AMA PCM Exam - Topic 1 Question 67 Discussion

Actual exam question for AMA's PCM exam

Question #: 67
Topic #: 1

Saleye Pharmaceuticals develops cheaper alternatives to proprietary drugs. Its mission statement states that it wants to create affordable medicine for everyone and create a healthier world. Saleye releases a new and improved version of its pain-relieving drug, Fento. Within a week, Saleye receives many complaints stating that the drug is inducing hallucinations and in some cases triggering certain anxiety disorders. Saleye was caught off-guard as its animal and human trials did not reveal any side effects. Saleye deliberated over the decision to recall the drug for over a week and by the time it eventually did, it had lost millions in stocks. Where did Saleye fail?

AIt did not have an ethical mission statement.

BIt did not have control measures in place.

CIt did not consider the target market before creating its drug.

DIt prioritized profits over effective drugs.

EIt did not conduct large-scale human trials.

Show Suggested Answer

Suggested Answer: D

by Judy at Mar 23, 2023, 08:37 AM

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Merissa

7 months ago

Their mission statement sounds good, but actions speak louder!

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Fanny

7 months ago

They lacked proper control measures for sure.

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Geraldo

7 months ago

Hallucinations? That sounds a bit extreme...

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Chu

7 months ago

I think they prioritized profits over safety.

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Willodean

7 months ago

They definitely should've done larger trials!

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Roxanne

8 months ago

I wonder if they considered the target market before creating the drug. If they had, maybe they would have anticipated the potential for anxiety disorders in certain users.

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Kati

8 months ago

I feel like they prioritized profits over effective drugs. Their mission statement sounds good, but the delay in recalling Fento suggests they were more focused on financial loss than patient safety.

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Tamra

8 months ago

I'm not entirely sure, but maybe they didn't have control measures in place? I remember a case study that emphasized the importance of monitoring drug effects post-launch.

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Latrice

8 months ago

I think Saleye might have failed because they didn't conduct large-scale human trials. It seems like a crucial step that could have caught those side effects earlier.

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Hildred

8 months ago

I thought their mission statement was solid, but maybe it didn’t translate into their practices. It’s confusing how they missed these issues during trials.

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Janessa

8 months ago

This reminds me of a case study we did on a similar situation where a company prioritized profits. I wonder if that played a role in Saleye's decision-making.

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Yen

8 months ago

I’m not entirely sure, but I think they might have underestimated the need for large-scale human trials. That could explain the unexpected side effects.

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Lashawnda

8 months ago

I remember discussing the importance of control measures in drug development. It seems like Saleye really dropped the ball there.

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Charlette

8 months ago

I'm not totally sure about this one. I'll need to review the concepts around translation patterns and route patterns before deciding.

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Emiko

8 months ago

Hmm, I'm a bit unsure about this one. The options seem to cover different aspects of customer success, but I'm not sure which one is the "best" summary. I'll have to think this through.

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Douglass

8 months ago

If I recall correctly, the 0.0.0.0 address means any IP can connect, which is broader than just one specific IP like 1.2.3.4. But I'm not completely confident in that.

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Quentin

1 year ago

I think the answer is B - Saleye didn't have the proper control measures in place to catch these serious side effects before releasing the drug. Their animal and human trials were clearly not comprehensive enough.

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Leota

11 months ago

C) It did not consider the target market before creating its drug.

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Scot

12 months ago

B) It did not have control measures in place.

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Fabiola

12 months ago

A) It did not have an ethical mission statement.

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Sena

1 year ago

Haha, 'a healthier world'? More like a world of hallucinating patients! Saleye needs to go back to the drawing board and remember that 'affordable' doesn't mean 'cutting corners'.

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Sharan

11 months ago

C) It did not consider the target market before creating its drug.

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Brandon

11 months ago

B) It did not conduct large-scale human trials.

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Leota

1 year ago

A) It did not have control measures in place.

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Marge

1 year ago

This is a classic case of prioritizing profits over safety. Saleye should have put the wellbeing of patients first, instead of rushing an untested drug to market. Their mission statement rings hollow now.

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Mitzie

12 months ago

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Tegan

12 months ago

B) It did not conduct large-scale human trials.

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Tasia

1 year ago

A) It did not have control measures in place.

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Brandon

1 year ago

Saleye clearly dropped the ball on quality control and testing. Skimping on large-scale human trials was a huge oversight, and their greed for profits blinded them to the real-world consequences.

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