An evaluation of the integration of standards and guidelines in community pharmacy practices.

OBJECTIVE: To explore the usefulness and implementation of practice standards in community pharmacy practice regarding contemporary core services. SETTING: Community pharmacies in South East Queensland, Australia. METHOD: During August and September 2006 semi-structured interviews with community pharmacists explored practice processes and procedures and the utilisation of endorsed standards and guidelines. Thematic content analysis of the interviews, inductive analysis and continual comparison of categories and concepts enabled common and distinct themes to be clarified. MAIN OUTCOME MEASURE: Usefulness and integration of practice standards in the provision of core pharmacy services, utilisation of support staff, record keeping and overall risk management processes in community pharmacy. RESULTS: Seventeen community pharmacists participated, representing a wide range of demographics, experience and pharmacy types. Staff utilisation and record keeping practices were analysed as well as two core services, namely: (1) the supply of over-the-counter medicines, and (2) the dispensing of prescriptions. The procedures followed concerning the supply of over-the-counter medicines varied. The majority of participants did not regard this as a pharmacist's immediate role, but rather relied on support staff to identify when the supply required a pharmacist's intervention. Whilst all participants involved dispensary assistants in the dispensing process, the delegation of procedures differed. Most participants did not clearly differentiate between pharmacists' and dispensary assistants' activities. Dispensing processes and the involvement of pharmacists in the provision of patient advice varied. Pharmacist intervention record keeping was uncommon and records of 'near misses' were not routinely kept by any of the participants. CONCLUSION: A lack of integration of practice standards indicated a need to review the standards for relevance. Additionally, pharmacists need to re-evaluate workflow models and the delegation of tasks in the light of new roles and responsibilities.

Developments in pharmacists' disciplinary processes and outcomes.

Pharmacy disciplinary processes and outcomes protect consumers by deterring pharmacists from unacceptable practices and maintaining the reputation and standing of the pharmacy profession. It is important that pharmacists are informed of disciplinary processes and outcomes in order to predict what is regarded as unacceptable behaviour and the potential consequences thereof. Disciplinary procedures and outcomes also play an important role in maintaining public trust in the pharmacy profession and it is therefore important that the public has confidence in the disciplinary structure. The outcomes of pharmacy disciplinary cases that reflect the patient care role of pharmacists are particularly important in helping to determine pharmacists' changed professional responsibility and potential legal liability in the provision of these patient care services.

Pharmacy practice developments: the potential impact on pharmacists' legal liability.

The practice of pharmacy has changed over recent years with a greater emphasis on the patient and the provision of patient care services. This expanded role of pharmacists as medication managers has resulted in changes to their professional responsibility and potential legal liability. Recent international case law demonstrates an increased legal liability of pharmacists in certain instances. However, pharmacists' liability in this new context in Australia is yet to be clarified.

The use of myocardial and testicular end points as a basis for estimating a proposed tolerable daily intake for sodium monofluoroacetate (1080).

This paper presents the development of a tolerable daily intake (TDI) for sodium monofluoroacetate (1080) using the quantal myocardial and testicular toxicity end points derived from the traditional NOAEL and newer benchmark dose (BMD) methods. 1080 is a highly toxic vertebrate pesticide that has been proven to be effective in controlling possums and other pests. By convention, the TDIs are derived using the traditional no-observed-adverse-effect-level (NOAEL) and applying appropriate default uncertainty factors (UF). In addition to the default UF, a statistically derived UF was also employed in deriving the TDI. The TDIs derived from the NOAEL and BMD approach, 0.075 and 0.10 mg/kg bw/day, respectively, were compared. The resulting TDI estimates using the BMDL, a statistical lower confidence bound on the BMD, were generally consistently slightly higher than those derived using the NOAEL approach. Based on the best fit of modelled dose-response data, a TDI of 0.03 micro g/kg bw/day is proposed for human health risk assessment of 1080.

A benchmark dose analysis for sodium monofluoroacetate (1080) using dichotomous toxicity data.

The use of a benchmark dose (BMD) as an alternative to a no-observed-adverse-effect-level (NOAEL) approach was investigated as a means to improve current risk assessment values of sodium monofluoroacetate (1080). The feasibility of implementing the two approaches was investigated for three critical toxicological end points, namely cardiomyopathy, testicular toxicity and teratogenic effects identified from the few available critical studies. The BMD provides better representation of the dose-response relationship, offering an advantage over the current NOAEL approach. The calculated BMDs and lower-bound confidence limits (BMDLs) for the three end points were estimated using the Weibull, probit and quantal linear models for each end point. All models passed the chi2 test statistics (p > or = 0.1) for all three toxicity endpoints tested. A benchmark response (BMR) of 10% (extra risk) was chosen and the Akaike's information criterion (AIC) was used in selecting the appropriate model. The BMDL estimates derived were found to be generally slightly higher but comparable to the NOAEL for those same endpoints. The BMD(10) and BMDL(10) for cardiomyopathy and testicular effects were 0.21 mgkg(-1) bw and 0.10 mgkg(-1) bw, respectively. These values are proposed for use in the eventual determination of the tolerable daily intake (TDI) for 1080.