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Among the myriad interventions pharmacists make every day in relation to prescriptions are calls to clinicians concerning the appropriateness or safety of a prescribed medicine for a particular patient. Pharmacists may need to raise concerns with prescribers about individual prescriptions, which may result from isolated errors, omissions or misunderstandings on the part of the prescriber, and also when they recognize a pattern of inappropriate, erroneous or unsafe prescribing, which may signal a clinician’s substandard practice or lack of competence.
Responsibilities of pharmacists
Pharmacists’ obligations to protect the health and safety of members of the public are set out in legislation and in standards of practice. The Pharmacy Council’s Code of Ethics requires that pharmacists act on concerns about a colleague’s competence where patient safety may be at risk (Obligation 3.10). Section 34(1) of the Health Practitioners Competence Assurance Act 2003 (HPCAA) provides that a health practitioner may notify the relevant authority if another health practitioner poses a risk of harm to the public by practising below the required standard of competence.
In June 2005, HDC received a complaint concerning a baby who had been admitted to hospital with acute dystonic symptoms that appeared to be the result of an overdose of Maxolon (05HDC07953 www.hdc.org.nz, see Pharmacy Today May 2007). Investigation into the complaint revealed the drug overdose was the cumulative effect of errors by both the doctor who prescribed the medicine and the pharmacist who dispensed it. Both practitioners were found to be in beach of the Code of Health and Disability Services Consumers’ Rights.
The investigation also revealed that staff at the pharmacy had been concerned for some time by the prescribing practices of the doctor, who was an international medical graduate working under supervision. The pharmacy’s Intervention Report recorded a number of occasions where staff had contacted the doctor regarding individual prescriptions, including inappropriately high doses of Maxolon for children. The pharmacy manager had alerted staff to be vigilant for any anomalies with prescribing, and all pharmacists were asked to keep copies of scripts where they had intervened. At the time of this incident, the pharmacy manager was “building the portfolio” of interventions so as to be “very certain” of her concerns before taking action, and had not yet discussed the issue of the doctor’s prescribing with her supervisor. The Commissioner commented that being “very certain” is an unduly high standard of the concern needed before a pharmacist has an ethical duty to act.
When to act
How much evidence of substandard practice is required to warrant a practitioner to formalise his or her concerns? Practitioners are often reluctant to raise concerns about their colleagues, and cases investigated by HDC suggest they will take action only when they have a significant level of concern or ample evidence (as in the case above). However, this may be an unduly high standard. Where a provider has reason to believe that another practitioner may pose a risk of harm to the public by unsafe prescribing, there is an ethical and legal duty to act (see HPCAA, s 34(1) and HDC Code, Right 4(2)). Definitive proof of poor performance is not required. If concerns have been raised (even informally) about an individual’s practice, then all reasonable attempts should be made to ascertain the validity of those concerns (eg, by an audit of past interventions), and any unsafe practices should be addressed without delay. Criticism may be levelled at practitioners who do not act promptly to follow up concerns.
Right 4(4) of the Code of Health and Disability Services Consumers’ Rights states that consumers have a right to services that minimize the potential harm to that consumer. A pharmacist who queries an individual prescription with a prescriber and is not satisfied with the response, and remains concerned about patient safety, may decline to dispense the medicine.
Patient safety depends not only on the recognition of isolated incidents, but on the appreciation of an emerging pattern of poor practice. Systems should be in place to monitor recorded interventions so that recurring incidents of poor practice are revealed. Concerns should be resolved locally in the first instance, in a constructive way. If no effective action results, practitioners should communicate concerns according to the Pharmacy Council’s Code of Ethics Obligation 3.10 — to a Medicines Control Advisor or the Medical Officer of Health.
Pharmacists who have concerns about a prescription have a responsibility to query it with the prescriber. If pharmacists become aware of recurring problems with prescribing, raising concerns that the competence of their colleague poses a risk of harm to the public, they need to act without delay. If they fail to do so, their own actions may become subject to scrutiny.
Pharmacy Today, June 2008