antacids, paracetamol etc.[ 1 ]

In recent years there has been an increasing trend in self medication with over-the-counter (OTC) medicines available in pharmacies and in retail outlets. In parallel, more products have been deregulated for purchase without a prescription [ 2 ]. The deregulation process has been championed by the pharmaceutical industry, the pharmacy profession and government health policy makers and is supported by the view that patients wish to have a greater role in their treatment choices [ 3 ]. Increasing availability of non-prescription medicines may encourage patients to believe that there is a drug treatment for every ailment. Furthermore, the use of such products may delay/mask the diagnosis of serious illness , [ 4 ] with increased risks of interactions and adverse reactions [ 5 , 6 ]. There is also the potential for misuse/abuse of such products [ 7 ].

In India, though the OTC has no legal recognition, all the drugs that are not included in the list of ‘prescription drugs’ are considered as non-prescription drugs (or

OTC drugs). Prescription Drugs are those that fall under two schedules of the Drug and Cosmetics Rules, 1945: Schedule H and Schedule X. Drugs falling under Schedule G require the following mandatory text on the label: “Caution: It is dangerous to take this preparation except under medical supervision” and hence are not advertised to the public voluntarily by the industry.

In India, the import, manufacture, distribution and sale of drugs and cosmetics are regulated by the Drugs and Cosmetics Act (DCA) and its subordinate legislation, the Drugs and Cosmetics Rules (DCR).This legislation applies to the whole of India and to all sorts of medicines (e.g. allopathic, ayurvedic, homeopathic, etc.) whether imported or made in India. The legislation is enforced by the Central Government ( Ministry of Health & Family Affairs ) in New Delhi, which is responsible for its overall supervision.

The OTC Committee of the Organization of Pharmaceutical Producers of India (OPPI) is working towards the promotion of responsible self-medication with a view to growing the OTC sector. It is aiming to get regulatory support for issues such as the accessibility of household OTC remedies and increasing the awareness of the importance of responsible

self-medication with the general public and the Government.

The Drug & Magic Remedies ( Objectionable Advertisement ) Act mentions a list of ailments for which no advertising is permitted. It also prohibits misleading advertisements, which, directly or indirectly, give false impressions regarding the true character of the drug; make false claims, or are otherwise false or misleading in any particular respect.

The following OTC medicines advertising can be seen on TV in India:

• Digestives, Antacids, Cold rubs and analgesic balms/creams

• Vitamins/tonics/health supplements (especially Ayurvedic-registered) • Medicated skin treatment, Analgesi, Antiseptic creams/liquids

• Glucose powders, Cough liquids,Band-aid, Baby gripe water. [ 8 ]

The present study was undertaken to assess the awareness and attitude towards over-the-counter (OTC) drugs amongst urban population.

Materials and Methods

A questionnaire focusing on adverse effects, contraindications, precautions and interaction with food and other drugs regarding OTC drug was distributed to the 100 persons those coming to the pharmacy for self medication. The questionnaire consisted of specific questions regarding knowledge about OTC drugs and opinion about OTC drugs.

Results

Knowledge and Opinions Of Persons
Number of Persons Not know anything about OTC + Banned the OTC Drugs Not know anything about OTC + OTC Drugs are very helpful Not know anything about OTC + Should have Information Leaflet Not know anything about OTC + Need of OTC Medicines Shop Know some information About OTC + OTC Drugs are very helpful Know some information About OTC + Should have Information Leaflet
16 34 32 10 4 4

Result of Questionnaire

Results are divided into two groups:-

Group A – Knowledge about OTC drugs (Fig-1)

  1. Th e majo r ity of t h e p e rsons (92%) said t hat t h e y n o t k now a n y t h i ng a b o ut t h e OTC dr u gs. 2. 8% p e rso n s sa i d t h a t t hey know some i n form at ion a b o ut the OTC dr u gs.1. The majority of the persons (92%) said that they not know anything about the OTC drugs. 2. 8% persons said that they know some information about the OTC drugs.

Group B – Opinion about OTC drugs (Fig-2)

  1. 1 6 % opini o ned that OTC d r u gs s h ou l d b e b an n ed because eve r ybody not know th eir a d ver s e e ff e c ts, i n ter a c tio n s, p r e c au t i o ns, cont r a i n d icat i o ns, a nd th e do s e o f t h e d rug.1. 16% opinioned that OTC drugs should be banned because everybody not know their adverse effects, interactions, precautions, contraindications, and the dose of the drug.

  2. 3 8 % o p i n ioned t hat OTC d r u gs is very h el p f ul f or p rompt r e l ief in h e ad a c he, b o dy ache, backache, to o t h a c he, f e ver, a n d c o ugh & col d , a nd for some p ro b l ems nob o dy wa n ts t o go to p h ysician.2. 38% opinioned that OTC drugs is very helpful for prompt relief in headache, body ache, backache, toothache, fever, and cough & cold, and for some problems nobody wants to go to physician.

  3. 3 6 % o p i n i o ned that i t s h o u l d h ave an I n f orm a t i on Lea f l e t which co nt a in t h eir a dverse eff e cts, in t er a c tio n s, p r ecaut i on s , contraindicati o ns, and t he d o se of the dr u g ( a d u l t / pedi a tric dose).3. 36% opinioned that it should have an Information Leaflet which contain their adverse effects, interactions, precautions, contraindications, and the dose of the drug (adult/pediatric dose).

  4. 1 0 % op i n i o n e d that t here is a n e ed of se p a rate OTC me d ici n e shops, o p erat e d b y a s p ecially trai n e d c h emist w ho a d v ise the persons about the co n ce r ned d r ugs.4. 10% opinioned that there is a need of separate OTC medicine shops, operated by a specially trained chemist who advise the persons about the concerned drugs.

Discussions

The findings from this study highlights the striking prevalence of the use of OTC drugs, the lack of knowledge and the risks associated with them. OTC drugs are widely used and so it is very difficult to restrict them. Measures should be directed towards their safer use. High volume of textual information on the OTC product labels is confusing, particularly to those with lower literacy skills and they often struggle to understand the prescription drug labels, dosing instructions and warning signs. The challenge in controlling the problem of OTC misuse and abuse is to achieve the necessary high level of consumer safety for the few at risk, while not restricting to OTC products for those who continue to use them safely. It may be recommended

that by monitoring usage of certain OTC products, in addition to data recording and education, safe and effective use of such medicines can be promoted.

Conclusions

Self-management of acute, intermittent and long-term conditions is likely to become more extensive in the future. A balance needs to be struck between safety and patient autonomy. Greater patient and public involvement in formulating both policy and practice against the OTC drugs will be needed. Education programs for the public and for health professionals will be necessary. Also as the main factor found to influence the people to use OTC drugs was pharmacist recommendations, pharmacists need to be more proactive in the management of inappropriate OTC drug use.

[ 1 ] HL Sharma KK Sharma. Principles of Pharmacology. Paras Med Pub India, 20 1 1.

[ 2 ] Bond C. Prim Care Pharm 2 001; 2: 5–7.

[ 3 ] Bradley C, Blenkinsopp A. Br Med J 1996; 3 12: 835–837.

[ 7 ] Hughes GF, McElnay JC, Hughes CM, McKenna P. Pharm World Sci 1999; 21: 251–255.

[ 8 ] Vijay Bhangale. IIMK 8 -10 April 2007:397-402.