DRUGS REGULATORY
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DRUGS REGULATORY DRUGS REGULATORY Document Transcript

  • I. Regulatory Affairs REGULATORY AFFAIRS Various laws and ethics govern pharmacy operations. While the laws are the legal framework within which a pharmacy and its personnel can operate, ethics are professional regulations, which govern a pharmacist in operating a pharmacy. This module highlights the various legal compulsions that are binding upon pharmacists with regard to the various categories of medicines, handling of prescriptions, dispensing, keeping records, and operating in this framework by implementing Good Pharmacy Practice. AIMS OF THIS MODULE: Ø To discuss the various legal aspects/ regulatory affairs related to dispensing in community pharmacy practice. Ø To illustrate the need to adhere to the laws. OBJECTIVES: By the end of this module, pharmacists will be able to describe § The laws related to pharmacy practice in India. § The importance of adhering to these laws. § Different categories of medicines § How to tackle emergency supplies. § Other legal aspects of dispensing This module has been grouped into the following sections to allow the free and easy flow of information. 1. Laws related to Community Pharmacy 1.1 The Drugs and Cosmetics Act, 1940 and Rules, 1945 1.2 The Narcotic Drugs and Psychotropic Substances Act and Rules, 1985. 1.3 Drugs Price Control Order, 1995 1.4 Consumer Protection Act, 1986 1.5 Infant Milk Substitutes, Feeding Bottles and Infant Foods Act, 1992 1.6 Drugs and Magic Remedies Act and Rules, 1954. 1.7 Prevention of Food and Adulteration Act, 1954. 2. Code of ethics 3. Legal aspects in the dispensing process 3.1 Legality and authenticity of the prescription a) Doctor's details Good Pharmacy Practice - I.P.A. - C.D.S.C.O. - W.H.O. INDIA COUNTRY OFFICE -1-
  • I. Regulatory Affairs b) Patient’s details c) Medicine details d) Other details i) Date ii) Refill information iii) Doctor's signature 3.2 Details of medicines and their legal requirements A. Schedules or categories of drugs a) Schedule H b) Narcotic Drugs and Psychotropic Substances c) Schedule X d) Schedule C and C (I) e) Schedule G f) Schedule K g) Schedule J h) Schedule P and P (I) i) Schedule Y B. OTC Medicines C. New Drug D. Veterinary medicines E. Brand substitution and bio-equivalence F. Indian systems of medicine and homoeopathy (ISM and H) G. Physician samples and ESIC medicines 3.3 Emergency supply of prescription medicines 3.4 Record keeping (i) Prescription Register (ii) Cash Memos (iii) Purchase Bills and Register (iv) Display of Licenses (v) Display of Registration Certificate 4. Presence of a pharmacist 5. Other aspects 1. LAWS RELATED TO COMMUNITY PHARMACY The legal aspects related to the retail purchasing, stocking and selling or dispensing products/ medicines in a pharmacy are prescribed and governed by various laws: • The Drugs and Cosmetics Act, 1940 and Rules, 1945. Good Pharmacy Practice - I.P.A. - C.D.S.C.O. - W.H.O. INDIA COUNTRY OFFICE -2-
  • I. Regulatory Affairs • The Narcotic Drugs and Psychotropic Substances Act and Rules, 1985. • Drugs Price Control Order, 1995. • Consumer Protection Act, 1986. • Infant Milk Substitutes, Feeding Bottles and Infant Foods Act, 1992. • Drugs and Magic Remedies Act and Rules, 1954. • Prevention of Food and Adulteration Act, 1954. These Acts have been devised because purchasing, stocking and dispensing the right medicines directly affect a patient's treatment or health. A slight error could become a matter of life and death for the patient. All pharmacists and other staff must thus ensure that the entire pharmacy operates within the legal framework of these laws. Need to adhere to laws Adhering to laws is essential for providing optimum health care by minimizing errors. Thus, carrying out duties according to the laws highlights professionalism, and wins the respect and confidence of the public/ or of clients. Laws regulate and lay down standards of conduct for the pharmacy trade/ profession. Legislation ensures that the patients receive drugs of required quality, tested and evaluated for safety as well as efficacy for the intended use. 1.1 The Drugs And Cosmetics Act, 1940, And Rules, 1945 The Drugs and Cosmetic Act, 1940, was enacted to regulate the import, manufacture, sale and distribution of drugs and cosmetics. The Act includes laws governing the setting up and operation of a pharmacy. The emphasis of the Act is on self-regulation, but it can also be an effective tool in the hands of the regulatory agencies for quality management through licensing, periodic inspections to assess the extent of compliance, and initiating steps to continuously enhance the degree of compliance. The Act intends to: 1. Prevent manufacture and distribution of substandard drugs. 2. Control the manufacture, sale and distribution of drugs and ensure standard and quality drugs. 3. Monitor the licenses of premises from which medicines are sold/ distributed. 4. Bring cosmetics in its purview, to regulate their import, manufacture, distribution and sale. 1.2 Narcotic Drugs And Psychotropic Substances Act And Rules, 1985 This Act, has been enacted: Good Pharmacy Practice - I.P.A. - C.D.S.C.O. - W.H.O. INDIA COUNTRY OFFICE -3- View slide
  • I. Regulatory Affairs Ø To consolidate and amend the law relating to narcotic drugs and psychotropic substances, Ø To make stringent provisions for the control and regulation of operations relating to narcotic drugs and psychotropic substances, Ø To provide for the forfeiture of property derived from, or used in, illicit traffic in narcotic drugs and psychotropic substances, Ø To implement the provisions of the International Convention on narcotic drugs and psychotropic substances, and for matters connected therewith. 1.3 Drugs (Prices Control) Order, 1995 The Drugs Prices Control Order, 1995, is an order that lays down rules with respect to the fixation of prices of bulk drugs and formulations. The Order covers details like Ø Fixation of maximum sales prices of bulk drugs Ø Calculation of retail price of formulations Ø Fixation of retail price and ceiling price of scheduled formulations Ø Maintenance of records Ø Penalties for contravention of provision of the Order Ø Other details The Drugs Price Control Order controls the prices of medicines, trying to make them available at fair prices. 1.4 The Consumer Protection Act, 1986 The Consumer Protection Act, 1986, is a milestone in the history of the socio-economic legislation in the country. It is one of the most progressive and comprehensive pieces of legislation enacted for the protection of consumers. Ø The main objective of the Act is to provide better protection of the consumers. Ø The Act intends to provide simple, speedy and extensive redress of the consumer's grievances. Ø The Act enshrines certain rights of the consumers and provides for the setting up of Consumer Protection Councils in the Centre and the states. The objective of these Consumer Protection Councils will be to promote and protect the rights of the consumers. The salient features of the Act are summed up as under: § The Act applies to all goods and services unless specifically exempted by the Central Government. Since a pharmacy provides goods and services, it is also covered under this Act. § It covers all the sectors whether private, public or cooperative. Good Pharmacy Practice - I.P.A. - C.D.S.C.O. - W.H.O. INDIA COUNTRY OFFICE -4- View slide
  • I. Regulatory Affairs § The provisions of the Act are compensatory in nature. § It enshrines the following rights of the consumers: i. The right to be protected against the marketing of goods, which are hazardous to life and property. ii. The right to be informed about the quality, quantity, potency, purity, standard and price of goods so as to protect the consumer against unfair trade practices. iii. The right to be assured, wherever possible, access to a variety of goods at competitive prices iv. The right to be heard and to be assured that the consumer’s interests will receive due consideration at appropriate forums. v. The right to seek redress against unfair trade practices or unscrupulous exploitation of consumers, and vi. The right to consumer education. 1.5 The Infant Milk Substitutes, Feeding Bottles And Infant Foods (Regulation Of Production, Supply And Distribution) Act, 1992 This Act provides for the regulation of production, supply and distribution of infant milk substitutes, feeding bottles and infant foods with a view to protect and promote breastfeeding and ensure the proper use of infant foods. Under this Act, “Health care system” means an institution or organization engaged, either directly or indirectly, in health care for mothers, infants or pregnant women, and includes health workers in private practice, in a pharmacy, in a drug store and any association of health workers According to this Act, no pharmacy should :- 1. Advertise, or take part in the publication of any advertisement, for the distribution, sale or supply of infant milk substitutes, infant foods or feeding bottles. 2. Give an impression or create a belief in any manner that feeding of infant milk substitutes and infant foods are equivalent to, or better than, mother's milk. 3. Take part in the promotion of infant milk substitutes, infant foods or feeding bottles. 4. Supply or distribute samples of infant milk substitutes or feeding bottles or infant food gifts of utensils or other articles. 5. Offer inducement of any other kind. 6. Use any health care system for displaying placards or posters relating to, or for the distribution of, materials for the purpose of promoting the use or sale of infant milk substitutes, infant foods or feeding bottles. 7. Demonstrate feeding with infant milk substitutes or infant foods to a mother of an infant or to any member of her family, except through a health worker. The health worker must clearly explain to the mother or to another member, the hazards of improper use of infant milk substitutes, infant foods or feeding bottles. 8. Fix the remuneration of any employee or give any commission to such employee on the basis of the volume of sale of such substitutes or bottles made by such employees. Good Pharmacy Practice - I.P.A. - C.D.S.C.O. - W.H.O. INDIA COUNTRY OFFICE -5-
  • I. Regulatory Affairs 9. Sell or otherwise distribute any infant milk substitute, infant foods and feeding bottles unless they conform to prescribed standards. 1.6 The Drugs And Magic Remedies (objectionable Advertisements) Act, 1954 This Act is enacted with a view to prevent objectionable and misleading advertisements in order to discourage self medication and self treatment, especially with regard to certain diseases of serious nature listed in the Act that can have a deleterious effect on the health of the community, and may affect the well being of the people. . The Drugs and Magic Remedies Act prohibits a person, from taking part in the publication of any advertisement referring to any drug which suggests the use of the drug for: a. Procurement of miscarriage of women, or prevention of conception in women. b. Maintenance or improvement of the capacity of human beings for sexual pleasure. c. The correction of menstrual disorder in women. d. The diagnosis, cure, mitigation, treatment or prevention of any venereal disease. This Act prohibits directly or indirectly giving a false impression regarding the true character of the drug, making a false claim for it, or conveying any false or misleading information about it. 1.7 Prevention Of Food And Adulteration Act 1954 The Act makes provision for the prevention of adulteration of food. The Prevention of Food and Adulteration Act is a social welfare legislation enacted to curb the widely spread evil of adulteration of food products endangering national health and human life. The Act covers details including Ø General provisions as to food. Ø Analysis of food. Ø Public analysts and inspectors Ø Packing and labeling of foods Ø Prohibition and regulation of sales Ø Additives present Ø Other details 2. CODE OF ETHICS Pharmacists are also bound by a Code of Ethics, generally laid down by the professional body, that regulates the profession in that particular state/country. In India, the Code of Ethics for the pharmacy profession is laid down by the Pharmacy Council of India. These ethics are enclosed as Annexure III. Good Pharmacy Practice - I.P.A. - C.D.S.C.O. - W.H.O. INDIA COUNTRY OFFICE -6-
  • I. Regulatory Affairs A Code of Ethics is a carefully formulated system of principles or rules of practice for the guidance of the members of the profession. It outlines the rules or the principles to be observed by the pharmacist while dealing with the job, with the public, with his fellow pharmacists and with other health professionals. Standards of professional conduct for the pharmacy profession are necessary in the public interest to ensure efficient pharmaceutical service. The pharmacist is responsible for safeguarding the health of the public and should keep this in mind while handling, selling, distributing and dispensing medicines and related products. Pharmacists should observe both, laws and ethical principles to maintain the standard of their profession. 3. LEGAL ASPECTS IN THE DISPENSING PROCESS In this section, we shall consider the different aspects, concerning allopathic medicines. (Medicines of other systems of medicine are dealt with in section 3.2) 3.1 Legality and Authenticity of a Prescription. A Prescription is a very important, legal document, required at all stages of dispensing of prescribed medicines. A prescription is said to be legal and complete when it is written by a Registered Medical Practitioner (R.M.P) * and contains all the essential information, with regard to parts of prescription. According to the Drugs and Cosmetics Act, a prescription should: Ø Be in writing and be signed by the Registered Medical Practitioner (R.M.P) with his usual signature and be dated by him. (In today's advanced world, a typed or computer printed prescription may be accepted, provided it is personally signed with usual signature and dated by the prescriber) Ø Specify the name and address of the person for whose treatment it is given, (or the name and address of the owner of the animal if the drug is meant for veterinary use). Ø Indicate the total amount of the medicine to be supplied and the doses to be taken. Good Pharmacy Practice - I.P.A. - C.D.S.C.O. - W.H.O. INDIA COUNTRY OFFICE -7-
  • I. Regulatory Affairs CHECKLIST Pharmacists are expected to verify the legality, genuineness and completeness of a prescription before dispensing it. With respect to the various parts of a prescription, the following aspects must be looked at. ( a) Doctor's details: The prescription must be prescribed by a R.M.P. *Definition of a R.M.P. : The Drugs and Cosmetics Rules, 1945, define a R.M.P as a person a) Holding a qualification granted by an authority specified or notified under Indian Medical Degrees Act 1916 (Schedule 3), or specified in the schedules to the Indian Medical Council Act, 1956, or b) Registered or eligible for registration in a medical register of a State meant for the registration of persons practicing the modern scientific systems of medicines (excluding Homoeopathic system of medicine). c) Registered in a medical register (other than for Homoeopathic Practitioners) of a state, who although not falling within a) and b) is declared by a general or specified order made by the State Government. in this behalf as a person practicing the modern scientific system of medicine for the purpose of this Act, or d) Registered or eligible for registration in the register of dentists for a state under the Dentists Act, 1948, or e) Who is engaged in the practice of veterinary medicine, and who possesses qualifications approved by the State Government. In simple terms, a R.M.P. means an allopathic doctor with a valid medicine degree (M.B.B.S) to practice the allopathic system of medicine, or a dentist (B.D.S. - Bachelor of Dental Sciences) or a veterinary doctor (B.V.Sc - Bachelor of Veterinary Sciences) with qualifications approved by the State Government, the respective Medical Council, and registered in the State Medical Register in which he practices & having a registration number. BE CAREFUL… The connotation/abbreviation 'R.M.P.' is often a misnomer, and often misused by quacks. Some unrecognized/fake universities offer fake certificates/degrees, by taking certain fees. Such degrees are often given the connotation 'R.M.P.’(which could mean anything, e.g. Rural Medical Practitioner) and also a registration number (which is fake/ illegal). Good Pharmacy Practice - I.P.A. - C.D.S.C.O. - W.H.O. INDIA COUNTRY OFFICE -8-
  • I. Regulatory Affairs Cross prescribing As per the Supreme Court judgement, a medical practitioner from one system of medicine can neither practice nor prescribe medicines from another system of medicine. Thus, by law, an Ayurvedic or Homoeopathic doctor cannot prescribe allopathic medicines, and an Allopathic doctor cannot prescribe Ayurvedic or Homoeopathic medicines. Therefore, by law, a pharmacist cannot honour/ dispense a medicine/ prescription for allopathic medicines, written by a Homoeopathic, Ayurvedic, Siddha, or Unani practitioner. Activity Organize a debate between fellow pharmacists and doctors on 'Cross-prescribing' in the context of different systems of medicines co-existing in India. 1 üWHAT TO CHECK? ü Doctor’s The pharmacist should ü CHECK the These are details that 2 confirm that the doctor is 3 authorized to prescribe. It ü Doctor’s rules out the possibility of a ü Doctor’s fake prescription prescribed by an unauthorized person. Dr. Kiran Shah M.B.B.S Incomplete information Dr. Kiran Shah M.B.B.S Correct way Reg.No. – MMC 2314 Good Pharmacy Practice - I.P.A. - C.D.S.C.O. - W.H.O. INDIA COUNTRY OFFICE -9-
  • I. Regulatory Affairs ü Also check The doctor's address, and telephone numbers further help to assess the authenticity, and also aids to track the doctor if a clarification is needed. These details about the doctor are generally printed on the prescription (and called as a 'Prescription Blank') The final confirmation about the authenticity of the prescription comes from the doctor's handwriting. A prescription of a doctor, which repeatedly comes to the pharmacy, is generally recognized by the pharmacist and other salespersons, by regular reading and experience receiving the same handwriting. *Important BE ALERT!! Please keep a watch/ check that people are not misusing prescription blanks that may have somehow fallen into their hands. Addicts often try to steal prescription blanks and write the prescription themselves to buy habit-forming drugs. If you come across such a prescription, immediately telephone the concerned doctor and inform him/her about the misuse of his/ her prescription blank. The doctor can then be more careful about his/ her blanks. (b)Patient's details: Check the prescription for: - This ensures that the right patient receives the prescribed medicines. It also makes it easier when the doctor’s opinion has to ü Patient’s full be asked over the phone. It is a requirement by law, and also needs to be entered on the bill. ü Patient’s age/ This is not mandatory, but it is a useful piece of information. It is important to assess the correctness of dose and type of dosage form. This may be especially important in pediatric and geriatric patients. ü Patient’s This is essential for follow-up or to get in touch with the patient in case of prescribing or dispensing errors. Besides, it is a legal requirement. It is important to assess the ü Patient’s sex appropriateness for the patient (e.g. pregnancy, breastfeeding) Good Pharmacy Practice - I.P.A. - C.D.S.C.O. - W.H.O. INDIA COUNTRY OFFICE - 10 -
  • I. Regulatory Affairs For, Mrs. Rachana Gupta F/36 yrs. Wt. 56 kg Correct way H. No. 23/D, Behind Peerless Hospital, Kolkatta. Tel. No. 26262220 For, Incorrect/ Mrs. Gupta insufficient information * If the prescription is for an animal, the name of the animal is not required but the name and the address of the owner should be stated on the prescription. However, all veterinary prescriptions should include the type of animal and, ideally, the weight of the animal. For, Dog (Rocky) of Breed : Alsation Anand Verma, 24 kg. 1/12, Lodhi Street, Delhi. (c) Medicine details: - The pharmacist should give special attention to the details of the prescribed medicines to ensure accurate dispensing. (* This aspect is dealt with in detail in the Module on 'Dispensing') Capsules. Omez 20mg............ (10) 1—0—0 x 10 days Take 1 capsule 1 hour before breakfast for 10 days § If you notice that any of the medicine details such as the strength have been overwritten, or are illegible or ambiguous, do not dispense without contacting the doctor. § If you notice that the quantity of medicines has been overwritten, be very careful because the patient may himself have made the change - with the intention of purchasing more than the prescribed quantity. This is especially a possibility in case of medicines of misuse/abuse. What should you check? Checklist: q Name of the medicine - either brand or generic (in case of doubt, or illegible handwriting always consult a senior pharmacist to avoid dispensing the wrong medicine due to reading error. If the name is not legible, or if you have a doubt, confirm with the doctor over the phone). q Strength or potency of the medicine (a drug may be available in more than one strength) - If the strength is illegible confirm with the doctor. If the strength is not written, it may be necessary to ask Good Pharmacy Practice - I.P.A. - C.D.S.C.O. - W.H.O. INDIA COUNTRY OFFICE - 11 -
  • I. Regulatory Affairs the doctor just in case an additional strength has been launched in the market and the pharmacist is not aware of it). q Dosage form (a drug could be available in the form of tablets, liquids, capsules, etc and it is important to confirm with the doctor which dosage form has been prescribed) q Dosage (the dosage prescribed varies for each individual depending on the patient's age, weight and severity of the condition. The dosage should be confirmed with the doctor if not written or not legible). q Dosing instructions (the instructions as to how and at what times of the day the medicines should be administered) q Total quantity (the total quantity mentioned indicates what quantity has to be dispensed. It also gives an idea of the duration of therapy that has been prescribed, and a clear idea of the dosage regimen). * The pharmacist should use and analyze the above information provided in the prescription to provide information and counseling to the patient, and to ensure compliance. Activity : Carefully scrutinize 10 prescriptions received by you, and check whether all the required details about the prescribed medicines are mentioned. (d) Other details: - i. Date: - The prescription should be dated by the prescriber. The pharmacist should üCHECK the date when the medicines were prescribed, as the date will mark the validity of the prescription. If the date indicates that the prescription is not fresh (not recently dated) and there is nothing mentioned about refill, then the pharmacist should use his personal judgement and reasoning to decide whether the prescription can be dispensed, depending on the medicines prescribed and the time that has elapsed since the prescription was written. A pharmacist, for example, may decide not to dispense an antibiotic prescription, which is not recently dated. In such cases, the patient should be politely advised to seek a new prescription from the physician. ii. Refill information: - A prescription should be refilled only if the doctor writes specific instructions saying so. Refill means getting the prescription dispensed (or filled) more than once by the pharmacist when so specified by the physician on the prescription. The physician advises a refill when he/she judges that the patient needs another course of the treatment after a particular/ specific interval of time. A prescription in which drugs listed under Schedule H (and Schedule X) have been prescribed, should have the refill information written by the doctor, stating whether the prescription has to be refilled or not (i.e. whether the patient has to take the same quantity of medicine again). The refill information should indicate the maximum number of times the prescription should be refilled and the intervals after which it should be refilled. Good Pharmacy Practice - I.P.A. - C.D.S.C.O. - W.H.O. INDIA COUNTRY OFFICE - 12 -
  • I. Regulatory Affairs • CHECK the prescription : ü Whether it is old, or recently dated ü Is already dispensed, or ü Whether there is any 'refill information' on it. A prescription which bears/ contains no refilling instructions by the prescriber SHOULD BE DISPENSED ONLY ONCE (SHOULD NOT BE DISPENSED MORE THAN ONCE) Guidelines for refilling a prescription By law, a person dispensing a prescription containing a drug specified in Schedule H (and Schedule X) should follow the guidelines given below: • Pharmacists should refill prescriptions only when the doctor mentions refill information on the prescription. • A prescription that does not contain refill information should not, by law, be dispensed more than once. • Where refill information is mentioned, the prescription should be refilled only for the number of times & at intervals specified on the prescription. • For this purpose, the pharmacist should make use of the 'Dispensed Stamp' to put on a prescription once it is dispensed for the first time. This stamp indicates the name of the pharmacy that dispensed the medicines, and the date on which they were dispensed. • If only a part of the prescription is dispensed, along with the 'Dispensed Stamp' the pharmacist should write down the quantity dispensed against each medicine along with the date. The next time the patient goes to any pharmacy to take the remaining quantity, the pharmacist can dispense the balance quantity and mention the quantity dispensed. Good Pharmacy Practice - I.P.A. - C.D.S.C.O. - W.H.O. INDIA COUNTRY OFFICE - 13 -
  • I. Regulatory Affairs Every time a prescription is refilled, the pharmacist should put a 'Dispensed stamp' and sign it along with the date of refill. Sample Rubber Stamp: DISPENSED ABC Pharmacy Mapusa, Goa. Date: ……………… Signature of Pharmacist ………. A Sample Dispensed Prescription: - Dr. Armaan Shukla MBBS, D.Ortho Reg.no. MMC 2314 Address: 12 Gharse Towers, M.G.Road, Mumb ai-4 Tel. no. 022-22242862 Date: 1/1/2005 For Mr L.M.Nayak Age – 17 years Address – 2/1 Antop Hill, Mumbai - 18 Tel. No. 2842862 Rx 1. Tab. Valdecoxib 20mg ……. ……. (10) DISPENSED þ ABC Pharmacy Date ….2/1/05 Sign of pharmacist sd/- sd/- Good Pharmacy Practice - I.P.A. - C.D.S.C.O. - W.H.O. INDIA COUNTRY OFFICE - 14 -
  • I. Regulatory Affairs In India, a typical commonplace situation occurs in pharmacies. Clients often do not buy the entire quantity of medicines prescribed by the doctor due to various reasons. A few reasons for not buying the entire quantity : § Financial constraints. § The doctor had changed the treatment half way last time, so this time the patient buys only half the quantity - deciding to buy the rest later. § Fear of adverse effects. § Would like to try out a small quantity first In such cases, the pharmacist should put down the quantity of the medicine dispensed, next to the 'DISPENSED' stamp. The quantity dispensed can also be written on the reverse side of prescription. Another alternative is attaching the cash memo (which denotes the quantity purchased) to the prescription. iii. Doctor's Signature: - The signature of the RMP makes the prescription a legal document. This has to be in indelible ink, and in full, so that the genuineness of the signature can be verified in case of any misuse or dispute. A Sample complete prescription Dr. A.B. Kumar M.B.B.S Reg. no. – 1650 (MMC) Clinic – Old Vaddo, Margao -Goa. Tel. no.: 0832-2765434 Consultation timings – 9.00 A.M to 1.00 P.M 4.00 P.M to 6.00 P.M Date: 1/1/2005 For Tina Age – 45 years Add: Flat no. A -01, Plaza Complex, Margao-Goa Tel: 0832-2765878 Rx 1. Tab. Alprax 0.5 mg. ……. ……. (10) þ Good Pharmacy Practice - I.P.A. - C.D.S.C.O. - W.H.O. INDIA COUNTRY OFFICE - 15 -
  • I. Regulatory Affairs Activity Go through the above prescription carefully, and point out if it is incomplete in any way. A Sample veterinary prescription Dr. A.B. Kumar, B.V.Sc. Reg. no. – 1560 Clinic – New Vaddem, Vasco, Goa Tel. no.: 0832-2773854 Consultation timings - 4.00 P.M to 8.00 P .M Date: 3/12/04 For Blacky (a dog) 6 months Owner: Anup Mehta, 3/T, Sapna Gardens, Vasco Rx 1. Praziquantel 50mg……………………… (1) þ Activity Collect 5 prescriptions of doctors in your neighborhood, and check each of them for : ü Validity ü Legality ü Completeness Make a brief report of each, and discuss with other pharmacist colleagues in the neighborhood, and find out how they handle incomplete prescriptions. Good Pharmacy Practice - I.P.A. - C.D.S.C.O. - W.H.O. INDIA COUNTRY OFFICE - 16 -
  • I. Regulatory Affairs If the prescription is found to be incomplete, or if the prescription is illegible, the pharmacist should contact the doctor (usually on telephone) either to get the prescription completed or clarified. A Prescription is an important legal document. The patient should understand the importance of bringing a prescription along at every visit to the pharmacy. The pharmacist should play a major role in identifying prescriptions that are not complete or not valid. A complete prescription makes the pharmacist's job easier as it provides all the information to ensure delivery of the right medicines with the right advice. 3.2 Details of Medicines and their Legal Requirements Veterinary MEDICINES AYUSH Ayurvedic, (Yoga), Unani, Siddha and Homeopathy. Allopathic Prescription Non-prescription Schedule G medicines medicines Schedule H Schedule X NDPS Schedule K OTC Prescription medicines and importance of adherence to laws Prescription medicines are medicines that can be sold by retail on the prescription of a Registered Medical Practioner only. Strict adherence to the law is required in case of prescription medicines because : Ø Prescription medicines are serious medicines. Ø Self-medication of these medicines can be harmful. Ø Selling medicines without a prescription leads to massive misuse of medicines. Ø Patients begin buying medicines without a prescription, and the seriousness of prescription medicines is lost. Activity 1. Prepare a small pamphlet (for distribution to your clients) in your local language explaining in simple terms, the importance of a prescription, and the need to buy prescription medicines only against a valid prescription. 2. Design an attractive poster to put up in your pharmacy, explaining in a simple manner the importance of bringing a prescription, and the seriousness of prescription medicines. Good Pharmacy Practice - I.P.A. - C.D.S.C.O. - W.H.O. INDIA COUNTRY OFFICE - 17 -
  • I. Regulatory Affairs A) Schedules or categories of drugs The Drugs and Cosmetics Act, 1940 and Rules thereunder classifies medicines into different schedules or categories. Schedules are lists of drugs according to their condition of sale in the pharmacy. The various schedules, and the drugs under them are listed in the appendices of the Drugs and Cosmetics Rules. a) Schedule H drugs Schedule H drugs contains a list of drugs, that § Are prescription drugs, i.e. these can be sold only against the prescription of a R.M.P. § Can be sold only under the personal/direct supervision of a Pharmacist. § Can be stocked and sold to the client/patient only by a pharmacy/ chemists and druggists/ medical store holding a valid retail license. § Carry on the label a mandatory warning 'Schedule H Drug - Warning: To § be sold by retail on the prescription of a Registered Medical Practitioner only.' Have the symbol ‘Rx’ conspicuously displayed on the left top corner of the label and a red line across the left side. H § Should be sold against a proper bill of sale. The proof/records of purchase and sale of the medicines should be retained for a period of at least 3 years. Examples of a few drugs under Schedule H Diclofenac Glimepiride Amoxycillin Betamethasone Atenolol Ibuprofen Allopurinol Alprazolam Activity: Prepare a list of Schedule H drugs, with a few brand names for each to be displayed or kept handy in your pharmacy. Ref: Drugs & Cosmetics Act & Rules Prescription drugs are medicines that can help a patient when taken according to the doctor's prescription but can cause considerable harm if misused. Pharmacists should therefore avoid dispensing prescription medicines without a prescription except in case of an emergency, but always exercising strict caution. (Refer to 'Emergency Supply of prescription medicines' in the next section.) If a Fixed Dose Combination (FDC) contains a non-prescription drug and a prescription drug then the FDC automatically becomes a 'Prescription medicine' Good Pharmacy Practice - I.P.A. - C.D.S.C.O. - W.H.O. INDIA COUNTRY OFFICE - 18 -
  • I. Regulatory Affairs b) Narcotic Drugs and Psychotropic Substances (NDPS) Substances and drugs coming under this Act are placed under following categories N Ø Ø Controlled substances Manufactured drugs D Ø Narcotic drugs P Ø Psychotropic substances S A pharmacy may obtain permission to stock drugs under the categories of manufactured drugs (e.g. pethidine, paracodine) and can stock psychotropic substances (e.g. alprazolam, diazepam). Manufactured drugs Manufactured drugs contains a list of drugs which :- § Are prescription drugs, i.e. these can be sold only against the prescription of a Registered Medical Practitioner. Under no circumstances, should these drugs be dispensed without a prescription. § Can be sold only under the personal/direct supervision of a Pharmacist. § Can be stocked and sold to the client/patient only by a pharmacy/ chemists and druggists/ medical store having a valid retail license. § All manufactured drugs are also included in Schedule H and therefore carry on the label a mandatory warning ' Schedule H Drug Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.' § Have the symbol NRx conspicuously displayed on the left top corner of the label § Should be sold against a proper bill of sale. The original prescription has to be defaced with a dispensed stamp and retained by the pharmacist. The prescriptions and detailed records of purchase and sale have to be maintained for a period of 3 years. Quarterly reports of purchase and sale have to be submitted to the FDA. § Have to be stored under lock and key and the key must be kept with the Chief Pharmacist or pharmacist in charge. § Have a potential for misuse and abuse and therefore should be carefully stored and carefully dispensed. Psychotropic substances Psychotropic substances includes a list of drugs which :- § Are prescription drugs, i.e. these can be sold only against the prescription of a Registered Medical Practitioner. Good Pharmacy Practice - I.P.A. - C.D.S.C.O. - W.H.O. INDIA COUNTRY OFFICE - 19 -
  • I. Regulatory Affairs § Can be sold only under the personal/direct supervision of a Pharmacist. § Can be stocked and sold to the client/patient only by a pharmacy/ chemists and druggists/ medical store having a valid retail license. § All the psychotropic substances are also included in Schedule H and therefore carry on the label a mandatory warning ' Schedule H Drug. Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.' § Have the symbol ‘NRx’ conspicuously displayed on the left top corner of the label and a red line across the left side. § Should be sold against a proper bill of sale. The proof/records of purchase and sale of the medicines should be retained for a period of at least 3 years. Activity: Prepare a list of drugs under NDPS Act along with a few brand names for each. Ref: Drugs and Cosmetics Act, 1940, NDPS Act Guidelines for dealing with NDPS Drugs : Purchase § Thoroughly check your invoice for correct Name and Address of Supplier, Drug License No, Sales Tax No, quantity, batch number and expiry. § Purchase minimum quantity possible. § Do not accept these drugs from unauthorized persons or medical representatives or on challan, etc § Let the supply come from the authorized wholesaler only. § Do not accept these drugs as replacement for settlement of expiry or claims. Sale § Insist on a valid prescription on letterhead with signature of doctor. § While preparing the bill write the complete name and address of the doctor and the patient with the exact quantity of medicine dispensed, batch number, expiry date, etc. § After dispensing the prescription, put a 'DISPENSED' stamp. § DO NOT dispense more than the prescribed quantity. Storage and records § Store all NDPS medicines safely and place them under the supervision of a qualified person or a responsible person. § In case of theft or loss, immediately inform the Drug Authorities. § Maintain proper records of all sales and purchases for a period of three years. § Avoid home delivery of these medicines. § Do not accept any telephonic orders. § Never SUBSTITUTE such medicines. Contact the doctor in case of unavailability or any other problem. § In case of any doubts, like huge quantity prescribed or a suspicious character with a bogus Good Pharmacy Practice - I.P.A. - C.D.S.C.O. - W.H.O. INDIA COUNTRY OFFICE - 20 -
  • I. Regulatory Affairs prescription immediately contact and confirm with the doctor/ prescriber, OR POLITELY REFUSE to dispense the prescription. § All expired/ damaged stock should be returned by filling in all the relevant details and obtaining stamps/ signatures on the “goods returned” proforma. If sent by transport/ courier, maintain a copy of the LR/RR or POD § Do not fall prey to evil designs of unscrupulous persons who would like to purchase huge quantities without bills and are ready to pay a premium. § Psychotropic drugs are generally habit forming and could have adverse effects if taken without proper care. It is, therefore advisable to be extra cautious while purchasing, storing and selling such products. § Educate pharmacy personnel to be extra cautious while purchasing, storing and selling such products. § Educate pharmacy personnel to follow the necessary guidelines given above, comply with the rules and counsel the patient whilst dispensing the products. c) Schedule X drugs: Schedule X contains a list of drugs which :- § § Need discretion while dispensing, and the pharmacist should ensure that these drugs are not sold without a prescription. Have a warning mentioned on the label 'Schedule X drug - Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.' The label will also have the symbol ‘XRx’ in red, X and conspicuously displayed on the top left corner of the label. After dispensing the drug, the pharmacist must § Stamp and retain the prescription. § Maintain a record of the purchase and sales of the drugs, and § Preserve it for a period of two years from the date of transaction Examples of a few drugs under Schedule X Amobarbital Barbital Amphetamine Cyclobarbital Dexamphetamine Glutethimide Meprobamate Methylphenidate Activity: Prepare a list of Schedule X drugs to be displayed in the Pharmacy or kept handy. Ref: Drugs and Cosmetics Act, 1940 Good Pharmacy Practice - I.P.A. - C.D.S.C.O. - W.H.O. INDIA COUNTRY OFFICE - 21 -
  • I. Regulatory Affairs d) Schedule C and C(1) (i) Schedule C The drugs under this schedule include biological and special products. Examples of a few drugs under Schedule C Toxins Insulin Vaccines (parenteral) Ophthalmic preparations Antibiotics (parenteral) Adrenaline The drugs in Schedule C are also listed under Schedule H, and thus are prescription medicines. A proper bill of sale has to be made against their sale. The proof/record of details of purchase and sale must be maintained for a period of at least three years. (ii) Schedule C (1) The drugs under this schedule include other special products Examples of a few drugs under Schedule C (1) • Fish Liver Oil and preparations containing Fish Liver Oil • Vaccines not in a form to be administered parenterally • Antibiotics and preparations thereof, not in a form to be administered parenterally • In vitro Blood Grouping Sera Those medicines from this schedule listed in Schedule H are to be sold against the prescription of a R.M.P., and against a proper bill of sale. The proof/record of details of purchase and sale must be maintained for a period of at least 3 years. e) Schedule G § Medicines listed as schedule G medicines carry on the label a caution: 'Caution : It is dangerous to take this preparation except under § § § medical supervision.' These can be sold without the prescription of a doctor/ R.M.P. However, it is necessary to make a proper bill of sale. Records of purchase and sale of these medicines must be maintained for a period of two years. G Good Pharmacy Practice - I.P.A. - C.D.S.C.O. - W.H.O. INDIA COUNTRY OFFICE - 22 -
  • I. Regulatory Affairs Examples of a few drugs under Schedule G Pheniramine Chlorpheniramine Cyclophosphamide Aminopterin Daunorubicin Glibenclamide Metformin Triprolidine Activity: Prepare a list of Schedule G drugs available in your pharmacy to be displayed in the pharmacy or kept handy. Ref: Drugs and Cosmetics Act, 1940 f) Schedule K Schedule K specifies the extent and conditions of exemption for certain classes of drugs. One of the clauses in Schedule K which is related to a K community pharmacy, is related to the sale of Household Remedies, namely § Aspirin tablets. § Paracetamol tablets. § Analgesic balms. § Antacid preparations. § Gripe Water for use of infants. § Inhalers, containing drugs for treatment of cold and nasal congestion. The provisions of the Drugs and Cosmetics Act, and the Rules there under state that the above mentioned household remedies can be sold, stocked or exhibited for sale, or distributed by retail by dealers who do not engage the services of a qualified person i.e. Pharmacist, by possessing a sales licence in Form 20A subject to the following conditions :- (a) The drugs are sold only in a village having a population of not more than one thousand persons, and where there is no licensed dealer under the Drugs and Cosmetics Act, (b) The drugs do not contain any substance specified in Schedules G, H or X. g) Schedule J Schedule J specifies the diseases and ailments, which a drug may not purport to prevent or cure or make claims to prevent or cure. It states that: “No drug may purport or claim to prevent or cure or may convey to the intending user thereof any idea that it may prevent or cure, one or more of the diseases or ailments specified in Schedule J”. Good Pharmacy Practice - I.P.A. - C.D.S.C.O. - W.H.O. INDIA COUNTRY OFFICE - 23 -
  • I. Regulatory Affairs Some of the diseases and ailments listed under this schedule include:- § AIDS § Angina Pectoris § Fairness of skin § Improvement in height of children/ adults § Premature ageing § Sexual impotence (The detailed list of 51 diseases and ailments can be found in the Drugs and Cosmetics Act and Rules) h) Schedule P Schedule P specifies the life period of drugs between the date of manufacture and date of expiry, which the labeled potency period of the drug should not exceed under the condition of storage specified. The Schedule includes antibiotics, vitamins, insulin preparations, normal human plasma, sera toxins and toxoids, other vaccines, antitoxins and miscellaneous drugs. The names of some drugs & their maximum shelf life period under this schedule are given below: SCHEDULE P Life Period of Drugs Name of the drug Period in months Conditions of storage Adriamycin 30 In a cool place Ampicillin 36 In a cool place Cephalexin 24 In a cool place Riboflavin 60 In a well-closed container, protected from light, in a cool place. 0 Insulin injection 24 At a temperature between 2 C - 80C, must not be allowed to freeze. Good Pharmacy Practice - I.P.A. - C.D.S.C.O. - W.H.O. INDIA COUNTRY OFFICE - 24 -
  • I. Regulatory Affairs Schedule P-I Schedule P-I specifies the pack sizes of certain drugs. It gives the names of drugs, along with the dosage form and the pack size. No other pack size than the one listed is allowed to be marketed. Examples of a few drugs under this schedule :- SCHEDULE P-I - Pack Sizes of Drugs Name of the Drug Dosage form Pack size Albendazole Suspension 10 ml Atenolol Tablets 14 Famotidine Tablets 14 Piperazine Granules 5 gm Syrup 30 ml Loxapine Oral liquid concentrate 15 ml i) Schedule Y Schedule Y specifies the requirements and guidelines for the import and/ or manufacture of a new drug. The Schedule covers details like :- Ø Chemical and pharmaceutical information Ø Animal tests, toxicology and pharmacology Ø Clinical trials § Nature of trials § Permission for trials § Responsibility of sponsor/investigator Each medicine is listed under a particular schedule for specific reasons. The label contains the necessary warning / caution, to make the pharmacist alert while dispensing such listed drugs. B) OTC Medicines There is no separate provision for Over the Counter (OTC) medicines in the Drugs and Cosmetics Act. Therefore, the drugs, which have not been included in any of the Schedules, may be considered as non- prescription or OTC drugs. OTC medicines are medicines that can be sold without the prescription of a Registered Medical Practitioner. Good Pharmacy Practice - I.P.A. - C.D.S.C.O. - W.H.O. INDIA COUNTRY OFFICE - 25 -
  • I. Regulatory Affairs These can either be recommended by a pharmacist, or requested/ purchased by a client independently. Since OTC medicines too can have adverse effects, pharmacists should assist clients in choosing/ selecting the right OTC remedy for their ailment. It is advisable for a pharmacy to purchase OTC medicines from a reliable source, against a proper bill, and also record the sale along with batch number and expiry in a cash memo. Examples of Non-prescription medicines § Paracetamol 500mg tablets § Calamine lotion § Chlorhexidine solution 5% § Lindane lotion 1% § Povidone iodine solution 5%/ ointment § Clotrimazole cream § Xylometazoline 0.1% C) New Drugs A drug or a Fixed Dose Combination (FDC) of 2 or more drugs or new drugs is said to be a 'New Drug' when :- 1) It is a new bulk drug substance of chemical, biological or biotechnological origin, and except during local clinical trials, has not been used in the country to a significant extent, and not been recognized in the country as safe and effective for the proposed claims. 2) A drug already approved by the licensing authority for certain claims, which is now proposed to be marketed with modified or new claims - namely indications, dosage, dosage form (including sustained release dosage form) and route of administration. 3) A fixed dose combination of two or more drugs, individually approved earlier for certain claims which are now proposed to be combined for the first time in a ratio, or if the ratio of ingredients in an already marketed combination is proposed to be changed with certain claims namely indications, dosage, dosage form (including sustained release dosage form) and route of administration. In India, a new drug shall continue to be considered as a new drug for a period of four years from the date of its first approval or its inclusion in the Indian Pharmacopoeia whichever is earlier. After 4 years, the drug as per latest decision of the DTAB (Drugs Technical Advisory Board) will be put in one of the schedules, (usually Schedule H). Good Pharmacy Practice - I.P.A. - C.D.S.C.O. - W.H.O. INDIA COUNTRY OFFICE - 26 -
  • I. Regulatory Affairs D) Veterinary Medicines : Ø The medicines for treatment of animals are to be labeled with the words “Not for human use- for treatment of animals only” and shall be stored :- § In a cupboard or drawer reserved solely for the storage of veterinary drugs, and § In a part of the premises separated from the remainder of the premises to which customers are not permitted to have access. Ø The sale of veterinary medicines requires a drug license to sell medicines, and the sale should be carried out under the direct supervision of a registered pharmacist. E) Brand Substitution and Bioequivalence The same generic drug may be marketed by different pharmaceutical companies, under different brand names. For example Atorva and TG TOR are brand names used by different companies, for the same drug Atorvastatin Calcium. If a physician prescribes a particular brand of a drug, and the pharmacy substitutes (dispenses) it with another brand of the same drug, it is called brand substitution. Reasons why a pharmacy may indulge in brand substitution 1. No stock in the shelves. 2. Shortage of the brand in the market. 3. The pharmacy tries to push a particular brand because it has excess stocks, or it gives more profits. 4. A pharmacy cannot afford to stock all brands in the market due to space or financial limitations. Bioequivalence evaluation • While evaluating bioavailability or bioequivalence, two things are looked at how much of the drug is absorbed into the bloodstream, and how fast. • One brand must match the standard brand name drug in bioavailability of the drug closely, but it need not be identical. That is because two formulations of the same drug can vary slightly in their absorption and still work equally well in the body. Ø Bioavailability: is an absolute term that indicates measurement of both, the true rate, and total amount (extent) of drug that reaches the general circulation from an administered dosage form. Ø Bioequivalence: indicates that a drug in two or more similar dosage forms reaches the general circulation at the same relative rate and the same relative extent, i.e. that the plasma (blood/serum) level profiles of the drug obtained using the 2 dosage forms are, within reason, 'super imposable’. Ø In case of drugs with a Narrow Therapeutic Index*, the slight decrease or increase in blood Good Pharmacy Practice - I.P.A. - C.D.S.C.O. - W.H.O. INDIA COUNTRY OFFICE - 27 -
  • I. Regulatory Affairs levels due to change in the brand could result in ineffective therapy or toxic effects respectively. It is very essential NOT to do brand substitution for such drugs. Doctors may authorize brand substitution incase the prescribed brand is not available, and keep a check on the effect of the new drug on the patient. Ø In patients on long-term therapy e.g. epilepsy, hypertension etc., fluctuations in blood levels of the drug due to shift in brands could cause ineffective control of condition, or toxicity. Example Patient is taking theophylline Brand A His asthma is under control, and he for a couple of months ð does not experience adverse effects Patient is forced to take theophylline Brand B, The patient's asthma remains in control, because Brand A is not available. however he experiences adverse effects Brand B is more bioavailable than Brand A ð (tachycardia, palpitations, nausea and gastro intestinal disturbances). Patient is forced to take Brand C because Brand A Patient does not experience adverse effects, is not available. Brand C is less bioavailable but he gets an attack of asthma, because than Brand A. ð sufficient theophylline levels were not maintained in the blood. *Narrow therapeutic index drugs are a critical class of drugs for which even slight decrease in blood levels may result in ineffective therapy, while slight increase in blood level may result in toxic effects. For these drugs, relatively small changes in systemic concentration lead to marked changes in pharmacodynamic response. E.g. Theophylline, phenytoin, digoxin Guidelines: According to the Drugs and Cosmetics Act, When the doctor specifies the brand name on the prescription, the pharmacist should dispense the same brand (i.e. brand substitution is not permitted). • In case of non-availability of the brand, the prescriber may be contacted by the pharmacist or the patient, seeking an alternate brand. The code of ethics for pharmacists does not permit brand substitution F) ISM and H (Indian Systems of Medicine and Homoeopathy) : In India, pharmacies also deal with other systems of medicines, other than allopathic (or modern system of medicine). The Department of AYUSH (Ayurvedic, Yoga and Naturopathy, Unani, Siddha and Good Pharmacy Practice - I.P.A. - C.D.S.C.O. - W.H.O. INDIA COUNTRY OFFICE - 28 -
  • I. Regulatory Affairs Homoeopathy), formerly known as the department of ISM and H (Indian System of Medicines and Homoeopathy), under the Ministry of Health & Family Welfare, recognizes only the following systems of medicine :- A- Ayurvedic Y- Yoga and Naturopathy U- Unani S- Siddha H- Homoeopathy (Other systems of medicine, e.g. Pranic healing, Reiki, Magnetotherapy, Acupressure, Acupuncture, etc are not recognized by the Ministry of Health & Family Welfare, Government of India) “Ayurvedic, Siddha or Unani drug” includes all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, and manufactured exclusively in accordance with the formulae described in, the authoritative books of Ayurvedic, Siddha and Unani systems specified in the First Schedule. “Patent or proprietary medicine” (in relation to Ayurvedic, Siddha or Unani Tibb systems of medicine) means: 'All formulations containing only such ingredients mentioned in the formulae described in the authoritative books of Ayurvedic, Siddha and Unani systems specified in the First Schedule, but does not include a medicine which is administered by parenteral route and also a formulation included in the specified authoritative books The First Schedule and the Second Schedule of The Drugs and Cosmetics Act, 1940. The First Schedule includes the standard reference books available for the Ayurvedic, Siddha and Unani Tibb systems The Second Schedule gives the standards to be complied with by imported drugs and by drugs manufactured for sale, stocked or exhibited for sale or distributed. Manufacture of Ayurvedic, Siddha and Unani medicines requires a manufacturing drug license (to be taken from the state FDA), and these have to be manufactured in accordance with the standards prescribed under the Drugs and Cosmetics Act, and the second Schedule. Sale of Ayurvedic, Siddha and Unani Drugs: As per laws, there is no drug license/ permission required to sell/ distribute Ayurvedic, Siddha and Unani medicines. These medicines can, therefore, be stocked and sold by any person, shop, outlet, etc, and not necessarily in a pharmacy. Such persons can however, sell, stock or exhibit or offer for sale or distribute only those Ayurvedic, Siddha or Unani medicines that have been manufactured according to the provisions of the Act. Expiry dates of Ayurvedic medicines: Ancient Ayurvedic texts and Indian Pharmacopoeia (Ayurvedic), which are the basis for the manufacture of Good Pharmacy Practice - I.P.A. - C.D.S.C.O. - W.H.O. INDIA COUNTRY OFFICE - 29 -
  • I. Regulatory Affairs classical Ayurvedic medicines, specify the expiry date for various categories of medicines. In spite of this, you may notice that most Ayurvedic medicines do not have any expiry date mentioned on the label. This is because, it is not yet mandatory to mention the expiry date on the label. However this does not imply that these medicines can be used indefinitely. There is a specific time period within which they can be used. Homoeopathic medicines include any drug which is recorded in Homoeopathic provings, or the therapeutic efficacy of which has been established through long clinical experience as recorded in the authoritative Homoeopathic literature of India and abroad and which is prepared according to the techniques of Homoeopathic pharmacy, and covers combination of ingredients of such Homoeopathic medicines, but does not include a medicine which is administered by parenteral route. Sale of Homoeopathic medicines 1. It is compulsory to obtain a license from the State Drug Licensing Authority to stock and sell Homeopathic medicines. 2. The license shall be displayed in a prominent place in a part of the premises open to the public. 3. Premises where homoeopathic medicines are stocked for sale should be maintained in a clean condition. 4. The sale of homoeopathic medicines is conducted under the supervision of a person, capable of dealing with homoeopathic medicines. 5. Records of purchase and sale of Homoeopathic medicines containing alcohol should be maintained. G) Physician samples, ESIC medicines A pharmacy SHOULD NOT stock or sell: A drug intended for distribution to the medical profession as free sample which bears a label on the container with the words “Physician's Sample, Not For Sale” OR A drug meant for consumption by the Employees State Insurance Corporation, the Central Government Health Scheme, the Government Medical Stores Depots, the Armed Forces Medical Stores or other Government institutions, which bears a distinguishing mark or any inscription on the drug or on the label affixed to the container thereof indicating this purpose shall be sold or stocked by the licensee on the premises. § This rule shall not be applicable to licensees who have been appointed as approved chemists, by the State Government in writing, under the Employees State Insurance Scheme, or have been appointed as authorized agents or distributors, by the manufacturer in writing, for drugs meant for consumption by the above institutions under those schemes, subject to the conditions that the stock shall be stored separately from the trade stocks and shall maintain separate records of the stocks received and distributed by them. Good Pharmacy Practice - I.P.A. - C.D.S.C.O. - W.H.O. INDIA COUNTRY OFFICE - 30 -
  • I. Regulatory Affairs 3.3. Emergency supply of prescription medicines [* Emergency supply of medicines is not a LEGAL provision in India today. § This is an attempt by us to provoke a thought in pharmacists who are faced with a dilemma whether to dispense a prescription medicine or not, in an emergency situation where a prescription is not produced by a client. § We feel that this is a much more logical approach to the situation, in comparison to the chaotic situation in India today, where prescription medicines are freely sold without a prescription being produced by clients. § The supply of prescription medicines needs to be carried out under STRICT CAUTION. Under no circumstances should pharmacists misuse this possible provision by dispensing prescription medicines without a prescription in any instance.] In the Drugs and Cosmetic Act and Rules (India), Emergency Supply of prescription medicines is NOT recognized. It is, however, a legal provision in some developed countries. We feel that at some point of time, such guidelines/provisions should be carefully considered and approved by the Health Ministry of India When a patient comes to the pharmacy asking for prescription medicines without a prescription, the pharmacist has to analyze the case carefully. He has to distinguish between genuine and fake requisites. In such cases, when the pharmacist is convinced that the need for the prescription medicines is genuine and is an emergency, an 'emergency supply' may be provided. Cases encountered could be of 2 types :- 1) The client has not brought a prescription, because he has genuinely forgotten it (left it at home) or lost it, and it is not practicable for him to bring one now, and he needs to take home the medicines as an emergency, and the patient's doctor is not contactable. 2) The client/patient has just arrived with the need for a medication, and is unable to go to a doctor or a doctor is unavailable. Points to consider • The pharmacist should consider the medical consequences of not supplying the medicine. • If the pharmacist does not know the patient, the patient's identity should be established by way of appropriate documentation. • It is best not to dispense drugs listed under the NDPS Act or those otherwise having a potential for misuse/ abuse, or contact the prescriber to confirm. • Also, contact the doctor, if the pharmacist does not know the doctor mentioned by the patient (if phone call is to be made, use the number from the Telephone directory rather than using the number that the patient has given). Good Pharmacy Practice - I.P.A. - C.D.S.C.O. - W.H.O. INDIA COUNTRY OFFICE - 31 -
  • I. Regulatory Affairs • Care should be taken to ask whether the patient's doctor has stopped the treatment, or whether the patient is taking any other medication. Proper questioning will enable pharmacists to get information that will help them to decide whether the request for prescription medicine is genuine, and whether it requires emergency supply of that medicine. 3.4 Record Keeping As per The Drugs and Cosmetics Act and Rules, a pharmacy has to maintain certain records. These records, besides being a legal requirement, can be useful for the pharmacist's personal records and observations. Such records are open to inspection by officers of the Drug Control Department. As per the Drugs and Cosmetics Act and Rules, the pharmacy has 2 options for recording the sale of medicines. Recording can be done at the time of supply in a : i) Prescription register specially maintained for the purpose and the serial number of the entry shall be entered on the prescription. The following particulars shall be entered in the register: a) Serial number of the entry. b) The date of supply. c) The name and address of the prescriber. d) The name and address of the patient, or the name and address of the owner of the animal if the drug supplied is for veterinary use. e) The name of the drug or preparation, and the quantity, or in the case of a medicine made up by the licensee, the ingredients and quantities there of. f) In the case of a drug specified in Schedule C or Schedule H, the name of the manufacturer of the drug, it's batch number and the date of expiry of potency, if any. g) The signature of the registered pharmacist by or under whose supervision the medicine was made up or supplied. This option of maintaining a prescription register is not being used by many pharmacies today because it is time consuming and tedious. In the case of drugs which are not compounded in the pharmacy and which are supplied from or in the original containers, the particulars specified in items (a) to (g) above may be entered in a cash or credit memo book, serially numbered and specifically maintained for this purpose. This is the easiest option, and is most commonly followed by pharmacies today. It is a more convenient option, and prevents duplication of work. The option to maintain a prescription register or a cash or credit memo book for drugs and medicines, which are supplied from or in the original container, shall be made in writing to the Licensing Authority at the time of application for the grant or renewal of the license to sell by retail. Good Pharmacy Practice - I.P.A. - C.D.S.C.O. - W.H.O. INDIA COUNTRY OFFICE - 32 -
  • I. Regulatory Affairs ii) Cash Memo Sample format Drug Lic. No.___________ CASH MEMO Sr. no. of Cash memo ______ TIN:---- Date: _________ Name of Patient: _______________________Name of Doctor: ___________ Address of Patient: ___________________________Address of Doctor: ______________ ___________________________ _______________ Qty. Product Name Sche Mfr. B. No. Exp. Amount in dule name Date Rs. Total - __________ XYZ Pharmacy Shop no. L/5, Opp. Blossom Complex, Panaji, Goa. ----------------------- Ph. no. 2227435 (Signature of Pharmacist) In a pharmacy, the retail sale of medicines has to be made against a cash memo/ bill. The following particulars should be written on every cash memo for medicines listed under Schedule H, X, G. :- § Medicine name (Brand, and Generic if there is no brand name) § Quantity. § Batch number. § Expiry date . § The Schedule under which the medicine is included. Also, the bill/ cash memo should indicate § Who the medicines are for (i.e. the patient's name and address) and § Who has prescribed them (i.e. the physician's name and address). The following particulars must be pre-printed (or printed along with medicine and patient details in case of a computerized bill) on the cash memo: § Name, address, and telephone number of the pharmacy, § Drug license numbers, § Serial number of the bill, § TIN i.e. Tax Identification Number (if applicable). The cash memo must always be signed by the pharmacist under whose supervision the medicines are dispensed. Good Pharmacy Practice - I.P.A. - C.D.S.C.O. - W.H.O. INDIA COUNTRY OFFICE - 33 -
  • I. Regulatory Affairs Guidelines: • It is the pharmacist's duty to ensure that medicines are sold against a cash memo / bill. • The bill should be legible enough to be understood by the patient / consumer. • The bill should contain all the necessary details. Patients have a right to information about medicines, as well as the right to receive a bill for whatever they buy. • All calculations should be checked properly before entering into the cash memo. • Once the bill is made, a final check should be performed. The items dispensed should be checked against the prescription, tallied against the bill, and then signed by the pharmacist under whose supervision the sale is made. (The person making the bill should also preferably sign). Who can make the bill? Any of the salespersons/technicians, or pharmacist can make the bill of sale. The cash memo can be written by hand, or can be computerized. Who should sign on the bill? The person making the bill should ideally sign, and the pharmacist under whose supervision the medicines have been dispensed should compulsorily (as a legal requirement) countersign. Good Pharmacy Practice - I.P.A. - C.D.S.C.O. - W.H.O. INDIA COUNTRY OFFICE - 34 -
  • I. Regulatory Affairs The carbon copies/duplicate copies of the cash memos should be maintained and preserved by the pharmacy as a record for a period of three years from the date of sale of the drug. The bills should be serially numbered by the pharmacy and maintained in a chronological order. Information which you may give your clients: - Clients should be requested to preserve the bill at least till the medicine is fully utilized, because Ø A Bill/cash memo is a proof of legal sale of quality medicines Ø The batch number, expiry date even if not on the part of the strip that is dispensed to them, the patient can find out from the bill. Ø It is easier to return medicines when a bill of sale is produced. Ø The bill is the only proof available to the patient that a medicine of a particular batch and manufacturer was purchased from that particular pharmacy, especially incase any complaints/defects have to be reported. iii) Purchase bills and register Records of purchases of drugs intended for sale, or sold by retail, should be maintained in the pharmacy in a purchase register. Example of recorded purchase details Date Sr.No Bill No Supplier Total 01/04/05 01 14 G K Pharma 5160.36 02/04/05 02 30055 L.M Agencies 2970.04 02/04/05 03 138 J.L Enterprises 1610.00 Purchase bills including cash or credit memos should be serially numbered by the licensee and maintained in chronological order. iv) Display of license § It is compulsory to obtain a license from the State Drug Licensing Authority to stock and sell medicines. § The license should be displayed in a prominent place in a part of the premises open to the public. v) Display of Pharmacist's Registration certificate § The supply by retail of medicines in the pharmacy should be carried out under the personal supervision of a pharmacist. § The registration certificate obtained from the State Pharmacy Council should be displayed in a prominent place in a part of the premises open to the public. Good Pharmacy Practice - I.P.A. - C.D.S.C.O. - W.H.O. INDIA COUNTRY OFFICE - 35 -
  • I. Regulatory Affairs 4. PRESENCE OF A PHARMACIST As per law, prescription medicines must be sold only under the personal supervision of a Registered pharmacist. This means that a pharmacist has to be present at all times of dispensing (during the entire working hours of a pharmacy). “Registered pharmacist” means a person who is a Registered Pharmacist as defined in clause (i) of Section (2) of the Pharmacy Act, 1948 (Act 8 of 1948): Provided that the provisions of sub clause (i) shall not apply to st those persons who are already approved as “qualified person” by the Licensing Authority on or before the 31 December, 1969. Along with pharmacists, there might be nonpharmacists (salespeople/pharmacy technicians) as well as trainee pharmacists working in the pharmacy. These persons can perform various functions including assembling of prescribed medicines. The final dispensing step must, however, be taken under the personal supervision of the pharmacist. Personal supervision of a pharmacist means : • Whenever a salesperson/pharmacy technician or trainee pharmacist carries out dispensing, the pharmacist should supervise and check that the medicines are correctly dispensed against the prescription, and only then sign the bill, and permit medicines to be packed and handed over to the client. • The pharmacist assures legality and completeness of prescription. • The pharmacist ensures that the correct medicines are dispensed. When the pharmacy has a single pharmacist, he/she will have to ensure that no prescription is dispensed unless checked by him/her. Legally, pharmacists are responsible for situations caused by negligence or incompetence of non-pharmacists when these are working under their supervision. Pharmacists have been authorized to supply these items on the understanding that they accept responsibility for ensuring their safe and effective use. Today, with increasing exposure to health related information and growing curiosity among the public, people expect much more. They look for professionalism where all queries will be answered, and will not settle for anything less. • Pharmacists are trained professionals. They can recommend medicines when customers require assistance in choosing OTC medicines for their conditions, so as to ensure rational, safe and effective use of medicines. Pharmacists are aware of the side effects of drugs as well as the incidence of drug interactions with other medication. Good Pharmacy Practice - I.P.A. - C.D.S.C.O. - W.H.O. INDIA COUNTRY OFFICE - 36 -
  • I. Regulatory Affairs • Pharmacists can do measurements of blood pressure, blood sugar, and weight, and give non- pharmacological advice to control them. • Pharmacists are in a position to give advice on the medicines prescribed, how and when to use them, and for how long. Guidelines : • Ensure the presence of a pharmacist during working hours, on the counter, for public access. • By law, all prescription medicines need to be sold under the direct/personal supervision of a pharmacist. • The pharmacist should ensure that dispensing occurs in accordance with statutory regulations, accurately reflects the prescriber's intentions, and is consistent with the needs and safety of the patient. • The pharmacist should sign all bills of sale after checking the dispensed medicines against the prescription to check for accuracy. • The pharmacist ensures that the patients and/or their caregivers have sufficient knowledge of their medications and medication delivery devices to facilitate their safe and effective use. If the pharmacist goes out for tea or to use the toilet, or takes a break for some other reason, prescription medicines should not be dispensed till the pharmacist is back. The client should be requested to wait for a while till the pharmacist resumes duty. If a pharmacist is absent or the only pharmacist resigns without a replacement, it is well justified that the pharmacy be closed down till a pharmacist resumes work. This is a legal requirement. Salesperson/Pharmacy Technicians: • Salespersons/ pharmacy technicians do not have formal education in pharmacy and cannot be considered competent in knowledge of drugs and their dosage forms. • They may have experience of dispensing but do not possess appropriate knowledge or awareness about drug interactions that could occur with OTC medicines, the drug or disease related aspects, the correctness of a prescription or the recent developments in the field of medicine and pharmacy. The law permits any person (regardless of qualifications) to stand at the pharmacy counter and dispense medications, but this can be done only under the personal/direct supervision of a registered pharmacist. Recommending medicines without the consent of the pharmacist could not only cause harm to the patient but could also result in loss of faith and reputation of the pharmacy. The seriousness and importance of accurate dispensing and proper advice is often not realized by technicians. Good Pharmacy Practice - I.P.A. - C.D.S.C.O. - W.H.O. INDIA COUNTRY OFFICE - 37 -
  • I. Regulatory Affairs Who is a Pharmacy Technician? The definition currently accepted in the U.S.A for a pharmacy technician is an “individual working in a retail pharmacy setting who under the supervision of a licensed pharmacist assists in pharmacy activities that do not require the education, training and professional judgement of a pharmacist” (Source: White Paper on Pharmacy Technicians 2002.) The concept of a pharmacy technician is very well established in the U.K, the U.S.A, and Australia. Infact, with each passing day, the role and function of a pharmacy technician is being maximized and the pharmacist is given sufficient time to focus on patient care. Today, in these countries, pharmacy technicians are performing several activities once exclusively performed by pharmacists. Pharmacists and pharmacy technicians work as a team to provide patient care services through the mutual recognition of their roles and responsibilities, and through the responsible and efficient use of technology and resources. It is time that in our country also, we begin giving sufficient training to our salespersons, and have licensing and examination/ accreditation systems for pharmacy technicians. 5. OTHER ASPECTS Telephonic orders by clients By law, telephonic orders by clients, for prescription medicines are not valid/not recognized, because a prescription is not produced. Supply of prescription medicines against such telephonic orders, amounts to sale of prescription medicines, without a prescription. Non-prescription medicines can be sold against telephonic orders/requests by clients. Door delivery If a prescription is physically produced at the pharmacy the prescribed medicines can be home-delivered. Non-prescription medicines can be sold and delivered to the door/home of the client/patient. Internet pharmacies Internet pharmacies are wrongly understood by many,as pharmacies on the Internet, where one can 'log on' and order any medicine one wants. This unfortunately is an inaccurate interpretation of Internet pharmacy. Often such pharmacies are operated by people who are out only to make money from vulnerable clients. Most often, such 'unlicensed' Internet pharmacies promote drugs of misuse (e.g. psychotropics, sex stimulants, anabolic steroids, etc). Such Internet pharmacies can be labeled as unauthorized or 'bogus'. Good Pharmacy Practice - I.P.A. - C.D.S.C.O. - W.H.O. INDIA COUNTRY OFFICE - 38 -
  • I. Regulatory Affairs Genuine Internet pharmacies have the following: § A physical, licensed and duly authorized pharmacy. § Authorization from the State/Country's FDA to run an Internet pharmacy. § They display their physical address as well as telephone numbers on their websites so that patients can get in touch with them, or verify online information. § Do not dispense prescription medicines unless an actual prescription is produced by the client, after physical examination by a physician. Currently, Internet pharmacies are not authorized in India. What the pharmacist would have learnt from this module : § The practice of pharmacy in India is governed by many laws It is important to adhere to these laws, and to perform all pharmaceutical activities within the purview of these laws. § The profession of pharmacy in the country is regulated by a Code of Ethics. § A prescription is an important, legal document and its legality and authenticity needs to be ascertained at all stages of dispensing. § Medicines are classified into different schedules or categories. Medicines should be sold only after taking into consideration the legal requirements for their sale. § According to the laws, the pharmacy is required to maintain records and other relevant documentation for specified periods of time. § The sale of medicines should only be undertaken under the personal supervision of a Registered Pharmacist. The dispensing of medicines requires the professional expertise of a pharmacist. Pharmacists are legally responsible for the quality of the product, which they distribute. It is for this reason that the law requires that the distribution of all drugs be strictly carried out under the supervision and direct involvement of the pharmacist. The pharmacist plays a pivotal role in the efficient functioning of the pharmacy. He should be vigilant, and should carry out this responsibility within the confinement of the laws. Further Reading :- 1) Drugs and Cosmetics Act 1940 and Rules 1945; Govt. of India 2) The Narcotic Drugs and Psychotropic Substances Act, & Rules,1985; Govt. of India. 3) The Drugs and Magic Remedies Act, & Rules; Govt. of India 4) British National Formulary (BNF 46) Royal Pharmaceutical Society of Great Britain. 5) Medicines, Ethics & Practice A Guide To Pharmacists; Royal Pharmaceutical Society of Great Britain; Pharmaceutical Press, U.K. 6) FIP Statement of Professional Standards FIP Code of Ethics. 7) A Textbook of Homoeopathic Pharmacy Dr. D. D. Banerjee. th 8) Indian Pharmacopoeia, 5 Edition; Govt. of India. Good Pharmacy Practice - I.P.A. - C.D.S.C.O. - W.H.O. INDIA COUNTRY OFFICE - 39 -