MINISTRY

OF HEALTH TRINIDAD & TOBAGO

Manual of Procedures related to the Inspection of Antibiotics and Narcotics
December 1994
Prepared by the Drug Inspectorate, Ministry of Health

Manual of Procedures- Drugs Inspectorate Introduction The role of the drug Inspectorate regarding the purchase, distribution, storage and disposal of antibiotics/narcotics is ensure that pharmacies and firms which deal in these drugs observe the regulation which are set out in the Antibiotics Act Chapter 30:02 and the Dangerous Drug Act, 1991. This manual of products is intended to guide pharmacists in complying with the provisions of the laws. 1.Inspection Pharmacists are reminded that a Drug Inspector may visit the premises of any pharmacy or firm between of 8:00 am and 6:00pm for the purpose of conducting an inspection of antibiotics and narcotics. Records must be kept for two (2) years. 1.1.Invoices All invoices for antibiotics/narcotics must be recorded. Invoices may be registered in a book or kardex or computerized system and each entry must provide the following information: a) b) c) d) e) f) The date on which the drugs was received; The name of the firm from which it was received The invoice number; The amount received; The expiry date; The signature of the pharmacist

Where the inventory system is computerized, pharmacists will be expected to produce a hard copy on which each entry must be signed.

Manual of Procedures- Drugs Inspectorate Sample Date Received Name of Firm Feb 14, 1994 ABC 1.2 Prescriptions After dispensing an antibiotic/narcotic prescription the pharmacist must record the following information on the prescription: The number of the prescription. This is sequential number and it must be unique; The date it was dispensed; The amount dispensed; If the generic name is prescribed the trade name/manufacturer of the drug dispensed must be noted on the prescription. Similarly, if the strength of the drug dispensed is different from the strength prescribed, this must also be noted on the prescription. Sample Prescription As Received As D ispensed 12/3/95 12/3/95 John Doe John Doe Cap Ampicillin 500mg Cap Ampicillin 500mg 9 6 h 5 5/7 Q 6 h 5 5/7 900356-Rx Number Servicillin 250mg-40 Dispensed 13/3/95- Date Dispensed Invoice No. 10101010 Amount Recd Expiry Date Signature 500 Dec 31, 2000 J.Dec

Manual of Procedures- Drugs Inspectorate 1.3 Recording The following information on all prescription must be entered in the ledger a) b) c) d) e) f) Sample Date Dispensed Mar13, 1995 Prescription Name No. Patient 900356 John Doe Of Amount Dispensed 40 Name of Doctor W. Xyz Signature J.Dee The number of the prescription; The Date it was dispensed; The name of the patient; The amount dispensed; The name of the doctor; The signature of pharmacist.

Inventory Control Each pharmacist must maintain an inventory of antibiotics/ narcotics in a register. Receipts, issue and balances should be recorded in the register. Date of receipt/Issue Mar131995 Mar131995 Invoice/ prescription No. 900356 09357 Firm/ Patient Doctor Receipt 100 Issue 40 Balance 22 122 Signature J.Dee J.Dee

John Doe W.Xyz ABC

Manual of Procedures- Drugs Inspectorate 1.5 Firms 1.1.5 Records Proper records for all drugs, samples, must be kept. Records of return from pharmacies and expired drugs must be kept. A recording system in a book, card or computer must be used. This system should maintain the following information; i. ii. iii. iv. v. vi. vii. viii. ix. Sample Syr Ceclor 250mg/5ml 5 60ml Date Invoice Manufacture/Pharmacy Expiry Receipt No. Date Batch Number Mar,1 100 LMN Mar 12, 1994 1995 Mar, 09357 ABC June, 11994 1997 Batch Number Ab Rec Iss Bal Signed order No. 10 2 J.Dee Date of receipt/ issue of stock Quantity of receipt/issue Balance Invoice number Antibiotics/narcotic order (from pharmacist/doctor number; Name of manufacture/pharmacy/doctor Expiry date of drug Batch numbers of stock Signature of pharmacist

BN 74593 123 BN195786

500

502 J.Dee

Where the system is computerized, pharmacists will be expected to produce a hard copy on which each entry must be signed. 5

Manual of Procedures- Drugs Inspectorate 1.5.2. Returned Antibiotics/Narcotics Records of returns from pharmacies must be kept a) The following information on drugs returned from pharmacies must be provided b) The name of the antibiotics/narcotic c) The name of the pharmacy/doctor from which it was returned d) The quantity returned e) The expiry date of antibiotic/narcotic f) The date on which the antibiotic/narcotic was returned Sample Name of Name of Antibiotic/Narcotic Pharmacy/ Doctor SynalarN CR Lmn Drugs 1.5.3 Expired Antibiotics/Narcotics Some of the firms stock will expire. Firms will also receive drugs from pharmacies. The following information on expired drugs must be provided; a) The name of the antibiotic/narcotic b) The quantity expired c) The expiry date if the antibiotic/narcotic Note: To avoid keeping expired antibiotic/narcotic with good stock it is suggested that the record of all expired drugs be removed from the register and kept separately on an Expired Drugs register. Sample Name of Quantity Antibiotic/Narcotic Expired Tobradex Eye 10 vials Drops 6 Expire Date Mar 1, 1994 Date Destroyed May 5, 1994 Signature of Inspector A.Bee Quantity Returned 12 tubes Expiry Date Date of Return

Mar 10, 1994 Jan 12,1994

Manual of Procedures- Drugs Inspectorate A firm should contact the Drugs inspectorate to have its expired antibiotics/narcotics destroyed as soon as the stock has expired. Provision should be made for the Drug Inspector to sign the register and record the date when destruction is done. 1.6 Pharmacies 1.6.1 Returned Antibiotics/Narcotics Pharmacists must provide supporting documentation as evidence of the return of antibiotics/narcotics to the supplier. This may take the form of a duplicate book entry, which gives a) b) c) d) e) Note: These will be checked against the firms records 1.6.2. Expired Antibiotic/Narcotics a) b) c) d) The Following information on expired drugs must be provided The name of the antibiotic/narcotic The quantity expired The expiry date of the antibiotic/narcotic The date on which the antibiotic/narcotics were returned The quantity returned The expiry date of the antibiotics/narcotics The firm to which it was returned The signature of the pharmacist

Note: To avoid keeping expired antibiotics/narcotics with good stock it is suggested that record of all expired drugs be removed from the register and kept separately on an Expired Drugs register. See Sample Above 7

Manual of Procedures- Drugs Inspectorate Opening/relocation/closure 2.1 Firms 2.1.1. Opening and Relocation Pharmacists are required to inform the Drug Inspectorate of their proposal to open a new firm or relocate to new premises as early as possible before the date of opening or relocation. The drug Inspectorate will inspect these premises for the following: a) Locked room and cupboards, with permanent labeling of Antibiotics on the outer side of the doors b) Locked room and cupboards, with permanent labeling of Narcotics on the outer side of the doors c) Adequate warehousing storage A recording system in a book , card or computer must be used . This system should maintain the following information: I. II. III. IV. V. VI. VII. VIII. IX. Date of receipt/issue of stock Quantity of receipt/issue Balance Invoice number Antibiotic/narcotic order (from pharmacist/doctor) number Name of manufacturer/pharmacy/doctor Expiry date of drug Batch numbers of stock Signature of pharmacist

Manual of Procedures- Drugs Inspectorate Sample Date of Invoice Manufacture/Pharmacy/Doctor Expiry Batch Receipt/issue No. Date Number Mar, 1 1994 Mar, 1 1994 Where the system is computerized, pharmacists will be expected to produce a hard copy on which each entry must signed. A Drug Inspector will inspect the new premises within five (5) working of the receipt of the notification. 2.1.2 Closure Pharmacists are required to notify the Drug Inspectorate when there is a proposal to close a firm. On receipt of this notification a Drug Inspector will visit the premises within five (5) working days to verify the closing stock. An antibiotics and narcotic will be to the custody of the Drug Inspectorate until arrangement are made for disposal stock or reopening. 2.2 Pharmacies 2.2.1 Opening and Relocation Pharmacists are required to notify the Drug Inspectorate of their proposal to open a new pharmacy or relocate to new premises as carly as possible, before the date of opening or relocation. The drug inspectorate will inspect these premises for the Following: a) Locked cupboards with permanent labeling of Antibiotics on the outside of the doors; 100 09357 LMN ABC Mar 12, 1995 June, 1997 BN74593 AB Rec Iss Bal Signed order No. 123 10 2 J. Dee 500 502 J.Dee

BN195786

Manual of Procedures- Drugs Inspectorate b) Locked cupboards with permanent labeling of Narcotics on the outer side of the doors. A recording system in a book, card or computer should be used. This system maintain the following information I. II. III. IV. V. VI. VII. Date of receipt/ prescription Invoice/ prescription number Name of the firm/patient Expiry date of drug Name of doctor Receipt/issue/balance Signature of pharmacist

Where the system is computerized, pharmacists will expected to produce a hardcopy on which entry must signed. A drug inspector will inspect the new premises within five (5) working days of the receipt of the notification. 2.2.2. Closure Pharmacists are required to notify the Drug Inspectorate when there is proposal to close pharmacy. On receipt of this notification a Drug Inspector will visit the premises within (5) working days to verify the closing stock. All antibiotics and narcotics will be removed to the custody of the Drug Inspectorate until arrangements are made for disposal of stock reopening. 3. Relocation/Change Of Pharmacist Pharmacists must notify the Drug Inspectorate as soon as possible before the last day on which they will work at a pharmacy or firm. Pharmacists must complete handover/takeover procedures before departure. In the absence of an incoming pharmacist a Drug Inspector will the premises on a pharmacists last working day to verify the closing stock. Antibiotic licences issued for the current year will be returned to the Drug Inspectorate

10