The American Pharmacists Association (APhA) issued a letter to the Senate urging a vote against Senator McCain’s (R-AZ) proposed prescription drug importation amendment to the Prescription Drug User Fee Act (PDUFA). APhA supports the reauthorization of PDUFA, but cautions against proposed amendments that may increase patient’s access to harmful products and avoidable medication errors.
Brian Gallagher, BSPharm, JD, APhA Senior Vice President, Government Affairs, stated, “We sympathize with patients who are having a tough time with the price of their medicines, but importing drugs from a foreign country without the safeguards of our system could be harmful. Right now, Congress is grappling with ways to further prevent recent problems with drugs that were manufactured in foreign countries. The local pharmacist is already there to help patients take their medications in the most cost efficient way possible. They also provide the added expertise of working with physicians and patients to ensure that the need for medication adherence, avoidance of side-effects or drug interactions and achievement of optimal health outcomes are not out-weighed by cost considerations. If we allow individuals to bring in medications from other countries without the oversight of the FDA and American pharmacists, we threaten the safety of our drug supply and the very patients we aim to protect.”
APhA supports existing Federal law prohibiting prescription drug importation based on the following patient safety concerns:
- Neither the federal government, pharmacists nor the public have assurance that these products are safe, cost-effective, do not pose additional risk, or have been produced under US quality control requirements to protect against contamination. Imported products may be contaminated, sub-potent (not contain enough active ingredient), super-potent (contain too much active ingredient), or may not include any active ingredient.
- Patients who do not tell their local pharmacist and medical providers about their medications from a foreign country could find themselves with a drug-to-drug interaction between their imported and US approved medications.
- Because the US does not regulate foreign distributors, there are no quality assurances even when a US-made drug is imported. Once the product leaves the US regulatory system, the distributors are no longer held to requirements for storage conditions or product labeling.
- The actual appearance or name of some foreign medications is different from the US manufactured counterpart. This may delay treatment of adverse drug reactions or side effects if a healthcare provider cannot determine what the patient is taking.
APhA believes prescription drug importation would offer only short-term cost savings that may yield long-term costs. There are concerns not only with the quality and oversight for these medications, but of the fact that appropriate medication use requires an understanding of how to use the medication and monitoring for unwanted side effects or potential interactions.
Source: American Pharmacists Association