2005 Edition Report on Drug Administration Procedure & Practices ...

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4. As with all medications, there should be an efficient and effective mechanism for recallingdrug samples when circumstances require. Different hospitals may have different practicesin the record keeping of drug samples, and, to date, there is still an absence of a quick andeffective way for retrieving the medication records for drug samples and recalling themfrom patients. For instance, cerivastatin (Lipobay®) was withdrawn globally in August2001 due to the occurrence of a fatal adverse effect of rhabdomyolysis and myopathy whenit was co-prescribed with fibrates. Although cerivastatin was not yet listed in the HA drugformulary at the time, it was being used as a drug sample in many HA hospitals. The globalwithdrawal necessitated an urgent recall from the hospitals. However, being a nonformularydrug, cerivastatin was not coded in the same way as other formulary drugs in theHA computerized pharmaceutical system. The recall had to be conducted by a manualsearch through each individual dispensing record under the Corporate Drug DispensingHistory (CDDH) system, which had proved to be an inaccurate and lengthy process.Mishandling of these situations could even result in delayed actions and seriousconsequences.5. The provision of free drug samples poses another problem of managing patients’expectation. When the drug samples are no longer free, doctors will face the dilemma ofeither continue prescribing the new drug, which in many cases are more expensive than thecurrent ones, or to change back to their usual preferred drugs. However, once the medicalconditions of the patients are stabilised with the drug sample, it would be difficult toconvince them that their therapy would be discontinued or changed to an alternative, unlessthe situation has been clearly explained to them prior to commencement of the drug sample.HA Drug Sample Policy6. In view of the above discussed issues associated with the handling of drug samples, it isimportant that a formal mechanism should exist for the control of drug samples in the HA.The JCAHO (Joint Commission on Accreditation of Healthcare Organisations) providesstandards for medication use in hospitals and institutions in the US. The JCAHO standardrequires that there should be a policy and procedure related to the control of drug samplesthroughout the institution. In addition, all other standards applicable to medication useapply to drug samples to the same extent as they apply to regular prescription medicationsdispensed by the hospital pharmacy.7. Proposed mechanism for the management of drug samples in the HA :7.1 There should be a system (defined by policy and procedure) for the control,accountability and security of all drug samples throughout the hospital and affiliatedclinics. The hospital Drug & Therapeutics Committee (DTC) (or an equivalentcommittee) would be a suitable body for overseeing the system.7.2 Only registered drugs should be used as drug samples.7.3 Hospitals are not required to introduce drug samples as formulary drugs beforeallowing for trial use in their institutions.7.4 Request for the use of drug samples by an individual doctor within the hospital willbe submitted through the COS to the hospital DTC for record. The COS will decideon and be accountable for all the drug samples used within his/her department. Eachrequest will clearly indicate the following details :7.4.1 indications for the use of drug sample; whether it is the only treatment optionor an alternative treatment option with claimed benefits over existingformulary drugs2
Action7.4.2 types of patients to be treated7.4.3 estimated number of patients to be treated7.4.4 duration of treatment for each patient7.4.5 total trial period7.5 Patients should be fully informed that the drug samples prescribed for them are fortrial use over a definite period only. The efficacy and safety of the drug sampleswould require further evaluation. HA could not commit to provide these drugsamples on a long-term basis. An information pamphlet for patients receiving drugsamples will be designed by HAHO and issued to hospitals for future distribution.7.6 Hospital DTC will inform HAHO (via CPO) of the use of drug sample in itsinstitutions. This will enable HAHO to keep an updated record of all the drugsample used in the HA, and facilitate appropriate action to be taken promptly if anyurgent situation such as recall or medication incidents should occur.7.7 Hospital DTC is responsible for the monitoring of the progress of the use of drugsamples in its institutions. If hospital DTC and the CPO have been notified of theuse of the drug sample, and that it is prescribed according to hospital guidelines, HAshould be able to cover liability associated with its use as with other formularydrugs.7.8 All drug samples must be stored by the pharmacy according to the manufacturer’sspecifications and prevailing law and regulation.7.9 Drug samples should be labeled and dispensed according to the same standardisedmethod that the hospital uses for non-sample medications i.e. dispensed throughhospital pharmacy.7.10 Documentation requirements for drug samples should be the same as for other nonsamplemedications ordered and dispensed by the hospital i.e. written records forordering and administering in hospitals should be kept on the MAR, and on MOE orprescriptions for out-patients. Computerised records should be kept on the CDDH(Corporate Drug Dispensing History) system and should be easily retrieved whenrequired.7.11 The recall mechanism for drug samples should be efficient and effective, and shouldfollow the same procedure that exists for other formulary drugs in the HA. Inaddition to the computerized records, a manual record may be kept by the hospitalpharmacy if such record keeping facilitates the recall procedures and is convenientto update.7.12 As with other medications, it is expected that significant medication errors andsignificant adverse drug reactions that occur with sample drugs are identified,reported and reviewed according to the same procedures for other drugs listed in theHA i.e. using the same MIRP and ADR reporting systems and indicating that thedrugs implicated are drug samples.8. All hospitals are advised to observe the recommendations outlined above in para 7 and todevise a hospital drug sample policy accordingly. These should be forwarded to HAHO forrecord.HAHO Feb 023
Page 2 and 3:
ForewordMedication safety and provi
Page 4 and 5:
Chapter 6 summarizes the specific r
Page 6 and 7:
Chapter 6Conclusions and Recommenda
Page 8 and 9:
CHAPTER ONETHE WORKING GROUPMEMBERS
Page 10 and 11:
CHAPTER TWOTHE PROGRESS REPORT2.1 P
Page 12 and 13:
CHAPTER THREEAREAS FOR IMPROVEMENT
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Existing In-patient Drug Administra
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Existing In-patient Drug Administra
Page 18 and 19: Existing In-patient Drug Administra
Page 20 and 21: Existing In-patient Drug Administra
Page 22 and 23: CHAPTER FOURRECOMMENDED PRACTICES A
Page 24 and 25: Drug Name4.11 There should be a hos
Page 26 and 27: Electronic prescribing (Medication
Page 28 and 29: 4.46 When the use of CM is permitte
Page 30 and 31: cytotoxic and central intravenous a
Page 32 and 33: 4.72 Special precautions should be
Page 34 and 35: 4.84 To prevent mixing up medicatio
Page 36 and 37: The Principle of Three checks and F
Page 38 and 39: 4.111 Three-way (red and blue) and
Page 40 and 41: or their discharge or death, should
Page 42 and 43: operational requirement but also it
Page 44 and 45: Quality Complaints on Pharmaceutica
Page 46 and 47: LEVELSHAHOCE / DTOOLS & MECHANISMDU
Page 48 and 49: Medication Incident Report<
Page 50 and 51: Continuing Education6.18 In order t
Page 52 and 53: APPENDICESAppendix 1Appendix 2Appen
Page 54 and 55: Hospital Authority Hospital No. : I
Page 56 and 57: Sensitivity:Prescription/ routewith
Page 58 and 59: Appendix 3aLists of HA-wide Approve
Page 60 and 61: DRUGTeniposideABBREVIATIONVM-26Thia
Page 62 and 63: Appendix 3b“Do Not Use Abbreviati
Page 64 and 65: Appendix 4Schedule for the Administ
Page 66 and 67: Appendix 5Mechanism for the Managem
Page 70 and 71: Appendix 6HA Guideline on Safe Mana
Page 72 and 73: 2.1 Concentrated potassium chloride
Page 74 and 75: Appendix 7Supply of Antidotes and D
Page 76 and 77: 複本 Antidotes and emeg drug lis
Page 78 and 79: Appendix 8Guidelines for Supply of
Page 80 and 81: substitution with other drugs in ac
Page 82 and 83: Appendix 9Samples of the Line Label
Page 84 and 85: Appendix 10Guidelines on the use of
Page 86 and 87: Appendix 11Guidelines on Patient Se
Page 88 and 89: Operational Guidelines7. The operat
Page 90 and 91: COC(N) Paper 12/2004Approved by COC
Page 92 and 93: 7.4 Evaluation Record and report th
Page 94 and 95: DISPOSAL OF HOSPITAL PHARMACEUTICAL
Page 96 and 97: Appendix 14Guidelines on the Handli
Page 98 and 99: Appendix 15Medication Incident <str
Page 100 and 101: Hospital Authority Medication Incid
Page 102 and 103: QUALITY ASSURANCE IN DRUG THERAPYHO
Page 104 and 105: Fig. 1: ADR voluntary reporting sys
Page 106 and 107: PROCEUDRE FOR QUALITY COMPLAINTSONP
Page 108: Part II Procurement Section, CPO1.
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