PROPOSED GUIDELINES FOR PRESCRIPTION WRITING & HANDLING FOR DRUGS HAVING MISUSE/ABUSE POTENTIAL (Proposed by FDA, Goa

at the Stakeholders Meeting Held on 23rd September, 2009) [Stakeholders present : IMA, Goa Medical Council, Goa Medical College, Goa College of Pharmacy, DHS, Chemists & Druggists Association, IPA] Extra special care needs to be taken for such drugs in prescribing, handling, storage, and dispensing : BENZODIAZEPINES i) Diazepam containing products ii) Alprazolam containing products iii) Lorazepam iv) Nitrazepam v) Flurazepam vi) Midazolam vii) Clonazepam viii) Clobazam ix) Chlordiazepoxide containing products OTHERS i) Pentzocaine ii) Buprenorphine iii) Dextropropoxyphene NON BENZODIAZEPINES i) Zopiclone ii) Zolpidem iii) Eszopiclone iv) Etizolam v) Phenobarbitone vi) Pentobarbitone

OTHER DRUGS WHICH HAVE HABIT FORMING/ABUSE/ADICTION POTENTIAL or could be MISUSED OR HARMFUL : 1. Codeine containing products 2. Tramadol containing products 3. Modafinil 4. Misoprostol 5. Mifepristone 6. Sildenafil citrate 7. Ketamine

Only a R.M.P. (Registered Medical Practitioner) who has registered with the respective State Medical Council is authorized to prescribe allopathic drugs. A R.M.P. includes an allopathic doctor (Minimum M.B.B.S), a Dentist (minimum B.D.S), a Veterinarian (minium BVSc). However, it is understood that a Dentist should prescribe only those drugs which are related to, and needed for his/her profession, and for his/her patients only; It is also understood that a Veterinary Doctor should prescribe only those drugs which are related to and needed, for his/her profession, and for his/her veterinary patients only; An Ayurvedic doctor, a Homeopathic doctor, etc. are NOT authorized to prescribe/recommend allopathic medicines. A Nurse or Pharmacist is not authorized to recommend allopathic prescription medicines to their patients. Unqualified persons or persons with dubious and unauthorized degrees, not recognized by the Govt. of India are also not authorized to prescribe allopathic drugs (These individuals are termed as Quacks). 1

 Special care and precautions are needed in prescribing drugs listed above, to avoid their misuse. For safety and proper handling of prescription, such drugs should be written on a separate prescription; Doctor should take extreme care in prescription for above drugs in the best interest of public to avoid their misuse. Certain medicines can be supplied on the prescription of doctors of a particular specialty only: e.g. Sildenafil Citrate : Urologist, Psychiatrist, Endocronologist, Dermatologist, Venerologist e.g. Letrozole : Cancer specialist/Gynaecologist/Institution/Hospital only

COMPLETE PRESCRIPTION FROM A PRIVATE DOCTOR (It is important to follow the format to ensure proper use of drug, avoid and detect any forgeries) Dr. Full Name, M.B.B.S., M.D. Reg. No.: GMC xxxx Address : Full Address, Tel No.: xxxxxxx Date : 29/8/2009 Patients Name : _______________________ Patients Address : _________________________________ Rx 1. Valium 5 mg 1 tab at night x 20
Name of the drug and its potency, total quantity recommended Space for Pharmacy to put a Dispensed Stamp Usual signature of Doctor (not a scribble), & dated by Dr. Rubber Stamp of Dr. with name, Qual, Reg.No. ________________________ To avoid refilling of prescription Prescription on a letterhead, with Doctors full name, Qualifications, GMC Reg. No., Full address, Tel. No. Date Patients Full name & address

--- 20 tab

DISPENSED Date : _____ Pharmacist :____ Name of Pharmacy City

Doctors usual sign, Dated Dr.s Full name, Qual(MBBS),Reg.No

DO NOT REFILL (DISPENSE ONLY ONCE)

COMPLETE PRESCRIPTION FROM A PUBLIC HOSPITAL

Medicine O.P.D. No. 12, Goa Medical College, Bambolim Tel. No. : xxxxxxxxxxxx Date : 29/8/2009 Patients Name : _______________________ Patients Address : _________________________________ Rx 2. Valium 5 mg 1 tab at night x 20

Prescription on a letterhead, (printed, computerized or using a rubber stamp Name of Dept., Full address, Tel. No. Date Patients Full name & address Name of the drug and its potency, total quantity recommended ---------------------------------Space for Pharmacy to put a Dispensed Stamp Usual signature of Doctor (not a scribble), & Dated Rubber stamp of Doctor containing Full Name, Qualification, G.M.C. Reg. No. To avoid refilling of prescription

--- 20 tab Usual Sign of Doctor Dated Doctors Full name, Qual. (M.B.B.S.), G.M.C. Reg. No.: xxxx

DISPENSED Date : _____ Pharmacist :____ Name of Pharmacy City

DO NOT REFILL (DISPENSE ONLY ONCE)

Note : 1. 2. 3. 4. 5. 6. Keep your Letterheads/prescription blanks secure to avoid misuse. Avoid overwriting. In case of overwriting, please countersign. Prescription may be typed, but has to be signed by Doctor in indelible ink. It is not good practice to allow nurses/assistants to write such prescriptions. Only allopathic doctors (including Dentists, Veterenirarians) can prescribe allopathic medicines. For safety, and to avoid misuse, use a separate prescription for such drugs. Ensure that the exact quantity to be dispensed is written - Do not write such things as Continue..

7. DO NOT prescribe/recommend such drugs over telephone or SMS. 8. Pharmacies are authorized to refuse to dispense prescriptions which do not confirm to the above format. 9. If Pharmacies dispense prescriptions which do not confirm to the above format are liable to be prosecuted under the Drugs & Cosemtics Act & Rules thereunder

VERY IMPORTANT : a. Above listed medicines should not be prescribed (recommended/told) to patients or pharmacy over the telephone or though text messages (SMS). Pharmacies are not authorized to dispense against such orders, for such drugs, and have the right to refuse to dispense. b. Quantities prescribed for such types of drugs should be reasonable. It is advisable to give due justification for large quantities of a particular such drug prescribed. If any doctor misuses his powers to indiscriminately prescribe large quantities for other than justified medical use, the Medical Council has the powers to deal with the doctor. Pharmacies are authorized to refuse to dispense such prescriptions if they suspect any misuse.

HELP THE PHARMACY TO SERVE YOUR PATIENTS BETTER HELP THE FDA TO IMPLEMENT THE DRUG LAWS PRESCRIPTIONS WRITTEN ON LETTERHEAD OF A PRIVATE HOSPITAL Generally it is advisable that doctors should prescribe medicines on their own letterhead. In case the doctor has not carried his letterhead to the hospital or the clinic of another doctor where he writes the prescription, and if the prescription is written on a letterhead of a private Hospital, following points need to be included in addition to the guidelines for prescription writing for private doctors : 1) Prescribing doctor should put his rubber stamp bearing his full name, qualification, & Reg. No. 2) Prescribing doctor should sign his usual signature and date it. If, the rubber stamp is not carried/not available, the doctor should write his full name, qualification, Reg. No. (A doctor should avoid writing a prescription on the letterhead of another doctor).

DOCTORS AND HOSPITALS PURCHASING DRUGS

1. As per Schedule K of the Drugs & Cosmetics Act, a qualified doctor can purchase medicines for use for his patients. If purchased for use for his patients, the doctor must keep a record of the details of dispensing the drugs; 2. While ordering, the doctor must issue a written order on a letterhead to the wholesaler/pharmacy, containing all the details of a complete prescription. The doctor must further justify/state for what purpose he wishes to procure the medicines (e.g. for use in his patients, for use in his clinic/hospital, or for personal use); 3. It is compulsory for the wholesaler/pharmacy to retain such written orders from the doctor for a period of 2 years. A wholesaler/pharmacy is authorized to dispense medications to the doctor only on the strength of a proper complete written order. 4. It is mandatory for the doctor to maintain a detailed record of the medicines purchased against such orders this includes maintaining the batch number and quantity purchased along with the invoice, and also a record of the medicines dispensed to his/her patients name and address of patient, name of medicines, quantity, batch number. These records are open to inspection by the Inspectors/authorities of the FDA. 5. It is not a correct practice to write self on a prescription and ask the patient to buy directly from the wholesaler or pharmacy. A doctor is expected to maintain records of such medicines purchased. 6. If a doctor visits a pharmacy and asks for a drug, the pharmacy is authorized to refuse to dispense the drug unless he is presented with a proper written order for the drugs by the doctor, which indicates his qualifications and registration number. In any event the pharmacy is within its rights to refuse to honor a self prescription for scheduled drugs. The written order needs to be kept by the pharmacy for a minimum of 2 years.

GUIDELINES FOR PHARMACIES/CHEMISTS & DRUGGISTS PURCHASE & STORAGE : The Pharmacy owner and Pharmacist should ensure that all the staff members are provided information and given training in handling of such medicines, and the need for such careful handling.
a) Only minimum quantities required should be ordered, as required, from authorized distributors/wholesaler/supplier, having a proper wholesale drug license. Prefer to stock reputed brands only. Avoid over stocking. b) These drugs should be checked as soon as they are received from the wholesaler One must tally the quantity, batch and expiry date on the medicine received with that on the invoice of the supplier (If any of these do not tally, please bring it to the notice of the supplier, and get it rectified from them immediately either as a new corrected invoice, or corrections done in pen and countersigned by the Qualified Person and rubber stamped). Please do not do the changes/corrections on the invoice yourself).

c) Once checked, these drugs should be immediately transferred to a specially designated cupboard, meant to stock only such drugs, and under lock & key. The Key should be with a responsible person. d) As a matter of caution it is advisable to check and tally these drugs from time to time to ensure that there is no pilferage. SALE/DISPENSING : A) These medicines should be sold strictly ONLY against a fresh prescription of a qualified/authorized doctor. B) A prescription which has been dispensed once should be stamped Dispensed on..date.. and signed by the Pharmacist, and should not be dispensed again unless the doctor indicates on the prescription that the prescription may be refilled, In such cases the doctor must indicate the number of times the prescription may be refilled and on each occasion the pharmacist should stamp the dispensed on date.

DISPENSED
Date : ______ Pharmacist :

______

Name of Pharmacy CITY

C) The pharmacist should check the prescription carefully for various aspects, as listed in the Guidelines for prescription writing for doctors, and ensure that it is complete in all respects. D) A Pharmacy has the right to refuse to dispense a prescription if : 1) ANY one or more of those listed items meant to be in a prescription are missing, incomplete or improper. 2) The Pharmacy has any doubt about the prescription - eg suspicion of forgery, overwriting, prescription written by an unqualified person. 3) The medicine/s prescribed are of unduly large quantities, and suspicious of misuse. E) The Pharmacist should double check the medicine being dispensed, by tallying against the prescription. He/she should double check the quantity on the prescription, actual quantity dispensed, and actually quantity billed. He/she must ensure that batch and expiry date on the medicine dispensed tallies with that on the bill. In case the patient wishes to purchase a quantity less than that prescribed, this could be indicated at the dispensed on stamp and an entry made as to the quantity purchased. F) The cash memo/bill should be complete in all respects It should contain the full name and address of the patient, name of the drug/s, Schedule, batch number, date of expiry, name of manufacturer, quantity dispensed, price, and signature of the Pharmacist. G) It must be ensured that the Pharmacist on duty signs every such bill, and his signature appears on the carbon/duplicate copy as well. H) A bill/cash memo should be made for every such medicine sold and a record of such medicines purchased and sold should be available whenever asked for, batch wise, quantity wise. I) The Pharmacist under whose supervision the medicine/s is dispensed should put a DISPENSED stamp on the prescription below the prescribed medicines. He/she should then date and sign it. J) A pharmacy need not keep a copy of the prescriptions dispensed.

K) If a part of the prescribed quantity is dispensed, the pharmacy must put the Dispensed stamp and write the quantity dispensed next to the Dispensed stamp, so that when the same prescription is produced next time by the patient, the balance quantity can be dispensed.

The owner of the Pharmacy must ensure that these medicines are sold ONLY when the pharmacist is present and under his/her personal supervision.

GUIDELINES FOR WHOLESALERS The owner of the wholesale distribution should ensure that all the staff members are provided information and given training in handling of such drugs, and the need for very careful handling.
PURCHASE AND STORAGE a) Only minimum quantities required should be ordered, as required, from authorized distributors/suppliers/C&F agents or manufacturers, having a proper wholesale drug license. One should prefer to stock reputed brands only, and avoid over stocking. b) These medicines should be checked as soon as they are received from the suppliers One must tally the quantity, batch and expiry date on the medicine received with that on the invoice of the supplier (If it does not tally, bring it to the notice of the supplier/manufacturer, and get it rectified from them immediately either as a new corrected invoice, or corrections done in pen and countersigned by the Qualified Person and rubber stamped). Please do not do the changes/corrections on the invoice yourself). c) Once checked, these should be immediately transferred to a specially designated shelf/cupboard, meant to stock only such drugs, and under lock & key. The Key should be with a responsible person. Sale to Retailers & Doctors/Hospitals : A) Wholesalers must sell to only retailers who are having valid retail drug license under Drugs & Cosmetics Act to stock such drugs B) Wholesalers should be doubly careful if any retailer asked for too (how much is too much?) much stock of such drugs. One should deal with such matters on a case to case basis. C) Orders for such drugs from Retailers must be on the letterhead of the retailer, rubber stamped and signed by the Pharmacist. D) It is advisable to make separate bills/invoice for any such drugs. And it is advisable to receive payments for such invoices by crossed cheque of the pharmacy/retailer only. E) Sale of such drugs to doctors/hospitals must be strictly against a written the order on a letterhead with all the doctors details, signature and date. If from a hospital, the order must be from the hospital pharmacist countersigned by the administrator or by a qualified doctor) letterhead of the doctor or the hospital, bearing all the details as per Guidelines. The doctor must be an authorized, qualified R.M.P. Such sale cannot be done to or against the prescription of unqualified doctors. 7

F) The record of receipt and sale of such drugs must be conveyed to the FDA once before the 5 th of every month. G) The wholesaler must keep a hard copy of all the orders received from doctors/hospitals and retailers, and retain the same for at least 2 years. H) The quantity sold against such orders must not be more than that ordered. I) The invoice should be complete with respect to name and address of the doctor/hospital or the pharmacy to whom sold, drug license number, name of the drug, quantity, batch number, expiry date, Schedule, price, and the signature of the Competent person. J) The Competent Person must ensure that the quantity, batch and expiry of the drug dispensed actually tallies with that on the invoice K) Such drugs must be dispensed only under the personal supervision of the Competent Person. Owners must ensure that such drugs are not sold in absence of Competent Person. L) The wholesaler must be able to produce the records of purchase and sale of all such drugs.

DOCTORS/PHARMACISTS/PHARMACY OWNERS ARE REQUESTED TO MAKE SUGGESTIONS TO THE PROPOSED GUIDELINES. PLEASE SEND IN YOUR SUGGESTIONS THROUGH YOUR LOCAL BRANCH/ASSOCIATION BY 10 th October, 2009.