Creating Value for Doctors, Pharmacists and Patients Vol:4
ue s Is s i Th n I
Issue: 20 Feb 1-15
2008 Price Rs 20/-
Doctors Section 1- 2 & 11-12 Pharmacist Pages 3 - 4 & 9 -10 Patient Education 5 - 6 & 7- 8
Guest Editorial
ANALGIN This is regarding the drug ANALGIN a drug also known as DIPYRONE, METIMAZOLE,NOVALGIN,MELUBRIN.a product synthesized by the German firm Hoechst.I had read, I VIVIDLY RECALL, long back ,however even today when I searched for the drug in GOODMAN GILLMAN’S The Pharmacological Basis of Therapeutics in the 1995 ,NINTH Edition ,this is what I found on page.643 IN SMALL PRINTS, “A variety of related pyrazolon derivatives also have enjoyed sporadic popularity,for example,dipyrone.It,too,can cause agranulocytosis. A full description of the pharmacological properties of these drugs may be found in earlier editions of this book. I remember very well, way back in late 1970’s or very early 1980’s I met a employee of Batas Shoe Company in Chandigarh, whom I knew quite well, when I went to his shop ,he looked very depressed and was very quiet. I asked him what the matter was,why was he so sad?. He said a week back he took his daughter to a local doctor ,she was running fever and body aches, the doctor gave him an injection, and within a few minutes of the injection she died. I asked him what was given to her and he said NOVALGIN INJECTION. I returned home and checked the edition of Goodman Gillman 1970/1975 it said that the drug can produce anaphylactoid reaction,and I was convinced that the shot of Novalgin had killed her. I can dismiss this statement by saying that this was just anecdotal hind sight. BUT I FEEL EVEN TODAY THAT NOVALGIN KILLED HER, AND IF I COULD, I WOULD HANG THE DOCTOR BY THE NEAREST POLE FOR THE SIMPLE REASON THAT HE USED A DRUG WHICH WAS REPORTED IN THE LITERATURE THAT IT COULD EVOKE A ANAPHYLACTOID REACTION. Again quoting from a recent publication of my much respected senior colleague,a emeritus professor of pharmacology Prof.P.C.Dandiya of Jaipur in his book co- edited with Bapna & Khilnani “The Complete FAMILY MEDICINE BOOK 9th revised edition 2005 They have the following to say” Analgin(Novalgin Analgin has various other names.......... noramidopyrine.The general belief that analgin is a powerful pain reliever than others is far from true.It is meant to be sold only on a doctor’s prescription(Schedule H drug) as it can cause serious adverse reaction.However,it is a pity that general shops sell it freely. Analgin depresses bone marrow, which is the blood forming organ,,due to an allergic reaction which is life threatening. In most western countries,it has virtually disappeared from the therapeutic scene but continues to be sold in some East European and most developing countries.In India,a ban has been put on the use of amidopyrine due to its adverse effects,but the closely related drug,analgin,which is nothing but noramidopyrine and produces similar adverse effects,continues.The argument that it is available in injection form and can be used in emergencies in unconscious patients,is not acceptable,as the safer drug,paracetamol,is also available in this form” I think my views on the matter is absolutely clear THERE IS NO JUSTIFICATION OF KEEPING NOVALGIN/ANALGIN available in India and every one knows that there is nothing like prescription only drugs,where there is NO effective check on obtaining,perhaps with the exception of Narcotics-All you need is money to pay and you have plenty of pharmacies where the counter boy,often not a pharmacist freely prescribes and dispenses any thing from fourth generation Cephalosporin’s to all kind of sieroids.Our Babus in THE Bhawans and The Councils LIVE IN THEIR IVORY TOWER and believe “THE JOB IS DONE WHEN THE PAPER WORK IS OVER”.IMPLEMENTATION IS NEVER PRACTICED only preached by the sewaks of Aam Admi
Prof V.S.Mathur, MD, D.Phil (OXON), FAMS College of Medicine, Arabian Gulf University, Baharain.
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Editor & Publisher
V. Bhava Narayana Associate Editors
EDITORIAL BOARD Prof.B.Suresh, President Pharmacy council of India
Dr. Aniruddha Malpani, M.D Dr. Mahesh Sharma,
Dr. Jawahar Bapna, Rtd Director, IIHMR
Prof. G.P.Mohanta
S.W. Deshpande, DG, AIDCOC
M.D (Ayurveda)
Dr. P.Hanumantha Rao, ASCI, Hyd
This Publication is Only for the use of Medical & Pharmacy Professionals Printed, Published and Owned by V. Bhavanarayana, and printed at Kala Jyothi Process Pvt. Ltd., 1-1-60/5, R.T.C. 'X' Roads, Musheerabad Hyderabad - 20. Published at 3-3-62/A New Gokhale Nagar, Ramanthapur, Hyderabad - 500 013, R.R. Dist. Editor : V. Bhavanarayana * RNI No.: APBIL/2004/12036 Postal LIC NO : HSE 806/2004-06. C Pharmed Trade News, 2004 * Person responsible under PRB act for selection of news Pharmed Trade News does not neccesarily subscribe to the views expressed in the publication. All views expressed to the magazine are those of the contributors Pharmed Trade News not responsible or accountble for any loss incurred, directly or indirectly as a result of the information provided.
HEALTH CARE IN PARLIAMENT
Affairs (Shri B.K. Handique)
In Lok Sabha and in Rajya Sabha
Discarded Drugs in Market
Publishing of Papers & Patents Through NIPER Q. Will the Minister or Chemicals and Fertiliser be pleased to State: (a) Whether the papers and patents published through National Institute of Pharmaceutical Education and Research (NIPER) are not in line with requirements of Scale Pharma Units; (b) If so, the details thereof; (c) Whether the Selection Committee and other related committees do not have any representative of Small Scale Pharma ndustry; and
Q. Will the ministers of Health & Family Welfare be pleased to state: (a) Whether it is a fact that drugs that have been globally discarded are available in Indian Market; (b) If so, brand names of drugs those are globally discarded; and (c) The action being taken by Government against the pharmaceutical companies and marketing those drugs in the country? Rajya Sabha Unstarred Question No.2049,
(d) If so, the reaction of the Government there to?
Shrimati Brinda Karat: Shri Jai Parakash Aggarwal
Loksabha Unstarred Question No.2925, Shri J.M.Aaron Rashid: Answered on 6.12.2007 CP – 122.2925. A. (a) & (b) : National Institute of Pharmaceuticals Education & Research carries out research in the area of pharmaceutical sciences and technology. Research findings published in the form of papers and patents can be used by any pharma industry irrespective of these being in the small or large pharma unit sectors.
Answered on 7.12.2007 CP-124. 2049 A. (a) No, Sir. There is no such term called “globally discarded drugs”. The rationality, safety and efficacy of a drug is ascertained based on risk benefit analysis as per the provisions of Schedule Y of Drugs and Cosmetics Rules before market approval in the country. There is regulatory system in place for ensuring safety and efficacy of marketed drugs in the country.
c) Selection Committee and other related committee are constituted strictly as per the provisions laid down in the statues which have been formulated in accordance to the NIPER Act.
The Drugs & Cosmetics Act 1940 was amended in 1982 to empower Central Government to prohibit manufacture and sale of drugs that are considered harmful or not rational, through notification under Sec. 26 a of the Drugs & Cosmetics Act. So far, 76 categories of drug formulations have been prohibited in the country.
d) Does not arise in view of (c) above.
(b) & (c): Question does not arise.
Minister of State in the Ministry of
The Minister of Health and Family Welfare
Chemicals & Fertilisers and Minister of
(Dr. Anbumani Ramadoss)
State in the Ministry of Parliamentary
Pharmaceutical Research Institute
Affairs (Shri B.K. Handique) Unknown Drugs Q. Will the minister of Chemicals & Fertilisers be pleased to State: a) Whether it is a fact that the Union Government has attempted to reduce prices of 886 brands mostly unknown and hardly used, instead of regulating the prices of life saving drugs as directed by the Supreme Court; b) If so, the details in this regard; and c) the reaction of the Government thereto? Lok Sabha unstarred question No. 2893. Shri Chengara Suprendran: Answered on 6.12.2007 CP-123.2893. A. a) to c): As a result of Government’s efforts the pharmaceutical industry has voluntarily agreed to reduce price of 886 generic formulation packs. Keeping in view the directions of the Supreme Court in SLP No. 3668 / 2003 and in line with the declared objective of the Government in the National Common Minimum Programme to make available life saving and essential drugs at reasonable prices to the poor, the draft National Pharmaceuticals Policy-2006 proposes, inter alia, that the basket for price control would be the essential medicines as contained in he National List of Essential Medicines, 2003 in addition to 74 drugs which are at present under price control under the Drugs (prices Control) Order, 1995. Draft national Pharmaceutical policy was considered by the Cabinet at its meeting held on 11.1.2007. The Cabinet has referred the policy to Group of Ministers (GOM). The first meeting of the GOM was held on 10.4.2007 and the second meeting was held on 12-9-2007. No time frame has been set for finalizing the National Pharmaceuticals policy. Minister of State in the Ministry of Chemicals & Fertilisers and Minister of
Q. Will the Minister of Health & Family Welfare be pleased to state: (a) Whether Government has proposal to establish research institutes for research on important life saving drugs and their manufacturing in the country; and (b) If so, the details thereof along with names of the States where the institutes are likely to be established? Rajya Sabha Unstarred Question No.2030. Shri N.R. Govinda Rajar: Answered on 7.12.2007 CP-125. 2030. A. a) & b): According to Indian Council of Medical Research (ICMR), recently the Union Minister for Chemicals & Fertilizers has announced to set up Six National Institute of Pharmaceutical Education and Research (NIPER) at Hyderabad (Andhra Pradesh), Hazipur (Bihar), Ahmedabad (Gujarat), Kolkata (West Bengal), Rai Bareilly (Uttar Pradesh) and Guwahati (Assam) The Minister of Health and Family Welfare (Dr. Anbumani Ramadoss) Category of Medicines Q. Will the Minister of Chemicals & Fertilisers be pleased to state: a) Whether it is a fact that medicines being sold in the country have been divided into two categories as first being, public price control and second non-Government price control; b) If not, the facts in this regard; c) Whether it is also a fact that the price of medicines if non-Governmental price-control has been increased almost 10 percent every year; and d) If so, the facts in this/regard and the reasons behind its so much increase as generally the rate of inflation has always remained less than 10 percent?
State in the Ministry of Parliamentary
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STRIP CUTTING BLUES By, Raj Vaidya, M.Pharm,
CONSEQUENCES OF STRIP CUTTING:
Arlene Avileli, B.Pharm,
The consequences of strip cutting are risky, dangerous, and loss making, both monetary, as well as to life…..
Pooja Borker, B.Pharm.
How Patients are affected:
( Community Pharmacists, at Hindu Pharmacy, Panaji )
The FDA - Maharashtra’s order asking chemists to cut strips for the benefit of the patient has sparked off another controversy. The problem of strip cutting is a constant nightmare to all retail chemist. The losses one faces because of loose tablets lying all over the place brings thoughts to the mind, “Is it worth the struggle, day in & out, scissor in hand, handing over 2 & 3 & even 1 tablet, because the customer cannot afford a strip, or to take care of his/her whims & fancies….??” The simple fact is that NO chemist would like to cut a strip. Yet, he is forced too, for various reasons : Because of the doctor : The doctor prescribes a dose which is other than the strip size : Out of ignorance of strip size. Wrong dose He prescribed a dose which he feels is correct according to the age/weight & extent of illness of the patient (which he feels best in his clinical judgement) Prescribing by Quacks Different companies have different pack sizes for the same drug/strength, which makes it impossible for the doctor to remember which company product has what pack size. The pack size keeps changing, with no prior or post intimation to the doctor. He knows that a strip can be cut at thence prescribes regardless of the strip size. He gives a few samples of the tab/cap, and tells the patient to buy the remaining number from the pharmacy. Because of the Patient: Economy : Patients do not have enough money to buy the whole strip/ dose, due to various reasons : Poverty (cannot arrange for the money now or later) Has not carried enough money with him/her. The costs of some drugs are beyond the imagination of many patients. Patient had carried some money, but some of it got over paying the doctor’s fess, thus not leaving enough to buy the medicines. Had some money, but not enough to buy everything. Patient thought he had to buy the bottle of tonic/enzyme preparation prescribed (worth Rs. 50 or so), hence did not have enough money to buy a whole strip of the other drugs. Patient thought he could buy a part of the strip now and the remaining later. He couldn’t buy half a bottle of tonic could he ?? Forgot! : The patient had dutifully bought the full dose, but he forgot to bring the day’s dose to office. He can’t skip the dose can he ? So, dear Pharmacist, please will you cut & give me only 2 tablets for now ? Other reasons : Patients do not have faith in the doctor, or the medicines – they therefore want to buy only “some” of the medicines now, and the rest later if they feel necessary, or after seeing them work! Testing times ! Patients asking for medicines for self medication insist on giving just a few and not the whole strip. It is the patient’s whim, and prerogative, as to how many tablets he wishes to buy, and the poor pharmacist has to oblige, or take a few glares, a shouting, or a couple of foul words ! Pharmacist: For all of the above-mentioned reasons, the pharmacist is left with no option but to cut strips, strictly against his own wishes.
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In some places, the pharmacy refuses to cut strips, and the patient has to go without buying it, or buy the whole strip, and throw away the remainder, unused portion. This may lead to large number of unused tablets and wastages, and monetary losses (especially for costly tablets). There are risks that chemists can push some expired tablets or even physician samples (without any batch details) along with genuine tablets. Expired strips & physician samples can be cut into appropriate pieces so as to dislodge the part carrying the batch details. This becomes even more convenient for blister packs, where the batch details are printed only on one side of the strip, consequently, the rest of the tablets can be sold long after their expiry. Cut pieces of strips/loose tablets often migrate in the mess & rush of customers. There are chances, that by mistake the pharmacy may give pieces of a strip of other tablets along with the correct ones (for similar looking tablets/strip packings). In order to reduce the cut tablets lying around in the box, the pharmacy often tries to give all the loose tablets lying around in the box even though a full strip is prescribed. The pharmacy will definitely think it right to get rid of the loose tablets, but the patient may doubt that he is getting old/expired tablets mixed with the real ones. It could be actually happenning too!! When cut tablet strips are given to patients, often with no name behind, the patient may get mixed up if 2 similar looking (but different) drugs are packed in the same prescription. He may end up taking a double dose of one drug, and not take the other drug the first few days, and then take only the second drug for the rest of the days. How a Pharmacy is affected: Cut tablets lie around in the box, and often pass on from the old box to the newer ones, on and on…..till they are sold, or new ones may keep generating. Many very often slip off from the slits in the flaps of the boxes and fall down. Here they get trampled beneath the feet, or get lost, or collect dust in the same or other shelf, thus making them unsaleable. Cut tablets are often not identifiable because the name of the drug may not appear on every part of the strip/foil, and as embossing on the tablet, and are a potential loss. The batch number, expiry, price details get cut off and the tablets lose their integrity, and the pharmacist is put in a dilemma – whether to sell such a drug (has it expired?? or not????), and what is the price? What details do I put on the bill? And the pharmacist is put in an embarassing situation when the patient asks, “What is the guarantee that these tablets you have given me have not expired? What is the batch number of the tablets, just in case I have to report an adverse reaction, or file a complaint??”. Most often, such tablets have to be thrown out, which is a big loss to the pharmacy! Cut strips which have expired are not settled by the stockists & manufacturers, thus are a loss to the pharmacy. Some strips are very difficult to cut (because the placement of tablets is awkward, or the tablets are placed too close to one another), because perhaps the pharmaceutical company does not want it to be cut (to make more sales), but the patient insists that it be cut! This may result in waste of precious time, and also, the blister or aluminium foil may peel off while maneuvering the scissors for cutting the strip. This results in one or more tablets getting exposed, and hence need to be discarded, and considered as a loss to the pharmacy. Loose tablets/strip portions are likely to fall around or slip out while packing the medicines at the pharmacy counter, thus causing inconvinience to both the patient and the pharmacy. The pharmacist, in discussing with the patient about how many tablets are to be given, and then cut the strips to suit the whims and the pocket of the FEB, 1-15, 2008
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patient, loses precious time. Further time is lost in calculating the cost per tablet, and the cost of tablets actually purchased by the customer. Since the number of tabets per strip varies from 1 to 50, often the pharmacist has to calculate the cost per tablet by dividing by awkward numbers such as 7, 8, 9, 15, 20, 25, 30, 40, 50, etc. There are higher possibilities of mistakes occurring in calculation, and time is lost in rechecking. It is very tedious & time consuming to make a bill for a few tablets of each medication purchased by the customer.
are to be used for conditions requiring long term usage, but tablets/capsules should not be too costly. For expensive drugs/formulations (say above Rs. 20 for 10 tablets), the strip size should be 6 or 4, and for a very costly drug/formulation a strip size of 2. For drugs which are habit forming (e.g. codeine), and which are likely to be misused, smaller pack sizes may be recommended if necessary. f.
Albendazole: 1 tab per strip.
Often, a strip of 8 or 12 looks like a strip of 10, leading to either undercharging, or overcharging, both awkward to the pharmacist. If a patient wants to return an unused portion of the strip (because of a drug allergy), what is the guarantee that it is the same strip taken from the pharmacy if it has no batch betails on it? The patient may return some old medications, which may have expired, and the pharmacy in turn will sell them again! A few important points, which need to be noted, are: The Drugs & Cosmetics Act is silent whether a strip can/should be cut or should not be come ! Every individual company, as per their wishes, and marketing strategies, determines the size of the strip. Very often, there is no rationale (from the pharmacists & patients perspective) for selecting the size of the strip. Only about 1 % of the drugs in the market today are governed by mandatory pack size fixation. Even if there is some rationale in having a particular strip size as per the dose, there is no rationale amongst the doctors, and quacks, who have their own dosing regimens, making ‘fixing’ of the size of the strip pointless, forcing it to be cut. Schedule P of the D & C Act specifies that some drugs (Famotidine, Atenolol, ASA) have to be packed in a strip of 14. However, experience at the retail pharmacy counters will show that the rationale with which pack size was decided by the authorities has no significance in actual practice. In other words, the authorities did not take into consideration the practical aspects that happen on a daily basis at the pharmacy counter. Pharmaceutical companies do not help either, for they have some weird strip sizes for some drugs. Since the pharmaceutical companies are free to decide the pack sizes, different drugs/formulations of different companies often have different sizes. Cut strips & loose tablets which are not sold, or are expired, are a tremendous loss to the nation ! Strip cutting is a serious problem, which neither the lawmakers, nor the FDA, nor the pharmaceutical industry will understand. It is finally the customers & the retail pharmacist who have to face the brunt of losses as well as conflicts with each other. Therefore, this is an attempt by a retail pharmacist behind the counter to suggest some perfectly viable solutions to take care of most of the shortcomings of the present system of pack sizes & problem of strip cutting. Possible solution to the problem of strip cutting: There is a need to have uniform strip size for a particular drug/formulation. (E.g., by law, all Amoxycillin 500 mg capsules, whether manufactured by Company A, B, or C, should have the same number of capsules per strip, to be specified under the D & C Act. In other words, all drugs & formulations should come under Schedule P.) What should be the actual strip size? It should definitely not be more than 10 tablets/capsules per strip. Present strip sizes of 12, 15, 20, 24, 25, 30, 40, 50, etc. are either too awkward for the chemist to handle, or they have to be cut to suite the budget/pocket of the patient. Exceptions: Oral contraceptives: 21 or 28 tablets (in any case, these strips are not being cut today, and are not a problem). b. Strips should have a few standard sizes: 10, 6, 4, and 2 (And, by law, should not be permitted to be cut). This means, that no strip size other than 10,6,4,2 (and the exceptions stated below) should be permitted. c. In general, a strip size of 10 should be fixed for drugs/formulations which: are not costly (Below Rs. 20)
Exceptions for specific drugs: Mebendazole: 6 tab per strip Oral contraceptives: 21 or 28 tab per strip. Any other exceptions may be reviewed by the authorities, and Accordingly approved.
Further : The authorities must undertake sufficient campaigning to make the new pack sizes be known to all doctors, pharmacies, and the public, and make them aware of the reasons & the rationale for having these new pack sizes. Doctors should know, so that they may prescribe certain medicines as per their pack size, and the public should know so that they do not make conflicts at the chemists’ counters. It also has to be suitably publicized to the doctors, public & pharmacies, that strip cutting is strictly prohibited, with heavy penalties to the chemist if found contravening this law. Obviously no chemist would like to cut a strip, but he is forced to do so because of various reasons & pressure from the patients to do so. A backing of the law, which disallows strip cutting, will give the chemist a concrete reason & support to explain to his customer why a strip cannot be cut. Therefore there will be uniformity throughout the country, at every chemist shop. In future, no pharmaceutical company should have the discretion of selecting the strip size. For any new drug/formulation introduced henceforth, the FDA should give directives each time, what the strip size will be. Possible losses/problems for the patients because of above changes/ recommendations: The patient may have to buy a few more tablets because strip cutting is disallowed. Some patients may not be able to buy the full strip because they do not have enough money. But the number of such patients will be low because costlier tablets are in smaller pack sizes. Patients may grumble that their freedom/discretion of deciding how many tablets they may want is lost because a strip cannot be cut. If a patient wants to return some unused tablets (due to adverse effects, or because the doctor changed the prescription), the pharmacy will not accept a cut strip now, as he used to before. The pharmaceutical companies may complain that changing the strip sizes would involve a big exercise of changing packaging machines, labels, carton & shipper sizes, etc. amounting to certain losses. However, this system has more advantages compared to the present system of strip cutting: Patients will get every time, drugs whose integrity and price is known and confirmed on the strips. (This will of course not apply if he is given spurious or counterfeit drugs). No possibility of being pushed physician samples or expired drugs. No mixing of cut/loose tablets from box to box. More chances for the pharmacist to explain why he should buy a whole strip and complete the recommended dosage. The loss in money because of buying extra tablets is low because the strip sizes are suitably restricted (maximum of 10; and 6, 4 or 2 for costlier drugs). Presently, in some locations, a patient is expected to buy a whole strip, whether prescribed or not, whether cheap or costly.
Con... page 9
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FEB, 1-15, 2008
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PATIENT EDUCATION SECTION may hurt your child. For example, do not give a child more than one medicine that has an antihistamine.
PUBLIC HEALTH ADVISORY Nonprescription Cough and Cold Medicine Use in Children FDA Recommends that Over-theCounter (OTC) Cough and Cold Products not be used for Infants and Children under 2 Years of Age FDA has completed its review of information about the safety of overthe-counter (OTC) cough and cold medicines in infants and children under 2 years of age. FDA is recommending that these drugs not be used to treat infants and children under 2 years of age because serious and potentially life-threatening side effects can occur. FDA’s recommendation is based on both the review of the information we received about serious side effects in children and the discussion and recommendations made at the October 18–19, 2007, public advisory committee meeting at which this issue was discussed. FDA strongly supports the actions taken by many pharmaceutical manufacturers to voluntarily withdraw cough and cold medicines that were being sold for use in this age group.
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Carefully following the directions in the DRUG FACTS part of the label. These directions tell you how much medicine to give and how often you can give it.
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Only using the measuring spoons or cups that come with the medicine or those made specially for measuring drugs. Do not use common household spoons to measure medicines for children since household spoons come in different sizes and are not meant for measuring medicines.
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Choosing OTC cough and cold medicines with childproof safety caps, when available, and store the medicines out of the reach of children.
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Understanding that using OTC cough and cold medicines are intended only to treat your child’s symptom(s). OTC cough and cold medicines do not treat the cause of the symptoms or shorten the length of time your child is sick. They only relieve symptoms and make your child feel more comfortable.
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Not using these products to sedate your child or make children sleepy.
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Calling a physician, pharmacist, or other healthcare professional if you have any questions about using cough or cold medicines in children 2 years of age and older.
FDA has not completed its review of information about the safety of OTC cough and cold medicines in children 2 through 11 years of age. We are aware of reports of serious side effects from cough and cold medicines in children 2 years of age and older. FDA is committed to completing its comprehensive and thorough review of the safety of OTC cough and cold medicines in children 2 years of age and older as quickly as possible and expects to communicate our recommendations to the public in the near future.
Not For Infants and Children Under 2 Years of Age Questions and Answers for Consumers
Pending completion of FDA’s ongoing review, if parents and caregivers use OTC cough and cold medicines in children 2 years of age and older, FDA recommends:
Most of the time, a cold will go away by itself. If you are concerned about making your child feel more comfortable, talk with your doctor about what approaches to take.
◆
◆
Checking the “active ingredients” section of the DRUG FACTS label. This will help you understand what “active ingredients” are in the medicine and what symptoms each active ingredient is intended to treat. Cough and cold medicines often have more than one “active ingredient” (such as an antihistamine, a decongestant, a cough suppressant, an expectorant, or a pain reliever/fever reducer). Being very careful if you are giving more than one OTC cough and cold medicine to a child. Many OTC cough and cold medicines have more than one “active ingredient.” If you use two medicines that have the same or similar “active ingredients” a child could get too much of an ingredient which
PhaRMeD TRADE NEWS
OTC COUGH AND COLD PRODUCTS
Q. What is FDA recommending about use of over-the-counter cough and cold products for infants and children under 2 years of age? A. FDA strongly recommends that over-the-counter (OTC) cough and cold products should not be used for infants and children under 2 years of age because serious and potentially life-threatening side effects could occur. Q. What are these side effects? A. There are a wide variety of serious adverse events reported with cough and cold products. They include death, convulsions, rapid heart rates, and decreased levels of consciousness.
FEB, 1-15, 2008
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Q. What ingredients may cause these effects, and what should I look for on the label to tell if these ingredients are present in an OTC product? A: OTC cough and cold products include these ingredients: decongestants (for unclogging a stuffy nose), expectorants (for loosening mucus so that it can be coughed up), antihistamines (for sneezing and runny nose), and antitussives (for quieting coughs). The terms on the label include “nasal decongestants”, “cough suppressants”, “expectorants” and “antihistamines.” Q. How did FDA arrive at its decision to issue these recommendations? A. FDA’s recommendation is based on the review of reports the agency has received about serious side effects, as well as a review of information presented at a joint Nonprescription Drugs and Pediatric Advisory Committee meeting on Oct.18-19, 2007. FDA has determined that OTC cough and cold medicines, which treat symptoms and not the underlying condition, have not been shown to be safe or effective in infants and children under 2. Q. Not effective? Does that mean they don’t work? A. FDA does not have any data to support that these products work in children less than 2 years of age. Q. My child has allergies. Does this alert affect the medicines for my child? A. This advisory relates only to the use of OTC products for the treatment of cough and cold.
A. No. This public health advisory does not include FDA’s final recommendation about use of cough and cold medicines in children ages 2 through 11 years. FDA’s review of the data for these age groups is continuing. The agency is committed to making a timely and comprehensive review of the safety of OTC cough and cold medicines in children. FDA plans to issue its recommendations on use of the products in children ages 2 to 11 as soon as the review is complete. Q. While FDA is completing its review for children ages 2 through 11, what should parents of children in this age group know about using cough and cold products? A. Giving too much cough and cold medicine can be dangerous. OTC cough and cold products can be harmful if more than the recommended amount is used, if they are given too often, or if more than one product containing the same active ingredient is being used. Parents need to be aware that many OTC cough and cold products contain multiple ingredients (for nasal congestion, cough, and fever). Giving more than one product could result in an overdose. There are many products that have similar names, so it is critical to identify the active ingredient(s) in the product, select the proper medicine, and use the correct dose. Reading the DRUG FACTS section of the label will help caretakers learn about what active ingredients are in the products. Also, children should not be given medicines that are packaged and made for adults.
Q. What should parents do if infants and children under 2 years of age experience cough and cold symptoms?
Pending completion of its review, FDA recommends these steps for consumers who use OTC cough and cold products in children 2 years of age and older:
A. A cold is a respiratory illness that is usually self-limited and lasts about a week. Cold symptoms typically include sneezing, coughing,
Check the “active ingredients” section of the DRUG FACTS label.
runny or stuffy nose, and sore throat. Children may also experience a fever. Most of the time, a cold will go away by itself. If you are concerned about making your child feel more comfortable, talk with your doctor about what approaches to take. Your doctor may recommend drinking plenty of fluids to help loosen mucus and keep children hydrated, and using saline nasal drops and gently suctioning mucus from the nose with a bulb syringe. Your doctor may also recommend fever reducers such as acetaminophen or ibuprofen. If your child’s cold symptoms do not improve or get worse, contact your doctor. A persistent cough may signal a more serious condition such as bronchitis or asthma.
Be very careful if you are giving more than one OTC cough and cold medicine to a child. If you use two medicines that have the same or similar “active ingredients,” a child could get too much of an ingredient which may hurt your child.
Q. Are particular products being recalled? A. No. This public health advisory does not mean that products are being recalled. In October 2007, the Consumer Healthcare Products Association (CHPA), on behalf of leading manufacturers of OTC cough and cold medicines, announced voluntary market withdrawals of OTC products for infants and children under 2 years of age. FDA strongly supports the actions taken by many manufacturers to voluntarily withdraw cough and cold medicines that were being marketed for infants. Q. Is FDA making a recommendation about whether cough and cold products should be used in age groups other than infants and children under 2 years of age at this time?
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Carefully follow the directions in the DRUG FACTS label. Only use the measuring spoons or cups that come with the medicine or those made specially for measuring drugs. Choose OTC cough and cold medicines with childproof safety caps, when available, and store the medicines out of reach of children. Understand that OTC cough and cold medicines do not cure or shorten the duration of the common cold. Do not use these products to sedate your child or make children sleepy. Call a physician, pharmacist, or other healthcare professional if you have any questions about using cough or cold medicines in children 2 years of age and older. For More Information FDA Public Health Advisory (January 17, 2008) www.fda.gov/cder/drug/advisory/cough_cold_2008.htm FDA Press Release (January 17, 2008) www.fda.gov/bbs/topics/NEWS/2008/NEW01778.html
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EGOTISM There was once a scientist who discovered the art of reproducing himself so perfectly that it was impossible to tell production from the original. One day he learnt that the Angel of Death was searching for him so he reproduced a dozen copies of himself. The Angel was at a loss to know which of the thirteen specimens before him was the scientist, so he left them all alone and returned to heaven. But not for long, for being an expert in human nature. The angel came up with a clever device. He said, “sir, you must be a genius to have succeeded in making such perfect reproductions of yourself. However, I have discovered a flaw in your work, just one tiny little flaw.” The scientist immediately jumped out and shouted, “Impossible! Where is the flaw?” “Right here,” said the Angel, as he picked up the scientist from among the reproductions and carried him off. Levels of Learning L1.A. While our skill takes us high, our ego pulls us down. B. At times our ego finds our end. L2.A. Share an incident where your ego let you down. B. Share an experience of someone known to you who had to pay a heavy price because of his ego. C. Share what ego means to you. L3.A. If your ego is the flaw in you, what prevents you from rectifying it? B. What is the nature of ‘ego’? C. Where does my ego come from?
BIRD FLU
STRESS MANAGEMENT THROUGH TRIBAL MEDITATION The first decade of the new millennium should be rightfully labelled as the "decade of stress". Rural folk in mofussil towns, even in India's most underdeveloped states are complaining of stress and are gulping down hundreds of rupees worth of anti-depressants, relaxants and sleeping pills in order to control their stress. However, most of these pill poppers do not seem to realize that allopathic medicines are no different from narcotics and sooner or later, these patients become addicted to these poisons, which slowly but surely destroy their victims. Initially, a single 100 milligrams tablet of valium is sufficient to put them to dreamless sleep but within a week, he needs two pills for getting the same effect and within a few months, he needs four. In a few years time, his medicine box resembles a chemist counter, as medical professionals prescribe him more coloured pills to prevent the side effects of the first pill! Acidity, diarrhoea, cough and allergic reactions are common side effects of simple aspirin which irritates the delicate lining of the stomach. All allopathic drugs used for combating stress, create more problems than they solve. This is
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the simple reason for the continued existence of stress among the population inspite of soaring profits of pharmaceutical companies. No wonder, the industry itself has phrased these poisons as drugs! They are drugs in the truest sense, as they destroy the economic as well as mental health of patients. This explains the reason behind countries with the highest per capita consumption of allopathic drugs also have the highest per capita rate of violent crimes! For every pill you pop, you have to take several others. Be prepared to take an anti-ulcerant and an anti-diahorreal with aspirin. 90% of American medical professionals agree that they would not take anti-depressants themselves if suffering from depression. Why are tranquilisers and allopathic medicines ineffective? These sleep inducing drugs mimic the action of natural neurotransmitters to create a false sense of calm. All allopathic drugs treat the physical body as medical science has no knowledge about the astral body. * Every human being spends approximately eight hours daily in sleep. This means that we spend one third of our lives sleeping. A 90 year old man has effectively slept for 30 years! When a normal man sleeps, he sees between two to four dreams in the rapid eye movement (REM) phase of sleep. These dreams may last from five to fifteen minutes each or longer. Dreams are a very important need of the astral body. Unless a sleeper sees dreams, his physical body and astral body are in disharmony and this disharmony is a major cause of stress! All allopathic anti-depressants, sleeping pills and tranquilisers put the physical body into dreamless sleep or sedation. That is why such drugs are also known as sedatives. This kind of drug induced dreamless sleep increases the disharmony between the physical and astral bodies. Thus, the physical body is sleeping, but the astral body is not experiencing dreams. This creates disharmony and this results in stress! Thus after a person wakes up from his drug induced dreamless sleep, he feels more stressful and the more sedation is needed. This creates a vicious cycle and increases the patient's dependence on these poisonous pills. Thus, these drugs provide temporary relief to patients but is ineffective in reducing stress levels. No wonder, .S. medical professionals refuse to take allopathic stress relievers themselves, as they have updated their knowledge by accepting the existence of the astral body. If allopathic medicine increases stress then what are effective solutions for stress management? The answers are simple. Physical stress can be controlled by regular exercise. Laughter is a powerful anti-stress agent, as laughter stimulates the brain to secrete natural neurotransmitters and endorphins. Listening to ancient tribal music (especially the soothing sound produced by tribal bamboo flute) and natural sounds of cascading mountain streams induce a state of trance and facilitate deep dreamful sleep. An ice cold water shower before sunrise. Long barefoot walks in the park, or at the beach. Surya namaskar. Yoga. These are highly effective tools to reduce physical stress. * Mental stress can be controlled by creative visualization, Zen meditation, affirmations and ZeNeuro-Linguistic Programming (ZeNLP). Combining Zen meditation followed by NLP visualizations is one of the most powerful techniques to reduce mental stress. One of the most recent research findings to control mental stress is tribal meditation or meditation techniques to connect with cosmic consciousness. Tribal meditation is a technique employed by most primitive tribes, living in inaccessible terrains over centuries, in countries as diverse as India, Mexico, Indonesia and Peru. to cope with mental and spiritual stress. One needs a small coin to practice tribal meditation. The coin is placed on the agnya charka ( where Hindu women wear the bindi) and pressed into the forehead till the coin sticks to the forehead and remains there. The attention of our unconscious mind focuses on the coin and this activates the pineal gland situated behind the agnya charka. As long as the coin rests on the forehead, it activates the subtle energy centres of the astral body and reduces mental stress! Tribal coin meditation is a common feature among tribes across continents and these tribes had no physical contact with each other! These ancient stress management techniques are as effective today, as they were for the pharaoh's of Egypt. Tribal meditation is the result of thousands of years of close experiences with nature, passed over generations through experiential learning. By undergoing tribal meditation, one is reliving the experience of the ancestors of present day most primitive tribes. The fact that these experiences have survived thousands of years inspite of no written documentation, among extremely vulnerable circumstances and continue to exist today means that these techniques merit investigation. They need to be researched and practiced. Most importantly, we need to incorporate tribal meditation into our daily regimen to combat stress. Murli Menon is President of phenomenon consultants inc., Ahmedabad. For further queries about phenoMenon's management development workshops based on tribal meditation, contact Murli Menon at@ zenlp@rediffmail.com
FEB, 1-15, 2008
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A FEW EXAMPLES HOW THE STRIP SIZE CAN BE DETERMINED: Drug/Formulation
Present strip size
Pyrantek Pamoate
2,3
Dosage varies from 1-3 tablets, depending on the body weight of thepatient; hence strip has to be cut many of the times.
1
Secnidazole 500mg/lg
2,4
Doctors prescribe any number from 1 – 4.
2
Tinidazole 300, 500, 1000 mg
2,4,10
Difficulty Faced
Recommended Strip Size
Doctors prescribe and patients demand any number from 2 to 20, making strip cutting inevitable most of the times.
2-for 1G 4-for 300,500mg
Reason To overcome the difficulties stated.
Same as above Same as above
Griseofulvin tab 250mg, 500mg
10
Pharmacist is forced to cut for various reasons.
10 (and disallow strip cutting)
There is no need for smaller strip size as this is a drug, which needs long-term therapy of at least a few week. Also price is quite affordable
Iron, Folic Acid
10,15,20,30,40
Pharmacist is forced to cut strip for various reasons.
10
These require therapy of at least 15-20 days, besides are not very costly
10
Needs long term therapy, and majority of patients needed therapy find it affordable to buy a strip of 10 at a time.
Simvostatiin, Lovastatin, Gemfibrozil
7,10,25
Pharmacist is forced to cut strip for various reasons.
Cephalexin, Amoxycillin (125,250,500 mg)
4,6,10,12,15
Pharmacist is forced to cut strip for various reasons.There are weird dosing by quacks and even some doctors, such as 13 capsules ??.
Ampicillin (125,250,500 mg)
4,8,10,15
Pharmacist is forced to cut strip for various reasons
Ciprofloxacin 250, 500 mg
4,6,10
Pharmacist is forced to cut strip for various reasons
6
4
For reasons similar to Amoxycillin (above) (generally q.i.d. dosing)
4
Ideal would be a strip of 10 (b.i.d for 5 days), for possibility of discontinuation due to adverse effects, and high cost, strip of 4 is more practical.
4 Lomefloxacin
Farmotidine
10
14 (Schedule P)
Pharmacist is forced to cut strip for various reasons Not practical to fix it at 14. Doctors are prescribing it more as a prophylactic for peptic ulcer for patients co-prescribed, NSAIDs and the quantity varies from 2-30. Even though Famotidine is cheap, the patient demands a cut strip.
Ideal would be to have a strip size of 15 to ensure that the patient completes the dose once he buys/pays for it. However, if there, are adverse effects, and premature discontinuation needed, the rest of the money would be a loss to the patient. Therefore, 6 could be more practical.(generally t.i.d. dosing)
Dose is once a day for 5-10 days.Cost is also relatively high.
10
For reasons stated.
Sudden orders form the FDA enforcing Maharashtra chemists to cut strips without doing a detail study of the matter, will only create unrest amongst the retailers. Such a sensitive issue needs deeper probe, analysis, views, hands on experience, and a neutral mind. Laos, the authorities need to give top priority to the safety of the health of the population, giving it more importance, than merely looking into monetary aspects. In the best interest of the public, as well as the retailers, it is strongly recommended that the concerned authorities seriously look into the matter, and after taking a opinion of a larger section of pharmacists, doctors, common man, NGOs working in health field, and the trade organizations, get into action, and frame new policies regarding pack sizes and overcome the problem of strip cutting.
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ABSTRACTS RETAIL PHARMACIES IN DEVELOPING COUNTRIES: A BEHAVIOR AND INTERVENTION FRAMEWORK. Goel P, Ross-Degnan D, Berman P, Soumerai S.
limits. Although alpha-HCH and gamma-HCH were present in almost all the samples, but other pesticides were not detected in these samples. DDT and DDE were found only in two samples.
Department of Ambulatory Care and Prevention, Harvard Medical School and Harvard Community Health Plan, Boston, MA 02115, USA.
PMID: 17922233 [PubMed - as supplied by publisher
Retail pharmacies in developing countries are one of the most important sources of advice on pharmaceuticals. Among the reasons the clients give are ease of access; availability of medicines; quality of service (no waiting and convenient hours of operation); and cheaper products, availability of credit, or the option to buy drugs in small amounts. However, the appropriateness of prescribing by retail pharmacy staff has been found to be far from acceptable. In childhood diarrhea, for example, oral rehydration salts (ORS), the appropriate diarrhea treatment, are recommended much less than pharmaceuticals of limited value, such as antimotility agents, adsorbents, etc. Little information is available for reasons underlying such behaviors. In this paper, we present a conceptual framework in which to analyze factors that may affect retail pharmacy prescribing, and we suggest strategies for behavior change. We developed this framework after examining relevant literature on retail pharmacy prescribing. We propose that pharmacy factors, client factors, physician practice and regulatory factors are the four sets of important factors for understanding pharmacy prescribing behavior. For intervention, we present four types of interventions which could be used for changing the behavior of pharmacy staff: information alone, persuasion, incentives and coercion. The behavior and intervention frameworks presented in this paper should also help in guiding further research in this area. For example, new information on the effects of ownership type, availability vs actual role of professional staff and authority structure on pharmacy treatment behaviors would be useful areas for future research. Similarly, additional research is needed on the comparative effects of coercive, persuasive and incentive strategies on pharmacy treatment behaviors.
1: Int J Tuberc Lung Dis. 2002 Feb;6(2):171-3. Links
PMID: 8737433 [PubMed - indexed for MEDLINE]
PMID: 11931419 [PubMed - indexed for MEDLINE]
TOXIC METALS AND ORGANOCHLORINE PESTICIDES RESIDUE IN SINGLE HERBAL DRUGS USED IN IMPORTANT AYURVEDIC FORMULATION - ‘DASHMOOLA’
Rai V, Kakkar P, Singh J, Misra C, Kumar S, Mehrotra S. Society of Ethnobotanists, National Botanical Research Institute, Lucknow, 226001, India, vartikarai@rediffmail.com. Herbal formulations are getting popularity throughout the world and commercialized extensively for various medicinal properties. WHO has emphasized the need for quality assurance of herbal products, including testing of heavy metals and pesticides residues. ‘Dashmoola’, a popular herbal formulation, with immunomodulator and febrifugal properties, consists of ten single root drugs. In view of WHO guidelines, single herbal drugs used in ‘Dashmoola’, were collected from different places of India for testing heavy metals and persistent pesticides residue. Although use of roots in ‘Dashmoola’ is prescribed in original ayurvedic literature but now many pharmacies use stem in place of roots. Therefore, in the present study both roots and stems were selected for estimation of six heavy metals namely arsenic (As), mercury (Hg), lead (Pb), cadmium (Cd), chromium (Cr) and nickel (Ni). Apart from these, the organochlorine pesticides residue viz. different metabolites of DDT, DDE, isomers of HCH and alphaendosulfan were checked in total 40 samples of single crude drugs. Heavy metals except Hg, were present in most of the samples. In few samples Pb and Cd concentration were beyond the WHO permissible
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PRIVATE PHARMACIES IN TUBERCULOSIS CONTROL—A NEGLECTED LINK. Rajeswari R, Balasubramanian R, Bose MS, Sekar L, Rahman F. Tuberculosis Research Centre, Indian Council of Medical Research, Chetput, Chennai. res_dismn_wkshp@yahoo.com In most settings in India, private pharmacies dispense prescriptions for anti-tuberculosis drugs made out by private practitioners. In a crosssectional study, we assessed the dispensing practices for tuberculosis and knowledge about the national tuberculosis programme of 300 pharmacies. In all, 2800 prescriptions were dispensed monthly by the pharmacies. Doctors’ prescriptions were for durations of several months, but half of the patients bought drugs one dose at a time for self-administration. This practice might promote drug resistance. Although 95% of pharmacists were not aware of the existence of the tuberculosis programme, the majority (97%) were willing to learn and contribute towards tuberculosis control. The need and the potential of private pharmacies for participation in tuberculosis control are highlighted.
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Rajya Sabha Unstarred Question No.1976. Shri Raj Mohinder Singh Majitha: Shri Murli Manohar Josh: Answered on 7.12.2007 CP-127. 1976. A. a) & d): The 74 bulk drugs specified in the First Schedule of the Drugs (Prices Control) order. 1995 (DPCO 95) and the formulations based thereon are under price control and their prices are fixed/revised by the National Pharmaceutical pricing Authority (NPPA) in accordance with the provisions of the DPCO, 95. These bulk drugs have been kept under price control on the basis of criteria mentioned in Modification in Drug Policy, 1986” announced in September, 1994.
themselves keeping in view various factors like cost of production, marketing/selling expense, R&D expenses, trade commission, market competition, product innovation, product quality etc. Prices of these drugs are regularly monitored and corrective measurers taken where public interest is found to be adversely affected. As a result of Government’s efforts, Pharmaceutical Industry had voluntarily agreed to reduce prices of 886 formulations. However, the availability of these formulations of reduced prices varies from State to State. The Drug Policy as announced from time to time is directed towards making available quality at reasonable prices to the poor.
Prices of non-scheduled formulations are fixed by the manufacturers themselves keeping in view the various factors like cost of production, marketing / selling expenses, R&D expenses, trade commission, market competition, product innovation, product quality etc. The government takes corrective measures where the public interest is found to be adversely affected. The Government has delegated powers to the National Pharmaceutical Pricing Authority (NPPA) for fixation of prices of non-scheduled formulations under para 10 (b) of Drugs (Prices Control) order, 1995 (DPCO 95). Further, Government has also reduced the permissible price increase limit in 12 calendar months from 20 per cent to 10 per cent for more effective check on price increases. The monitoring of prices of non-scheduled formulations is currently on the basis of data from ORG-IMS. Based on in-house data-based analysis by NPPA of ORG IMS DATA for the period December, 1994 to July 2007, it has been observed that the prices of 15 top medicines of 15 top bulk drugs which went out of price control consequent to the promulgation of PPCO 95, have gone up by 9.65% annually.
Minister of State in the Ministry of Chemicals & Fertilisers and Minister of State in the Ministry of Parliamentary Affairs (Shri B.K. Handique) Smuggling of Medicine Out of the Country Q. Will the Minister of Finance be pleased to state: a) Whether cough syrups like corex of M/s Pifzer and Phensedyl of M/s Nicholas Piramal are being smuggled to Bangladesh; b) If so, the complete details thereof along with cation taken/being taken thereon; c) Whether some other countries have also informed the Government in regard to this; and d) If so, details thereof? Lok Sabha Unstarred Question No. 3137. Ch. Munawar Hassan: Answered on 7.12.2007. 3137.
Minister of State in the Ministry of Chemicals & Fertilisers and Minister of State in the Ministry of Parliamentary
A. a) to b): Yes, Sir. The details of case of seizure of Phensedyl and Corex syrup by Customs field formations are as follows: (Rs. In lakhs)
Affairs (Shri S.K. Handique) Prices of Medicines
Year
Q. Will the Minister of Chemicals & Fertilisers be pleased to state: a) Whether it is a fact that Government has reduced the prices of some medicines; b) If so, the names of the medicines and name of the manufacturing companies; c) Whether Government’s attention has also drawn that 50 per cent of these medicines are not available in the market after reduction of prices; and d) What septs are being taken to ensure the availability of these medicines in the market?
2004 - 2005 2005 - 2006 2006 - 2007 2007 - 2008 (upto Oct. 07)
Brand Name of the cough Syrup
No.of seizure cases
Value
Corex Phenesedyl Corex Phenesedyl Corex Phenesedyl Corex Phenesedyl
02 341 01 455 26 602 23 438
0.70 48.63 0.05 58.64 2.40 90.90 0.76 34.97
Rajya Sabha Unstarred Question No.1977. Shri Uday Pratap Singh: Answered on 7.12.2007 CP-128. 1977. A. a) to d): The prices of 74 bulk drugs specified in the First schedule of the Drugs (prices control) order, 1995 (DPCO, 95) and the formulations based thereon are controlled in accordance with the provisions of the DPCO, 95 by the National Pharmaceutical Pricing Authority (NPPA). Fixation/revision of prices of bilk drugs and formulations is an on-going exercise undertaken by the NPPA. Prices of non-scheduled formulations are fixed by the manufactures
Appropriate action has been initiated against the offenders under the Customes Act, 1962 and NDPS Act, 1985. The field formations have been directed to keep constant vigil to curb smuggling of cough syrup along the international border, Bilateral agreement between India and Bangladesh has been signed for mutual cooperation on drug related matters. c) No, Sir. d) ‘Nil’ In view of (c) above Minister of State in the Ministry of Finance (Shri S.S. Palnimanickam)
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POSTAL LIC NO : HSE-806/2006-08
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The secret is to learn how to manage yourself. This book will teach you time management, knowledge management, and relationship management skills, so that you can become a more productive, happier and more successful doctor. This 300 page book is packed with information, gleaned from many years of practice. You can apply this immediately to your own practice, and start flourishing ! The secret is to learn how to manage yourself. This book will teach you time management, knowledge management, and relationship management skills, so that you can become a more productive, happier and more successful doctor. This 300 page book is packed with information, gleaned from many years of practice. You can apply this immediately to your own practice, and start flourishing !
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