1. Lecture – 5 11-04-2012 25-04-2012 DR. SHAHNAZ USMAN Associate Professor Dept. of Pharmaceutics RAKMHSU Narcotic drugs and Psychotropic substances Act 1

2. Contents: 1.Recording Controlled Drugs. 2.Administering the Narcotics in Private Hospitals. 3.Management of CDs in hospital pharmacies: Accountability and responsibility. 4.Security, Ordering and Receipts. 5.Labeling of Controlled Drugs. 6.Registers for Controlled Drugs. 2

3. Recording Controlled Drugs  In Pharmacies and Stores, the law requires all transactions relating to Narcotics and CDA (Psychotropic) drugs to be recorded in a register.  These registers are available from Ministry.  Separate registers should be kept for Narcotics, CDA and CDB.  At the level of the ward or department a Narcotics register is required. 3

4. For Narcotic and CDA drugs the register must;  Be bound (cannot contain loose pages).  Contain separate sections for each individual drug.  Have the name of the drug specified at the top of each page.  Have the entries in chronological order  The date of each transaction must be clear and each entry must be made on the same day of the transaction.  Have the entries made in indelible ink. 4

5.  Not have cancellations, obliterations or alterations. If a correction is required, make a comment in the “Remarks” section and make the corrected entry in the next available line below.  Be kept at the establishment to which it relates and be available for inspection at any time.  A separate register must be kept for each establishment.  Be kept for a minimum of five years after the date of the last entry.  Not be used for any other purpose. 5

6. Other important Narcotic and CDA Recording Responsibilities include: 1.Clinical area: At shift changes, nurses must have a formal handover of the narcotic drugs including a check of the inventory. 2.Hospital Pharmacy: Must keep an up to date specimen signature record of the prescribers and nurses who order narcotics drugs. 3.Ensure that there is a program of internal narcotic inspections at ward level. This should be agreed with the director of nursing and this should include an independent review of registers and inventory every 1-2 month s. 6

7. 4.Private Pharmacy: Keep all invoices and prescriptions for CDAs for 5 years. 5.Drug stores: Keep all invoices (from vendors) and delivery notes (to UAE customers) for CDAs for 5 years. 6.Private clinics: Physicians in private clinics must NOT keep samples of controlled medicines. 7

8. Administering Narcotics in Private Hospitals:  Before a narcotic drug can be administered there must be a valid physicians order and a completed Narcotic Prescription form.  The nurse in charge must have control of the Controlled Drug cupboard keys and remove the prescribed drug from the cabinet and with a witness (another nurse, the physician or a pharmacist), check the balance in stock.  The cupboard is then re-locked and the dose can be prepared. 8

9.  In some specialist settings, e.g. the operating room, the direct control of the narcotics may be under a physician and each anesthetist may have their own dedicated narcotics cabinet and register.  The following Figure is an example of an In-patient “Narcotics Prescription form" 9

10. 10 Narcotic Drug Prescription

11. Measuring Oral liquids:  Oral liquids, example: Morphine solution 2mg/5mL must be measured using an oral syringe NOT a measuring cup or spoon.  Using an ampoule for more than one patient.  For each narcotic ampoule that is used there should be at least one narcotic prescription form.  A narcotic ampoule / vial can be used for more than one patient 11

12.  Example: on a Neonatal Intensive care unit or Ketamine during an operating session.  However, there must be a narcotic prescription form for each dose and the form must clearly state that there was another form relating to the same ampoule /vial.  The reference number of the other form(s) should be recorded on each narcotic prescription form. 12

13.  Discarding part-used / excess injection.  If the dose requires only part of an ampoule the excess must be discarded in the presence of a witness before administering the dose.  The discarding of the excess must be recorded in the register (counter-signed by the witness).  The empty ampoule is returned to the cupboard. 13

14. Witnessing administration:  Administration to the patient should be witnessed by a second nurse.  If the dose is to be given via infusion the second nurse should witness the start of the infusion.  The witness must sign the narcotic prescription sheet. 14

15. Unused doses:  If the dose has been prepared for administration but cannot be given for some reason e.g. patient refuses, the dose cannot be returned to stock.  The dose must be discarded in the presence of a witness.  The discarding of the unusable dose must be recorded on the narcotic prescription form (countersigned by the witness). 15

16.  After administration, the dose must be recorded in the register and the completed narcotic prescription form is filed according to the date.  There are no special prescription-requirements for ordering psychotropic CDB drugs for in or out- patients and therefore these are ordered using a normal medical prescription. 16

17.  In accordance with Federal Law No. 4 (1983), the minimum legal requirement for a medical prescription in the UAE includes; 1.Prescriber must have a valid UAE medical license. 2.Name and stamp of the prescriber must be clear 17

18. Management of CDs in hospital pharmacies: Accountability and responsibility  The chief pharmacist is responsible for the safe and appropriate management of CDs in the pharmacy.  Day-to-day management of CDs (for example, receipt into and issue from dispensary stock) in the pharmacy will normally be delegated to a suitably-trained, competent registered pharmacy technician or pharmacist.  However, legal responsibility for CDs remains with the Chief Pharmacist. 18

19. Security of CDs:  The pharmacy should have standard operating procedures (SOPs) covering each of the aspects of the safe management of CDs such as ordering, receipt, record-keeping etc.  SOPs should be kept up-to-date, reflecting current legal and good practice requirements for CDs, and each one should be clearly marked with the date of issue and review date. 19

20. Ordering and Receipt:  Ordering of CDs from wholesalers and manufacturers and receipt of CDs should follow the principles of good procurement.  Local procedures should ensure that there is a robust audit trail and that the opportunities for diversion are minimized. 20

21. Ordering :  Routine orders to wholesalers and manufacturers for Controlled Drugs for stock.  Stock levels should be determined by need and kept to a minimum, but should not be so low that there is a danger of running out at busy periods.  This will normally be calculated by the pharmacy stock management system.  It may be necessary to increase stock levels temporarily when it is anticipated that there may be a greater demand, for example, during long holiday breaks. 21

22. Receipt :  There should be a local procedure for the receipt of CDs into the pharmacy department.  The procedure should ensure the security of CDs and should be auditable.  It should include: 1.Who should sign for receipt. 2.How the goods should be checked (e.g. matching of the details on the delivery note to the goods) and appropriate stock control documentation completed. 22

23. 3.Any tamper-evident seals on packs should be left intact when they are received from the supplier. This will simplify and speed up routine balance checks. 4.If when the tamper evident seal is broken, the contents do not match the expected amount stated on the pack, the pharmacy should contact the supplier. 5.The action should be taken if the item received is incorrect. 23

24. 6.Arrangements for storage of incorrect items for return, if appropriate. 7.Specifications of the entry required in the register including who should make the register entry and whether a witness is required.  It is good practice to record the receipt at the first opportunity, and in any event no later than 24 hours after receipt.  As a matter of good practice the balance in stock should be checked and recorded and corrected by the person making the entry. 24

25.  The stock must be put away into the appropriate section of the Controlled Drug cabinet promptly Storage :  Pharmacy CD cabinets must comply with the Misuse of Drugs (Safe Custody) Regulations.  This is a minimum security standard and may not be sufficient for areas where there are large amounts of CDs in stock at a given time and/or there is not a 24-hour staff presence or easy control of access. 25

26. Issuing of CDs to wards and departments:  There should be a local procedure for the issuing of CDs to wards and departments.  The procedure should ensure the security of the CDs and should be auditable. It should include:  The procedure for checking that the requisition is valid (complete and signed by an authorized signatory– names should be detailed in local SOPs).  The mechanism for correcting an incomplete or inaccurate requisition. 26

27. Specifications of the details required on Registers:  Specification of entry required in the register including who should make the register entry?  Whether a witness is required. The decision as to whether a witness is required or not should be made following a risk assessment.  Arrangements for transfer of the CDs to the ward or department. 27

28. Electronic systems :  Where electronic systems for the requisitioning of CDs are introduced, safeguards in the software should be put in place to ensure that: 1. Only individuals who are authorized to requisition CDs from the pharmacy can do so 2. Entries cannot be altered at a later date 3. A log of all data entered is kept and can be recalled for audit purposes. 28

29. Labeling of CDs  There should be a standardized procedure for labeling CDs.  The label should state: Drug name, form and strength Quantity “Store in CD cupboard” Department / ward name or number Date of issue “Keep out of reach and sight of children” 29

30. Expiry date if dispensed from bulk. (Certain preparations have a reduced expiry once opened). Address of pharmacy.  Depending on local circumstances, some pharmacies may also wish to add The requisition number The batch number of a product that has been dispensed from bulk  Each carton, syringe or bottle must be labeled individually.  In addition, labels may also be placed on outer wrappers or containers. 30

31. Record-keeping in Pharmacy: CD Registers:  Pharmacy department are required to keep registers of receipts and supplies CDs. a. Register entries must be made in consecutive, chronological order. b. The entry must be made on the day when the drug is received or supplied, or on the next day. c. Entries must be in ink or be otherwise undeletable. 31

32. d. If a mistake is made the entry should not be crossed out, deleted, obliterated or defaced; liquid paper must not be used. e. If an error is found, it must be bracketed and accompanied by a clearly recognized signature; the balance shown should be accurate and easily read.  A footnote should be added to explain the alteration. 32

33. The following staff may complete the CD register:  Any registered pharmacist under their own authority.  Any competent member of Pharmacy staff, ideally a regulated healthcare professional under the authority of the chief pharmacist, provided this is included in the SOP.  Any person who is being trained by a competent member of pharmacy staff, such as a trained technician or a pharmacist, under their supervision.  The supervisor should countersign entry 33

34.  Each drug form and strength should be on a different page in the register.  The drug name, form and strength must be written at the top of the page.  An index should be kept at the front of the register.  For CDs supplied, the register entry must also include: Date of transaction. Name and address of person/ department supplied. 34

35. License or authority of person/department supplied. Amount supplied. Form in which supplied. Name of patient, if individually dispensed.  For CDs received into stock the following details must be recorded in the CD register: The date on which the CD was received. The name and address of the supplier, e.g. wholesaler, pharmacy. 35

36. The quantity received. The name, form and strength of the CD.  The stock balance in the register should be checked against both the quantity in the CD cabinet and the balance shown in the pharmacy stock control system.  The frequency of such checks should be determined locally following a risk assessment. 36

37.  The 2001 Regulations were amended in July 2006 to make clear that the record keeping requirements of the CD Regulations are a minimum and can not be prevented, a person is required to keep a register for including additional relevant information.  Additionally in the CD Register, a separate part of the CD Register used for each class of drug, separate pages (in paper) or sections for each strength and form of CD will be required. 37

38.  The name, strength and form of the drug must be entered at the top of each page or section and the mandatory fields of information recorded under the specified headings. 38

39. SUMMARY ON REGISTER ENTRIES:  For CDs supplied, the register entry must also include: Date supplied Name/address of person or firm supplied Details of authority to possess, prescriber or license holder details Quantity supplied  For CDs obtained the following details must be recorded in the CD Register Date supply received Name and address from whom received Quantity received 39

40. References: 1.Pharmacy Law and Practice by Jonathan Merrills and Jonathan Fisher, Fourth Edition 2006 (Elsevier) 2.Pharmacy Practice and The Law by Richard R. Abood, Fifth edition 2008 (Jones and Bartlett Publishers). 3.A textbook of Forensic Pharmacy by N.K.Jain, seventh edition, pg no. 20. 4.Text book o Forensic Pharmacy by CK Kokate, Pharma Book Syndicate, pg.no. 19. 40

41. 1. What’s the criteria should follow for the recording of narcotic and psychotropic drugs? 2. What will be the quality of register for maintaining the records of Narcotic and CDA drugs? 3. What is the procedure for measuring Oral liquids? 4. At the time of administration of narcotic and psychotropic drugs what is the importance of the presences of witness? 5. Explain the procedure for unused dose of CDs 6. Explain the procedure for Ordering and Receipt of 7. Discuss the label requirement for CDs 8. What types of information should be present in CDs register 41