Guest guest Posted February 1, 2011 Report Share Posted February 1, 2011 Dear Gitanjali Madam, Thanks for expressing your opinion about increasing the availability and accessibility of OTC medicines to needy people. I believe that any society will be judged by its ability to provide universal healthcare for its people. This does not merely entail the ability to treat diseases and ailments but also to prevent their onset by means of suitable systems and measures. The rich at least have access to information about health related issues. That is not the case with the many lower income groups and poorer people. There is a total absence of health awareness among these sections. And even if they want to, many of them cannot afford a visit to a doctor, or afford regular medication when it is urgently required. More often than not, they end up relying on quacks, thus the need for empowering them through health education for self management of common ailments to start of and finally to prevent common ailments. As you have already explained in your earlier post, there is an urgent need to promote Responsible Self Medication. Regards, Dr. Mangesh Bankar Nagpur Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 1, 2011 Report Share Posted February 1, 2011 On OTC availability of bannable medicines: Please read me in: " Pharmacovigilance: Is it possible if bannable medicines are available over the counter? " by Thawani Vijay, Sharma S, Gharpure K in Indian Journal of Pharmacology 2005; Vol:37: Issue:3;191. Vijay Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 1, 2011 Report Share Posted February 1, 2011 Dear Friends, We must not only take this serious discussion on OTC medicines to a conclusion, but also chalk out plans how we can propose changes at the level of various stakeholders, and also do a follow up. Some observations that I had to make based on the various issues raised and discussed : Household Remedies – This was a concept introduced in 1961, and needs to be revisited. Quinine & Iodochlorhydroxyquinoline in the list are no longer relevant, and some others are barely used today. We need to carefully distinguish between a. GSL (General Sales Medicines) (e.g. in U.K.) – which are available in non-pharmacy stores also, And b. OTC medicines – which means that they are not available for pick up from the shelf by the client. The client has to “ask” for it across the counter, and the salesperson will hand it over to the client. If there is a need felt for counseling, giving specific instructions, control over “how much” quantity to be sold at a time, etc., the same is given, and if intervention of a Pharmacist is necessary, the Pharmacist is called for before dispensing the medicine. While doing this, we also need to finalize which drugs can be advertised to the public and which cannot, and the contents of the advertisements. Otherwise, companies creat a havoc, and consumers get misled into treating themselves with the wrong things. We have seen the damage done by the Emergency Pill ads ! Information to consumer – We recently did a study of labels of a 100 OTC medicines (which according to us are surely, non-controvertially OTC), and compared with the US FDA requirements for labelling of OTC medicines. The findings were not surprising – the information on the immeditae label of the strips is barely readable (even with a magnifying glass), some have an outer covering/packing, the information there is readable, BUT the information available is more related to legal requirements, and minimal related to utility of the consumer to make a proper choice to consume the medicine. While some did have, most did not have the dose, the child dose, precautions, Contraindications, ADRs, possible drug interactions, etc. And thirdly, the information was in English ONLY (except 1 label – where the name was in Devanagri also). Summary of findings in brief : 1. 55% did not specify therapeutic category 2. 25% failed to mention Indications 3. 99% did not mention possible side effects 4. 68% did not give overdosage instructions 5. 92% did not give info regarding usage in pregnancy & lactation 6. No contraindications or possible drug interactions on 87% labels 7. 73% did not advise to seek medical guidance in case patient’s condition does not improve 8. 64% did not state that it is to be kept out of reach of children 9. Storage conditions – 88% did provide storage conditions, but 64% of them were abstruse and imprecise 10. Directions – 46% did not mention the amount to be used, 34% of did not mention the dosing interval, 85% did not mention the maximm dose permitted per day, 75% failed to mention the dose for children 11. Legibility – 40% of the labels were clearly read only when a magnifying glass was used, 22% were read with dificulty even with magnifying glass. 12. Additional information – Only 3 contained a PPI (Patient Package Insert). In 56%, a secondary package was found to be available to the patient, but only 36% of these gave information to the patient than the primary label. Therefore, there is a need also to look at improvement of labeling of OTC medicines, and mandatory inclusion of PPIs (in at least a couple of languages), so that people can read about the medicines and make a “responsible choice” (At least those who can read). Schedule G – in India, Pheniramine, Metformin, and a few others are in this Schedule. Different Drug Inspectors have different interpretations whether these can be sold without a prescription, or need a prescription for sale. Nothing to this effect is written on the label warning. OTC in India – It could be erroneous to say that what is not under Sch C, G, X, and C & C1 is “OTC”. On many such products, there is no label warning about sale only by prescription. I am sure we would not like to consider Corticosteroid creams, FDC creams of corticosteroids, antibiotics & antifungal, various eye drops (including antibiotics), etc. to be OTC. On the other hand, in our country, many drugs which are in OTC category iin other countries, and by now ought to be OTC in our country are still in Schedule H – e.g. Albendazole, Loperamide, Ibuprofen 200, etc. There is also chaos sometimes – some Albendazole preparations state that they should be sold only against a prescription, while some have no warning. So also with certain corticosteroid creams. Overall, there are no proper systems and control in our country on such aspects. Irrespective of all this, it is sad that most prescription medicines are availabe without a prescription in most pharmacies. Govt. needs to take steps to curb this. Pharmacist only Medicines – We Pharmacists would certainly be glad to have such a category in India (in the level between prescription only and the OTC category), and give us some authority and armamentarium. Unfortunately, India is not yet ready for this. Because many a times a Pharmacistst in not always present at the pharmacy, and in some states, the number ofpharmacies licensed to operate is about 10 to 20 times the total number of pharmacists in the state ! Talk of proper implementation of laws ! It is simply not possible ! Jago Grahak Jago – I recently saw a TV ad by Jago Grahak Jago – it said that one should not ask the Chemist for any treatment. Even for simple illnesses one should go to the doctor ! How typically anti-OTC !!!!!! There is a urgent need therefore to address all the issues. We need to document them systematically, and take them up at appropriate levels. With regards RAJ ---------------------------------------------------------------------------------------------------------------------------- RAJ VAIDYA, M. Pharm, Community Pharmacist, Hindu Pharmacy, Panaji – Goa & Vice President & Chairman, Indian Pharmaceutical Association – Community Pharmacy Division On Tue, Feb 1, 2011 at 8:18 PM, mangesh bankar <drmangesh_bankar@...> wrote: Dear Geer Ishaq sir,I completely agree with your opinion that pharma companies should take consumer centric approach in designing OTC products where priority should be given on consumer education and there by his empowerment. I think packaging of OTC medicines in multilingual and simple language will be better for Indian market since it can be more customized and is less costly. Regards,Dr. Mangesh BankarAssistant Professor,Pharmacology,GMC, Nagpur. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 2, 2011 Report Share Posted February 2, 2011 Dear Raj Vaidya sir, I am extremely thankful to you for providing important data of your study on labeling of OTC medicines. I completely agree with your concerns regarding OTC labeling in India. OTC labeling must be improved to allow consumers to garner pertinent dosage and cautionary information from the packaging. Your study has indicated that product labels are written in language above the reading abilities of the general population. It is incumbent on the pharmaceutical companies to promote OTC medicines in a responsible manner with specific instructions for the consumer to consult a pharmacist or healthcare provider if he/she is currently taking prescription or other OTC medicines. There is no doubt that increasing economic, societal and corporate influences will assure that more medicines and medicine classes will be reclassified as OTC products. In this regard, prescriber and consumer awareness of the potential for adverse effects and significant interactions involving OTC medicines must be heightened. Regards, Dr. Mangesh Bankar Nagpur Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 3, 2011 Report Share Posted February 3, 2011 Dear Members, The package insert should concentrate on good communication, with the important aspects being highlighted. It is the important issues that should be highlighted, including pictorially, and the less significant and uncommon side-effects should be diminished in presentation. A time limit should be set for a course of over-the-counter treatment and advice given as to when a medical consultation should be sought. The testing of these leaflets by the manufacturer must be structured and thorough. Regards, Dr. Mangesh Bankar Nagpur Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 3, 2011 Report Share Posted February 3, 2011 Dear Members, The patient should be able to make the diagnosis, or should at least know what the diagnosis is, based on an authoritative opinion. Medicine be sufficiently safe, The risks of unwanted effects can be reduced by limiting the dosage strengths of over-the-counter formulations. Regards, Dr. Mangesh Bankar Nagpur Quote Link to comment Share on other sites More sharing options...
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