key: cord-0997713-grebd0od authors: Lynch, Matthew; O'Leary, Aisling title: COVID-19 related regulatory change for pharmacists – The case for its retention post the pandemic date: 2020-08-22 journal: Res Social Adm Pharm DOI: 10.1016/j.sapharm.2020.07.037 sha: 3db20e37687295cc61a383164929167ec4661989 doc_id: 997713 cord_uid: grebd0od The delivery of healthcare including the provision of pharmacy services globally is highly regulated internationally in order to protect public health and welfare. However, the onset of the COVID-19 pandemic has precipitated the need internationally to amend the model of regulation in order to ensure that people were able to continue to access a range of healthcare services in a timely and effective manner. Many of the changes introduced to the regulation of pharmacy services in Ireland have been replicated in other countries including the introduction of electronic means to transmit prescriptions and other orders for medications, relaxing the legal restrictions in place controlling the emergency supply of prescription only medicines and more fully utilizing the professional competency of pharmacists by empowering them to use their expertise and judgment to support their patients accessing the healthcare services that they need. Many of the regulatory changes that have been introduced to support the COVID-19 public health emergency effort are ones that pharmacists have previously sought to enable them provide a more effective and expanded model of pharmaceutical care to their patients. Accordingly, many pharmacists will want these regulatory changes to be retained and further expanded in the aftermath of the COVID-19 public health emergency in order to extend their scope of practice and support them in the care of their patients. reactionary, dynamic and innovative to ensure patients continued to have access to their 114 medicines. Governments responded to ensure that deviations from the existing legal 115 requirements regulating the supply of medicines were not necessitated by introducing changes 116 to the legal frameworks regulating the provision of medications in the primary care setting, to 117 ensure and prioritize seamless supply to patients. in March 2020(32). This wide-ranging Act introduced provisions to address issues related to the 128 pandemic including the operation of residential tenancies, planning and development and the 129 introduction of a temporary wage subsidy. In order to address shortages in key frontline 130 healthcare personnel as a result of the pandemic, it also included provisions to allow healthcare usual fee payable by those previously registered pharmacists applying to be restored to the Register of Pharmacists was waived for those applying under the newly introduced Section 77. 139 The PSI has confirmed that a total of 38 pharmacists were restored to the Register of 140 Pharmacists under Section 77 to the 30 th June 2020. The period of registration for any 141 pharmacist re-registered under Section 77 of the Pharmacy Act is due to expire on 31 st July 142 2020. However, the Minister for Health is empowered under the Emergency Measures Act to 143 extend that date by Ministerial order. 144 Changes to the supply of medicines 145 The sale and supply of medicines in Ireland is primarily regulated by two sets of Regulations as Table 2 . 188 A summary of the changes to the regulations were provided to all community pharmacists by The public health emergency that presented with COVID-19 required national governments across the world to rapidly introduce a range of regulatory measures to address not only its 193 containment, but to make appropriate provision for its citizens whose ability to engage in 194 normal daily activities such as working and obtaining essential supplies were severely curtailed. 195 In Ireland, the introduction of the Emergency Measures in the Public Interest (COVID-19) Act in 196 March 2020 was a key legislative response in this regard making appropriate provision in areas 197 as diverse as residential tenancy agreements, temporary wage subsidies for those whose Agility (48) (49) (50) . In summary, the model of regulation and its implementation by PSI was not 306 perceived overall by community pharmacists as fulfilling the principles of better regulation. While there was agreement that the Act and associated regulation was necessary, its implementation by the PSI was not viewed as being effective, targeted, proportional and 309 consistent. The Act was not sufficiently agile to respond to changes in pharmacy practice. 310 In terms of fulfilling the principles of "better regulation", the amendments to both the 311 Medicinal Products and Misuse of Drugs Regulations can be reasonably considered to fulfil the 312 "better regulation" principles of: necessity; effectiveness/targeted; proportionality and agility. 313 As the public health emergency unfolded, the changes were necessary in order to ensure the 314 continuity of supply of medicines to patients. They are effective insofar as they are 315 appropriately targeted at maintaining the medicines supply chain and proportional in that there 316 does not appear to have been an alternative regulatory approach available to achieving the 317 required public health outcome. Agile regulation is concerned with being able to look forward 318 to the future and being able to anticipate change and adapt accordingly (50) . As reported by 319 Merks et al, the range of regulatory changes introduced internationally in the sphere of 320 pharmacy practice alone together with the various legislative changes in Ireland in response to 321 the emergence of the COVID-19 pandemic epitomize the concept of agility in regulation (40) . 322 However, agile regulation heretofore has not been perceived as a feature of the regulation of May be dispensed on three further occasions where in the opinion of the pharmacist it is appropriate and necessary for the continued treatment of the person for further supplies to be made May be dispensed on the no. of occasions indicated on the prescription at such intervals as the pharmacist considers appropriate having due regard to the specified dose rate up the expiry of the prescription 6 months from the date specified thereon May be supplied by the pharmacist for up to 6 months from the date specified on the prescription as the pharmacist considers appropriate having regard to the specified rate of dosage. May be supplied by the pharmacist for up to 6 months from the date specified on the prescription at the intervals stated on the prescription May be supplied for the specified number of occasions at such intervals that the pharmacist considers appropriate, having regard to the specified dose rate and period of validity of the prescription (6 months from the date specified thereon) No further supplies could be made by the pharmacist ii. An emergency supply (unlimited quantity) of the following drugs listed in Schedule 3 of the Misuse of Drugs Regulations could be supplied for the treatment of epilepsy: phenobarbitone, phenobarbitone sodium and methylphenobarbitone. When fear and misinformation go viral: Pharmacists' role in deterring medication misinformation during the "infodemic" surrounding COVID-19 How to Fight an Infodemic: The Four Pillars of Infodemic Management Social Media Spread During Covid-19: The Pros and Cons of Likes and Shares The Lancet Infectious Diseases. 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