Clarification on Tramadol Dispensing Requirements
The Ministry of Health has clarified the formalities required for dispensing tramadol-based medications intended for use other than parenteral administration, prescribed on a “white prescription” (i.e., at the patient’s expense). Specifically, these requirements align with those for medications listed in Section D of the drug table.
This clarification follows a request from the ASP of Trapani regarding information on tramadol-based medications for use other than parenteral administration, as listed in the Table of Medicines Section D, Annex III bis, prescribed at the patient’s expense. Federfarma had also raised concerns about the possibility of these medications creating “difficulties for users in a particularly sensitive healthcare area, such as pain therapies.”
Pharmacist Obligations: Operational Guidance
Pharmacists must adhere to the obligations outlined in Article 45, paragraph 6-bis, of DPR 309/90. This includes noting the buyer’s full name and identification document details on the prescription. The pharmacist must then retain a copy or photocopy of the prescription for two years, starting from the date of last registration. This practice ensures the pharmacist can demonstrate the legal possession of the dispensed medication to the patient or designated recipient.
Addressing Lingering Uncertainties and Best Practices to Avoid Disputes
Communication from the union emphasizes that the doubt surrounding the applicability of these provisions stemmed from the belief that they initially applied to drugs transitioning from Section A to D in 2009, both temporarily and permanently through law 38/2010, which modified Presidential Decree 309/90. If the aforementioned rule had intended to apply generally to all medications within Section D, it wouldn’t have specified “medicines included in Section D of the medicines table after 15 June 2009.”
The union highlights that local health authorities have consistently requested application of these formalities when dispensing such medications. In light of the Ministerial Decree of July 29th, 2022, which updated drug tables by including tramadol in Annex III-bis, health companies may raise objections regarding the implementation of the Ministerial Decree itself.
Therefore, the advice to pharmacies is to strictly follow the instructions issued by local health authorities, recognizing their institutionally mandated role in supervising narcotic medications.
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How does the Ministry of Health’s clarification on tramadol dispensing align with the DEA’s regulations and recommendations for prescribing, administering, and dispensing controlled substances as outlined in the Practitioner’s Manual? [[1]](https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-071)(EO-DEA226)_Practitioner’s_Manual_(final).pdf)
## Interview: Clarifying Tramadol Dispensing Requirements
**Interviewer:** Welcome to the show. Today, we’re discussing recent clarifications made by the Ministry of Health regarding the dispensing of tramadol-based medications. With us is [Guest Name], a practicing pharmacist who can shed light on these new guidelines.
**Guest:** Thanks for having me.
**Interviewer:** Firstly, what prompted these clarifications from the Ministry of Health?
**Guest:** Well, there was some ambiguity surrounding the dispensing of tramadol medications intended for non-parenteral use, specifically those prescribed on “white prescriptions” meaning the patient pays out of pocket. The ASP of Trapani requested clarification, and Federfarma raised concerns about potential issues for patients needing pain management.
**Interviewer:** So, what are the key changes pharmacists need to be aware of?
**Guest:** Essentially, the Ministry clarified that these tramadol medications should be dispensed following the same requirements as those listed in Section D of the drug table. This means pharmacists need to carefully record the patient’s full name and identification details on the prescription, and keep a copy for two years. This ensures proper documentation and accountability, as outlined in Article 45, paragraph 6-bis, of DPR 309/90.
**Interviewer:** Why is this clarification important, especially for patients relying on these medications for pain relief?
**Guest:** The clarification removes uncertainty for both pharmacists and patients. It guarantees clear guidelines on how tramadol can be dispensed, ensuring those who need it for pain management can access it without undue difficulties while maintaining necessary regulations and controls.
**Interviewer:** Thank you for providing your expertise on this important topic. We appreciate your time.