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Pharmacy Act, 1974 (Act No. 53 of 1974)

Board Notices

Rules Relating to Good Pharmacy Practice

Chapter 2 : Professional Standard for Services

2.11 Minimum Standards for Clinical Pharmaceutical Services in Institutional Pharmacies

 

2.11.1 Introduction

 

Clinical pharmacy is concerned with the application of pharmaceutical expertise to help maximise drug efficacy and minimise drug toxicity in individual patients. Clinical pharmacy can be separated into two components. The first is the overall management of medicines in the ward through advice on safe handling and formulary management. The second is the contribution to the care of the individual patient through the provision of drug information and assistance in problem solving.

 

2.11.2 Ward pharmacy services

 

Ward pharmacy is a patient-orientated, decentralised service where the pharmacist becomes an integral and indispensable part of the professional health team of the hospital/institution.

(a) Ward pharmacists must utilise their knowledge and skills of pharmaceutical sciences and product awareness to promote safety, efficacy and economy in the use of medicines.
(b) Ward pharmacists must offer advice to clinicians and nurses on appropriate medication to ensure that medicines are used correctly and in the appropriate therapeutic context.
(c) The responsible pharmacist must co-operate with clinicians in determining the minimum number of ward rounds to be attended to ensure that the ward pharmacist has a full appreciation of the clinical context in which advice on the use of medicines is given.
(d) Ward pharmacists should participate in specialist care teams.
(e) Close involvement with decisions on therapy will bring the pharmacist closer to the patient and provide opportunities for advising patients on self-administration of medicines.
(f) Where a local formulary is in operation the ward pharmacist in close co-operation with other health care professionals is responsible for ensuring that all new treatment prescribed takes account of the recommendations of the formulary.
(g) Ward pharmacists must provide a patient counselling service where the need arises.
(h) In order to safeguard the patient and ensure that documents relating to prescribing and administration remain at ward level, a prescription monitoring service must be provided. It should be tailored to the individual needs of patients on each type of ward.

 

2.11.3 Prescription monitoring

 

The purpose of prescription monitoring is to help ensure that patients receive drug treatment as intended by the prescriber and as required for optimal care. Prescription monitoring is a component of, and not a substitute for, the assessment of patients to identify patient and medication risk factors. Through prescription monitoring, the pharmacist must identify problems or opportunities for optimising treatment.

(a) A multi-disciplinary approach must be followed regarding the monitoring of prescriptions.
(b) The prime objective of this service is to safeguard the patient and ensure the optimal use of medicine. Potential problems must be communicated to the prescriber and resolved preferably before the medicine is dispensed or the first dose is administered.
(c) Use should be made of all information available, including that contained within the patient's notes, obtained on ward rounds, by direct communication with the patient, the prescriber and/or other health care professionals.
(d) Potential medicine-related problems must be discussed with the clinician(s) and suitable advice relating to alternative treatment should be offered. The frequency of monitoring should be determined according to the patient's condition and the nature of medicines prescribed.
(e) The occurrence of any problems relating to the use of medicines must be documented by a pharmacist, clinician or nurse and must become a permanent record in the patient's notes. Confidentiality must be respected at all times.
(f) Prescriptions must be evaluated for the following reference materials:
(i) legality, legibility and completeness;
(ii) relative efficacy of the medicine for the clinical indication;
(iii) duplication of pharmacologically similar drugs;
(iv) potential adverse reactions to medicines, including allergies;
(v) possible drug/disease incompatibilities;
(vi) significant drug/drug interactions;
(vii) correct dosage, route, dosage interval and duration of treatment;
(viii) appropriate dosage form and route of administration;
(ix) problems relating to intravenous administration, including potential incompatibilities, medicine stability, volume of intravenous fluid for medicine administration and rate of administration;
(x) compliance with any applicable formulary/treatment guidelines, e.g. appropriate EDL/STG.
(g) Patients and their medicine therapy must be monitored for the following:
(i) the manifestation of adverse reactions or drug toxicity. The pharmacist should attempt to detect these adverse effects at an early stage. Any recognised reaction or adverse effect whether possibly or definitely drug-related, must be investigated and reported according to the guidelines published by the MCC;
(ii) possible altered kinetics of drug absorption, distribution, metabolism or excretion which may affect therapy. This may include the interpretation of pharmacokinetic laboratory data and utilisation of the data to establish an appropriate dose. If necessary, recommendations should be made regarding the need for blood concentration monitoring of certain drugs and the critical relationship between the time of administration and the collection of the blood samples;
(iii) the appropriate duration of therapy;
(iv) administration errors and omissions;
(v) drug/laboratory test interference;
(vi) drug/food interactions;
(vii) drug/drug interactions;
(viii) additional medication which may be needed for optimum response or prevention of adverse effects; and
(ix) the patient's response to therapy to determine if it is adequate or excessive in relation to the desired therapeutic endpoint.
(h) Patients with special problems likely to affect therapeutic efficacy of medicines, will require more intensive monitoring, according to the following criteria:
(i) patients whose age, weight, clinical state or condition may affect drug absorption or disposition, alter dosage requirements or predispose the patient to adverse reactions or drug toxicity;
(ii) patients taking medicines known to have a high risk of toxicity and a narrow therapeutic index;
(iii) patients taking medicines which may interact;
(iv) patients taking an investigational medicine;
(v) patients whose therapy is changed frequently; and
(vi) patients receiving intravenous therapy.
(i) Monitoring schedules must be set at a frequency suitable for the patient mix and prescribing practice.
(j) All pharmacists monitoring prescriptions must be able to provide appropriate information on request using local or other information sources.

 

2.11.4 Provision of drug information and advice

 

The purpose of this service is to ensure that appropriate advice is available timeously to meet the requirements of health care professionals. The advice could range from the rational choice of medicines within a particular class of drugs in order to support formulary review, to the selection of an appropriate dosage regimen for an individual patient.

 

If a drug information service is established within the hospital, it must be maintained and developed in conjunction with other established drug information centres. This service must take cognisance of the specific needs of the hospital personnel and patients. If a drug information service is established, it must comply with the standards as set out hereunder.

 

2.11.4.1 Minimum requirements for a drug information service

 

(a) Allocated space should be sufficient for reference collection and provision of the service.
(b) Minimum essential furniture and equipment including a dedicated telephone, computer and lockable filing cabinets must be available.
(c) The unit should maintain a current collection of reference materials appropriate to the scope and nature of the service provided. These references should include books, journals, drug profiles, relevant formularies and manufacturers' information.
(d) The unit should have access to at least one secondary reviewed and referenced literature source.
(e) A system for consultation with specialists in the various fields for problem cases is necessary.
(f) Access to a medical library with an inter-library loan facility is recommended.
(g) Access to other drug information centres, including specialised centres, is necessary for:
(i) handling of enquiries beyond the unit's scope;
(ii) providing access to appropriate computer-based information; and
(iii) providing access to a medical library with an inter-library loan facility.
(h) Adequate personnel for the size of the institution and the number of enquiries must be employed.
(i) The personnel must develop and maintain a current Standard Operating Procedure manual outlining procedures appropriate to the services provided.
(j) The service must be available during normal pharmacy hours. If provided, a toxicology service must be available 24 hours a day.
(k) Methods must be in place for:
(i) the receiving, researching, answering, referencing, logging and storing of medicine information queries;
(ii) a patient counselling service;
(iii) publication of a bulletin or newsletter directed at identified drug-related problem areas of that specific hospital;
(iv) reporting adverse drug events;
(v) providing statistical analyses of enquiries;
(vi) research and retrieval of new data and previously researched and answered queries;
(vii) filing of collected material and product information;
(viii) providing verbal and written responses to queries;
(ix) continuing education of pharmacists and other personnel of the hospital/institution; and
(x) quality assurance.