The Department of Health (DH) has launched its long-awaited consultation on decriminalising dispensing errors.
Community pharmacy professionals who make an inadvertent dispensing error will no longer face criminal sanctions if the DH goes ahead with its proposed changes to the law, announced yesterday (February 12).
In its consultation, originally scheduled for January 2014, the DH said that a pharmacy professional or unregistered member of staff should have a defence against a criminal sanction for an inadvertent error if they met "strict conditions". These included showing they had acted “in the course of [their] profession”, had made a supply on the back of a prescription or patient group directive, and “promptly” informed the patient about the error once discovered, it said.
Criminal sanctions should only apply if there was proof "beyond reasonable doubt" that the pharmacist had either misused their professional skills "for an improper purpose" or shown "a deliberate disregard for patient safety", the DH said. Failing to follow the pharmacy's procedures would not constitute grounds for criminal proceedings on its own, it stressed.
Removing the threat of criminal sanctions for inadvertent errors would address a "significant fear among pharmacy professionals” that was inhibiting error reporting, the DH said. “Ultimately this change should support increased reporting and learning from errors, thereby improving patient safety and promoting better professional practice,” it said.
The DH also suggested removing the need for the General Pharmaceutical Council (GPhC) to put its premises standards into legislative rules. This should support the regulator's aim to take an "outcomes-based" approach rather than an “inflexible" one, it said.
This would prevent pharmacy owners from seeing standards as a "checklist" and encourage them to "consider how best to meet standards [and] focus on the needs of patients", the DH said.
Standards for registered pharmacies should also become the sole responsibility of the pharmacy owner, rather than the superintendent, the DH said.
If passed, the changes would be brought in as two orders under section 60 of the Health Act, the DH said. They formed part of broader plans to “rebalance” medicines law so that relevant issues were dealt with by pharmacy regulators rather than the criminal courts, the DH said.
Ken Jarrold, chair of the board set up to rebalance medicines legislation, said the proposals were of “great importance” to pharmacy professionals, and urged them to give the consultation “serious consideration”.
It is not yet known when the proposals will come into force. Although the new legislation was originally due to come in this year, last month PSNC suggested it could take until 2016.
Pharmacists have until May 14 to respond to the consultation online. The views of the public and stakeholders were “critically important”, said the DH, which published details of a series of consultation events it was hosting in March on its consultation web page.