October 26, 2016

Monica Bharel, M.D., MPHCommissionerDepartment of Public Health250 Washington St.Boston, MA 02108-4619

Re: Serious Incident Reporting (105 CMR 130.331) and Chapter 159 of the Acts of 2014

Dear Commissioner Bharel:

The Massachusetts Society of Health-System Pharmacists (MSHP), on behalf of our membership, appreciates the opportunity to submit comments on the proposed amendments to the Department of Public Health (DPH) hospital licensure regulations, in particular the Serious Adverse Drug Event reporting regulations.

While we believe the proposed changes are helpful and well-intentioned, we are concerned with these proposed changes in two specific areas: 1) the proposed changes expand/increase hospital reporting and hospital notifications that are duplicative, costly, and provide no additional value to the healthcare system; and 2) the terminology used in the proposed regulations is not based on terms used in national, or even local, standards or practice.

Attached please find our detailed set of comments, requested clarifications, and suggested amendments to various terms and requirements outlined in the proposed regulations. We support these changes to ensure that healthcare providers are best able to effectively improve their services and facilities in a manner consistent with state and federal healthcare reform implementation and delivery system innovation goals to reduce administrative burdens while promoting simplification.

If you have any questions about our comments, please do not hesitate to contact me at (617) 264-5849 or dseaver@partners.org.

Sincerely,

David E. Seaver, RPh, JD.Legislative Committee ChairmanMassachusetts Society of Health-System Pharmacists

Serious Incident and Accident Reports (105 CMR 130.331)

MSHP is very concerned with the proposed changes in 130.331(C) and (E), which seeks to remove Serious Reportable Events (SRE) and adds in Serious Adverse Drug Events (SADE) to the serious incident requirements. The actual SRE report is part of the serious incident reporting structure and reporting system and therefore should continue to be incorporated in the overall process. It does not make sense as to why the state is decoupling these requirements and removing the reference of SRE but adding in a reference to SADE within this section. We would request that SRE be added back as a reference as currently provided in the regulations.

Serious Reportable Event (SRE) and Serious Adverse Drug Events (SADE) (105 CMR 130.332)

MSHP fully supports the various operational changes that are proposed for SREs within 130.322 (B) and (C) as it actually removes unnecessary administrative reporting that only contributed to patient and insurer confusion, duplicative reporting, and increased resources with no measurable outcomes.

MSHP further requests that DPH consider a few technical corrections and develop further guidance on the new language related to Serious Adverse Drug Events (SADE). In particular, MSHP is concerned with the new definition of an SADE as outlined in 130.322(A). Specifically, the definition includes reporting on occurrences related to all controlled substances. Massachusetts law defines controlled substances to include drugs within a Schedule I through VI drug. The number of drugs that this could impact as well as the number of reports that would be filed would run counter to the goal of Chapter 159 of the Acts of 2014 as well as the governor’s executive order of administrative simplification. Chapter 159 in particular was developed for identifying adverse events related to compounded drugs issued from non-institutional pharmacies. We urge DPH to consider including within the definition that the term “controlled substances” reflects a specific subset of high-risk drugs, such as a compounded drug within a Schedule II through IV that are not provided from an institutional pharmacy.

In addition to the changes in the definition, we also request that DPH consider the following changes within 130.332(E), which outlines the criteria for reporting an SADE to DPH:

1) Subpart (E)(1), requires that a medication error that occurs on the premises of a hospital must be reported within 7 days to DPH. We are very concerned that this provision is a direct contradiction of the requirements of Chapter 159 of the Acts of 2014. The purpose of the law was to ensure reporting and appropriate notice to all affected parties when a hospital identifies that a patient is being treated for a condition caused by a drug that was compounded/manufactured from outside the hospital. It is important to note that the law was developed as a result of the patient safety violations by Ameridose and the New England Compounding Center for drugs that were distributed to patients on an outpatient basis. The intent was never to require a reporting of medication errors that are the result of drugs developed within a hospital (as that would fall under other reporting requirements). Instead, the goal was to ensure that the hospital community is reporting all patient harm that is caused by inappropriate drug manufacturing by non-institutional pharmacies. To that end, we request the following clarifications to (E)(1):

a. Within seven days of the treatment of a patient whose condition was caused by a medication error from a non-institutional pharmacy, a hospital shall report this as an SADE to the Department as specified in guidelines of the Department.

2) Subpart (E)(2), would require a hospital to submit a duplicative SADE and SRE report on the same incident. This would go against the goal of the governor’s executive order for removing duplicative reporting requirements. To that end, we request that DPH remove the word “also” as it appears the second time in the sentence and replace it with “instead”. If an SADE is identified, then the hospital should only be following the SRE reporting requirements for the Department and not complete two separate reports on the same incident.

3) In subpart (E)(4), DPH is planning to require a new fine and hospital licensure revocation if there is a delay or failure to submit one of the SADE reports in this section. We are very concerned with the strict nature of this provision and the lack of a mechanism to work with a provider to ensure reporting is done in a timely manner. As the state is aware, the number of reporting requirements has increased exponentially and there is no way that any one staffer in a large or small hospital can keep up with every requirement. However, while staff is doing their best, if they miss a reporting requirement then the state should at least try and work with a provider before taking such a harsh and unrealistic position. A hospital is not like many companies where revocation of license has limited impact; this provision would significantly impact the health and welfare of several communities due to what may very well be simple mistakes in missing a reporting deadline or requirement. Further, there is nothing in Chapter 159 of the Acts of 2014 that supports a hospital’s license being revoked or fined for failure to report. There is no similar requirement in the SREs provision, so we are confused as to how this was included in the hospital licensure requirements.